Jasmine medicinal properties and contraindications. Yasminasmin Yasmin tablets reviews

Last updated description by manufacturer 23.09.2015

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Active substance:

ATX

Pharmacological group

Nosological classification (ICD-10)

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Composition

Description of the dosage form

Film-coated tablets, light yellow, engraved on one side with a hexagon with the letters "DO" inside.

pharmachologic effect

pharmachologic effect- contraceptive, estrogen-progestational.

Pharmacodynamics

Yarina ® is a low-dose monophasic oral combined estrogen-gestagenic contraceptive drug.

The contraceptive effect of Yarina ® is mainly carried out by suppressing ovulation and increasing the viscosity of cervical mucus.

The incidence of venous thromboembolism (VTE) in women with or without risk factors for VTE, using ethinyl estradiol / drospirenone-containing oral contraceptives at a dose of 0.03 mg / 3 mg, is the same as in women using levonorgestrel-containing combined oral contraceptives or other combined oral contraceptives ... This was confirmed in a prospective, controlled database study comparing women using oral contraceptives 0.03 mg ethinylestradiol / 3 mg drospirenone with women using other combined oral contraceptives. Analysis of the data revealed the same risk of VTE among the sample.

In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful menstrual bleeding is less common, the intensity and duration of bleeding decreases, as a result of which the risk of iron deficiency anemia decreases. There is also evidence of a reduced risk of endometrial and ovarian cancer.

Drospirenone contained in Yarin® has an anti-mineralocorticoid effect and is able to prevent weight gain and the appearance of other symptoms (eg edema) associated with estrogen-dependent fluid retention. Drospirenone also has antiandrogenic activity and helps to reduce acne (blackheads), oily skin and hair. This effect of drospirenone is similar to that of the natural progesterone produced by the female body. This should be taken into account when choosing a contraceptive, especially for women with hormone-dependent fluid retention, as well as for women with acne (acne) and seborrhea. If used correctly, the Pearl index (an indicator reflecting the number of pregnancies in 100 women using contraceptives during the year) is less than 1. If pills are missed or misused, the Pearl index may increase.

Pharmacokinetics

Drospirenone

When taken orally, drospirenone is rapidly and almost completely absorbed. After a single oral administration, C max of drospirenone in serum, equal to 37 ng / ml, is achieved after 1-2 hours. Bioavailability ranges from 76 to 85%. Food intake does not affect the bioavailability of drospirenone.

Drospirenone binds to serum albumin (0.5-0.7%) and does not bind to sex hormone binding globulin (SHBG) or corticosteroid binding globulin (CABG). Only 3-5% of the total concentration in the blood serum is in free form. The increase in SHBG induced by ethinylestradiol does not affect the binding of drospirenone to plasma proteins.

After oral administration, drospirenone is completely metabolized.

Most of the metabolites in plasma are represented by acidic forms of drospirenone, which are formed without the involvement of cytochrome P450.

The concentration of drospirenone in blood plasma decreases in 2 phases. Drospirenone is not excreted unchanged. Drospirenone metabolites are excreted by the kidneys and through the intestines in a ratio of approximately 1.2-1.4. T 1/2 for the excretion of metabolites in urine and feces is approximately 40 hours.

During cyclic treatment, the maximum equilibrium serum concentration of drospirenone is reached in the second half of the cycle.

A further increase in the serum concentration of droperinone is noted after 1-6 cycles of administration, after which an increase in concentration is not observed.

In women with moderate hepatic impairment (class B on the Child-Pugh scale), AUC is comparable to the corresponding indicator in healthy women with similar C max values ​​in the absorption and distribution phases. T 1/2 of drospirenone in patients with moderate hepatic dysfunction was 1.8 times higher than in healthy volunteers with intact liver function.

In patients with moderate hepatic dysfunction, there was a 50% decrease in drospirenone clearance compared with women with intact liver function, while there were no differences in the concentration of potassium in the blood plasma in the studied groups. When diabetes mellitus is detected and the concomitant use of spironolactone (both conditions are regarded as factors predisposing to the development of hyperkalemia), an increase in the concentration of potassium in the blood plasma has not been established.

It should be concluded that drospirenone is well tolerated in women with mild to moderate hepatic impairment (class B on the Child-Pugh scale).

The concentration of drospirenone in blood plasma upon reaching an equilibrium state was comparable in women with mild renal impairment (Cl creatinine - 50-80 ml / min) and in women with intact renal function (Cl creatinine -> 80 ml / min). Nevertheless, in women with moderate renal impairment (Cl creatinine - 30-50 ml / min), the mean plasma concentration of drospirenone was 37% higher than in patients with intact renal function. Drospirenone was well tolerated by all groups of patients. There was no change in the concentration of potassium in the blood plasma with the use of drospirenone.

Ethinylestradiol

After oral administration, ethinyl estradiol is rapidly and completely absorbed. C max in blood plasma, equal to about 54-100 pg / ml, is achieved in 1-2 hours. During absorption and first passage through the liver, ethinyl estradiol is metabolized, as a result of which its oral bioavailability is, on average, about 45%.

Ethinylestradiol is almost completely (approximately 98%), although nonspecifically, bound to albumin. Ethinylestradiol induces the synthesis of SHBG.

Ethinylestradiol undergoes presystemic conjugation, both in the mucous membrane of the small intestine and in the liver. The main metabolic pathway is aromatic hydroxylation.

The decrease in the concentration of ethinyl estradiol in the blood plasma is biphasic. It is not excreted unchanged from the body. Ethinyl estradiol metabolites are excreted in the urine and bile in a ratio of 4: 6 with a T 1/2 of about 24 hours.

C ss is reached during the second half of the cycle.

Indications of the drug Yarina ®

Contraception (prevention of unwanted pregnancy).

Contraindications

Yarina ® should not be used in the presence of any of the conditions / diseases listed below:

thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), cerebrovascular disorders;

conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history;

migraine with focal neurological symptoms at present or in history;

diabetes mellitus with vascular complications;

multiple or severe risk factors for venous or arterial thrombosis, incl. complicated lesions of the valve apparatus of the heart, atrial fibrillation, diseases of the vessels of the brain or coronary arteries; uncontrolled arterial hypertension, serious surgery with prolonged immobilization, smoking over the age of 35;

pancreatitis with severe hypertriglyceridemia at present or in history;

liver failure and severe liver disease (before normalization of liver function tests);

liver tumors (benign or malignant), current or history;

severe and / or acute renal failure;

identified hormone-dependent malignant diseases (including genitals or mammary glands) or suspicion of them;

vaginal bleeding of unknown origin;

pregnancy or suspicion of it;

lactation period;

hypersensitivity to any component of Yarina ®.

If any of these conditions develop for the first time while taking Yarina ®, the drug should be discontinued immediately.

CAREFULLY

The potential risk and expected benefit of using combined oral contraceptives in each individual case should be carefully weighed in the presence of the following diseases / conditions and risk factors:

risk factors for the development of thrombosis and thromboembolism: smoking, obesity, dyslipoproteinemia, arterial hypertension, migraine, heart valve defects, prolonged immobilization, serious surgical interventions, extensive trauma, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age -or from the next of kin);

other diseases in which peripheral circulation disorders may occur (diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia), phlebitis of superficial veins;

hereditary angioedema;

hypertriglyceridemia;

liver disease;

diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (for example, jaundice and / or itching associated with cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, herpes of pregnant women, Sydenham's chorea);

postpartum period.

Application during pregnancy and lactation

The drug is not prescribed during pregnancy and lactation. If pregnancy is detected while taking Yarina ®, it should be canceled immediately. However, extensive epidemiological studies have not revealed an increased risk of developmental defects in children born to women who received sex hormones before pregnancy or teratogenic effects in cases of taking sex hormones inadvertently in early pregnancy. At the same time, data on the results of taking Yarina® during pregnancy are limited, which does not allow any conclusions to be drawn about the negative effect of the drug on pregnancy, the health of the newborn and the fetus. Currently, no significant epidemiological data are available.

Taking combined oral contraceptives can reduce the amount of breast milk and change its composition, so their use is not recommended until breastfeeding is stopped. Small amounts of sex steroids and / or their metabolites can be excreted in milk.

Side effects

The most commonly reported adverse reactions to Yarina® are nausea and breast pain. They occurred in more than 6% of women using this drug.

Arterial and venous thromboembolism are serious adverse reactions.

The table below shows the frequency of adverse reactions. which were reported in the course of clinical trials of the drug Yarina ® (N = 4897). Within each group, allocated depending on the frequency of occurrence of an adverse reaction, adverse reactions are presented in order of decreasing severity. By frequency, they are divided into frequent (≥1 / 100 and<1/10), нечастые (≥1/1000 и <1/100) и редкие (≥1/10000 и <1/1000). Для дополнительных нежелательных реакций, выявленных только в процессе постмаркетинговых исследований, и для которых оценку частоты возникновения провести не представлялось возможным, указано «частота неизвестна» (см. табл. 1).

Table 1

System Organ Classes (MedDRA version) Often Infrequently Frequency unknown
Mental disorders Mood swings, depression, depressed mood, decreased or loss of libido
Nervous system Migraine
Vascular disorders Venous or arterial thromboembolism *
Gastrointestinal tract Nausea
Skin and subcutaneous tissue Erythema multiforme
Reproductive system and mammary glands Pain in the mammary glands, irregular uterine bleeding, bleeding from the genital tract of unspecified origin

Adverse events from clinical trials have been codified using the MedDRA (Medical Dictionary of Regulatory Activities, version 12.1). Various MedDRA terms reflecting the same symptom have been grouped together and presented as the only adverse reaction to avoid weakening or blurring the true effect.

* - Approximate frequency based on the results of epidemiological studies covering the group of combined oral contraceptives. Frequency bordering on very rare.

Venous or arterial thromboembolism includes the following nosological units: peripheral deep vein occlusion, thrombosis and embolism / pulmonary vascular occlusion, thrombosis, embolism and infarction / myocardial infarction / cerebral infarction and stroke not defined as hemorrhagic.

For venous and arterial thromboembolism, migraine, see also "Contraindications" and "Special instructions".

Additional Information

Listed below are adverse reactions with a very rare frequency of occurrence or with delayed symptoms, which are believed to be associated with taking drugs from the group of combined oral contraceptives (see also "Contraindications" and "Special instructions").

Tumors:

The frequency of diagnosing breast cancer in women taking combined oral contraceptives is slightly increased. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the number of breast cancer diagnoses in women taking combined oral contraceptives is insignificant in relation to the overall risk of this disease.

Liver tumors (benign and malignant).

Other conditions:

Erythema nodosum;

Women with hypertriglyceridemia (increased risk of pancreatitis while taking combined oral contraceptives);

Increased blood pressure;

Conditions that develop or worsen while taking combined oral contraceptives, but their relationship with taking the drug has not been proven (jaundice and / or pruritus associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; Sydenham's chorea ; herpes of pregnant women; hearing loss associated with otosclerosis);

In women with hereditary angioedema, estrogen intake can cause or worsen its symptoms;

Liver dysfunction;

Impaired glucose tolerance or impact on insulin resistance;

Crohn's disease, ulcerative colitis;

Chloasma;

Hypersensitivity (including symptoms such as rash, hives).

Interaction. The interaction of combined oral contraceptives with other drugs (inducers of liver microsomal enzymes, some antibiotics) can lead to breakthrough bleeding and / or a decrease in contraceptive effectiveness (see "Interaction").

Interaction

The interaction of oral contraceptives with other drugs can lead to breakthrough bleeding and / or a decrease in contraceptive reliability. Women taking these drugs should temporarily use barrier methods of contraception in addition to Yarina ®, or choose another method of contraception.

The following interactions have been reported in the literature.

Effect on hepatic metabolism. The use of drugs that induce liver microsomal enzymes can lead to an increase in the clearance of sex hormones, which in turn can lead to breakthrough bleeding or a decrease in the reliability of contraception. These drugs include: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, rifabutin, possibly also oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John's wort.

HIV protease inhibitors(such as ritonavir) and non-nucleoside reverse transcriptase inhibitors(eg nevirapine) and combinations thereof can also potentially affect hepatic metabolism.

Effect on intestinal-hepatic circulation... According to some studies, some antibiotics (for example, penicillins and tetracycline) can reduce the intestinal-hepatic circulation of estrogens, thereby lowering the concentration of ethinyl estradiol.

During the reception drugs that affect microsomal enzymes, and within 28 days after their cancellation, you should additionally use a barrier method of contraception.

During the reception antibiotics(such as penicillins and tetracyclines) and within 7 days after their cancellation, you should additionally use a barrier method of contraception. If during these 7 days of the barrier method of contraception the tablets in the current package run out, then you should start taking the tablets from the next package of Yarina ® without the usual interruption in taking the tablets.

The main metabolites of drospirenone are formed in plasma without the participation of the cytochrome P450 system. Therefore, the effect of inhibitors of the cytochrome P450 system on the metabolism of drospirenone is unlikely.

Combined oral contraceptives can interfere with the metabolism of other drugs, resulting in an increase (for example, cyclosporine) or a decrease (for example, lamotrigine) in plasma and tissue concentrations.

Based on interaction studies in vitro as well as research in vivo on female volunteers taking omeprazole, simvastatin and midazolam as markers, it can be concluded that the effect of drospirenone at a dose of 3 mg on the metabolism of other medicinal substances is unlikely.

There is a theoretical possibility of an increase in serum potassium levels in women receiving Yarina® at the same time as other drugs that can increase serum potassium levels. These drugs include angiotensin II receptor antagonists, certain anti-inflammatory drugs, potassium-sparing diuretics, and aldosterone antagonists. However, in studies evaluating the interaction of drospirenone with ACE inhibitors or indomethacin, there was no significant difference between serum potassium concentration compared with placebo.

Method of administration and dosage

Inside, in the order indicated on the package, every day at about the same time, with a little water.

Take one tablet a day continuously for 21 days. Taking the tablets from the next pack begins after a 7-day break, during which menstrual bleeding usually develops (withdrawal bleeding). As a rule, it starts on the 2-3rd day after taking the last pill and may not end before taking the pills from a new package.

How to start taking Yarina ®

In the absence of taking any hormonal contraceptives in the previous month

Taking Yarina ® begins on the first day of the menstrual cycle (i.e. on the first day of menstrual bleeding). It is allowed to start taking on the 2-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the pills from the first package.

When switching from other combined oral contraceptives, vaginal ring, or contraceptive patch

It is preferable to start taking Yarina ® the next day after taking the last active tablet from the previous package, but in no case later than the next day after the usual 7-day break (for drugs containing 21 tablets) or after taking the last inactive tablet (for drugs, containing 28 tablets per pack). Taking Yarina ® should be started on the day of removing the vaginal ring or patch, but no later than the day when a new ring is to be inserted or a new patch is glued on.

When switching from contraceptives containing only progestogens ("mini-pills", injectable forms, implant), or from a progestogen-releasing intrauterine contraceptive (Mirena)

You can switch from "mini-pili" to Yarina ® any day (without interruption), from an implant or intrauterine contraceptive with gestagen - on the day of its removal, from an injectable form - from the day when the next injection is to be made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills.

After an abortion in the first trimester of pregnancy

You can start taking the drug immediately, on the day of the abortion. If this condition is met, the woman does not need additional contraception.

After childbirth or abortion in the second trimester of pregnancy

You should start taking the drug no earlier than 21-28 days after childbirth (in the absence of breastfeeding) or abortion in the II trimester of pregnancy. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills. However, if a woman has already had sexual intercourse, pregnancy should be ruled out before taking Yarina ® or it is necessary to wait for the first menstruation.

Taking missed pills

If the delay in taking the drug is less than 12 hours, contraceptive protection is not reduced. The woman should take the pill as soon as possible, the next one is taken at the usual time.

If the delay in taking the pills is more than 12 hours, contraceptive protection is reduced. The more pills are missed and the closer the pass is to the 7-day pill break, the more likely you are to get pregnant.

In this case, you can be guided by the following two basic rules:

The drug should never be interrupted for more than 7 days;

To achieve adequate suppression of hypothalamic-pituitary-ovarian regulation, 7 days of continuous pill intake are required.

Accordingly, the following tips can be given if the delay in taking the pills is more than 12 hours (the interval since taking the last pill is more than 36 hours).

The first week of taking the drug

It is necessary to take the last missed pill as soon as possible, as soon as the woman remembers about it (even if this requires taking two pills at the same time). The next pill is taken at the usual time. Additionally, a barrier method of contraception (such as a condom) must be used for the next 7 days. If intercourse took place within a week before the pill was missed, the likelihood of pregnancy must be taken into account.

The second week of taking the drug

It is necessary to take the last missed pill as soon as possible, as soon as the woman remembers about it (even if this requires taking two pills at the same time). The next pill is taken at the usual time. Provided that the woman took the pills correctly within 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as when skipping two or more pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.

The third week of taking the drug

The risk of pregnancy increases due to the upcoming pill break. A woman must strictly adhere to one of the two options below. Moreover, if within 7 days preceding the first missed pill, all pills were taken correctly, there is no need to use additional contraceptive methods.

1. It is necessary to take the last missed pill as soon as possible, as soon as the woman remembers it (even if this requires taking two pills at the same time). The next pills are taken at the usual time until the end of the pills in the current package. Taking the tablets from the next package should be started immediately without interruption. Withdrawal bleeding is unlikely until the second pack runs out, but spotting and breakthrough bleeding may occur while taking the pills.

2. You can interrupt taking pills from the current package, thus starting a 7-day break (including the day you skip the pills), and then start taking the pills from the new package.

If a woman misses taking the pills and then does not have withdrawal bleeding during a break in taking, it is necessary to exclude pregnancy.

In case of vomiting or diarrhea in the period up to 4 hours after taking the tablets, absorption may be incomplete, and additional measures should be taken to prevent unwanted pregnancy. In such cases, you should focus on the above recommendations when skipping tablets.

Change in the day of the onset of menstrual bleeding

In order to postpone the onset of menstrual bleeding, it is necessary to continue taking the pills from the new Yarina ® package without a 7-day break. The tablets from the new packaging can be taken as long as necessary, incl. until the tablets from the package run out. While taking the drug from the second package, spotting bleeding from the vagina or breakthrough uterine bleeding is possible. You should resume taking Yarina ® from the next package after the usual 7-day break.

In order to postpone the day of the onset of menstrual bleeding to another day of the week, a woman should shorten the next break in taking pills for as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding, and in the future there will be spotting and breakthrough bleeding while taking the second pack (as well as in the case when she would like to delay the onset of menstrual bleeding).

Additional information for special categories of patients

Children and adolescents. Yarin's drug is indicated only after the onset of menarche. Available data do not suggest dose adjustment in this patient population.

Elderly patients. Not applicable. Yarina ® is not indicated after menopause.

Patients with liver disorders. The drug Yarina ® is contraindicated in women with severe liver disease until the liver function indicators return to normal (see also "Contraindications" and "Pharmacokinetics").

Patients with renal impairment. Yarina ® is contraindicated in women with severe renal failure or acute renal failure (see also "Contraindications" and "Pharmacokinetics").

Overdose

Symptoms(identified based on the total experience of using oral contraceptives): nausea, vomiting, spotting spotting or metrorrhagia.

Treatment: symptomatic. There is no specific antidote.

Serious overdose irregularities have not been reported.

special instructions

If any of the conditions, diseases and risk factors listed below are currently available, then the potential risks and expected benefits of using combined oral contraceptives in each individual case should be carefully weighed and discussed with the woman before she decides to start taking drug. In the event of an aggravation, increase or the first manifestation of any of these conditions, diseases or an increase in risk factors, a woman should consult with her doctor, who can decide whether to discontinue the drug.

CVD diseases

The results of epidemiological studies indicate a relationship between the use of combined oral contraceptives and an increase in the incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders) when taking combined oral contraceptives. These diseases are rare. The risk of developing VTE is highest in the first year of taking such drugs. The increased risk is present after initial use of combined oral contraceptives or resumption of use of the same or different combined oral contraceptives (after an interval between doses of 4 weeks or more). Data from a large prospective study involving 3 patient groups indicate that this increased risk is present predominantly during the first 3 months.

The overall risk of VTE in patients taking low-dose combined oral contraceptives (ethinyl estradiol content is less than 50 μg) is 2-3 times higher than in non-pregnant patients who do not take combined oral contraceptives, however, this risk remains lower compared to with the risk of VTE during pregnancy and childbirth. VTE can be life threatening or fatal (in 1-2% of cases).

VTE, manifested as deep vein thrombosis or pulmonary embolism, can occur with any combination oral contraceptive pill.

Very rarely, when using combined oral contraceptives, thrombosis of other blood vessels (for example, hepatic, mesenteric, renal, cerebral veins and arteries or vessels of the retina) occurs. There is no consensus on the relationship between the occurrence of these events and the use of combined oral contraceptives. Symptoms of deep vein thrombosis (DVT) include the following: unilateral swelling of the lower limb or along a vein in the leg, pain or discomfort in the leg only when standing upright or when walking, a local fever in the affected leg, redness or discoloration of the skin on the leg.

The symptoms of pulmonary embolism (PE) are as follows: difficulty breathing or rapid breathing; sudden cough, incl. with hemoptysis; sharp pain in the chest, which may worsen with a deep breath; sense of anxiety; severe dizziness; a fast or irregular heartbeat. Some of these symptoms (eg shortness of breath, cough) are nonspecific and can be misinterpreted as signs of other more or less severe events (eg, respiratory tract infection).

Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction. The symptoms of a stroke are: sudden weakness or loss of sensation in the face, arm, or leg, especially on one side of the body, sudden confusion, problems with speech and understanding; sudden unilateral or bilateral loss of vision; sudden gait disturbance, dizziness, loss of balance or coordination of movements; sudden, severe, or prolonged headache for no apparent reason; loss of consciousness or fainting with or without an epileptic seizure. Other signs of vascular occlusion: sudden pain, swelling and slight blue discoloration of the limbs, acute abdomen.

Symptoms of myocardial infarction include: pain, discomfort, pressure, heaviness, tightness or distention in the chest, arm, or behind the breastbone; discomfort radiating to the back, cheekbone, larynx, arm, stomach; cold sweats, nausea, vomiting or dizziness, severe weakness, anxiety, or shortness of breath; a fast or irregular heartbeat. Arterial thromboembolism can be fatal. The risk of developing thrombosis (venous and / or arterial) and thromboembolism increases:

With age;

In smokers (with an increase in the number of cigarettes or an increase in age, the risk increases, especially in women over 35).

In the presence of:

Obesity (body mass index more than 30 kg / m 2);

Family history (for example, venous or arterial thromboembolism ever in close relatives or parents at a relatively young age). In the case of a hereditary or acquired predisposition, a woman should be examined by an appropriate specialist to decide on the possibility of taking combined oral contraceptives;

Prolonged immobilization, major surgery, any leg surgery, or major trauma. In these situations, it is advisable to stop using combined oral contraceptives (in the case of a planned operation, at least 4 weeks before it) and not resume taking it within 2 weeks after the end of immobilization;

Dyslipoproteinemia;

Arterial hypertension;

Migraine;

Heart valve disease;

Atrial fibrillation.

The question of the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial. Consideration should be given to the increased risk of thromboembolism in the postpartum period.

Peripheral circulatory disorders can also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), and sickle cell anemia. An increase in the frequency and severity of migraine during the use of combined oral contraceptives (which may precede cerebrovascular disorders) may be the reason for the immediate discontinuation of these drugs.

Biochemical indicators indicating a hereditary or acquired predisposition to venous or arterial thrombosis include the following: resistance to activated protein C, hyperhomocysteinemia, lack of antithrombin-III, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus antibodies). In assessing the risk / benefit ratio, it should be borne in mind that adequate treatment of the condition may reduce the associated risk of thrombosis. It should also be borne in mind that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose oral contraceptives (ethinyl estradiol content - 0.05 mg).

Tumors

The most significant risk factor for cervical cancer is persistent human papillomavirus infection. There are reports of a slight increase in the risk of developing cervical cancer with long-term use of combined oral contraceptives. However, the relationship with the use of combined oral contraceptives has not been proven. The possibility of interconnection of these data with disease screening is discussed. Controversy persists as to the extent to which these data are associated with screening for cervical pathology or with features of sexual behavior (more rare use of barrier methods of contraception).

A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of developing breast cancer diagnosed in women currently taking combined oral contraceptives (relative risk - 1.24). The increased risk gradually disappears over 10 years after you stop taking these drugs. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the number of breast cancer diagnoses in women taking combined oral contraceptives currently or recently is insignificant in relation to the overall risk of this disease. Its connection with the use of combined oral contraceptives has not been proven. The observed increase in risk may also be due to close observation and earlier diagnosis of breast cancer in women using combined oral contraceptives. Women who have ever used combined oral contraceptives have earlier stages of breast cancer than women who have never used them.

In rare cases, against the background of the use of combined oral contraceptives, the development of benign, and in extremely rare cases, malignant liver tumors was observed, which sometimes led to life-threatening intra-abdominal bleeding. In the event of severe abdominal pain, enlarged liver, or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis. Malignant tumors can be life threatening or fatal.

Other conditions

Clinical studies have shown no effect of drospirenone on plasma potassium concentration in patients with mild to moderate renal failure. However, in patients with impaired renal function and an initial potassium concentration at the VGN level, the risk of developing hyperkalemia while taking drugs, leading to potassium retention in the body, cannot be excluded.

Women with hypertriglyceridemia (or a family history of this condition) may have an increased risk of developing pancreatitis while taking combined oral contraceptives.

Despite the fact that a small increase in blood pressure has been described in many women taking combined oral contraceptives, clinically significant increases were rarely observed. However, if a persistent, clinically significant increase in blood pressure develops while taking the drug, these drugs should be discontinued and treatment of arterial hypertension should be started. The drug can be continued if normal blood pressure values ​​are achieved with the help of antihypertensive therapy. The following conditions have been reported to develop or worsen both during pregnancy and when taking combined oral contraceptives (but their relationship with taking combined oral contraceptives has not been proven): jaundice and / or pruritus associated with cholestasis; the formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes of pregnant women; hearing loss associated with otosclerosis. Cases of Crohn's disease and ulcerative colitis are also described with the use of combined oral contraceptives. In women with hereditary forms of angioedema, exogenous estrogens can cause or worsen symptoms of angioedema.

Acute or chronic abnormalities in liver function may require discontinuation of the drug until liver function values ​​return to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of the drug. Although combined oral contraceptives can affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose combined oral contraceptives (ethinyl estradiol content less than 0.05 mg). However, women with diabetes should be monitored closely while taking this drug.

Chloasma can sometimes develop, especially in women with a history of pregnant chloasma. Women with a tendency to chloasma while taking Yarina ® should avoid prolonged exposure to the sun and exposure to UV radiation.

Preclinical safety data

Preclinical data obtained in the course of standard studies for the detection of toxicity with repeated doses of the drug, as well as genotoxicity, carcinogenic potential and toxicity to the reproductive system, do not indicate the presence of a particular risk to humans. However, it should be remembered that sex steroids can promote the growth of some hormone-dependent tissues and tumors.

Laboratory tests

Taking combined oral contraceptives can affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal gland function, plasma transport proteins, carbohydrate metabolism, blood clotting and fibrinolysis. Changes usually do not go beyond the normal range. Drospirenone increases plasma renin activity and plasma aldosterone levels, which is associated with its anti-mineralocorticoid effect.

Decreased efficiency

The effectiveness of Yarina ® can be reduced in the following cases: when you skip taking pills, with vomiting and diarrhea (see "Taking missed tablets") or as a result of drug interactions.

Insufficient control of the menstrual cycle

While taking Yarina ®, you may experience irregular (acyclic) spotting / bleeding from the vagina (spotting spotting or breakthrough bleeding), especially during the first months of use. Therefore, any irregular menstrual bleeding should be assessed after an adaptation period of approximately 3 cycles. If irregular menstrual bleeding recurs or develops after previous regular cycles, a thorough examination should be carried out to rule out malignant neoplasms or pregnancy.

Some women may not develop withdrawal bleeding during a pill break. If Yarina ® was taken as recommended, it is unlikely that the woman is pregnant. However, with irregular use of the drug and the absence of two consecutive menstrual bleeding, the drug cannot be continued until pregnancy is excluded.

Medical examinations

Before starting or resuming the use of Yarina ®, it is necessary to familiarize yourself with the life history, family history of the woman, conduct a thorough general medical and gynecological examination, and exclude pregnancy. The volume of studies and the frequency of follow-up examinations should be based on existing standards of medical practice, with the necessary consideration for the individual characteristics of each patient. As a rule, blood pressure, heart rate are measured, body mass index is determined, the condition of the mammary glands, abdominal cavity and pelvic organs is checked, including cytological examination of the epithelium of the cervix (Pap test). Usually, control examinations should be carried out at least once every 6 months.

Composition

Drospirenone; Ethinyl Estradiol

Therapeutic indications

Provided in section Therapeutic indications Yasmin 21 Yasmin 21 Therapeutic indications in the instructions for the medicine Yasmin 21

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Coated tablets

contraception;

contraception and treatment for mild acne (acne vulgaris);

contraception and treatment of severe premenstrual syndrome (PMS).

Contraception (prevention of unwanted pregnancy).

Method of administration and dosage

Provided in section Method of administration and dosage Yasmin 21 the information has been compiled on the basis of data about another medicine with exactly the same composition as the medicine Yasmin 21(Drospirenone, Ethinyl Estradiol). Be careful and be sure to check the information on the section Method of administration and dosage in the instructions for the medicine Yasmin 21 directly from the package or from the pharmacist at the pharmacy.

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Film-coated tablets; Pills

Coated tablets

How to take Jess ®

Reception mode "24 + 4"

Inside. The tablets should be taken in the order indicated by the arrows on the package, at approximately the same time every day, with a little water. The tablets are taken without interruption. It should be taken one tablet a day consecutively for 28 days. Taking tablets from each subsequent package should be started the next day after taking the last tablet from the previous package. Withdrawal bleeding usually begins 2-3 days after you start taking the white inactive pills and may not end before you start taking the pills from the next pack. You should always start taking pills from a new package on the same day of the week, and withdrawal bleeding will occur on approximately the same days of each month.

Flexible reception mode

The flexible mode of taking Jess ® can only be used with the Click dispenser. (Clyk) and flex cartridges. One tablet should be taken daily at the same time with a small amount of liquid.

The tablets should be taken continuously for at least 24 days. Between the 25th and 120th days of using the drug Jess ®, at the decision of the patient, a 4-day break in taking the tablets can be made. The break in taking pills should not exceed 4 days. The 4-day pill break should be made no later than 120 days of continuous pill intake. After each 4-day pill break, a new cycle begins with a minimum duration of 24 days and a maximum duration of 120 days. Typically, withdrawal bleeding occurs within a 4-day pill break, but may not be complete until the next pill is taken. If spotting / bleeding from the vagina appears between the 25th and 120th day for 3 consecutive days, it is recommended to take a 4-day break from taking the tablets. This will reduce the total number of bleeding days.

Brief operating instructions for the Clyk dispenser

Before starting and during operation, you should carefully read the detailed operating instructions for the dispenser.

General description of the click dispenser (Clyk)(see fig. 1).

Picture 1.

Side keys. Pressing area to get a tablet.

Flex cartridge eject button. Pressing this button ejects the flex cartridge.

Pill dispensing area. The part of the dispenser in which the dispensed tablets appear.

Pill time indicator. Shows the time of taking the pill.

Display. Displays the main screen and menu items.

OK button. Pressing the button confirms an action, such as starting a 4-day pill break and changing the reminder sound.

Most important functions

Activating a new dispenser: the flex cartridge (containing 30 tablets) should be removed from the packaging and immediately inserted into the dispenser. Insert the narrow end of the flex cartridge into the dispenser so that the dispenser window (as well as the tablets in the flex cartridge) is clearly visible (see Fig. 2). The flex cartridge must be fully inserted.

Figure 2. Preparing to use the Click dispenser (Clyk).

The dispenser will automatically record the time to dispense the first tablet, setting this time as the time to take. Thus, a woman should be sure that:

That she unpacks and inserts the flex cartridge on the day she plans to start taking the pills;

That the dispensing time of the first tablet will be convenient for the daily pill intake. Every 24 hours, a signal will appear on the display of the dispenser about the time to take the next pill.

Removing the tablet

With one hand, press both side buttons at the same time to eject the tablet, which will be received by the other hand.

Replacing the Flex Cartridge

In normal use, the flex cartridge can be removed only if it is empty; otherwise, follow the instructions in the detailed operating instructions for the Click dispenser. (Clyk).... The empty flex cartridge is removed by pressing the eject button on the flex cartridge. The dispenser retains all information about the current cycle, and a new, filled flex cartridge should be inserted according to the instructions above. Before starting and during use, you should carefully read the detailed operating instructions for the Click dispenser. (Clyk). enclosed in the package with the drug.

How to start taking Jess ®

In the absence of taking any hormonal contraceptive drugs in the previous month. Taking Jess ® should be started on the first day of the menstrual cycle (i.e., on the first day of menstrual bleeding), in this case no additional contraceptive measures are required. It is allowed to start taking on the 2-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the pills from the first package. The tablets must then be taken in the order indicated for the 24 + 4 or flexible dosing regimen.

When switching from other combined contraceptive drugs (COC, vaginal ring or transdermal patch). It is preferable to start taking Jess ® the next day after taking the last active tablet from the previous package, but in no case later than the next day after the usual 7-day break (for drugs containing 21 tablets) or after taking the last inactive tablet (for preparations containing 28 tablets per package). You should start taking Jess ® on the day you remove the vaginal ring or patch, but no later than the day when a new ring is to be inserted or a new patch is glued on.

When switching from contraceptive preparations containing only progestogens (mini-pills, injectable forms, implant), or from a progestogen-releasing intrauterine contraceptive. A woman can switch from mini-drinking to Jess ® any day (without interruption); from an implant or intrauterine contraceptive with gestagen - on the day of its removal; from an injectable contraceptive - on the day the next injection is to be made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills.

After an abortion in the first trimester of pregnancy. A woman can start taking the drug immediately after a spontaneous or medical abortion in the first trimester of pregnancy. If this condition is met, a woman does not need additional contraceptive measures.

After an abortion in the second trimester of pregnancy or childbirth. You can start taking the drug on the 21-28th day after a spontaneous or medical abortion or after childbirth, in the absence of breastfeeding. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills. However, if sexual intercourse has already taken place, pregnancy should be excluded or it is necessary to wait for the first menstruation before taking Jess ®.

Discontinuation of the drug Jess ®. You can stop taking the drug at any time. If a woman is not planning a pregnancy or a woman is contraindicated in pregnancy because she is taking drugs potentially harmful to the fetus, other methods of contraception should be discussed with the doctor. If a woman is planning a pregnancy, it is recommended to stop taking the drug and wait for the natural menstrual bleeding, and only then try to get pregnant. This will help you more accurately calculate the gestational age and delivery time.

Instructions for handling the packaging of the drug Jess ® for the "24 + 4" regimen

A blister is glued into the package of Jess ®, which contains 24 active hormone-containing light pink tablets and 4 inactive white, hormone-free tablets (last row). The package also includes a self-adhesive appointment calendar, consisting of 7 self-adhesive strips with the names of the days of the week marked on them. You need to select the strip where the first day of the week is indicated on which you plan to start taking the pills. For example, if a woman starts taking pills on Wednesday, use a strip that starts with "Wed." (see fig. 3).

Figure 3.

The strip is glued along the top of the package so that the designation of the first day is above the tablet, to which the arrow with the inscription "Start" is directed (Fig. 4).

Figure 4.

This will show which day of the week each tablet should be taken (Fig. 5).

Figure 5.

Taking the missed pills. Skipping inactive white pills can be ignored. However, they should be thrown away so as not to accidentally extend the period of taking the inactive pills. The following recommendations apply only to skipping active light pink tablets:

If the delay in taking the drug is less than 24 hours, contraceptive protection is not reduced. A woman should take the missed pill as soon as possible, and the next should be taken at the usual time;

If the delay in taking the pills is more than 24 hours, contraceptive protection may be reduced. The more pills are missed and the closer the pills are skipped to the phase of taking inactive pills when using the "24 + 4" regimen or to the period free from taking pills against the background of a flexible regimen, the higher the likelihood of pregnancy.

In this case, you can be guided by the following basic rules:

The intake of the drug should never be interrupted for more than 7 days (it is necessary to pay attention to the fact that the recommended interval for taking inactive white tablets is 4 days for the "24 + 4" mode of administration, and for a flexible mode of administration - the interval WITHOUT taking the tablets should not exceed 4 days);

To achieve adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous pill intake are required.

Dispenser Click (Clyk) allows you to control the intake of pills and warns a woman about the need to use an additional method of contraception.

A warning symbol (exclamation mark) appears on the display when a pill is missed or when a pill is taken irregularly for more than 7 days in a row. This symbol disappears after 7 days of continuous dispensing of tablets from the dispenser. If more than one tablet is missed, it is recommended to consult a doctor. In the case of the "24 + 4" reception mode, as well as in the flexible mode, if the information from the Click dispenser (Clyk) is not available or there are doubts about its reliability, you must adhere to the following recommendations:

If you miss during the 1st to the 7th day of taking the pills. A woman should take the last missed pill as soon as she remembers it, even if it means taking two pills at the same time. She continues to take the next pills at the usual time. In addition, over the next 7 days, you must additionally use a barrier method of contraception (for example, a condom). If sexual intercourse took place within 7 days before skipping the pill, the possibility of pregnancy should be taken into account;

If you skip during the 8th to 14th day of taking pills with the “24 + 4” regimen or if you skip during the 8th to 24th day of taking pills with a flexible regimen. A woman should take the last missed pill as soon as she remembers it, even if it means taking two pills at the same time. She continues to take the next pills at the usual time. Provided that the woman took the pills correctly within 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as when skipping two or more pills, it is necessary to additionally use barrier methods of contraception (for example, a condom) for 7 days, and with a flexible mode of administration, barrier methods of contraception should be used until the continuous period of taking the pills reaches 7 days;

If you skip from the 15th to the 24th day of taking pills with the "24 + 4" regimen or if you skip the 25th to 120th day of taking pills with a flexible regimen. The risk of reduced reliability is inevitable due to the approaching period of taking inactive white pills in the case of a 24 + 4 dosing regimen or a pill-free period with a flexible dosing regimen. You must strictly adhere to one of the following two options. Moreover, if in 7 days preceding the first missed pill, all pills were taken correctly, there is no need to use additional contraceptive methods. Otherwise, the woman should use the first of the following regimens and additionally use a barrier method of contraception (for example, a condom) for 7 days.

1. A woman should take the last missed pill as soon as possible, as soon as she remembers (even if that means taking two pills at the same time). For the "24 + 4" regimen: the following tablets are taken at the usual time, until the active light pink tablets in the package run out. Discard the 4 inactive white tablets and start taking the tablets immediately from the next pack. Withdrawal bleeding is unlikely until the active light pink tablets in the second pack run out, but spotting and / or breakthrough bleeding may occur while taking the tablets. In the case of a flexible regimen, at least 7 tablets should be taken without interruption. (1 table daily).

2. For the "24 + 4" mode: the woman can also interrupt taking the active light pink pills from the current package. Then she should take a break for no more than 4 days, including the days of missing pills, and then start taking the drug from a new package. If a woman missed taking active light pink pills and while taking inactive white pills there was no withdrawal bleeding, pregnancy should be excluded. For flexible dosing: a woman can also take a 4-day pill break, including a day of missing a pill, to cause withdrawal bleeding, and then start a new drug cycle. If a woman missed taking the pills and there was no withdrawal bleeding in the next period of the break in taking the pills, the possibility of pregnancy should be taken into account.

Recommendations for gastrointestinal disorders. In severe gastrointestinal disorders, absorption may be incomplete, so additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3-4 hours after taking the active light pink pill, you should be guided by the recommendations when skipping the pills. If a woman does not want to change her usual dosage regimen and postpone the onset of menstruation to another day of the week, an additional active light pink pill should be taken.

How to change the time of the onset of withdrawal bleeding or delay the onset of withdrawal bleeding against the background of the "24 + 4" regimen. To delay the onset of withdrawal bleeding, the woman should continue taking the tablets from the next pack of Jess ®, skipping the inactive white tablets from the current pack. Thus, the cycle can be extended as desired for any period until the active light pink tablets from the second package run out, i.e. about 3 weeks later than usual. If you plan to start the next cycle earlier, you need to stop taking active light pink tablets from the second package at any time, throw out the remaining active light pink tablets and start taking white inactive tablets (maximum - within 4 days), and then start taking the tablets from new packaging. In this case, about 2-3 days after taking the last light pink pill from the previous package, withdrawal bleeding should begin. While taking the drug from the second package, a woman may experience spotting and / or breakthrough uterine bleeding. Regular use of Jess ® is then resumed after the end of the period of taking inactive white tablets. To postpone the onset of withdrawal bleeding to another day of the week, the woman should shorten the next period of taking the inactive white tablets by the desired number of days. The shorter the interval, the higher the risk that she will not have withdrawal bleeding, and in the future there will be spotting and / or breakthrough bleeding while taking the pills from the second pack.

Application in special categories of patients

Children and adolescents. The drug Jess ® is indicated only after the onset of menarche. Available data do not suggest dose adjustment in this patient population.

Elderly patients. Not applicable. Jess ® is not indicated after menopause.

Patients with impaired liver function. The drug Jess ® is contraindicated in women with severe liver disease until the indicators of liver function tests return to normal (see also "Contraindications" and "Pharmacodynamics").

Patients with impaired renal function. Jess ® is contraindicated in women with severe renal failure or acute renal failure (see also "Contraindications" and "Pharmacodynamics").

Inside, in the order indicated on the package, every day at about the same time, with a little water.

Take one tablet a day continuously for 21 days. Taking the tablets from the next pack begins after a 7-day break, during which menstrual bleeding usually develops (withdrawal bleeding). As a rule, it starts on the 2-3rd day after taking the last pill and may not end before taking the pills from a new package.

How to start taking Yarina ®

In the absence of taking any hormonal contraceptives in the previous month

Taking Yarina ® begins on the first day of the menstrual cycle (i.e. on the first day of menstrual bleeding). It is allowed to start taking on the 2-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the pills from the first package.

When switching from other combined oral contraceptives, vaginal ring, or contraceptive patch

It is preferable to start taking Yarina ® the next day after taking the last active tablet from the previous package, but in no case later than the next day after the usual 7-day break (for drugs containing 21 tablets) or after taking the last inactive tablet (for drugs, containing 28 tablets per pack). Taking Yarina ® should be started on the day of removing the vaginal ring or patch, but no later than the day when a new ring is to be inserted or a new patch is glued on.

When switching from contraceptives containing only progestogens ("mini-pills", injectable forms, implant), or from a progestogen-releasing intrauterine contraceptive (Mirena)

You can switch from "mini-pili" to Yarina ® any day (without interruption), from an implant or intrauterine contraceptive with gestagen - on the day of its removal, from an injectable form - from the day when the next injection is to be made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills.

After an abortion in the first trimester of pregnancy

You can start taking the drug immediately, on the day of the abortion. If this condition is met, the woman does not need additional contraception.

After childbirth or abortion in the second trimester of pregnancy

You should start taking the drug no earlier than 21-28 days after childbirth (in the absence of breastfeeding) or abortion in the II trimester of pregnancy. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills. However, if a woman has already had sexual intercourse, pregnancy should be ruled out before taking Yarina ® or it is necessary to wait for the first menstruation.

Taking missed pills

If the delay in taking the drug is less than 12 hours, contraceptive protection is not reduced. The woman should take the pill as soon as possible, the next one is taken at the usual time.

If the delay in taking the pills is more than 12 hours, contraceptive protection is reduced. The more pills are missed and the closer the pass is to the 7-day pill break, the more likely you are to get pregnant.

In this case, you can be guided by the following two basic rules:

The drug should never be interrupted for more than 7 days;

To achieve adequate suppression of hypothalamic-pituitary-ovarian regulation, 7 days of continuous pill intake are required.

Accordingly, the following tips can be given if the delay in taking the pills is more than 12 hours (the interval since taking the last pill is more than 36 hours).

The first week of taking the drug

It is necessary to take the last missed pill as soon as possible, as soon as the woman remembers about it (even if this requires taking two pills at the same time). The next pill is taken at the usual time. Additionally, a barrier method of contraception (such as a condom) must be used for the next 7 days. If intercourse took place within a week before the pill was missed, the likelihood of pregnancy must be taken into account.

The second week of taking the drug

It is necessary to take the last missed pill as soon as possible, as soon as the woman remembers about it (even if this requires taking two pills at the same time). The next pill is taken at the usual time. Provided that the woman took the pills correctly within 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as when skipping two or more pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.

The third week of taking the drug

The risk of pregnancy increases due to the upcoming pill break. A woman must strictly adhere to one of the two options below. Moreover, if within 7 days preceding the first missed pill, all pills were taken correctly, there is no need to use additional contraceptive methods.

1. It is necessary to take the last missed pill as soon as possible, as soon as the woman remembers it (even if this requires taking two pills at the same time). The next pills are taken at the usual time until the end of the pills in the current package. Taking the tablets from the next package should be started immediately without interruption. Withdrawal bleeding is unlikely until the second pack runs out, but spotting and breakthrough bleeding may occur while taking the pills.

2. You can interrupt taking pills from the current package, thus starting a 7-day break (including the day you skip the pills), and then start taking the pills from the new package.

If a woman misses taking the pills and then does not have withdrawal bleeding during a break in taking, it is necessary to exclude pregnancy.

In case of vomiting or diarrhea in the period up to 4 hours after taking the tablets, absorption may be incomplete, and additional measures should be taken to prevent unwanted pregnancy. In such cases, you should focus on the above recommendations when skipping tablets.

Change in the day of the onset of menstrual bleeding

In order to postpone the onset of menstrual bleeding, it is necessary to continue taking the pills from the new Yarina ® package without a 7-day break. The tablets from the new packaging can be taken as long as necessary, incl. until the tablets from the package run out. While taking the drug from the second package, spotting bleeding from the vagina or breakthrough uterine bleeding is possible. You should resume taking Yarina ® from the next package after the usual 7-day break.

In order to postpone the day of the onset of menstrual bleeding to another day of the week, a woman should shorten the next break in taking pills for as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding, and in the future there will be spotting and breakthrough bleeding while taking the second pack (as well as in the case when she would like to delay the onset of menstrual bleeding).

Children and adolescents. Yasmin 21 is indicated only after menarche. Available data do not suggest dose adjustment in this patient population.

Elderly patients. Not applicable. Yasmin 21 ® is not indicated after menopause.

Yasmin 21 ® is contraindicated in women with severe liver disease until the liver function tests return to normal (see also "Contraindications" and "Pharmacokinetics").

Yasmin 21 ® is contraindicated in women with severe renal failure or acute renal failure (see also "Contraindications" and "Pharmacokinetics").

Contraindications

Provided in section Contraindications Yasmin 21 the information has been compiled on the basis of data about another medicine with exactly the same composition as the medicine Yasmin 21(Drospirenone, Ethinyl Estradiol). Be careful and be sure to check the information on the section Contraindications in the instructions for the medicine Yasmin 21 directly from the package or from the pharmacist at the pharmacy.

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Film-coated tablets; Pills

Coated tablets

Jess ® is contraindicated in the presence of any of the conditions / diseases listed below. If any of these conditions / diseases develop for the first time while taking, the drug should be stopped immediately.

hypersensitivity to any component of Jess®;

thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction), cerebrovascular disorders;

identified acquired or hereditary predisposition to venous or arterial thrombosis, including resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant);

the presence of a high risk of venous or arterial thrombosis (see "Special instructions");

liver failure and severe liver disease (before normalization of liver function indicators);

severe renal failure, acute renal failure;

adrenal insufficiency;

identified hormone-dependent malignant diseases (including genitals or mammary glands) or suspicion of them;

lactose intolerance, lactase deficiency, glucose-galactose malabsorption (the drug contains lactose monohydrate);

period of breastfeeding.

CAREFULLY

If any of the conditions / risk factors listed below are currently available, then the potential risk and the expected benefit from the use of combined oral contraceptives in each individual case should be carefully weighed:

risk factors for thrombosis and thromboembolism: smoking; thrombosis, myocardial infarction or cerebrovascular accident at a young age in any of the next of kin; obesity; dyslipoproteinemia, arterial hypertension; migraine; heart valve disease; heart rhythm disturbances, prolonged immobilization, serious surgical interventions, extensive trauma;

diseases in which peripheral circulatory disorders may occur: diabetes mellitus; systemic lupus erythematosus; hemolytic uremic syndrome; Crohn's disease and ulcerative colitis; sickle cell anemia; as well as phlebitis of superficial veins;

hypertriglyceridemia;

liver disease;

diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (for example, jaundice, cholestasis, gallbladder disease, otosclerosis with hearing impairment, porphyria, herpes of pregnant women, Sydenham's chorea).

Yasmin 21 ® should not be used if you have any of the conditions / diseases listed below:

thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), cerebrovascular disorders;

conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history;

migraine with focal neurological symptoms at present or in history;

diabetes mellitus with vascular complications;

multiple or severe risk factors for venous or arterial thrombosis, incl. complicated lesions of the valve apparatus of the heart, atrial fibrillation, diseases of the vessels of the brain or coronary arteries; uncontrolled arterial hypertension, serious surgery with prolonged immobilization, smoking over the age of 35;

pancreatitis with severe hypertriglyceridemia at present or in history;

liver failure and severe liver disease (before normalization of liver function tests);

liver tumors (benign or malignant), current or history;

severe and / or acute renal failure;

identified hormone-dependent malignant diseases (including genitals or mammary glands) or suspicion of them;

vaginal bleeding of unknown origin;

pregnancy or suspicion of it;

lactation period;

hypersensitivity to any component of Yasmin 21 ®.

If any of these conditions develop for the first time while taking Yarina ®, the drug should be discontinued immediately.

CAREFULLY

The potential risk and expected benefit of using combined oral contraceptives in each individual case should be carefully weighed in the presence of the following diseases / conditions and risk factors:

risk factors for the development of thrombosis and thromboembolism: smoking, obesity, dyslipoproteinemia, arterial hypertension, migraine, heart valve defects, prolonged immobilization, serious surgical interventions, extensive trauma, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age -or from the next of kin);

other diseases in which peripheral circulation disorders may occur (diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia), phlebitis of superficial veins;

hereditary angioedema;

hypertriglyceridemia;

liver disease;

diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (for example, jaundice and / or itching associated with cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, herpes of pregnant women, Sydenham's chorea);

postpartum period.

Side effects

Provided in section Side effects Yasmin 21 the information has been compiled on the basis of data about another medicine with exactly the same composition as the medicine Yasmin 21(Drospirenone, Ethinyl Estradiol). Be careful and be sure to check the information on the section Side effects in the instructions for the medicine Yasmin 21 directly from the package or from the pharmacist at the pharmacy.

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Film-coated tablets; Pills

Coated tablets

The following most common adverse reactions have been reported in women using Jess ® in a 24 + 4 regimen according to the indications "Contraception" and "Contraception and treatment of moderate acne. (acne vulgaris)»: Nausea, pain in the mammary glands, irregular uterine bleeding, bleeding from the genital tract of unspecified origin. These adverse reactions occurred in more than 3% of women. Patients using Jess ® for the indication "Contraception and treatment of severe premenstrual syndrome" reported the following most common adverse reactions (in more than 10% of women): nausea, pain in the mammary glands, irregular uterine bleeding. Serious adverse reactions are arterial and venous thromboembolism, and breast cancer and focal nodular hyperplasia of the liver are additionally noted for the "flexible" regimen of the drug. Below is the frequency of adverse reactions, which were reported during clinical trials of the drug Jess ® for the regimen of reception "24 + 4" according to the indications "Contraception" and "Contraception and treatment of moderate forms of acne (acne vulgaris)"(N = 3565), according to the indication" Contraception and treatment of severe premenstrual syndrome "(N = 289), as well as a flexible regimen of Jess ® (N = 2738). Within each group, selected depending on the frequency of occurrence of an adverse reaction, those are presented in decreasing order of their severity. By frequency, they are divided into developing often (≥1 / 100 and<1/10); нечасто (≥1/1000 и <1/100) и редко (≥1/10000 и <1/1000).

For additional adverse reactions identified only during post-registration observations, and for which it was not possible to estimate the frequency of occurrence, the "frequency is unknown" is indicated.

The frequency of adverse reactions in clinical trials of the drug Jess ® (mode "24 + 4" and "flexible" mode of administration *)

On the part of the blood and lymphatic system: rarely - anemia, thrombocythemia.

From the immune system: rarely - an allergic reaction; frequency unknown - hypersensitivity.

From the side of metabolism and nutrition: rarely - increased appetite, anorexia, hyperkalemia, hyponatremia.

Mental disorders: often - emotional lability, depression, decreased libido; infrequently - nervousness, drowsiness, rarely - anorgasmia, insomnia.

From the nervous system: often - headache; infrequently - dizziness, paresthesia; rarely - vertigo, tremor.

On the part of the organ of vision: rarely - conjunctivitis, dryness of the mucous membrane of the eyes.

From the side of the heart: rarely - tachycardia.

From the side of the vessels: often - migraine; infrequently - varicose veins, increased blood pressure; rarely - phlebitis, epistaxis, fainting, venous thromboembolism (VTE), arterial thromboembolism (ATE).

From the gastrointestinal tract: often - nausea; infrequently - abdominal pain, vomiting, dyspepsia, flatulence, gastritis, diarrhea; rarely - bloating, a feeling of heaviness in the abdomen, hiatal hernia, oral candidiasis, constipation, dry mouth.

From the liver and biliary tract: rarely - biliary dyskinesia, cholecystitis.

On the part of the skin and subcutaneous tissues: infrequently - acne, itching, rash; rarely - chloasma, eczema, alopecia, acne dermatitis, dry skin, erythema nodosum, hypertrichosis, striae, contact dermatitis, photodermatitis, skin nodule; frequency unknown - erythema multiforme.

Musculoskeletal and connective tissue disorders: infrequently - back pain, limb pain, muscle cramps.

On the part of the genitals and mammary gland: often - pain in the mammary glands, metrorrhagia **, absence of menstrual bleeding; infrequently - vaginal candidiasis, pain in the pelvic area, enlargement of the mammary glands, fibrocystic formations in the mammary gland, spotting / bleeding from the genital tract **, discharge from the genital tract, hot flashes, vaginitis, painful menstrual bleeding, scanty menstrual bleeding, heavy menstrual bleeding, dry vaginal mucosa, abnormal Papanicolaou test results; rarely - dyspareunia, vulvovaginitis, postcoital bleeding, withdrawal bleeding, breast hyperplasia, neoplasm in the mammary gland, cervical polyp, endometrial atrophy, ovarian cyst, uterine enlargement.

General disorders and disorders at the injection site: infrequently - asthenia, increased sweating, edema (generalized edema, peripheral edema, facial edema); rarely - malaise

Laboratory and instrumental data: infrequently - an increase in body weight; rarely - weight loss.

* In cases where adverse reactions occurred with different frequencies against the background of the use of the "24 + 4" and flexible modes, the highest frequency is indicated

** The frequency of irregular bleeding decreases as the duration of taking Jess ® increases.

For more information on VTE and ATE, migraine, breast cancer, and focal nodular liver hyperplasia, see also Contraindications and Special Instructions.

Additional Information

Listed below are adverse reactions with a very rare frequency of occurrence or delayed symptoms that are believed to be associated with taking drugs from the COC group (see also "Contraindications" and "Special instructions").

Tumors

The frequency of diagnosing breast cancer in women taking COCs is slightly increased. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the number of breast cancer diagnoses in women taking COCs is insignificant in relation to the overall risk of this disease;

Other conditions

Erythema nodosum, erythema multiforme (only for flexible dosing regimen);

Women with hypertriglyceridemia (increased risk of pancreatitis while taking COCs);

Increased blood pressure;

Conditions that develop or worsen while taking COCs, but their relationship has not been proven: jaundice and / or pruritus associated with cholestasis; cholelitis Yasmin 21; porphyria; systemic lupus erythematosus; hemolyticouremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis;

Liver dysfunction;

Changes in glucose tolerance or effects on insulin resistance;

Chloasma;

Interaction. The interaction of COCs with other drugs (enzyme inducers) can lead to breakthrough bleeding and / or a decrease in contraceptive efficacy (see "Interaction").

The most commonly reported adverse reactions to Yasmin 21® are nausea and breast pain. They occurred in more than 6% of women using this drug.

Arterial and venous thromboembolism are serious adverse reactions.

The table below shows the frequency of adverse reactions. reported in clinical trials with Yasmin 21® (N = 4897). Within each group, allocated depending on the frequency of occurrence of an adverse reaction, adverse reactions are presented in order of decreasing severity. By frequency, they are divided into frequent (≥1 / 100 and<1/10), нечастые (≥1/1000 и <1/100) и редкие (≥1/10000 и <1/1000). Для дополнительных нежелательных реакций, выявленных только в процессе постмаркетинговых исследований, и для которых оценку частоты возникновения провести не представлялось возможным, указано «частота неизвестна» (см. табл. 1).

Table 1

Adverse events from clinical trials have been codified using the MedDRA (Medical Dictionary of Regulatory Activities, version 12.1). Various MedDRA terms reflecting the same symptom have been grouped together and presented as the only adverse reaction to avoid weakening or blurring the true effect.

* - Approximate frequency based on the results of epidemiological studies covering the group of combined oral contraceptives. Frequency bordering on very rare.

Venous or arterial thromboembolism includes the following nosological units: peripheral deep vein occlusion, thrombosis and embolism / pulmonary vascular occlusion, thrombosis, embolism and infarction / myocardial infarction / cerebral infarction and stroke not defined as hemorrhagic.

For venous and arterial thromboembolism, migraine, see also "Contraindications" and "Special instructions".

Additional Information

Listed below are adverse reactions with a very rare frequency of occurrence or with delayed symptoms, which are believed to be associated with taking drugs from the group of combined oral contraceptives (see also "Contraindications" and "Special instructions").

Tumors:

The frequency of diagnosing breast cancer in women taking combined oral contraceptives is slightly increased. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the number of breast cancer diagnoses in women taking combined oral contraceptives is insignificant in relation to the overall risk of this disease.

Liver tumors (benign and malignant).

Other conditions:

Erythema nodosum;

Women with hypertriglyceridemia (increased risk of pancreatitis while taking combined oral contraceptives);

Increased blood pressure;

Conditions that develop or worsen while taking combined oral contraceptives, but their relationship with taking the drug has not been proven (jaundice and / or pruritus associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; Sydenham's chorea ; herpes of pregnant women; hearing loss associated with otosclerosis);

In women with hereditary angioedema, estrogen intake can cause or worsen its symptoms;

Liver dysfunction;

Impaired glucose tolerance or impact on insulin resistance;

Crohn's disease, ulcerative colitis;

Chloasma;

Hypersensitivity (including symptoms such as rash, hives).

Interaction. The interaction of combined oral contraceptives with other drugs (inducers of liver microsomal enzymes, some antibiotics) can lead to breakthrough bleeding and / or a decrease in contraceptive effectiveness (see "Interaction").

Overdose

Provided in section Overdose Yasmin 21 the information has been compiled on the basis of data about another medicine with exactly the same composition as the medicine Yasmin 21(Drospirenone, Ethinyl Estradiol). Be careful and be sure to check the information on the section Overdose in the instructions for the medicine Yasmin 21 directly from the package or from the pharmacist at the pharmacy.

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Symptoms(identified based on the total experience of using oral contraceptives): nausea, vomiting, spotting spotting or metrorrhagia.

Treatment: symptomatic. There is no specific antidote.

Serious overdose irregularities have not been reported.

Pharmacodynamics

Provided in section Pharmacodynamics Yasmin 21 the information has been compiled on the basis of data about another medicine with exactly the same composition as the medicine Yasmin 21(Drospirenone, Ethinyl Estradiol). Be careful and be sure to check the information on the section Pharmacodynamics in the instructions for the medicine Yasmin 21 directly from the package or from the pharmacist at the pharmacy.

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Film-coated tablets; Pills

Coated tablets

Jess ® is a combined hormonal contraceptive with antimineralocorticoid and antiandrogenic action. The contraceptive effect of COCs is based on the interaction of various factors, the most important of which are suppression of ovulation and changes in the properties of the cervical secretion, as a result of which it becomes impermeable to sperm. If used correctly, the Pearl index (the number of pregnancies per 100 women per year) is less than 1. If tablets are missed or misused, the Pearl index may increase. In women taking COCs, the menstrual cycle becomes more regular, painful periods are less common, and the intensity of bleeding decreases, which reduces the risk of anemia. In addition, according to epidemiological studies, when using COCs, the risk of developing endometrial and ovarian cancer is reduced. Drospirenone contained in Jess ® has an anti-mineralocorticoid effect. It prevents an increase in body weight and the appearance of edema associated with estrogen-induced fluid retention, which ensures good tolerance of the drug. Drospirenone has a positive effect on PMS.

Clinical efficacy of Jess ® has been shown in relieving symptoms of severe PMS, such as severe psychoemotional disorders, breast engorgement, headache, pain in muscles and joints, weight gain and other symptoms associated with the menstrual cycle. Drospirenone also has antiandrogenic activity and helps to reduce the symptoms of acne (acne), oily skin and hair. This action of drospirenone is similar to the action of natural progesterone produced by the body. Drospirenone does not possess androgenic, estrogenic, corticosteroids and antiglucocorticoid activity. All this, in combination with antimineralocorticoid and antiandrogenic action, provides drospirenone with a biochemical and pharmacological profile similar to natural progesterone.

In combination with ethinyl estradiol, drospirenone demonstrates a beneficial effect on the lipid profile, characterized by an increase in HDL cholesterol. Jess ® can be used both in the usual mode (“24 + 4” regimen: taking active pills for 24 days, then taking inactive pills for 4 days), and in a flexible mode.

The adaptable extended regimen (flexible regimen) of the drug Jess ® is based on the previously approved regimen of the drug "24 + 4" and consists in the fact that the active tablets of the drug can be taken daily continuously for up to 120 days. Thus, the continuous period of taking active tablets can be 24-120 days, and the duration of the break in taking the tablets should not exceed 4 days. A flexible mode of administration is possible only with the presence of the Clyk dispenser and flex cartridges that allow you to comply with the drug intake regimen (see "Dosage and Administration"). The results of a multicenter, comparative, open, randomized, parallel group study showed that a flexible Jess ® regimen aimed at achieving a maximum duration of bleeding-free intervals of up to 120 days reduced the total number of menstrual days per year from 66 (24 + 4 regimen) up to 41 days ("flexible" reception mode).

Yasmin 21 ® is a low-dose monophasic oral combined estrogen-gestagenic contraceptive drug.

The contraceptive effect of Yarina ® is mainly carried out by suppressing ovulation and increasing the viscosity of cervical mucus.

The incidence of venous thromboembolism (VTE) in women with or without risk factors for VTE, using ethinyl estradiol / drospirenone-containing oral contraceptives at a dose of 0.03 mg / 3 mg, is the same as in women using levonorgestrel-containing combined oral contraceptives or other combined oral contraceptives ... This was confirmed in a prospective, controlled database study comparing women using oral contraceptives 0.03 mg ethinylestradiol / 3 mg drospirenone with women using other combined oral contraceptives. Analysis of the data revealed the same risk of VTE among the sample.

In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful menstrual bleeding is less common, the intensity and duration of bleeding decreases, as a result of which the risk of iron deficiency anemia decreases. There is also evidence of a reduced risk of endometrial and ovarian cancer.

Drospirenone contained in Yarin® has an anti-mineralocorticoid effect and is able to prevent weight gain and the appearance of other symptoms (eg edema) associated with estrogen-dependent fluid retention. Drospirenone also has antiandrogenic activity and helps to reduce acne (blackheads), oily skin and hair. This effect of drospirenone is similar to that of the natural progesterone produced by the female body. This should be taken into account when choosing a contraceptive, especially for women with hormone-dependent fluid retention, as well as for women with acne (acne) and seborrhea. If used correctly, the Pearl index (an indicator reflecting the number of pregnancies in 100 women using contraceptives during the year) is less than 1. If pills are missed or misused, the Pearl index may increase.

Pharmacokinetics

Provided in section Pharmacokinetics Yasmin 21 the information has been compiled on the basis of data about another medicine with exactly the same composition as the medicine Yasmin 21(Drospirenone, Ethinyl Estradiol). Be careful and be sure to check the information on the section Pharmacokinetics in the instructions for the medicine Yasmin 21 directly from the package or from the pharmacist at the pharmacy.

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Coated tablets

Drospirenone

Absorption

When taken orally, it is rapidly and almost completely absorbed. After a single oral administration, the C max of drospirenone in serum, equal to about 38 ng / ml, is achieved after about 1-2 hours. Bioavailability ranges from 76 to 85%. Compared to taking the substance on an empty stomach, food intake does not affect the bioavailability of drospirenone.

Distribution

After oral administration, a two-phase decrease in serum drug level is observed, with T 1/2 (1.6 ± 0.7) and (27 ± 7.5) h, respectively. Binds to serum albumin and does not bind to ° with SHBG) or corticosteroid-binding globulin (CBG). Only 3-5% of the total serum concentration is present as a free steroid. An increase in SHBG induced by ethinylestradiol does not affect the binding of drospirenone to serum proteins. The average apparent V d is (3.7 ± 1.2) l / kg.

Metabolism

After oral administration, it is metabolized. Most of the metabolites in plasma are acid forms of drospirenone. Drospirenone is also a substrate for oxidative metabolism, catalyzed by the cytochrome P450CYP3A4 isoenzyme.

Excretion from the body

The metabolic clearance rate of drospirenone in serum is (1.5 ± 0.2) ml / min / kg. It is excreted unchanged only in trace amounts. Drospirenone metabolites are excreted in feces and urine in a ratio of approximately 1.2: 1.4. T 1/2 with the excretion of metabolites in urine and feces is approximately 40 hours.

During cyclic treatment, the equilibrium serum C min of drospirenone is reached between the 7th and 14th days of treatment and is approximately 70 ng / ml. There was an increase in serum concentration by about 2-3 times (due to cumulation), which was due to the ratio of T 1/2 in the terminal phase and the dosing interval. A further increase in the concentration of drospirenone in the blood plasma is observed between the 1st and 6th cycles of administration, after which there is no increase in concentration.

Special patient populations

Impact of renal failure: C ss of drospirenone in serum in women with mild renal insufficiency (Cl creatinine = 50-80 ml / min) were comparable to those in women with normal renal function (Cl creatinine> 80 ml / min). In women with moderate renal impairment (Cl creatinine = 30-50 ml / min), the serum level of drospirenone was on average 37% higher than in women with normal renal function. The treatment was well tolerated in all groups. Drospirenone intake did not have a clinically significant effect on serum potassium concentration. The pharmacokinetics of drospirenone in severe renal failure has not been studied.

Impact of liver failure: Drospirenone is well tolerated by patients with mild to moderate hepatic impairment (class B on the Child-Pugh scale). Pharmacokinetics in severe hepatic impairment has not been studied.

Ethinylestradiol

Absorption

After oral administration, it is rapidly and completely absorbed. C max in blood plasma after a single oral administration is achieved in 1-2 hours and is about 88-100 pg / ml. The absolute bioavailability resulting from presystemic conjugation and first-passage metabolism is approximately 60%. Concomitant food intake reduces the bioavailability of ethinyl estradiol in about 25% of the examined subjects, while in other subjects similar changes were not observed.

Distribution

The concentration of ethihyl estradiol in serum decreases in two phases, the terminal phase is characterized by a T 1/2 of about 24 hours. It is very significantly, but not specifically, associated with serum albumin (about 98.5%) and causes an increase in the concentration of SHBG in blood plasma. The apparent Vd is about 5 l / kg.

Metabolism

Ethinylestradiol undergoes presystemic conjugation in the mucous membrane of the small intestine and liver. Ethinylestradiol and its oxidative metabolites are primarily conjugated with glucuronides or sulfate. The metabolic clearance rate of ethinyl estradiol is about 5 ml / min / kg.

Excretion from the body

Ethinylestradiol is practically not excreted unchanged. Ethinyl estradiol metabolites are excreted by the kidneys and through the intestines in a ratio of 4: 6. T 1/2 of metabolites is approximately 24 hours.

The C ss state is achieved during the second half of the treatment cycle, and the concentration of ethinyl estradiol in the blood plasma increases by about 1.5-2.3 times ..

Preclinical safety data

Preclinical data obtained in the course of standard studies for the detection of toxicity with repeated doses of the drug, as well as genotoxicity, carcinogenic potential and toxicity to the reproductive system, do not indicate the presence of a particular risk to humans. However, it should be remembered that sex steroids can promote the growth of some hormone-dependent tissues and tumors.

Drospirenone

When taken orally, drospirenone is rapidly and almost completely absorbed. After a single oral administration, the C max of drospirenone in serum, equal to 37 ng / ml, is achieved after 1-2 hours. Bioavailability ranges from 76 to 85%. Food intake does not affect the bioavailability of drospirenone.

Drospirenone binds to serum albumin (0.5-0.7%) and does not bind to sex hormone binding globulin (SHBG) or corticosteroid binding globulin (CABG). Only 3-5% of the total concentration in the blood serum is in free form. An increase in SHBG induced by ethinylestradiol does not affect the binding of drospirenone to plasma proteins.

After oral administration, drospirenone is completely metabolized.

Most of the metabolites in plasma are represented by acidic forms of drospirenone, which are formed without the involvement of cytochrome P450.

The concentration of drospirenone in blood plasma decreases in 2 phases. Drospirenone is not excreted unchanged. Drospirenone metabolites are excreted by the kidneys and through the intestines in a ratio of approximately 1.2-1.4. T 1/2 for the excretion of metabolites in the urine and feces is approximately 40 hours.

During cyclic treatment, the maximum equilibrium serum concentration of drospirenone is reached in the second half of the cycle.

A further increase in the serum concentration of droperinone is noted after 1-6 cycles of administration, after which an increase in concentration is not observed.

Additional information for special categories of patients

Patients with liver disorders. In women with moderate hepatic impairment (class B on the Child-Pugh scale), the AUC is comparable to the corresponding indicator in healthy women with similar C max values ​​in the absorption and distribution phases. T 1/2 of drospirenone in patients with moderate hepatic dysfunction was 1.8 times higher than in healthy volunteers with intact liver function.

In patients with moderate hepatic dysfunction, there was a 50% decrease in drospirenone clearance compared with women with intact liver function, while there were no differences in the concentration of potassium in the blood plasma in the studied groups. When diabetes mellitus is detected and the concomitant use of spironolactone (both conditions are regarded as factors predisposing to the development of hyperkalemia), an increase in the concentration of potassium in the blood plasma has not been established.

It should be concluded that drospirenone is well tolerated in women with mild to moderate hepatic impairment (class B on the Child-Pugh scale).

Patients with renal impairment. The concentration of drospirenone in the blood plasma upon reaching an equilibrium state was comparable in women with mild renal impairment (Cl creatinine - 50-80 ml / min) and in women with intact renal function (Cl creatinine -> 80 ml / min). Nevertheless, in women with moderate renal impairment (Cl creatinine - 30-50 ml / min), the mean plasma concentration of drospirenone was 37% higher than in patients with intact renal function. Drospirenone was well tolerated by all groups of patients. There was no change in the concentration of potassium in the blood plasma with the use of drospirenone.

Ethinylestradiol

After oral administration, ethinyl estradiol is rapidly and completely absorbed. C max in blood plasma, equal to about 54-100 pg / ml, is achieved in 1-2 hours. During absorption and first passage through the liver, ethinyl estradiol is metabolized, as a result of which its oral bioavailability is, on average, about 45%.

Ethinylestradiol is almost completely (approximately 98%), although nonspecifically, bound to albumin. Ethinylestradiol induces the synthesis of SHBG.

Ethinylestradiol undergoes presystemic conjugation, both in the mucous membrane of the small intestine and in the liver. The main metabolic pathway is aromatic hydroxylation.

The decrease in the concentration of ethinyl estradiol in the blood plasma is biphasic. It is not excreted unchanged from the body. Ethinyl estradiol metabolites are excreted in the urine and bile in a ratio of 4: 6 with a T 1/2 of about 24 hours.

Interaction in the instructions for the medicine Yasmin 21 directly from the package or from the pharmacist at the pharmacy.

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Coated tablets

The effect of other drugs on Jess ®

Interaction with drugs that induce microsomal enzymes is possible, as a result of which the clearance of sex hormones can increase, which, in turn, can lead to breakthrough uterine bleeding and / or a decrease in the contraceptive effect. Women who receive treatment with such drugs in addition to Jess ® are advised to use a barrier method of contraception or choose another non-hormonal method of contraception. The barrier method of contraception should be used during the entire period of taking concomitant medications, as well as within 28 days after their cancellation. If the period of using the barrier method of contraception ends later than the active tablets in the Jess ® package, you should start taking the Jess ® tablets from a new package without interruption in taking the active tablets.

Substances that increase the clearance of Jess ® (weakening the effectiveness by induction of enzymes): phenytoin, barbiturates, primidone, carbamazepine, rifampicin and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin, as well as preparations containing St. John's wort.

Substances with different effects on the clearance of Jess ®... When used together with Jess ®, many HIV protease inhibitors or hepatitis C virus and NNRTIs can both increase and decrease the concentration of estrogens or progestins in the blood plasma. In some cases, this effect may be clinically significant.

Substances that reduce the clearance of COCs (enzyme inhibitors). Strong to moderate CYP3A4 inhibitors such as azole antimycotics (eg itraconazole, voriconazole, fluconazole), verapamil, macrolides (eg clarithromycin, erythromycin), diltYasmin 21em, and grapefruit juice may increase plasma concentrations of estrogen, or both.

It has been shown that etoricoxib at doses of 60 and 120 mg / day, when taken together with COCs containing 0.035 mg of ethinyl estradiol, increases the concentration of ethinyl estradiol in blood plasma by 1.4 and 1.6 times, respectively.

The effect of Jess ® on other drugs

COCs can affect the metabolism of other drugs, which leads to an increase (for example, cyclosporine) or a decrease (for example, lamotrigine) their concentration in blood plasma and tissues. In vitro drospirenone is able to weakly or moderately inhibit the cytochrome P450 enzymes CYP1A1, CYP2C9, CYP2C19 and CYP3A4.

in vivo in female volunteers who took omeprazole, simvastatin or midazolam as marker substrates, it can be concluded that a clinically significant effect of 3 mg drospirenone on drug metabolism mediated by cytochrome P450 enzymes is unlikely.

In vitro ethinyl estradiol is a reversible inhibitor of CYP2C19, CYP1A1 and CYP1A2, as well as an irreversible inhibitor of CYP3A4 / 5, CYP2C8 and CYP2J2. In clinical trials, administration of a hormonal contraceptive containing ethinyl estradiol did not lead to any increase or led to only a slight increase in the concentration of CYP3A4 substrates in blood plasma (for example, midazolam), while plasma concentrations of CYP1A2 substrates may increase slightly (for example, theophylline) or moderately (eg melatonin and tizanidine).

Other forms of interaction

In patients with intact renal function, the combined use of drospirenone and ACE inhibitors or NSAIDs does not have a significant effect on the concentration of potassium in the blood plasma. However, the combined use of Jess ® with aldosterone antagonists or potassium-sparing diuretics has not been studied. In such cases, the concentration of potassium in the blood plasma must be monitored during the first cycle of taking the drug (see "Special instructions").

The interaction of oral contraceptives with other drugs can lead to breakthrough bleeding and / or a decrease in contraceptive reliability. Women taking these drugs must temporarily use barrier methods of contraception in addition to Yasmin 21®, or choose another method of contraception.

The following interactions have been reported in the literature.

Effect on hepatic metabolism. The use of drugs that induce liver microsomal enzymes can lead to an increase in the clearance of sex hormones, which in turn can lead to breakthrough bleeding or a decrease in the reliability of contraception. These drugs include: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, rifabutin, possibly also oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John's wort.

HIV protease inhibitors(such as ritonavir) and non-nucleoside reverse transcriptase inhibitors(eg nevirapine) and combinations thereof can also potentially affect hepatic metabolism.

Effect on intestinal-hepatic circulation... According to some studies, some antibiotics (for example, penicillins and tetracycline) can reduce the intestinal-hepatic circulation of estrogens, thereby lowering the concentration of ethinyl estradiol.

During the reception drugs that affect microsomal enzymes, and within 28 days after their cancellation, you should additionally use a barrier method of contraception.

During the reception antibiotics(such as penicillins and tetracyclines) and within 7 days after their cancellation, you should additionally use a barrier method of contraception. If during these 7 days of the barrier method of contraception the tablets in the current package run out, then you should start taking the tablets from the next package of Yarina ® without the usual interruption in taking the tablets.

The main metabolites of drospirenone are formed in plasma without the participation of the cytochrome P450 system. Therefore, the effect of inhibitors of the cytochrome P450 system on the metabolism of drospirenone is unlikely.

Combined oral contraceptives can interfere with the metabolism of other drugs, resulting in an increase (for example, cyclosporine) or a decrease (for example, lamotrigine) in plasma and tissue concentrations.

Based on interaction studies in vitro as well as research in vivo on female volunteers taking omeprazole, simvastatin and midazolam as markers, it can be concluded that the effect of drospirenone at a dose of 3 mg on the metabolism of other medicinal substances is unlikely.

There is a theoretical possibility of an increase in serum potassium levels in women receiving Yarina® at the same time as other drugs that can increase serum potassium levels. These drugs include angiotensin II receptor antagonists, certain anti-inflammatory drugs, potassium-sparing diuretics, and aldosterone antagonists. However, in studies evaluating the interaction of drospirenone with ACE inhibitors or indomethacin, there was no significant difference between serum potassium concentration compared with placebo.

03.04.2004, 04:26

I found very few reviews about them on other sites. Here they are, I quote in part:

1. I have been taking contraceptives for 3 years, first Orthocyclen, then Mersilon, and then Yasmin (by the way, it is produced by Italy, at least the Israeli version). There have never been any side effects. But the difference, of course, is felt. Yasmin is beyond competition. No pain, no PMS, the "red days of the calendar" are shorter and there is less discharge. (sorry for the details). And most importantly, Yasmin does not contain progesterone, which is exactly the factor that increases the risk of blood clots.
It is reliably known about Diana pills (and some others, I do not know the names) that they can lead to the formation of nodules in the chest, this has been scientifically proven.
Of course, blood tests must be done before taking the pills, and then at least once a year.

2. Tell me, is anyone taking the new Yasmin tablets? They seem to have appeared on sale a year ago, but here in Italy - only two months. I have heard a lot of positive things about them: they lose weight, and the water does not linger, and there is practically no PMS ... Today I visited my gynecologist and asked about them. The doctor told me that in addition to all of the above, they also reduce the feeling of hunger and the hormones in them are even less. My tests are all right, so they were prescribed to me. How to start a new package - I'll tell you about the "miracle"!

And another question - where can you buy them in Moscow and how much do they cost?

03.04.2004, 18:05

You found few reviews because in Russia they go under the name Janine, but they are the same. I accepted - no side effects, very happy.

wild Orchid

03.04.2004, 19:45

Are they even better (if you can compare) Logest? Are there less hormones? I took Logest, and now, after the spiral, I was advised again Logest or Janine, but I don't know which one to choose ...

03.04.2004, 20:15

If this is Janine, as written above, then I can say that the pills are super! I lost so much weight on them after giving birth that I now weigh it like at 16 :-), I can't even believe it. however, the instructions say that you should not smoke while taking the pills, because the risk of blood clots increases. It means that he still exists.

03.04.2004, 21:29

If we are talking about Zhanina, then I will subscribe :) I drink for a year 100% satisfied No complaints and side effects :)

03.04.2004, 22:57

Are you absolutely sure of this? It's just that I found an article about Yasmin two years ago that this is a new OK and its advantage is that it doesn't make you fat. Here is the link http://www.medinfo.ru/news/worldnews/world-19-04-2002-4.php3 Janine new OK? And in English the name Janine is JEANINE (found on the site).

03.04.2004, 23:13

Is it sold by prescription in Moscow or free?

04.04.2004, 00:53

and for this month, what are your feelings about side effects, completeness, etc.?

I've just found here information about what Yasmin is called in Russian Yarina (???) http://www.doctor-sex.ru/enciklop/ginekolog/kontracepc.html

In Russian pharmacies I did not find either Russian or English names. :-(

04.04.2004, 07:51

about the fullness, tk. I got fat for a long time, but I didn't seem to gain weight :-). I can’t say for sure, either. the whole month I was ill with colds and felt terrible, but from what - I can not say. Plus, I have a lot of other medications. My gynecologist was very complimentary. I can't say anything at all yet. Ask in a couple of months :-).

04.04.2004, 10:53

Free.

04.04.2004, 16:22

I never took a pill, I'm a little afraid to tell

04.04.2004, 16:36

Are you in the states? Did the doctor tell you anything about a break when taking OK? I read in one source what is needed in tech. to take a two-month break for a year, in another that a year to take and then take a break, all Russian gynecologists unanimously say that breaks are needed. My doctor assures me that there is no need to take any breaks. And I took it for 5 months, maybe I will take a break for 2 months, and in Russia I will already try the much-praised Janine. Here in thought ...

04.04.2004, 16:48

For me personally, nothing good. I accept it because endometriosis is suspected, otherwise I would not do it. True, I tried only one pill, but there were enough side pills, one of which was to start gaining weight. :-( About Janine I haven't heard anything bad yet, maybe I'll go over to them. My American doctor claims that you need to try different ones to find those that suit me. But you need to try every OK for 3 or more months, maybe all these side effects after 3 months supposedly go away. So you can look for suitable OK for years. There are sites that describe the positive effects of OK, for example http://www.doctor-sex.ru/enciklop/ginekolog/kontracepc. But after reading the annotation to any OK you can see that side the effects from them are ten times more positive. So, without the need, I would not.

The site provides background information for informational purposes only. Diagnosis and treatment of diseases must be carried out under the supervision of a specialist. All drugs have contraindications. A specialist consultation is required!

Once the Duke of Tuscany, who owned the only bush in Italy jasmine, forbade his gardener to pick and give anyone the shoots of this plant. The gardener honored his master's desire exactly until the day he fell in love with a beautiful girl. It was to her that he first gave a bouquet of jasmine branches, which she planted in her garden. Since then, jasmine in Italy has become a symbol of love, and love, which is not afraid of any barriers or prohibitions. There are many legends about jasmine. They all turn this flower into a sacred plant.

Description and chemical composition of the plant

Jasmine is an evergreen shrub with curly stems and flowers clustered in star-shaped inflorescences. Jasmine leaves can be simple, trifoliate and pinnate, opposite or alternate. The flowers of this plant are white, yellow or red. Arabia and East India are considered the birthplace of jasmine. Jasmine contains: essential oil, salicylic, benzoic, formic and other acids. Salicylic acid gives jasmine its anti-inflammatory properties. Benzoic acid has an antiseptic effect. Eugenol, which is part of jasmine, has an inherent antibacterial effect.

What pathologies will jasmine help?

Due to all these, as well as many other components, jasmine has found its widespread use in both traditional and folk medicine. For medicinal purposes, flowers, leaves, roots and shoots, as well as the seeds of this plant, are used. Jasmine is part of some dietary supplements (BAA). Let's start with its use in traditional medicine. Being a part or being in the base of the drug, jasmine is used for hepatitis, cirrhosis of the liver, for strengthening the nervous system, in the fight against insomnia, and for apathy. Quite often, these drugs are used to reduce headaches, pain in the abdomen, to alleviate the condition of a woman in labor, as well as in the fight against various diseases of the uterus.

Traditional medicine uses jasmine to wash the eyes, cleanse the blood, treat scurvy and rheumatism, and make cough syrup. Chronic bronchitis and bronchial asthma are two more diseases that can be treated with a decoction of jasmine flowers and leaves. If you take a jasmine leaf, grind it and attach it to a tumor or corn, then after 3 to 4 days they will completely disappear. A decoction of jasmine leaves will help you with colitis and dysentery, as well as colds and tuberculosis.

Jasmine recipes

The site's medical board wants to present you with several recipes that include jasmine. The first such recipe will be a prescription for the treatment of bronchitis and bronchial asthma. For it, you need to take one tablespoon of chopped dry young branches and leaves of jasmine and pour 200 ml of water over them, then boil for a maximum of five minutes. The infusion must be left for 60 minutes, after which it will need to be filtered. An infusion of jasmine is taken in the fight against bronchitis and bronchial asthma, one to two tablespoons in the morning, at lunchtime and in the evening.

There is another way to make jasmine tincture. For him, you will need to take one hundred grams of fresh jasmine flowers and fill them with one hundred milliliters of alcohol. Leave this infusion for a week, strain and use for applying lotions for skin diseases. Before using this infusion, it is necessary to dilute one teaspoon of this infusion into half a glass of boiled cold water.

Quite often we suffer from chapped skin on our hands. To combat this problem, you need to prepare the following jasmine remedy. Pour jasmine, rose, and linden petals into the bottle and cover it all with corn oil. Leave to infuse for half an hour, then lubricate the skin of your hands with the oil obtained.

Use jasmine and be healthy!

Jasmine is a tropical plant that does not grow in our area. The Indians call this flower "moonlight", thus emphasizing its graceful inflorescences and wonderful scent.

Jasmine with yellow flowers is not used for medicinal purposes at all. Plants with very large semi-double flowers are also unsuitable. Exceptionally multi-flowered or medicinal jasmine is beneficial.

Healing properties

Almost all parts of this plant have medicinal properties, from the root to the flowers. Salicylic acid is anti-inflammatory. This plant is also a good antiseptic thanks to benzoic acid, and equenol provides antibacterial action.

Jasmine is widely used in medicine. For example, this plant is necessary for the manufacture of medicines for hepatitis, cirrhosis of the liver, and is also used for abdominal pain. With the help of jasmine, you can also suppress apathy, normalize sleep and strengthen the nervous system.

Preparations based on this plant are also used for low blood pressure and allergy outbreaks. In folk medicine, jasmine is used to treat scurvy, rheumatism, to cleanse the blood and wash the eyes. A decoction of flowers and leaves of this plant is widely used in the treatment of chronic bronchitis and bronchial asthma.

The aroma of jasmine also has a beneficial effect on the nervous system, it is able to lift the mood and give a feeling of joy. That is why the oil of this plant is widely used in aromatherapy. You should not inhale the smell of jasmine for a long time, as it may cause a headache. In this regard, it is not recommended to spray the scent of jasmine in the bedroom.

A properly prepared decoction from the flowers of this plant can increase the secretion of breast milk, and a decoction from the leaves can stop it.

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A decoction from this plant helps with dysentery and colitis. On one leaf of the plant, you need to take a glass of boiling water, pour it over it and boil for 2 minutes. You need to take 2 tablespoons of the broth three times a day before meals.

With bronchial asthma or bronchitis, you need to take a tablespoon of dry shoots and jasmine leaves, grind them and pour a glass of boiling water. Boil the infusion for 5 minutes and leave it for an hour, then strain. You need to take 2 tablespoons of the infusion three times a day before meals.

With a strong cough, you need to take syrup from the flowers of this plant. Pour half a glass of flowers with a glass of boiling water and boil for 4 minutes. After that, you need to quickly strain and squeeze out the flowers, add half a glass of sugar to the broth and heat to dissolve the sugar. You need to take 1 teaspoon of syrup three times a day.

An infusion of fresh flowers of jasmine and lavender helps from insomnia and nervous overexcitement. You need to take 2 tablespoons of herbs and pour them with a liter of boiling water, cover and leave for half an hour, then strain. You need to take a bath with this infusion.

Jasmine tea will help relieve fatigue. It is enough to mix dry jasmine flowers with green tea and drink it in the morning to feel cheerfulness again.

Jasmine will also help get rid of blisters and swellings. It is enough to knead one leaf of this plant well and tie it to a sore spot, changing the bandage every 6 hours.

Beauty recipes

In the fight against chapped skin of the hands, cosmetic oils from linden, rose petals, jasmine and corn oil are useful. All ingredients must be mixed and left in the sun for 3 hours, then stored in the refrigerator.

A tonic infusion of green tea with jasmine will also be useful. If you have oily or inflammation-prone skin, wipe it with this infusion in the morning and in the evening. You can also freeze it in ice cube trays and wipe your face and décolleté with ice cubes.

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Jasmine useful properties and contraindications - recipes for use

Jasmine is a shrub with fragrant flowers. It is believed that the presented plant originated in India and Arabia. Thanks to the fragrant aroma of flowers, jasmine is able to keep a person in a vigorous state for a long time. In addition, the jasmine plant has many other beneficial properties.

Useful properties of jasmine

It has been proven that the scent of flowers has a beneficial effect on a person as a whole. Catching their aroma, active processes begin in the body. As a result, the nervous system calms down, the feeling of anxiety goes away, depression evaporates, sleep is normalized, a person feels better in general. In addition, during the inhalation of the smell, an improvement in human brain activity is observed, a feeling of harmony and happiness is formed.

Jasmine is actively used by both folk and traditional medicine. It should be noted that different parts of the flower are used for the use of drugs, but all of them are involved. This is due to the fact that absolutely all of its parts have useful properties.

Thus, the leaves are actively used as an antipyretic agent. They are also used to treat ulcers with compresses. It's no secret that jasmine flowers are added to teas. As a result, not only the aroma of the drink improves, but also the person receives useful substances.

As a rule, the root of the plant is used raw in folk medicine. So, it allows you to fight painful sensations, insomnia, headache. It is accepted that the essential oil of the presented plant has the properties of a strong antidepressant. Due to this, it is able to combat feelings of anxiety and anxiety.

Existing contraindications

As such, the presented plant has no contraindications. However, there is a not unfounded opinion that the presented plant is capable of causing any harm if consumed in pure form. In other words, the jasmine decoction is 100 percent and will not be diluted with anything. Then allergic reactions of any kind may occur.

That is why it is recommended to consume jasmine internally only as an additive to tea. In this case, the occurrence of an allergy is unlikely. However, there is another contraindication to use - individual intolerance to the product.

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Female interest

Since ancient times, people have used herbs to cure ailments. In every village there were herbalists who healed the sick. The secrets of making tinctures and decoctions passed from one generation to another. Until now, our grandmothers use herbs instead of pharmaceutical preparations. This article will describe jasmine officinalis. The aroma of this flower is unique and amazing. He is called "The King of Smells", "Moonlight of Love", "The Scent of Bliss."

Jasmine is a genus of shrubs from the olive family. Asia Minor and China are considered its homeland. Jasmine is Pakistan's national flower. It is used as a decoration for weddings in Indonesia. In addition to the amazing smell and beautiful flower, jasmine has useful and medicinal properties.

Useful properties of jasmine

Antiseptic. The growth and development of microorganisms is suppressed.

Pain relievers.

Soothing, mood-enhancing.

Jasmine indications

Depression, stress.

Insomnia.

Wounds, dermatitis, eczema, other damage to the skin epithelium.

Hormonal imbalance in the body. Disruption of the endocrine system.

Headache.

Bronchial asthma, bronchitis.

Jasmine, whose beneficial properties are remarkable, is usually used in the form of an infusion, decoction, essential oil, tea. The most common way to use it is green tea with this plant. It helps a person to cope with emotional stress, improves mood, and increases efficiency. Its scent inspires new achievements and victories.

Jasmine green tea recipe

To prepare this drink you will need: 0.5 tbsp. jasmine and 1 tbsp. black or green tea. Mix the ingredients and boil with boiling water. Insist for 10 minutes. Add honey or lemon.

Compresses and lotions are used to treat wounds. One glass of water needs 3 tsp. this flower.

For inflammatory processes on the face with oily or combination skin (acne, rash, pustules), use a mask.

Face mask recipe

To prepare the mask, you need 3 tablespoons. jasmine flowers. They must be ground to a state of gruel. Then mix the resulting mixture with 100 gr. butter. Apply to problem areas and remove after 10-15 minutes. Use externally.

Jasmine essential oil, which also has beneficial properties, has a beneficial effect on the body. It soothes, improves mood, and helps relieve headaches. In combination with other oils, it is used as an aphrodisiac.

People with asthma or bronchitis are prescribed jasmine inhalations.

Jasmine - Contraindications

Each plant has contraindications and side effects for use. Jasmine, despite the beneficial properties of soy, has contraindications. Therefore, it is better to start using small amounts. Carefully monitor your feelings and health conditions.

1. Jasmine essential oil in high concentration or high doses (instead of 5 drops 15) leads to headaches and nosebleeds.

2. May cause allergic reactions.

3. The period of pregnancy and lactation.

4.Children under 6 years old (if inside).

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What are the medicinal properties of Jasmine?

The use of jasmine is extremely diverse. Jasmine can be found as a constituent part in cosmetic and perfumery products, in medical products. In cosmetics, jasmine oil is added not only to impart aromatic properties (which are simply amazing) but also to affect the skin, jasmine oil, blending into the surface of the skin, has a cleansing effect, tones the skin, helping to smooth out wrinkles on the face. The use of jasmine oil in the production of shampoo, shower gel, bath foam is a popular decision of manufacturers, the trend of which has become the positive characteristics of the population using products containing jasmine. Research centers of scientific medicine have identified general statistical indicators of the effect of jasmine on humans, which include stabilization of the nervous system (regardless of what jasmine is part of), a relaxing effect. The use of jasmine in medicine is due to the following indicators: removal of nervous tension, stimulation of sexual activity (regardless of gender), normalization of sleep, removal of muscle spasms, elimination of colic, treatment of hypertension (affects pressure reduction), normalizes the menstrual cycle in women due to effects on the endocrine glands, sedation, disinfection, anti-inflammatory effect, anti-allergic effect.

For preventive solutions, jasmine is used in aroma lamps, which are not difficult to acquire. The prevention effect of the "jasmine" aroma lamp is to achieve calming of the nervous system, mental balance and balance, improving the functioning of the respiratory system. To prepare the solution, pour boiled water into a container of an aroma lamp and add three drops of jasmine oil there. There is another version of the "jasmine" aroma lamp, which is no less effective. For this, dried jasmine flowers are taken, crushed to a powdery state, then about half a glass of boiling water is added to 1 tablespoon of "jasmine powder" (the amount of water added depends on what concentration of jasmine infusion you want to obtain), the resulting solution is thoroughly mixed and aged about one hour. Before pouring the infusion into the capacity of the aroma lamp, the solution must be thoroughly filtered, this is due to the design of the aroma lamp, which is an electrical appliance in which the heating element is located.