Janine is a low-dose monophasic oral contraceptive with antiandrogenic properties.

Release form and composition

The dosage form of Janine is dragees: smooth, white (21 pieces in blisters, 1 or 3 blisters in a cardboard pack).

• Dienogest – 2 mg;
• Ethinyl estradiol – 0.03 mg.

Auxiliary components: potato starch, lactose monohydrate, gelatin, magnesium stearate, talc.

Shell composition: calcium carbonate, sucrose, macrogol 35,000, dextrose, polyvidone K25, carnauba wax, titanium dioxide (E171).

Pharmacological properties

Pharmacodynamics

Janine is a monophasic low-dose combined estrogen-progestogen oral contraceptive drug. Its contraceptive effect is achieved through complementary mechanisms, the most important of which are inhibition of ovulation and increased viscosity of cervical mucus, ensuring impermeability to sperm.

The use of Zhanin in compliance with the recommended dosage regimen ensures that the Pearl index (the number of pregnancies per 100 women taking this contraceptive throughout the year) is less than one. Skipping a pill or using it incorrectly may increase this value.

Dienogest is a gestagenic component in Janine, has clinically proven antiandrogenic activity and helps improve the lipid profile of the blood, increasing the amount of HDL (high-density lipoprotein) in its composition.

Taking combined oral contraceptives regulates the menstrual cycle, inhibits the intensity and duration of menstrual bleeding, thereby reducing the risk of developing iron deficiency anemia (IDA), relieves pain, and also reduces the risk of developing endometrial and ovarian cancer.

Pharmacokinetics

Pharmacokinetic characteristics of dienogest:

• absorption: after oral administration, the substance is quickly and completely absorbed from the gastrointestinal tract. The maximum concentration (Cmax) is 51 ng/ml, achieved 2.5 hours after taking the pill; bioavailability is ~96%;
• distribution: binding to blood proteins (up to 90% nonspecifically bound to serum albumin), dienogest does not interact with SHBG (sex steroid-binding globulin) and CSG (corticoid-binding globulin). Up to 10% of the substance is found in the blood serum in free form. Induction of SHPS synthesis by ethinyl estradiol does not affect the binding of dienogest to serum protein, and the serum level of SHPS does not affect the pharmacokinetics of dienogest. Daily intake of tablets increases the serum concentration of dienogest by approximately 1.5 times;
• metabolism; dienogest is almost completely metabolized, its clearance after taking a single dose is approximately 3.6 l/h;
• excretion: half-life (T 1/2) is ~ 8.5–10.8 hours; a small part is excreted unchanged through the kidneys, metabolites are excreted in bile and urine in a ratio of approximately 1 to 3, half-life of metabolites is 14.4 hours.

Pharmacokinetic characteristics of ethinyl estradiol:

• absorption: after oral administration, the hormone is quickly and completely absorbed from the gastrointestinal tract. The maximum concentration (Cmax) is 67 pg/ml, achieved 1.5–4 hours after taking the pill; during absorption and during presystemic elimination (the effect of the first passage through the liver) as a result of metabolic transformations of ethinyl estradiol, its bioavailability is ~ 44%;
• distribution: almost completely (up to 98%) ethinyl estradiol binds nonspecifically to serum albumin, the hormone induces the synthesis of SHBG. Its apparent volume of distribution (Vd) varies from 2.8 to 8.6 l/kg. Ethinyl estradiol reaches steady-state concentration in the blood (C ss) in the second half of the therapeutic cycle;
• metabolism: during presystemic conjugation in the mucous membrane of the small intestine and in the liver, ethinyl estradiol undergoes aromatic hydroxylation. The plasma clearance rate is 2.3–7 ml/min/kg;
• excretion: the decrease in the serum level of ethinyl estradiol is divided into two stages: the first stage - T1/2 is ~1 hour, the second stage - the T1/2 indicator is from 10 to 20 hours. The hormone is not excreted from the body unchanged, its metabolites are excreted with bile and urine in a ratio of approximately 6 to 4, T1/2 of metabolites is 24 hours.

Indications for use

The use of Zhanine is indicated for women as oral contraception.

Contraindications

• Diabetes mellitus with vascular complications;
• Venous and arterial thrombosis (including pulmonary embolism), deep vein thrombosis, cerebrovascular disorders, myocardial infarction (history or current);
• Diseases of the coronary arteries of the heart or cerebral vessels, complicated lesions of the valvular apparatus of the heart, uncontrolled arterial hypertension, atrial fibrillation, smoking over the age of 35 years, major surgery with prolonged immobilization and other severe risk factors for arterial or venous thrombosis;
• Angina pectoris, transient ischemic attacks and other conditions preceding thrombosis (history or current);
• Severe liver diseases and liver failure (until liver tests normalize);
• Pancreatitis with severe hypertriglyceridemia (history or current);
• Benign or malignant liver tumor (history or current presence);
• Migraine with neurological focal symptoms (history or current);
• Vaginal bleeding of unknown etiology;
• Malignant hormone-dependent diseases of the mammary glands or genital organs (diagnosed or suspected);
• Pregnancy period or suspicion of it;
• Breastfeeding period;
• Hypersensitivity to the components of the drug.

If any of the listed conditions appear while using Zhanine, the drug should be discontinued immediately.

According to the instructions, Janine should be taken with caution, only after assessing the expected benefits and potential risks of taking it, for the following diseases and conditions:

• Liver diseases;
• The presence of risk factors for the development of thrombosis and thromboembolism: obesity, smoking, dyslipoproteinemia, migraine, arterial hypertension, heart valve defects, extensive trauma, major surgical interventions, prolonged immobilization, hereditary predisposition to thrombosis, the presence of a disorder in one of the immediate family at a young age cerebrovascular accident or myocardial infarction;
• Hereditary angioedema;
• Diabetes mellitus, hemolytic uremic syndrome, Crohn's disease, systemic lupus erythematosus, ulcerative colitis, sickle cell anemia, phlebitis of superficial veins;
• Hypertriglyceridemia;
• The period after childbirth;
• Cholestasis, jaundice, gallbladder disease, porphyria, Sydenham's chorea, otosclerosis with hearing impairment, herpes of pregnant women and other pathologies that worsened or arose during previous hormonal contraception or during pregnancy.

Instructions for use of Janine: method and dosage

Dragee Janine is taken orally with a small amount of water.

The order of administration is indicated on the package, the dosage of the drug is 1 tablet per day, always at the same time, for 21 days. Then, during a seven-day break, menstrual-like withdrawal bleeding occurs, which can begin 2-3 days after taking the last pill and continue until the start of the next package.

In the absence of hormonal contraception in the previous month, you should start taking Zhanine on the 1st day of menstrual bleeding (cycle). If treatment is started on days 2-5 of the cycle, it is necessary to use barrier contraception for the first 7 days after starting to take the tablets from the first package.

When switching from combined oral contraceptives, Janine should be taken the next day after taking the last tablet with the active substance of the previous drug (for a calendar pack of 28 tablets) and no later than the next day after the usual 7-day break (for preparations containing 21 tablets).

When switching from a transdermal patch or vaginal ring, it is advisable to start taking Zhanine on the day of their removal, but no later than the day of the supposed new application of the patch or insertion of the ring.

When switching from an injectable contraceptive, pills should be taken on the day of the expected next injection; from contraceptives consisting only of gestagens (“mini-pill”) - any day, without a break; from an implant or intrauterine contraceptive - on the day of their removal. In each of these cases, in the first 7 days of taking the pill, it is necessary to additionally use a barrier method of contraception.

Taking Zhanine after an abortion in the first trimester of pregnancy can be started immediately, without additional contraception.

After an abortion in the second trimester of pregnancy or childbirth, Zhanine is recommended to be used only from 21 to 28 days; in case of a later start of use, additional barrier methods of contraception are required during the first 7 days of taking the pill. Women who had sexual intercourse between abortion or childbirth and the start of taking Janine tablets should wait until their first menstrual bleeding or exclude pregnancy.

Janine provides reliable contraceptive protection when taken continuously at strictly prescribed times. The effect of the drug is not reduced if the delay is less than 12 hours; the missed pill should be taken as soon as you remember, and the next pill at the usual time.

It is also necessary to take into account that the break in taking Janine should never exceed more than 7 days, and for normal suppression of the hypothalamic-pituitary-ovarian system, continuous use of the pill is required for 7 days.

If the delay in taking was more than 12 hours (that is, more than 36 hours from the moment of taking the last active pill) in the first week of using Janine, the missed pill should be taken as soon as possible, even if it is necessary to take two pills at the same time. The next tablet is taken at the prescribed time, and for the next 7 days a barrier method of contraception should be used.

If a woman had sexual intercourse in the next week before missing the pills, the risk of pregnancy increases. The likelihood of pregnancy depends on the number of pills missed and how close this happened to the expected break in taking.

If the delay was more than 12 hours in the second week of using Janine, the missed pill should be taken as soon as possible, even if it requires taking two pills at the same time, and the next pill should be taken according to the schedule at the usual time. Women who take the drug regularly for 7 days before the first missed tablet do not require additional contraceptive measures. Otherwise, if more than two pills are missed, barrier methods of contraception must be used over the next 7 days.

If a delay of more than 12 hours occurs in the third week of taking Zhanine, the likelihood of pregnancy increases due to the upcoming break in taking the pill. Women who took everything else correctly before the first missed tablet do not require additional methods of contraception. Further use of Janine should be carried out according to one of the following options:

1. You can stop taking it from the current package, take a 7-day break, including the missed day, and start taking it from a new package. If during the break the woman does not experience withdrawal bleeding, pregnancy must be excluded;
2. The second option is used if the woman decides to continue taking from this package. First of all, you should take the missed pill as soon as possible, even if you need to take two pills at the same time, the next pills are taken according to the schedule at the usual time before the end of the package. Without taking a break, you must start the next package of Janine. Before it ends, menstrual-like bleeding is unlikely, but breakthrough bleeding or spotting may occur.

If a woman has diarrhea or vomiting within the first 4 hours after taking the pills, absorption of the active substances may be incomplete, so additional protective measures should be taken, based on the recommendations when skipping pills.

To change the onset of menstruation to another day of the week, you need to shorten the break in taking pills from the nearest package by the desired number of days. The shorter the interval, the greater the risk of absence of withdrawal bleeding and the presence of spotting and breakthrough bleeding during the period of taking the second package.

In order to delay the onset of menstruation, a woman can continue taking pills from a new package without interrupting the previous one. You can continue taking it for as long as the woman wishes, right up to the end of the pill. While taking the second package in a row, a woman may experience breakthrough uterine bleeding or spotting. The use of Janine from a new package should be resumed after the usual 7 days break.

For children and adolescents, the use of the drug is indicated only after the onset of menarche.

You should not take Janine after menopause.

In women with impaired renal function, the effect of Janine has not been specifically studied, so the available information does not suggest changes in treatment in such patients.

Side effects

• From the nervous system: often – headache; infrequently – migraine, dizziness; rarely – cerebrovascular disorders, ischemic stroke, dystonia;
• From the reproductive system and mammary glands: often - engorgement of the mammary glands, pain and/or discomfort in the mammary glands; infrequently - intermenstrual bleeding (including metrorrhagia and vaginal bleeding), heavy withdrawal bleeding (including menorrhagia, hypomenorrhea, amenorrhea and oligomenorrhea), edema of the mammary gland, increase (swelling and feeling of fullness) in the size of the mammary glands, dysmenorrhea, ovarian cysts, discharge from vaginal or genital tract pain in the pelvic area; rarely - cervical dysplasia, mammary gland cysts, uterine appendage cysts, pain in the uterine appendages, menstrual irregularities, dyspareunia, fibrocystic mastopathy, galactorrhea; possibly – discharge from the mammary glands;
• From the lymphatic system and blood: rarely – anemia;
• From the endocrine system: rarely – virilization;
• From the senses: rarely - dizziness, oscillopsia, irritation and/or dryness of the mucous membrane of the eyes, tinnitus, impaired or sudden hearing loss; possibly – intolerance (unpleasant sensations when wearing) contact lenses;
• From the cardiovascular system: infrequently – arterial hypotension or hypertension; rarely - tachycardia (including increased heart rate), cardiovascular disorders, thrombosis or thromboembolism of the pulmonary artery, thrombophlebitis, orthostatic circulatory dystonia, diastolic hypertension, hot flashes, venous pathology (including varicose veins and pain in the veins);
• From the respiratory system: rarely - bronchial asthma, hyperventilation;
• From the digestive system: infrequently - pain in the upper and lower abdomen, bloating or discomfort, nausea, vomiting, diarrhea; rarely – dyspepsia, gastritis, enteritis;
• From the musculoskeletal system: rarely - myalgia, discomfort in the bones and muscles, pain in the back and/or limbs;
• Allergic reactions: rarely - allergic dermatitis and other manifestations of allergic reactions; possibly – erythema nodosum, urticaria;
• Dermatological reactions: infrequently - acne, alopecia, macular and other rashes, itching (including generalized); rarely - eczema, hirsutism, neurodermatitis or atopic dermatitis, psoriasis, chloasma, hyperhidrosis, pigmentation disorder or hyperpigmentation, dandruff, seborrhea, pathological skin changes (orange peel, spider veins); possibly erythema multiforme;
• From the side of metabolism: infrequently – increased appetite, rarely – anorexia;
• Psychiatric disorders: uncommon – decreased mood; rarely – mental disorders, depression, sleep disorders, insomnia, aggression; possibly – decreased or increased libido, mood changes;
• Infections and infections: uncommon – vaginal candidiasis, vaginitis and other vulvovaginal infections; rarely - salpingoophoritis (adnexitis), cystitis, urinary tract infections, mastitis, fungal infections, cervicitis, candidiasis, viral infections, including influenza, herpetic lesions of the oral cavity, sinusitis, bronchitis, upper respiratory tract infections;
• Malignant, benign and unspecified tumors, including cysts and polyps: rarely - breast lipoma, uterine fibroids;
• General symptoms: uncommon – fatigue, poor health, asthenia; rarely - peripheral edema, chest pain, irritability, flu-like symptoms (fever and inflammation); possibly fluid retention;
• Indicators of examination results: infrequently – changes in body weight (decrease, increase or fluctuations); rarely – increased levels of triglycerides in the blood, hypercholesterolemia;
• Genetic and congenital disorders: rarely - polymastia.

In addition, Janine can cause irregular bleeding, in the form of spotting or breakthrough bleeding, especially in the first months of use.

While taking Janine, women may develop the following side effects: venous and/or arterial thromboembolic complications, arterial hypertension, cerebrovascular complications, hypertriglyceridemia, effects on insulin resistance of peripheral tissues, changes in glucose tolerance, functional liver disorders, benign or malignant liver tumors, chloasma .

Exogenous estrogens in women with the pathology of hereditary angioedema can intensify the exacerbation of symptoms.

The relationship between taking Janine and the occurrence or worsening of the following conditions has not been clearly proven: itching and/or jaundice associated with cholestasis, porphyria, formation of gallstones, herpes of pregnancy, systemic lupus erythematosus, hemolytic-uremic syndrome, ulcerative colitis, Sydenham's chorea, otosclerosis with hearing loss, cervical or breast cancer, Crohn's disease.

Overdose

Data on serious violations due to an overdose of Janine were not recorded. Possible symptoms of the condition may be nausea/vomiting, spotting, metrorrhagia.

special instructions

In women taking Zhanine, the likelihood of deep vein thrombosis increases, but no more than during pregnancy.

The risk of thrombosis increases with age; it is lower in non-smoking women, so smoking patients over the age of 35 are advised to give up the habit.

A temporary increase in the risk of developing deep vein thrombosis is observed during periods of prolonged immobilization or surgery. Before a planned operation or hospitalization, you should warn your doctor about taking Zhanine and decide on a temporary cessation of oral contraception, as a rule, we are talking about a period of 4 weeks before and 2 weeks after forced immobility.

The effect of Zhanine on the likelihood of developing breast cancer has not been established, but in women on combined oral contraception it is detected more often than in women of the same age who are not taking Zhanine. This may be due to more frequent and regular examination of patients and diagnosis of the disease at an early stage.

While taking sex steroids, in rare cases, the development of benign, and in extremely rare cases, malignant liver tumors is observed. Although a connection with the use of Janine has not been proven, it is recommended to consult a doctor immediately if you experience unexpected severe abdominal pain.

Persistent human papillomavirus infection is the most common cause of cervical cancer, the likelihood of which is higher in women on long-term oral combined contraception. The negative effect of the drug has not been proven; this may be due to both sexual behavior and more frequent examinations by a gynecologist.

The effectiveness of Zhanine decreases with vomiting or diarrhea, irregular intake, or concomitant use of other medications.

If you are prone to chloasma, you should avoid prolonged exposure to sunlight and ultraviolet radiation.

If intermenstrual vaginal bleeding continues for more than 3 cycles, you should consult a doctor.

If there are no two menstruation periods in a row, you should immediately consult a doctor to rule out pregnancy.

During the period of use of Zhanine, regular (at least once a year) control examinations are necessary.

It is necessary to stop taking the pills and immediately consult a doctor if symptoms characteristic of thrombosis appear.

Janine does not protect against sexually transmitted diseases, including HIV infection (AIDS).

Impact on the ability to drive vehicles and complex mechanisms

The effect of the contraceptive drug Zhanine on the ability to drive vehicles and other complex mechanisms has not been identified.

Use during pregnancy and lactation

Janine is not prescribed during pregnancy and breastfeeding.

If pregnancy occurs while taking a hormonal contraceptive, Janine should be discontinued immediately. Extensive epidemiological studies have not identified an increased risk of malformations in children born to women who received sex hormones before pregnancy, or the teratogenic effects of sex hormones taken inadvertently in early pregnancy.

Since oral administration of combined contraceptive drugs can suppress lactation and change the composition of breast milk, they are contraindicated in women who are breastfeeding. Sex steroids and/or their metabolites may be excreted in milk in small quantities.

Use in childhood

In pediatrics, Janine can be used in girls only after menarche.

For impaired renal function

The potential ability of Janine to influence the biochemical characteristics of renal function should be taken into account.

For liver dysfunction

Patients with liver failure and severe liver dysfunction may require temporary discontinuation of Zhanine until these laboratory parameters normalize.

For mild to moderate liver disease, caution is recommended when prescribing a contraceptive.

Zhanine is contraindicated for use in the presence of benign or malignant liver tumors currently or in history.

The development of cholestatic jaundice/cholestatic itching, which appeared for the first time during pregnancy or during previous use of sex hormones, requires discontinuation of the drug.

Use in old age

Janine is not prescribed after menopause.

Drug interactions

The doctor prescribes Zhanin based on the patient’s full clinical data, taking into account the effect of possible simultaneous use of other medications on the effectiveness of contraception.

Analogs

Analogues of Zhanin are: Bonade, Belara, Diecyclen, Dayla, Jess, Dimia, Evra, Zhenetten, Logest, Lindinet 30, Midiana, Mercilon, Marvelon, Oralcon, Siluet, Yarina, Egestrenol, Femoden.

Terms and conditions of storage

Store at temperatures up to 25 °C. Keep away from children.

Shelf life – 3 years.

Janine is a hormonal contraceptive drug.

Active substance

Ethinylestradiol + Dienogest.

Release form and composition

They are produced in the form of white smooth dragees, every 21 of which are packed in blisters. One or three blisters are included in a cardboard box.

Indications for use

Prevention of unwanted pregnancy.

Used as primary and auxiliary treatment for the following conditions and diseases:

• dysmenorrhea (painful menstruation);
• amenorrhea (lack of menstruation);
• menorrhagia (heavy menstruation);
• endometriosis;
• reproductive dysfunction;
• increased levels of male sex hormones in a woman’s blood (which often results in acne, very oily skin, and excessive hair growth of the skin);
• the period after gynecological surgical interventions (for the purpose of recovery after surgery and consolidation of its results).

Contraindications

• period of pregnancy and lactation;
• venous and arterial thrombosis, thromboembolism and conditions preceding them (angina pectoris, ischemia);
• neurological migraines;
• cardiovascular complications of diabetes mellitus;
• damage to the valvular apparatus of the heart, arrhythmias, vascular diseases of the brain and heart;
• liver failure, liver diseases, incl. tumors;
• malignant formations of the genital organs and mammary glands;
• after extensive surgical interventions.

Instructions for use Janine (method and dosage)

Dragees are taken orally, 1 piece per day at the same time, following the order indicated on the drug packaging. The duration of the course is 21 days, then a break is taken for 7 days. Menstruation begins 2-3 days after finishing taking the drug.

Transfer from other drugs

If you have not previously taken hormonal medications, the course begins on the first day of menstruation. It is acceptable to start MC on days 2-5, but in this case it is recommended to use additional barrier methods of contraception for 7 days.

When switching from other oral contraceptives, use should begin the day after taking the last tablet from the previous package. A break of more than 7 days should not be allowed.

When switching to drugs after removing the vaginal ring, you should start taking pills on the day the ring or patch is removed.

When changing progestin contraceptives to drugs, you can start taking the drug at any time - on the day of implant removal or the last injection. In this case, it is necessary to use additional methods of contraception for 7 days.

After an abortion

After abortive termination of pregnancy in the first trimester, you can start taking it on the day of surgery. Additional contraception is not required.

After an abortion in the 2nd trimester or childbirth, you should start taking the drug 21-28 days after surgery or childbirth. In case of a later start of the course, it is recommended to use additional (barrier) contraceptives.

In case of missed appointment

If you miss taking the drug for less than 12 hours, the effect of the contraceptive is not reduced. A woman should take the pills as soon as she remembers, and the next ones are taken as usual.

If the break between tablets is more than 36 hours, you must adhere to the following recommendations:

• If you miss a pill in the first week, it is recommended to take the pill immediately and continue the course as usual. It is recommended to additionally use barrier methods of contraception for 7 days.
• If you miss a pill in week 2, take the pill as quickly as possible and continue therapy at the recommended dosage. If you have not missed taking the drug before, additional methods of contraception are not required.
• If a dose is missed in the third week, the woman should take the pill as soon as possible and continue taking it from the current pack. In this case, a break before starting the next package is not required. During this period, menstrual-like bleeding may be extremely rare, but menstruation will begin after the end of the second package. Otherwise, a woman can take a seven-day break (taking into account the missed day) and then start taking the drug with a new package.

If vomiting or diarrhea occurs within four hours after taking the drug, incomplete absorption of the active ingredient may occur, so the use of additional contraception is required. In this case, you must adhere to the rules regarding skipping pills.

If you need to delay the onset of menstruation, you must start taking pills from a new package immediately after the end of the previous one (without a break). To shorten the duration of MC, it is necessary to stop taking the drug as early as the woman needs.

Side effects

Janine may cause the following side effects:

• headache;
• soreness and engorgement of the mammary glands;
• increased appetite;
• dizziness;
• bleeding during the intermenstrual period;
• nausea;
• disturbance of psycho-emotional state.

Significantly less common:

• decreased libido;
• acne;
• abdominal pain, diarrhea, vomiting;
• rash, itchy skin;
• vaginitis, vulvovaginitis, vaginal candidiasis and other fungal infections;
• hyper- and hypotension.

Very rare side effects include:

• spider veins, cellulite, pigmentation disorders;
• dandruff, seborrhea;
• psoriasis, allergic skin reactions, eczema;
• gastritis;
• varicose veins, thrombophlebitis;
• blurred vision, dry mucous membrane of the eyes;
• sleep disturbance, depression, aggression;
• anemia;
• benign tumors of the uterus and mammary gland.

Overdose

In case of an overdose of Janine, nausea, metrorrhagia, and vomiting are observed.

Symptomatic therapy is carried out. There is no specific antidote.

Analogs

Analogues according to the ATX code: Angeletta, Belara, Bonade, Diecyclen, Zhenetten.

Do not decide to change the drug on your own; consult your doctor.

pharmachologic effect

Ethinyl estradiol is a synthetic estrogen; when it enters the body, it performs all the functions of endogenous (own) estrogen.

Dienogest can be called an analogue of natural progesterone. Despite the slight similarity (only 10%) with progesterone, it has powerful progestogenic activity (it can effectively imitate the action of progesterone).

The pharmacological effect of the tablets is contraceptive. It occurs as a result of the implementation of three complementary mechanisms:

• Suppression of ovulation by influencing the hypothalamic-pituitary system.
• Changing the properties (mainly viscosity) of cervical mucus in such a way as to make it impermeable to sperm.
• Structural and functional changes in the endometrium, during which implantation of even a fertilized egg cannot occur.

The effect of the drug is not limited to the contraceptive effect. When taken, the menstrual cycle is normalized, pain and the amount of discharge during menstruation are reduced, the development of certain gynecological diseases is prevented or stopped, and a woman’s reproductive function is restored. After regular use of the drug, an improvement in the condition of the skin, hair, and nails is observed; the drug has a positive effect on the female body as a whole.

special instructions

Taking pills does not protect against sexually transmitted diseases.

Before the appointment, a complete medical examination of the patient is carried out and the possibility of pregnancy is excluded.

During pregnancy and breastfeeding

Contraindicated during pregnancy and breastfeeding.

In childhood

Not prescribed for children and adolescents under 18 years of age.

In old age

Not used in old age after menopause.

For impaired renal function

Information is absent.

For liver dysfunction

Contraindicated in severe liver diseases.

Drug interactions

• Combined use with phenytoin, barbiturates, rifampicin, primidone, carbamazepine, topiramate, felbamate can lead to an increase in the clearance of sex hormones. In this case, we additionally recommend using barrier methods of contraception.
• Non-nucleoside reverse transcriptase and HIV protease inhibitors may impair hepatic metabolism.
• Penicillin and tetracycline antibiotics reduce the enterohepatic circulation of estrogen, which can lead to a decrease in ethinyl estradiol levels.

Conditions for dispensing from pharmacies

Dispensed by prescription.

Storage conditions and periods