Janine what is it for? Janine (side effects, contraindications). Which is better: Claira or Janine

A contraceptive based on estrogen (ethinyl estradiol) and progestogen (dienogest). One package contains one blister with 21 tablets and 3 blisters of 21 tablets.

Zhanine belongs to the new generation of contraceptives and is a low-dose monophasic drug. The Janine effect is achieved through a complex effect on the body:

• suppression of ovulation;
• impact on the properties of cervical mucus - it becomes denser and impermeable to sperm;
• impact on the structure of the endometrium, as a result of which the fertilized cell cannot attach to it.

Like many modern contraceptives, Janine is characterized by a low hormone content and has minimal side effects. However, there are a number of situations in which taking Janine is either completely contraindicated or should be carried out with extreme caution, especially in the first months.

Contraindications are:

• thrombosis (venous and arterial) and thromboembolism, both currently diagnosed and present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction);
• conditions preceding thrombosis, for example, transient ischemic attacks, angina pectoris;
• migraine;
• diabetes mellitus with vascular complications;
• diseases of cardio-vascular system, such as: damage to the valvular apparatus of the heart, heart rhythm disturbances, diseases of the cerebral vessels or coronary arteries of the heart, high blood pressure;
• pancreatitis with severe hypertriglyceridemia;
• liver failure and severe liver disease; liver tumors;
• diagnosed hormone-dependent malignant diseases or suspicion of them;
• vaginal bleeding of unknown origin.

Janine should not be taken during pregnancy, if pregnancy is suspected, or during lactation. Dosage should be canceled (or the start of dosage delayed) in situations involving prolonged limitation in physical activity, planned or emergency surgery, or serious injuries.

Janine should be used with caution, listening to the body's reactions in the following cases:

• severe disorders of fat metabolism (obesity, hyperlipidemia);
• thrombophlebitis of superficial veins;
• otosclerosis with hearing loss;
• congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes);
• diabetes;
• systemic lupus erythematosus;
• hemolytic uremic syndrome;
• Crohn's disease;
• sickle cell anemia;
• hypertension.

If pregnancy is detected while taking the drug Zhanine, it must be discontinued immediately. There is no need to panic and think that a contraceptive taken in the early stages of pregnancy can cause severe pregnancy or fetal pathologies. Numerous and large-scale studies clearly indicate that such consequences will not occur.

We will tell you below how quickly after giving birth you can start taking Janine. However, you should always remember that this depends primarily on whether the mother is breastfeeding or not. Remember: hormonal contraceptives affect the composition and quantity of breast milk; their use during lactation is unacceptable!

Reception scheme

The tablets are taken every day, preferably at the same time. The order in which tablets are selected is determined by the arrows on the blister. It is recommended to take the tablets drinking water. Duration of treatment: 21 days. This is followed by a week-long break, during which menstrual-like bleeding usually occurs (in most cases it begins on the second or third day after taking the last tablet).

Start of taking Janine

The choice of the first day of admission depends on many factors. In particular, it depends on what contraceptives the woman used previously.

If hormonal contraceptives were not used in the previous month (in other words, in the previous menstrual cycle), then taking Zhanine should be started on the first day of the menstrual cycle, that is, on the day when menstrual bleeding began. It is also possible to start taking it on the second to fifth day of the cycle, but in this case you should additionally use barrier contraceptives for a week (until seven tablets from the package are taken).

If you took another oral contraceptive in the previous month, then it is better to start taking Zhanine the next day after taking the last tablet of the previous drug. It does not matter whether this drug was biphasic or monophasic (that is, it contained 21 or 28 tablets in the package). Thus, there is no one-week break between two cycles of taking contraceptives.

It is possible to start taking Janine with a break between cycles, but you should not allow the break to be more than seven days.

If in the previous month you took an oral contraceptive containing only gestagens (“mini-pills”), then you can switch to taking Janine any day. A break between the two drugs is not required.

If a contraceptive injection was used in the previous month, then the switch to Janine is carried out on the day when the next injection was supposed to be given.

If an intrauterine contraceptive or implant was used, then the transition to Janine is carried out on the day of removal of the contraceptive or implant.

Note: in all cases of transition from progestin drugs or agents, it is recommended to additionally use barrier methods of contraception for a week in the first week of taking Zhanine.

Starting after an abortion or childbirth

After an abortion in the first trimester of pregnancy, you can start taking Zhanine immediately, on the same day. Additional contraception in in this case not required.

After premature birth or abortion in the second trimester of pregnancy, taking Zhanine should begin on days 21-28. If the day of taking the first pill is later, then barrier contraceptives should also be used during the week. Please note: if sexual contact has taken place during the time that has passed since childbirth or abortion, before taking Zhanine you need to make sure that there is no pregnancy. As an option, wait until your first menstruation after childbirth or abortion and start taking the drug according to the regimen indicated above.

What to do if you forget to take your pill?

If the delay is less than 12 hours, the contraceptive effect is not reduced. The drug still has its effects on the body. Therefore in similar situation you need to take the pill as soon as possible. No other measures are required. The subsequent tablet is taken according to the usual schedule.

If the delay is more than 12 hours, the contraceptive effect is reduced and conception becomes more likely. Actions in such a situation depend on which week of admission it occurred. You also need to always remember two rules:

1. Reception of Janine should not be interrupted for a period exceeding seven days.
2. In order for the maximum contraceptive effect to be achieved, it is necessary to take the drug for at least seven days.

Actions when the interval between two tablets exceeds 36 hours (delay in taking more than 12 hours):

First week of taking the drug

You need to take the missed pill as soon as possible - if the delay is approaching 24 hours, then you need to take two pills at the same time. Then the intake continues according to the usual schedule, but barrier methods of protection are also used during the week. It is necessary to take into account that if there was a sexual contract during the week before missing the pill, there is a possibility of pregnancy. Remember: the more pills you miss, and the closer they are to the week break, the greater the chance of pregnancy. In other words, a missed pill in the third week of use entails a greater likelihood of pregnancy than a missed pill in the first week.

Second week of taking the drug

Take the missed pill as soon as possible, then proceed according to your usual schedule. If a woman is sure that she adhered to the dosage schedule during the week before missing the pill, additional precautions are not required. If the previous appointment occurred with serious deviations from the schedule, then it makes sense to additionally use barrier methods.

Third week of taking the drug

If you miss taking a pill in the third week, the risk of a decrease in the contraceptive effect, as well as the risk of possible pregnancy, is inevitable. You can act in such a situation according to two schemes.

First scheme

1. Take the missed pill as soon as possible, then take the drug according to your usual schedule.
2. When all the pills from the current package have been consumed, they move on to the next package - that is, without a seven-day break.

With this regimen, the onset of menstrual-like bleeding in the current cycle is unlikely; scanty spotting and breakthrough bleeding may occur while taking the second package.

Second scheme

1. We consider the current packaging to be complete. We don’t take the remaining pills in it - we take a week’s break, the first day of which is considered the day you missed taking a pill.
2. After the break, we begin taking tablets from the next package.

If bleeding occurs during the break, pregnancy must be ruled out.

Cases where vomiting or diarrhea occurs within 4 hours after taking a pill should be regarded as missing a pill. And act according to the recommendations presented above.

Possible side effects:

• painful sensations, enlargement and tension of the mammary glands, discharge from the mammary glands;
• spotting bloody issues and bleeding on days of taking pills, abdominal pain;
• headaches, migraine, nausea, vomiting, diarrhea;
• change in libido;
• mood changes, irritability, fatigue;
• poor tolerance to contact lenses, blurred vision;
• skin rash, itching, allergic reactions;
• fluid retention in the body, swelling;
• changes in body weight, leg pain, cramps.

Sometimes taking Janine can cause chloasma, especially in women with a history of chloasma during pregnancy. In such cases, prolonged exposure to the sun should be avoided.

A few more points that are important to know

1. If you are undergoing elective surgery, you should stop taking Janine four weeks in advance. After surgery, you can start taking it no earlier than two weeks later.
2. If you are taking drugs that affect microsomal enzymes, you must additionally use a barrier method of contraception during this period, as well as for 28 days after stopping taking these drugs.
3. While taking antibiotics (such as ampicillins and tetracyclines), as well as for a week after their discontinuation, you should additionally use a barrier method of contraception.
4. You should stop taking the drug and consult a doctor in the following cases:
   • pain in the legs, swelling of the legs;
   • sudden severe pain in the chest or abdomen;
   • sudden shortness of breath, weakness, dizziness;
   • coughing attacks without a cold;
   • any unusual, strong, long-lasting headache;
   • problems with vision and speech.
5. Irregular light bleeding or breakthrough bleeding may occur while taking the tablets, especially during the first months of use. If such bleeding appears after three months of regular use of Janine, you should consult a doctor. Consultation is also required in situations where irregular bleeding occurs after several regular cycles.
6. Before starting to use Zhanine, it is recommended to undergo a thorough general medical and gynecological examination (including examination of the mammary glands and cytological examination of cervical mucus) and exclude pregnancy. In addition, disorders of the blood coagulation system should be excluded.
7. With long-term use of the drug, it is necessary to conduct control examinations every six months.

Janine: instructions for use and reviews

Latin name: Jeanine

ATX code: G03AA

Active substance: ethinylestradiol + dienogest (ethinylestradiol + dienogest)

Manufacturer: Bayer Weimar GmbH and Co. KG (Bayer Weimar, GmbH & Co. KG) (Germany)

Updating the description and photo: 20.08.2019

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 IDA ( iron deficiency anemia), 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 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 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 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. IN otherwise If you miss more than two pills, 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 outside 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 ( discomfort 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 outside respiratory system: rarely – bronchial asthma, hyperventilation;
• From the outside digestive system: uncommon – 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, bad feeling, 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 development 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 shown an increased risk of developmental defects in children, born by women who received sex hormones before pregnancy, or the teratogenic effect of sex hormones taken inadvertently in early pregnancy have not been identified.

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.

Dispensed by prescription.

Latin name: JEANINE
ATX code: G03A A16
Active substance: ethinyl estradiol, dienogest
Manufacturer: BAYER PHARMA (Germany)
Dispensing from the pharmacy: On prescription
Storage conditions: in the dark, at temperatures up to 25 °C
Best before date: 3 years

The drug Janine is one of the most effective means modern oral contraception.

Composition and dosage form

One dragee Janine contains the following components:

• Active: 30 mcg ethinyl estradiol, 2 mg dienogest
• Additional: lactose (in the form of monohydrate), potato starch, gelatin, E572, talc, sucrose, glucose syrup, macrogol-35000, calcium carbonate, povidone K-25, E171, palm wax.

Contraceptive drugs are available in the form of pills - small pills with a white coating. The product is packaged in blisters of 21 pieces. In a cardboard pack there are 1 or 3 plates, an accompanying annotation.

Medicinal properties

The contraceptive effect of Janine occurs due to the targeted action of two components - ethinyl estradiol and dienoget. The processes they trigger cause multiple biochemical reactions, the most significant among them are blocking ovulation, changing the structure and composition of cervical secretion. As a result of the influence of OC, sperm lose the ability to penetrate the uterine cavity.

When all conditions of administration are met, the value of the Pearl index is less than 1. If the pills are taken with omissions or there are other violations, then the value increases.

Due to the gestagenic properties of dienogest, OC has an antiandrogenic effect, which is confirmed by numerous studies and observations. In addition to the contraceptive effect, the substance simultaneously has a beneficial effect on blood characteristics, increasing the content of dense lipoproteins.

Patients who took Zhanine noted that as a result of OK, the circulatory cycle was normalized, the intensity of PMS decreased or disappeared completely, the duration or intensity of menstruation was reduced, which sharply reduced the threat of IDA. In addition, there is medical evidence that the contraceptive can prevent the occurrence of ovarian and/or endometrial cancer.

• Dienogest

Belongs to the group of nortestosterone derivatives, has pronounced antiandrogenic properties, and is characterized by a strong progestogenic effect. After penetration into the uterine cavity, it affects the nerve endings of the endometrium, suppressing trophic effects. With long-term use, it helps to attenuate endometrioid lesions and reduces the increased synthesis of estrogen by the ovaries.

After taking the pill, the substance is absorbed quite quickly from the gastrointestinal tract, peak concentration values ​​are formed after 2.5-3 hours. It is characterized by high bioavailability - almost 96%. Almost completely metabolized.

It is excreted from the body mainly through urine, a small amount is excreted along with bile. The duration of the process ranges from 8 to 10 hours.

• Ethinyl estradiol

The substance is a synthetic analogue of the hormone estrogen, and therefore has almost the same effect. Activates the formation of the uterus, tubes and secondary signs of sex, affects the condition of the endometrium, increases the excitability of the uterus. In addition, the artificial compound is involved in nitrogen metabolism, reduces lipid content, and regulates the presence of cholesterol. In large doses, it can retain fluid in the body, contributing to swelling.

After oral administration, it is quickly and completely absorbed. The highest concentrations are formed within 1-4 hours. Transformed to form metabolites in the small intestine and liver. It is excreted from the body in two stages along with urine and bile.

Mode of application

To take Zhanine, the instructions for use prescribe one tablet per day, identical watches and in accordance with the calendar index on the blister. It is not advisable to bite or break the dragee - you should only drink it whole with a small amount of water. After the contents of the blister are finished, a one-week break is observed, during which menstrual-like bleeding should occur. It usually occurs 2-3 days after taking the last pill. After a week, they resume taking OK from a new blister.

When to start drinking OK

If before Zhanine’s appointment the patient was not protected by other OCs or there was a break in taking it for at least a month, then the first pill should be taken on the 1st day of the MC. If this is done later - between days 2 and 5, then you will need an additional week of protection with condoms.

If other OCs are used before Janine, the pills are drunk the next day after taking the previous active tablet (or placebo). In this case, a break of more than a week should not be allowed.

If a woman was protected using a TD patch or vaginal ring, then the pills are drunk on the day the product is removed. In the case of injections - on the day of the next injection.

After stopping the course of drugs with gestagens, start taking pills the next day after taking the tablet from the previous OC, on the day of removal of the uterine contraceptive or on the day of the next hormonal injection. In all cases, additional protection with barrier agents will be required.

After a miscarriage or abortion in the first 3 months of pregnancy, Janine is taken immediately after the termination of pregnancy.

If the pregnancy ends in the 2nd stage, then you need to wait from 21 to 28 days before taking Janine. Later intake should be accompanied by the use of condoms. If an unprotected PA occurred before taking the pill, you will need to make sure there is no pregnancy or postpone the course until your period begins.

What to do in case of omissions OK

If for some reason a woman was unable to drink the pills on time, and the delay was less than 12 hours, then there is nothing particularly to worry about, since the content of substances in the blood, although it will decrease somewhat, will retain the contraceptive effect. She'll just have to take the pills as soon as the opportunity arises.

If more than 12 hours are missed, the contraceptive concentration of the medication will decrease more, and to restore the normal dosage schedule, the woman can use one of the following methods:

• Missing the first week of the course: take the forgotten pill, and the next one according to the schedule. If the methods coincide, drink two pieces at once and then use additional means of protection for a week.
• Skipping in the 2nd week of the course: drink the missed one, and the next one according to the schedule, if the doses coincide - two pieces at once. If there were no violations in the course in the first 7 days, then there is no need for condoms. In case of the same forgetfulness, use them for a week.
• Skipping in the 3rd week of the course: take the forgotten pill and another at the usual hours. After finishing one blister, start a new one, without observing any intervals. Withdrawal bleeding should not occur, but may appear as spotting or breakthrough bleeding.

There is another option to correct the situation: do not replenish the tablets, but take a 7-day break, and after it ends, start a new package of OK.

A decrease in the concentration of substances may occur due to vomiting or diarrhea in the first 4 hours after administration. In this case, you will need to drink another pill.

• How to delay or reschedule a MC day

To reschedule your period to another day, you do not need to take a break, but immediately start taking a new blister and drink the number of pills that you need until it ends completely. Then wait 7 days without pills before taking from the next pack.

To change the start of the MC to a different date, you need to shorten the break by the desired number of days.

Reception features

Teenagers can take Janine only after the first bleeding occurs.

Older menopausal women do not require OK.

If the patient has liver problems, then OK can be taken only after the condition has completely stabilized.

The nuances of taking it in women suffering from kidney pathologies have not been studied. Therefore, it is better to check with your gynecologist whether or not you can drink OK and how to take Janine correctly.

Janine's therapy for endometriosis

Thanks to the active substances it contains, the contraceptive medication can be used in the treatment of endometrial pathology. A significant advantage of OC is that it can be taken in various forms of the disease: both in the early stages and in advanced cases. Depending on the indications, the most effective option is developed for each patient. On average, treatment with the drug takes about 63 days, that is, you need to drink 3 blisters of 21 tablets.

Application regimen: one tablet per day, strictly at the same time. After completing the dose, a seven-day break is observed for menstrual bleeding.

After analyzing the results of therapy, the gynecologist makes a decision whether to continue taking the OC. But usually one course of Janine’s therapy for endometriosis is enough to eliminate excess tissue growth.

If the pathology is more advanced, then the course of therapy may take a longer time - 84 days.

During pregnancy and lactation

Average price: No. 21 – 1005 rubles, No. 63 – 2480 rubles.

The drug should not be used while pregnant or breastfeeding. If during the course it turns out that a woman is pregnant, you must immediately stop taking the medication to avoid unforeseen consequences. but so far, various epidemiological studies have not confirmed any pathologies in the development of children born to women who took hormonal pills Janine in the early stages of pregnancy.

Lactating women should not use the medication, as the active ingredients can negatively affect the production and volume of milk. In addition, small amounts of sex hormones and their metabolites may be excreted into milk. If a woman needs to take OK, she must stop lactation during the course of the pills.

Contraindications

Contraceptive pills Janine should not be taken if at least one of the following factors is present. If during the course such conditions or pathologies arose for the first time, then hormonal OC should be immediately canceled. The drug is prohibited for:

• Thrombosis or thromboembolism at the time of prescription or in the past
• Diseases or conditions that increase the risk of blood clots (current or past)
• Congenital or acquired tendency to thrombosis
• Existing high risk of venous/arterial thrombosis
• Migraines with associated neurological manifestations at the time of prescription or in the past
• Diabetes with damage to the vascular system
• Pancreatitis with severely elevated plasma triglyceride concentrations (current and past)
• Renal failure, severe organ damage (use is possible only after
• Liver neoplasms (benign and malignant) at the time of Zhanine’s appointment or existing in the past
• Benign hormone-dependent neoplasms confirmed by examination and the assumption of their presence
• Vaginal bleeding of unspecified origin
• Confirmed or suspected pregnancy, breastfeeding
• Individual hypersensitivity to the components of Janine
• Congenital lactose intolerance, deficiency of lactase, sucrase in the body, GG malabsorption syndrome (due to lactose and sucrose in the composition).

OCs should be used with caution if a woman has:

• Predisposition, risk of pulmonary embolism, thrombosis and conditions preceding them
• Tobacco smoking
• Overweight, obesity
• Hypertension amenable to drug correction
• Migraine without focal symptoms
• Congenital tendency to thrombus formation.
• Pathologies that can provoke the development of thrombosis due to circulatory disorders (SLE, diabetes, KS anemia, Crohn's disease, etc.)
• Liver diseases that are not included in the list of categorical contraindications
• Pathologies that first appeared during pregnancy or worsened during gestation
• Postnatal period (about one and a half months).

Precautionary measures

OK Janine should be prescribed by a gynecologist after a thorough analysis of the patient’s condition through general and gynecological examination, passing tests and finding out the intricacies of family history, unfavorable conditions in the past, the presence bad habits and other risk factors. In case of indications for long-term use, the patient should be informed of the need for regular examinations by physicians (usually once a year). In addition, she should be warned that OC cannot protect against sexually transmitted infections and HIV infection.

If a woman has any risk signs that can accelerate or intensify the onset of new diseases or complications of existing ones, then the question of the possibility of using OCs should be decided individually. If prescribed, the patient must be aware possible consequences and know what to do when they arise.

The results of numerous studies have confirmed the presence of a relationship between taking OCs and an increase in cases of pathologies of the heart and blood vessels: MI, thrombosis, PE, VTE, etc. Although such complications occur quite rarely, the threat cannot be excluded.

The occurrence of VTE is especially common in the first year of taking OCs. An increase in risk is also noted when the course of OK is resumed after a break (at least a month). This usually happens in the first three months of taking contraceptives.

In addition, there is data on isolated cases where the use of OCs led to death.

Damage to blood vessels of other organs is observed less frequently, so medical opinions are divided on the issue of the “guilt” of OK. Manifestations of hepatic vein thrombosis include the development of unilateral swelling of the leg (pain in the vein area is possible), pain and discomfort in the limb when walking or standing, local temperature, and changes in skin tone.

PE can be recognized by the following signs:

• Difficulty breathing
• Unexplained cough (sometimes with blood)
• Severe chest pain, more intense when inhaling
• Vertigo
• Disturbance of normal heartbeat.

In addition, dyspnea and cough can be precursors of PE, so it is important to interpret them correctly and not confuse them with manifestations of other diseases.

Arterial TE can provoke stroke, MI, and vascular damage. Its manifestations are:

• Unexpected weakness
• Insensitivity of the face and limbs (specific symptom – unilateral paresthesia)
• Spontaneous blackout
• Speech Impairment
• Sudden deterioration of vision
• Gait disorder
• Disorientation in space
• Uncoordinated movements, loss of balance
• Spontaneous severe headache
• Fainting (may be with an epileptic attack).

Typical signs of MI are:

• Pain and discomfort in the chest, a feeling of heaviness or fullness
• Unpleasant sensations radiating to the back, arm, stomach
• Cold perspiration, sweat
• Nausea (with or without vomiting)
• Unexplained weakness, dyspnea
• Increased anxiety
• Increased heart rate.

The risk of thrombosis increases:

• As age increases
• In smokers (especially women 35+ with a long history)
• For obesity
• Presence of pathology in relatives
• Prolonged remaining stationary (including during long flights)
• For hypertension, heart valve pathology, atrial damage
• Postpartum period.

Women who have recently given birth, diabetics, patients with SLE, chronic intestinal inflammation, and KS anemia are also at risk.

The occurrence of migraines or worsening attacks is a reason to discontinue the OC.

Cross-drug interactions

Combining the use of OCs with other medications may cause breakthrough bleeding or reduce the effect of OCs, which will increase the risk of unplanned pregnancy. Therefore, Zhanin’s instructions for use advise taking birth control pills, taking into account possible complications. Such undesirable reactions occur in the following combinations:

• The use of drugs that induce liver enzymes can increase the clearance of sex hormones. Such reactions occur when Janine is combined with barbiturates, Phenytoin, and the anti-tuberculosis drug Rifampicin. It is assumed that Oxcarbazpin, Griseofulvin, and medications based on St. John's wort have the same effects.
• Similar effects can be observed when combined with HIV protease inhibitors (PIs) and NNRTIs: Ritonavir and Nevirapine, since the drugs directly affect the rate of hepatic metabolism.
• Certain antibiotic drugs (primarily tetracycline and penicillin groups) can reduce the content of ethinyl estradiol by reducing the circulation of estrogen in the liver and intestines. Therefore, if treatment with these agents is necessary, the patient is recommended to additionally protect herself using other barrier agents or products.
• The effect of OCs changes under the influence of drugs inhibitors of cytochrome CYP3A4 enzymes. The plasma content of Janine's substances will be increased when the contraceptive drug is combined with Ketoconazole and other antimycotics, Cimetidine, Erythromycin, psychotropic drugs (antidepressants), as well as with grapefruit juice.
• If during Janine’s course drugs were used that affect liver enzymes, then after their withdrawal you should use auxiliary means of protection against pregnancy for 28 days.
• Antibiotics reduce the contraceptive effect of OCs (except for Rifampicin, griseofulvin), therefore, during their course and for a week after discontinuation, you should either abstain from intimacy or take additional protection.
• Oral contraceptives can also change the actions of other drugs. Janine increases the plasma levels of Cyclosporine and reduces Laomtrigine.

If at the time of prescribing Janine the conditions for combining it with other medications were not specified, then if other drugs are prescribed, you must inform the doctor about the OC you are taking and clarify the nuances of joint use.

Side effects and overdose

When using Zhanine tablets, the following body reactions are possible:

• Infectious pathologies: vaginitis, thrush, salpino-oophoritis, herpes infection oral cavity, flu-like condition, bronchitis, diseases of the urinary tract, respiratory system
• Neoplasms of any etiology, uterine fibroids, lipoma (fat) of the mammary gland
• Blood-forming organs: anemia
• Individual reactions due to hypersensitivity
• Virilism
• Metabolic processes: increased or lack of appetite
• Psycho-emotional state: mental disorders, depression, sleep disturbances, insomnia, unmotivated aggression, mood lability, loss of sexual interest
• NS: headaches, vertigo, migraines, stroke, circulatory disorders in the brain, dystonia
• Visual organs: dryness of the mucous tissues of the eyes, irritation, decreased visual acuity, pain, inability to wear contact lenses
• Hearing organs: temporary hearing loss or decrease, tinnitus
• CVS: cardiovascular complications, rapid heartbeat, sharp increase or decrease in blood pressure, thrombus formation, thrombophlebitis, varicose veins, flushing of the face, dilated and painful veins
• Respiratory system: asthma attacks, hyperventilation
• Gastrointestinal tract: pain in the peritoneum, nausea, vomiting, diarrhea, gastritis, inflammation of the small intestine, difficult digestion
• Skin: acne, rash, hair loss, baldness, itching, dermatitis (allergic and atopic), hyperpigmentation, chloasma, seborrhea, male pattern hair, cellulite, nevus, urticaria, erythema multiforme
• Locomotor system: pain in the back muscles, bones, limbs
• Reproductive system: breast discomfort and tenderness, intermenstrual bleeding, cyst (uterus, mammary glands), mastopathy, cervical dysfunction, nipple discharge
• Other disorders: fatigue, chest pain, peripheral edema, “flu-like” state, increased irritability, accumulation of fluid in the body, weight change (increase or decrease), increased TG levels in the blood.

Possible risks of using Janine

• Women who use hormonal pills are slightly more likely to be diagnosed with breast cancer than women who do not take contraceptives. There is no evidence yet of a direct relationship between the occurrence of pathology and the use of OCs.
• In patients with congenital angioedema, the risk of exacerbation increases.
• Increased threat of liver damage
• Impaired glucose tolerance and insulin resistance
• Breakthrough bleeding if other drugs were used while using OK Janine.

Consequences of taking overdoses

The active ingredients have virtually no acute toxicity, so the development of intoxication is unlikely. It is assumed that the medicine Janine, taken in overdoses, can cause increased side effects, but mainly the consequences manifest themselves in the form of nausea, vomiting, and girls may experience spotting.

Due to the lack of a specific antidote to Janine, the resulting unfavorable condition can be relieved with the help of symptomatic therapy.

Analogues

If for some reason a woman cannot take the medication, she should contact a gynecologist so that he can determine what to replace Janine with. Today, there are many drugs that act no less effectively: Bonade, Vidora, Jess and Jess Plus, Microgenon, Leya, etc. Which drug is best will be determined only by an experienced specialist.

Laboratorios Leon-Farma (Spain)

Average cost:(21 pcs.) – 395 rub., (63 pcs.) – 876 rub.

An oral contraceptive containing the same composition of active ingredients and in an identical dosage as in Janine. The slight difference lies only in the composition of the auxiliary ingredients included in the structure of the core and shell, and the dosage form: the medication is produced in tablets.

The dosage regimen is also similar: one piece per day.

Pros:

• Helps with serious disorders of the reproductive system
• Can be drunk for a long time.

Flaw:

• Side effects
• Decreased sensitivity in erogenous zones.

GEDEON RICHTER (Hungary)

Average cost: No. 21 – 723 rubles, No. 63 – 1813 rubles.

A contraceptive medication whose effect is provided by ethinyl estradiol and chloramadinone in the form of acetate.

OK is available in tablets. The drug is designed for 21 days of use with a mandatory one-week break for withdrawal bleeding.

Pros:

• Good quality
• Protects against unnecessary pregnancy.

Flaws:

• Acne appears
• Reduces interest in sex.

One of the highly effective combined contraception The new generation drug is considered to be Janine. In addition to its high contraceptive effect, the drug is often prescribed to treat gynecological problems. The tablets do not pose a threat to women's health and can be used for a fairly long period of time. Most reviews about the drug Janine are very positive.

Janine is a monophasic drug that has a contraceptive effect. The composition combines unique components (artificial analogs of female hormones) that prevent the onset of unplanned pregnancy, help regulate the menstrual cycle, as well as eliminate intermediate bleeding and pain, especially with irregular and heavy menstrual bleeding (which can lead to everything else anemia) . The drug Janine includes dienogest (a new generation artificial gestagen, an analogue of progesterone, which has a mild effect and is easily excreted, which contributes to the infrequent occurrence of side effects) and ethinyl estradiol, which, when exposed to certain areas of the hormonal system, prevent the processes of development and maturation of the egg, which in turn turn prevents ovulation. In addition, dienogest helps treat acne because it inhibits the activity of male hormones.

The mechanism of action of Zhanine birth control pills does not differ from that of other drugs of similar properties. They block the maturation of the egg, prevent the onset of ovulation, their effect is also aimed at thickening the cervical mucus from the cervix, as a result of which the penetration of sperm into the uterus becomes impossible, and this also leads to changes in the endometrium. All this in combination prevents the onset of unwanted pregnancy.

Regimen for taking the drug Janine.
It should be remembered that you cannot prescribe this or that contraceptive drug yourself; this is done by an experienced gynecologist after a thorough examination, because every woman’s body is individual.

One package of the drug Zhanine contains twenty-one tablets (including a week-long break), they must be taken constantly at the same time of day for three weeks, after which there is a week-long break (menstruation usually begins on the second or third day after stopping taking the tablets) , then new packaging begins. It is necessary to start taking the drug Zhanine from the first day of the menstrual cycle. If the drug was started after a few days, additional methods of contraception (condom) should be used. If you miss taking the drug (regardless of the reason), the effectiveness and reliability of the drug remains for another twelve hours; if more than twelve hours have passed, you should use an additional condom.

Indications for use of the drug Janine.

• preventing unplanned pregnancy;
• acne treatment;
• prevention of gynecological diseases;
• regulation of the menstrual cycle.

In addition, the drug helps restore a woman’s reproductive function, improves the condition of her skin and hair, and eliminates dandruff.

Side effects of hormonal pills Janine.
In most cases, women tolerate the hormonal drug Janine well. And, nevertheless, there are cases of headaches, nausea, and in the first days of taking it, hardening and soreness of the mammary glands may be observed. There may also be increased irritability, drowsiness, increased appetite, which leads to changes in body weight, spotting (bloody discharge), pain in the lower abdomen, and decreased libido. Constant and long-term use of the drug reduces or completely eliminates all unpleasant symptoms.

It is worth noting that thrombosis of veins or arteries occurs quite rarely. As a result, if shortness of breath, pain, swelling, coughing fits, or double vision occurs, use of the drug should be stopped immediately and consult a doctor.

In rare cases, more pronounced reactions to the drug occur due to individual intolerance. In this case, the gynecologist selects other contraceptives.

Contraindications for the drug Janine.

• individual intolerance to the drug;
• nonspecific ulcerative colitis;
• history of myocardial infarction;
• diabetes mellitus, vascular damage, angina pectoris, pre-stroke condition;
• liver diseases;
• pregnancy or suspicion of it;
• pulmonary embolism and cerebral circulatory disorders;
• hormone-dependent malignant diseases of the female genital organs, mammary glands or suspicion of them;
• obesity;
• arterial hypertension;
• valvular heart defects;
• thrombosis of arteries and veins;
• jaundice;
• migraine;
• vaginal bleeding of unknown origin.

When taking others medicines Before prescribing oral contraceptives, you should inform your doctor about this, since Janine is incompatible with some medications, which may reduce the contraceptive effect.

If, when taking the contraceptive drug Zhanine, menstruation is absent for two cycles in a row or the dosage regimen has been violated, you should exclude possible pregnancy(visit a gynecologist).

Dosage form

Sugar coated tablets

Compound

One tablet contains

active substances: ethinyl estradiol 0.03 mg,

dienogest 2.0 mg,

Excipients: lactose monohydrate, corn starch, maltodextrin, magnesium stearate,

cshell remaining: sucrose, liquid glucose, calcium carbonate, povidone K 25, macrogol 35000, titanium dioxide (E 171), carnauba wax.

Description

Smooth, white, sugar-coated tablets, round in shape

Pharmacotherapeutic group

Sex hormones and modulators of the reproductive system.

Hormonal contraceptives for systemic use.

Progestogens and estrogens (fixed combination). Dienogest and estrogens.

ATX code G03AA16

Pharmacological properties

The state of equilibrium concentration is achieved during the second half of the treatment cycle, when the serum level of the drug increases by approximately 2 times compared to the level when taking a single dose of the drug.

Pharmacodynamics

Janine â – an oral combined contraceptive drug containing ethinyl estradiol and the progestagen dienogest.

The contraceptive effect of the drug Zhanin® is based on the interaction of various factors, the most important of which are inhibition of ovulation and changes in the secretion of cervical mucus.

Dienogest is a derivative of nortestosterone with an affinity for progesterone receptors in vitro that is 10-30 times less than other synthetic progestogens.

In vivo animal data demonstrated potent progestogenic and antiandrogenic activity.

Dienogest does not have significant androgenic, mineralocorticoid or glucocorticoid activity in vivo.

Dienogest has been found to inhibit ovulation at a dose of 1 mg per day.

When using high-dose oral contraceptives (0.05 mg ethinyl estradiol), the risk of developing endometrial and ovarian cancer is reduced. The extent to which these data apply to low-dose contraceptives requires further study.

Indications for use

Oral contraception (see section "Special instructions")

Directions for use and doses

The tablets should be taken orally in the order indicated on the package, every day at approximately the same time, with a small amount of water. Take one tablet per day continuously for 21 days. The next package begins after a 7-day break from taking pills, during which withdrawal bleeding usually occurs. Bleeding usually begins 2-3 days after taking the last tablet and may not stop until you start taking a new pack.

How to start taking Janine ®

If you have not taken any hormonal contraceptives in the previous month

Taking Janine® begins on the first day of the menstrual cycle (i.e., on the first day of menstrual bleeding).

When switching from other combined oral contraceptives (COCs)

It is preferable to start taking Zhanine® the day after taking the last hormone-containing tablet from the previous package of the combined oral contraceptive, but in no case later than the next day after the usual 7-day break (for preparations containing 21 tablets) or after taking the last hormone-free tablet for drugs containing 28 tablets per package).

· When switching from a vaginal ring, transdermal patch

It is preferable to start taking Janine® on the day the last ring or patch is removed, but in no case later than the day when the next ring or patch was to be applied.

· When switching from contraceptives containing only gestagens (mini-pills, injection forms, implant) or from a gestagen-releasing intrauterine system (IUD).

A woman can switch from a mini-pill to Janine® on any day (without a break), from an implant or intrauterine contraceptive with a gestagen - on the day of its removal, from an injection form - from the day when the next injection was due. 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. If this condition is met, the woman does not need additional contraceptive protection.

· After childbirth or abortion in the second trimester of pregnancy

It is recommended to start taking the drug 21-28 days after childbirth or abortion. If use 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 been sexually active, pregnancy should be excluded before taking Zhanine® or she must wait until her first menstruation.

For information regarding breastfeeding, see the "Special Instructions" section.

Taking missed pills

If the delay in taking the drug is less than 12 hours, contraceptive protection is not reduced. A woman should take the missed pill as soon as possible, as soon as she remembers, and take the next pill at the usual time.

If the delay in taking the pills is more than 12 hours, contraceptive protection may be reduced. In this case, you can be guided by the following two basic rules:

· The drug should never be interrupted for more than 7 days.

· 7 days of continuous tablet use are required to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation.

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

· First week of taking the drug

A woman should take the last missed pill as soon as she remembers (even if this means taking two pills at the same time). The next tablet is taken at the usual time. Additionally, a barrier method of contraception (for example, a condom) should be used for the next 7 days. If sexual intercourse took place within a week before missing a pill, the reliability of the drug is reduced, so the possibility of pregnancy must be taken into account.

As the number of missed tablets increases and the period of a regular break in taking the drug approaches, the likelihood of pregnancy increases.

· Second week of taking the drug

A woman should take the last missed pill as soon as she remembers (even if this means taking two pills at the same time). The next tablet is taken at the usual time.

If a woman has taken her pills correctly in the 7 days preceding her first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as if you miss two or more tablets, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.

· Third week of taking the drug

The risk of decreased reliability is inevitable due to the upcoming break in taking the pills. However, weakening of contraceptive protection can still be prevented by adjusting the pill taking schedule. Therefore, by adhering to one of the two regimens proposed below, you can do without additional precautions, provided that within 7 days before the first pill was missed, the woman took all the pills correctly. Otherwise, she should be advised to use the first of the following regimens and, in parallel, use additional methods of contraception for 7 days.

1. A woman should take the last missed pill as soon as she remembers (even if this means taking two pills at the same time). She then continues to take the pills at the usual time. The next package should be started immediately after taking the tablets from the current package, that is, without a break in taking the tablets. Withdrawal bleeding is unlikely until the second pack is finished, but spotting and breakthrough bleeding may occur while taking the tablets.

2. A woman can also stop taking pills from the current package. She should then take a break for 7 days, including the day she missed the pill, and then start taking a new pack.

If a woman misses taking pills and then does not have withdrawal bleeding during the pill break, pregnancy must be ruled out.

Changing the start day of the menstrual cycle

In order to delay the onset of menstruation, a woman should continue taking tablets from the new package of Janine® immediately after taking all the tablets from the previous one, without interruption. Tablets from the new package can be taken for as long as the woman wishes (until the package runs out).

While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. You should resume taking Janine® from a new pack after the usual 7-day break.

In order to postpone the start of menstruation to another day of the week, a woman is recommended to shorten the duration of the next break in taking pills by as many days as she wishes. 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 package (the same as in the case when she would like to delay the onset of menstruation).

Additional information for special categories of patients

Children and teenagers

Elderly patients

Not applicable. The drug Zhanine® is not indicated after menopause.

Patients with liver disorders

The drug Zhanine® is contraindicated in women with severe liver disease (See also section “Contraindications”).

Side effects

Below is the frequency of side effects while taking Zhanine®, based on clinical trial data:

Often (≥1/100,<1/10)

Headache

Breast pain, including discomfort and tension

mammary glands

Uncommon (≥1/1,000,< 1/100)

Vaginitis/vulvovaginitis, vaginal candidiasis or other fungal vulvovaginal infections

Increased appetite

Decreased mood

Dizziness, migraine

Arterial hypertension and hypotension

Abdominal pain, including in the upper and lower sections, discomfort and a feeling of “fullness” in the abdominal area, nausea, vomiting, diarrhea

Rash, including macular and acne rash, alopecia, itching, including generalized

Vaginitis/vulvovaginitis, vaginal candidiasis or others

Pathological withdrawal bleeding, including menorrhagia, hypomenorrhea, oligomenorrhea, amenorrhea, intermenstrual bleeding (vaginal or uterine), increase in the size of the mammary glands, including swelling and a feeling of tide, swelling of the mammary glands, dysmenorrhea, discharge from the genital tract; ovarian cysts, pain in the pelvic area

Fatigue, including malaise and asthenia

Weight gain

Rarely (≥1/10,000,<1/ 1000)

Hypersensitivity reactions

Salpingo-oophoritis, urinary tract infections, cystitis, mastitis, cervicitis, fungal infections, candidiasis, influenza, herpes of the oral mucosa, bronchitis, sinusitis, upper respiratory tract infections, viral infection

Uterine leiomyoma, breast lipoma

Virilization

Anorexia

Depression, mental disorders, insomnia, sleep disorders, aggression

Ischemic stroke, cerebrovascular disorders, dystonia

Dry eyes, eye irritation, blurred vision, oscillopsia

Sudden hearing loss, tinnitus, vertigo, hearing loss

Cardiovascular disorders, tachycardia

Venous thromboembolism (VTE), arterial thromboembolism, pulmonary embolism, thrombophlebitis, diastolic

hypertension, orthostatic circulatory dysregulation, hot flashes, varicose veins, changes in veins, pain in veins

Bronchial asthma, hyperventilation

Dyspepsia, gastritis, enteritis

Allergic dermatitis, atopic dermatitis/neurodermatitis, eczema, psoriasis, hyperhidrosis, chloasma, pigmentation disorders/hyperpigmentation, seborrhea, dandruff, hirsutism, skin reactions and skin changes, orange skin symptom, spider nevus

Back pain, musculoskeletal discomfort, myalgia, pain in the limbs

Cervical dysplasia, adnexal cyst, adnexal pain, breast cyst, fibrocystic breast disease, genital pain associated with sexual intercourse, galactorrhea, menstrual irregularities

Chest pain, peripheral edema, influenza-like illness, inflammatory diseases, pyrexia, irritability

Elevated plasma triglycerides, hypercholesterolemia, weight loss, changes in body weight

Manifestation of asymptomatic accessory mammary gland

With unknown frequency (identified only during post-marketing surveillance)

Mood changes, decreased libido, increased libido

Contact lens intolerance

Urticaria, erythema nodosum, erythema multiforme

Discharge from the mammary glands

Fluid retention

Description of selected adverse reactions

The following adverse reactions have been reported in women using combined oral contraceptives, which are also described in the “Special Instructions” section:

The incidence of breast cancer diagnosis is slightly increased among women taking oral contraceptives. Because breast cancer is rare in women under 40 years of age, the increase in diagnosis is small relative to the overall risk of developing the disease. Its connection with the use of combined oral contraceptives has not been proven.

Liver tumors (benign and malignant)

Cervical cancer

Other states

Women with hypertriglyceridemia are at increased risk of developing pancreatitis while taking combined oral contraceptives.

Arterial hypertension

The appearance or worsening of the following conditions, the relationship of which with the use of combined oral contraceptives has not been proven: jaundice and/or itching associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes of pregnancy, hearing loss associated with otosclerosis

In women with hereditary angioedema, provocation or exacerbation of symptoms of the disease under the influence of exogenous estrogens

Liver dysfunction

Impaired glucose tolerance or effects of peripheral insulin resistance

Crohn's disease and ulcerative colitis

Chloasma

Interactions

Breakthrough bleeding and/or decreased contraceptive effectiveness of the drug due to interactions of combined oral contraceptives with drugs (liver enzyme inducers)

Contraindications

Combined hormonal contraceptives should not be used if any of the conditions listed below are present. If any of these conditions develop for the first time while taking a combined hormonal contraceptive, the drug should be discontinued immediately.

Presence or risk of venous thromboembolism

· venous thromboembolism currently (on anticoagulant therapy) or in history (for example, deep vein thrombosis, or pulmonary embolism)

hereditary or acquired predisposition to venous thromboembolism (for example, resistance to activated protein C (including factor V Leiden), deficiency of antithrombin III, protein C or protein S

· major surgical interventions with prolonged immobilization

· high risk of venous thromboembolism due to the presence of multiple risk factors (See also section “Special instructions”).

Presence or risk of arterial thromboembolism

current or history of arterial thromboembolism (eg, myocardial infarction) or conditions preceding arterial thromboembolism (eg, angina pectoris)

· cerebrovascular disorders - current or history of stroke or conditions preceding cerebrovascular disorders (for example, transient ischemic attacks)

hereditary or acquired predisposition to arterial thromboembolism (for example, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies and lupus anticoagulant)

history of migraine with focal neurological symptoms

high risk of developing arterial thromboembolism due to the presence of multiple risk factors, such as:

Diabetes mellitus with vascular complications

Severe arterial hypertension

Severe dyslipoproteinemia

Pancreatitis with severe hypertriglyceridemia, currently or in history.

Current or history of severe liver disease (before liver tests normalize)

Current or history of liver tumors (benign or malignant)

Detected or suspected hormone-dependent malignant diseases (for example, genitals or mammary glands)

Vaginal bleeding of unknown origin

Hypersensitivity to any of the components of the drug

Drug interactions

When prescribing concomitant therapy, it is necessary to familiarize yourself with the drug interactions section of each of the prescribed drugs to identify potential interactions.

Effects of other drugs on Janine â

There may be an interaction with drugs that induce liver enzymes, which may increase the clearance of sex hormones and lead to breakthrough bleeding and/or a decrease in the contraceptive effectiveness of the drug.

Enzyme induction can be observed after just a few days of treatment. Maximum enzyme induction usually occurs within a few weeks. After cessation of treatment, enzyme induction may persist for 4 weeks.

Short course of treatment

Women undergoing a short course of treatment with drugs that induce liver enzymes are advised to use a barrier method of contraception in addition to Janine or choose another method of contraception. In this case, a barrier method of contraception should be used during the period of concomitant use of drugs and for 28 days after their discontinuation. If the period of use of the barrier method of contraception ends later than the tablets in the Zhanin pack, you need to move on to the next Zhanin pack â without the usual break in taking pills.

Long course of treatment

Women undergoing long-term treatment with drugs that induce liver enzymes are recommended to use another reliable, non-hormonal method of contraception.

Janine's influence ® for other drugs

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

However, based on data from in vitro studies, the development of inhibition of cytochrome P450 enzymes is unlikely when dienogest is prescribed at a therapeutic dose.

Data from clinical studies suggest that ethinyl estradiol inhibits the clearance of CYP1A2 substrates, resulting in mild (eg, theophylline) to moderate (eg, tizanidine) increases in CYP1A2 substrate concentrations.

special instructions

The decision to prescribe Zhanine should be made on an individual basis, taking into account the woman’s risk factors, in particular the development of venous thromboembolism and assessing the risk of developing venous thromboembolism while taking Zhanine in comparison with other combined hormonal contraceptives.

Precautions and Warnings

If any of the conditions/risk factors listed below currently exist, the advisability of using Janine should be discussed with the woman.

If any of these conditions or risk factors intensify or manifest for the first time, a woman should consult her doctor, who may decide whether to discontinue Janine.

If venous thromboembolism (VTE) or arterial thromboembolism (ATE) is suspected or confirmed, combined hormonal contraceptives should be discontinued. If a woman is prescribed anticoagulant therapy, adequate contraception should be provided by an alternative method, given the teratogenic effect of anticoagulant therapy (coumarins).

· Circulatory disorders

Risk of venous thromboembolism

The use of any combined hormonal contraceptives increases the risk of developing VTE in patients compared to women who do not use them.

Drugs containing levonorgestrel, norgestimate and norethisterone have the lowest risk of developing VTE. It is unknown what risk Zanine has compared to these low-risk drugs.

The decision to use such drugs over any other low-risk VTE drug should only be made after a joint discussion with the woman. This is to ensure that the woman is aware of the risk of developing VTE with Janine, how her risk factors will affect that risk, and that the risk of VTE is greatest in the first year of use.

In addition, there is some evidence that an increased risk may be seen when a combined oral contraceptive is restarted after a break of 4 weeks or more.

In women who do not use combined hormonal contraceptives and are not pregnant, VTE develops with a frequency of 2 per 10,000 cases over 1 year. However, this risk may increase significantly depending on each woman's individual risk factors (see below).

The results of epidemiological studies showed that among women using low-dose combined hormonal contraceptives (<0,05 мг этинилэстрадиола ВТЭ возникает у 9–12 из 10 000 женщин) в течение года.

It is estimated that out of 10,000 women taking combined hormonal contraceptives containing levonorgestrel, 6 will develop VTE within 1 year.

Limited data from epidemiological studies suggest that the risk of VTE with COCs containing dienogest may be similar to the risk with COCs containing levonorgestrel.

The reported incidence of VTE during the year is lower than expected during pregnancy and the postpartum period.

Venous thromboembolism can be fatal in 1-2% of cases.

Thrombosis of other blood vessels, such as hepatic, mesenteric, renal, cerebral arteries and veins, as well as retinal vessels, has been extremely rarely reported in women taking combined hormonal contraceptives.

Risk factors for the development of venous thromboembolism

The risk of developing venous thromboembolic complications while taking combined hormonal contraceptives may increase significantly if a woman has additional risk factors, especially if there are multiple risk factors.

The use of Zhanin is contraindicated if a woman has multiple risk factors that pose a high risk of developing venous thrombosis.

The possibility of an increased synergistic risk of thrombosis in women with a combination of several risk factors or a higher severity of one of the risk factors should be considered. In such cases, the increased risk may be greater than the total risk taking all factors into account. Combined hormonal contraceptives should not be prescribed if the risk/benefit ratio is negative (see section "Contraindications").

Symptoms of venous thromboembolism (deep vein thrombosis and pulmonary embolism)

Risk of arterial thromboembolism

Data from epidemiological studies indicate an increased risk of developing ATE (myocardial infarction) or cerebrovascular events (eg, transient ischemic attacks, stroke).

Arterial thromboembolic processes can be fatal.

Symptoms of arterial thromboembolism

If the symptoms listed below appear, a woman should immediately pay attention to this and inform the doctor that she is using combined hormonal contraceptives.

Symptoms of cerebrovascular disorders may include:

sudden weakness or numbness of the face, upper or lower extremities, especially on one side of the body, sudden confusion, difficulty speaking, or difficulties with perception; sudden loss of vision in one or both eyes, sudden disturbance in gait, dizziness, loss of balance or coordination, sudden severe or prolonged headache for no apparent reason, loss of consciousness or fainting with or without a seizure. Other signs of vascular occlusion may also include sudden pain, swelling or mild blueness of the extremities, and symptoms of an “acute abdomen.”

Symptoms of myocardial infarction include:

pain, discomfort, pressure, heaviness, a feeling of squeezing or fullness in the chest, in the arm or behind the sternum, a feeling of discomfort radiating to the back, cheekbones, larynx, arm, stomach, a feeling of fullness or fullness in the stomach, a feeling of suffocation, cold sweat, nausea , vomiting or dizziness, severe weakness, anxiety, shortness of breath, fast or irregular heartbeat.

Risk factors for the development of venous and arterial thromboembolism

The risk of developing thrombosis (venous and/or arterial), thromboembolic or cerebrovascular disorders increases:

With age (over 35 years);

In smokers (women should stop smoking if they intend to take COCs. For women over 35 years of age who continue to smoke, other methods of contraception are strictly recommended);

If there is a family history (i.e., venous or arterial thromboembolism ever in siblings or parents at a relatively young age under 50 years). If a hereditary predisposition is known or suspected, the woman should consult a doctor to decide on the possibility of taking combined oral contraceptives;

For obesity (body mass index more than 30 kg/m2). The risk increases with increasing BMI. It is especially important to consider the presence of other risk factors;

With dyslipoproteinemia;

For arterial hypertension;

For migraines;

For diseases of the heart valves;

With atrial fibrillation;

With 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 planned surgery, at least four weeks before it) and not to resume use for two weeks after the end of immobilization. Temporary immobilization, including airplane flights of more than 4 hours, may increase the risk of VTE, particularly in women with other risk factors.

To prevent unplanned pregnancy, you must use another method of contraception.

If discontinuation of the drug Zhanin has not been carried out in advance, the need to prescribe antithrombotic therapy should be considered.

The possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial.

The increased risk of thromboembolism during pregnancy and especially during the 6 weeks postpartum period should be taken into account.

Circulatory abnormalities may also occur with tumors, 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 use of combined oral contraceptives (which may precede cerebrovascular events) may be grounds for immediate discontinuation of these drugs.

The most significant risk factor for developing cervical cancer is a viral infection - persistent human papilloma (HPV). There have been reports of some increased risk of cervical cancer with long-term use of combined oral contraceptives, but there remains conflicting information about the extent to which this may be related to other factors, including screening for cervical pathology and sexual behavior ( less frequent use of barrier methods of contraception).

A meta-analysis of 54 pharmacoepidemiological studies demonstrated that there is a slightly increased relative risk (RR=1.24) of developing breast cancer diagnosed in women who were currently taking combined oral contraceptives. The increased risk gradually disappears within 10 years of stopping these drugs. Because breast cancer is rare in women under 40 years of age, the increase in the incidence of breast cancer in women currently taking or recently taking combined oral contraceptives is small relative to the overall risk of developing this disease. Its connection with the use of combined oral contraceptives has not been proven. The observed increased risk may be due to earlier diagnosis of breast cancer in women using combined oral contraceptives, biological effects of combined oral contraceptives, or a combination of both. Women who have ever used combined oral contraceptives are diagnosed with earlier stages of breast cancer than women who have never used them.

In rare cases, the development of benign liver tumors and, in even more rare cases, the development of malignant liver tumors have been observed during the use of combined oral contraceptives. In some cases, liver tumors can lead to life-threatening intra-abdominal bleeding. If women taking combined oral contraceptives experience severe pain in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding, the possibility of a liver tumor should be taken into account when making a differential diagnosis.

Malignant tumors can be life-threatening or fatal.

The woman should be warned that hormonal contraceptives do not protect against HIV infection (AIDS) and other diseases transmitted X by sexual intercourse.

Reduced efficiency

The effectiveness of combined oral contraceptives may be reduced by missing pills, gastrointestinal problems, or drug interactions.

Effect on the menstrual cycle

While taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately three cycles.

If irregular bleeding recurs or develops after previous regular cycles, careful evaluation should be performed to rule out malignancy or pregnancy. This may include curettage.

Pregnancy and lactation

Janine® is not prescribed during pregnancy.

If pregnancy is detected while taking the drug, you must immediately stop taking it. However, extensive pharmacoepidemiological studies have not revealed any increased risk of developmental defects in children born to women who received combined oral contraceptives before pregnancy or teratogenic effects when combined oral contraceptives were taken inadvertently in early pregnancy.

Animal studies have shown undesirable effects of the drug during pregnancy and lactation.

Lactation

Janine® should not be used until the nursing mother has completely weaned her baby.

Children and teenagers

The drug Zhanine® is indicated only after the onset of menarche.

Features of the effect of the drug on the ability to drive vehicles and potentially dangerous mechanisms.

Release form and packaging

21 tablets in a blister pack made of polyvinyl chloride film and aluminum foil.

1 blister pack together with instructions for medical use in the state and Russian languages ​​are placed in a cardboard pack.

Storage conditions

Store at a temperature not exceeding 25o C.

Keep out of the reach of children!

Shelf life

Do not use after expiration date.