Janine, 21 pcs., 0.03 mg+2 mg, film-coated tablets

Janine

Use during pregnancy and breastfeeding

Zhanine® is not prescribed during pregnancy and breastfeeding.
If pregnancy is detected while taking Janine, the drug should be discontinued immediately. However, extensive epidemiological studies have not shown an increased risk of developmental defects in children born to women who received sex hormones before pregnancy, or teratogenic effects when sex hormones were inadvertently taken in early pregnancy.

Taking combined oral contraceptives can reduce the amount of breast milk and change its composition, therefore, their use is contraindicated during lactation. Small amounts of sex steroids and/or their metabolites may be excreted in milk.

Use for liver dysfunction

If liver dysfunction occurs, temporary discontinuation of Zhanine may be required until laboratory parameters normalize. If cholestatic jaundice or cholestatic itching develops (first occurring during pregnancy or previous use of sex hormones), Zhanine should be discontinued.

Use for renal impairment

Taking Zhanine may affect biochemical indicators of kidney function.

special instructions

Before starting or resuming the use of the drug Zhanin®, it is necessary to familiarize yourself with the woman’s life history, family history, conduct a thorough general medical examination (including measurement of blood pressure, heart rate, determination of body mass index) and gynecological examination, including examination of the mammary glands and cytological examination of scrapings from the cervix (test Papanicolaou test), exclude pregnancy. The scope of additional studies and the frequency of follow-up examinations are determined individually. Typically, follow-up examinations should be carried out at least once a year.

A woman should be informed that Janine® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

If any of the conditions, diseases and risk factors listed below currently exist, the potential risks and expected benefits of combined oral contraceptives should be carefully weighed on an individual basis and discussed with the woman before she decides to start taking drug. If risk factors become more severe, intensify, or when risk factors first appear, it may be necessary to discontinue the drug.

Diseases of the cardiovascular system

The results of epidemiological studies indicate a relationship between the use of combined oral contraceptives and an increased incidence of venous and arterial thrombosis and thromboembolism (deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular diseases) when taking combined oral contraceptives. These diseases are rare.

The risk of developing venous thromboembolism (VTE) is greatest in the first year of taking such drugs. An increased risk is present after initial use of oral contraceptives or resumption of use of the same or different combined oral contraceptives (after a dosing interval of 4 weeks or more). Data from a large prospective study involving 3 groups of patients suggest that this increased risk is predominantly present during the first 3 months.

The overall risk of VTE in patients taking low-dose combined oral contraceptives (<50 mcg ethinyl estradiol) is 2-3 times higher than in non-pregnant patients not taking combined oral contraceptives, however, this risk remains lower than the risk VTE during pregnancy and childbirth. VTE can be fatal (in 1-2% of cases).

Venous thromboembolism (VTE), manifested as deep vein thrombosis or pulmonary embolism, can occur with the use of any combined oral contraceptives.

It is extremely rare that when using combined oral contraceptives, thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels. There is no consensus regarding the relationship between the occurrence of these events and the use of combined oral contraceptives. Symptoms of deep vein thrombosis (DVT) include: unilateral swelling of the lower extremity or along a vein in the leg, pain or discomfort in the leg only when standing or walking, localized warmth in the affected leg, redness or discoloration of the skin on the leg.

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

Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction. Symptoms of a stroke: sudden weakness or loss of sensation in the face, arm or leg, especially on one side of the body, sudden confusion, problems with speech and comprehension; sudden unilateral or bilateral vision loss; 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 an epileptic seizure. Other signs of vascular occlusion: sudden pain, swelling and slight blue discoloration of the extremities, acute abdomen.

Symptoms of myocardial infarction include: pain, discomfort, pressure, heaviness, a feeling of squeezing or fullness in the chest, arm, or behind the breastbone; discomfort radiating to the back, cheekbone, larynx, arm, stomach; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety or shortness of breath; fast or irregular heartbeat.

Arterial thromboembolism can be fatal.

The risk of developing thrombosis (venous and/or arterial) and thromboembolism increases:

• with age;
• in smokers (with increasing number of cigarettes or increasing age, the risk increases, especially in women over 35 years of age);
• for obesity (body mass index more than 30 kg/m2);
• if there is a family history (for example, venous or arterial thromboembolism ever occurred in close relatives or parents at a relatively young age). In the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking combined oral contraceptives;
• 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 resume use for two weeks after the end of immobilization;
• with dyslipoproteinemia;
• with arterial hypertension;
• for migraines;
• for diseases of the heart valves;
• with atrial fibrillation.

The possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial. The increased risk of thromboembolism in the postpartum period should be taken into account.

Peripheral circulatory disorders may also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.

An increase in the frequency and severity of migraine during use of combined oral contraceptives (which may precede cerebrovascular events) may be grounds for immediate discontinuation of these drugs.

Biochemical indicators indicating a hereditary or acquired predisposition to venous or arterial thrombosis include: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

When assessing the risk-benefit ratio, it should be taken into account that adequate treatment of the relevant condition may reduce the associated risk of thrombosis. It should also be taken into account that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose oral contraceptives (<50 mcg ethinyl estradiol).

Tumors

The most significant risk factor for developing cervical cancer is persistent papilloma viral infection. There are reports of a slight increase in the risk of developing cervical cancer with long-term use of combined oral contraceptives. However, the connection with the use of combined oral contraceptives has not been proven. Controversy remains regarding the extent to which these findings are related to screening for cervical pathology or to sexual behavior (lower use of barrier methods of contraception).

A meta-analysis of 54 epidemiological studies found that there is a slightly increased relative risk of breast cancer diagnosed in women who used 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 breast cancer diagnoses in women currently or recently taking combined oral contraceptives is small relative to the overall risk of breast cancer. Its connection with the use of combined oral contraceptives has not been proven. The observed increased risk may also be a consequence of earlier diagnosis of breast cancer in women using combined oral contraceptives. 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, during the use of combined oral contraceptives, the development of liver tumors has been observed, which in some cases led to life-threatening intra-abdominal bleeding. If severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding occur, this should be taken into account when making a differential diagnosis.

Other states

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

Although slight increases in blood pressure have been described in many women taking combined oral contraceptives, clinically significant increases have rarely been reported. However, if a persistent, clinically significant increase in blood pressure develops while taking combined oral contraceptives, these drugs should be discontinued and treatment of hypertension should be initiated. Taking combined oral contraceptives can be continued if normal blood pressure values ​​are achieved with antihypertensive therapy.

The following conditions have been reported to develop or worsen both during pregnancy and while taking combined oral contraceptives, but their association with combined oral contraceptives has not been proven: jaundice and/or pruritus associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; Sydenham's chorea; herpes during pregnancy; hearing loss associated with otosclerosis. Cases of Crohn's disease and ulcerative colitis have also been described during the use of combined oral contraceptives.

In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen symptoms of angioedema.

Acute or chronic liver dysfunction may require discontinuation of combined oral contraceptives until liver function tests return to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of combined oral contraceptives.

Although combined oral contraceptives may have an effect on insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose combined oral contraceptives (less than 50 mcg ethinyl estradiol). However, women with diabetes mellitus should be carefully monitored while taking combined oral contraceptives.

Chloasma can sometimes develop, especially in women with a history of pregnancy chloasma. Women prone to chloasma should avoid prolonged exposure to the sun and ultraviolet radiation while taking combined oral contraceptives.

The effectiveness of combined oral contraceptives may be reduced if pills are missed, vomiting and diarrhea occur, or as a result of 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.

Some women may not develop withdrawal bleeding during a break from taking the tablets. If combined oral contraceptives are taken as directed, the woman is unlikely to be pregnant. However, if combined oral contraceptives have not been taken regularly before or if there are no consecutive withdrawal bleeds, pregnancy should be ruled out before continuing to take the drug.

Impact on laboratory test performance

Taking combined oral contraceptives may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma transport protein levels, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond normal values.

Preclinical safety data

Preclinical data from routine repeated-dose toxicity, genotoxicity, carcinogenicity and reproductive toxicity studies do not indicate a particular risk to humans. However, it should be remembered that sex steroids can promote the growth of certain hormone-dependent tissues and tumors.

Impact on the ability to drive vehicles and operate machinery

Not found.

Compound

The active ingredients in Janine include 2 mg of dienogest and 30 mcg of ethinyl estradiol .
In addition to these substances, the tablets contain lactose in the form of monohydrate, potato starch, magnesium stearate, talc, and gelatin. The shell is made using sucrose, dextrose, macrogol 35000, calcium carbonate , polyvidone, titanium dioxide, carnauba wax.

Pharmacodynamics and pharmacokinetics

The action of the pill is aimed at inhibiting the secretion of gonadotropic pituitary hormones, inhibiting the maturation of follicles and suppressing ovulation . With the use of the drug, the viscosity of the mucus filling the cervical canal increases, which creates obstacles for the penetration of sperm into the uterine cavity.

Taking Janine pills is accompanied by normalization of the menstrual cycle , a decrease in the pain of menstruation and the intensity of discharge, thereby significantly reducing the risk of developing anemia .

Dienogest , the progestin component of the drug, is a derivative of nortestosterone . Clinical studies of the use of this substance in patients with acne have established its pronounced antiandrogenic activity. In addition, dienogest is characterized by the ability to increase the concentration of high-density drugs in the blood.

After p/os administration of 1 tablet, dienogest is quickly and completely absorbed from the gastrointestinal tract . Plasma concentration reaches a maximum after 2 hours 30 minutes. The absolute bioavailability indicator is at the level of 96% (and this value remains the same in combination with the estrogenic component of Janine tablets).

About 1/10 of the administered dose of dienogest remains in the plasma in free form, the remaining 90% is nonspecifically bound to albumin . The substance does not bind to specific transport proteins. And this is precisely the reason that it does not displace cortisol and testosterone from their connections with CSG and SHBG, respectively.

The effect of the first passage is negligible. The resulting metabolic products are inactive.

The half-life of dienogest with a single dose is about 9 hours, with multiple doses - about 10. After oral administration, a little more than 85% of the dose is eliminated within 6 days (about half during the first day).

After p/os administration, ethinyl estradiol is quickly and completely absorbed from the digestive tract; the maximum plasma concentration is achieved in the next 1.5-4 hours after taking one tablet.

The substance is subject to the first passage effect, which accounts for its low bioavailability (this figure usually does not exceed 44%).

In free form, about 1.5% ethinyl estradiol , approximately 98.5% of the substance is bound to albumin . Ethinyl estradiol enhances the biosynthesis of CSG and SHBG without binding to these transport proteins .

After taking one tablet, the half-life of ethinyl estradiol is 10 hours. After three cycles of using the drug, it increases to 15 hours.

From 30 to 50% of metabolic products are excreted in the urine, about 30-40% are excreted in the intestinal contents.

Contraindications

Contraindications to the use of birth control pills are:

• thrombosis of veins and arteries (including a history; including PE, DVT, myocardial infarction , cerebrovascular disorders );
• conditions preceding thrombosis (including a history; for example, angina pectoris attacks of focal or cerebral disorders associated with cerebral circulation
• diabetes mellitus occurring with vascular complications ;
• severe and/or multiple factors that increase the risk of thrombosis of veins or arteries ;
• severe forms of liver disease (including a history; taking the drug is allowed only if the liver test results are normal);
• liver tumors;
• malignant diseases of the mammary glands or reproductive organs (as well as suspicion of them) caused by an imbalance of hormones
• vaginal bleeding of unspecified etiology;
• established or suspected pregnancy ;
• hypersensitivity to substances contained in the tablets.

During pregnancy

In the course of epidemiological studies, it was found that Janine does not increase the risk of teratogenic effects in a child whose mother took birth control pills before pregnancy or, unknowingly, in the first weeks.

However, during pregnancy, taking the drug is contraindicated.

Since combined hormonal drugs are characterized by the ability to suppress lactation and affect the composition of breast milk, nursing women are advised to refrain from taking them.

If you are planning a child, you should stop using birth control pills. Doctors advise trying to get pregnant from the beginning of a new cycle. Pregnancy usually occurs fairly quickly after taking the pills.

Reviews about Janine

Reviews about Janine on the forums are quite varied. For the most part, they are positive, since the drug is well tolerated by women, is easy to use, and copes well with its main task.

In addition, patients and doctors in reviews of Janine note that the drug, in addition to contraception, has a number of other positive side effects: it helps with acne, normalizes the menstrual cycle, and reduces the intensity and pain of bleeding. In women who stop taking Zhanine tablets due to a desire to become pregnant, pregnancy after discontinuation of the drug often occurs within the first 2-3 cycles.

Due to the drug's ability to stabilize hormonal levels and suppress foci of pathological growth of the endometrium , it is often effective for fibroids and endometriosis (usually in situations where the disease is not too advanced).

However, there are also negative reviews about the drug, which are associated either with the lack of results in the treatment of endometriosis , or with side effects that significantly worsen the woman’s quality of life. Experts are inclined to believe that such phenomena can occur if the product was selected without taking into account contraindications for use, or is simply not suitable for a particular woman.

Analyzing doctors' reviews of Zhanine birth control pills, we can conclude that experts speak positively about this drug. Such a high rating is due to the fact that, being a low-dose drug, the latter has a pronounced contraceptive effect, helps restore hormonal imbalances and has a positive effect on the general condition of a woman.

Use with alcohol

In the instructions for the drug, the manufacturer does not give any recommendations regarding the possibility of using Janine tablets with alcoholic beverages.

The recommended dose of alcohol for a woman taking oral contraceptives is 20 grams of ethanol (a glass of wine).

However, please remember that:

• the reaction of different organisms to the same dose of alcohol may differ;
• hormonal drugs are an additional burden for the liver , which is responsible for the breakdown of ethyl alcohol (i.e., with an overdose of alcohol, the consequences can be quite serious both for the liver and for the body as a whole);
• with increased activity of liver enzymes due to an overdose of alcohol, the breakdown and elimination of substances contained in the drug are significantly accelerated (i.e., the contraceptive effect may be reduced);
• An overdose of alcohol, accompanied by vomiting, leads to the fact that the active substances of the tablets do not have time to be absorbed from the gastrointestinal tract, and as a result, the effectiveness of the drug decreases.

According to doctors, you should wait at least 3 hours between taking pills and alcoholic drinks.

Analogs

Level 4 ATC code matches:
Ovidon

Rigevidon

Non-Ovlon

Mercilon

Yarina Plus

Yarina

Miniziston 20 fem

Novinet

Microgynon

Lindineth

Cyclo-Proginova

Regulon

Logest

Midiana

Belara

Femoden

Jess Plus

Jess

Zoely

Generics: Zhenetten , Diecyclen , Siluet , Bonade .

Analogues of Zhanin by mechanism of action: Belara , Yarina , Dailla , Midiana , Jess , Logest , Evra , Lindinet 30 , Mercilon , Marvelon , Egestrenol , Femoden , Oralcon , Dimia .

Janine or Silhouette - which is better?

The drugs Zhanine and Silhouette are structural analogues, that is, they contain identical substances in the same dosage as active components, they have the same mechanism of action, indications and contraindications.

The products are produced by different companies and have a significant difference in price; Silhouette is about half the price of its counterpart.

Which is better: Claira or Janine?

The basis of the drug Qlaira is dienogest and estradiol valerate of 17β-estradiol produced by the human body ). Each package contains 5 types of tablets, which differ in the composition of the active ingredients and their concentration.

The ethinyl estradiol contained in the Janine dragee exhibits greater metabolic stability in contrast to the estrogenic component of Qlaira , however, it also has a more pronounced effect on the liver .

The mechanism of action of Qlaira is due to the ability of its active components to suppress ovulation and change the properties of cervical mucus. In addition, the drug reduces pain and intensity of bleeding during menstruation , prevents the development of iron deficiency anemia , and reduces the risk of developing ovarian and endometrial cancer .

Which is better: Janine or Diana 35?

Diane-35 is a combination of cyproterone (2 mg) and ethinyl estradiol (35 mcg). If Zhanine is prescribed primarily to prevent pregnancy in women with endometriosis , then the use of Diane-35 is advisable for contraception in women with pronounced signs of androgenization .

Janine or Visanne - which is better?

The drug Visanne of micronized dienogest as an active component . The drug is intended for the treatment of endometriosis. To achieve a therapeutic effect, the tablets are taken for six months.

The main indication for use of the drug Zhanine is contraception (in particular contraception in women with endometriosis ).

According to doctors and patients who were treated with both drugs, treatment of endometriosis with Janine is not always as effective as treatment with Visanne. In addition, the latter is often better tolerated and causes fewer side effects.

When wondering which drug to choose, you should remember that each woman’s body is individual, in addition, in each specific case, the indications for use may differ. In this regard, a specialist must prescribe this or that remedy.

Side effects of Janine

The most common side effects of taking estrogen-progestin oral contraceptives are:

• an increase in the size and tension of the mammary glands, their soreness, as well as the appearance of discharge from them;
• bloody discharge from the genital tract of varying intensity (can be spotting or have the character of breakthrough bleeding);
• headaches (migraine attacks are also possible);
• mood lability;
• change in libido ;
• deterioration of tolerance to contact lenses;
• visual impairment;
• abdominal pain;
• nausea;
• skin rashes;
• vomit;
• changes in the nature of vaginal discharge;
• nodular (nodous) or erythema multiforme ;
• cholestatic jaundice;
• generalized itching;
• weight fluctuations;
• fluid retention;
• allergic reactions.

Sometimes side effects of Zhanine are expressed in the form of increased plasma concentrations of triglycerides , diarrhea , increased fatigue, decreased tolerance to carbohydrates, chloasma (the risk of focal hyperpigmentation is especially high in women who chloasma during pregnancy).

Like other combined hormonal contraceptives for oral use, Janine can cause thrombosis or thromboembolism .

Interaction

The simultaneous use of Zhanine birth control pills with drugs that induce microsomal enzymes of liver cells (including barbiturates , hydantoins , Rifampicin , Carbamazepine , Primidon and, probably, Topiramate , Griseofulvin , Felbamate ), provokes an increase in the clearance of dienogest and ethinyl estradiol , which may cause a decrease in contraceptive effect.

As a rule, the maximum activity of liver enzymes is observed 2-3 weeks after the start of treatment with these drugs, however, it can be observed over the next 4 weeks after completion of the course.

When Zhanine is used in combination with ampicillin and tetracycline of ethinyl estradiol decreases .

It should be remembered that women who take any of the above-mentioned drugs for a short course should additionally use barrier contraceptives throughout the entire period of treatment and for 7 days after its completion.

If a woman is undergoing treatment with Rifampicin , the need to use additional contraceptive measures continues for a full 4 weeks after its completion. If concomitant therapy is started at the end of taking a package of hormonal tablets, the next one should be started without taking the usual break.