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Janine - instructions for use and composition, release form, dosage regimen, dosage and price. Janine - instructions for use, doses, side effects, contraindications, price, where to buy - geotar medicinal reference Terms of sale in pharmacies

Name: Jeanine

Indications for use:
Contraception.

Pharmachologic effect:
Janine is a low-dose monophasic oral combined estrogen-progestogen contraceptive product.
The contraceptive effect of Zhanin is carried out through three complementary mechanisms:
—suppression of ovulation at the level of hypothalamic-pituitary regulation;
- changes in the properties of cervical secretion, as a result of which it becomes impermeable to sperm;
- changes in the endometrium, which makes implantation of a fertilized egg impossible.

In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful menstruation is less common, and the intensity of bleeding is reduced, resulting in a reduced risk of iron deficiency.

Pharmacokinetics
Dienogest
Absorptions. After oral administration, dienogest is rapidly and completely absorbed, its highest serum concentration of 52 ng/ml is achieved after approximately 2.5 hours. Bioavailability is approximately 91-96%.
Distribution. Dienogest binds to serum albumin and does not bind to sex hormone binding globulin (SHBG) and corticoid binding globulin (CBG). In free form, it is within 10% of the total concentration in blood serum; within 90% - not specifically associated with serum albumin. The induction of SHBG synthesis by ethinyl estradiol does not affect the binding of dienogest to serum protein.
Metabolism. Dienogest is almost completely metabolized. Serum clearance is approximately 3.4-3.7 L/h.
Excretion. The half-life is in the range of 8.5-10.8 hours. A small amount in unchanged form is excreted in the urine, in the form of metabolites (T1/2 - 14.4 hours), excreted in urine and bile in a ratio of approximately 3:1.
Equilibrium concentration. The pharmacokinetics of dienogest is not affected by the level of SHBG in the blood serum. As a result, every day the product is taken, the level of the substance in the serum increases by approximately 1.5 times.

Absorption. After oral administration, ethinyl estradiol is rapidly and completely absorbed. The maximum serum concentration of approximately 67 pg/ml is achieved within 1.5-4 hours. During absorption and first passage through the liver, ethinyl estradiol is metabolized, resulting in its oral bioavailability of approximately 44%.
Distribution. Ethinyl estradiol is almost completely (approximately 98%), although nonspecifically, bound by albumin. Ethinyl estradiol induces the synthesis of SHBG. The apparent volume of distribution of ethinyl estradiol is 2.8 - 8.6 l/kg.
Metabolism. Ethinyl estradiol undergoes presystemic conjugation, both in the mucosa of the small intestine and in the liver. The main route of metabolism is aromatic hydroxylation. The clearance rate from blood plasma is 2.3 - 7 ml/min/kg.
Excretion. The decrease in the concentration of ethinyl estradiol in the blood serum is biphasic; the first phase is characterized by a half-life of 1 hour, the second - 10-20 hours. It is not excreted from the body unchanged. Metabolites of ethinyl estradiol are excreted in urine and bile in a ratio of 4: 6 with a half-life of within 24 hours.
Equilibrium concentration. Equilibrium concentration is achieved during the second half of the treatment cycle.

Janine method of administration and dosage:
The pills should be taken orally in the order indicated on the pack, 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 the tablets, during which withdrawal bleeding usually occurs. Bleeding, as a rule, begins 2-3 days after taking the last pill and may not stop before taking a new package.

How to start taking Janine
In the absence of taking 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). It is allowed to start taking it at 2-5 menstrual cycles, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking pills from the first package.

When switching from other combined oral contraceptives.

It is preferable to start taking Janine the next day after taking the last active pill from the previous package, but in no case later than the next day after the usual 7-day break (for products containing 21 pills) or after taking the last inactive pill ( for products containing 28 tablets per pack).

When switching from contraceptives containing only gestagens (mini-pills, injectable forms, implant) or from a gestagen-releasing intrauterine contraceptive ().

A woman can switch from a mini-pill to Janine on any day (without a break), from an implant or intrauterine contraceptive with gestagen - every day of its removal, from an injection form - from the day when the next injection would have been given. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pill.

After an abortion in the first trimester of pregnancy.

A woman can start taking the product 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 product on days 21-28 after childbirth or abortion in the second trimester of pregnancy. If use is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pill. However, if a woman has already been sexually active, pregnancy must be excluded before taking Zhanine or she must wait until her first menstruation.

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

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

The use of the product should never be interrupted for more than 7 days.
7 days of continuous use of the pills are required to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation.

Accordingly, the following advice can be given if the delay in taking the pill is more than 12 hours (the interval from the moment of taking the next pill is more than 36 hours):
First week of taking the product
A woman must take the missed pill as soon as possible, as soon as she remembers (even if this means taking two pills at the same time). The next pill 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 during the week before missing the pills, the possibility of pregnancy must be taken into account.

The more tablets are missed, and the closer they are to a break in taking active substances, the greater the likelihood of pregnancy.
Second week of taking the product
A woman must take the missed pill as soon as possible, as soon as she remembers (even if this means taking two pills at the same time). The next pill is taken at the usual time.

Provided that the woman took the pill correctly during the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, even if you miss two or more pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.
Third week of taking the product
The risk of decreased reliability is inevitable due to the upcoming break in taking the pill.
A woman must strictly adhere to one of the following two options. Moreover, if in the 7 days preceding the first missed pill, all pills were taken correctly, there is no need to use additional contraceptive methods.

1. A woman must take the missed pill as soon as possible, as soon as she remembers (even if this means taking two pills at the same time). The next pill is taken at the usual time, until the pills from the current package run out. The next pack should be started immediately. Withdrawal bleeding is unlikely until the second pack is finished, but spotting and breakthrough bleeding may occur while taking the pills.
2. A woman can also stop taking pills from the current package. Then she must take a break for 7 days, including the day she missed the pills, and then start taking a new package.
If a woman misses taking the pill and then does not have withdrawal bleeding during the break in taking the pill, pregnancy must be ruled out.

If a woman has had vomiting or diarrhea within 4 hours of taking active tablets, absorption may not be complete and additional contraceptive measures should be taken. In these cases, you should follow the recommendations when skipping pills.

In order to delay the onset of menstruation, a woman must continue taking pills from the new package of Janine immediately after taking all the pills from the previous one, without interruption in taking. The pills from this new package can be taken for as long as the woman wishes (until the pack runs out). While taking the product 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 should be advised to shorten the next break in taking the pills by as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding, and in the future, there will be spotting and breakthrough bleeding while taking the second package (the same as in the case when she would like to delay the onset of menstruation. In order to delay the beginning of menstruation, the woman must continue taking the product, using subsequently 10 tablets from another package of Janine, without taking a break in taking it. Thus, the cycle can be extended for a period of up to 10 days until the end of the second package. While taking the product from the second package, a woman may experience spotting or breakthrough uterine bleeding.Regular use of Janine is then resumed after the usual 7-day break from taking the pill.
In order to postpone the start of menstruation to another day of the week, a woman should shorten the next break in taking pills by the desired number of days. The shorter the interval, the higher the risk that she will not have withdrawal bleeding; in the future, she will have 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).

Janine contraindications:
Janine should not be used if you have any of the conditions listed below. If any of these conditions develop for the first time while taking the product, the product should be discontinued immediately.
Thrombosis (venous and arterial) and thromboembolism currently or in history (including myocardial, cerebrovascular disorders).
Conditions preceding thrombosis (including transient ischemic attacks) currently or in history.
with a history of focal neurological symptoms.
with vascular complications.
Multiple or severe risk factors for venous or arterial thrombosis, including damage to the heart valves, cardiac arrhythmias, cerebrovascular disease or coronary artery disease; uncontrollable.
with severe hypertriglyceridemia currently or in history.
and severe liver disease (until liver tests return to normal).
Liver tumors (benign or malignant) currently or in history.
Identified hormone-dependent malignant diseases (including genital organs or mammary glands) or suspicion of them.
Vaginal bleeding of unknown origin.
Pregnancy or suspicion of it.
Breastfeeding period.
Hypersensitivity to any of the components of the Janine product.
Prolonged immobilization, major surgery, leg surgery, major injuries.

Janine side effects:
Soreness and tension of the mammary glands, enlargement of the mammary glands, discharge from the mammary glands; spotting and breakthrough uterine bleeding; headache; migraine; change in libido; decreased/changes in mood; poor tolerance to contact lenses; visual impairment; nausea; vomit; stomach ache; changes in vaginal secretion; skin rash; erythema nodosum; erythema multiforme; generalized itching; cholestatic; fluid retention; change in body weight; allergic reactions. Rarely - increased levels of plasma triglycerides, decreased tolerance to carbohydrates, high fatigue, diarrhea.

Chloasma can sometimes develop, especially in women with a history of pregnancy chloasma.

As with other combined oral contraceptives, in rare cases the development of thrombosis and thromboembolism is possible.

Pregnancy:
Janine is not prescribed during pregnancy and breastfeeding.
If pregnancy is detected while taking the Janine product, the product should be discontinued immediately. However, extensive epidemiological studies have not revealed any increased risk of developmental defects in babies born to women who received sex hormones before pregnancy or teratogenic effects when sex hormones were taken inadvertently 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 can be excreted in milk, but there is no evidence of their negative effects on the health of the newborn.

Overdose:
Symptoms that may occur in case of overdose: nausea, vomiting, spotting or metrorrhagia.

There is no specific antidote; symptomatic treatment should be carried out.

Use with other medications:
Sulfonamides and pyrazolone derivatives can enhance the metabolism of the steroid hormones included in the product.
Long-term treatment with products that induce liver enzymes, which increases the clearance of sex hormones, may lead to breakthrough bleeding and/or a decrease in the contraceptive effectiveness of Janine.
These drugs include: phenytoin, barbiturates, primidone, and rifampicin; There are also suggestions for oxcarbazepine, topiramate, felbamate, ritonavir and griseofulvin and products containing St. John's wort.
Contraceptive protection is reduced when taking antibiotics (such as ampicillins and tetracyclines), since, according to some data, some antibiotics may reduce the intrahepatic circulation of estrogens, thereby lowering the concentration of ethinyl estradiol.
Oral combined contraceptives may affect the metabolism of other products (including cyclosporine), which leads to changes in their concentrations in plasma and tissues.
When taking estrogen-progestin products, adjustment of the dosage regimen of hypoglycemic products and indirect anticoagulants may be required.

Release form:
21 dragees in a pack (blister) made of polyvinyl chloride film and covered with coated aluminum foil. A blister of 21 tablets or 3 blisters of 21 tablets together with instructions for use are placed in a cardboard box.

Storage conditions:
Store at a temperature not exceeding 25o C in places inaccessible to children.
Shelf life: 3 years.
Cannot be used after expiration date.
Dispensing conditions from pharmacies are by prescription.

Janine composition:
White smooth dragees.
Each dragee contains:
- active ingredients: 0.03 mg ethinyl estradiol and 2.0 mg dienogest.
- excipients: lactose monohydrate, potato starch, gelatin, talc, magnesium stearate, sucrose, sugar syrup, polyvidone K 25, macrogol 35000, calcium carbonate, titanium dioxide (E 171), carnauba wax.

Additionally:
The drug should be used with caution in the following cases:
— pronounced disorders of fat metabolism (,);
- superficial veins;
- otosclerosis with hearing impairment, idiopathic jaundice or itching during previous pregnancy;
— ;
— ;
—congenital (Gilbert, Dubin-Johnson and Rotor syndromes);
-diabetes;
— system red;
— hemolytic uremic syndrome;
— ;
—sickle cell anemia;
-arterial hypertension.

While taking products that affect microsomal enzymes, and for 28 days after their discontinuation, you should additionally use a barrier method of contraception.
While taking antibiotics (such as ampicillins and tetracyclines) and for 7 days after their discontinuation, you should additionally use a barrier method of contraception.
If the period of using the barrier method of protection ends later than the pills in the pack, you need to move on to the next pack of Zhanine without the usual break in taking the pills.

If any of the conditions/risk factors listed below currently exist, the potential risks and expected benefits of Janine treatment should be carefully weighed in each individual case and discussed with the woman before she decides to start taking the product. In case of worsening, intensification or the first manifestation of any of these conditions or risk factors, the woman must consult with her doctor, who may decide whether to discontinue the product.
Diseases of the cardiovascular system
There is evidence of an increased incidence of venous and arterial thrombosis and thromboembolism when taking combined oral contraceptives.
However, the incidence of venous thromboembolism (VTE) developing with combined oral contraceptives is less than the incidence associated with pregnancy (6 per 10,000 pregnant women per year).
In women taking combined oral contraceptives, extremely rare cases of thrombosis of other blood vessels, such as the hepatic, mesenteric, renal arteries and veins, the central retinal vein and its branches, have been described. The connection with the use of combined oral contraceptives has not been proven.
A woman should stop taking the product and consult a doctor if symptoms of venous or arterial thrombosis or cerebrovascular disorders develop, which may include: unilateral leg pain and/or swelling; sudden severe chest pain, with or without radiation to the left arm; sudden shortness of breath; sudden attack of cough; any unusual, severe, prolonged headache; sudden partial or complete loss of vision; diplopia; slurred speech or aphasia; dizziness; loss of consciousness with/or without a seizure; weakness or very significant loss of sensation that suddenly appears on one side or in one part of the body; movement disorders; symptoms of "acute abdomen".
The risk of thrombosis (venous and/or arterial) and thromboembolism increases:
-with age;
- in smokers (with an increase in the number of cigarettes or an increase in age, the risk further increases, especially in women over 35 years of age);
in the presence of:
- family history (i.e. venous or arterial thromboembolism once or in close relatives or parents at a relatively young age); in case of hereditary predisposition, the woman must be examined by an appropriate specialist to decide on the possibility of taking COCs;
obesity (body mass index more than 30 kg/m2);
- dislipoproteinemia;
- arterial hypertension;
- migraine;
— diseases of the heart valves;
- atrial fibrillation;
- 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.
The increased risk of thromboembolism in the postpartum period should be taken into account.
Circulatory abnormalities may also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease) and sickle cell anemia.

An increase in the frequency and severity of migraines during use of combined oral contraceptives (which may precede cerebrovascular events) may warrant immediate discontinuation of these products.
Biochemical parameters that may be indicative of hereditary or acquired susceptibility to venous or arterial thrombosis include activated protein C resistance, hyperhomocysteinemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

There are reports of an increased risk of developing cervical cancer with long-term use of combined oral contraceptives. Its connection with the use of combined oral contraceptives has not been proven. Controversy remains regarding the extent to which these findings are attributable to sexual behavior and other factors such as human virus (HPV).
It was also found that there is a slightly increased relative risk of developing breast cancer diagnosed in women who used combined oral contraceptives. Its connection with the use of combined oral contraceptives has not been proven. The observed increase in risk may be a consequence of earlier diagnosis of breast cancer in women using combined oral contraceptives.
In rare cases, the development of liver tumors has been observed during the use of combined oral contraceptives. In case of severe abdominal pain, liver enlargement or signs of intra-abdominal bleeding, 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 been reported infrequently. However, if a persistent, clinically significant increase in blood pressure develops while taking combined oral contraceptives, these products 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 relationship with taking combined oral contraceptives has not been proven: jaundice and/or pruritus associated with cholestasis; formation of gallstones; ; systemic lupus erythematosus; hemolytic uremic syndrome; Sydenham; pregnant women; hearing loss associated with otosclerosis. Cases of Crohn's disease and nonspecific ulcers have also been described during the use of combined oral contraceptives.
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 tolerance, there is no need to change the therapeutic regimen in patients with diabetes mellitus using low-dose combined oral contraceptives (

Janine (ethinyl estradiol + dienogest) is a combined oral contraceptive from the German pharmaceutical company Bayer Schering Pharma AG. The products of this company are known all over the world. Suffice it to say that the first tablet contraceptive Anovlar in Europe is also the merit of Bayer Schering Pharma AG. Since then, work to create effective and safe contraception has advanced significantly. Research has developed in two directions: determining the optimal dose of estrogen and creating a new generation of improved progestins. The culmination of this work was the development of dienogest, an innovative progestin, which is the active ingredient in the contraceptive Janine. Unlike earlier generations of progestins, dienogest does not contain an ethynyl group, which excludes the possibility of its influence on cytochrome-dependent liver enzymes. In addition to this, dienogest has a very short half-life, so it does not accumulate in the body. The innovativeness of the composition gives Janine a high degree of contraceptive reliability, the ability to have a positive effect on the menstrual cycle (reduce the intensity and duration of bleeding, eliminate its pain), which, in turn, minimizes the risk of developing iron deficiency anemia. Dienogest is devoid of androgenic properties (which is the “sin” of other gestagens). Moreover: it has the most positive effect on hair and skin (changes the size of the sebaceous glands towards reduction, suppresses excess secretion of sebum), which gives Janine not only a therapeutic, but also an aesthetic effect. The results of multicenter randomized, placebo-controlled clinical trials demonstrated the high efficacy and favorable safety profile of Zhanine.

The same was confirmed by post-marketing studies conducted after the drug entered the global pharmaceutical market.

The contraceptive effect of Zhanine is realized through several complementary physiological patterns, the key of which are the inhibition of ovulation and an increase in the thickness of cervical mucus in the epithelium of the cervical canal, due to which sperm cannot penetrate to the egg. Rules for taking the drug - every day at approximately the same time in strict accordance with what is indicated in the package insert. The start of use should coincide with the beginning of the menstrual cycle. Duration of treatment: 3 weeks. The frequency of administration is once a day. A new package of Janine should be started seven days after the previous one ends. Skipping the next dose within 12 hours does not reduce contraceptive protection. In this case, the next dose must be taken as quickly as possible. If you are more than 12 hours late, the contraceptive effect is reduced. A decrease in the contraceptive effect also occurs in the case of vomiting and diarrhea within 4 hours after taking the drug. Janine is not indicated for women during menopause. Before prescribing the drug, it is necessary to collect comprehensive anamnestic data about the woman and her family, conduct a series of diagnostic studies, including measuring blood pressure, heart rate, determining BMI, examining the mammary glands, and a Papanicolaou test. The need for additional laboratory and instrumental studies is determined individually in each specific case.

Pharmacology

Low-dose monophasic oral combined estrogen-progestogen contraceptive drug.

The contraceptive effect of Janine is carried out through complementary mechanisms, the most important of which include suppression of ovulation and a change in the viscosity of cervical mucus, as a result of which it becomes impermeable to sperm.

When used correctly, the Pearl index (an indicator reflecting the number of pregnancies in 100 women taking a contraceptive during the year) is less than 1. If pills are missed or used incorrectly, the Pearl index may increase.

The gestagenic component of Janine - dienogest - has antiandrogenic activity, which is confirmed by the results of a number of clinical studies. In addition, dienogest improves the blood lipid profile (increases the amount of high-density lipoproteins).

In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful menstruation is less common, the intensity and duration of bleeding decreases, resulting in a reduced risk of developing iron deficiency anemia. In addition, there is evidence of a reduced risk of endometrial and ovarian cancer.

Pharmacokinetics

Dienogest

Suction

After oral administration, dienogest is quickly and completely absorbed from the gastrointestinal tract. Cmax is reached after 2.5 hours and is 51 ng/ml. Bioavailability is approximately 96%.

Distribution

Dienogest binds to serum albumin and does not bind to sex steroid binding globulin (SGBS) and corticoid binding globulin (CBG). About 10% of the total concentration in the blood serum is found in free form; about 90% are nonspecifically associated with serum albumin. Induction of SHPS synthesis by ethinyl estradiol does not affect the binding of dienogest to serum protein.

The pharmacokinetics of dienogest is not affected by the level of SHPS in the blood serum. As a result of daily administration of the drug, the level of dienogest in the serum increases approximately 1.5 times.

Metabolism

Dienogest is almost completely metabolized. Serum clearance after a single dose is approximately 3.6 L/h.

Removal

T1/2 is about 8.5-10.8 hours. A small part of dienogest is excreted by the kidneys unchanged. Metabolites are excreted in urine and bile in a ratio of about 3:1 with T1/2 equal to 14.4 hours.

Ethinyl estradiol

Suction

After oral administration, ethinyl estradiol is rapidly and completely absorbed. Cmax in blood serum is reached after 1.5-4 hours and is 67 pg/ml. During absorption and "first pass" through the liver, ethinyl estradiol is metabolized, resulting in its oral bioavailability averaging about 44%.

Distribution

Ethinyl estradiol is almost completely (approximately 98%), although nonspecifically, bound to albumin. Ethinyl estradiol induces the synthesis of SHBG. The apparent V d of ethinyl estradiol is 2.8-8.6 l/kg.

C ss is achieved during the second half of the treatment cycle.

Metabolism

Ethinyl estradiol undergoes presystemic conjugation, both in the mucous membrane of the small intestine and in the liver. The main route of metabolism is aromatic hydroxylation. The clearance rate from blood plasma is 2.3-7 ml/min/kg.

Removal

The decrease in the concentration of ethinyl estradiol in the blood serum is biphasic; the first phase is characterized by T1/2 of the first phase - about 1 hour, T1/2 of the second phase - 10-20 hours. It is not excreted unchanged from the body. Ethinyl estradiol metabolites are excreted in urine and bile in a ratio of 4:6 with T1/2 of about 24 hours.

Release form

The dragees are white, smooth.

Excipients: lactose monohydrate - 27.97 mg, potato starch - 15 mg, gelatin - 1.5 mg, talc - 1.5 mg, magnesium stearate - 0.5 mg.

Shell composition: sucrose - 23.6934 mg, dextrose - 1.65 mg, macrogol 35,000 - 1.35 mg, calcium carbonate - 2.4 mg, polyvidone K25 - 0.15 mg, titanium dioxide (E171) - 0.74244 mg, carnauba wax - 0.01416 mg.

21 pcs. - blisters (1) - cardboard packs.
21 pcs. - blisters (3) - cardboard packs.

Dosage

The pills should be taken orally in the order indicated on the package, every day at approximately the same time, with a small amount of water. Zhanine ® should be taken 1 tablet/day continuously for 21 days. Each subsequent package begins after a 7-day break, during which withdrawal bleeding (menstrual-like bleeding) is observed. It usually begins on the 2-3rd day after taking the last pill and may not end until you start taking a new package.

Start of taking Janine

If you have not taken any hormonal contraceptives in the previous month, you should begin taking Zhanine on the 1st day of the menstrual cycle (i.e., on the 1st day of menstrual bleeding). It is possible to start taking it on the 2-5th day of the menstrual cycle, but in this case it is recommended to use a barrier method of contraception during the first 7 days of taking the tablets from the first package.

When switching from combined oral contraceptives, a vaginal ring, or a transdermal patch, taking Zhanine should begin the day after taking the last active pill from the previous package, but in no case later than the next day after the usual 7-day break in taking (for drugs containing 21 tablets) or after taking the last inactive tablet (for drugs containing 28 tablets per package). When switching from a vaginal ring or transdermal patch, it is preferable to start taking Janine on the day the ring or patch is removed, but no later than the day when a new ring is to be inserted or a new patch is applied.

When switching from contraceptives containing only gestagens ("mini-pills", injectable forms, implant) or from a gestagen-releasing intrauterine contraceptive (Mirena), a woman can switch from taking the "mini-pill" to Zhanine ® on any day (without a break), from an implant or intrauterine contraceptive with gestagen - on the day of its removal, from an injectable contraceptive - on the day when the next injection is due. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pill.

After an abortion in the first trimester of pregnancy, a woman can start taking the drug immediately. In this case, the woman does not need additional methods of contraception.

After childbirth or abortion in the second trimester of pregnancy, it is recommended to start taking the drug on the 21-28th day after childbirth or abortion in the second trimester of pregnancy. If use is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pill. However, if a woman has already been sexually active, pregnancy should be excluded before taking Zhanine or she must wait until her first menstruation.

Taking missed pills

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

If the delay in taking the pill is more than 12 hours, contraceptive protection may be reduced.

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

  • taking the drug should never be interrupted for more than 7 days;
  • To achieve adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous use of the pill are required.

Accordingly, if the delay in taking active pills was more than 12 hours (the interval from the moment of taking the last active pill was more than 36 hours), the following can be recommended:

First week of taking the drug

It is necessary to take the last missed pill as soon as possible, as soon as the woman remembers it (even if this means taking two pills at the same time). The next pill 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 the pills, the possibility of pregnancy must be taken into account. The more tablets are missed, and the closer they are to a break in taking active substances, the greater the likelihood of pregnancy.

Second week of taking the drug

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

Third week of taking the drug

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

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

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 pills, and then start taking a new pack.

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

If a woman has vomiting or diarrhea within 4 hours of taking active tablets, absorption may not be complete and additional contraceptive measures should be taken. In these cases, you should follow the recommendations when skipping pills.

Changing the start day of the menstrual cycle

To delay the onset of menstruation, a woman should continue taking pills from a new package of Janine immediately after taking all the pills from the previous one, without interruption. The pills from this 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 package after the usual 7-day break.

To move the start of menstruation to another day of the week, a woman should shorten the next break in taking the pills by as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and will continue to have 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

For children and adolescents, Zhanine ® is indicated only after menarche.

After menopause, Zhanine ® is not indicated.

Zhanine ® is contraindicated in women with severe liver disease until liver function tests have returned to normal.

The drug Zhanine ® has not been specifically studied in patients with impaired renal function. Available data do not suggest changes in treatment in these patients.

Overdose

No serious adverse events have been reported following overdose.

Symptoms: nausea, vomiting, spotting or metrorrhagia.

Treatment: carry out symptomatic therapy. There is no specific antidote.

Interaction

Interaction of oral contraceptives with other drugs may lead to breakthrough bleeding and/or decreased contraceptive reliability.

The following types of interactions have been reported in the literature.

Effect on hepatic metabolism

The use of drugs that induce microsomal liver enzymes can lead to an increase in the clearance of sex hormones. Such drugs include phenytoin, barbiturates, primidone, carbamazepine, rifampicin; There are also suggestions for oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John's wort.

HIV protease inhibitors (eg, ritonavir) and non-nucleoside reverse transcriptase inhibitors (eg, nevirapine) and combinations thereof also have the potential to affect hepatic metabolism.

Effect on enterohepatic circulation

According to individual studies, some antibiotics (for example, penicillins and tetracyclines) may reduce the enterohepatic circulation of estrogens, thereby lowering the concentration of ethinyl estradiol.

While taking any of the above medications, a woman should additionally use a barrier method of contraception (for example, a condom).

Substances affecting the metabolism of combined hormonal contraceptives (enzyme inhibitors)

Dienogest is a substrate of cytochrome P450 (CYP)3A4. Known CYP3A4 inhibitors, such as azole antifungals (eg, ketoconazole), cimetidine, verapamil, macrolides (eg, erythromycin), diltiazem, antidepressants, and grapefruit juice, may increase plasma levels of dienogest.

While taking medications that affect microsomal enzymes, and for 28 days after their discontinuation, you should additionally use a barrier method of contraception.

While taking antibiotics (with the exception of rifampicin and griseofulvin) and for 7 days after their discontinuation, you should additionally use a barrier method of contraception. If the period of use of the barrier method of protection ends later than the pill in the package, you need to move on to the next package of Janine without the usual break in taking the pill.

Oral combination contraceptives may affect the metabolism of other drugs, resulting in increased (eg cyclosporine) or decreased (eg lamotrigine) plasma and tissue concentrations.

Side effects

When taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. While taking the drug Zhanine ® , women experienced other undesirable effects listed in the table below. Within each group, allocated depending on the frequency of the undesirable effect, undesirable effects are presented in order of decreasing severity.

Determination of the frequency of adverse reactions: often (≥1/100 and<1/10), нечасто (≥1/1000 и <1/100), редко (≥1/10 000 и <1/1000). Для дополнительных побочных реакций, выявленных только в процессе постмаркетинговых наблюдений и для которых оценку частоты провести не представляется возможным, указано - частота неизвестна.

Often
(≥1/100 and<1/10)
Infrequently
(≥1/1000 and<1/100)
Rarely
(≥1/10,000 and<1/1000)
Frequency
unknown
Infections and infection
Vaginitis/vulvovaginitis
Vaginal candidiasis or other vulvovaginal infections
Salpingoophoritis (adnexitis)
Urinary tract infections
Cystitis
Mastitis
Cervicitis
Fungal infections
Candidiasis
Herpetic lesions of the oral cavity
Flu
Bronchitis
Sinusitis
Upper respiratory tract infections
Viral infections
Benign, malignant and unspecified tumors (including cysts and polyps)
Uterine fibroids
Breast lipoma
Blood and lymphatic system
Anemia
Endocrine system
Virilization
Metabolism
Increased appetiteAnorexia
Psychiatric disorders
Decreased moodDepression
Mental disorders
Insomnia
Sleep disorders
Aggression
Mood changes
Decreased libido
Increase libido
Nervous system
HeadacheDizziness
Migraine
Ischemic stroke
Cerebrovascular disorders
Dystonia
Sense organs
Dryness of the mucous membrane of the eyes
Irritation of the mucous membrane of the eyes
Oscillopsia
Sudden hearing loss
Noise in ears
Dizziness
Hearing impairment
Intolerance to contact lenses (unpleasant sensations when wearing them)
The cardiovascular system
Arterial hypertension
Arterial hypotension
Cardiovascular disorders
Tachycardia, including increased heart rate
Pulmonary artery thrombosis/thromboembolism
Thrombophlebitis
Diastolic hypertension
Orthostatic circulatory dystonia
Tides
Phlebeurysm
Vein pathology
Pain in the veins
Respiratory system
Bronchial asthma
Hyperventilation
Digestive system
Abdominal pain, including upper and lower abdominal pain, discomfort/bloating
Nausea
Vomit
Diarrhea
Gastritis
Enteritis
Dyspepsia
Dermatological reactions
Acne
Alopecia
Rash, including macular rash
Itching, including generalized itching
Atopic dermatitis/neurodermatitis
Eczema
Psoriasis
Hyperhidrosis
Chloasma
Pigmentation disorder/hyperpigmentation
Seborrhea
Dandruff
Hirsutism
Pathological changes in the skin
Orange peel
Spider veins
Erythema multiforme
Allergic reactions
Manifestations of allergic reactions, including allergic dermatitisHives
Erythema nodosum
Musculoskeletal system
Back pain
Feeling of discomfort in muscles and bones
Myalgia
Pain in the limbs
Reproductive system and mammary glands
Pain in the mammary glands, feeling of discomfort, engorgement of the mammary glandsAbnormal withdrawal bleeding, including menorrhagia, hypomenorrhea, oligomenorrhea, and amenorrhea
Intermenstrual bleeding, including vaginal bleeding and metrorrhagia
Increased size of the mammary glands, swelling and feeling of fullness of the mammary glands
Breast swelling
Dysmenorrhea
Genital tract/vaginal discharge
Ovarian cysts
Pain in the pelvic area
Cervical dysplasia
Uterine cysts
Pain in the area of ​​the uterus
Breast cysts
Fibrocystic mastopathy
Dipareunia
Galactorrhea
Menstrual irregularities
Discharge from the mammary glands
General symptoms
Fatigue
Asthenia
Bad feeling
Chest pain
Peripheral edema
Flu-like symptoms
Inflammation
Temperature increase
Irritability
Fluid retention
Survey results
Changes in body weight (weight gain, loss, and fluctuations)Increased TG levels in the blood
Hypercholesterolemia
Congenital and genetic disorders
Detection of additional breasts/polymastia

The following adverse effects have been reported in women receiving combined oral contraceptives: venous thromboembolic complications, arterial thromboembolic complications, cerebrovascular complications, hypertension, hypertriglyceridemia, changes in glucose tolerance or effects on insulin resistance of peripheral tissues, liver tumors (benign or malignant), disorders liver functions, chloasma.

In women with hereditary angioedema, exogenous estrogens may exacerbate symptoms.

The occurrence or worsening of conditions for which the relationship with the use of combined oral contraceptives has not been clearly proven: jaundice and/or itching associated with cholestasis, formation of gallstones, porphyria, systemic lupus erythematosus; hemolytic-uremic syndrome, Sydenham's chorea, herpes of pregnancy, otosclerosis with hearing impairment, Crohn's disease, ulcerative colitis, cervical cancer.

In women using combined oral contraceptives, there is a very small increase in the incidence of breast cancer. Because Breast cancer rarely occurs in women under 40 years of age, and given the overall risk of breast cancer, the additional number of cases is very small. The relationship with the use of combined oral contraceptives is not known.

Indications

  • contraception.

Contraindications

Janine ® should not be used if you have any of the conditions/diseases listed below. If any of these conditions develop for the first time while taking it, the drug should be discontinued immediately.

  • the presence of thrombosis (venous and arterial) currently or in history (for example, deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
  • the presence or history of conditions preceding thrombosis (for example, transient ischemic attacks, angina pectoris);
  • diabetes mellitus with vascular complications;
  • current or history of migraine with focal neurological symptoms;
  • the presence of severe or multiple risk factors for venous or arterial thrombosis (including complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of the cerebral vessels or coronary arteries of the heart, uncontrolled arterial hypertension, major surgery with prolonged immobilization, smoking over the age of 35 years);
  • liver failure and severe liver diseases (until normalization of liver tests);
  • current or history of pancreatitis with severe hypertriglyceridemia;
  • the presence or history of benign or malignant liver tumors;
  • identified or suspected hormone-dependent malignant diseases of the genital organs or mammary glands;
  • vaginal bleeding of unknown origin;
  • pregnancy or suspicion of it;
  • breastfeeding period;
  • hypersensitivity to the components of the drug.

Carefully

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

  • risk factors for the development of thrombosis and thromboembolism (smoking, obesity, dyslipoproteinemia, arterial hypertension, migraine, valvular heart disease, prolonged immobilization, major surgery, extensive trauma, hereditary predisposition to thrombosis/thrombosis, myocardial infarction or cerebrovascular accident at a young age in anyone - or one of the closest relatives/);
  • other diseases in which peripheral circulatory disorders may occur (diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, phlebitis of superficial veins);
  • hereditary angioedema;
  • hypertriglyceridemia;
  • liver diseases;
  • diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (for example, jaundice, cholestasis, gallbladder disease, otosclerosis with hearing impairment, porphyria, herpes pregnant, Sydenham's chorea);
  • postpartum period.

Features of application

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 Zhanine ®, 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 мкг этинилэстрадиола), в 2-3 раза выше, чем у небеременных пациенток, которые не принимают комбинированные пероральные контрацептивы, тем не менее, этот риск остается более низким по сравнению с риском ВТЭ при беременности и родах. ВТЭ может привести к летальному исходу (в 1-2% случаев).

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 chest; 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 мкг этинилэстрадиола).

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

Planning a life scenario is often associated with the need to use contraception. If the choice is made in favor of oral methods (tablets), then it is important to take the safest possible remedy. Many gynecologists recommend a drug that has been on the market for a long time and has been tested by time, which has the trade name Janine. The product gently regulates the natural processes of a woman’s body, preventing conception. Before use, you must carefully read the instructions.

Composition and release form

The drug Jeanine is presented on the pharmaceutical market in the form of white, smooth dragees, which are packaged in 21 pieces in blisters (one or three in a cardboard package). Composition of the product:

Pharmacological properties

Instructions for use of Zhanin contain information that the pill inhibits the secretion of gonadotropic pituitary hormones, inhibits the maturation of follicles and leads to the arrest of ovulation. Taking pills increases the viscosity of the mucus filling the cervical canal, which makes it difficult for sperm to penetrate into the uterine cavity. Dragee normalizes the menstrual cycle, reduces the pain of menstruation and the intensity of discharge, which reduces the risk of developing iron deficiency anemia.

The gestagenic component of the drug dienogest is a derivative of nortestosterone, which has antiandrogenic activity, tested in patients with acne. The substance increases the concentration of high-density lipoproteins in the blood and is quickly absorbed from the stomach. The component reaches maximum concentration after 2.5 hours and has 96% bioavailability.

About 10% of the administered dose of dienogest is retained in free form, the rest is bound to albumin. Due to the fact that the component does not bind to transport proteins, it does not displace testosterone and cortisol. The substance has an insignificant first-passage effect; it forms inactive metabolites. The half-life is 9-10 hours, 85% of the dose is eliminated in 6 days.

Ethinyl estradiol is similarly rapidly absorbed in the stomach, reaching maximum concentration after 1.5-4 hours, and undergoes a first-pass effect through the liver. This explains its low (44%) bioavailability. Only 1.5% of the substance is found in the free state in the blood plasma, the rest is bound to albumin. The half-life of ethinyl estradiol is 10 hours, after three cycles of use it increases to 15 hours. 40% of the product is excreted in the urine, the rest in the intestines.

Indications for use

Taking the drug Zhanine is indicated for women for reliable hormonal contraception, as well as for endometriosis. In addition to its main purpose, the medication is used for the treatment of acne, both during exacerbation and in chronic cases. Janine's targets include diseases such as hirsutism (male pattern hair growth), seborrhea and androgenetic alopecia (fragmented hair loss).

How to take Janine

Contraceptive pills Janine, according to the instructions, should be used regularly. If you violate the regimen for taking pills, this will lead to intermenstrual bleeding and reduce the contraceptive effectiveness of the drug. The tablets are taken every day, washed down with water. The order of administration is indicated on the package. The application cycle lasts 21 days, followed by a week break. On the second or third day, menstrual-like bleeding begins.

How to take Janine for the first time

According to the instructions, if the drug Zhanine is used for the first time, and the woman has not previously taken any hormonal drugs, then the pills begin to be taken from the first day of the menstrual cycle (the first day of bleeding). If you start taking it on days 2-5 of the cycle, then in the first week after taking the first pill you should use barrier methods of contraception.

Switching from other contraceptives

According to the instructions, if a woman switches to taking Zhanine from other combined hormonal drugs, then taking the pills begins the next day after the last use of the previous drug. The medication should be taken no later than the next day when using contraceptives (21 pills) or after using placebo pills (28 pcs.). When switching from a progestin medication, tablets are taken on any day when switching from a mini-pill, from the day of the next injection or on the day of implant removal. You need to use barrier contraceptives for a week.

Taking pills after childbirth or abortion

Hormonal tablets Janine, according to the instructions, can be taken immediately after termination of pregnancy in the first 13 weeks. In this case, additional protection is not needed. If pregnancy is terminated at 14-27 weeks or after childbirth, pills should be taken on days 21-28 of the cycle. If taken later, condoms must be used in the first week. If there was sexual intercourse between taking the pills and childbirth or abortion, you need to make sure there is no pregnancy or wait until your first period before taking the medicine.

Skipping pills

If the interval between taking the drug exceeds 12 hours, this will reduce the contraceptive effect. Intervals between doses of contraceptives should not be allowed for more than a week, because during this time the activity of the pituitary-hypothalamus-ovarian system is completely restored. If a delay of more than 12 hours occurs in the first two weeks of taking Zhanine, the next dose is taken as soon as the woman remembers the omission (you can take 2 pieces at the same time).

In the first week, use condoms. The more pills you skip, the closer the skip is to the standard weekly break, the higher the risk of getting pregnant. If a dose is missed for more than 12 hours after 15-21 days of administration, then you need to take it as soon as possible, even if taking 2 tablets at the same time. Then the medicine is taken as usual. For the next seven days, you need to use condoms for contraception, and after finishing the package, immediately start the next one, without having to wait seven days of “rest”.

In this case, bleeding when taking Janine will not begin until the second package is completed, but spotting and breakthrough bleeding may occur during use. If, after skipping pills during the seven-day period free from taking pills, there is no bleeding when taking pills, this may indicate pregnancy. Prolonged vomiting (lasting 3-4 hours) can reduce the absorption of the active substances of the drug. In such a situation, you need to take pills, as if you missed it.

If a woman does not intend to change her usual regimen of taking pills, she can take a few additional pills from the next package to delay the onset of menstruation. You can even finish the entire pack, but after that you must definitely take a seven-day break.

Janine with endometriosis

Doctors have not yet established the exact cause of endometriosis. It is only known that some cases are caused by hormonal dysfunction. In the second phase of the cycle after ovulation, the organs of the reproductive system intensively prepare for pregnancy, and the uterine lining grows. The use of Zhanine prevents ovulation from occurring (the release of an egg from the ovary), and therefore reduces the severity of post-ovulation changes in the endometrium of the uterus.

Gynecologists prescribe pills for endometriosis to relieve pain, normalize the disrupted cycle, reduce the intensity of bleeding and the severity of other symptoms of the disease. In a healthy woman, bleeding during menstruation is caused by rejection of the uterine lining; with endometriosis, this is accompanied by vascular damage. The dragee prevents the endometrium from actively growing, inflaming tissues, and squeezing nerve trunks.

The effectiveness of the drug has been proven for genital and extragenital endometriosis. The components of the composition exhibit high activity, which allows them to be used in a minimum dosage. There are several regimens for taking pills for endometriosis; the choice of method is up to the doctor. The standard use of tablets over three cycles is popular. After this, the patient undergoes tests for blood clotting, the biochemical composition of plasma, the condition of the liver and foci of endometriosis.

Another scheme of use, according to the instructions, is to continuously take the tablets for 63-84 days in a row, after which a week-long break is taken. Due to the fact that during treatment there is one instead of 3-4 menstruation, the patient’s condition improves. According to doctors, the use of Janine for endometriosis is effective in 85% of cases. Patients note rare side effects and good tolerability.

Up to what age can Janine be taken?

The instructions for use of the tablets do not limit the age of use of contraceptives, except for the period when menopause has occurred. Each woman has her own milestone. After menopause, pills are ineffective and can cause serious problems with the functioning of the reproductive organs. Likewise, you should not take the medicine before your period.

Drug interactions

The instructions for use of Janine talk about drug interactions between the drug and other medications. This may cause negative reactions:

  1. Barbiturates, Rifampicin, hydantoins, Carbamazepine, Topiramate, Parimidon, Felbamate, Griseofulvin can reduce the contraceptive effect of the drug.
  2. Ampicillins and tetracyclines can reduce the concentration of ethinyl estradiol.
  3. When completing a course of Rifamcin, you should additionally use contraceptive measures for a month after the end of treatment.

special instructions

When prescribing the drug, one must take into account the risk of signs of intra-abdominal bleeding, enlargement of the liver (even the appearance of tumors), and abdominal pain. The period of adaptation to the medication is three cycles, during which irregular bleeding may occur (both in the form of breakthrough and spotting). Such bleeding can occur and recur after regular cycles have ended if there is a non-hormonal cause. The use of Zhanine increases the risk of thrombosis, especially in women over 35 years of age who smoke.

According to the instructions, when planning a surgical operation, you need to warn your doctor about oral contraception. If blood pressure increases, the doctor decides whether to discontinue the medication. If you use the drug regularly, you will need to be examined by a doctor at least once a year. Janine does not increase resistance to sexually transmitted diseases.

During pregnancy

Available data from epidemiological studies in the instructions indicate that the drug does not increase the likelihood of disruption of the embryonic development of children in women who took Zhanine shortly before pregnancy or some time after pregnancy (due to ignorance of the fact of pregnancy). At the same time, the manufacturer prohibits taking the drug during pregnancy and during breastfeeding. Hormonal contraceptives suppress lactation and change the composition of breast milk. After stopping the pills, pregnancy occurs within a short time.

Alcohol compatibility

The manufacturer's instructions for the drug do not limit the combination of dragees with alcoholic beverages. Many pharmacists allow the simultaneous use of tablets and alcohol, but in a volume of no more than one glass of wine (20 g of ethanol). Consider the following factors:

  • the body's perception of alcohol is individual;
  • hormonal contraceptives increase the load on the liver, and together with alcohol the load increases;
  • with high activity of liver enzymes, provoked by high doses of alcohol, the breakdown and elimination of the active substances of the drug is accelerated;
  • alcohol intoxication, leading to vomiting, leads to the removal of the medication from the gastrointestinal tract, which naturally reduces the effectiveness of the drug (it is recommended to maintain a 3-hour interval between the use of other drugs and Janine).

Side effects of Janine

An overdose of the drug is treated symptomatically; there is no antidote. The use of hormonal estrogen-gestagen contraceptives may be accompanied by the appearance of side effects indicated in the instructions:

  • an increase in the volume and elasticity of the mammary glands, accompanied by pain;
  • headache (migraine);
  • rapid change of emotional mood;
  • nausea and vomiting;
  • widespread itching;
  • abdominal pain;
  • jaundice;
  • erythema multiforme or nodosum;
  • weight fluctuations;
  • allergic reactions;
  • arterial hypertension;
  • decreased libido;
  • metabolic pathologies;
  • fluid retention in the body;
  • visual impairment;
  • circulatory disorders: thromboembolism and thrombosis;
  • in rare cases, diarrhea, chloasma (hyperpigmentation), fatigue.
  • angina pectoris;
  • liver failure and severe liver disease;
  • pancreatitis complicated by hypertriglyceridemia;
  • liver tumors;
  • vaginal bleeding of unknown origin;
  • migraine with focal symptoms of neuralgia;
  • hormone-dependent diseases of the genital organs or mammary glands of a malignant nature;
  • pregnancy and breastfeeding;
  • high sensitivity to the constituent components of Janine;
  • climacteric condition.
  • Terms of sale and storage

    The sale of medicine from pharmacies is permitted if the buyer has a prescription. The drug should be stored at a temperature of no more than 25 degrees, out of the reach of children.

    Analogs

    Janine is a non-unique drug; it can be replaced with other oral contraceptives. Popular analogues of the product are:

    • Belara - combined tablets containing chlormadinone, ethinyl esradiol;
    • Yarina - contraceptive pills based on ethinyl estradiol, drospirenone;
    • Midiana is a contraceptive containing drospirenone and ethinyl estradiol;
    • Logest - combined tablets based on gestodene and ethinyl estradiol;
    • Lindinet 30 is a product based on the sex hormones ethinyl estradiol, gestodene;
    • Mercilon is an estrogen-progestogen agent containing desogestrel, ethinyl estradiol;
    • Marvelon - contraceptive pills based on ethinyl estradiol, desogestrel;
    • Femoden is an estrogen-progestin medicine containing gestodene, ethinyl estradiol;
    • Silhouette is a structural analogue of Janine, contains the same components;
    • Qlaira is a drug based on dienogest and estradiol valerate; the pack contains 5 types of tablets;
    • Visanne - tablets that contain only micronized dienogest.

    Janine is a low-dose monophasic combined oral contraceptive with an antiandrogenic effect. The medicine contains ethinyl estradiol and dienogest. Contraceptive pills Zhanine are available in the form of pills, the quantitative content of the drug in the package is 21 pieces.

    Auxiliary components are: lactose, starch, gelatin, glucose, povidone, titanium dioxide.

    Janine has a contraceptive effect by changing the viscosity of mucus. When using the drug, ovulation is suppressed, and cervical mucus becomes impermeable to sperm.

    Dienogest is a progestin component of the drug Zhanine and helps to provide an antiandrogenic effect and improve the blood lipid profile. When using the drug, an increase in high-density lipoproteins (“good” cholesterol) is observed.

    Patients who use low-dose monophasic oral contraceptives, including Janine, experience the following positive effects:

    • The menstrual cycle is normalized.
    • Reducing the intensity and duration of bleeding.
    • Elimination of painful sensations during the next menstruation.
    • Reducing the risk of iron deficiency anemia.

    According to the results of clinical studies, the use of birth control pills Janine decreased the number of cases of endometrial and ovarian cancer.

    Indications for use

    The main indication for the use of the drug Zhanine is the provision of contraceptive effects.

    Thanks to its multicomponent composition, Janine can be used in the complex treatment of breast diseases, including mastopathy.

    Contraindications

    The use of the drug Zhanine is contraindicated in the presence of one of the following conditions:

    The development of thrombosis and thromboembolism (including the presence of these diseases in the patient’s history), including pulmonary embolism, myocardial infarction, stroke, deep vein thrombosis and cerebrovascular disorders.

    The presence of conditions that precede the development of thrombosis.

    For migraine, which is accompanied by the development of focal neurological symptoms.

    For diabetes mellitus, which is complicated by vascular disorders.

    For pancreatitis, which is accompanied by severe hypertrigceridemia.

    For liver failure and severe liver disease. If liver tests are normal, taking the drug Janine is possible with the approval of a doctor.

    When identifying and hormone-dependent malignant neoplasms or in case of suspicion of them.

    With the development of bleeding from the vagina of unknown origin.

    In case of hypersensitivity to the main or auxiliary components of the drug.

    If any of the listed diseases develop while taking the drug Zhanine, you must stop using the pills and immediately consult a doctor.

    Use with extreme caution

    Janine should be used with extreme caution and after carefully weighing the potential benefit against the perceived risk in the presence of the following conditions:

    • Risk factors that can contribute to the development of thrombosis: smoking, obesity, arterial hypertension, migraines, major surgical interventions, heart valve defects, hereditary predisposition to the development of thrombosis.
    • Other diseases that can contribute to the development of peripheral circulatory disorders: diabetes mellitus, Crohn's disease and ulcerative colitis, lupus erythematosus, sickle cell anemia.
    • With hereditary angioedema.
    • With elevated levels of triglycerides in the blood plasma.
    • For liver diseases.
    • During the postpartum period.

    Use during pregnancy and breastfeeding

    If pregnancy is suspected, as well as during breastfeeding, the use of the drug Zhanine is contraindicated.

    If pregnancy is detected while using the drug Zhanine, the drug should be stopped immediately.

    According to the results of extensive epidemiological studies, there has been no increased risk of developing any defects in children whose mother took sex hormones before pregnancy.

    There is also no increased risk of toxic effects if the drug was taken inadvertently in the early stages of pregnancy.

    When using the drug Janine during lactation, the risk of a decrease in the amount of breast milk increases and its composition changes. Sex steroids or their compounds can be excreted in breast milk.

    Mode of application

    Janine must be taken in the order indicated by the numbers on the package. The pills are taken daily, at approximately the same time of day. The medicine should be taken with a small amount of water.

    The pills are taken without interruption for 21 days. Taking the next package can begin after a 1 week break. During this time, withdrawal bleeding should develop. Bleeding begins a few days after taking the last pill.

    How to start taking the drug

    If you did not take any hormonal medications in the previous month, then taking Janine’s medication should begin on the first day of the menstrual cycle. If necessary, you can start taking pills from days 2 to 5 of the cycle, but in this case there is a need to use barrier methods of contraception.

    If you are switching from other contraceptive drugs (this group includes combined oral contraceptives, vaginal rings and transdermal patches), then taking Zhanine should start the day after taking the last tablet from the previous package.

    If switching from vaginal rings or transdermal patches, taking Janine should begin on the day the ring is removed or the patch is removed.


    When switching from contraceptives that contain only gestagens (these include Mirena, mini-pills), taking Janine can begin on any day. In this case, the use of barrier methods of contraception for 1 week is required.

    How to take the missed pill?

    If a dose of the drug was missed, additional recommendations must be followed.

    If the missed period is less than 12 hours, the contraceptive effect of the drug will not decrease. In this case, you should take the drug as quickly as possible. Further reception is carried out according to the usual scheme.

    If the missed period is more than 12 hours, the contraceptive effect is reduced. In this case, the use of the pill should not be suspended for more than 1 week. In order to suppress the hypothalamic-pituitary-ovarian regulation, 1 week of continuous medication is required.

    • Missed 1 week of admission. The drug should be taken as soon as possible in the first week, even if this means taking two tablets at once. Further reception is carried out according to the usual scheme. In the future, it is necessary to use barrier methods of contraception for the next 7 days.
    • Skip in week 2. Taking the drug in the second week: you should take the missed tablet as soon as possible, even if this means taking two tablets at once. If during the first week the drug was taken in accordance with the manufacturer's recommendations, then the use of barrier methods of contraception is not required.
    • Skip in week 3. Third week: The risk of decreased effectiveness increases as the drug break approaches. You should take the missed pill as quickly as possible, even if this means taking two pills at the same time. When you run out of pills from the current package, you should immediately start taking a new package. In this case, the development of bleeding is unlikely, but spotting may be observed.

    If you skipped taking the drug Zhanine and no bleeding is observed during the break, then it is necessary to exclude the possibility of pregnancy.

    If a woman begins vomiting or diarrhea within 3-5 hours after taking the drug, additional contraceptive measures must be used. It is also necessary to adhere to the recommendations regarding the usual skipping of tablets.

    If a woman wants to change the start date of her next menstruation, she should take pills from a new package without interruption. Reception can be carried out for as long as it is necessary to delay the next menstruation. When using the drug from a new package, mild spotting may be observed.

    Side effects

    While using Janine tablets, the following undesirable side reactions may develop:

    Most often, patients note the development of headache, soreness and hardening of the mammary glands.

    Infrequently, the drug can contribute to the development of vulvovaginitis, candidiasis, increased appetite, decreased mood, the development of dizziness and migraines, increased or decreased blood pressure, abdominal pain, nausea, vomiting, diarrhea, acne and rash, itching, intermenstrual bleeding, swelling of the mammary glands , development of dysmenorrhea, ovarian cysts, increased fatigue, poor health, weight gain.

    In rare cases, the drug may contribute to the development of cystitis, fungal infections, candidiasis, herpetic lesions of the oral cavity, influenza, bronchitis, sinusitis, uterine fibroids, anemia, allergic reactions, anorexia, depression, mental disorders, insomnia, aggression, ischemic stroke, cerebrovascular disorders, dystonia, dryness and irritation of the mucous membranes of the eyes, impaired visual acuity, sudden hearing loss, tinnitus, cardiovascular disorders, tachycardia, increased heart rate, thrombosis, thrombophlebitis, hot flashes, varicose veins, pain in the veins, gastritis, enteritis, dyspepsia, allergic and atopic dermatitis, eczema, psoriasis, dandruff, seborrhea, hirsutism, orange peel, myalgia, pain in the back and limbs, cervical dysplasia, menstrual irregularities.

    Women who used the drug Janine most often reported the following complications:

    • Venous thromboembolic complications.
    • Arterial thromboembolic complications.
    • Cerebrovascular complications.
    • Arterial hypertension.
    • Hypertriglyceridemia.
    • Liver tumors.
    • Worsening of the course of systemic and chronic diseases.

    An increase in breast cancer diagnosis rates has also been reported.

    In case of an overdose of the drug, nausea, vomiting, diarrhea, and spotting may develop. A doctor's examination and symptomatic treatment are required.

    Additional Information

    During the use of oral contraceptives, changes in laboratory parameters of carbohydrate metabolism, adrenal and thyroid hormones, as well as coagulation parameters may be observed. As a rule, changes do not exceed acceptable limits.

    A woman should inform her doctor who prescribes the use of Zhanine about all concomitant diseases. Hormone replacement therapy should be carried out only after a careful balance of benefits and harms.

    Before prescribing such a drug, the doctor must familiarize himself with the patient’s medical history, identify the presence of hereditary pathologies and conduct a comprehensive examination (measurement of blood pressure and heart rate, determine body mass index). A gynecological examination includes examination of the mammary glands, as well as a cytological scraping from the cervix.

    The doctor should warn the patient that taking Zhanine is not able to protect against HIV infection and other sexually transmitted diseases.

    The effectiveness of the drug decreases if you miss taking pills, with the development of vomiting, diarrhea, as well as incorrect drug interactions.

    During the use of hormonal contraceptives, the regularity and intensity of bleeding may vary (from spotting to more abundant and prolonged). The effect of the drug on bleeding can be assessed after a period of adaptation of the body to the new drug. The duration of the period can be 2-4 cycles.

    If the patient continues to complain of irregular bleeding after 2-4 cycles, then a comprehensive examination is required to exclude malignant neoplasms or pregnancy.

    The risk of thromboembolism increases during the first year of using the drug. In patients who take low-dose oral contraceptives, the risk of developing thromboembolism is several times higher than in women who do not take such drugs.

    In women with a history of a hereditary form of angioedema, the symptoms of the disease may be aggravated by the use of Zhanine.

    The ability of the drug to influence psychomotor reactions and driving has not been identified.

    Drug interactions

    If used concomitantly, use of oral combination contraceptives may increase cyclosporine concentrations and decrease lamotrigine plasma and tissue concentrations.

    Concomitant use of antifungal drugs, veropamil, macrolides, antidepressants and grapefruit juice may increase the concentration of dienogest in the blood plasma.

    If it is necessary to combine Zhanine with antibacterial drugs (excluding rifampicin and griseofulvin), barrier methods of contraception should be used for 1 week after discontinuation of antibiotics.

    Analogues and cost

    The cost of the drug Janine for the period of autumn 2016 was formed as follows:

    • Janine dragee No. 21 – 900-1200 rubles.
    • Janine dragee No. 63 – 2050-3400 rub.

    Analogs of the drug Janine are the following drugs: Diecyclen and Siluet. If necessary, replacement of the drug should be carried out only in agreement with the attending physician.

    Selecting a hormonal drug for contraception is not easy. In addition to protecting against pregnancy, many of these products help cope with skin problems (acne), menstrual irregularities, and ovarian cysts. “Janine” is able to interfere with the balance of sex hormones, reducing the manifestations of hyperandrogenemia. This is his positive side. But the instructions for use of “Zhanine” indicate many side effects. How is the drug tolerated and is it safe?

    Hormonal medications should be selected together with a gynecologist. Despite their general similarity (they contain estrogens and gestagens), the effect of use can vary greatly. “Janine” is a drug that is not suitable for everyone.

    Composition and principle of action

    "Zhanine" is a low-dose monophasic combined oral contraceptive. Each concept has an important meaning:

    • low-dose– the hormone content is relatively low;
    • monophasic - each tablet contains the same dose of medication;
    • To combined – the composition contains estrogens and gestagens, which imitate a woman’s two-phase menstrual cycle;
    • oral – tablets are taken orally.

    The composition includes the following hormones.

    • 0.03 mg ethinyl estradiol. Mimics the effect of estrogen. Ethinyl estradiol increases the viscosity of cervical secretions, which impairs sperm motility in the cervical canal.
    • 2 mg dienogest. Acts on the pituitary gland, suppressing the production of follicle-stimulating hormone (FSH), which leads to a lack of growth of new follicles. As a result, the ovaries are in a “dormant state” without ovulation. The distinctive ability of dienogest is that it has antiandrogenic activity. Thanks to this, after some time of use, the manifestations of hirsutism decrease.

    Constant low concentrations of hormones in the blood affect the endometrium of the uterine cavity, leading to its atrophy. This entails a decrease in the abundance and duration of menstrual bleeding, as well as a decrease in foci of endometriosis throughout the body.

    After entering the intestine, the drug is absorbed into the systemic circulation. It undergoes transformation in the liver, creating additional stress on the organ and bile ducts. Metabolic products of “Zanina” are excreted in feces and urine.

    When to use

    The main purpose of hormonal tablets "Zhanine" is to provide protection against pregnancy. Additionally, the drug is used to treat the following conditions:

    • endometriosis - thanks to the “dormant state” of the ovaries and a decrease in the activity of the pituitary gland of the brain, all foci of endometriosis (including adenomyosis) are significantly reduced, which leads to a decrease in the severity of pain, spotting, and heavy menstruation;
    • when – prescribed after conservative and surgical treatment of ovarian cysts, including endometriotic ones, for a period of three to six months;
    • uterine fibroids – like all contraceptives, it can somewhat reduce the growth rate of nodes;
    • for mastopathy - regular use reduces the likelihood of developing mastopathy by half, and also reduces symptoms such as pain and tension in the mammary glands;
    • with endometrial hyperplasia – can be used as a treatment for benign endometrial hyperplasia and glandular polyps;
    • with polycystic disease - the drug normalizes the menstrual cycle, reduces the manifestations of hyperandrogenemia and its effect on the entire body;
    • for chronic adnexitis - regular use leads to attenuation of inflammatory processes in the appendage area, reducing the likelihood of ovarian dysfunction;
    • for cosmetic effect– while taking “Janine”, the severity of acne (pimples) on the face, back and arms decreases, however, the effect does not last long after stopping the medication (one to two months).

    In addition, "Janine", like other contraceptives, has a rebound effect - after discontinuation, the likelihood of multiple pregnancies increases due to the activation of the ovaries and the simultaneous maturation of several follicles.

    Restrictions

    Contraindications to taking the drug correspond to those common to all hormonal drugs containing estrogens and gestagens. The list includes the following states:

    • allergic reactions to drug components;
    • history of blood clots, tendency to them;
    • migraines, even if the last episode was a long time ago;
    • diabetes;
    • prosthetic heart valves;
    • arterial hypertension of the third and fourth degree;
    • prolonged immobility, for example, after fractures;
    • diseases of the liver, biliary tract;
    • pancreatic diseases;
    • pregnancy and breastfeeding;
    • suspected or specified malignant tumors;
    • vaginal bleeding of unknown cause;
    • smoking;
    • overweight with an index of more than 40;
    • systemic connective tissue diseases;

    How is it transferred

    With careful selection of the drug, “Zhanine” is well tolerated. However, during use, the following side effects may occur with a frequency of more than one case per thousand women taking the medicine:

    • headache, migraine;
    • dizziness;
    • nausea and vomiting, bowel dysfunction;
    • increased appetite and weight gain;
    • hair loss, rash and itchy skin;
    • increased blood pressure;
    • decreased sexual desire (libido);
    • recurrent candidal colpitis;
    • increased blood sugar levels;
    • thrombosis and thromboembolism;
    • tearfulness, irritability, depression.

    Reviews about birth control pills "Janine" are contradictory. Some people do not observe side effects and use the drug for contraception or treatment for many years, while others cannot withstand even a week of use due to unpleasant changes in their well-being and behavior.

    With a frequency of less than one case per thousand of women taking the drug, the following side effects occur:

    • relapses of viral and bacterial infections;
    • insomnia;
    • dry mucous membranes;
    • skin diseases such as seborrhea, psoriasis;
    • bronchial asthma;
    • enteritis, gastritis.

    In cases of overdose, side effects intensify. Treatment in these cases is symptomatic.

    In addition, in the first months when taking Janine, a woman may be bothered by periodic spotting from the genital tract and even intermenstrual bleeding. This is explained by the body getting used to the new regimen of a fixed dose of hormones. Usually the adaptation period takes no more than two to three months, otherwise it is necessary to replace the drug or adjust the dosage regimen.

    "Janine": instructions for use

    How long and how many tablets can I take Janine? The regimen for taking Zhanine tablets is no different from that of other oral contraceptives. The main postulates are as follows:

    • pills are taken - inside, wash down with a small amount of water; for 21 days, take one tablet from the package;
    • start of use - must coincide with the first day of menstruation in the first month;
    • reception time is strictly fixed, for example, always in the morning at 6.00;
    • after finishing packaging - it is necessary to take a seven-day break, usually on the second or third day menstrual flow appears;
    • after a seven-day break - you should start taking a new package.

    “Janine” can be drunk without interruption for many years. After discontinuation, ovarian function is restored within three to six months. To delay menstruation, you can take two packages of the drug without a seven-day break. In this case, the cycle will be 42-45 days. However, you should not get carried away with such properties of the drug, as this can lead to acyclic discharge and bleeding.

    Frequent clinical situations

    Often the indications for use of the drug are various situations and diseases. You should take Zhanine tablets taking into account the following points.

    • After an abortion, miscarriage. If the pregnancy was terminated in the first trimester, you should start taking the pills on that day or the next day. If an abortion or miscarriage occurs in the second trimester, it is recommended to start taking it on days 21-28; you don’t even have to wait for menstruation, provided that pregnancy is excluded.
    • After childbirth. The drug is allowed to be used only after completion of lactation. If a woman does not support breastfeeding, starting is possible no earlier than 21-28 days after birth.
    • After others OK. You should start drinking Janine during a seven-day break or taking dummy tablets. If a transdermal patch, Mirena intrauterine device or vaginal ring is removed, it is recommended to take the first tablet on the same day. If injections of hormonal drugs were used, the start should coincide with the first day of the intended injection. When switching from mini-pills (containing only gestagen), the intake can be timed to any day.

    If you miss a pill

    Reviews from doctors and women point to the fact that most often one has to deal with a violation of the pill regimen. How to take “Janine” correctly in such cases? If 12 hours have not passed since the scheduled time, you must take the missed tablet, and then the next one at the appointed time. If 12 hours have already passed, the action algorithm is as follows:

    • first week of admission– take the missed pill as quickly as possible, and the next one according to the usual schedule; additional methods of protection must be used within a week;
    • second week of admission- take the missed pill immediately, no additional protection is needed if the dosage regimen has been followed up to this point;
    • third week of admission– you can either continue taking the pack and start the next one without a seven-day break, or take a break of a week on the missed pill and then start a new pack.


    What affects efficiency

    While taking Janine, various situations are possible, including illness conditions. You need to know that some drugs and symptoms can reduce the contraceptive effect of pills:

    • antibiotics - macrolides (for example, Azithromycin, Johamycin, Clarithromycin, Erythromycin), penicillins (Amoxiclav, Ampicillin), tetracyclines (Doxycycline);
    • antifungal drugs –"Ketoconazole";
    • antidepressants– “Fluoxetine”;
    • anticonvulsants –"Carbamazepine";
    • for blood pressure - Diltiazem.
    • vomiting and diarrhea - if the episode occurs within four hours of taking the pill, additional contraception must be used in the next week; if after four hours, the protective effect remains, the drug is already completely in the blood.

    Considering the interaction with other medications, side effects and contraindications for use, “Zhanine” should only be prescribed by a doctor. He must be made aware of the regular use of other medications.

    Analogs

    There are complete analogues of the drug with the same composition and dose of active substances. The list is as follows:

    • "Silhouette";
    • "Diecyclen";
    • "Bonade."

    Tablets "Zhanine" for endometriosis, hyperandrogenemia, after removal of ovarian cysts are the drug of choice. The medicine is suitable for the prevention of acne in women with disrupted hormonal levels, as well as simply for contraception. The drug is prescribed only on the recommendation of a doctor, as it has contraindications and complications from use.