Janine starts to act. Jeanine - instructions for the use of birth control pills, dosage regimen, side effects, analogues and price

23.02.2021

Janine- low-dose monophasic oral combined estrogen-progestin contraceptive drug.
contraceptive Janine effect carried out through three complementary mechanisms:

suppression of ovulation at the level of hypothalamic-pituitary regulation;
changes in the properties of the cervical secret, as a result of which it becomes impermeable to spermatozoa;
changes in the endometrium, which makes it impossible to implant a fertilized egg.

In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful periods are less common, the intensity of bleeding decreases, resulting in a reduced risk of iron deficiency anemia.

Indications for use

Contraception.

Mode of application

The dragee should be taken orally in the order indicated on the package, every day at about the same time, with a little water. Take one tablet per day continuously for 21 days. The next pack is started after a 7-day break in taking the pills, during which withdrawal bleeding usually occurs. Bleeding usually starts 2-3 days after taking the last pill and may not end before starting a new pack.
How to start taking Jeanine
In the absence of taking any hormonal contraceptives in the previous month.
Janine reception begins on the first day of the menstrual cycle (i.e. the first day of menstrual bleeding). It is allowed to start taking 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 the pills from the first package.
When switching from other combined oral contraceptives.
Preferably start taking Janina 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 drugs containing 21 pills) or after taking the last inactive pill (for drugs containing 28 pills per pack) .
When switching from contraceptives containing only gestagens ("mini-pill", injectable forms, implant) or from a progestogen-releasing intrauterine contraceptive (Mirena).
A woman can switch from a mini-pill to Janine on any day (without a break), from an implant or intrauterine contraceptive with a progestogen - on the day of its removal, from an injection form - from the day when the next injection should have been made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the dragee.
After an abortion in the first trimester of pregnancy.
A woman can start taking the drug immediately. If this condition is met, the woman does not need additional contraceptive protection.
After childbirth or abortion in the second trimester of pregnancy.
It is recommended to start taking the drug on the 21-28th day after childbirth or abortion in the second trimester of pregnancy. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills. However, if a woman has already lived sexually, before taking Janina pregnancy must be excluded or the first menstruation must be waited.
Taking missed pills
If the delay in taking the drug was less than 12 hours, contraceptive protection is not reduced. A woman should take the pill as soon as possible, the next one is taken at the usual time.
If the delay in taking the pill was more than 12 hours, contraceptive protection may be reduced. In this case, you can be guided by the following two basic rules:
The drug should never be interrupted for more than 7 days.
7 days of continuous intake of dragees 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 was more than 12 hours (the interval from the moment the last pill was taken was more than 36 hours):
First week of taking the drug
The woman should take the last missed tablet as soon as she remembers (even if it means taking two tablets at the same time). The next dragee is taken at the usual time. Additionally, a barrier method of contraception (such as a condom) must be used for the next 7 days. If sexual intercourse took place within a week before skipping the dragee, the likelihood of pregnancy should be considered.
The more pills 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
The woman should take the last missed tablet as soon as she remembers (even if it means taking two tablets at the same time). The next dragee is taken at the usual time.
Provided that the woman has taken the pill correctly within 7 days preceding the first missed pill, there is no need to use additional contraceptive measures.

Otherwise, as well as when skipping two or more pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.
Third week of taking the drug
The risk of a decrease in reliability is inevitable due to the upcoming break in taking pills.
A woman must strictly adhere to one of the two following options. Moreover, if in the 7 days preceding the first missed tablet, all the tablets were taken correctly, there is no need to use additional contraceptive methods.
1. The woman should take the last missed tablet as soon as she remembers (even if it means taking two tablets at the same time). The next dragee is taken at the usual time until the dragees 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 the dragee from the current package. Then she should take a break for 7 days, including the day she skipped the dragee, and then start taking a new package.
If a woman misses taking the pills, and then during the break in taking the pills she does not have withdrawal bleeding, pregnancy should be excluded.
If a woman has had vomiting or diarrhea up to 4 hours after taking active pills, absorption may not be complete and additional contraceptive measures should be taken. In these cases, you should be guided by the recommendations when skipping the dragee.
In order to delay the onset of menstruation, a woman should continue taking pills from a new package. Janina immediately after taking all the pills from the previous one, without interruption in taking. Dragees 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. Resume appointment Janina from a new pack follows after the usual 7-day break.
In order to move the day of the onset of menstruation to another day of the week, a woman should be advised to shorten the next break in taking pills by as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding, and subsequently, spotting and breakthrough bleeding during the second pack (as well as in the case when she would like to delay the onset of menstruation. In order to delay the beginning of menstruation, the woman should continue taking the drug, using the last 10 pills from another package Janina without interrupting the intake. Thus, the cycle can be extended up to 10 days until the end of the second package. While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. Regular intake Janina then resumed after the usual 7-day break in taking pills.
In order to move the day of 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, spotting, and breakthrough bleeding during the second pack (just as she would like to delay the onset of her period).

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; decrease/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 jaundice; fluid retention; change in body weight; allergic reactions. Rarely - an increase in the level of triglycerides in blood plasma, a decrease in carbohydrate tolerance, increased fatigue, diarrhea.
Occasionally, chloasma may develop, especially in women with a history of chloasma of pregnancy.
As with other combined oral contraceptives, in rare cases, the development of thrombosis and thromboembolism is possible.

Contraindications

Janine should not be used in the presence of any of the conditions listed below. If any of these conditions develop for the first time while taking the drug, the drug should be immediately discontinued.
Thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders).
Conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history.
Migraine with a history of focal neurological symptoms.
Diabetes mellitus with vascular complications.
Multiple or severe risk factors for venous or arterial thrombosis, including valvular heart disease, cardiac arrhythmias, cerebrovascular or coronary artery disease; uncontrolled arterial hypertension.
Pancreatitis with severe hypertriglyceridemia at present or in history.
Liver failure and severe liver disease (until liver tests return to normal).
Liver tumors (benign or malignant) at present 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 drug Janine.
Prolonged immobilization, major surgery, leg surgery, extensive trauma.

Pregnancy

Janine not prescribed during pregnancy and during lactation.
If pregnancy is detected while taking the drug Janine, the drug is immediately canceled. However, extensive epidemiological studies have not found any 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 early in pregnancy.
Taking combined oral contraceptives can reduce the amount of breast milk and change its composition, therefore, their use is contraindicated during lactation. A small amount of sex steroids and / or their metabolites can be excreted in milk, but there is no evidence of their negative impact on the health of the newborn.

Interaction with other drugs

Sulfonamides, pyrazolone derivatives are able to enhance the metabolism of the steroid hormones that make up the drug.
Long-term treatment with drugs that induce liver enzymes, which results in increased clearance of sex hormones, may lead to breakthrough bleeding and / or reduce the contraceptive effectiveness of the drug Janine.
These drugs include: phenytoin, barbiturates, primidone, carbamazepine 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 reports, some antibiotics can reduce the intrahepatic circulation of estrogens, thereby lowering the concentration of ethinyl estradiol.
Oral combined contraceptives can affect the metabolism of other drugs (including cyclosporine), which leads to a change in their concentration in plasma and tissues.
When taking estrogen-progestin drugs, it may be necessary to adjust the dosing regimen of hypoglycemic drugs and indirect anticoagulants.

Overdose

Symptoms that may occur in overdose include nausea, vomiting, spotting or metrorrhagia.
There is no specific antidote, symptomatic treatment should be carried out.

Release form

21 dragees in a package (blister) made of PVC film and covered with coated aluminum foil. A blister of 21 tablets or 3 blisters of 21 tablets, together with instructions for use, is placed in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25 ° C, out of the reach of children.
Shelf life - 3 years.
Cannot be used after the expiration date.
Conditions for dispensing from pharmacies - by prescription.

Compound

White smooth dragees.
Each dragee contains:

active ingredients: 0.03 mg of ethinyl estradiol and 2.0 mg of 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:

severe disorders of fat metabolism (obesity, hyperlipidemia);
thrombophlebitis of superficial veins;
otosclerosis with hearing impairment, idiopathic jaundice or itching during a previous pregnancy;
epilepsy;
migraine with aura;
congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes);
diabetes;
systemic lupus erythematosus;
hemolytic uremic syndrome;
Crohn's disease;
sickle cell anemia;
arterial hypertension.

In the case of a planned operation, it is recommended to stop taking the drug at least 4 weeks before it and not resume taking it within 2 weeks after the end of immobilization.
While taking drugs that affect microsomal enzymes, and within 28 days after their withdrawal, you should additionally use a barrier method of contraception.
While taking antibiotics (such as ampicillins and tetracyclines) and within 7 days after their withdrawal, 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 package, you need to move on to the next package of Jeanine without the usual break in taking the pills.
If any of the conditions/risk factors listed below are currently present, then the potential risk and expected benefit of treatment with Jeanine should be carefully weighed in each individual case and discussed with the woman before she decides to start taking the drug.

If any of these conditions or risk factors worsen, worsen, or first appear, the woman should consult her physician, who may decide whether to discontinue the drug.

Diseases of the cardiovascular system

There is evidence of an increase in the incidence of venous and arterial thrombosis and thromboembolism when taking combined oral contraceptives.
However, the frequency of venous thromboembolism (VTE) developing when taking combined oral contraceptives is less than the frequency 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 hepatic, mesenteric, renal arteries and veins, the central retinal vein and its branches, have been described. The relationship with the use of combined oral contraceptives has not been proven.
A woman should stop taking the drug 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 radiating to the left arm; sudden shortness of breath; a sudden attack of coughing; 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 appeared on one side or in one part of the body; movement disorders; symptoms of an 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 old);
in the presence of:

Family history (i.e. venous or arterial thromboembolism ever in close relatives or parents at a relatively young age); in the case of a hereditary predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking COCs;
obesity (body mass index over 30 kg/m2);
- dyslipoproteinemia;
- arterial hypertension;
- migraine;
- diseases of the heart valves;
- atrial fibrillation;
- prolonged immobilization, major surgery, any operation on the legs or major trauma.

In these situations, it is advisable to stop the use of combined oral contraceptives (in the case of a planned operation, at least four weeks before it) and not resume taking within two weeks after the end of immobilization.
An increased risk of thromboembolism in the postpartum period should be taken into account.
Circulatory disturbances can also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), and sickle cell anemia.
An increase in the frequency and severity of migraine during the use of combined oral contraceptives (which may precede cerebrovascular disorders) may be grounds for immediate discontinuation of these drugs.
Biochemical parameters that may be indicative of 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 (cardiolipin antibodies, lupus anticoagulant).
Tumors
There are reports of an increased risk of developing cervical cancer with long-term use of combined oral contraceptives. Its relationship with the use of combined oral contraceptives has not been proven. Controversy remains as to the extent to which these findings relate to sexual behavior and other factors such as human papillomavirus (HPV).
It has also been found that there is a slightly increased relative risk of developing breast cancer diagnosed in women who used combined oral contraceptives. Its relationship with the use of combined oral contraceptives has not been proven. The observed increase in risk may be due to earlier diagnosis of breast cancer in women using combined oral contraceptives.
In rare cases, against the background of the use of combined oral contraceptives, the development of liver tumors was observed. In the event of severe pain in the abdomen, liver enlargement, or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.
Other states
In women with hypertriglyceridemia (or a family history of this condition), there may be an increased risk of developing pancreatitis while taking combined oral contraceptives.
Although a slight increase in blood pressure has been described in many women taking combined oral contraceptives, clinically significant increases have been rare. However, if a persistent, clinically significant increase in blood pressure develops while taking combined oral contraceptives, these drugs should be discontinued and treatment of arterial 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 when taking combined oral contraceptives, but their relationship with taking combined oral contraceptives has not been proven: jaundice and / or itching associated with cholestasis; the formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes of pregnant women; hearing loss associated with otosclerosis. Cases of Crohn's disease and non-specific ulcerative colitis have also been described with the use of combined oral contraceptives.
Acute or chronic liver dysfunction may require discontinuation of the use of combined oral contraceptives until liver function tests return to normal. Recurrent cholestatic jaundice that 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 (<0,05 мг этинилэстрадиола). Тем не менее, женщины с сахарным диабетом должны тщательно наблюдаться во время приема комбинированных пероральных контрацептивов.
Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.
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 the boundaries of normal values.
While taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, evaluation of any irregular bleeding should be done only after an adaptation period of approximately three cycles.
If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be carried out to exclude malignant neoplasms or pregnancy.
Some women may not develop withdrawal bleeding during a break in taking pills. If combined oral contraceptives were taken as directed, it is unlikely that the woman is pregnant. However, if combined oral contraceptives have been taken irregularly before, or if there are no consecutive withdrawal bleedings, pregnancy should be excluded before continuing to take the drug.
Before starting the drug Janine a woman is recommended to undergo a thorough general medical and gynecological examination (including examination of the mammary glands and a cytological examination of cervical mucus), to exclude pregnancy. In addition, violations of the blood coagulation system should be excluded.
In the case of long-term use of the drug, it is necessary to conduct control examinations every 6 months.
Women should be warned that drugs such as Janine do not protect against HIV infection (AIDS) and other sexually transmitted diseases!
Effects on the ability to drive a car and machinery have not been identified.

Main settings

Name:	JANINE
ATX code:	G03AA14 -

Jeanine (ethinylestradiol + 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 Anovlar, the first oral contraceptive in Europe, is also a merit of Bayer Schering Pharma AG. Since then, work on the development of effective and safe contraceptives has advanced significantly. Research has developed in two directions: determining the optimal dose of estrogen and creating improved next-generation progestins. The crown of this work was the development of dienogest, an innovative progestin, which is the active ingredient in the contraceptive Jeanine. Unlike progestins of earlier generations, dienogest does not contain an ethynyl group, which excludes the possibility of its effect 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 reduce the duration of bleeding, eliminate their pain), which, in turn, minimizes the risk of developing iron deficiency anemia. Dienogest is devoid of androgenic properties (what other gestagens "sin" with). Moreover, it has the most positive effect on hair and skin (reduces the size of the sebaceous glands, suppresses excessive secretion of sebum), which gives Jeanine not only a therapeutic, but also an aesthetic effect. The results of multicenter, randomized, placebo-controlled clinical trials have demonstrated the high efficacy and favorable safety profile of Zhanin.

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

The contraceptive action of Jeanine is realized through several physiological patterns that complement each other, the key of which are the obstruction of ovulation and the increase in the density of cervical mucus in the epithelium of the cervical canal, due to which spermatozoa cannot penetrate the egg. Rules for taking the drug - every day at approximately the same time in strict accordance with that indicated in the leaflet. The beginning of the reception should coincide with the beginning of the menstrual cycle. Duration of admission - 3 weeks. Multiplicity of reception - once a day. A new pack of Jeanine must be started seven days after the previous one has ended. Skipping the next dose within 12 hours does not reduce contraceptive protection. In this case, the next dose should be taken as soon as possible. If more than 12 hours late, the contraceptive effect is reduced. A decrease in the contraceptive effect also occurs in 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 case.

Pharmacology

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

The contraceptive effect of Jeanine is mediated through complementary mechanisms, the most important of which are the suppression of ovulation and the change in the viscosity of the cervical mucus, making it impermeable to spermatozoa.

When used correctly, the Pearl Index (an indicator that reflects 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 Zhanin - dienogest - has antiandrogenic activity, which is confirmed by the results of a number of clinical studies. In addition, dienogest improves the lipid profile of the blood (increases the amount of high density lipoproteins).

In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful periods are 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 cancer and ovarian cancer.

Pharmacokinetics

Dienogest

Suction

After oral administration, dienogest is rapidly and completely absorbed from the gastrointestinal tract. C max 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 (SHBG) and corticoid-binding globulin (CBG). In the free form is about 10% of the total concentration in the blood serum; about 90% - non-specifically associated with serum albumin. The induction of SHBG synthesis by ethinylestradiol does not affect the binding of dienogest to serum protein.

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

Metabolism

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

breeding

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

Ethinylestradiol

Suction

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

Distribution

Ethinylestradiol is almost completely (approximately 98%), although non-specifically bound to albumin. Ethinylestradiol induces the synthesis of SHBG. The apparent V d of ethinylestradiol is 2.8-8.6 l / kg.

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

Metabolism

Ethinylestradiol undergoes presystemic conjugation, both in the mucosa of the small intestine and in the liver. The main metabolic pathway is aromatic hydroxylation. The rate of clearance from blood plasma is 2.3-7 ml / min / kg.

breeding

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

Release form

Dragee 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) - packs of cardboard.
21 pcs. - blisters (3) - packs of cardboard.

Dosage

Dragee should be taken orally in the order indicated on the package, every day at about the same time, with a small amount of water. Janine ® should be taken 1 tablet / day continuously for 21 days. Reception of each next pack begins after a 7-day break, during which withdrawal bleeding (menstrual-like bleeding) is observed. It usually starts on the 2-3rd day after taking the last pill and may not end before the start of a new package.

Start taking Jeanine

In the absence of taking any hormonal contraceptives in the previous month, Zhanin is started on the 1st day of the menstrual cycle (i.e. on the 1st day of menstrual bleeding). It is allowed to start taking it on the 2nd-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 pills from the first package.

When switching from combined oral contraceptives, a vaginal ring, a transdermal patch, Janine should be taken the next day after taking the last active dragee from the previous package, but in no case, no 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 preparations containing 28 tablets per pack). When switching from a vaginal ring, a transdermal patch, it is preferable to start taking Janine on the day the ring or patch is removed, but no later than the day a new ring or patch is to be inserted or pasted.

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

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 II trimester of pregnancy, it is recommended to start taking the drug on the 21-28th day after childbirth or abortion in the II trimester of pregnancy. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills. However, if a woman has already had a sexual life, pregnancy should be excluded before taking Zhanin, or it is necessary to wait for the first menstruation.

Taking missed pills

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

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

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

the drug should never be interrupted for more than 7 days;
to achieve adequate suppression of the hypothalamic-pituitary-ovarian system requires 7 days of continuous intake of dragees.

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

First week of taking the drug

It is necessary to take the last missed tablet as soon as possible, as soon as the woman remembers this (even if this requires taking two tablets at the same time). The next dragee is taken at the usual time. Additionally, a barrier method of contraception (such as a condom) must be used for the next 7 days. If sexual intercourse took place within a week before skipping the dragee, the likelihood of pregnancy should be considered. The more pills 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 tablet as soon as possible, as soon as the woman remembers this (even if this requires taking two tablets at the same time). The next dragee is taken at the usual time. Provided that the woman has taken the pill correctly within 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as when skipping two or more pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.

Third week of taking the drug

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

1. It is necessary to take the last missed tablet as soon as possible, as soon as the woman remembers it (even if this requires taking two tablets at the same time). The next dragee is taken at the usual time until the dragees 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 pills.

2. A woman can also stop taking the dragee from the current package. Then she should take a break for 7 days, including the day she skipped the dragee, and then start taking a new package.

If a woman misses taking the pills, and then during the break in taking she does not have withdrawal bleeding, pregnancy should be excluded.

If a woman has had vomiting or diarrhea up to 4 hours after taking active pills, absorption may not be complete and additional contraceptive measures should be taken. In these cases, you should be guided by the recommendations when skipping the dragee.

Changing the start date of the menstrual cycle

To delay the onset of menstruation, a woman should continue taking the pills from the new Jeanine package immediately after all the pills from the previous one have been taken, without interruption in the reception. Dragees 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. Resume taking Janine from a new package after the usual 7-day break.

To move the day of the start of menstruation to another day of the week, a woman should shorten the next break in taking 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 have further spotting and breakthrough bleeding during the second pack (just as she would like to delay her period).

Additional information for special categories of patients

For children and adolescents, Jeanine ® is indicated only after the onset of menarche.

After the onset of menopause, the drug Janine ® is not indicated.

Jeanine ® is contraindicated in women with severe liver disease until liver function tests are normal.

Janine® has not been specifically studied in patients with impaired renal function. Available data do not suggest a change in treatment in these patients.

Overdose

Serious violations in case of overdose have not been reported.

Symptoms: nausea, vomiting, spotting or metrorrhagia.

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

Interaction

Interactions of oral contraceptives with other medicinal products may result in breakthrough bleeding and/or reduced contraceptive reliability.

The following types of interaction 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. These 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 interfere with hepatic metabolism.

Effects on enterohepatic circulation

According to separate studies, some antibiotics (eg, penicillins and tetracyclines) can reduce the enterohepatic circulation of estrogens, thereby lowering the concentration of ethinyl estradiol.

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

Substances that affect the metabolism of combined hormonal contraceptives (enzyme inhibitors)

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

While taking drugs that affect microsomal enzymes, and within 28 days after their withdrawal, you should additionally use a barrier method of contraception.

While taking antibiotics (with the exception of rifampicin and griseofulvin) and within 7 days after their withdrawal, 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 package, you need to move on to the next package of Jeanine without the usual break in taking the pills.

Oral combined contraceptives may interfere with the metabolism of other drugs, leading to an increase (eg, cyclosporine) or a decrease (eg, lamotrigine) in 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 Janine ® in women, other undesirable effects were observed, indicated in the table below. Within each group, allocated depending on the frequency of an undesirable effect, undesirable effects are presented in order of decreasing severity.

Determining 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 contagion
	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 Appetite	Anorexia
Psychiatric disorders
	Decreased mood	Depression Mental disorders Insomnia Sleep disorders Aggression	Mood changes Decreased libido Increased libido
Nervous system
Headache	Dizziness 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 loss	Contact lens intolerance (discomfort when wearing them)
The cardiovascular system
	Arterial hypertension Arterial hypotension	Cardiovascular disorders Tachycardia, including increased heart rate Thrombosis/thromboembolism of the pulmonary artery 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 Impaired pigmentation/hyperpigmentation seborrhea Dandruff hirsutism Pathological skin changes Orange peel Vascular asterisks	Erythema multiforme
allergic reactions
		Manifestations of allergic reactions, including allergic dermatitis	Hives erythema nodosum
Musculoskeletal system
		Back pain Feeling of discomfort in the muscles and bones Myalgia Pain in the limbs
Reproductive system and mammary glands
Breast pain, discomfort, breast engorgement	Abnormal withdrawal bleeding, including menorrhagia, hypomenorrhea, oligomenorrhea, and amenorrhea Intermenstrual bleeding, including vaginal bleeding and metrorrhagia An increase in the size of the mammary glands, swelling and a feeling of fullness of the mammary glands Swelling of the mammary gland Dysmenorrhea Discharge from the genital tract/discharge from the vagina ovarian cysts Pain in the pelvic area	cervical dysplasia Adnexal cysts Pain in the uterine appendages Breast cysts Fibrocystic mastopathy Dipareunia Galactorrhea Menstrual irregularities	Discharge from the mammary glands
General symptoms
	Fatigue Asthenia Feeling unwell	Chest pain Peripheral edema Flu-like symptoms Inflammation Temperature increase Irritability	Fluid retention
Survey results
	Changes in body weight (increase, decrease and fluctuations in body weight)	An increase in the level of TG in the blood Hypercholesterolemia
Congenital and genetic disorders
		Detection of an additional mammary gland / polymastia

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

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

The occurrence or aggravation 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, the formation of gallstones, porphyria, systemic lupus erythematosus; hemolytic-uremic syndrome, Sydenham's chorea, herpes in 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, given the overall risk of developing 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 in the presence of any of the conditions/diseases listed below. If any of these conditions develop for the first time while taking it, the drug should be immediately discontinued.

the presence of thrombosis (venous and arterial) at present 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;
the presence or history of migraine with focal neurological symptoms;
the presence of severe or multiple risk factors for venous or arterial thrombosis (including complicated valvular heart disease, atrial fibrillation, cerebrovascular disease or coronary artery disease, uncontrolled arterial hypertension, major surgery with prolonged immobilization, smoking over the age of 35 years);
liver failure and severe liver disease (before normalization of liver tests);
the presence or history of pancreatitis with severe hypertriglyceridemia;
the presence or history of benign or malignant liver tumors;
identified hormone-dependent malignant diseases of the genital organs or mammary glands or suspicion of them;
vaginal bleeding of unknown origin;
pregnancy or suspicion of it;
breastfeeding period;
hypersensitivity to the components of the drug.

Carefully

The potential risk and expected benefit 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 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 whom - or from the next of kin/);
other diseases in which peripheral circulatory disorders may occur (diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease, UC, sickle cell anemia, phlebitis of superficial veins);
hereditary angioedema;
hypertriglyceridemia;
liver disease;
diseases that first arose or worsened during pregnancy or against the background of a previous intake of sex hormones (for example, jaundice, cholestasis, gallbladder disease, otosclerosis with hearing loss, porphyria, herpes pregnant, Sydenham's chorea);
postpartum period.

Application features

Use during pregnancy and lactation

Jeanine ® is not prescribed during pregnancy and during breastfeeding.

If pregnancy is detected while taking Janine, the drug should be discontinued immediately. However, extensive epidemiological studies have not found an increased risk of malformations in children born to women who received sex hormones before pregnancy, or teratogenicity when sex hormones were inadvertently taken early in 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.

Application for violations of liver function

If abnormal liver function occurs, Zhanin may need to be temporarily discontinued until laboratory parameters return to normal. With the development of cholestatic jaundice or cholestatic pruritus (first encountered during pregnancy or previous use of sex hormones), Janine ® should be discontinued.

Application for violations of kidney function

Janine's intake may affect the biochemical parameters of kidney function.

special instructions

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

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

If any of the conditions, diseases and risk factors listed below are currently present, then the potential risk and expected benefit of using combined oral contraceptives should be carefully weighed in each individual case and discussed with the woman before she decides to start taking drug. With weighting, strengthening, or at the first manifestation of risk factors, drug withdrawal may be required.

Diseases of the cardiovascular system

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

The risk of developing venous thromboembolism (VTE) is highest in the first year of taking these drugs. An increased risk is present after the initial use of oral contraceptives or the resumption of use of the same or different combined oral contraceptives (after a break between doses of 4 weeks or more). Data from a large prospective study in 3 groups of patients show 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 any combined oral contraceptive.

Very rarely, when using combined oral contraceptives, thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or vessels of the retina. 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 fever in the affected leg, redness or discoloration of the skin on the leg.

Symptoms of pulmonary embolism (PE) are as follows: difficulty or rapid breathing; sudden cough, incl. with hemoptysis; sharp pain in the chest, which may worsen with a deep breath; sense of anxiety; severe dizziness; 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 speaking and understanding; sudden unilateral or bilateral loss of vision; sudden disturbance of gait, dizziness, loss of balance or coordination of movements; sudden, severe or prolonged headache with no apparent cause; loss of consciousness or fainting with or without an epileptic seizure. Other signs of vascular occlusion: sudden pain, swelling and slight blueness of the extremities, acute abdomen.

Symptoms of a myocardial infarction include: pain, discomfort, pressure, heaviness, a feeling of tightness or fullness in the chest, arm, or chest; discomfort with irradiation 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 an increase in the number of cigarettes or an increase in age, the risk increases, especially in women over 35 years old);
with obesity (body mass index more than 30 kg / m 2);
if there is a family history (for example, venous or arterial thromboembolism ever in close relatives or parents at a relatively young age). In the case of a hereditary or acquired predisposition, a woman should be examined by an appropriate specialist to decide on the possibility of taking combined oral contraceptives;
with prolonged immobilization, major surgery, any operation on the legs or major trauma. In these situations, it is advisable to stop the use of combined oral contraceptives (in the case of a planned operation, at least four weeks before it) and not resume taking within two weeks after the end of immobilization;
with dyslipoproteinemia;
with arterial hypertension;
with migraine;
with diseases of the heart valves;
with atrial fibrillation.

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

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

An increase in the frequency and severity of migraine during the use of combined oral contraceptives (which may precede cerebrovascular disorders) may be 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, lack of antithrombin III, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

In assessing the risk-benefit ratio, it should be taken into account that adequate treatment of the respective condition may reduce the associated risk of thrombosis. It should also be borne in mind that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose oral contraceptives (< 50 мкг этинилэстрадиола).

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

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

In rare cases, against the background of the use of combined oral contraceptives, the development of liver tumors was observed, which in some cases led to life-threatening intra-abdominal bleeding. In the event of severe pain in the abdomen, 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 a slight increase in blood pressure has been described in many women taking combined oral contraceptives, clinically significant increases have been rare. However, if a persistent, clinically significant increase in blood pressure develops while taking combined oral contraceptives, these drugs should be discontinued and treatment of arterial 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 when taking combined oral contraceptives, but their relationship with taking combined oral contraceptives has not been proven: jaundice and / or itching associated with cholestasis; the formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea of Sydenham; herpes of pregnant women; hearing loss associated with otosclerosis. Cases of Crohn's disease and non-specific ulcerative colitis have also been described with the use of combined oral contraceptives.

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

Acute or chronic liver dysfunction may require the withdrawal of combined oral contraceptives until liver function returns to normal. Recurrent cholestatic jaundice that 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 micrograms of ethinyl estradiol). However, women with diabetes should be closely monitored while taking combined oral contraceptives.

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

The effectiveness of combined oral contraceptives may be reduced by missing pills, vomiting and diarrhea, 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, evaluation of any irregular bleeding should be done only after an adaptation period of approximately three cycles. If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be carried out to exclude malignant neoplasms or pregnancy.

Some women may not develop withdrawal bleeding during a break in taking pills. If combined oral contraceptives were taken as directed, it is unlikely that the woman is pregnant. However, if combined oral contraceptives have been taken irregularly before, or if there are no consecutive withdrawal bleedings, pregnancy should be excluded before continuing to take the drug.

Impact on lab test scores

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 the boundaries of normal values.

Preclinical safety data

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

Influence on the ability to drive vehicles and control mechanisms

Jeanine is a low-dose monophasic oral contraceptive drug. Instructions for use indicate that tablets and dragees have antiandrogenic properties. Doctors - gynecologists indicate that the drug helps with endometriosis and in contraception in healthy women.

Release form and composition

Jeanine is made in the dosage form of dragees for oral (inside) intake. They are white in color, rounded and smooth. The dragee contains 2 main active ingredients, which include ethinylestradiol (0.03 mg in 1 dragee) and dienogest (2 mg in 1 dragee). Also, the composition of the dragee includes auxiliary components.

Jeanine tablets are packaged in blisters of 21 pieces. A cardboard pack contains one (21 dragees) or three (63 dragees) blisters and instructions for using the drug.

Indications for use

What helps Janine? Tablets are used as a means:

hormonal contraception;
from endometriosis;
elimination of manifestations of hirsutism;
for the treatment of acne;
with androgenetic alopecia and seborrhea.

Instructions for use

Jeanine Dragee should be taken orally in the order indicated on the package, every day at about the same time, with a small amount of water. Jeanine should be taken 1 tablet per day continuously for 21 days.

Reception of each next pack begins after a 7-day break, during which withdrawal bleeding (menstrual-like bleeding) is observed. It usually starts on the 2-3rd day after taking the last pill and may not end before the start of a new package.

Start taking Jeanine

When switching from a vaginal ring, a transdermal patch, it is preferable to start taking Janine on the day the ring or patch is removed, but no later than the day a new ring or patch is to be inserted or pasted.

When switching from contraceptives containing only gestagens (“mini-pill”, injectable forms, implant) or from a progestogen-releasing intrauterine contraceptive (Mirena), a woman can switch from taking “mini-pill” to Jeanine on any day (without interruption), with implant or intrauterine contraceptive with a progestogen - on the day of its removal, from an injectable contraceptive - on the day when the next injection should be made.

In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the dragee.

After an abortion in the 1st 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 2nd trimester of pregnancy, it is recommended to start taking the drug on the 21-28th day after childbirth or abortion in the 2nd trimester of pregnancy.

If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills. However, if a woman has already had a sexual life, pregnancy should be excluded before taking Zhanin, or it is necessary to wait for the first menstruation.

Taking missed pills

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

In this case, you can be guided by the following two basic rules: the drug should never be interrupted for more than 7 days; to achieve adequate suppression of the hypothalamic-pituitary-ovarian system requires 7 days of continuous intake of dragees. Accordingly, if the delay in taking active dragees was more than 12 hours (the interval from the moment of taking the last active dragee is more than 36 hours), the following can be recommended.

First week of taking the drug

If sexual intercourse took place within a week before skipping the dragee, the likelihood of pregnancy should be considered. The more pills 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

Provided that the woman has taken the pill correctly within 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as when skipping two or more pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.

Third week of taking the drug

Withdrawal bleeding is unlikely until the second pack is finished, but spotting and breakthrough bleeding may occur while taking the pills. A woman can also stop taking pills from the current package. Then she should take a break for 7 days, including the day she skipped the dragee, and then start taking a new package. If a woman misses taking the pills, and then during the break in taking she does not have withdrawal bleeding, pregnancy should be excluded.

Changing the start date of the menstrual cycle

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

See also: how to take birth control pills.

pharmachologic effect

Ethinylestradiol is a synthetic estrogen, when ingested it performs all the functions of endogenous (own) estrogen. Dienogest can be called an analogue of natural progesterone. Despite a slight similarity (only 10%) with progesterone, it has a powerful progestogenic activity (it can effectively mimic the action of progesterone).

The pharmacological action of Janine tablets is contraceptive. It comes as a result of the implementation of three complementary mechanisms:

Suppression of ovulation by influencing the hypothalamic-pituitary system.

Changing the properties (mainly viscosity) of cervical mucus in such a way as to make it impermeable to spermatozoa.

Structural and functional changes in the endometrium, in which implantation of even a fertilized egg cannot occur.

The action of the drug is not limited to the contraceptive effect. Against the background of taking Jeanine, the menstrual cycle normalizes, pain and the amount of discharge during menstruation decrease, the development of certain gynecological diseases is prevented or suspended, and the reproductive function of a woman is restored.

After regular use of the drug, there is an improvement in the condition of the skin, hair, nails, the drug has a positive effect on the female body as a whole.

Contraindications

Contraindications to the use of birth control pills are:

severe forms of liver disease (including a history; taking the drug is allowed only if the liver samples are normal);
hypersensitivity to the substances contained in the dragee;
established or suspected pregnancy;
severe and / or multiple factors, against which the risk of thrombosis of veins or arteries increases;
conditions preceding thrombosis (including a history; for example, angina pectoris or attacks of focal or cerebral disorders associated with impaired cerebral circulation);
due to an imbalance of hormones, malignant diseases of the mammary glands or organs of the reproductive system (as well as suspicion of them);
liver tumors;
vaginal bleeding of unspecified etiology;
thrombosis of veins and arteries (including history; including but not limited to pulmonary embolism, DVT, myocardial infarction, cerebrovascular disorders);
diabetes mellitus with vascular complications.

Side effects

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

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

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

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

Children, during pregnancy and lactation

Contraindicated during pregnancy and breastfeeding. It is not prescribed for children and adolescents under 18 years of age.

special instructions

Before you start using Janine dragees, you should carefully read the instructions for the drug. There are specific guidelines for its use, which include:

The risk of developing cardiovascular complications in the form of thrombosis or thromboembolism is significantly increased when using the drug against the background of smoking (especially over the age of 35 years), obesity, the presence of thrombosis in close relatives (aggravated family history), migraine, arterial hypertension, prolonged decrease in motor activity , atrial fibrillation or an artificial valve.

In the case of a burdened family history regarding an increased risk of developing thrombosis or thromboembolism, mandatory monitoring of laboratory indicators of hemostasis (blood coagulation) is carried out.

There is evidence of the possible likelihood of developing cervical cancer while taking the drug, especially if there is a concomitant human papillomavirus infection.

In women with a hereditary predisposition to elevated blood lipids, while taking Janine dragees, the risk of developing pancreatitis increases.

Against the background of taking the drug, the development of intermenstrual bleeding is possible.

Taking the drug only protects against unwanted pregnancy and is not a prophylactic for infections with a predominant sexual route of transmission.

drug interaction

Complex intake of Jeanine with phenytoin, barbiturs, rifampicin, primidone, carbamazepine, topiramate, felbamate can lead to an increase in the clearance of sex hormones. In this case, it is additionally recommended to use barrier methods of contraception.

Non-nucleoside reverse transcriptase and HIV protease inhibitors may impair hepatic metabolism. Antibiotics of the penicillin and tetracycline series reduce the enterohepatic circulation of estrogens, which can lead to a decrease in the level of ethinyl estradiol.

Jeanine's analogs

According to the structure, analogues are determined:

Diecyclene.
Bonade.
Genettin.

Zhanin's analogues according to the mechanism of action:

Femoden.
Logest.
Midian.
Evra.
Dimia.
Egestrenol.
Oralcon.
Belara.
Mercilon.
Marvelon.
Dailla.
Jess.
Lindinet 30.

Holiday conditions and price

The average cost of Jeanine (tablets No. 21) in Moscow is 1046 rubles. In pharmacies, Jeanine dragees are dispensed only by prescription. It is not recommended to start their independent reception or use on the advice of third parties.

Store below 25 C. Keep away from children. Shelf life - 3 years.

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Last update of the description by the manufacturer 25.09.2014

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Active substance:

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Nosological classification (ICD-10)

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Compound

Description of the dosage form

White smooth dragees.

Characteristic

Low-dose monophasic oral combined estrogen-progestogen contraceptive drug. Due to the antiandrogenic effect of the progestogen component of dienogest, it contributes to clinical improvement in patients with inflamed acne (acne).

pharmachologic effect

pharmachologic effect- contraceptive.

Pharmacodynamics

The contraceptive effect of Jeanine ® is mediated by various complementary mechanisms, the most important of which are the suppression of ovulation and the change in the viscosity of the cervical mucus, as a result of which it becomes impermeable to spermatozoa.

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

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

Pharmacokinetics

Dienogest

Absorption. When taken orally, dienogest is rapidly and completely absorbed, its C max in blood serum, equal to 51 ng / ml, is reached after about 2.5 hours. Bioavailability is approximately 96%.

Distribution. Dienogest binds to serum albumin and does not bind to sex steroid-binding globulin (SHBG) and corticoid-binding globulin (CBG). In the free form is about 10% of the total concentration in the blood serum; about 90% are nonspecifically bound to serum albumin. The induction of SHBG synthesis by ethinylestradiol does not affect the binding of dienogest to serum albumin.

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

Withdrawal. T 1 / 2 from plasma is about 8.5-10.8 hours. In unchanged form, it is excreted in the urine in a small amount; in the form of metabolites - by the kidneys and through the gastrointestinal tract in a ratio of approximately 3: 1 with T 1/2 - 14.4 hours.

equilibrium concentration. The pharmacokinetics of dienogest is not affected by the level of SHBG in the blood serum. As a result of daily administration of the drug, the level of the substance in the serum increases by about 1.5 times.

Ethinylestradiol

Absorption. After oral administration, ethinylestradiol is rapidly and completely absorbed. C max in serum, equal to approximately 67 ng / ml, is reached in 1.5-4 hours. During absorption and the first passage through the liver, ethinylestradiol is metabolized, resulting in its oral bioavailability averaging about 44%.

Distribution. Ethinyl estradiol is almost completely (approximately 98%), although non-specific, bound to albumin. Ethinylestradiol induces the synthesis of SHPS. The apparent volume of distribution of ethinylestradiol is 2.8-8.6 l/kg.

Metabolism. Ethinylestradiol undergoes presystemic biotransformation both in the mucosa of the small intestine and in the liver. The main metabolic pathway is aromatic hydroxylation. The rate of clearance from blood plasma is 2.3-7 ml / min / kg.

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

equilibrium concentration. The equilibrium concentration is reached during the second half of the treatment cycle.

Indications for Janine ®

Contraception.

Contraindications

Janine ® should not be used in the presence of any of the conditions listed below. If any of these conditions develop for the first time while taking the drug, the drug should be immediately canceled:

hypersensitivity to any of the components of the drug Janine ® ;

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

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

migraine with focal neurological symptoms at present or in history;

diabetes mellitus with vascular complications;

multiple or pronounced risk factors for venous or arterial thrombosis, incl. complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of the vessels of the brain or coronary arteries of the heart;

uncontrolled arterial hypertension;

major surgery with prolonged immobilization;

smoking over the age of 35;

pancreatitis with severe hypertriglyceridemia at present or in history;

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

liver tumors (benign or malignant) at present 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;

period of breastfeeding.

CAREFULLY

risk factors for thrombosis and thromboembolism: smoking; obesity (dyslipoproteinemia); arterial hypertension; migraine; valvular heart disease; prolonged immobilization, major surgical interventions, extensive trauma; hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the next of kin);

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

hereditary angioedema;

hypertriglyceridemia;

liver disease;

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

postpartum period.

Use during pregnancy and lactation

Jeanine ® is not prescribed during pregnancy and lactation.

If pregnancy is detected while taking the drug Janine ® , it should be immediately canceled. However, extensive epidemiological studies have not found any increased risk of malformations in children born to women who received sex hormones before pregnancy, or teratogenic effects when sex hormones were inadvertently taken early in pregnancy.

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

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 Janine ® in women, other undesirable effects were observed, indicated in the table below. Within each group, allocated depending on the frequency of an undesirable effect, undesirable effects are presented in order of decreasing severity.

By frequency, undesirable effects are divided into frequent (≥1 / 100 and<1/10), нечастые (≥1/1000 и <1/100) и редкие (≥1/10000 и <1/1000). Для дополнительных нежелательных эффектов, выявленных только в процессе постмаркетинговых наблюдений и для которых оценку частоты провести не представляется возможным, указано «частота неизвестна».

Organ system	Frequency
Organ system	Often - ≥1 / 100	Uncommon - ≥1/1000 and<1/100	Rarely -<1/1000	Frequency unknown
Infections and contagion		Vaginitis/vulvovaginitis	Salpingoophoritis (adnexitis)
		Vaginal candidiasis or other fungal vulvovaginal infections	Urinary tract infections
			Cystitis
			cervicitis
			Mastitis
			Fungal infections
			Candidiasis
			Herpetic lesions of the oral cavity
			Flu
			Bronchitis
			Sinusitis
			Upper respiratory tract infections
			Viral infection
Benign, malignant and unspecified tumors (including cysts and polyps)			uterine fibroids
			Breast lipoma
Blood and lymphatic system			Anemia
The immune system			allergic reactions
Endocrine system			virilism
Metabolism		Increase in appetite	Anorexia
Psychiatric disorders		Decreased mood	Depression	Mood change
			Mental disorders	Decreased libido
			Insomnia	Increased libido
			Sleep disturbance
			Aggression
Nervous system	Headache	Dizziness	Ischemic stroke
		Migraine	Cerebrovascular disorders
			Dystonia
Organ of vision			Dryness of the mucous membrane of the eyes	Contact lens intolerance (discomfort when wearing them)
			Irritation of the mucous membrane of the eyes
			Oscillopsia
			visual impairment
hearing organ			Sudden hearing loss
			Noise in ears
			Dizziness
			Hearing loss
A heart			Cardiovascular disorders
A heart			Tachycardia, including increased heart rate
Vessels		Hypertension, hypotension	Thrombosis/PE
			Thrombophlebitis
			diastolic hypertension
			Orthostatic circulatory dystonia
			tides
			Varicose veins
			Vein pathology
			Pain in the veins
Pathology of the respiratory tract, chest and mediastinum			Bronchial asthma
Pathology of the respiratory tract, chest and mediastinum			Hyperventilation
gastrointestinal tract		Abdominal pain, including lower and upper abdominal pain, discomfort, bloating	Gastritis
		Nausea	Enteritis
		Vomit	Dyspepsia
		Diarrhea
Skin and subcutaneous tissue		acne	Allergic dermatitis	Hives
		Alopecia	Atopic dermatitis/neurodermatitis	erythema nodosum
		Rash, including macular rash	Eczema	Erythema multiforme
		Itching, including generalized itching	Psoriasis
			Hyperhidrosis
			Chloasma
			Impaired pigmentation/hyperpigmentation
			seborrhea
			Dandruff
			hirsutism
			Skin pathology
			skin reactions
			Orange peel
			Vascular asterisks

In women receiving COCs, the development of the following undesirable effects has been reported (see also the section "Special Instructions"):

Venous thromboembolic complications;

Arterial thromboembolic complications;

Cerebrovascular complications;

hypertension;

Hypertriglyceridemia;

Change in glucose tolerance or effect on insulin resistance in peripheral tissues;

Tumors of the liver (benign or malignant);

Violations of the liver;

Chloasma;

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

The occurrence or aggravation of conditions for which the relationship with the use of COCs has not been clearly proven: jaundice and / or itching associated with cholestasis; the formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes of pregnant women; otosclerosis with hearing impairment, Crohn's disease, ulcerative colitis, cervical cancer.

There is a very small increase in the incidence of breast cancer in women using COCs. Because breast cancer rarely occurs in women under 40, given the overall risk of developing breast cancer, there are very few additional cases. The relationship with the use of COCs is not known. Additional information is presented in the sections "Contraindications" and "Special Instructions".

Interaction

Interactions of oral contraceptives with other drugs may lead to breakthrough bleeding and/or reduced contraceptive reliability. The following types of interaction 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. These drugs include: phenytoin, barbiturates, primidone, carbamazepine, rifampicin; there are also suggestions for oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John's wort.

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

Effect on enterohepatic circulation: According to separate studies, some antibiotics (eg penicillins and tetracyclines) can reduce the enterohepatic circulation of estrogens, thereby lowering the concentration of ethinyl estradiol.

During the appointment of any of the above drugs, a woman should additionally use a barrier method of contraception (for example, a condom).

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

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

During the reception antibiotics(with the exception of rifampicin and griseofulvin) and within 7 days after their cancellation, you should additionally use a barrier method of contraception. If the period of using the barrier method of protection ends later than the tablets in the package, you need to move on to the next package without the usual break in taking the pills.

Oral combined contraceptives can interfere with the metabolism of other drugs, leading to an increase (eg cyclosporine) or decrease (eg lamotrigine) in plasma and tissue concentrations.

Dosage and administration

inside, with a small amount of water, daily at about the same time of day, in the order indicated on the package. Take 1 tablet per day, continuously for 21 days. The next pack is started after a 7-day break in taking the pills, during which withdrawal bleeding usually occurs. Bleeding usually starts 2-3 days after taking the last pill and may not end before starting a new pack.

Reception of Jeanine ® begins:

- in the absence of taking any hormonal contraceptives in the previous month. Janine ® is started on the first day of the menstrual cycle (i.e. the first day of menstrual bleeding). It is allowed to start taking it on the 2nd-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the pills from the first package;

- when switching from other combined oral contraceptives (from the vaginal ring, transdermal patch). It is preferable to start taking Janine ® the next day after taking the last active dragee from the previous package, but in no case later than the next day after the usual 7-day break (for preparations containing 21 tablets), or after taking the last inactive dragee (for preparations containing 28 dragees per package). When switching from a vaginal ring, a 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 or patch is to be inserted;

- when switching from contraceptives containing only gestagens ("mini-pili", injectable forms, implant), or a progestogen-releasing intrauterine contraceptive (Mirena). A woman can switch from a “mini-drink” to Janine ® any day (without a break), from an implant or intrauterine contraceptive with a progestogen - on the day it is removed, from an injection form - from the day when the next injection should have been made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the dragee;

- after an abortion in the first trimester of pregnancy. A woman can start taking the drug immediately. Subject to this condition, the woman does not need additional contraceptive protection;

- after childbirth or abortion in the second trimester of pregnancy. It is recommended to start taking the drug on the 21-28th day after childbirth or abortion in the second trimester of pregnancy. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills. If a woman has already been sexually active, pregnancy must be ruled out before taking Zhanin ®, or it is necessary to wait for the first menstruation.

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

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

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

To achieve adequate suppression of the hypothalamic-pituitary-ovarian regulation, 7 days of continuous administration of the dragee are required.

If the delay in taking the pill was more than 12 hours (the interval from the moment the last pill was taken was more than 36 hours), the following advice can be given.

First week of taking the drug

The woman should take the last missed tablet as soon as possible (even if it means taking two tablets at the same time). The next dragee is taken at the usual time. Additionally, a barrier method of contraception (such as a condom) must be used for the next 7 days. If sexual intercourse took place within a week before skipping the dragee, the likelihood of pregnancy should be considered. The more pills missed and the closer the break in taking active substances, the greater the likelihood of pregnancy.

Second week of taking the drug

The woman should take the last missed tablet as soon as possible (even if it means taking two tablets at the same time). The next dragee is taken at the usual time.

Provided that the woman has taken the pill correctly within 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as skipping 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 a decrease in reliability is inevitable due to the upcoming break in taking pills.

A woman must strictly adhere to one of the following two options (if in the 7 days preceding the first missed tablet, all tablets were taken correctly, there is no need to use additional contraceptive methods):

1. A woman should take the last missed pill as soon as possible (even if it means taking two pills at the same time). The next dragee is taken at the usual time until the dragees 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 the dragee from the current package. Then she should take a break for 7 days, including the day she skipped the dragee, and then start taking a new pack.

If a woman misses taking the pills and then during the break in taking the pills she does not have withdrawal bleeding, pregnancy should be excluded.

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

Changing the start date of the menstrual cycle

In order to delay the onset of menstruation, a woman should continue taking the pills from the new Janine ® pack immediately after taking all the pills from the previous one, without interrupting the intake. Dragees 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. Resume taking Janine ® from a new pack after the usual 7-day break.

In order to move the day of the start of menstruation to another day of the week, a woman should be advised to shorten the next break in taking 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 have spotting and breakthrough bleeding during the second pack (as well as if she would like to delay the onset of her period).

Additional information for special categories of patients

Children and teenagers. The drug Jeanine ® is indicated only after the onset of menarche.

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

Patients with liver disorders. Jeanine ® is contraindicated in women with severe liver disease until liver function tests return to normal (see also section "Contraindications").

Patients with kidney disorders. Janine® has not been specifically studied in patients with renal impairment. Available data do not suggest a change in treatment in these patients.

Overdose

Symptoms: nausea, vomiting, spotting or metrorrhagia. Serious violations in case of overdose have not been reported.

Treatment: symptomatic treatment. There is no specific antidote.

special instructions

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

Diseases of the cardiovascular system

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

The risk of developing venous thromboembolism (VTE) is highest in the first year of taking these drugs. An increased risk is present after the initial use of combined oral contraceptives or the resumption of use of the same or different combined oral contraceptives (after a break between doses of 4 weeks or more). Data from a large prospective study in 3 groups of patients show 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 (the content of ethinyl estradiol -<50 мкг), 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).

VTE manifesting as deep vein thrombosis or pulmonary embolism can occur with any combined oral contraceptive.

Very rarely, when using combined oral contraceptives, thrombosis of other blood vessels (for example, hepatic, mesenteric, renal, cerebral veins and arteries or vessels of the retina) occurs. There is no consensus regarding the relationship between the occurrence of these events and the use of combined oral contraceptives.

Symptoms of deep vein thrombosis (DVT) include the following: unilateral swelling of the lower extremity or along a vein in the leg, pain or discomfort in the leg only when standing or walking, localized fever in the affected leg, redness or discoloration of the skin on the leg.

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

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

With age;

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

In the presence of:

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

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

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

Dyslipoproteinemia;

arterial hypertension;

Migraine;

heart valve disease;

Atrial fibrillation.

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

An increased risk of thromboembolism in the postpartum period should be taken into account.

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

Tumors

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

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

Other states

In women with hypertriglyceridemia (or a family history of this condition), there may be an increased risk of developing pancreatitis while taking combined oral contraceptives.

Although a slight increase in blood pressure has been described in many women taking combined oral contraceptives, a clinically significant increase was rarely observed. However, if a persistent, clinically significant increase in blood pressure develops while taking combined oral contraceptives, these drugs should be discontinued and treatment of arterial hypertension should be started. 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 when taking combined oral contraceptives, but their relationship with taking combined oral contraceptives has not been proven: jaundice and / or itching associated with cholestasis; the formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes of pregnant women; hearing loss associated with otosclerosis. Cases of Crohn's disease and non-specific ulcerative colitis have also been described with the use of combined oral contraceptives.

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

Although combined oral contraceptives may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose combined oral contraceptives (ethinyl estradiol content -<0,5 мг). Тем не менее, женщины с сахарным диабетом должны тщательно наблюдаться во время приема комбинированных пероральных контрацептивов.

Preclinical safety data

Laboratory tests

Reduced efficiency

The effectiveness of combined oral contraceptive preparations may be reduced in the following cases: when missing pills, vomiting and diarrhea, or as a result of drug interactions.

Effect on the menstrual cycle

If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be carried out to exclude malignant neoplasms or pregnancy.

Some women may not develop withdrawal bleeding during their pill break. If combined oral contraceptives were taken as directed, it is unlikely that the woman is pregnant. However, if previously combined oral contraceptives were taken irregularly or there are no two withdrawal bleedings in a row, pregnancy should be excluded before continuing to take the drug.

Medical examinations

A woman should be warned that preparations such as Jeanine ® do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Contraception Contraception intrauterine Local contraception Oral contraception Contraception in women with androgenization phenomena Local contraception Insertion and removal of the intrauterine device Z30.0 General advice and advice on contraceptionsafe sex intrauterine contraception Contraception Contraception intrauterine Contraception in adolescents oral contraception Oral contraception during lactation and when estrogens are contraindicated Postcoital contraception Pregnancy protection Prevention of pregnancy (contraception) Prevention of unwanted pregnancy emergency contraception Episodic contraception

Janine is a popular contraceptive. In addition to the contraceptive effect, the use of the drug gives good results in the treatment of a large number of gynecological problems. Tablets do not harm a woman's health and can be used for many years, you can learn more from the reviews on the site.

This is a unique monophasic drug, in its composition it has synthetic analogues of female hormones, due to which contraceptive effect. The action of Janine tablets is no different from similar contraceptive drugs. The use of the drug in adolescents should be under the strict supervision of a gynecologist until the age of 18.

It is forbidden to take a contraceptive without a doctor's prescription, reviews on the Internet are only a method of research, and not a guide to action!

Release form

Jeanine contraceptive is produced in the form of milky, white or cream-colored pills for oral administration. The composition includes two main substances:

ethinylestradiol;
Dienogest (analogous to progesterone);

As well as excipients:

The cardboard pack contains 21 tablets packed in a blister. The package may contain one or three blisters. Also inside the package is an insert-instruction for use. In order not to become a victim of fakes, check out the reviews and appearance of Janine tablets on the Internet, photos will help you not to make a mistake.

The action of the drug

The main action of drugs and is carried out through the action of complementary mechanisms. Including an increase in the density of cervical mucus and inhibition of ovulation. Due to this, she does not miss sperm.

Proper use is a prerequisite for the use of the drug. Therefore, before starting the course, it is necessary to study the instructions and reviews. Otherwise, skipping pills or errors in the course can lead to an increase in the Pearl index.

Dienogest- the main progestogen component of janine tablets, the antiandrogenic activity of which is confirmed by clinical studies. It also increases the level of high density lipoproteins. Eliminates acne by inhibiting the activity of male hormones.

In addition to all of the above, the use of Janine tablets alleviates premenstrual syndrome in women. Long-term use normalizes the cycle, reduces pain, reduces the intensity and duration of discharge.

The drug is rapidly absorbed by the gastrointestinal tract after application, and dienogest is completely metabolized in the body. A certain amount of the component is excreted from the body in an unchanged state along with metabolites through urine and bile in a ratio of 3:1. Also, ethinylestradiol metabolites are excreted in the urine in a ratio of 4:6. Ethinylestradiol itself is completely absorbed in the body of a woman.

When choosing a drug, operate not only with reviews on the Internet, but also with the recommendations of your doctor.

It is necessary to take the drug strictly according to the instructions, 21 days 1 tablet per day. It is necessary to drink dragees with clean water. After consuming 1 pack, a seven-day break is required, during which the so-called withdrawal period is possible. These are menstrual-like discharges that begin a day or two after the last pill intake and can last until the start of the next package.

The drug janine is prescribed to women if any hormonal preparations were not taken in the previous months. In this case, the first tablet is consumed on the first day of bleeding. You can start on the second - fifth day of menstruation, but then the next seven days you need to use barrier contraception.

If a woman decides to switch to Janine after using the vaginal ring, oral contraceptives, transdermal patch. tablets should be taken one day after the previous drug, but no later than the last day of the seven-day break. When switching from a ring or patch, it is best to start taking pills immediately after removal and no later than the day the new ring or patch is inserted.

If the previous method of contraception was mini-pill, implant, injectable forms or Mirena, then a woman can switch to Janine any day, without a break from the mini-pill, and on the day of removal or the next injection. In all these cases, within a week after taking the starter pill, janine must be additionally protected by the barrier method.

If a woman has had an abortion in the third trimester of pregnancy, the use of dragees can begin immediately without additional protection.

After a postponed childbirth or abortion in the second trimester of pregnancy, the use of the drug occurs 21–28 days after the procedure. If more than 28 days have passed since the abortion or childbirth, then additional barrier contraception is required after the start of the course for seven days.

Persons under 18 years of age should be taken with extreme caution. In the first year of using the drug, carefully monitor your well-being.

If you forgot to take the drug

Delay in taking medications less than 12 hours does not reduce the effectiveness of protection, but the next dragee needs to be drunk as soon as possible. The next pill is taken as scheduled at the right time. A delay greater than 12 hours cancels the protective effect. (This refers to an interval of about 36 hours after taking the previous dragee.

Principles of taking contraceptives Jeanine:

Adequate contraceptive effect is achieved within seven days after the start;
Do not interrupt the drug for more than seven days;

So, what if the medicine has not been taken for more than 12 hours? It all depends on the period of taking the dragee and the stage of the course. In the first, second and third weeks of taking the drug, various measures are necessary. The closer the missed pill is to the seven-day break, the greater the likelihood of pregnancy. So, What should I do if I missed a dragee?

Starting week of medication. The next dragee should be taken as quickly as possible, even if it requires drinking a couple of pieces at once. The subsequent administration of the drug is carried out at the standard time and during the week it is necessary to additionally use barrier contraception.
The second week of taking the drug. It is necessary, as in the previous case, to take the next dragee as soon as the woman remembers this. The next pill is taken as usual. If during the previous seven days before the first missed pill, the woman took pills regularly, there is no need to use barrier contraception. However, if there was a recent break or this is not the first pass, additional barrier contraception must be used.
Third week of taking the drug. The risk of pregnancy is very high due to the upcoming break in the course. Therefore, a woman has two options for action in such a situation. The first option includes the standard prim rules for being late. The next dragee is taken at the standard time, before the end of the pack. Then you must immediately start drinking dragees from the next package, that is, cancel the seven-day break. Breakthrough bleeding and spotting may occur during this time, and withdrawal periods are possible but unlikely. The second option is to interrupt the course of taking the drug for 7 days, including the missed day. Then you need to start taking a new pack.

Please note: if during the break between packs a woman does not experience withdrawal bleeding, and there were missed pills in the previous month, it is necessary to consult a gynecologist and exclude pregnancy.

Nuances and features of taking the drug

If, after taking the drug, a woman had bouts of vomiting or diarrhea in the interval of 4 hours, absorption, most likely, did not occur completely. Must use barrier contraception. Further, be guided by the recommendations in the instructions, section. what to do when skipping a dragee.

By taking Janine, a woman can control the day of her next period. If it is necessary to delay the day of the start of the discharge, the woman should continue the course of the drug immediately without a break between packs. At this time, spotting and breakthrough uterine bleeding are possible. You can take medicines until the package runs out. The next pack must be started after a weekly interval.

If it is necessary to change the day of the week of the onset of menstruation, it is necessary to reduce the dragee break by the required number of days. The shorter the interval, the greater the likelihood of spotting and withdrawal bleeding at the beginning of the course of the next pack.

The price of the drug may vary depending on your region and country of residence. The average price in Ukraine is UAH 246; The price in Russia is 573 rubles.

Contraindications and side effects

The drug should not be taken by women with liver disease until the problem is resolved. This is the main contraindication for taking pills. As well as:

Jeanine is contraindicated in children under 18 years of age; shown only after the onset of the first menstruation;
Not indicated for women after menopause;

Among other things, the drug has a number of side effects that you need to discuss with your doctor. Perhaps you will be assigned an analogue.

Janine side effects:

Starting for the first time taking the drug janine, you need to carefully monitor your well-being. If one of the following diseases is present, the drug is contraindicated, and if they occur during the reception, the use of the drug should be immediately discontinued. They may provoke the development of complications.

Janine during pregnancy and breastfeeding

Jeanine is contraindicated pregnant and lactating women, and if pregnancy was detected while taking a contraceptive, the drug should be stopped immediately. However, studies have not identified fetal developmental disorders due to the use of hormonal contraceptives in the period before pregnancy or in the early stages.

The use of janine oral contraceptives or analogues can lead to a decrease in the amount of breast milk. In addition, some hormones can be excreted in breast milk.

special instructions

The use of janine, similar drugs prohibited without a doctor's prescription. They can adversely affect a woman's health, so a full medical examination is necessary before starting the course. In zhanin, the composition has a unique formula, and, in addition to the contraceptive function, it eliminates many gynecological problems. However, taking synthetic hormones, if there are certain factors, is a risky business.

A woman who decides to protect herself with contraceptive pills should understand that they do not protect against HIV infection and other sexually transmitted diseases.

If you are in doubt about the choice of contraceptives, it is recommended to read the reviews on the Internet. Or you can read reviews on our website. They will help you weigh the pros and cons.

At the beginning of the use of the drug Janine, contraindications were frightened. Was it worth it for a long time? But after a detailed medical examination, she nevertheless decided and was satisfied.

Angela Kerch

I had never taken hormonal contraceptives before, I was very afraid to start. The Internet is full of different rumors on this topic, there is something to be afraid of. But now I'm extremely happy! My cycle returned to normal, and the discharge became less intense. Particularly pleased with the possibility of adjusting the cycle.

Tatiana Sumy

I have had problems with my menstrual cycle since childhood. In addition to being unstable, I was constantly in severe pain. But with the beginning of the course, I was pleasantly surprised by the changes, in addition to excruciating pain and heavy discharge, I got rid of the monthly acne that had always accompanied me these days.

Olga, Sevastopol