Janine tablets 0.03 mg/2 mg in blister pack. in pack No. 21x1 (ethinyl estradiol + dienogest)

Janine

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

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

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

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

Contraindications are:

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

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

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

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

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

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

Reception scheme

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

Start of taking Janine

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

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

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

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

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

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

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

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

Starting after an abortion or childbirth

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

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

What to do if you forget to take your pill?

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

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

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

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

First week of taking the drug

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

Second week of taking the drug

Take the missed pill as soon as possible, then proceed according to your usual schedule. If a woman is confident that she adhered to her dosage schedule during the week before missing the pill, no additional precautions are required. If the previous appointment occurred with serious deviations from the schedule, then it makes sense to additionally use barrier methods.

Third week of taking the drug

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

First scheme

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

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

Second scheme

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

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

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

Possible side effects:

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

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

A few more points that are important to know

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

Compound

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

Use with alcohol

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

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

However, please remember that:

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

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

Pharmacodynamics and pharmacokinetics

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

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

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

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

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

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

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

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

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

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

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

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

Analogs

Level 4 ATC code matches:
Ovidon

Rigevidon

Non-Ovlon

Mercilon

Yarina Plus

Yarina

Miniziston 20 fem

Novinet

Microgynon

Lindineth

Cyclo-Proginova

Regulon

Logest

Midiana

Belara

Femoden

Jess Plus

Jess

Zoely

Generics: Zhenetten , Diecyclen , Siluet , Bonade .

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

Janine or Silhouette - which is better?

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

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

Which is better: Claira or Janine?

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

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

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

Which is better: Janine or Diana 35?

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

Janine or Visanne - which is better?

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

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

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

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

Interaction

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

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

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

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

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

Side effects of Janine

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

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

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

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

special instructions

The use of the drug Zhanine is contraindicated before the onset of menarche and after the onset of menopause .

In some cases, the use of sex hormones can cause the development of tumors in the liver . liver size , severe abdominal pain, as well as signs of intraperitoneal bleeding must be taken into account when making a differential diagnosis.

Taking the drug Janine may be accompanied by irregular bleeding (both in the form of spotting and breakthrough bleeding), especially in the first months of therapy. In this regard, assessment of irregular bleeding should be carried out only after an adaptation period of approximately 3 cycles.

If such bleeding recurs or occurs after previous regular cycles, a non-hormonal cause should be sought. Diagnosis is carried out to exclude the presence of a malignant neoplasm or pregnancy . In some cases, diagnostic curettage may be required.

Janine does not protect against STDs and HIV infection.

Contraindications

Contraindications to the use of birth control pills are:

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

During pregnancy

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

However, during pregnancy, taking the drug is contraindicated.

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

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