Hormonal pills janine instructions for use. Hormonal pills janine instruction

Country of origin

Product group

Monophasic oral contraceptive with antiandrogenic properties

Release forms

• 21 - blisters (1) - packs of cardboard. 21 - blisters (1) - packs of cardboard. 21 - blisters (3) - cardboard packs

Description of the dosage form

• Dragee Dragee Dragee white, smooth.

pharmachologic effect

Pharmacokinetics

Special conditions

Compound

• ethinylestradiol 30 mcg dienogest 2 mg Excipients: lactose monohydrate, potato starch, gelatin, talc, magnesium stearate. Shell composition: sucrose, dextrose, macrogol 35,000, calcium carbonate, polyvidone K25, titanium dioxide (E171), carnauba wax.

Jeanine indications for use

• contraception.

Janine contraindications

• Jeanine 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 lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of the cerebral vessels or coronary arteries of the heart, uncontrolled arterial hypertension

Janine 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, as 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.

drug interaction

Overdose

Storage conditions

• store at room temperature 15-25 degrees
• keep away from children

Jeanine is a new generation hormonal contraceptive for systemic use. The action of the drug is aimed at inhibiting the secretion of gonadotropic pituitary hormones, inhibiting the maturation of follicles and suppressing ovulation.

The contraceptive effect of Zhanin is due to the suppression of ovulation, an increase in the viscosity of the cervical secret, a change in the endometrium, which reduces the possibility of implantation of a fertilized egg.

Active ingredient: 1 dragee contains ethinylestradiol 30 mcg, dienogest 2 mg.

Ethinylestradiol is a synthetic estrogen hormone that is normally produced in women by the ovaries and adrenal cortex. When administered orally to the body, it performs all the functions of endogenous (own) estrogen. After oral administration, ethinylestradiol is rapidly and completely absorbed. It is not excreted from the body unchanged. Metabolites of ethinylestradiol are excreted in the urine and bile in a ratio of 4:6.

Dienogest can be called an analogue of natural progesterone, this compound has antiandrogenic activity and improves the blood lipid profile (increases HDL). Dienogest is almost completely metabolized. A small part of dienogest is excreted by the kidneys in an unchanged state.

Indications for use Jeanine

• Oral contraception (prevention of unwanted pregnancy);
• Acne (acne), seborrhea;
• hirsutism;
• Androgenetic alopecia.

According to the instructions, Jeanine is recommended to be taken by women who live a regular sexual life to prevent unwanted pregnancy. The action of the drug is not limited to the contraceptive effect. The intake of Jeanine dragees is accompanied by the normalization of the menstrual cycle, a decrease in the pain of menstruation and the intensity of discharge, which significantly reduces the risk of developing anemia associated with iron deficiency.

Sometimes when taking the drug, there were cases of a decrease in the manifestations of endometriosis.

Instructions for use Jeanine, 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. Jeanine should be taken 1 tablet / day. continuously for 21 days.

Taking tablets from each subsequent package should be started after a seven-day break in taking the drug, during which withdrawal bleeding (menstrual-like bleeding) should occur. It usually starts on the 2-3rd day after taking the last pill and may not end before the start of a new package.

With irregular use, the therapeutic and / or contraceptive effect after Zhanin may be reduced, for this reason it is important not to forget about taking the drug in a timely manner. The permissible delay in taking Janine is 12 hours. The next dragee is taken at the usual time.

Application features

Before starting or resuming the use of the drug Janine, it is recommended to take a complete medical history (including family history) and exclude pregnancy.

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

After the onset of menopause, the drug Jeanine is not used.

The intake of alcohol and fatty foods does not affect the action of the hormonal drug. No contraindications for driving vehicles and working with precise mechanisms have been identified.

Side effects and contraindications of Jeanine

• soreness and tension of the mammary glands, their increase, swelling and the appearance of discharge from the nipples;
• spotting and breakthrough uterine bleeding;
• headache, including migraine;
• a change in libido (both a decrease in desire and an increase in interest in sexual intercourse);
• decrease / mood changes, drops, emotional jumps;
• poor tolerance to contact lenses;
• visual impairment;
• nausea;
• vomit;
• pain in the epigastric region;
• changes in vaginal secretion;
• skin rash, urticaria;
• erythema nodosum;
• erythema multiforme;
• generalized itching;
• cholestatic jaundice;
• fluid retention in the tissues, the appearance of swelling;
• change in body weight, both upward and downward;
• allergic reactions.

Rarely, there is an increase in plasma triglyceride levels, a decrease in carbohydrate tolerance, increased fatigue, and diarrhea.
Against the background of taking combined oral contraceptives in women, other undesirable effects were observed.

Overdose

Symptoms: nausea, vomiting, spotting (mucus, clots, blood particles, etc.) or metrorrhagia. Serious violations in case of overdose have not been reported.

Treatment: symptomatic treatment. There is no specific antidote.

Contraindications

• the presence of thrombosis at the time of admission or in history;
• migraine with focal neurological symptoms at present or in history;
• the presence at the time of admission or in the anamnesis of signs indicating future thrombosis (example: transient ischemic attacks, angina pectoris);
• diabetes mellitus with vascular complications;
• the presence of a sufficient number of reasons for the occurrence of venous or arterial thrombosis;
• the presence at the time of admission or a history of jaundice or dangerous liver pathologies (until the liver recovers);
• pancreatitis with severe hypertriglyceridemia at present or in history;
• the presence at the time of admission or a history of benign or cancerous liver pathologies;
• calculated hormone-dependent cancerous pathologies of the genitals or mammary glands or the likelihood of their presence;
• discharge of blood from the vagina of unknown origin;
• pregnancy or its symptoms;
• lactation period;
• individual intolerance to any components of the contraceptive.

Jeanine's analogues, list of drugs

Jeanine's analogues by action and scope, list:

1. Midian;
2. Diana-35;
3. Regulon;
4. Marvelon;
5. Yarina;
6. Lindinet 30;
7. Levonorgestrel;
8. Mirena;
9. Lactinet;
10. Postinor.

It is important to understand that the instructions for the use of Jeanine tablets, the price and reviews do not apply to analogues and cannot be used for self-treatment, prescription or other therapeutic actions. Replacing Jeanine with an analogue should be carried out by a specialist, dosage adjustment may be required. Before using the drug, it is important to consult a doctor.

Jeanine is the choice of those who want to prevent unwanted pregnancy without using a condom and other local contraceptives and also solve a number of other problems, for example, reduce the manifestations of endometriosis. Like any drug, Jeanine has side effects and contraindications. An experienced gynecologist will help to weigh all the pros and cons, a visit to which is a must before taking medicinal dragees!

Jeanine is a monophasic drug with a contraceptive effect. The composition combines unique components (artificial analogues of female hormones) that prevent the onset of an unplanned pregnancy.

The drug contributes to the regulation of the menstrual cycle, as well as the elimination of intermediate bleeding and pain, especially with irregular and heavy menstrual bleeding (which can lead to everything else to anemia).

In this article, we will consider why doctors prescribe Jeanine, including instructions for use, analogues and prices for this drug in pharmacies. If you have already used Janine, leave your feedback in the comments.

Release form and composition

The drug is produced in the form of white smooth dragees, each 21 of which are packed in blisters. One or three blisters are enclosed in a cardboard pack of the drug.

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.

Clinical and pharmacological group: monophasic oral contraceptive with antiandrogenic properties.

What is Jeanine used for?

According to the instructions, Jeanine is recommended to be taken by women who live a regular sexual life to prevent unwanted pregnancy. In addition, in medical practice, Janine tablets are often used as the main and auxiliary treatment for the following conditions and diseases:

• endometriosis;
• violation of reproductive function;
• dysmenorrhea (painful menstruation);
• amenorrhea (lack of menstruation);
• menorrhagia (heavy menstruation);
• the period after gynecological surgical interventions (in order to recover after the operation and consolidate its results);
  an increased content of male sex hormones in the blood of a woman (which often results in acne, very oily skin, excessive hair growth of the skin).

pharmachologic effect

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.

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.

Instructions for use

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 / 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.

• How to start taking Janine if you have not taken any hormonal contraceptives in the previous month. Janine is started on the first day of the menstrual cycle (i.e. on 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 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 progestogen-only oral contraceptives (mini-pill), you can stop taking the mini-pill any day and start taking Janine the next day, at the same time. During the first 7 days of taking the pills, you must also use an additional barrier method of contraception.
• When switching from an injectable contraceptive, an implant, or a progestogen-releasing intrauterine contraceptive (Mirena). Start Janine on the day your next injection is due or on the day your implant or intrauterine contraceptive is removed. During the first 7 days of taking the pills, you must also use an additional barrier method of contraception.
• 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 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.

If no more than 12 hours have passed since the pass in taking the dragee, then the contraceptive effect of the drug does not decrease. It is necessary to take the missed pill as soon as possible. Then switch to normal reception mode.

Taking missed pills

If the gap exceeds 12 hours, then contraceptive protection is reduced. There are two basic rules to be aware of:

1. It is impossible to interrupt the reception of the dragee for more than 7 days,
2. For 7 days of continuous intake of dragees, adequate inhibition of the hypothalamus-pituitary-ovaries system is achieved.

• 1 Week. The last missed tablet should be taken as soon as possible. Even if you have to take two pills at a time. Then continue to take the dragee at the usual time. Over the next 7 days, it is recommended to use an additional method of protection, such as a condom. If sexual intercourse took place in the previous 7 days, the possibility of pregnancy should not be ruled out. The closer the break in taking the drug and the more pills missed, the higher the risk of pregnancy.
• 2 weeks. 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 skipping two or more pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.
• 3 weeks. With the approach of a break in taking dragees, unreliability increases. But if the regimen is followed, a decrease in contraceptive protection can be avoided. The need to use additional contraceptives will not arise if one of the following options is followed, if there were no violations in taking pills for 7 days before the pass. Consider the recommendations below for options. If there have been violations before. then additional protection for the next 7 days.

You can stop taking the dragee from the current package. In this case, including the days of skipping, the break in taking the drug should be up to 7 days. You need to start taking dragees with a new package. If there are violations of the gastrointestinal tract, then the absorption of the drug will not be complete, which means that additional means of protection must be used. It is advisable to skip taking the dragee if vomiting occurs within 3-4 hours after taking it. If there is no desire to change your usual regimen of taking the drug, then you need to take additional (s) pills from another package.

To delay the onset of menstruation, you do not need to take a break in taking the drug, but continue taking the drug from the new package. Reception can be continued until the end of the second package. This does not rule out bloody or breakthrough bleeding. After a 7-day break, the usual intake of Jeanine is restored.

In order to shift the time of the onset of menstruation to another day of the week, it is recommended to reduce the break in taking pills by the required number of days. The duration of the break affects the absence/presence of menstrual-like bleeding and breakthrough or bloody bleeding.

Contraindications

Jeanine 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.

1. Bleeding from the vagina of unknown origin.
2. Pregnancy or suspicion of it.
3. breastfeeding period.
4. Conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history.
5. Migraine with focal neurological symptoms at present or in history.
6. Diabetes mellitus with vascular complications.
7. Pancreatitis with severe hypertriglyceridemia at present or in history.
8. Liver failure and severe liver disease (before normalization of liver tests).
9. Liver tumors (benign or malignant) at present or in history.
10. Identified hormone-dependent malignant diseases (including genital organs or mammary glands) or suspicion of them.
11. Multiple or severe risk factors for venous or arterial thrombosis, including complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of the cerebral vessels or coronary arteries of the heart; uncontrolled arterial hypertension, major surgery with prolonged immobilization, smoking over the age of 35 years.
12. Thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), cerebrovascular disorders.

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; visual impairment; nausea; vomit; stomach ache; changes in vaginal secretion; skin rash; erythema nodosum; migraine; change in libido; decrease/changes in mood; poor tolerance to contact lenses; erythema multiforme; generalized itching; cholestatic jaundice; fluid retention; change in body weight; allergic reactions.

Rarely - an increase in the level of triglycerides in the blood plasma, a decrease in carbohydrate tolerance, increased fatigue, diarrhea. As with other combined oral contraceptives, in rare cases, the development of thrombosis and thromboembolism is possible.

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).

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.

special instructions

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

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

Taking the drug Jeanine 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, the assessment of irregular bleeding should be carried out only after the adaptation period, which is approximately 3 cycles.

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

Jeanine does not protect against STDs and HIV infection.

Analogues

Zhanin's analogues according to the mechanism of action: Belara, Yarina, Dailla, Midian, Jess, Logest, Evra, Lindinet 30, Mercilon, Marvelon, Egestrenol, Femoden, Oralcon, Dimia.

Prices

The average price in pharmacies (Moscow) is 1178 rubles.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life - 3 years.

Today, there are hormonal contraceptives "Janine", which belong to a new generation of drugs. They were developed by specialists from a German pharmaceutical company called Schering. She has been researching sex hormones for a long period of time in order to develop such remedies that could help in the treatment of many gynecological diseases.

The composition of the medicinal product

The main topic that worries the fair sex is the Janine medication and endometriosis. After all, they so want to get rid of such a disease by any means. The composition of hormonal contraceptives contains synthetic analogues of progesterone and estrogens, which are female sex hormones. They are able to stop the release and synthesis of pituitary hormones. Consequently, the egg does not mature and does not leave the follicle under the influence of hormones. In other words, ovulation does not occur. That is why a woman does not get pregnant. At the time when Janine is taken, the mucus in the cervix becomes quite viscous, and it is very difficult for sperm to get inside to fertilize the egg. Even if fertilization has occurred, the mucous membrane changes in the uterine cavity, and it is very difficult for the egg to penetrate into it. The composition of this contraceptive contains ethinyl estradiol and dienogest - analogues of female hormones, which have quite a few side effects, because, despite the fact that they are quickly absorbed into the body, they are also quickly decomposed and excreted.

Effect on the female body

This hormonal contraceptive has not only a contraceptive effect. It has a great effect on the entire female body. One of the painful topics for many ladies is the menstrual cycle. This drug not only brings it back to normal, but also reduces pain during this period. As for the connection between Janine and endometriosis, it should be noted that it can help prevent the development of this disease and restore a woman's ability to have children. Additional pleasant moments are the improvement of the skin condition, the disappearance of oily sheen and acne. This drug also has a great effect on hair and nails. They become strong and healthy.

Help in the treatment of diseases

To understand the connection between the drug "Janine" and endometriosis, you first need to find out how the drug acts on the body and what effect to expect from it. This disease causes very unpleasant sensations. Many women cannot get pregnant or have a normal child because of it. But this is the main mission of the fair sex. Today, progress does not stand still. And ladies who have learned about such a disease should not despair. It's not a verdict yet. Now such a disease is treated and quite successfully.

But this will take a lot of time. Many do not know anything about the nature of enometriosis, so it is worth understanding it a bit. As a rule, the uterus of a healthy woman is covered inside with special cells. They respond to various hormonal changes. They are able to grow, reject and regenerate. Such processes occur monthly, which makes it possible for a woman to conceive a baby. Hereditary predisposition, chronic gynecological diseases, traumatic childbirth, abortions lead to the fact that endometrioid growths appear in other organs, and during the menstrual cycle they become larger and begin to put pressure on neighboring organs. There is a feeling of severe pain, sometimes the membranes and tissues grow together, adhesions appear. So, how are the Janine contraceptive and endometriosis related? This drug does not cure the disease, but fights its symptoms.

Indications and contraindications

A woman begins to take contraceptives in order to avoid an unwanted pregnancy. But it happens that the doctor prescribes it to those girls whose blood contains a large amount of androgens, male hormones. It becomes noticeable on the outside. Acne, seborrhea or baldness begins to appear. Those ladies who are prone to blood clots or have hypersensitivity to some components of the drug may suffer from varicose veins, coronary heart disease and other similar ailments. It is also not recommended for people who have impaired liver function. Therefore, before you start taking the drug "Janine", you should carefully examine and consult with your doctor.

Side effects

As a rule, this contraceptive is well tolerated. But every woman needs to know all the possible side effects in order to be ready for them. So, there may be bleeding between periods, nausea, headache, decrease or increase in sexual desire, soreness and engorgement of the mammary glands. However, do not immediately cancel this drug. You just need to go to the doctor, and he will make the appropriate decision. However, if an allergic reaction, liver disease, thrombosis occurs, then taking this remedy must be stopped.

Correct reception

The package of the drug "Janine" contains 21 tablets. It is necessary to start taking from the first day of menstruation and do it daily, preferably at the same time. A delay of 12 hours is allowed. You need to drink this drug for three weeks, after seven days do not take it, and then start again with the next package. If everything is done correctly, then pregnancy does not occur. Many women are interested in the question: "Does the medicine "Janine" have analogues?" Indeed, they are. These are Dienogest + Ethinylestradiol, Diecyclen and Silhouette tablets. However, you should not make a choice on your own. It is better to consult a doctor about this.

Instructions for the medical use of the drug

Description of the pharmacological action

Jeanine is a 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 indicator reflecting the number of pregnancies in 100 women taking a contraceptive during the year is less than 1. If pills are missed or used incorrectly, this indicator may increase.

In women taking combined oral contraceptives (COCs), 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.

Indications for use

Contraception.

Release form

21 dragees in a package (blister) made of PVC film and covered with coated aluminum foil.
Blister of 21 tablets or 3 blisters of 21 tablets.

Pharmacodynamics

The contraceptive effect of Jeanine is mediated through various complementary mechanisms, the most important of which are the suppression of ovulation and the change in the viscosity of cervical mucus, as a result of which it becomes 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 Jeanine - 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 Cmax 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% - non-specifically associated with 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. T1 / 2 from plasma is about 8.5–10.8 hours. In unchanged form, it is excreted in the urine in small quantities; in the form of metabolites - by the kidneys and through the gastrointestinal tract in a ratio of approximately 3: 1 with T1 / 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. Cmax 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 T1 / 2 about 1 hour, the second - T1 / 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 T1 / 2 of about 24 hours.

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

Use during pregnancy

Jeanine is not prescribed during pregnancy and during lactation.

If pregnancy is detected while taking Janine, it should be discontinued immediately. 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.

Use in impaired renal function

Jeanine has not been specifically studied in patients with renal impairment. Available data do not suggest a change in treatment in these patients.

Other special occasions when taking

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").

Contraindications for use

Jeanine 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 Jeanine;

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;

breastfeeding period.

Side effects

Jeanine 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 Jeanine.
Prolonged immobilization, major surgery, leg surgery, extensive trauma.

Dosage and administration

Inside, with a small amount of water, every day 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 begins 2-3 days after taking the last pill and may not end before a new pack is taken.

Reception Janine begin:

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. on the first day of menstrual bleeding). It is allowed to start taking on the 2-5th 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 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 is to be inserted or a new patch is pasted;

When switching from contraceptives containing only gestagens ("mini-pill", injectable forms, implant), or a progestogen-releasing intrauterine contraceptive (Mirena). A woman can switch from a “mini-pill” to Jeanine 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 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 had a sexual life, pregnancy should be excluded before taking Janine, 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 pill, all pills 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 Jeanine package 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. Resuming taking Jeanine from a new pack should be 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).

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.

Interactions with other drugs

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.

Influence on hepatic metabolism: the use of drugs that induce microsomal liver enzymes may 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 also have the potential to affect 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.

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 CYP3A4 inhibitors 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 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 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.

Precautions for use

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.

Special instructions for admission

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 increase in risk factors, the woman should consult her doctor, who can decide on the need to discontinue the drug.

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 -
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, and 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 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.

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).

In the presence of:

Obesity (body mass index over 30 kg/m2);
- 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 operation on the legs 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;
- diseases of the heart valves;
- 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 the following: resistance to activated protein C, hyperhomocysteinemia, lack of antithrombin III, lack of protein C, lack of protein S, 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 (ethinyl estradiol content -
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 about the extent to which these data are related to screening for cervical pathology or to sexual behavior (less 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.

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

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 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.

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 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 -
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 sun exposure and exposure to UV radiation.

Storage conditions

At a temperature not higher than 25 °C.

Keep out of the reach of children.

Shelf life

Belonging to ATX-classification:

** The Medication Guide is for informational purposes only. For more information, please refer to the manufacturer's annotation. Do not self-medicate; Before you start using Jeanine, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of the information posted on the portal. Any information on the site does not replace the advice of a doctor and cannot serve as a guarantee of the positive effect of the drug.

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** Attention! The information provided in this medication guide is intended for medical professionals and should not be used as a basis for self-medication. The description of the drug Jeanine is given for informational purposes and is not intended for prescribing treatment without the participation of a doctor. Patients need specialist advice!

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