Janine is a combined contraceptive drug for oral administration. The drug suppresses ovulation, changes the properties of the endometrium, and makes the cervical secretion impermeable to sperm.

Endometriosis is characterized by the proliferation of endometrial cells lining the uterine cavity beyond the inner layer of the organ. The tissue may spread into the pelvic peritoneum or grow into the muscles of the uterus. The disease causes acute pain in the lower abdomen, uterine bleeding, menstrual irregularities, and infertility develops in advanced stages. Excessive blood loss leads to anemia and a deterioration in the woman’s general well-being.

Endometriosis can cause infertility in girls of reproductive age. Often the pathology is combined with other ailments caused by hormonal disorders - these are uterine fibroids, endometrial hyperplasia.

The gestogen (Dienogest) contained in Zhanin suppresses the secretion of testosterone, causes the transition of the mucous membrane from the proliferation phase to the secretory stage and prevents pathological cell proliferation, eliminates lesions (heterotopia). The substance has high bioavailability, so small doses are sufficient to obtain a positive result. in combination with Dienogest stimulates the growth and development of the follicle, which leads to the restoration of the menstrual cycle, and prevents uterine bleeding during breaks in treatment.

The use of Zhanin in the treatment of endometriosis gives a positive result both in the genital form of the disease and in the extragenital form, when the endometrium grows in the peritoneal area.

In addition, Janine does not cause weight gain, acne goes away, the intensity of pain during menstruation decreases, menstrual blood loss and symptoms disappear. The effectiveness of the contraceptive drug has been confirmed by clinical trials. According to medical reviews and instructions for use, Janine for endometriosis in 85% of patients leads to a decrease in pathological symptoms or complete recovery. Relapses of the disease occur only in 7% of cases.

Indications for use of Janine

A combined oral contraceptive (COC) is prescribed in the following cases:

• As monotherapy for endometriosis, if there are no indications for surgical treatment.
• During the period of preparation for surgery.
• For infertility due to endometriosis.
• To prevent relapse of the disease after surgical treatment.

The treatment regimen is selected by the gynecologist taking into account the severity of the disease, the presence of concomitant pathologies, the patient’s hormonal background and existing contraindications.

Methods of using Janine

Before starting treatment, a woman should undergo a complete gynecological and general medical examination to rule out pregnancy, chronic diseases, tumors, allergic reactions, and genital infections.

Having figured out how to take Janine for endometriosis, you can begin the course. Treatment is carried out according to a specific prolonged regimen, which is selected by the attending physician individually for each patient. The tablets must be taken daily for 63–84 days, and the course must be started on the first day of the menstrual cycle.

Take 1 capsule per day, and this should be done at the same time. For convenience, the days of the week are indicated on the blister. If the interval between the last pill taken is more than 12 hours, the effectiveness of the drug is reduced. If for some reason a woman misses her next pill dose, she needs to take a COC as quickly as possible. Otherwise, an unwanted pregnancy may occur. After the course of treatment, an interval of 4–7 days is made, then the pills are continued according to the same regimen.

Women often ask: how long can you drink Janine if you have endometriosis? Therapy takes about 6 months. The drug artificially stops menstruation; they begin only during the break between pills. Bloody discharge appears 2–3 days after discontinuation; it can be copious or, conversely, scanty and spotting. Menstruation ends after you resume taking the contraceptive.

You can buy Janine at the pharmacy with a doctor's prescription. The price for it is from 1 thousand rubles. There are several forms of release of dragees: 21 or 63 pieces in one package.

Contraindications

Treatment with Janine is contraindicated for the following diseases:

• diabetes mellitus, diabetic angiopathy;
• hormone-dependent cancerous tumors of the liver, mammary glands, genital organs;
• individual intolerance to active substances;
• hypertension;
• angina pectoris;
• epilepsy;
• arrhythmia;
• atherosclerosis;
• pancreatitis;
• blood diseases;
• varicose veins, thrombosis, especially in mature women;
• vaginal bleeding of unknown etiology;
• chronic liver diseases;
• pregnancy and breastfeeding;
• prolonged immobility;
• recent surgical operations, injuries.

If pregnancy is detected during treatment, the drug is discontinued, although Janine does not have a negative effect on the development of the fetus. You should not take pills during lactation, as the medicine causes breast milk to burn out.

The use of Janine causes a slight increase in blood pressure. If this worsens a woman’s well-being, the condition is compensated. In case of uncontrolled hypertension, COCs should be discontinued. Patients with diabetes may need to change the dosage of hypoglycemic drugs.

Interaction of Janine with other medications

In case of concomitant treatment with other medications, you should consult your doctor about their interaction with Janine. Some antibiotics, barbiturates, and anticoagulants can reduce the effect of the contraceptive and cause breakthrough intermenstrual bleeding.

Such means include:

• antiepileptics;
• anti-tuberculosis;
• antiviral;
• antibiotics of the penicillin and tetracycline series;
• sedatives based on St. John's wort;
• medications used for HIV infection.

Antiulcer drugs, antimycotics, macrolides, and medications to lower blood pressure can negatively affect the metabolism of the active components of Janine. When visiting the dental office, you must tell the doctor that you are taking oral contraceptives.

Possible complications and side effects

The drug can be taken only as prescribed by a doctor. Too long treatment increases the risk of developing cervical, breast, and liver cancer. The combined contraceptive may cause pancreatitis, increased blood pressure, swelling, breast tenderness, migraine, increased fatigue, decreased libido, blurred vision, and weight gain.

From the digestive tract:

• nausea;
• vomit;
• diarrhea;
• abdominal pain.

As allergies develop, skin rash, erythema, severe itching, and swelling appear. If heavy periods occur during COC withdrawal, iron deficiency anemia may develop.

During the period of withdrawal from the tablets, menstruation may not begin - in such cases it is necessary to undergo examination for a possible pregnancy. Conceiving a child against the background of endometriosis and Janine is unlikely, but sometimes it happens if you skip regular pills. The interval between courses of treatment may cause an increase in testosterone levels. As a result, acne appears, hair falls out, and women become irritable.

During treatment, you should not be in direct sunlight or visit a solarium. The medicine sometimes causes spotting, spotting, and uterine bleeding. Most often this occurs in the first months of endometriosis therapy and goes away after adaptation after 3 cycles. If it is necessary to continue treatment for more than 6 months, women must undergo a thorough follow-up examination.

In case of overdose, nausea, vomiting, acyclic bleeding or scanty spotting occurs. Treatment is carried out symptomatically, the possibility of discontinuing COCs is decided by the gynecologist.

When you need to urgently visit a doctor

Consultation and examination by a specialist is necessary if the following symptoms appear:

• heavy uterine bleeding;
• absence of menstruation during the withdrawal period;
• increased blood pressure;
• dizziness, fainting;
• if a woman forgets to take pills for longer than 7 days;
• swelling of the limbs;
• painful hardening and swelling of the mammary glands.

A general deterioration in health and the development of side effects are reasons to visit a doctor for a possible drug change or dosage adjustment. Women should undergo regular examinations during treatment. Based on the results of instrumental or laparoscopic examination, the result of therapy is assessed and the issue of the need to extend or discontinue oral contraceptives is decided.

Janine is effectively used for the treatment of genital and extragenital forms of endometriosis in women of different ages. After a course of therapy, the pathological growth of the epithelium stops, the menstrual cycle normalizes, and pain during menstruation decreases.

Bibliography

1. Miscarriage, infection, innate immunity; Makarov O.V., Bakhareva I.V. (Gankovskaya L.V., Gankovskaya O.A., Kovalchuk L.V.) - “GEOTAR - Media”. - Moscow. - 73 pp. - 2007.
2. Metabolic syndrome and thrombophilia in obstetrics and gynecology. Makatsaria A.D., Pshenichnikova E.B. 2006 Publisher: MIA.
3. Women's consultation. Management, Editor: Radzinsky V.E. 2009 Publisher: Geotar-Media.
4. Miscarriage. A textbook for students, residents, graduate students, and students of FUVL.A. Ozolinya, T.N. Savchenko, T.N., Sumedi.-Moscow.-21s.-2010.

Causes and symptoms of uterine bleeding

Uterine bleeding occurs when blood leaks from the uterus. Compared to monthly bleeding, uterine bleeding is characterized by a longer duration and volume of bleeding.

Bleeding occurs due to various diseases of the uterus and appendages. These include fibroids and tumor formations, both benign and malignant. Another cause of bleeding may be difficulties during childbirth and pregnancy. Bleeding may occur without visible disturbances in the functioning of internal organs. In such cases, the reason lies in disturbances in the secretion of hormones that affect the functioning of the genital organs.

Liver damage can also cause uterine bleeding. This can also happen due to diseases accompanied by blood clotting disorders.

Symptoms of uterine bleeding are as follows:

• A sharp increase in the volume of blood released during bleeding.
• Increased duration of bleeding. Uterine bleeding lasts longer than a week.
• The regularity of menstrual flow is disrupted.
• After sexual intercourse, bleeding may begin.
• Bleeding during menopause.

As a result of the loss of large volumes of blood, patients develop anemia. It is often accompanied by weakness, shortness of breath, dizziness and pale skin.

Uterine bleeding of various etiologies

Uterine bleeding is divided into dysfunctional and juvenile. The first category of bleeding occurs due to a failure in the production of sex hormones. It can be caused by the following factors:

• Pathologies of the heart and blood vessels.
• Disorders of the circulatory system.
• Impact of stress and nervous disorders.
• Changes in general hormonal levels due to abortion.
• Traumatic injuries of the genitourinary system.
• General intoxication of the body

Juvenile bleeding most often occurs in girls under 18 years of age who suffer from gynecological abnormalities. This happens due to infectious diseases, as well as mental trauma and nervous overload.

Uterine bleeding with clots, how to stop?

To stop uterine bleeding with clots, it is important to follow some simple recommendations:

1. Since cold plays an important role in bleeding, it is necessary to place ice or a cold compress on the lower abdomen.
2. When bleeding, you should not make sudden movements, as this will harm the process of stopping it. A woman should lie on her back motionless with her legs elevated and bent at the knees.
3. You need to drink a lot of fluids. If it is not possible to install an IV at home, it is recommended to give the lady water or sweetened tea.

Drugs, especially hemostatic ones, must be taken carefully. Their use must be agreed with a doctor.

Uterine bleeding during menopause, how to stop?

To stop uterine bleeding during menopause, you should:

1. Seek help from a doctor immediately. In some cases, it is mandatory to call an ambulance.
2. Position the woman horizontally. To reduce pressure on the uterus, the woman can be placed on her side with her legs bent.
3. Apply a heating pad with ice or a cold compress to the area of ​​most intense pain.
4. If the pain is severe, you need to take a painkiller. An indispensable condition for its use is that the patient does not have an allergic reaction to it.

Often, when there is uterine bleeding, a gynecologist or attending physician prescribes medications with a high content of vitamin K. Drugs that stimulate uterine contractility are also indicated.

How to stop uterine bleeding with fibroids

Stopping uterine bleeding with fibroids is performed regardless of at what stage of the monthly cycle the bleeding occurs. For this purpose, homeostatic therapy is performed, which is divided into two types:

1. Surgical therapy. It is used to reduce the size of a tumor or completely eliminate it. In this case, the blood flow in the arteries that feed the formation node is blocked, as a result of which its regression begins. In this case, the fibroids may decompose; the products of its decomposition will be excreted through the blood. There may be a slight increase in the patient's body temperature.
2. Conservative type therapy involves the use of drugs that are extracted from the constituent components of human blood. There are hormonal and non-hormonal types of drug homeostasis.

There are cases when surgical intervention is indicated to eliminate the consequences of unsuccessful conservative treatment. This is necessary to reduce blood loss.

How to stop uterine bleeding with endometrial hyperplasia

Stopping uterine bleeding with endometrial hyperplasia involves the use of oral contraceptives, which include gestagens and estrogens. These include Janine, Yarina, Marvelon, Logest. The drugs should be used in an amount of five on the first day of use. The dosage of use is reduced by one tablet every day. After this, you should take one tablet for three weeks, counting from the day when five tablets were taken.

If there is a loss of a large amount of blood, the bleeding is stopped by curettage of the uterine cavity. The process is monitored by a gastroenterologist.

It is very difficult to stop the bleeding of the uterus without leaving home. Only short-term relief of the woman’s condition is possible.

First of all, you need to call an ambulance. Before her arrival, the woman should take a horizontal position. You need to raise your legs a little. A cold compress should be placed on the woman's lower abdomen. Do not use a heating pad or other means of warming.

How to stop uterine bleeding with folk remedies

Nettle has proven itself to be a non-standard remedy for stopping bleeding of the uterus. It can be used both in the preparation of decoctions and in the form of compresses. Water pepper, yarrow, and shepherd's purse also have a good hemostatic effect. Since the characteristics of each female body are individual, before prescribing a specific drug to stop uterine bleeding, you need to consult a doctor.

How to stop uterine bleeding: drugs

Very often, when there is a need to stop uterine bleeding at home, a woman begins to look for hemostatic drugs. Most often, Vikasol is used for this, both in tablets and in the form of injections. Its use requires compliance with the instructions for use. In addition, the use of Oxytocin, Oxytocin-Richter, Dicynon will give good results. The latter drug slows down bleeding by artificially accelerating platelet maturation and increasing their total number in the bloodstream.

How to quickly stop uterine bleeding

If it is necessary to quickly stop bleeding of the uterus, one must proceed from its nature, as well as the age of the patient and the individual characteristics of the body. A medical examination of the patient should first be carried out to correctly determine the causes of bleeding. Intravenous conjugated estrogens are expected to be administered, and oral progestins and oral contraceptives should also be prescribed. In this case, it is necessary to take into account the possible existence of prohibitions on this type of treatment.

If the woman’s condition cannot be called stable, surgical intervention is required. When performing it, one should take into account the presence of additional painful conditions in the victim. After eliminating bleeding in a short time, it is recommended to move on to long-term treatment, which involves a set of preventive measures.

Some medicinal herbs have a powerful hemostatic effect and their use is indicated when it is necessary to quickly stop uterine bleeding. They should be used only in consultation with your doctor. Uncontrolled use of traditional medicines can only worsen the overall situation.

In this article you can read the instructions for using the contraceptive drug Janine. Reviews of site visitors - consumers of this medicine, as well as the opinions of specialist doctors on the use of Janine in their practice are presented. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Analogues of Zhanin in the presence of existing structural analogues. Use for contraception in healthy women. Side effects (bleeding, pain), as well as during pregnancy while taking the drug.

Janine- low-dose monophasic oral combined estrogen-progestogen contraceptive drug.

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

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

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

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

Pharmacokinetics

After oral administration, dienogest is quickly and completely absorbed from the gastrointestinal tract. Dienogest is almost completely metabolized. A small part of dienogest is excreted unchanged by the kidneys. Metabolites are excreted in urine and bile in a ratio of about 3:1.

After oral administration, ethinyl estradiol is rapidly and completely absorbed. It is not excreted from the body unchanged. Ethinyl estradiol metabolites are excreted in urine and bile in a ratio of 4:6.

Indications for use

• contraception.

Release forms

Dragee 2 mg + 30 mcg (not available in tablet form).

Instructions for use and dosage regimen

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

Start of taking Janine

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

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

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

After an abortion in the 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 use is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pill. However, if a woman has already been sexually active, pregnancy should be excluded before taking Zhanine or she must wait until her first menstruation.

Taking missed pills

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

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

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

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

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

First week of taking the drug

It is necessary to take the last missed pill as soon as possible, as soon as the woman remembers it (even if this means taking two pills at the same time). The next pill is taken at the usual time. Additionally, a barrier method of contraception (for example, a condom) should be used for the next 7 days. If sexual intercourse took place within a week before missing the pills, the possibility of pregnancy must be taken into account. The more tablets are missed, and the closer they are to a break in taking active substances, the greater the likelihood of pregnancy.

Second week of taking the drug

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

Third week of taking the drug

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

1. It is necessary to take the last missed pill as soon as possible, as soon as the woman remembers it (even if this means taking two pills at the same time). The next pill is taken at the usual time, until the pills from the current package run out. The next pack should be started immediately without interruption. Withdrawal bleeding is unlikely until the second pack is finished, but spotting and breakthrough bleeding may occur while taking the pill.
2. A woman can also stop taking pills from the current package. She should then take a break for 7 days, including the day she missed the pills, and then start taking a new pack.

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

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

Changing the start day of the menstrual cycle

To delay the onset of menstruation, a woman should continue taking pills from a new package of Janine immediately after taking all the pills from the previous one, without interruption. The pills from this new package can be taken for as long as the woman wishes (until the package runs out). While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. You should resume taking Janine from a new package after the usual 7-day break.

To move the start of menstruation to another day of the week, a woman should shorten the next break in taking the pills by as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and will continue to have spotting and breakthrough bleeding while taking the second package (the same as in the case when she would like to delay the onset of menstruation).

Additional information for special categories of patients

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

After menopause, the drug Zhanine is not indicated.

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

Side effects

• vaginitis;
• salpingoophoritis (adnexitis);
• urinary tract infections;
• cystitis;
• mastitis;
• cervicitis;
• fungal infections;
• candidiasis;
• herpetic lesions of the oral cavity;
• viral infections;
• uterine fibroids;
• anorexia;
• anemia;
• gastritis;
• enteritis;
• dyspepsia;
• eczema;
• psoriasis;
• hyperhidrosis;
• myalgia;
• pain in the limbs;
• cervical dysplasia;
• cysts of the uterine appendages;
• pain in the area of ​​the uterine appendages;
• chest pain;
• peripheral edema;
• flu-like symptoms;
• fatigue;
• asthenia;
• bad feeling;
• headache;
• dizziness;
• migraine.

Contraindications

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

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

Use during pregnancy and breastfeeding

Janine is not prescribed during pregnancy and breastfeeding.

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

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

special instructions

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

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

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

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

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

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

Effect on the menstrual cycle

While taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately three cycles. If irregular bleeding recurs or develops after previous regular cycles, careful evaluation should be performed to rule out malignancy or pregnancy.

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

Impact on laboratory test performance

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

Impact on the ability to drive vehicles and operate machinery

Not found.

Drug interactions

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

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

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

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

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

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

Analogues of the drug Zhanine

Structural analogues of the active substance:

• Silhouette

If there are no analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and look at the available analogues for the therapeutic effect.

Catad_pgroup Combined oral contraceptives

The most physiological contraceptive that preserves the quality of sexual life. For the treatment of heavy and/or prolonged menstrual bleeding without organic pathology.
INFORMATION IS PROVIDED STRICTLY
FOR HEALTH PROFESSIONALS

Janine - official* instructions for use

*registered by the Ministry of Health of the Russian Federation (according to grls.rosminzdrav.ru)

JEANINE ®

Registration number:

P N013757/01

Tradename

Dosage form

Compound

Each dragee contains:

Active ingredients: ethinyl estradiol 0.03 mg and dienogest 2.0 mg.

Excipients: lactose monohydrate, potato starch, gelatin, talc, magnesium stearate, sucrose, dextrose (glucose syrup), macrogol 35000, calcium carbonate, povidone K25, titanium dioxide (E 171), carnauba wax.

Description

White smooth dragees.

Pharmacotherapeutic group

Combined contraceptive (estrogen + gestagen)

ATX code G 03 AA

Pharmacological properties

Pharmacodynamics

Zhanine is a low-dose monophasic oral combined estrogen-progestogen contraceptive drug.

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

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

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

In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful menstruation is less frequent, 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 and ovarian cancer.

Pharmacokinetics

· Dienogest

Absorption. When taken orally, dienogest is rapidly and completely absorbed, its maximum serum concentration of 51 ng/ml is achieved after approximately 2.5 hours. Bioavailability is approximately 96%.

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

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

Excretion. The half-life is about 8.5-10.8 hours. A small amount in unchanged form is excreted by the kidneys in the form of metabolites (half-life - 14.4 hours), which are excreted by the kidneys and through the gastrointestinal tract in a ratio of approximately 3:1.

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

· Ethinyl estradiol

Absorption. After oral administration, ethinyl estradiol is rapidly and completely absorbed. The maximum serum concentration of approximately 67 pg/ml is achieved within 1.5-4 hours. During absorption and first passage through the liver, ethinyl estradiol is metabolized, resulting in its oral bioavailability averaging about 44%.

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

Metabolism. Ethinyl estradiol undergoes presystemic conjugation, both in the mucosa of the small intestine and in the liver. The main route of metabolism is aromatic hydroxylation. The clearance rate from blood plasma is 2.3 - 7 ml/min/kg. Excretion. The decrease in the concentration of ethinyl estradiol in the blood serum is biphasic; the first phase is characterized by a half-life of about 1 hour, the second - 10-20 hours. It is not excreted from the body unchanged. Ethinyl estradiol metabolites are excreted in urine and bile in a ratio of 4:6 with a half-life of about 24 hours.
Equilibrium concentration. Equilibrium concentration is achieved during the second half of the treatment cycle.

Indications for use

Contraception.

Contraindications

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

· Thrombosis (venous and arterial) and thromboembolism currently or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), cerebrovascular disorders.
· Conditions preceding thrombosis (including transient ischemic attacks, angina) currently or in history.
· Migraine with focal neurological symptoms currently or in history.
· Diabetes mellitus with vascular complications.
· Multiple or severe risk factors for venous or arterial thrombosis, including complicated lesions of the heart valve apparatus, atrial fibrillation, cerebral vascular disease or coronary artery disease; uncontrolled arterial hypertension, major surgery with prolonged immobilization, smoking over the age of 35 years.
· Pancreatitis with severe hypertriglyceridemia, currently or in history.
· Liver failure and severe liver disease (until liver tests normalize).
· Liver tumors (benign or malignant) currently or in history.
· Identified or suspected hormone-dependent malignant diseases (including genital organs or mammary glands).
· Bleeding from the vagina of unknown origin.
· Pregnancy or suspicion of it.
· Breastfeeding period.
· Hypersensitivity to any of the components of the drug Janine.

With caution

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

· Risk factors for the development of thrombosis and thromboembolism: smoking; obesity; dyslipoproteinemia, arterial hypertension; migraine; heart valve defects; prolonged immobilization, serious surgical interventions, extensive trauma; hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the immediate relatives)
· 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 diseases
· Diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (for example, jaundice, cholestasis, gallbladder disease, otosclerosis with hearing impairment, porphyria, herpes of pregnancy, Sydenham's chorea)
· Postpartum period

Pregnancy and lactation
Janine should not be used during pregnancy and breastfeeding. If pregnancy is detected while taking the drug Janine, it should be discontinued immediately and consult a doctor. However, extensive epidemiological studies have not revealed an increased risk of developmental defects in children born to women who received sex hormones before pregnancy or when taking sex hormones inadvertently in early pregnancy.
Taking combined oral contraceptives may reduce the amount of breast milk and change its composition, so their use is not recommended until you stop breastfeeding.

Directions for use and doses

When and how to take pills
The calendar pack contains 21 tablets. In the package, each pill is marked with the day of the week on which it should be taken. Take the tablets orally at the same time every day with a small amount of water. Follow the direction of the arrow until all 21 tablets have been taken. You do not take the drug for the next 7 days. Menstruation (withdrawal bleeding) should begin within these 7 days. It usually starts 2-3 days after taking Janine’s last pill. After a 7-day break, start taking the tablets from the next pack, even if the bleeding has not stopped yet. This means that you will always start a new pack on the same day of the week, and that your withdrawal bleed will occur on approximately the same day of the week each month.
Reception of the first package of Janine
· When no hormonal contraceptive was used in the previous month
Start taking Janine on the first day of the cycle, that is, on the first day of menstrual bleeding. Take the pill that is marked with the corresponding day of the week. Then take the pills in order. You can also start taking it on days 2-5 of the menstrual cycle, but in this case you must use an additional barrier method of contraception (condom) during the first 7 days of taking the tablets from the first package.
· When switching from other combined oral contraceptives, vaginal ring or contraceptive patch
You can start taking Janine the day after you take the last tablet of the current package of combined oral contraceptive (ie, without taking a break). If the current package contains 28 tablets, you can start taking Janine the day after taking the last active tablet. If you are not sure which pill it is, ask your doctor. You can also start taking it later, but in no case later than the next day after the usual break in taking (for drugs containing 21 tablets) or after taking the last inactive tablet (for drugs containing 28 tablets in a package).
Taking Janine should begin on the day the vaginal ring or patch is removed, but no later than the day when a new ring is to be inserted or a new patch is applied.
· When switching from oral contraceptives containing only gestagen (mini-pills)
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 from a progestogen-releasing intrauterine contraceptive (Mirena)
Start taking Janine on the day your next injection is due or on the day your implant or intrauterine device is removed. During the first 7 days of taking the pills, you must also use an additional barrier method of contraception.
· After childbirth
If you have just given birth, your doctor may recommend that you wait until the end of your first normal menstrual cycle before starting Janine. Sometimes, on the recommendation of a doctor, it is possible to start taking the drug earlier.
· After spontaneous miscarriage or abortion in the first trimester of pregnancy
Check with your doctor. It is usually recommended to start taking it immediately.
Taking missed pills
· If the delay in taking the next pill is less than 12 hours, the contraceptive effect of Zhanine remains. Take the pill as soon as you remember. Take your next pill at the usual time.
· If the delay in taking the pill is more than 12 hours, contraceptive protection may be reduced. The more pills in a row you miss, and the closer this skip is to the start of the dose or to the end of the dose, the higher the risk of pregnancy.
In this case, you can be guided by the following rules:
· Forgot more than one tablet from the package Consult your doctor.
· One tablet was missed in the first week of taking the drug
Take the missed pill as soon as you remember (even if this means taking two pills at the same time). Take your next pill at the usual time. Additionally, use a barrier method of contraception for the next 7 days. If sexual intercourse took place within a week before missing the pills, the possibility of pregnancy must be taken into account. Consult your doctor immediately.
· One tablet was missed in the second week of taking the drug
Take the missed pill as soon as you remember (even if this means taking two pills at the same time). Take your next pill at the usual time. If you have taken the pill correctly during the 7 days preceding the first missed pill, the contraceptive effect of Janine is maintained and you do not need to use additional contraceptive measures. Otherwise, as well as if you miss two or more tablets, you must additionally use barrier methods of contraception for 7 days.
· One tablet was missed during the third week of taking the drug
If all tablets have been taken correctly during the 7 days preceding the first missed tablet, there is no need to use additional contraceptive methods. You can stick with either of the following two options
1. Take the missed pill as soon as you remember (even if this means taking two pills at the same time). Take your next pill at the usual time. Start the next pack immediately after finishing taking the pills from the current pack, so there is no break between packs. Withdrawal bleeding is unlikely until the tablets from the second package are finished, but spotting or breakthrough bleeding may occur on the days you take the drug.
2. Stop taking the tablets from the current package, take a break of 7 days or less (including the day you skipped the tablets) and then start taking the tablets from a new package.

Using this regimen, you can always start taking the tablets from the next package on the day of the week when you usually do it.
If after a break in taking the tablets you do not get your expected menstruation, you may be pregnant. Consult your doctor before you start taking pills from a new package.
In situations where you are advised to stop taking a combined oral contraceptive, or when the reliability of COCs may be reduced, you should abstain from sexual intercourse or use a non-hormonal method of contraception (such as a condom or other barrier methods). Rhythmic or temperature methods should not be used. These methods may be unreliable because... Taking COCs leads to changes in temperature and cervical mucus.
Recommendations in case of vomiting and diarrhea
If you have had vomiting or diarrhea (stomach upset) within 4 hours of taking Janine, the active ingredients may not have been completely absorbed. This situation is similar to skipping a drug dose. Therefore, follow the instructions for missed pills.
Delaying the onset of menstruation
You can delay the onset of menstruation if you start taking the tablets from the next package of Janine immediately after finishing the current package. You can continue taking the tablets from this pack for as long as you wish, or until the pack runs out. If you want your period to start, stop taking the pills. While taking Janine from the second package, spotting or bleeding may occur on the days of taking the pills. Start the next pack after the usual 7-day break.
Changing the day your period starts
If you take the pills as recommended, you will have your period on about the same day every 4 weeks. If you want to change it, shorten (but do not lengthen) the period of time free from taking pills. For example, if your menstrual cycle usually starts on Friday, but in the future you want it to start on Tuesday (3 days earlier), the next pack should start 3 days earlier than usual. If the break from taking pills is very short (for example, 3 days or less), menstruation may not occur during the break. In this case, bleeding or spotting may occur while taking the pills from the next package.

Additional information for special categories of patients
Children and teenagers
The drug Zhanine is indicated only after the onset of menarche.
Elderly patients
Not applicable. The drug Zhanine is not indicated after menopause.
Patients with liver disorders
Zhanine is contraindicated in women with severe liver disease until liver function tests return to normal. See also section "Contraindications".
Patients with kidney problems
Zhanine has not been specifically studied in patients with renal impairment. Available data do not suggest changes in treatment in these patients.

Side effect

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, other undesirable effects may occur, although their occurrence is not necessary in all patients.
Serious unwanted effects:
See sections "With caution" and "Special instructions". Please read these sections carefully and if you experience any unwanted effects, including serious drug-related reactions, consult your doctor.
Other undesirable effects identified during the study of the drug Janine:
Common undesirable effects (more than 1/100 and less than 1/10):
- headache;
- pain in the mammary glands, including discomfort in the mammary glands and engorgement of the mammary glands.
Infrequent adverse effects (more than 1/1000 and less than 1/100):
- vaginitis/vulvovaginitis (inflammation of the female genital organs);
- vaginal candidiasis (thrush) or other fungal vulvovaginal infections;
- increased appetite;
- decreased mood;
- dizziness;
- migraine;
- high or low blood pressure;
- abdominal pain (including pain in the upper and lower abdomen, discomfort/bloating);
- nausea, vomiting or diarrhea;
- acne;
- alopecia (hair loss);
- rash (including macular rash);
- itching (sometimes itching of the whole body);
Abnormal menstruation, including menorrhagia (heavy periods), hypomenorrhea (scanty periods), oligomenorrhea (irregular periods), and amenorrhea (absence of periods);
- intermenstrual bleeding, including vaginal bleeding and metrorrhagia (irregular bleeding between periods);
- an increase in the size of the mammary glands, including swelling and distension of the mammary glands;
- swelling of the mammary glands;
- dysmenorrhea (painful menstruation);
- vaginal discharge;
- ovarian cysts;
- pain in the pelvic area;
- fatigue, including asthenia (weakness) and malaise (fatigue, including weakness and general poor health);
- weight change (increase or decrease).
Rare undesirable effects (more than 1/10000 and less than 1/1000):
- adnexitis (inflammation of the fallopian (uterine) tubes and ovaries);
- urinary tract infections;
- cystitis (inflammation of the bladder);
- mastitis (inflammation of the mammary gland);
- cervicitis (inflammation of the cervix);
- candidiasis or other fungal infections;
- herpetic lesions of the oral cavity;
- flu;
- bronchitis;
- sinusitis;
- upper respiratory tract infections;
- viral infection;
- uterine fibroids (benign tumors in the uterus);
- breast lipoma (benign tumors of adipose tissue);
- anemia;
- hypersensitivity (allergic reactions);
- virilism (development of male secondary sexual characteristics);
- anorexia (severe loss of appetite);
- depression;
- mental disorders;
- insomnia;
- sleep disorders;
- aggression;
- ischemic stroke (reduced or suddenly stopped blood supply to part of the brain);
- cerebrovascular disorders (disorders of the blood flow system to the brain);
- dystonia (muscle tension (contractures) caused by an uncomfortable posture);
- dryness or irritation of the mucous membrane of the eyes;
- oscillopsia (impaired visual clarity, illusion of motionless objects oscillating) or other visual disturbances;
- sudden hearing loss;
- noise in ears;
- dizziness;
- hearing impairment;
- cardiovascular disorders (impaired blood supply to the heart);
- tachycardia (rapid heartbeat);
- thrombosis (formation of a blood clot in blood vessels);
- pulmonary embolism (acute blockage of the branches of the pulmonary artery by blood clots);
- thrombophlebitis (inflammation of the venous wall with the formation of a blood clot in the lumen of the vein);
- increase in diastolic pressure (the minimum blood pressure indicator, corresponds to the pressure in the arterial vessels between heartbeats);
- orthostatic circular dystonia (feeling of dizziness, weakness or fainting when changing body position from sitting or lying to vertical);
- tides;
- phlebeurysm;
- vein pathology, pain in the vein area;
- bronchial asthma;
- hyperventilation;
- gastritis;
- enteritis;
- dyspepsia (digestion);
- skin reactions;
- skin pathology, including allergic dermatitis, neurodermatitis/atopic dermatitis, eczema, psoriasis;
- hyperhidrosis (excessive sweating);
- Chloasma (golden-brown pigment spots, so-called “pregnancy spots”, mainly on the face);
- pigmentation disorder/hyperpigmentation;
- seborrhea (oily skin);
- dandruff;
- hirsutism (male pattern hair growth);
- Orange peel;
- spider veins (expansion of subcutaneous vessels in the form of a mesh with a central red spot);
- back pain;
- discomfort in the muscles and bones of the skeleton;
- myalgia (muscle pain);
- pain in the arms and legs;
- cervical dysplasia (abnormal changes in the epithelium of the cervix);
- pain in the area of ​​the uterine appendages or cysts of the uterine appendages (ovaries and fallopian (fallopian) tubes);
- breast cysts;
- fibrocystic mastopathy (benign neoplasms in the mammary glands);
- dyspareunia (pain during sexual intercourse);
- galactorrhea (milk secretion);
- menstrual irregularities;
- chest pain;
- peripheral edema;
- flu-like conditions;
- inflammation.
Adverse effects identified during the study of the drug, the frequency of which is unknown: mood changes, increased or decreased libido, contact lens intolerance, urticaria, skin disorders (such as erythema nodosum or multiforme), breast discharge, fluid retention.
If you have hereditary angioedema, medicines containing certain female sex hormones (estrogens) may worsen symptoms (see Precautions section).
If any of the side effects become serious, or if you notice any side effects not listed in the instructions, please tell your doctor or pharmacist.
Overdose
No serious problems have been reported with a single dose of a large number of Janine tablets.
Symptoms that may occur in case of overdose: nausea, vomiting, spotting or vaginal bleeding.
In case of overdose, consult a doctor.

Interaction with other drugs

Some medicines may reduce the effectiveness of Janine. These include drugs used to treat epilepsy (eg, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate), tuberculosis (eg, rifampicin, rifabutin), and HIV infection (eg, ritonavir, nevirapine); antibiotics to treat certain other infectious diseases (eg penicillin, tetracyclines, griseofulvin); and St. John's wort medicines (used mainly to treat low mood).
Oral combination contraceptives may affect the metabolism of other drugs (eg, cyclosporine and lamotrigine).
Some drugs may affect the metabolism of the active components of the drug Janine. These include antifungals (eg, ketoconazole), H2-blockers to treat gastric and duodenal ulcers (eg, cimetidine), some drugs to treat hypertension (eg, verapamil, diltiazem), antibiotics to treat bacterial infections (macrolides, for example, erythromycin), antidepressants, grapefruit juice.
Always tell your doctor who prescribes Janine what medications you are already taking. Also tell any doctor or dentist who prescribes other drugs, or the pharmacist who sells drugs at your pharmacy, that you are taking Janine.
In some cases, your doctor may recommend that you additionally use a barrier method of contraception (condom).

special instructions

The following warnings regarding the use of other combined oral contraceptives should also be taken into account when using Janine.
Thrombosis
Thrombosis is the formation of a blood clot (thrombus) that can block a blood vessel. When a blood clot breaks off, thromboembolism develops. Sometimes thrombosis develops in the deep veins of the legs (deep vein thrombosis), vessels of the heart (myocardial infarction), brain (stroke), and extremely rarely in the vessels of other organs.
The risk of deep vein thrombosis in women taking combined oral contraceptives is higher than in those not using them, but not as high as during pregnancy.
The risk of developing thrombosis increases with age and also increases with the number of cigarettes smoked. When using Janine, you should stop smoking, especially if you are over 35 years old.
The risk of deep vein thrombosis temporarily increases during surgery or prolonged immobilization (immobilization), for example, when applying a cast to the leg, prolonged bed rest. If you are planning surgery or hospitalization, tell your doctor in advance that you are taking combined oral contraceptives. Your doctor may advise you to stop using the drug (if you are planning to have surgery, at least four weeks before it) and not to restart it for two weeks after your immobilization ends.
If your blood pressure is high, your doctor may recommend that you stop taking combined oral contraceptives.
Tumors
The connection between taking combined oral contraceptives and breast cancer has not been proven, although it is detected slightly more often in women taking combined oral contraceptives than in women of the same age who are not using them. This difference may be due to the fact that women are screened more often when taking the drug and therefore breast cancer is detected at an early stage.
In rare cases, during the use of sex steroids, the development of benign, and in extremely rare cases, malignant liver tumors, which can lead to life-threatening intra-abdominal bleeding, has been observed. The connection with the use of drugs has not been proven. If you suddenly experience severe abdominal pain, consult your doctor immediately.
The most significant risk factor for developing cervical cancer is persistent papilloma viral infection. Cervical cancer was detected slightly more often in women using combined oral contraceptives for a long period of time. The connection with the use of combined oral contraceptives has not been proven. This may be due to more frequent gynecological examinations to detect cervical diseases or to characteristics of sexual behavior (less frequent use of barrier methods of contraception).
Reduced efficiency
The effectiveness of combined oral contraceptives may be reduced in the following cases: missed pills, vomiting and diarrhea, or as a result of drug interactions.
Women with a tendency to chloasma while taking combined oral contraceptives, prolonged exposure to the sun and exposure to ultraviolet radiation should be avoided.
· In women with hereditary forms of angioedema exogenous estrogens may cause or worsen symptoms of angioedema

Intermenstrual bleeding
As with other combined oral contraceptives, when taking Janine during the first few months, irregular vaginal bleeding (spotting or breakthrough bleeding) may occur between menstrual periods. Use hygiene products and continue taking your tablets as usual. Intermenstrual vaginal bleeding usually stops as your body adapts to Janine (usually after 3 cycles of taking the pills). If they continue, become severe, or return after stopping, consult your doctor.
Lack of regular menstruation
If you took all the pills correctly and did not vomit while taking the pills or taking other medications at the same time, then the likelihood of pregnancy is low. Continue taking Janine as usual.
If you miss two periods in a row, consult your doctor immediately. Do not start taking tablets from the next pack until your doctor rules out pregnancy.

When to consult a doctor
Regular checkups
If you are taking Janine, your doctor will tell you to have regular checkups, at least once a year.
Consult your doctor as soon as possible:

• if you have any health changes, especially any of the conditions listed in this leaflet (see also Contraindications and Caution);
• with local compaction in the mammary gland; if you are going to use other medications (see also “Interactions with other medications”);
• if long-term immobility is expected (for example, the leg is in a cast), hospitalization or surgery is planned (check with your doctor at least 4 to 6 weeks in advance);
• if unusual heavy vaginal bleeding occurs;
• if you forgot to take a pill in the first week of taking the package and had sexual intercourse seven days before;
• you have missed your next period twice in a row or you suspect that you are pregnant (do not start taking the next pack until you have consulted your doctor).

Stop taking the pills and consult your doctor immediately if you notice possible signs of thrombosis: new: unusual cough; unusually severe pain behind the sternum, radiating to the left arm; unexpected shortness of breath; unusual, severe or prolonged headache or migraine attack; partial or complete loss of vision or double vision; slurred speech; sudden changes in hearing, smell, or taste; dizziness or fainting; weakness or loss of sensation in any part of the body; severe abdominal pain; severe leg pain or sudden swelling of either leg.

When taking Zhanine birth control pills, women may experience spotting. This is an adaptation of the body to taking the drug. According to statistics, in 40-45% of women they disappear within three months. If brown discharge occurs for longer than 6 months while taking Janine, you should consult a doctor to change the drug.

"Janine": definition

"Zhanine" is an oral contraceptive, the main effect of which is through inhibition of the anterior pituitary gland and a decrease in the production of gonadotropic hormones FSH and LH. This suppresses ovulation in the ovary and prevents the possibility of conception. The active components in “Janine” include:

• ethinyl estradiol;
• dienogest (progesterone drug).

"Janine" and menstruation

During puberty, the synthesis of GnRH by the hypothalamus increases. This increases the production of gonadotropic hormones by the adenohypophysis: FSH and LH. Under the influence of FSH, the follicle matures. This process is caused by FSH receptors on the surface of the follicle. During one cycle, on average, 10-15 follicles can respond to FSH, since they have enough receptors for this, but, as a rule, only one matures and it produces insulin-like growth factor, which stimulates it to further maturation.

The remaining follicles undergo atresia. Under the influence of FSH, the follicle synthesizes estrogens: they prepare the body for fertilization, thin the vaginal mucus, creating optimal conditions for sexual intercourse and promoting sperm survival. A high content of estradiol promotes the release of gonadoliberins and an increase in the levels of LH and FSH. At the same time, the production of follicular fluid increases, causing the Graafian vesicle to burst and the egg to come out. Ovulation is ensured mainly by LH, the peak concentration of which is observed one day before ovulation. There is a trend between the hormones FSH and LH: FSH begins to rise earlier and its peak concentration occurs earlier than for LH. The released egg goes first into the fallopian tube and then into the uterus.

At the site of the burst follicle, a menstrual corpus luteum is formed, producing large amounts of progesterone, as well as oxytocin, relaxin, prostaglandin, and inhibin. Progesterone suppresses the synthesis of FSH, but activates the release of prolactoliberin by the hypothalamus, which promotes the release of prolactin by the pituitary gland. Progesterone maintains high LH production. If pregnancy occurs, fetal chorionic gonadotropin supports the production of progesterone by the corpus luteum until the placenta develops, which will become the main source of progesterone from the second trimester of pregnancy. High levels of progesterone and prolactin inhibit follicle maturation.

If fertilization of the egg does not take place, then hCG does not support the production of progesterone by the corpus luteum, and it undergoes reduction. As a consequence, a drop in progesterone leads to a decrease in prolactin concentration. This hormonal background removes the inhibition from the pituitary gland, and it again begins to increase the levels of FSH and LH. This leads to a new start of the cycle.

In parallel with hormonal changes, cyclic processes occur in the endometrium of the uterus, where four stages are distinguished:

1. Desquamation - against the background of reduction of the corpus luteum, ischemia of the spiral vessels of the uterus, vascular thrombosis and bleeding occurs, leading to rejection of the overgrown layer of the endometrium.
2. Regeneration – healing occurs after bleeding.
3. Proliferation - under the influence of high concentrations of estrogen, the basal layer of the endometrium actively proliferates.
4. Secretion – accumulation of glycogen and glucosamine occurs.

Periodically in the life of every woman, anovulatory cycles are observed, when ovulation does not occur and only the follicular phase with endometrial proliferation is observed. After reduction of the follicle, menstrual-like bleeding occurs.

Selection of contraceptives

Combined oral contraceptives (COCs) provide contraception by inhibiting the hypothalamic-pituitary-ovarian axis, follicular growth and ovulation. The main role of the progestogen component of COCs is to prevent ovulation through a negative feedback mechanism, which leads to a decrease in luteinizing hormone (LH). The action of progesterone also reduces the receptivity of the cervix and reduces the thickness of the endometrium. Estrogens contribute to the contraceptive mechanism of COCs by inhibiting both follicle-stimulating hormone (FSH) and LH. FSH inhibition is related to the dose and duration of estrogen. Most COCs do not completely suppress the development of ovarian follicles. The likely reason for this is complete clearance of the drug during the 7-day break.

In a normal menstrual cycle, the selection of the dominant follicle occurs in the first 7 days. These physiologically selected dominant follicles secrete estradiol, which stimulates their maturation and inhibits the growth of subordinate follicles. Dominant follicles (≥ 10 mm) have the greatest potential for further development and ovulation. Among women using COCs, loss of endocrine suppression during the 7-day break is associated with follicular development. Research data indicate that 86% of dominant follicles appear during a 7-day break, regardless of the drug regimen. Women who begin using COCs after 7 days of follicular growth may already have a dominant follicle that may continue to develop and possibly ovulate.

Modern COCs may also provide incomplete ovarian suppression due to reduced estrogen dosage. Early COCs contained doses of estrogen up to 150 mcg. Although lower doses of ethinyl estradiol in modern COCs (≤ 35 mcg) improve safety and tolerability, accumulating evidence suggests that lowering the dose of ethinyl estradiol may reduce the degree of hypothalamic-pituitary-ovarian axis suppression by oral contraceptives during the 7-day break. The lower the ethinyl estradiol level, the sooner complete clearance of the drug will occur during the break. To achieve stable levels of progestogen and estrogen after a break, obese women may need up to 12 days. In this case, follicular development can continue throughout the first week of taking the drug. Pharmacokinetics in obese women may be very different from those in women of normal weight.

Recommendations for taking "Zhanina"

“Janine” is a combined oral contraceptive and its action is determined by the general principles of action of similar drugs: that is, gonadotropins are suppressed in the pituitary gland, which inhibits the development of the follicle and prevents ovulation.

Often, “Janine” is used according to the 21/7 scheme. That is, it is taken daily for 21 days, and then a week is taken off, during which menstrual-like bleeding occurs. The start of taking “Zhanine” coincides with the first day of menstruation. A delay of up to 2-5 days is allowed, but additional contraceptives are used.

Highlights against the background of “Janine”

Menstruation is defined as brown discharge when taking Janine. This is due to the fact that there are no physiological cyclic changes in the uterus, the proliferative and secretory phases of changes in the endometrium are suppressed. But usually, the discharge when taking Janine according to the 21/7 regimen may be red, although the abundance of this discharge varies. Dysmenorrhea may disappear, menstruation may become painless due to the small amount of endometrial rejection.

A dosage regimen is often practiced when, after finishing one box of the drug, they immediately begin taking another. If a woman is involved in professional sports, then from time to time she needs to move the start of her period. To do this, after finishing the box of “Janina,” you can take tablets from the next pack in accordance with the number of days by which you need to delay the onset of bleeding. With long-term use of the drug "Zhanine", the discharge is less abundant and painful; spotting may be observed when taking "Zanine".

If you miss a pill, you should take it as soon as possible, and take the next pill at regular hours, even if you have to take it along with the “missed” pill.

63 days scheme

“Janine” is used as a means of contraception, but sometimes it is recommended to drink it, for example, to treat adenomyosis or endometriosis. And at the same time, long-term use of “Janine” is often indicated according to the scheme of 63 days continuously. Quite often, a woman who has been prescribed to take “Janine” does not feel the best: vaginal discharge may be smeared with blood or dark brown secretions, body weight may increase, swelling of the extremities may occur, and tinnitus may appear. It all depends on individual sensitivity to the drug and sometimes it has to be discontinued.

Among the positive effects of “Zhanine”, it is worth noting the minimal risk of developing endometrial and ovarian cancer, reducing the pain of menstruation, reducing the duration of bleeding, eliminating signs of iron deficiency anemia, the drug has antiandrogenic activity, improves the lipid profile, which is expressed in an increase in the proportion of high-density lipoproteins.

Cancellation of "Janine"

"Zhanine" should not be taken if a woman has a tendency to thrombosis, since taking this drug increases the frequency of deep vein thrombosis and pulmonary embolism, as well as the frequency of ischemic strokes and heart attacks.

In case of liver pathology, “Janine” is also unfavorable; it increases cholelithiasis, gastritis, enteritis, nausea, and dyspepsia. May cause headache, tinnitus, hearing loss, and dystonia. Possible dizziness, decreased mood, increased appetite.

"Janine" can suppress the local immunity of the vagina, contributing to the development of candidiasis and vulvovaginitis. Virilization, enlargement of the mammary glands, and the formation of cysts in various organs of the reproductive system are possible.

This drug should not be taken for diabetes mellitus complicated by diabetic angiopathy. It is not prescribed for liver diseases (until liver tests are normalized). An absolute contraindication is pancreatitis, which is combined with hypertriglyceridemia. "Janine" is not prescribed during lactation, since sex hormones can pass into breast milk.

Like every drug, Janine has its own range of contraindications. Given that this medication interferes with the pituitary gland, it is expected that it may cause significant changes in metabolism and overall hormonal regulation. Its appointment should be made after a thorough history taking and examination of the woman. Indications for use must be clearly justified. This approach will prevent unwanted complications and choose the optimal method of therapy.