Janine candles. Birth control pills Janine, use, side effects

The instructions for use of the drug Zhanine for endometriosis indicate that it is effective as a prophylactic agent that prevents the development of pathology.

The instructions for use of the drug Zhanine state that it is an oral contraceptive that suppresses ovulation in endometriosis. Janine affects the properties of the endometrium, and therefore it is used to prevent the spread of endometriosis and improve the health of women with this disease.

Endocrinologist's advice:“I can only recommend one effective and safe remedy for normalization hormonal levels and diseases associated with its violation, of course...”

What is endometriosis

Endometriosis – This is the growth of the endometrium, in which inner layer the uterus goes deep into its walls. When the disease extends beyond the organ, adenomyosis begins.

With this pathology, uterine tissue in most cases is found in:

• bladder;
• fallopian tubes;
• ovaries;
• abdominal cavity;
• vagina.

If the inner layer of the uterus thickens, this indicates endometrial hyperplasia.

Symptoms of endometriosis

You should think about the presence of endometriosis if you notice the following signs:

• painful menstruation;
• irregular cycle;
• heavy bleeding due to endometriosis;
• pain during bowel movements and urination.

What treats endometriosis? One of the most effective means turned out to be a contraceptive Janine, which is used in the composition complex therapy endometriosis.

Composition of Janine

According to the instructions, the drug for endometriosis contains 2 components:

• estrogen in the form of ethinyl estradiol, in an amount of 30 mcg;
• gestagen in the form of dienogest at a dose of 2 mg.

The instructions for use say that one tablet of Janine contains microdoses of hormones, and therefore the drug is one of the most safe contraceptives and is the best treatment for endometriosis.

Properties of the drug

Dienogest interferes with the production of testosterone and prevents pathological cell proliferation. In combination with ethinyl estradiol, it regulates the growth and development of the follicle. Thus, according to the instructions for use, the drug Janine restores her menstrual cycle , eliminating uterine bleeding.

Janine is prophylactic, inhibiting the occurrence of relapses of endometriosis.

In addition, Janine has the following influences:

• suppresses ovulation;
• due to thickening of cervical mucus, it impairs the patency of the cervix for sperm;
• regulates the menstrual cycle;
• eliminates pain during menstruation;
• reduces the amount of androgens in the blood.

How does the drug work on endometriosis?

The instructions for use state that the drug Janine prevents hormonal surges , preventing ovulation. If there is no ovulation, then menstruation does not occur. The disease endometriosis stops progressing.

A similar condition occurs in the body during pregnancy and lactation. It is induced artificially so that the endometrium degrades.

Indications for use

According to the instructions for use, Janine is prescribed in the following cases:

• when endometriosis symptoms, not confirmed by laboratory research;
• at mild form endometriosis;
• for treatment ovarian cysts;
• diagnosed adenomyosis;
• elimination of pain in the pelvis and lower abdomen;
• prevention development of anemia due to heavy menstruation;
• as a preventive measure for recurrence of the disease after surgical removal external endometriosis;
• recovery fertility.

Contraindications

Also, according to the instructions for use, Janine is not prescribed in the following situations:

• arrhythmia;
• diabetes;
• pathologies of the heart and blood vessels, leading to their blockage;
• angina pectoris;
• obesity;
• thyroid pathology;
• disorders of the liver, kidneys and pancreas;
• breast-feeding;
• malignant formations;
• pregnancy;
• long-term rehabilitation after surgery;
• excessive sensitivity to ingredients.

With caution, Janine is prescribed for endometriosis in the following conditions:

• with a tendency to blood clots;
• inflammation Gastrointestinal tract, ulcer;
• increased content triglycerides;
• diseases discovered or aggravated during pregnancy (cholestasis, jaundice, herpes, gallbladder disease, pathological bone growth in inner ear, porphyria, rheumatism);
• recent birth.

How to take Janine correctly

According to the instructions for use, Janine should be prescribed by a doctor after an appropriate examination of the woman in order to exclude the presence of contraindications. The diseases endometriosis and endometrial hyperplasia are treated using the same dosage regimen.

Reception modes: table

Treatment regimen

According to the instructions for use, Janine is drunk daily. The duration of taking Janine according to the instructions for use is 63–84 days. When is the best time to start treatment? You need to take the Janine tablet for the first time on the first day menstrual cycle according to the instructions.

Important! Janine is used for endometriosis 1 capsule at the same time according to the instructions. It is necessary to monitor the timeliness of taking Zhanine’s medication.

After completing the course of treatment with Zhanin, follow the instructions for use pause for 4–7 days, after which taking the tablets is resumed according to the scheme described above.

Treatment of endometriosis with Janine according to the instructions lasts minimum 6 months. With the help of Zhanine, menstruation stops, which occurs during the break between taking pills.

Discharge begins 2-3 days after stopping the use of Janine according to the instructions, and can be copious or scanty. After re-taking Janine according to the instructions for use, menstruation stops.

For endometriosis, another way to use Janine is possible, always following the instructions. It is called continuous and with this method Janine can be taken for a long time for endometriosis.

During treatment of endometriosis, you must take Janine according to the instructions: 1 tablet per day without a break. Duration of therapy is 6 months. This method used for severe forms of endometriosis.

How to drink Janine for endometriosis if you accidentally missed a dose according to the instructions? A woman should not worry if she is late taking Janine's tablet less than 12 hours. During this time, the contraceptive properties of the pill do not disappear. In such cases, Janine is taken according to instructions as early as possible.

If more than 12 hours have passed since the delay in taking Janine for endometriosis, the contraceptive effectiveness of the drug is reduced.

The possibility of pregnancy increases the more you miss taking pills.

Consultation with a gynecologist is necessary if:

• missed more than 1 tablet;
• missed taking Janine for endometriosis in the first week.

Side effects

Taking any hormonal drug can be accompanied by side effects, and Janine with endometriosis is no exception.

When taking Zhanine for endometriosis, patients complain of:

• scanty periods;
• vaginitis;
• hair loss;
• depression;
• bloating;
• seborrhea;
• insomnia;
• excessive sweating;
• pain in the mammary glands;
• increased appetite;
• noise in ears;
• weight gain;
• hair growth by male type.

What complications are possible when taking Janine?

According to the instructions for use, the drug Janine can cause the following complications:

1. If you have an allergy, a rash, swelling, and redness appears on the skin. Patients note severe itching. If, during periods of stopping taking Zhanine for endometriosis, heavy periods occur, it is possible Iron-deficiency anemia .
2. If menstruation does not begin when Zhanine is discontinued for endometriosis, pregnancy must be excluded. Of course, you cannot conceive a child while taking Zhanine and having endometriosis. However, this is possible if you miss regularly taking the tablets according to the instructions for use.
3. During the break between Janine's courses, there is a possibility increasing testosterone levels . This leads to acne and hair loss.
4. The woman becomes irritable aggression .
5. There is a risk of benign tumors appearing in the uterus and mammary glands.

Video

When passing treatment course Zhanina for endometriosis according to instructions for use It is not recommended to be in direct sunlight or visit a solarium.

Use of the medicine Zhanina according to the instructions for endometriosis may be accompanied by spotting and lead to uterine bleeding. As a rule, this happens at the very beginning of therapy with Janine and lasts 3 cycles.

If there is a need to be treated with Janine according to the instructions for use for endometriosis for longer than 6 months, you must undergo medical examination. Also, before using Zhanine according to the instructions, you should consult with your doctor if the woman is planning any surgery or will be immobile for a long period of time (for example, with fractures).

The need to take Zhanine according to the instructions for use for endometriosis is questioned if a woman complains of:

• absence of menstruation;
• swelling of the limbs;
• dizziness;
• in the presence of painful lump in the mammary glands;
• if the woman has not taken the drug for more than 7 days.

What happens in case of an overdose

If an overdose of Zhanine occurs according to the instructions for use for endometriosis, the woman will experience:

• vomit;
• bleeding outside the menstrual cycle;
• nausea;
• meager bloody issues.

Symptoms of overdose are eliminated symptomatically; there is no antidote to Janine.

If a woman needs treatment with any medications at the same time as Janine, a doctor's consultation is required. Some drugs (anticoagulants, barbiturates, antibiotics) reduce the activity of Janine. Therefore, there is a possibility of intermenstrual bleeding.

Medicines that reduce the effect of Janine in endometriosis include:

• antibiotics tetracycline, penicillin, griseofulvin;
• antituberculosis drugs (rifabutin, ethambutol, rifampicin);
• antiepileptic (carbamazepine, phenytoin, topiramate, felbamate, oxcarbazepine);
• medications prescribed for HIV.

According to the instructions for use in endometriosis, Zhanine’s metabolism is affected by:

• macrolide antibiotics;
• drugs to eliminate ulcers (cimetidine);
• antidepressants;
• medications to treat hypertension.

When visiting a dentist, you must notify the doctor about the appointment. oral contraceptives.

Janine – contraceptive, if the instructions for taking the drug are followed, pregnancy is excluded. Janine, according to the instructions for use for endometriosis, does not have a negative effect on a woman’s ability to bear a child, in some situations it even restores it. After completing the course of treatment, you will be able to get pregnant without any problems.

The menstrual cycle after stopping the use of the drug is restored within a few months. If pregnancy does not occur, an examination by a doctor is necessary to determine the cause of infertility. This has nothing to do with Janine’s use of contraception.

If this does not happen, you need to contact a gynecologist and undergo an examination to find out and eliminate the source of infertility.

Advantages and disadvantages

Surveys of doctors about the pros and cons of the contraceptive Janine in the treatment of endometriosis showed that the advantages of the drug are:

1. This is the only contraceptive with the progesterone component Dienogest that is recommended for the treatment of endometriosis.
2. Antiandrogenic effect (improves skin and hair condition).
3. 85% of patients were able to get rid of endometriosis with the help of Zhanine.
4. Rare relapses of endometriosis disease, only 7%.

Disadvantages of the drug for use:

1. Janine is not a cure for endometriosis, but is intended only to stop its spread and improve a woman’s well-being.
2. When taking Zhanine, surgical intervention is not excluded.
3. The drug has many side effects that not every woman can withstand.

Bayer Weimar GmbH & Co. KG/ Bayer Pharma AG Bayer Schering Pharma AG Jenapharm GmbH & Co. Company of the Schering Jenapharm GmbH & Co. KG Group

Country of origin

Germany

Product group

Hormonal drugs

Monophasic oral contraceptive with antiandrogenic properties

Release forms

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

Description of the dosage form

• Dragee Dragee Dragee white, smooth.

pharmachologic effect

Low-dose monophasic oral combined estrogen-progestogen contraceptive drug. Contraceptive effect Janine is carried out through complementary mechanisms, the most important of which include the 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 lipid profile blood (increases the amount of lipoproteins high density). In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful menstruation is less common, the intensity and duration of bleeding decreases, resulting in a reduced risk of developing iron deficiency anemia. In addition, there is evidence of a reduced risk of endometrial and ovarian cancer.

Pharmacokinetics

Dienogest Absorption After oral administration, dienogest is quickly and completely absorbed from the gastrointestinal tract. Cmax is reached after 2.5 hours and is 51 ng/ml. Bioavailability is approximately 96%. Distribution Dienogest binds to serum albumin and does not bind to sex steroid binding globulin (SGBS) and corticoid binding globulin (CBG). About 10% of the total concentration in the blood serum is found in free form; about 90% are nonspecifically associated with serum albumin. Induction of SHPS synthesis by ethinyl estradiol does not affect the binding of dienogest to serum protein. The pharmacokinetics of dienogest is not affected by the level of SHPS in the blood serum. As a result of daily administration of the drug, the level of dienogest in the serum increases approximately 1.5 times. Metabolism Dienogest is almost completely metabolized. Serum clearance after a single dose is approximately 3.6 L/h. Elimination T1/2 is about 8.5-10.8 hours. A small part of dienogest is excreted by the kidneys unchanged. Metabolites are excreted in urine and bile in a ratio of about 3:1 with a T1/2 of 14.4 hours. Ethinyl estradiol Absorption After oral administration, ethinyl estradiol is quickly and completely absorbed. Cmax in blood serum is reached after 1.5-4 hours and is 67 pg/ml. During absorption and "first pass" through the liver, ethinyl estradiol is metabolized, resulting in its oral bioavailability averaging about 44%. Distribution Ethinyl estradiol is almost completely (approximately 98%), although nonspecifically, bound to albumin. Ethinyl estradiol induces the synthesis of SHBG. The apparent Vd of ethinyl estradiol is 2.8-8.6 l/kg. Css is achieved during the second half of the treatment cycle. Metabolism Ethinyl estradiol undergoes presystemic conjugation, as in the mucous membrane 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. Elimination The decrease in the concentration of ethinyl estradiol in the blood serum is biphasic; the first phase is characterized by T1/2 of the first phase - about 1 hour, T1/2 of the second phase - 10-20 hours. It is not excreted unchanged from the body. Metabolites of ethinyl estradiol are excreted in urine and bile in a ratio of 4:6 with T1/2 for about 24 hours.

Special conditions

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 measuring blood pressure, heart rate, determining body mass index) and gynecological examination, including breast examination and cytological examination scraping from the cervix (Papanicolaou test) to rule out pregnancy. Volume additional research and the frequency of follow-up examinations is determined individually. Typically, follow-up examinations should be carried out at least once a year. A woman should be informed that Janine® does not protect against HIV infection (AIDS) and other sexually transmitted diseases. If any of the conditions, diseases and risk factors listed below currently exist, you should carefully consider potential risk and the expected benefit of using combined oral contraceptives in each individual case and discuss it with the woman before she decides to start taking the drug. If risk factors become more severe, intensify, or when risk factors first appear, it may be necessary to discontinue the drug. Diseases of cardio-vascular system The results of epidemiological studies indicate a relationship between the use of combined oral contraceptives and an increased incidence of venous and arterial thrombosis and thromboembolism (deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular diseases) when taking combined oral contraceptives. These diseases are rare. The risk of developing venous thromboembolism (VTE) is greatest in the first year of taking such drugs. An increased risk is present after initial use of oral contraceptives or resumption of use of the same or different combined oral contraceptives (after a dosing interval of 4 weeks or more). Data from a large prospective study involving 3 groups of patients show that this increased risk present mainly during the first 3 months. The overall risk of VTE in patients taking low-dose combined oral contraceptives (

Compound

• ethinyl estradiol 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.

Janine indications for use

• contraception.

Janine 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. - 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 heart valve apparatus, atrial fibrillation, cerebral vascular disease or coronary arteries heart, uncontrolled arterial hypertension

Janine side effects

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

Drug interactions

Interaction of oral contraceptives with other drugs may lead to breakthrough bleeding and/or decreased contraceptive reliability. The following types of interactions have been reported in the literature. Effect on hepatic metabolism The use of drugs that induce microsomal liver enzymes can lead to an increase in the clearance of sex hormones. Such drugs include phenytoin, barbiturates, primidone, carbamazepine, rifampicin; There are also suggestions for oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John's wort. HIV protease inhibitors (eg, ritonavir) and non-nucleoside inhibitors reverse transcriptase(eg, nevirapine) and combinations thereof may also potentially affect hepatic metabolism. Effects on enterohepatic circulation: Some antibiotics (eg, penicillins and tetracyclines) may reduce enterohepatic circulation in some studies.

Overdose

nausea, vomiting, spotting or metrorrhagia

Storage conditions

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

Information provided

Photo of the drug

Latin name: Jeanine

ATX code: G03AA14

Active substance: Ethinylestradiol + Dienogest

Manufacturer: Bayer Pharma (Germany)

Products webpage: bayer.ru

Description is valid on: 09.11.17

Janine is a hormonal contraceptive drug.

Active substance

Ethinylestradiol + Dienogest.

Release form and composition

They are produced in the form of white smooth dragees, every 21 of which are packed in blisters. One or three blisters are included in a cardboard box.

Indications for use

Prevention of unwanted pregnancy.

Used as primary and auxiliary treatment for the following conditions and diseases:

• dysmenorrhea (painful menstruation);
• amenorrhea (lack of menstruation);
• menorrhagia (heavy menstruation);
• endometriosis;
• reproductive dysfunction;
• increased levels of male sex hormones in a woman’s blood (the result of which is often acne, very oily skin, excessive hair growth of the skin);
• period after gynecological surgical interventions(for the purpose of recovery after surgery and consolidation of its results).

Contraindications

• period of pregnancy and lactation;
• venous and arterial thrombosis, thromboembolism and conditions preceding them (angina pectoris, ischemia);
• neurological migraines;
• cardiovascular complications of diabetes mellitus;
• damage to the valvular apparatus of the heart, arrhythmias, vascular diseases brain and heart;
• liver failure, liver diseases, incl. tumors;
• malignant formations of the genital organs and mammary glands;
• after extensive surgical interventions.

Instructions for use Janine (method and dosage)

Dragees are taken orally, 1 piece per day at the same time, following the order indicated on the drug packaging. The duration of the course is 21 days, then a break is taken for 7 days. Menstruation begins 2-3 days after finishing taking the drug.

Transfer from other drugs

If you have not previously taken hormonal medications, the course begins on the first day of menstruation. It is acceptable to start MC on days 2-5, but in this case it is recommended to use additional barrier methods contraception for 7 days.

When switching from other oral contraceptives, use should begin the day after taking the last tablet from the previous package. A break of more than 7 days should not be allowed.

When switching to drugs after removing the vaginal ring, you should start taking pills on the day the ring or patch is removed.

When changing progestin contraceptives to drugs, you can start taking the drug at any time - on the day of implant removal or the last injection. In this case, it is necessary to use additional methods of contraception for 7 days.

After an abortion

After abortive termination of pregnancy in the first trimester, you can start taking it on the day of surgery. Additional contraception is not required.

After an abortion in the 2nd trimester or childbirth, you should start taking the drug 21-28 days after surgery or childbirth. In case of a later start of the course, it is recommended to use additional (barrier) contraceptives.

In case of missed appointment

If you miss taking the drug for less than 12 hours, the effect of the contraceptive is not reduced. A woman should take the pills as soon as she remembers, and the next ones are taken as usual.

If the break between tablets is more than 36 hours, you must adhere to the following recommendations:

• If you miss a pill in the first week, it is recommended to take the pill immediately and continue the course as usual. It is recommended to additionally use barrier methods of contraception for 7 days.
• If you miss a pill in week 2, take the pill as quickly as possible and continue therapy at the recommended dosage. If you have not missed a dose before, additional methods contraception is not required.
• If a dose is missed in the third week, the woman should take the pill as soon as possible and continue taking it from the current pack. In this case, a break before starting the next package is not required. During this period, menstrual-like bleeding may be extremely rare, but menstruation will begin after the end of the second package. Otherwise, a woman can take a seven-day break (taking into account the missed day) and then start taking the drug with new packaging.

If vomiting or diarrhea occurs within four hours after taking the drug, incomplete absorption of the active ingredient may occur, so the use of additional contraception is required. In this case, you must adhere to the rules regarding skipping pills.

If you need to delay the onset of menstruation, you must start taking pills from a new package immediately after the end of the previous one (without a break). To shorten the duration of MC, it is necessary to stop taking the drug as early as the woman needs.

Side effects

Janine may cause the following side effects:

• headache;
• soreness and engorgement of the mammary glands;
• increased appetite;
• dizziness;
• bleeding during the intermenstrual period;
• nausea;
• disturbance of psycho-emotional state.

Significantly less common:

• decreased libido;
• acne;
• abdominal pain, diarrhea, vomiting;
• rash, itchy skin;
• vaginitis, vulvovaginitis, vaginal candidiasis and others fungal infections;
• hyper- and hypotension.

To very rare side effects applies:

• spider veins, cellulite, pigmentation disorders;
• dandruff, seborrhea;
• psoriasis, allergic reactions skin, eczema;
• gastritis;
• varicose veins veins, thrombophlebitis;
• blurred vision, dry mucous membrane of the eyes;
• sleep disturbance, depression, aggression;
• anemia;
• benign tumors of the uterus and mammary gland.

Overdose

In case of an overdose of Janine, nausea, metrorrhagia, and vomiting are observed.

Symptomatic therapy is carried out. There is no specific antidote.

Analogues

Analogues according to the ATX code: Angeletta, Belara, Bonade, Diecyclen, Zhenetten.

Do not decide to change the drug on your own; consult your doctor.

pharmachologic effect

Ethinyl estradiol is a synthetic estrogen; when it enters the body, it performs all the functions of endogenous (own) estrogen.

Dienogest can be called an analogue of natural progesterone. Despite the slight similarity (only 10%) with progesterone, it has powerful progestogenic activity (it can effectively imitate the action of progesterone).

The pharmacological effect of the tablets is contraceptive. It occurs as a result of the implementation of three complementary mechanisms:

• Suppression of ovulation by influencing the hypothalamic-pituitary system.
• Changing the properties (mainly viscosity) of cervical mucus in such a way as to make it impermeable to sperm.
• Structural and functional changes in the endometrium, during which implantation of even a fertilized egg cannot occur.

The effect of the drug is not limited contraceptive effect. While taking it, the menstrual cycle is normalized, pain and the amount of discharge during menstruation are reduced, and the development of certain symptoms is prevented or stopped. gynecological diseases, is being restored reproductive function women. After regular use of the drug, an improvement in the condition of the skin, hair, nails is observed, the drug has positive influence on female body generally.

special instructions

Taking pills does not protect against sexually transmitted diseases.

Before the appointment, a complete medical examination of the patient is carried out and the possibility of pregnancy is excluded.

During pregnancy and breastfeeding

Contraindicated during pregnancy and breastfeeding.

In childhood

Not prescribed for children and adolescents under 18 years of age.

In old age

Not used in old age after menopause.

For impaired renal function

Information is absent.

For liver dysfunction

Contraindicated in severe liver diseases.

Drug interactions

• Combined use with phenytoin, barbiturates, rifampicin, primidone, carbamazepine, topiramate, felbamate can lead to an increase in the clearance of sex hormones. In this case, we additionally recommend using barrier methods of contraception.
• Non-nucleoside reverse transcriptase and HIV protease inhibitors may impair hepatic metabolism.
• Penicillin and tetracycline antibiotics reduce the enterohepatic circulation of estrogen, which can lead to a decrease in ethinyl estradiol levels.

Conditions for dispensing from pharmacies

Dispensed by prescription.

Storage conditions and periods

4.29 out of 5 (12 Votes)

Prices in online pharmacies:

Tradename

Description

White smooth dragees

Pharmacotherapeutic group

Combined contraceptive (estrogen + gestagen)

ATX code:

Janine does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Dosage form, composition and packaging

Active components	1 dragee
Dienogest	2 mg
Ethinyl estradiol	0.03 mg
Excipients: lactose monohydrate, potato starch, gelatin, talc, magnesium stearate, sucrose, dextrose (glucose syrup), macrogol 35000, calcium carbonate, povidone K25, titanium dioxide (E171), carnauba wax.
Release form: 21 tablets in a blister made of polyvinyl chloride film and aluminum foil. 1 or 3 blisters along with instructions for use are placed in a cardboard box.

Structural formula, gross formula and chemical name

Pharmacological properties

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 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 frequent, and 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.

Indications

Contraception (prevention of unwanted pregnancy).

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 the drug, 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, cerebrovascular 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 serious illnesses liver (until liver tests normalize).
• Liver tumors (benign or malignant) currently or in history.
• Identified hormone dependent malignant diseases(including genitals or mammary glands) or suspicion of them.
• Bleeding from the vagina of unknown origin.
• Pregnancy or suspicion of it.
• Breastfeeding period.
• Hypersensitivity to any of the components of the drug Janine.

Carefully

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

• Risk factors for the development of thrombosis and thromboembolism: smoking; obesity; dyslipoproteinemia, arterial hypertension; migraine; heart valve defects; prolonged immobilization, serious surgical interventions, extensive trauma; hereditary predisposition to thrombosis (thrombosis, myocardial infarction or disorder cerebral circulation V at a young age from any 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 non-specific 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, pregnancy herpes, Sydenham's chorea).
• Postpartum period.

Pregnancy and lactation

Janine should not be taken during pregnancy or while 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 by women who received sex hormones before pregnancy or when taking sex hormones through negligence early dates pregnancy.

Taking combined oral contraceptives may reduce the amount breast milk and change its composition, so their use is not recommended until breastfeeding is stopped.

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 in 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 week, and that your withdrawal bleed will occur on approximately the same day of the week each month.

Taking the first package of Janine

• When no hormonal contraceptive not used in the previous month

Start taking Janine on the first day of the cycle, that is, on the first day 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 pill (condom) during the first 7 days of taking the pills 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 one 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 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 per package).
Taking Janine should begin on the day of removal of the vaginal ring or patch, but not later in the day when a new ring is to be inserted or a new patch is to be applied.

• When switching from oral contraceptives containing only gestagen (mili-pili)

• 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 (first trimester)

Taking missed pills

• If the delay in taking the next pill is less than 12 hours, contraceptive effect Janine 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:
  More than one pill from the package was forgotten
  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 pill, 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 them within 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. 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 for 7 days or less (including the day you missed the pills) and then start taking pills from a new package.
      Using the scheme, you can always start taking the tablets with the next pack 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.

If you have vomiting or diarrhea (stomach upset) within 4 hours of taking Janine tablets, active substances 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 Zhanine from the second package, you may experience spotting or bleeding on the days you take the pills. Start the next pack with a normal 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 three days earlier than usual. 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 is indicated only after 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 the section “Contraindications”.

Patients with kidney problems

Janine 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 may occur (“spotting” or breakthrough bleeding), 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.

Other undesirable effects identified during the study of the drug Janine

Undesirable effects of the drug Janine

Frequent adverse effects (more than 1/100 and less than 1/10)	Uncommon adverse effects (more than 1/1000 and less than 1/100)	Rare adverse effects (more than 1/10000 and less than 1/1000)
- Headache; - pain in the mammary glands, including unpleasant ones sensations in the mammary glands and engorgement of the mammary glands.	— Vaginitis/vulvovaginitis (inflammation of female genitals); - vaginal candidiasis (thrush) or other fungal vulvovaginal infections; - increased appetite; - decreased mood; - dizziness; - migraine; - increased or decreased blood pressure; - in a stomach (including pain in the upper and lower abdomen, discomfort/bloating); nausea, vomiting and diarrhea; - acne; - alopecia (hair loss); - rash (including macular rash); - itching (sometimes whole body itching); - abnormal menstruation, including menorrhagia (heavy menstruation) hypomenorrhea (scanty menstruation), oligomenorrhea (irregular menstruation), and amenorrhea (absence of menstruation); - intermenstrual bleeding, including vaginal bleeding and metrorrhagia (irregular bleeding between periods); - sizes mammary glands, including swelling and distension 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 overall bad - well-being); weight change (increase or decrease).	-Adnexitis (inflammation of the fallopian (uterine) tubes and ovaries); - infections urinary tract; - cystitis (inflammation 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; - infections of the upper respiratory tract; — viral infection; - uterine fibroids ( benign neoplasms 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 uncomfortable posture); - dryness or irritation of the mucous membrane of the eyes; -oscillopsia (impaired visual clarity, illusion of vibration of stationary objects) or others visual disturbances; — sudden loss hearing; - noise in ears; - dizziness; - hearing impairment; — cardiovascular disorders(impaired blood supply to the heart); - tachycardia (rapid heartbeat); - thrombosis (formation of a blood clot in the 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); - increased diastolic pressure ( minimum indicator blood pressure, 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 dark spots, so-called “pregnant 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); - backache; - 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.

Overdose

ABOUT serious violations with a single dose of a large number of Janine tablets was not reported.

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, topiromate, felbamate), tuberculosis (eg, rifampicin, rifabutin), and HIV infection (eg, ritonavir, nevirapine); antibiotics to treat certain others infectious diseases(eg penicillin, tetracyclines, griseofulvin), and St. John's wort medicines (used mainly in the treatment of low mood).

Oral combined contraceptives may affect the metabolism of other drugs (for example, cyclosporine and lamotrigine).

Some medications may affect metabolism active ingredients drug Janine. These include antifungal drugs(eg, ketoconazole), H2-blockers to treat gastric and duodenal ulcers (eg, cimetidine), certain 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. In some cases, your doctor may recommend that you additionally use a barrier method of contraception.

Intermenstrual bleeding

When taking Janine during the first few months, irregular vaginal bleeding may be observed (“spotting” spotting or breakthrough bleeding) during the intermenstrual period. 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 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 to at least, at least once a year.

Consult your doctor as soon as possible: for any health changes, especially any conditions listed in the instructions for use of the drug (see also “Contraindications”); at local compaction in the mammary gland; if you are going to use others medications(see also “Interaction with other drugs”); if prolonged immobility is expected (for example, a plaster cast is applied to the leg), hospitalization or surgery is planned. if you experience unusual heavy vaginal bleeding; if you forgot to take a pill in the first week of taking the package and had sexual intercourse 7 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 thrombosis for the first time: unusual cough; unusual strong pain behind the sternum, extending into left hand; unexpected shortness of breath; unusual, severe or prolonged headache or migraine attack; partial or total loss 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.

Impact on the ability to drive a car and operate machinery

Not found.

Conditions for dispensing from pharmacies

On prescription.

Price in pharmacies

For one package (blister of 21 tablets) on average from 750 - 1200 rubles.

For one package (3 blisters of 21 tablets) on average from 2150 - 2900 rubles.

Analogues

The decision to change the drug is made by the attending physician; do not take it yourself.

Manufacturer

Bayer Pharma AG, Germany

D-13342 Berlin

Bayer Pharma AG, Germany

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Dosage form

Sugar coated tablets

Compound

One tablet contains

active ingredients: ethinyl estradiol 0.03 mg,

dienogest 2.0 mg,

excipients: lactose monohydrate, corn starch, maltodextrin, magnesium stearate,

shell composition: sucrose, liquid glucose, calcium carbonate, povidone K 25, macrogol 35000, titanium dioxide (E 171), carnauba wax.

Description

Smooth, white, sugar-coated tablets, round in shape

Pharmacotherapeutic group

Sex hormones and modulators of the reproductive system.

Hormonal contraceptives for systemic use.

Progestogens and estrogens (fixed combination). Dienogest and estrogens.

ATX code G03AA16

Pharmacological properties"type="checkbox">

Pharmacological properties

Pharmacokinetics

Dienogest

Absorption

After oral administration dienogest is rapidly and almost completely absorbed, its maximum serum concentration of 51 ng/ml is reached after approximately 2.5 hours. Bioavailability in combination with ethinyl estradiol is approximately 96%.

Distribution

Dienogest binds to serum albumin and does not bind to sex hormone binding globulin (SHBG) and corticoid binding globulin (CBG). About 10% of the total concentration in the blood serum is found in free form; about 90% are nonspecifically associated with serum albumin. Induction of SHBG synthesis by ethinyl estradiol does not affect the binding of dienogest to serum protein. The apparent volume of distribution for dienogest is approximately 37-45 L/kg.

Metabolism

Dienogest is metabolized primarily by hydroxylation and conjugation to form inactive metabolites. These metabolites are quickly cleared from the blood plasma, thus, not a single active metabolite is detected in the plasma, and only dienogest is found in an unchanged state. The total clearance is about 3.6 l/h after a single use.

Removal

A decrease in the level of dienogest in the blood serum occurs with a half-life of about 9 hours. Only a small part of dienogest is excreted by the kidneys in an unchanged state. When taken orally at a dose of 0.1 mg per kg of body weight, metabolites are excreted in urine and bile in a ratio of about 3:2. After oral administration, approximately 86% of the dose received is excreted within 6 days, with the main part, 42%, excreted in the first 24 hours, mainly in the urine.

Equilibrium concentration

The pharmacokinetics of dienogest are independent of SHBG levels. As a result of daily administration of the drug, the level of dienogest in the serum increases approximately 1.5 times, and the equilibrium concentration is achieved after 4 days of administration.

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 an average oral bioavailability of approximately 44%.

Distribution

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

Ethinyl estradiol undergoes presystemic conjugation, both in the mucosa of the small intestine and in the liver. Ethinyl estradiol is primarily metabolized by aromatic hydroxylation, resulting in the formation of various hydroxylated and methylated metabolites, presented both as free metabolites and as conjugates with glucuronic and sulfuric acids. The clearance rate from blood plasma is 2.3 - 7 ml/min/kg.

Removal

The decrease in the concentration of ethinyl estradiol in the blood serum is biphasic; the first phase is characterized by 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

The state of equilibrium concentration is achieved during the second half of the treatment cycle, when the serum level of the drug increases by approximately 2 times compared to the level when taking a single dose of the drug.

Pharmacodynamics

All hormonal contraceptives have very low rate“method failure” if used in accordance with the instructions for use (for example, when missing tablets).

IN clinical studies The following Pearl index was calculated.

The Pearl Index (adjusted) for method failure is 0.182 (upper two-sided 95% confidence interval: 0.358).

Overall Pearl Index (unadjusted, method failure + patient bias): 0.454 (upper two-sided 95% confidence interval: 0.701).

Zhanin is an oral combined contraceptive drug containing ethinyl estradiol and the progestagen dienogest.

The contraceptive effect of the drug Zhanin® is based on the interaction various factors, the most important of which are inhibition of ovulation and alteration of cervical mucus secretion.

Dienogest is a derivative of nortestosterone with an affinity for progesterone receptors in vitro that is 10-30 times less than other synthetic progestogens.

In vivo animal data demonstrated potent progestogenic and antiandrogenic activity.

Dienogest does not have significant androgenic, mineralocorticoid or glucocorticoid activity in vivo.

Dienogest has been found to inhibit ovulation at a dose of 1 mg per day.

When using high-dose oral contraceptives (0.05 mg ethinyl estradiol), the risk of developing endometrial and ovarian cancer is reduced. The extent to which these data apply to low-dose contraceptives requires further study.

Indications for use

Oral contraception (see section " special instructions»)

Directions for use and doses

The tablets should be taken orally in the order indicated on the package, every day at approximately the same time, with a small amount of water. Take one tablet per day continuously for 21 days. The next package begins after a 7-day break from taking pills, during which withdrawal bleeding usually occurs. Bleeding usually begins 2-3 days after taking the last tablet and may not stop until you start taking a new pack.

How to start taking Janine®

In the absence of taking any hormonal contraceptives in the previous month

Taking Janine® begins on the first day of the menstrual cycle (i.e., on the first day of menstrual bleeding).

When switching from other combined oral contraceptives (COCs)

It is preferable to start taking Zhanine® the day after taking the last hormone-containing tablet from the previous package of the combined oral contraceptive, 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 hormone-free tablet for drugs containing 28 tablets per package).

· When switching from a vaginal ring, transdermal patch

It is preferable to start taking Janine® on the day the last ring or patch is removed, but in no case later than the day when the next ring or patch was to be applied.

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

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

· After an abortion in the first trimester of pregnancy

A woman can start taking the drug immediately. If this condition is met, the woman does not need additional contraceptive protection.

· After childbirth or abortion in the second trimester of pregnancy

It is recommended to start taking the drug 21-28 days after childbirth or abortion. If use 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 been sexually active, pregnancy should be excluded before taking Zhanine® or she must wait until her first menstruation.

For information regarding breastfeeding, see the "Special Instructions" section.

Taking missed pills

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

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

· The drug should never be interrupted for more than 7 days.

· 7 days of continuous tablet use are required to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation.

Accordingly, the following advice can be given in daily practice if the delay in taking pills is more than 12 hours (the interval since taking the last pill is more than 36 hours).

First week of taking the drug

A woman should take the last missed pill as soon as she remembers (even if this means taking two pills at the same time). Next pill accepted at normal times. 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 a pill, the reliability of the drug is reduced, so the possibility of pregnancy must be taken into account.

As the number of missed tablets increases and the period of a regular break in taking the drug approaches, the likelihood of pregnancy increases.

Second week of taking the drug

A woman should take the last missed pill as soon as she remembers (even if this means taking two pills at the same time). The next tablet is taken at the usual time.

If a woman has taken her pills correctly in the 7 days preceding her first missed pill, there is no 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 example, a condom) for 7 days.

Third week of taking the drug

The risk of decreased reliability is inevitable due to the upcoming break in taking the pills. However, weakening of contraceptive protection can still be prevented by adjusting the pill taking schedule. Therefore, by adhering to one of the two regimens proposed below, you can do without additional precautions, provided that within 7 days before the first pill was missed, the woman took all the pills correctly. Otherwise, she should be advised to use the first of the following regimens and, in parallel, use additional methods of contraception for 7 days.

1. A woman should take the last missed pill as soon as she remembers (even if this means taking two pills at the same time). She then continues to take the pills at the usual time. The next package should be started immediately after taking the tablets from the current package, that is, without a break in taking the tablets. Withdrawal bleeding is unlikely until the second pack is finished, but spotting and breakthrough bleeding may occur while taking the tablets.

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 pill, and then start taking a new pack.

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

In severe gastrointestinal disorders, absorption of the drug may be incomplete. In this case, you should take additional measures contraception.

If a woman vomits within 3-4 hours after taking a pill, you should follow the advice regarding skipping pills. If a woman does not want to change the normal regimen of taking the drug, she should take an additional tablet (or 2 tablets from another package) if necessary.

Changing the start day of the menstrual cycle

In order to delay the onset of menstruation, a woman should continue taking tablets from the new package of Janine® immediately after taking all the tablets from the previous one, without interruption. Tablets from the 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 pack after the usual 7-day break.

In order to postpone the start of menstruation to another day of the week, a woman is recommended to shorten the duration of the next break in taking pills by as many days as she wishes. The shorter the interval, the higher the risk that she will not have withdrawal bleeding, and in the future, there will be spotting and breakthrough bleeding while taking the second package (the same as in the case when she would like to delay the onset of menstruation).

Additional information for special categories of patients

Children and teenagers

Elderly patients

Not applicable. The drug Zhanine® is not indicated after menopause.

Patients with liver disorders

The drug Zhanine® is contraindicated in women with severe liver disease (See also section “Contraindications”).

Patients with kidney problems

Zhanine® has not been specifically studied in women with impaired renal function. Available data do not suggest dose adjustment in this group of patients.

Side effects

Below is the frequency side effects while taking Zhanine®, based on clinical trial data:

Often (≥1/100,<1/10)

Headache

Breast pain, including discomfort and tension

mammary glands

Uncommon (≥1/1,000,<1/100)

Vaginitis/vulvovaginitis, vaginal candidiasis or other fungal vulvovaginal infections

Increased appetite

Decreased mood

Dizziness, migraine

Arterial hypertension and hypotension

Abdominal pain, including in the upper and lower sections, discomfort and a feeling of “fullness” in the abdominal area, nausea, vomiting, diarrhea

Rash, including macular and acne rash, alopecia, itching, including generalized

Vaginitis/vulvovaginitis, vaginal candidiasis or others

Pathological withdrawal bleeding, including menorrhagia, hypomenorrhea, oligomenorrhea, amenorrhea, intermenstrual bleeding (vaginal or uterine), increase in the size of the mammary glands, including swelling and a feeling of tide, swelling of the mammary glands, dysmenorrhea, discharge from the genital tract; ovarian cysts, pain in the pelvic area

Fatigue, including malaise and asthenia

Weight gain

Rarely (≥1/10,000,<1/ 1000)

Hypersensitivity reactions

Salpingo-oophoritis, urinary tract infections, cystitis, mastitis, cervicitis, fungal infections, candidiasis, influenza, herpes of the oral mucosa, bronchitis, sinusitis, upper respiratory tract infections, viral infection

Uterine leiomyoma, breast lipoma

Virilization

Anorexia

Depression, mental disorders, insomnia, sleep disorders, aggression

Ischemic stroke, cerebrovascular disorders, dystonia

Dry eyes, eye irritation, blurred vision, oscillopsia

Sudden hearing loss, tinnitus, vertigo, hearing loss

Cardiovascular disorders, tachycardia

Venous thromboembolism (VTE), arterial thromboembolism, pulmonary embolism, thrombophlebitis, diastolic

hypertension, orthostatic circulatory dysregulation, hot flashes, varicose veins, changes in veins, pain in veins

Bronchial asthma, hyperventilation

Dyspepsia, gastritis, enteritis

Allergic dermatitis, atopic dermatitis/neurodermatitis, eczema, psoriasis, hyperhidrosis, chloasma, pigmentation disorders/hyperpigmentation, seborrhea, dandruff, hirsutism, skin reactions and skin changes, orange skin symptom, spider nevus

Back pain, musculoskeletal discomfort, myalgia, pain in the limbs

Cervical dysplasia, adnexal cyst, adnexal pain, breast cyst, fibrocystic breast disease, genital pain associated with sexual intercourse, galactorrhea, menstrual irregularities

Chest pain, peripheral edema, influenza-like illness, inflammatory diseases, pyrexia, irritability

Elevated plasma triglycerides, hypercholesterolemia, weight loss, changes in body weight

Manifestation of asymptomatic accessory mammary gland

With unknown frequency (identified only during post-marketing surveillance)

Mood changes, decreased libido, increased libido

Contact lens intolerance

Urticaria, erythema nodosum, erythema multiforme

Discharge from the mammary glands

Fluid retention

Description of selected adverse reactions

The following adverse reactions have been reported in women using combined oral contraceptives, which are also described in the “Special Instructions” section:

The incidence of breast cancer diagnosis is slightly increased among women taking oral contraceptives. Because breast cancer is rare in women under 40 years of age, the increase in diagnosis is small relative to the overall risk of developing the disease. Its connection with the use of combined oral contraceptives has not been proven.

Liver tumors (benign and malignant)

Cervical cancer

Other states

Women with hypertriglyceridemia are at increased risk of developing pancreatitis while taking combined oral contraceptives.

Arterial hypertension

The appearance or worsening of the following conditions, the relationship of which with the use of combined oral contraceptives has not been proven: jaundice and/or itching associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes of pregnancy, hearing loss associated with otosclerosis

In women with hereditary angioedema, provocation or exacerbation of symptoms of the disease under the influence of exogenous estrogens

Liver dysfunction

Impaired glucose tolerance or effects of peripheral insulin resistance

Crohn's disease and ulcerative colitis

Chloasma

Interactions

Breakthrough bleeding and/or decreased contraceptive effectiveness of the drug due to interactions of combined oral contraceptives with drugs (liver enzyme inducers)

Contraindications

Combined hormonal contraceptives should not be used if any of the conditions listed below are present. If any of these conditions develop for the first time while taking a combined hormonal contraceptive, the drug should be discontinued immediately.

Presence or risk of venous thromboembolism

· venous thromboembolism currently (on anticoagulant therapy) or in history (for example, deep vein thrombosis, or pulmonary embolism)

hereditary or acquired predisposition to venous thromboembolism (for example, resistance to activated protein C (including factor V Leiden), deficiency of antithrombin III, protein C or protein S

· major surgical interventions with prolonged immobilization

· high risk of venous thromboembolism due to the presence of multiple risk factors (See also section “Special instructions”).

Presence or risk of arterial thromboembolism

current or history of arterial thromboembolism (eg, myocardial infarction) or conditions preceding arterial thromboembolism (eg, angina pectoris)

· cerebrovascular disorders - current or history of stroke or conditions preceding cerebrovascular disorders (for example, transient ischemic attacks)

hereditary or acquired predisposition to arterial thromboembolism (for example, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies and lupus anticoagulant)

history of migraine with focal neurological symptoms

high risk of developing arterial thromboembolism due to the presence of multiple risk factors, such as:

Diabetes mellitus with vascular complications

Severe arterial hypertension

Severe dyslipoproteinemia

Pancreatitis with severe hypertriglyceridemia, currently or in history.

Current or history of severe liver disease (before liver tests normalize)

Current or history of liver tumors (benign or malignant)

Detected or suspected hormone-dependent malignant diseases (for example, genitals or mammary glands)

Vaginal bleeding of unknown origin

Hypersensitivity to any of the components of the drug

Drug interactions

When prescribing concomitant therapy, it is necessary to familiarize yourself with the drug interactions section of each of the prescribed drugs to identify potential interactions.

Effects of other drugs on Janine â

There may be an interaction with drugs that induce liver enzymes, which may increase the clearance of sex hormones and lead to breakthrough bleeding and/or a decrease in the contraceptive effectiveness of the drug.

Enzyme induction can be observed after just a few days of treatment. Maximum enzyme induction usually occurs within a few weeks. After cessation of treatment, enzyme induction may persist for 4 weeks.

Short course of treatment

Women undergoing a short course of treatment with drugs that induce liver enzymes are advised to use a barrier method of contraception in addition to Janine or choose another method of contraception. In this case, a barrier method of contraception should be used during the period of concomitant use of drugs and for 28 days after their discontinuation. If the period of use of the barrier method of contraception ends later than the tablets in the Janine package, you need to move on to the next package of Janine without the usual break in taking the tablets.

Long course of treatment

Women undergoing long-term treatment with drugs that induce liver enzymes are recommended to use another reliable, non-hormonal method of contraception.

Substances that increase the clearance of combined oral contraceptives (reduce the effectiveness of combined oral contraceptives due to induction of liver enzymes), for example:

phenytoin, barbiturates, primidone, carbamazepine and rifampicin; There are also suggestions for oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John's wort.

Substances with varying effects on the clearance of combined oral contraceptives

When used in combination with combined oral contraceptives, many HIV/HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors may increase or decrease plasma concentrations of estrogens or progestins. These changes may be relevant in some cases.

Therefore, it is necessary to read the instructions for use of drugs used in conjunction with Zhanin to identify potential interactions and make any recommendations. Women receiving treatment with protease inhibitors or non-nucleoside reverse transcriptase inhibitors should use an additional barrier method of contraception when in doubt

Substances that reduce the clearance of combined oral contraceptives (enzyme inhibitors)

The clinical significance of potential interactions with enzyme inhibitors is unknown.

Concomitant use with strong CYP3A4 inhibitors may increase plasma concentrations of estrogen or progestin or both.

Etoricoxib at a dose of 60 to 120 mg/day increases plasma ethinyl estradiol concentrations by 1.4 to 1.6 times when coadministered with combined hormonal contraceptives containing 0.035 mg ethinyl estradiol.

Effect of Zhanine® on other drugs

Combined oral contraceptives may affect the metabolism of other drugs, resulting in an increase (for example, cyclosporine) or a decrease (for example, lamotrigine) in their plasma and tissue concentrations.

However, based on data from in vitro studies, the development of inhibition of cytochrome P450 enzymes is unlikely when dienogest is prescribed at a therapeutic dose.

Data from clinical studies suggest that ethinyl estradiol inhibits the clearance of CYP1A2 substrates, resulting in mild (eg, theophylline) to moderate (eg, tizanidine) increases in CYP1A2 substrate concentrations.

Other forms of interaction

Laboratory tests

Taking contraceptive steroids may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, plasma concentrations of proteins, such as corticosteroid binding globulins and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and coagulation parameters. Changes usually do not go beyond normal values.

special instructions

The decision to prescribe Zhanine should be made on an individual basis, taking into account the woman’s risk factors, in particular the development of venous thromboembolism and assessing the risk of developing venous thromboembolism while taking Zhanine in comparison with other combined hormonal contraceptives.

Precautions and Warnings

If any of the conditions/risk factors listed below currently exist, the advisability of using Janine should be discussed with the woman.

If any of these conditions or risk factors intensify or manifest for the first time, a woman should consult her doctor, who may decide whether to discontinue Janine.

If venous thromboembolism (VTE) or arterial thromboembolism (ATE) is suspected or confirmed, combined hormonal contraceptives should be discontinued. If a woman is prescribed anticoagulant therapy, adequate contraception should be provided by an alternative method, given the teratogenic effect of anticoagulant therapy (coumarins).

Circulatory disorders

Risk of venous thromboembolism

The use of any combined hormonal contraceptives increases the risk of developing VTE in patients compared to women who do not use them.

Drugs containing levonorgestrel, norgestimate and norethisterone have the lowest risk of developing VTE. It is unknown what risk Zanine has compared to these low-risk drugs.

The decision to use such drugs over any other low-risk VTE drug should only be made after a joint discussion with the woman. This is to ensure that the woman is aware of the risk of developing VTE with Janine, how her risk factors will affect that risk, and that the risk of VTE is greatest in the first year of use.

In addition, there is some evidence that an increased risk may be seen when a combined oral contraceptive is restarted after a break of 4 weeks or more.

In women who do not use combined hormonal contraceptives and are not pregnant, VTE develops with a frequency of 2 per 10,000 cases over 1 year. However, this risk may increase significantly depending on each woman's individual risk factors (see below).

The results of epidemiological studies showed that among women using low-dose combined hormonal contraceptives (<0,05 мг этинилэстрадиола ВТЭ возникает у 9–12 из 10 000 женщин) в течение года.

It is estimated that out of 10,000 women taking combined hormonal contraceptives containing levonorgestrel, 6 will develop VTE within 1 year.

Limited data from epidemiological studies suggest that the risk of VTE with COCs containing dienogest may be similar to the risk with COCs containing levonorgestrel.

The reported incidence of VTE during the year is lower than expected during pregnancy and the postpartum period.

Venous thromboembolism can be fatal in 1-2% of cases.

Thrombosis of other blood vessels, such as hepatic, mesenteric, renal, cerebral arteries and veins, as well as retinal vessels, has been extremely rarely reported in women taking combined hormonal contraceptives.

Risk factors for the development of venous thromboembolism

The risk of developing venous thromboembolic complications while taking combined hormonal contraceptives may increase significantly if a woman has additional risk factors, especially if there are multiple risk factors.

The use of Zhanin is contraindicated if a woman has multiple risk factors that pose a high risk of developing venous thrombosis.

The possibility of an increased synergistic risk of thrombosis in women with a combination of several risk factors or a higher severity of one of the risk factors should be considered. In such cases, the increased risk may be greater than the total risk taking all factors into account. Combined hormonal contraceptives should not be prescribed if the risk/benefit ratio is negative (see section "Contraindications").

Symptoms of venous thromboembolism (deep vein thrombosis and pulmonary embolism)

Symptoms of deep vein thrombosis include the following:

unilateral swelling in the leg or along a vein in the leg, pain or discomfort in the leg only in an upright position or when walking, a local increase in temperature in the affected limb, redness or discoloration of the skin on the leg.

Symptoms of pulmonary embolism include: sudden onset of unexplained shortness of breath or rapid breathing, a sudden attack of coughing that may be accompanied by hemoptysis, severe chest pain that may worsen with deep breathing, anxiety, severe dizziness; fast or irregular heartbeat.

Some of these symptoms (eg, "shortness of breath" and "cough") are nonspecific and may therefore be misinterpreted as signs of more common and less severe conditions (eg, respiratory tract infection).

Other signs of vascular occlusion may include the following:

Sudden pain, swelling and blue discoloration of the limb.

Ocular vascular occlusion may cause blurred vision, which may progress to vision loss. In some cases, almost sudden vision loss may occur.

Risk of arterial thromboembolism

Data from epidemiological studies indicate an increased risk of developing ATE (myocardial infarction) or cerebrovascular events (eg, transient ischemic attacks, stroke).

Arterial thromboembolic processes can be fatal.

Risk factors for developing ATE

The risk of developing arterial thromboembolic complications or cerebrovascular disorders while taking combined hormonal contraceptives increases if a woman has risk factors.

The use of Zhanin is contraindicated if a woman has one significant factor or multiple risk factors that cause a high risk of developing arterial thrombosis.

The possibility of an increased synergistic risk of thrombosis in women with a combination of several risk factors or a higher severity of one of the risk factors should be considered.

In such cases, the increased risk may be greater than the total risk taking all factors into account. Combined oral contraceptives should not be prescribed if the risk/benefit ratio is negative (see section "Contraindications").

Symptoms of arterial thromboembolism

If the symptoms listed below appear, a woman should immediately pay attention to this and inform the doctor that she is using combined hormonal contraceptives.

Symptoms of cerebrovascular disorders may include:

sudden weakness or numbness of the face, upper or lower extremities, especially on one side of the body, sudden confusion, difficulty speaking, or difficulty understanding; sudden loss of vision in one or both eyes, sudden disturbance in gait, dizziness, loss of balance or coordination, sudden severe or prolonged headache for no apparent reason, loss of consciousness or fainting with or without a seizure. Other signs of vascular occlusion may also include sudden pain, swelling or mild blueness of the extremities, and symptoms of an “acute abdomen.”

Symptoms of myocardial infarction include:

pain, discomfort, pressure, heaviness, a feeling of squeezing or fullness in the chest, in the arm or behind the sternum, a feeling of discomfort radiating to the back, cheekbones, larynx, arm, stomach, a feeling of fullness or fullness in the stomach, a feeling of suffocation, cold sweat, nausea , vomiting or dizziness, severe weakness, anxiety, shortness of breath, fast or irregular heartbeat.

Risk factors for the development of venous and arterial thromboembolism

The risk of developing thrombosis (venous and/or arterial), thromboembolic or cerebrovascular disorders increases:

With age (over 35 years);

In smokers (women should stop smoking if they intend to take COCs. For women over 35 years of age who continue to smoke, other methods of contraception are strictly recommended);

If there is a family history (i.e., venous or arterial thromboembolism ever in siblings or parents at a relatively young age under 50 years). If a hereditary predisposition is known or suspected, the woman should consult a doctor to decide on the possibility of taking combined oral contraceptives;

For obesity (body mass index more than 30 kg/m2). The risk increases with increasing BMI. It is especially important to consider the presence of other risk factors;

With dyslipoproteinemia;

For arterial hypertension;

For migraines;

For diseases of the heart valves;

With atrial fibrillation;

With prolonged immobilization, major surgery, any leg surgery or major trauma. In these situations, it is advisable to stop using combined oral contraceptives (in the case of planned surgery, at least four weeks before it) and not to resume use for two weeks after the end of immobilization. Temporary immobilization, including airplane flights of more than 4 hours, may increase the risk of VTE, particularly in women with other risk factors.

To prevent unplanned pregnancy, you must use another method of contraception.

If discontinuation of the drug Zhanin has not been carried out in advance, the need to prescribe antithrombotic therapy should be considered.

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

The increased risk of thromboembolism during pregnancy and especially during the 6 weeks postpartum period should be taken into account.

Circulatory abnormalities may also occur with tumors, diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), and sickle cell anemia.

An increase in the frequency and severity of migraine during use of combined oral contraceptives (which may precede cerebrovascular events) may be grounds for immediate discontinuation of these drugs.

The most significant risk factor for developing cervical cancer is a viral infection - persistent human papilloma (HPV). There have been reports of some increased risk of cervical cancer with long-term use of combined oral contraceptives, but there remains conflicting information about the extent to which this may be related to other factors, including screening for cervical pathology and sexual behavior ( less frequent use of barrier methods of contraception).

A meta-analysis of 54 pharmacoepidemiological studies demonstrated that there is a slightly increased relative risk (RR=1.24) of developing breast cancer diagnosed in women who were currently taking combined oral contraceptives. The increased risk gradually disappears within 10 years of stopping these drugs. Because breast cancer is rare in women under 40 years of age, the increase in the incidence of breast cancer in women currently taking or recently taking combined oral contraceptives is small relative to the overall risk of developing this disease. Its connection with the use of combined oral contraceptives has not been proven. The observed increased risk may be due to earlier diagnosis of breast cancer in women using combined oral contraceptives, biological effects of combined oral contraceptives, or a combination of both. Women who have ever used combined oral contraceptives are diagnosed with earlier stages of breast cancer than women who have never used them.

In rare cases, the development of benign liver tumors and, in even more rare cases, the development of malignant liver tumors have been observed during the use of combined oral contraceptives. In some cases, liver tumors can lead to life-threatening intra-abdominal bleeding. If women taking combined oral contraceptives experience severe pain in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding, the possibility of a liver tumor should be taken into account when making a differential diagnosis.

Malignant tumors can be life-threatening or fatal.

Other states

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

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 Janine®, this drug should be discontinued and treatment of arterial hypertension should be initiated. Taking Janine® can be continued if normal blood pressure values ​​are achieved with antihypertensive therapy.

The following conditions observed during pregnancy may also appear or worsen when taking combined oral contraceptives: jaundice and/or itching associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis. However, the relationship between the development of these conditions and the use of combined oral contraceptives has not been proven.

In women with hereditary angioedema, exogenous estrogens contained in the drug can provoke or aggravate the symptoms of this disease.

In the presence of acute or chronic liver dysfunction, it is necessary to consider stopping the use of combined oral contraceptives until liver function tests return to normal. If recurrent cholestatic jaundice develops, which develops for the first time during pregnancy or previous use of sex hormones, you should stop taking combined oral contraceptives.

Although combined oral contraceptives may have an effect on insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose combined oral contraceptives (<0,05 мг этинилэстрадиола). Тем не менее, женщины с сахарным диабетом должны тщательно наблюдаться во время приема препарата Жанин®.

During the use of combined oral contraceptives, manifestations of Crohn's disease and ulcerative colitis, as well as worsening of endogenous depression and epilepsy, were observed.

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

Women with a tendency to develop chloasma should avoid prolonged sun exposure and exposure to ultraviolet radiation while taking Janine®.

One tablet of the drug Zhanin® contains 27 mg of lactose and 1.65 mg of glucose. In patients with rare hereditary disorders such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption who are on a lactose-free diet, the amount of lactose contained in the drug should be taken into account.

Medical examinations

Before or resumption of taking Zhanine®, you should familiarize yourself in detail with the patient’s medical history, including family history, and exclude pregnancy. Blood pressure should be measured and a physical examination should be performed, taking into account contraindications and warnings (see section "Special Instructions").

It is very important to draw a woman’s attention to information about arterial and venous thromboembolism, including the risk of blood clots when taking Zhanine® in comparison with other CGPs; symptoms of venous and arterial thromboembolism; known risk factors and what actions to take if thrombosis is suspected.

The woman should be instructed to carefully read the instructions for use of the drug and follow the recommendations specified therein.

The frequency and nature of screening should be based on established practice guidelines and determined individually for each woman.

A woman should be warned that hormonal contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of combined oral contraceptives may be reduced by missing pills, gastrointestinal problems, or 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. This may include curettage.

Some women may not develop withdrawal bleeding during a pill-free break. 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.

Pregnancy and lactation

Janine® is not prescribed during pregnancy.

If pregnancy is detected while taking the drug, you must immediately stop taking it. However, extensive pharmacoepidemiological studies have not revealed any increased risk of developmental defects in children born to women who received combined oral contraceptives before pregnancy or teratogenic effects when combined oral contraceptives were taken inadvertently in early pregnancy.

Animal studies have shown undesirable effects of the drug during pregnancy and lactation. Based on the data obtained from these animal studies, an undesirable effect associated with the hormonal action of the active compounds of the drug cannot be excluded. However, general experience with combined oral contraceptives during pregnancy does not indicate actual adverse effects in humans.

The increased risk of developing venous thromboembolism should be taken into account when taking Zhanine® again in the postpartum period (see section "Special instructions").

Lactation

Taking combined oral contraceptives affects lactation as they can reduce the amount of breast milk and change its composition. Small amounts of sex steroids and/or their metabolites may be excreted in milk when taking combined oral contraceptives and may affect the baby.

Therefore, Janine® should not be used until the nursing mother has completely weaned her baby.

Children and teenagers

The drug Zhanine® is indicated only after the onset of menarche.

Features of the effect of the drug on the ability to drive vehicles and potentially dangerous mechanisms.

No studies have been conducted.

The use of the drug does not affect the ability to drive vehicles and potentially dangerous mechanisms.

Overdose

The acute toxicity of ethinyl estradiol and dienogest is very low. For example, if a child accidentally took several Zhanine® tablets at the same time, it is unlikely that this will lead to the development of symptoms of intoxication.

Symptoms: nausea, vomiting and, in young girls, minor vaginal bleeding.

Shelf life

Do not use after expiration date.

Conditions for dispensing from pharmacies

On prescription

Manufacturer

Bayer Weimar GmbH and Co.KG, Germany