Janine for 1 month. Pros, cons and side effects of birth control pills

Registration Certificate Holder:
BAYER SCHERING PHARMA AG

Produced:
SCHERING GmbH & Co. Products KG

ATX codes for JANINE

G03AA (Progestogens and estrogens (fixed combinations))

Analogues of the drug according to ATC codes:

Before using the drug JANINE, you should consult your doctor. These instructions for use are for informational purposes only. For more complete information, please refer to the manufacturer's instructions.

Clinical and pharmacological group

23.035 (Monophasic oral contraceptive with antiandrogenic properties)

Release form, composition and packaging

Dragee white, smooth.

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.

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

Pharmacological action

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

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

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

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

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

Pharmacokinetics

Dienogest

Suction

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.

Removal

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

Suction

After oral administration, ethinyl estradiol is rapidly 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 nonspecific, 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, both in the mucous membrane of the small intestine and in the liver. The main route of metabolism is aromatic hydroxylation. The clearance rate from blood plasma is 2.3-7 ml/min/kg.

Removal

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.

JANINE: DOSAGE

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

Start of taking Janine

In the absence of taking any hormonal contraceptives in the previous month, taking Janine starts on the 1st day menstrual cycle(i.e. on the 1st day of menstrual bleeding). It is possible to start taking it on the 2-5th day of the menstrual cycle, but in this case it is recommended to use a barrier method of contraception during the first 7 days of taking the tablets from the first package.

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

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

After an abortion in the first trimester of pregnancy, a woman can start taking the drug immediately. In this case, the woman does not need additional methods of contraception.

After childbirth or abortion in the second trimester of pregnancy, it is recommended to start taking the drug on the 21-28th day after childbirth or abortion in the second trimester of pregnancy. If use is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pill. However, if a woman has already been sexually active, pregnancy should be excluded before taking Zhanine or she must wait until her first menstruation.

Taking missed pills

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

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

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

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

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

First week of taking the drug

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

Second week of taking the drug

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

Third week of taking the drug

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

1. It is necessary to take the last missed pill as soon as possible, as soon as the woman remembers it (even if this requires taking two pills at the same time). The next pill is taken at the usual time, until the pills from the current package run out. The next pack should be started immediately without interruption. Withdrawal bleeding is unlikely until the second pack is finished, but spotting and breakthrough bleeding may occur while taking the pill.

2. A woman can also stop taking pills from the current package. She should then take a break for 7 days, including the day she missed the pills, and then start taking a new pack.

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

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

Changing the start day of the menstrual cycle

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

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

Additional information for special categories of patients

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

After menopause, Zhanine® is not indicated.

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

The drug Zhanin® has not been specifically studied in patients with impaired renal function. Available data do not suggest changes in treatment in these patients.

Overdose

No serious adverse events have been reported following overdose.

Symptoms: nausea, vomiting, spotting or metrorrhagia.

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

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 reverse transcriptase inhibitors (eg, nevirapine) and combinations thereof also have the potential to affect hepatic metabolism.

Effect on enterohepatic circulation

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

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

Substances affecting the metabolism of combined hormonal contraceptives (enzyme inhibitors)

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

While taking medications that affect microsomal enzymes, and for 28 days after their discontinuation, you should additionally use a barrier method of contraception.

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

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

Pregnancy and lactation

Zhanine® is not prescribed during pregnancy and breastfeeding.

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

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

JANINE: SIDE EFFECTS

When taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. While taking the drug 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.

Determination of the frequency of adverse reactions: often (≥1/100 and

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

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

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

In women using combined oral contraceptives, there is a very small increase in the incidence of breast cancer. Because Breast cancer rarely occurs in women under 40 years of age, and given the overall risk of developing breast cancer, the additional number of cases is very small. The relationship with the use of combined oral contraceptives is not known.

Common (≥1/100 and Uncommon (≥1/1000 and Rare (≥1/10,000 and Frequency unknown)
Infections and infection
Vaginitis/vulvovaginitisVaginal candidiasis or other vulvovaginal infections
Salpingo-oophoritis (adnexitis) Urinary tract infections Cystitis Mastitis Cervicitis Fungal infections Candidiasis Herpetic lesions of the oral cavity Influenza Bronchitis Sinusitis Upper respiratory tract infections Viral infections
Benign, malignant and unspecified tumors (including cysts and polyps)
Uterine fibroids Breast lipoma
Blood and lymphatic system
Anemia
Endocrine system
Virilization
Metabolism
Increased appetite
Anorexia
Psychiatric disorders
Decreased mood
DepressionMental disordersInsomniaSleep disordersAggression
Mood changesDecreased libidoIncreased libido
Nervous systemHeadache
DizzinessMigraine
Ischemic strokeCerebrovascular disordersDystonia
Sense organs
Dryness of the mucous membrane of the eyes Irritation of the mucous membrane of the eyes Oscillopsia Sudden hearing loss Tinnitus Dizziness Hearing loss
Contact lens intolerance ( discomfort when wearing them)
Cardiovascular system
Arterial hypertensionArterial hypotension
Cardiovascular disordersTachycardia, including increased heart rateThrombosis/thromboembolism of the pulmonary arteryThrombophlebitisDiastolic hypertensionOrthostatic circulatory dystoniaHot flashesVaricose veinsVein pathologyVein pain
Respiratory system
Bronchial asthmaHyperventilation
Digestive system
Abdominal pain, including upper and lower abdominal pain, discomfort/bloating Nausea Vomiting Diarrhea
GastritisEnteritisDyspepsia
Dermatological reactions
Acne Alopecia Rash, including macular rash Pruritus, including generalized pruritus
Atopic dermatitis/neurodermatitisEczemaPsoriasisHyperhidrosisChloasmaPigmentation disorder/hyperpigmentationSeborrheaDandruffHirsutismPathological skin changesOrange peelSpider veins
Erythema multiforme
Allergic reactions
Manifestations of allergic reactions, including allergic dermatitis
UrticariaErythema nodosum
Musculoskeletal system
Back painDiscomfort in the muscles and bonesMyalgiaPain in the limbs
Reproductive system and mammary glandsPain in the mammary glands, discomfort, engorgement of the mammary glands
Abnormal withdrawal bleeding, including menorrhagia, hypomenorrhea, oligomenorrhea and amenorrhea Intermenstrual bleeding, including vaginal bleeding and metrorrhagia Breast enlargement, swelling and fullness of the breasts Breast swelling Dysmenorrhea Genital tract/vaginal discharge Ovarian cysts Pelvic pain
Cervical dysplasiaAdnexal cystsPain in the area of ​​the uterine adnexaBreast cystsFibrocystic mastopathyDipareuniaGalactorrheaMenstrual disorders
Discharge from the mammary glands
General symptoms
FatigueAstheniaFeeling unwell
Chest painPeripheral edemaFlu-like symptomsInflammationFeverIrritability
Fluid retention
Survey results
Changes in body weight (weight gain, loss, and fluctuations)
Increased TG levels in the bloodHypercholesterolemia
Congenital and genetic disorders
Detection of additional breasts/polymastia

Storage conditions and periods

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

Indications

• contraception.

Contraindications

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

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

With caution

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

• risk factors for the development of thrombosis and thromboembolism (smoking,
• obesity,
• dyslipoproteinemia,
• arterial hypertension,
• migraine,
• heart valve defects,
• long-term immobilization,
• serious surgical interventions,
• extensive injury,
• hereditary predisposition to thrombosis/thrombosis,
• myocardial infarction or cerebrovascular accident at a young age in one of the immediate family/);
• other diseases,
• in which peripheral circulatory disorders may occur (diabetes mellitus,
• systemic lupus erythematosus,
• hemolytic uremic syndrome,
• Crohn's disease
• 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 diseases,
• otosclerosis with hearing loss,
• porphyria,
• pregnancy herpes,
• Sydenham's chorea);
• postpartum period.

Special instructions

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

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

If any of the conditions, diseases and risk factors listed below currently exist, the potential risks and expected benefits of combined oral contraceptives should be carefully weighed on an individual basis and discussed with the woman before she decides to start taking drug. If risk factors become more severe, intensify, or at the first manifestation of risk factors, it may be necessary to discontinue the drug.

Diseases of the cardiovascular 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 indicate that this increased risk is predominantly present during the first 3 months.

The overall risk of VTE in patients taking low-dose combined oral contraceptives (

Venous thromboembolism (VTE), manifested as deep vein thrombosis or pulmonary embolism, can occur with the use of any combined oral contraceptives.

It is extremely rare that when using combined oral contraceptives, thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels. There is no consensus regarding the relationship between the occurrence of these events and the use of combined oral contraceptives. Symptoms of deep vein thrombosis (DVT) include: unilateral swelling lower limb 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 leg, redness or discoloration of the skin on the leg.

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

Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction. Symptoms of a stroke: sudden weakness or loss of sensation in the face, arm or leg, especially on one side of the body, sudden confusion, problems with speech and comprehension; sudden unilateral or bilateral vision loss; 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 an epileptic seizure. Other signs of vascular occlusion: sudden pain, swelling and slight blue discoloration of the extremities, acute abdomen.

Symptoms of myocardial infarction include: pain, discomfort, pressure, heaviness, a feeling of squeezing or fullness in the chest, arm, or behind the breastbone; discomfort radiating to the back, cheekbone, larynx, arm, stomach; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety or shortness of breath; fast or irregular heartbeat.

Arterial thromboembolism can be fatal.

The risk of developing thrombosis (venous and/or arterial) and thromboembolism increases:

• with age;
• in smokers (with increasing number of cigarettes or increasing age, the risk increases,
• especially in women over 35 years old);
• for obesity (body mass index more than 30 kg/m2);
• if there is a family history (for example,
• venous or arterial thromboembolism ever in close relatives or parents at a relatively young age).
• In the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking combined oral contraceptives;
• with prolonged immobilization,
• serious surgical intervention,
• any leg surgery or major injury.
• In these situations, it is advisable to stop using combined oral contraceptives (in the case of planned surgery,
• at least,
• four weeks before) and do not resume taking it for two weeks after the end of immobilization;
• with dyslipoproteinemia;
• with arterial hypertension;
• for migraines;
• for diseases of the heart valves;
• with atrial fibrillation.

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

Peripheral circulatory disorders can also be observed in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory diseases intestines (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.

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

When assessing the risk-benefit ratio, it should be taken into account that adequate treatment of the relevant condition may reduce the associated risk of thrombosis. It should also be taken into account that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose oral contraceptives (

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

A meta-analysis of 54 epidemiological studies found that there is a slightly increased relative risk of breast cancer diagnosed in women who used 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 breast cancer diagnoses in women currently or recently taking combined oral contraceptives is small relative to the overall risk of breast cancer. Its connection with the use of combined oral contraceptives has not been proven. The observed increased risk may also be a consequence of earlier diagnosis of breast cancer in women using combined oral contraceptives. 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, during the use of combined oral contraceptives, the development of liver tumors has been observed, which in some cases led to life-threatening intra-abdominal bleeding. If severe pain in the abdominal area, liver enlargement or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.

Other states

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

Although 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, these drugs should be discontinued and treatment of arterial hypertension should be started. Taking combined oral contraceptives can be continued if normal blood pressure values ​​are achieved with antihypertensive therapy.

The following conditions have been reported to develop or worsen both during pregnancy and while taking combined oral contraceptives, but their association with combined oral contraceptives has not been proven: jaundice and/or pruritus associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; Sydenham's chorea; herpes during pregnancy; hearing loss associated with otosclerosis. Cases of Crohn's disease and ulcerative colitis have also been described during the use of combined oral contraceptives.

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

Acute or chronic liver dysfunction may require discontinuation of combined oral contraceptives until liver function tests return to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of combined oral contraceptives.

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

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

Efficacy of combined oral contraceptives may be reduced by missing pills, vomiting and diarrhea, or as a result of drug interactions.

Effect on the menstrual cycle

While taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, 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 malignant neoplasms or pregnancy.

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

Impact on laboratory test performance

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

Preclinical safety data

Preclinical data obtained from standard repeated dose toxicity studies, as well as genotoxicity, carcinogenic potential and toxicity to reproductive system, do not indicate a particular risk to humans. However, it should be remembered that sex steroids can promote the growth of certain hormone-dependent tissues and tumors.

Impact on the ability to drive vehicles and operate machinery

Not identified.

Use for renal impairment

Taking Zhanine may affect biochemical indicators of kidney function.

Use for liver dysfunction

If liver dysfunction occurs, temporary discontinuation of Zhanine may be required until laboratory parameters normalize. If cholestatic jaundice or cholestatic itching develops (first occurring during pregnancy or previous use of sex hormones), Zhanine should be discontinued.

Instructions

"Janine" is a low-dose estrogen-progestin contraceptive; it blocks ovulation and changes the viscosity of mucus cervical canal, making it impermeable to sperm. "Janine" is taken daily at the same time for 21 days, then take a 7-day break. During this break, menstrual-like bleeding occurs, it is also called withdrawal bleeding. It is not menstruation, since there was no ovulation, but it allows the uterine mucosa to renew itself, the woman feels more comfortable, since her usual routine of life has been preserved. Bleeding usually occurs 2-3 days after taking the last tablet. It is necessary to start taking the first tablet from the next package after a 7-day break, regardless of whether the bleeding has stopped or not. Each tablet in the package is labeled according to the day. This simplifies control and allows women to start taking it any day of the week.

The initial dose begins on the first day of the menstrual cycle, that is, on the first day of menstrual bleeding. In this case, the contraceptive effect occurs by the end of the first day. A woman can start taking “Janine” up to the 5th day of the menstrual cycle; this may be necessary if it is necessary to shift the withdrawal bleeding for several days. In this case, you must refrain from intimate relationships or use barrier methods during the first week of taking Janine.

For women who start taking Janine after combined contraceptives, transdermal patches or a vaginal ring, a special regimen is provided. You should start taking “Janine” immediately after taking the last pill from the blister of combined contraceptives. If the contraceptives contained 21 tablets, then a break is allowed, but not more than 7 days. This allows the woman to adjust her withdrawal bleeding schedule. If there are 28 tablets in a blister, then the last 7 are inactive, and therefore taking “Janine” should be started immediately after all the tablets in the blister are finished. Taking “Janine” after removing a vaginal ring or patch should begin on the day of removal, but no later than the day when a new ring was supposed to be inserted.

When switching from progestin drugs, injection forms and implants, additional contraception is required for 7 days after taking the first Zhanine tablet. When switching from progestin drugs, a woman may not finish the rest of the package, but immediately start drinking “Janine”. When switching from implants or intrauterine contraceptives, you should wait until removal or the day of the next injection, otherwise an overdose will occur hormonal drugs.

After an abortion, they begin to take “Zhanine” immediately, in this case the contraceptive effect is observed from the first day of administration. After childbirth and after an abortion in the second trimester of pregnancy, “Zanine” is started on days 21-28, and if the woman has already had sexual intercourse, pregnancy must be excluded. Usually, an analysis for hCG is used, since the ultrasound method at this period may not be informative.

If the missed pill was less than 12 hours, then the missed pill should be taken immediately, and the subsequent pills should be taken as usual. Additional contraceptive measures are not required. If the pill is missed for more than 12 hours, then it is necessary to take the missed pill immediately and use barrier methods of contraception for 7 days. It is allowed to take two tablets in a row. If you missed a pill in the third week of taking it, it is recommended to start taking it from the next package without a 7-day break. To correct the day of menstruation, for example during a vacation, you can cancel “Janine” on any day of administration, or start taking pills from the second package. The dragees from the second package can be taken until they are gone. If pregnancy occurs while taking Zanine, the drug should be discontinued. The woman needs to see a doctor. Continuing the pregnancy is recommended, since “Janine” does not have a negative effect on the fetus, but if the woman wishes, she may be offered to terminate the pregnancy.

Selecting a hormonal drug for contraception is not easy. In addition to protecting against pregnancy, many of these products help cope with skin problems (acne), menstrual irregularities, and ovarian cysts. “Janine” is able to interfere with the balance of sex hormones, reducing the manifestations of hyperandrogenemia. This is his positive side. But the instructions for use of “Zhanine” indicate many side effects. How is the drug tolerated and is it safe?

Hormonal medications should be selected together with a gynecologist. Despite their general similarity (they contain estrogens and gestagens), the effect of use can vary greatly. “Janine” is a drug that is not suitable for everyone.

Composition and principle of action

"Zhanine" is a low-dose monophasic combined oral contraceptive. Each concept has an important meaning:

• low-dose– the hormone content is relatively low;
• monophasic - each tablet contains the same dose of medication;
• To combined – the composition contains estrogens and gestagens, which imitate a woman’s two-phase menstrual cycle;
• oral – tablets are taken orally.

The composition includes the following hormones.

• 0.03 mg ethinyl estradiol. Mimics the effect of estrogen. Ethinyl estradiol increases the viscosity of cervical secretions, which impairs sperm motility in the cervical canal.
• 2 mg dienogest. Acts on the pituitary gland, suppressing the production of follicle-stimulating hormone (FSH), which leads to a lack of growth of new follicles. As a result, the ovaries are in a “dormant state” without ovulation. The distinctive ability of dienogest is that it has antiandrogenic activity. Thanks to this, after some time of use, the manifestations of hirsutism decrease.

Constant low concentrations of hormones in the blood affect the endometrium of the uterine cavity, leading to its atrophy. This entails a decrease in the abundance and duration of menstrual bleeding, as well as a decrease in foci of endometriosis throughout the body.

After entering the intestine, the drug is absorbed into the systemic circulation. It undergoes transformation in the liver, creating additional stress on the organ and bile ducts. Metabolic products of “Zanina” are excreted in feces and urine.

When to use

Main purpose hormonal pills“Janine” – providing protection against pregnancy. Additionally, the drug is used to treat the following conditions:

• endometriosis - thanks to the “dormant state” of the ovaries and a decrease in the activity of the pituitary gland of the brain, all foci of endometriosis (including adenomyosis) are significantly reduced, which leads to a decrease in the severity of pain, spotting, and heavy menstruation;
• when – prescribed after conservative and surgical treatment ovarian cysts, including endometrioid ones, for a period of three to six months;
• uterine fibroids – like all contraceptives, it can somewhat reduce the growth rate of nodes;
• for mastopathy - regular use reduces the likelihood of developing mastopathy by half, and also reduces symptoms such as pain and tension in the mammary glands;
• with endometrial hyperplasia – can be used as a treatment for benign endometrial hyperplasia and glandular polyps;
• with polycystic disease - the drug normalizes the menstrual cycle, reduces the manifestations of hyperandrogenemia and its effect on the entire body;
• for chronic adnexitis - regular use leads to attenuation of inflammatory processes in the appendage area, reducing the likelihood of ovarian dysfunction;
• for cosmetic effect– while taking “Janine”, the severity of acne (pimples) on the face, back and arms decreases, however, the effect does not last long after stopping the medication (one to two months).

In addition, "Janine", like other contraceptives, has a rebound effect - after discontinuation, the likelihood of multiple pregnancies increases due to the activation of the ovaries and the simultaneous maturation of several follicles.

Restrictions

Contraindications to taking the drug correspond to those common to all hormonal drugs containing estrogens and gestagens. The list includes the following states:

• allergic reactions to drug components;
• history of blood clots, tendency to them;
• migraines, even if the last episode was a long time ago;
• diabetes mellitus;
• prosthetic heart valves;
• arterial hypertension of the third and fourth degree;
• prolonged immobility, for example, after fractures;
• diseases of the liver, biliary tract;
• pancreatic diseases;
• pregnancy and breastfeeding;
• suspicion or clarified malignant tumors;
• vaginal bleeding of unknown cause;
• smoking;
• overweight with an index of more than 40;
• systemic connective tissue diseases;

How is it transferred

With careful selection of the drug, “Zhanine” is well tolerated. However, during use the following may occur: side effects with a frequency of more than one case per thousand women taking the medicine:

• headache, migraine;
• dizziness;
• nausea and vomiting, bowel dysfunction;
• increased appetite and weight gain;
• hair loss, rash and itchy skin;
• increased blood pressure;
• decreased sexual desire (libido);
• recurrent candidal colpitis;
• increased blood sugar levels;
• thrombosis and thromboembolism;
• tearfulness, irritability, depression.

Reviews about birth control pills"Janine" is contradictory. Some people do not observe side effects and use the drug for contraception or treatment for many years, while others cannot withstand even a week of use due to unpleasant changes in their well-being and behavior.

With a frequency of less than one case per thousand of women taking the drug, the following side effects occur:

• relapses of viral and bacterial infections;
• insomnia;
• dry mucous membranes;
• skin diseases such as seborrhea, psoriasis;
• bronchial asthma;
• enteritis, gastritis.

In cases of overdose, side effects intensify. Treatment in these cases is symptomatic.

In addition, in the first months when taking Janine, a woman may be bothered by periodic spotting from the genital tract and even intermenstrual bleeding. This is explained by the body getting used to the new regimen of a fixed dose of hormones. Usually the adaptation period takes no more than two to three months, otherwise it is necessary to replace the drug or adjust the dosage regimen.

"Janine": instructions for use

How long and how many tablets can I take Janine? The regimen for taking Zhanine tablets is no different from that of other oral contraceptives. The main postulates are as follows:

• pills are taken - inside, wash down with a small amount of water; for 21 days, take one tablet from the package;
• start of use - must coincide with the first day of menstruation in the first month;
• reception time is strictly fixed, for example, always in the morning at 6.00;
• after finishing packaging - it is necessary to take a seven-day break, usually on the second or third day menstrual flow appears;
• after a seven-day break - you should start taking a new package.

“Janine” can be drunk without interruption for many years. After discontinuation, ovarian function is restored within three to six months. To delay menstruation, you can take two packages of the drug without a seven-day break. In this case, the cycle will be 42-45 days. However, you should not get carried away with such properties of the drug, as this can lead to acyclic discharge and bleeding.

Frequent clinical situations

Often the indications for use of the drug are various situations and diseases. You should take Zhanine tablets taking into account the following points.

• After an abortion, miscarriage. If the pregnancy was terminated in the first trimester, you should start taking the pills on that day or the next day. If an abortion or miscarriage occurs in the second trimester, it is recommended to start taking it on days 21-28; you don’t even have to wait for menstruation, provided that pregnancy is excluded.
• After childbirth. The drug is allowed to be used only after completion of lactation. If a woman doesn't support breast-feeding, the beginning is possible no earlier than 21-28 days after birth.
• After others OK. You should start drinking Janine during a seven-day break or taking dummy tablets. If the transdermal patch is removed, intrauterine device Mirena or vaginal ring - it is recommended to take the first tablet on the same day. If injections of hormonal drugs were used, the start should coincide with the first day of the intended injection. When switching from mini-pills (containing only gestagen), the intake can be timed to any day.

If you miss a pill

Reviews from doctors and women point to the fact that most often one has to deal with a violation of the pill regimen. How to take “Janine” correctly in such cases? If 12 hours have not passed since the scheduled time, you must take the missed tablet, and then the next one at the appointed time. If 12 hours have already passed, the action algorithm is as follows:

• first week of admission– take the missed tablet as quickly as possible, and use the next one according to the usual schedule within a week additional methods protection;
• second week of admission- take the missed pill immediately, no additional protection is needed if the dosage regimen has been followed up to this point;
• third week of admission– you can either continue taking the pack and start the next one without a seven-day break, or take a break of a week on the missed pill and then start a new pack.

What affects efficiency

While taking Janine, various situations are possible, including illness conditions. You need to know that some drugs and symptoms can reduce the contraceptive effect of pills:

• antibiotics - macrolides (for example, Azithromycin, Johamycin, Clarithromycin, Erythromycin), penicillins (Amoxiclav, Ampicillin), tetracyclines (Doxycycline);
• antifungal drugs –"Ketoconazole";
• antidepressants– “Fluoxetine”;
• anticonvulsants –"Carbamazepine";
• for blood pressure - Diltiazem.
• vomiting and diarrhea - if the episode occurs within four hours of taking the pill, additional contraception must be used in the next week; if after four hours, the protective effect remains, the drug is already completely in the blood.

Considering interactions with other medications, side effects and contraindications for use, “Janine” should only be prescribed by a doctor. He must be made aware of the regular use of other medications.

Analogs

There are complete analogues of the drug with the same composition and dose of active substances. The list is as follows:

• "Silhouette";
• "Diecyclen";
• "Bonade."

Tablets "Zhanine" for endometriosis, hyperandrogenemia, after removal of ovarian cysts are the drug of choice. The medicine is suitable for the prevention of acne in women with disrupted hormonal levels, as well as simply for contraception. The drug is prescribed only on the recommendation of a doctor, as it has contraindications and complications from use.

Endometriosis is a disease of the female reproductive system, which is based on the proliferation of hormonally dependent endometrioid tissue outside its typical location - in the pelvis, in abdominal cavity and other parts of the body. Therapeutic and surgical measures are used to treat this disease. Laparoscopy is widely used among surgical interventions. The main components of pharmacotherapy are combined oral contraceptives. The drug of choice in this group of drugs, Janine, for endometriosis significantly improves the well-being of patients in more than 87-90% of cases.

Zhanine tablets inhibit the growth and development of endometrioid ectopia

“Janine” is a modern and safe means of contraception, which, for many gynecological pathologies has a pronounced therapeutic effect.

Each tablet contains two active substances estrogen and progestin series. The number of drug components is constant, regardless of the day of the menstrual cycle, so the drug belongs to monophasic combined OCs.

“Janine”: pharmacokinetics and features of the chemical structure of components

The drug includes:

• 2 mg dienogest;
• 0.03 mg ethinyl estradiol.

Dienogest is a “hybrid” substance that combines the best features of 19-northosterone and progestins. It has high bioavailability (95-98%). It is characterized by complex gestagen-antiandrogenic activity and the absence of unwanted corticosteroid effects.

Ethinyl estradiol is an artificial derivative of estrogens. The structural features of the molecule allow it to easily penetrate into the blood from the gastrointestinal tract. The metabolism of this compound contributes to the manifestation of the necessary therapeutic effect of the drug.

The drug blocks enzymes responsible for the production of prostaglandins (especially PG E2) - the main mediators of pain and inflammation

How “Janine” affects the body: pharmacodynamic properties

“Janine” prevents conception and the development of unwanted pregnancy due to its effect on the “hypothalamus-pituitary-ovarian” system.

Based on the principle of negative feedback, it inhibits the release of gonadotropic hormones, as a result of which ovulation does not occur in the ovaries, and estrogen production also decreases.

The function of smooth muscles also changes fallopian tubes, peristaltic contractions of their walls become less pronounced, making it difficult for the egg to advance.

Due to the stabilization of hormonal levels, the endometrium in the uterus changes its structure in such a way that the embryo cannot implant into the mucous membrane.

These tablets inhibit the growth and development of endometrioid ectopia. Due to the action of dienogest, “pseudodecidualization” occurs - a complex of local histological and biochemical changes in the tissues of the lesion, similar to those that occur in the early stages of pregnancy. In the stroma, cells mature and differentiate, the composition of the extracellular substance changes, and the epithelium exhibits secretory features. The result of such processes is a decrease in size and atrophy of atypically located formations.

It has been proven that if you take “Zhanine, then” tablets, the risk of malignancy of endometriotic formations is reduced

“Janine” blocks enzymes responsible for the production of prostaglandins (especially PG E2) - the main mediators of pain and inflammation. Thanks to this, patients get rid of pain and dysmenorrhea, and their physical and mental condition improves. The menstrual cycle stabilizes, the duration and volume of bleeding decreases.

The drug accelerates the breakdown of active estrogens to inactive ectopic foci in the epithelium - this is another mechanism of its antiproliferative action. In the surrounding tissues, the amount of growth factors decreases, and local angiogenesis is inhibited. The body's immune defense is activated, which also helps eliminate ectopia.

Thanks to the general antiandrogenic effect, women's skin and hair condition improves, especially those who suffer from acne and hirsutism. It has been proven that if you take “Zhanine, then” tablets, the risk of malignancy of endometriotic formations is reduced.

A patient who started taking these pills needs to have a biochemical blood test done every 3 months.

“Janine”: what treatment regimens exist?

The drug “Zhanine” is used in the presence of endometriosis at different stages of the disease. Depending on this, the doctor selects a dosage of medication and a treatment plan for each patient.

These tablets are prescribed for:

• recently diagnosed endometriosis as empirical therapy;
• as part of preoperative preparation;
• postoperative therapy to prevent relapses.

If a woman wants to become pregnant soon or has been diagnosed with endometriosis early stage, the “cyclic” reception scheme “21+7” is shown. The patient needs to take the prescribed dose of the drug every day for three weeks, and then take a break for seven days. After 2-4 days, she will begin to have menstrual-like bleeding. Treatment lasts 3-4 months.

If the patient has undergone laparoscopic intervention or has an advanced pathological process, the use of a “prolonged” treatment regimen is indicated: “42 / 63 / 84 + 7”. The tablets must be taken for 42, 63, 84 days respectively (6, 9, 12 weeks) daily. The interval between courses is 7 days, during which a menstrual-like reaction is observed. The duration of this therapeutic regimen is at least 6-12 months.

Drinking “Janine” begins on the 1st day of the menstrual cycle. If use is started from days 2 to 5 of the cycle, the gynecologist should advise the woman to additionally use barrier contraceptives in the first week of use.

A patient who has started taking these pills needs to do a biochemical blood test every 3 months, monitor liver function and blood clotting, and undergo an ultrasound of the pelvic organs.

“Janine”: what side effects may occur and who should not take it?

During treatment, Zhanine tablets may cause side effects. The most common of them are:

• thromboembolic complications (stroke, myocardial infarction or other organs, thrombosis, thrombophlebitis of the superficial or deep veins of the extremities);
• migraine-like headaches;
• emotional lability;
• changes in eating behavior (hyperrexia);
• blurred vision and intolerance to contact lenses;
• cholestatic jaundice, dyspeptic symptoms, stool changes;
• allergic skin rashes;
• spotting scanty bloody discharge from the vagina;
• engorgement, tenderness of the mammary glands.

When treated, Zhanine tablets can cause blurred vision and intolerance to contact lenses.

This medicine should not be taken if the patient suffers from:

1. thromboembolic diseases or suffered them in the past;
2. diabetes mellitus;
3. arterial hypertension:
4. hormonally dependent tumors of the reproductive organs or mammary glands;
5. any severe liver pathologies (including cholelithiasis);
6. migraine attacks or epilepsy.

How does Janine interact with other medications?

Drugs that induce microsomal oxidation enzymes in the liver (barbiturates, carbamazepine, rifampicin, tetracycline antibiotics, etc.) reduce the contraceptive and therapeutic effect of “Janine”.

Treatment of endometriosis by Zhanin will relieve every woman of unpleasant symptoms, give her health and well-being, and in case of infertility, help to conceive a child.

CONTROL CONTROL PILLS

International name: Ethinyl estradiol + Dienogest (Ethinylestradiol + Dienogest)
Group affiliation: Contraceptive
Description of the active substance (INN): Ethinyl estradiol + Dienogest
Dosage form : dragee.

Pharmacological action:

Low-dose monophasic oral contraceptive estrogen-gestagen agent. The contraceptive effect of Zhanin is based on the interaction of various factors, the most important of which is inhibition of ovulation and changes in the viscosity of cervical mucus. In addition to the contraceptive effect, the combination of estrogen and progestin has other positive effects that should be taken into account when choosing a method of birth control. The cycle becomes more regular, painful menstruation is observed less frequently, and the intensity of bleeding decreases, resulting in a reduced risk of iron deficiency anemia. The progestin component, dienogest, is an active progestogen and is the only nortestosterone derivative with antiandrogenic activity. Dienogest has a positive effect on the lipid profile, increasing the concentration of HDL.

Indications:
Hormonal contraception

Contraindications:
Hypersensitivity, thrombosis (venous and arterial), incl. history (deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders). Conditions preceding thrombosis (for example, transient ischemic attacks, angina), incl. in the anamnesis. Diabetes mellitus with vascular complications. The presence of severe or multiple risk factors for venous or arterial thrombosis. Severe liver diseases (until liver tests return to normal), incl. history of benign or malignant liver tumors, incl. history, identified or suspected hormone-dependent malignant diseases of the genital organs or mammary glands, vaginal bleeding of unknown origin, pregnancy or suspected pregnancy. With caution. Obesity, dyslipoproteinemia, arterial hypertension, valvular heart disease, atrial fibrillation, prolonged immobilization, diabetes mellitus, SLE, hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, jaundice and/or itching due to cholestasis (including . in anamnesis, with worsening during pregnancy), cholelithiasis, porphyria, minor chorea (Sydenham's disease), history of herpes during pregnancy, hearing loss associated with otosclerosis (including worsening during previous pregnancy).

Side effects:

engorgement, tenderness of the mammary glands, galactorrhea; headache; migraine; change in libido; decreased mood; poor tolerance to contact lenses; nausea; vomit; changes in vaginal secretion; various skin reactions; fluid retention; change in body weight; allergic reactions. Rarely - chloasma (especially if there is a history of chloasma during pregnancy). Janine overdose. Symptoms: nausea, vomiting, slight vaginal bleeding (in girls). Treatment: symptomatic, there is no specific antidote.

Directions for use and dosage:

Inside, daily, preferably at the same time, in the order indicated on the package, with a small amount of water. Take 1 tablet per day continuously for 21 days. Each subsequent package begins after a 7-day break, during which withdrawal bleeding (menstrual-like bleeding) is observed. It usually begins 2-3 days after taking the last pill and can continue until you start taking a new package. In the absence of taking any hormonal contraceptives in the previous month, taking Zhanine begins on the first day of the menstrual cycle (on the first day of menstrual bleeding). It is allowed to start taking it on days 2-5 of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the pills from the first package.

When switching from a previous use of combined oral contraceptives, it is preferable to start taking the drug the next day after taking the last active pill from the previous package, but no later than the next day after the usual 7-day break in taking (for drugs containing 21 pills) or after taking the last inactive pill dragees (for preparations containing 28 pills per package). When switching from contraceptives containing only gestagens (mini-pills, injection forms, implant), the drug Zhanine is taken: from the mini-pill - on any day (without a break), from the implant - on the day of its removal, from the 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 Janine tablets.

After an abortion in the first trimester of pregnancy, you can start taking Zhanine immediately. If this condition is met, there is no need for additional contraceptive protection. After childbirth or abortion in the second trimester of pregnancy, it is recommended to start taking the drug on days 21-28 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 pill. However, if a woman has already been sexually active, pregnancy should be excluded before starting to take the drugs or she must wait until her first menstruation.

Special instructions:
Irregular use of Janine can lead to intermenstrual bleeding and impair therapeutic and contraceptive reliability. Taking pills should never be interrupted for more than 7 days. 7 days of continuous administration of the pills are required to achieve adequate suppression of the hypothalamic-pituitary-ovarian system.

Before starting use, it is recommended to conduct a thorough general medical and gynecological examination (including examination of the mammary glands and cytological examination of cervical mucus) and exclude pregnancy. In addition, disorders of the blood coagulation system should be excluded. In case of long-term use of the drug, it is necessary to carry out preventive control examinations every 6 months. The woman should be warned that the drug Janine does not protect against HIV infections (AIDS) and other sexually transmitted diseases.

Prescribing a combined contraceptive with antiandrogenic properties may be especially useful for patients with acne, seborrhea, hirsutism and androgenetic alopecia. During the treatment period, prolonged exposure to the sun or UV irradiation should be avoided.

Taking combined oral contraceptives may reduce the amount of breast milk and change its composition, so their use is generally not recommended during lactation. Small amounts of sex hormones and/or their metabolites may be excreted in milk, but there is no evidence of their negative effects on the health of the newborn. While taking a combination of estrogen-progestogens, irregular bleeding ("spotting" or "breakthrough" bleeding) may occur, especially during the first months of treatment. Therefore, assessment of any irregular bleeding is only meaningful after an adaptation period of approximately 3 cycles. If irregular bleeding recurs or develops after previous regular cycles, non-hormonal causes should be considered and adequate diagnostic measures taken to exclude malignancy or pregnancy. These may include diagnostic curettage. In some women, withdrawal bleeding may not develop during a break from taking the pill. If combined oral contraceptives are taken as directed, pregnancy is unlikely to occur. However, if combined oral contraceptives have not been taken regularly before or if there are no 2 withdrawal bleedings in a row, pregnancy should be excluded before continuing to take combined oral contraceptives.

Interaction:
Long-term treatment with drugs that induce liver enzymes (phenytoin, barbiturates, primidone, carbamazepine, rifampicin, topiramate, felbamate and griseofulvin) may increase the clearance of sex hormones and reduce clinical effectiveness. Typically, the maximum increase in enzyme activity is observed no earlier than 2-3 weeks after starting to take these drugs, but may persist for at least 4 weeks after their discontinuation. In rare cases, a decrease in the concentration of estradiol is observed with the simultaneous administration of certain antibiotics (for example, penicillins and tetracyclines). When using the above-mentioned drugs together, in addition to Zhanine, it is necessary to temporarily use a barrier method of contraception and for 7 days after their discontinuation (for rifampicin, within 28 days after its discontinuation). If a concomitant drug is started at the end of a package of Janine, the next package of Janine should be started without the usual break in administration.

ATTENTION! A number of drugs are available only with a prescription! The information presented on the project pages is not intended for self-medication; medications may have contraindications; be sure to consult a doctor before use!