Janine

Use during pregnancy and breastfeeding

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 shown an increased risk of developmental defects in children born to women who received sex hormones before pregnancy, or teratogenic effects when sex hormones were inadvertently taken in early pregnancy.

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

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.

Use for renal impairment

Taking Zhanine may affect biochemical indicators of kidney function.

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 when risk factors first appear, 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 suggest 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 (<50 mcg ethinyl estradiol) is 2-3 times higher than in non-pregnant patients not taking combined oral contraceptives, however, this risk remains lower than the risk VTE during pregnancy and childbirth. VTE can be fatal (in 1-2% of cases).

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 of the lower extremity or along a vein in the leg, pain or discomfort in the leg only when standing or walking, localized warmth 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 the chest, which may intensify with deep inspiration; sense of anxiety; severe dizziness; fast or irregular heartbeat. Some of these symptoms (eg, shortness of breath, cough) are nonspecific and may be misinterpreted as 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 of age);
for obesity (body mass index more than 30 kg/m2);
if there is a family history (for example, venous or arterial thromboembolism ever occurred 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, 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 resume use 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 may also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.

An increase in the frequency and severity of migraine during 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 (<50 mcg ethinyl estradiol).

Tumors

The most significant risk factor for developing 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 abdominal pain, liver enlargement, or signs of intra-abdominal bleeding occur, 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 develops while taking combined oral contraceptives, these drugs should be discontinued and treatment of hypertension should be initiated. Taking combined oral contraceptives can be continued if normal blood pressure values are achieved with antihypertensive therapy.

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 exposure to the sun and ultraviolet radiation while taking combined oral contraceptives.

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

Effect on the menstrual cycle

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

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

Impact on laboratory test performance

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

Preclinical safety data

Preclinical data from routine repeated-dose toxicity, genotoxicity, carcinogenicity and reproductive toxicity studies 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 found.

Janine dragee 21 pcs ➤ instructions for use

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. Starting taking Zhanine If you have not taken any hormonal contraceptives in the previous month, taking Zhanine starts on the 1st day of the menstrual cycle (i.e. on the 1st day of menstrual bleeding). It is possible to start taking it on the 2-5th day of the menstrual cycle, but in this case it is recommended to use a barrier method of contraception during the first 7 days of taking the tablets from the first package. When switching from combined oral contraceptives, a vaginal ring, or a transdermal patch, taking Zhanine should begin the day after taking the last active pill from the previous package, but in no case later than the next day after the usual 7-day break in taking (for drugs containing 21 tablets) or after taking the last inactive tablet (for drugs containing 28 tablets per package). When switching from a vaginal ring or transdermal patch, it is preferable to start taking Janine on the day the ring or patch is removed, but no later than the day when a new ring is to be inserted or a new patch is applied. When switching from contraceptives containing only gestagens (“mini-pills”, injectable forms, implant) or from a gestagen-releasing intrauterine contraceptive (Mirena), a woman can switch from taking the “mini-pill” to Zhanine® on any day (without a break), from an implant or intrauterine contraceptive with gestagen - 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 is more than 36 hours), the following can be recommended: The 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 requires 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 tablet as soon as possible, as soon as the woman remembers it (even if this requires taking two tablets 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. Recommendations in case of vomiting and diarrhea 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 day of the start of the menstrual cycle To delay the onset of menstruation, a woman should continue taking pills from the new package of Janine immediately after taking all the pills from the previous one, without interruption in taking. 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.

Janine, 21 pcs., 0.03 mg+2 mg, film-coated tablets

If any of the conditions, diseases or risk factors listed below currently exist, the potential risks and expected benefits of using Janine should be carefully weighed in each individual case and discussed with the woman before she decides to start taking drug. If any of these conditions, diseases or risk factors worsen, intensify or manifest for the first time, a woman should consult her doctor, who may decide whether to discontinue the drug.

— Diseases of the cardiovascular system

There is epidemiological evidence of an increased incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke) when taking COCs. These diseases are rarely observed.

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 a COC or resumption of use of the same or a different COC (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 women taking low-dose COCs (<0.05 mg ethinyl estradiol) is two to three times higher than in non-pregnant patients not taking COCs, although this risk remains lower than the risk of VTE during pregnancy and childbirth.

VTE can be life-threatening or lead to death (in 1-2% of cases).

VTE, manifested as deep vein thrombosis or pulmonary embolism, can occur with the use of all COCs.

It is extremely rare when using COCs that thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels.

Symptoms of deep vein thrombosis: unilateral swelling of the lower extremity or swelling along a vein in the lower extremity, pain or discomfort in the lower extremity only in an upright position or when walking, local increase in temperature in the affected lower extremity, redness or discoloration of the skin of the lower extremity.

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

Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction. Symptoms of a stroke include: sudden weakness or loss of sensation in the face or limbs, 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 limbs, “acute” abdomen.

Symptoms of myocardial infarction: pain, discomfort, pressure, heaviness, a feeling of compression or fullness in the chest or behind the sternum, radiating to the back, jaw, left upper limb, epigastric region; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety or shortness of breath; fast or irregular heartbeat. Arterial thromboembolism can be life-threatening or fatal.

In women with a combination of several risk factors or high severity of one of them, the possibility of their mutual reinforcement should be considered. In such cases, the degree of increase in risk may be higher than with a simple summation of factors. In this case, taking the drug Zhanin® is contraindicated (see section “Contraindications”).

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

- with age;

- in smokers (with an increase in the number of cigarettes or an increase in age, the risk increases, especially in women over 35 years old);

in the presence of:

— obesity (body mass index more than 30 kg/m2);

- family history (for example, venous or arterial thromboembolism ever in close relatives or parents at a relatively young age). In the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking the drug Zhanine®;

- prolonged immobilization, extensive surgery, any operation on the lower extremities or major trauma. In these cases, taking the drug Zhanin® must be stopped (in the case of a planned operation, at least four weeks before it) and not resumed for two weeks after the end of immobilization. Temporary immobilization (eg, air travel lasting more than 4 hours) may also be a risk factor for the development of venous thromboembolism, especially in the presence of other risk factors;

- dislipoproteinemia;

- arterial hypertension;

- migraine;

— diseases of the heart valves;

- atrial fibrillation.

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

The increased risk of thromboembolism in the postpartum period should be taken into account.

An increase in the frequency and severity of migraine during use of the drug Zhanin® (which may precede cerebrovascular disorders) is grounds for immediate discontinuation of this drug.

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

— Tumors

The most significant risk factor for developing cervical cancer is persistent human papillomavirus infection. There are reports of a slight increase in the risk of developing cervical cancer with long-term use of COCs. However, the connection with taking COCs 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 showed that there is a slightly increased relative risk of developing breast cancer diagnosed in women currently taking COCs (relative risk 1.24). 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 current or recent COC users is small relative to the overall risk of breast cancer. Its connection with COC use has not been proven. The observed increased risk may also be a consequence of earlier diagnosis of breast cancer in women using COCs. In women who have ever used COCs. earlier stages of breast cancer are detected than in women who have never used them.

In rare cases, during the use of COCs, the development of benign, and in extremely rare cases, malignant liver tumors, which in some cases led to life-threatening intra-abdominal bleeding, was observed. If severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding occur, 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 COCs.

Although slight increases in blood pressure have been described in many women taking COCs, clinically significant increases have rarely been reported. However, if a persistent clinically significant increase in blood pressure develops while taking COCs, these drugs should be discontinued and treatment of arterial hypertension should be initiated. The drug 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 COCs, but their relationship with COC use has not been proven: jaundice and/or pruritus associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis. Cases of worsening the course of endogenous depression, epilepsy, Crohn's disease and ulcerative colitis during the use of COCs have also been described.

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 COCs until liver function tests return to normal. Recurrence of cholestatic jaundice, which developed for the first time during a previous pregnancy or previous use of sex hormones, requires discontinuation of COC use.

Although COCs may have an effect on insulin resistance and glucose tolerance, there is usually no need to adjust the dose of hypoglycemic drugs in patients with diabetes mellitus using low-dose COCs (<0.05 mg ethinyl estradiol). However, women with diabetes mellitus should be carefully monitored while taking COCs.

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

Preclinical data on safety

Preclinical data from routine repeated-dose toxicity, genotoxicity, carcinogenicity and reproductive toxicity studies do not indicate a particular risk to humans. However, it should be remembered that sex hormones can promote the growth of certain hormone-dependent tissues and tumors.

Laboratory tests

Taking the drug Zhanin® may affect the results of some laboratory tests, including indicators of liver, kidney, thyroid, adrenal function, the concentration of transport proteins in plasma, indicators of carbohydrate metabolism, parameters of blood coagulation and fibrinolysis. Changes usually do not go beyond normal values.

Reduced efficiency

The effectiveness of Zhanine® may be reduced in the following cases: missed pills, gastrointestinal disorders or as a result of drug interactions.

Frequency and severity of menstrual-like bleeding

While taking the drug Zhanine®, irregular bleeding may occur (“spotting” spotting and/or “breakthrough” uterine bleeding), 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.

No regular menstrual bleeding

Some women may not develop bleeding during a break in taking the pills. “ooContraindications” and “With caution”;

— Local compaction in the mammary gland;

- Concomitant use of other medications (see also “Interaction with other medications”);

- If prolonged immobility is expected (for example, a cast is applied to the lower limb), hospitalization or surgery is planned (at least four weeks before the proposed operation);

- Unusually heavy bleeding from the vagina;

- Missed a pill in the first week of taking the package and had sexual intercourse seven days or less before;

— Absence of regular menstrual-like bleeding two times in a row or suspicion of pregnancy (you should not start taking pills from the next package before consulting your doctor).

You should stop taking the pills and consult your doctor immediately if there are possible signs of thrombosis, myocardial infarction or stroke: unusual cough; unusually severe pain behind the sternum, radiating to the left arm; unexpected shortness of breath, unusual, severe and prolonged headache or migraine attack; partial or complete loss of vision or double vision; slurred speech; sudden changes in hearing, smell, or taste; dizziness or fainting; weakness or loss of sensation in any part of the body; severe abdominal pain; severe pain in the lower limb or sudden swelling of any of the lower limbs.

Jeanine®

— Diseases of the cardiovascular system

The risk of developing VTE is greatest in the first year of taking such drugs. An increased risk is present after initial use of a COC or resumption of use of the same or a different COC (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.

VTE can be life-threatening or lead to death (in 1-2% of cases).

VTE, manifested as deep vein thrombosis or pulmonary embolism, can occur with the use of all COCs.

It is extremely rare when using COCs that thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels.

In women with a combination of several risk factors or high severity of one of them, the possibility of their mutual reinforcement should be considered. In such cases, the degree of increase in the risk of blood clots may be higher than with a simple summation of factors. In this case, taking the drug Zhanin® is contraindicated (see section “Contraindications”).

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

- with age;

- in smokers (with an increase in the number of cigarettes or an increase in age, the risk increases, especially in women over 35 years old);

in the presence of:

— obesity (body mass index 30 kg/m2 or more);

- family history (for example, venous or arterial thromboembolism ever in close relatives or parents under the age of 50 years). 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 the drug Zhanine®;

- dislipoproteinemia;

- arterial hypertension;

- migraine;

— diseases of the heart valves;

- atrial fibrillation.

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

The increased risk of thromboembolism in the postpartum period should be taken into account.

An increase in the frequency and severity of migraine during use of the drug Zhanin® (which may precede cerebrovascular disorders) is grounds for immediate discontinuation of this drug.

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

— Tumors

A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of developing breast cancer (BC) diagnosed in women currently taking COCs (relative risk 1.24). The increased risk gradually disappears within 10 years of stopping these drugs. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the number of breast cancer diagnoses in women who are currently or recently taking COCs is insignificant in relation to the overall risk of this disease. Its connection with COC use has not been proven. The observed increase in the risk of developing breast cancer may be due not only to earlier diagnosis of breast cancer, but also to the biological effect of sex hormones or a combination of these two factors. Women who have ever used COCs are diagnosed with earlier stages of breast cancer than women who have never used them.

— Other states

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

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

Although COCs may have an effect on insulin resistance and glucose tolerance, there is usually no need to adjust the dose of hypoglycemic drugs in diabetic patients using low-dose COCs (<0.05 mg ethinyl estradiol). However, women with diabetes mellitus should be carefully monitored while taking COCs.

Preclinical safety data

Preclinical data from routine repeated-dose toxicity, genotoxicity, carcinogenicity and reproductive toxicity studies do not indicate a particular risk to humans. However, it should be remembered that sex hormones can promote the growth of certain hormone-dependent tissues and tumors.

Laboratory tests

Reduced efficiency

The effectiveness of Zhanine® may be reduced in the following cases: missed pills, gastrointestinal disorders or as a result of drug interactions.

Frequency and severity of menstrual-like bleeding

If irregular bleeding recurs or develops after previous regular cycles, careful evaluation should be performed to rule out malignancy or pregnancy.

No regular menstrual bleeding

Some women may not develop bleeding during a break in taking pills. “Contraindications” and “With caution”;

— Local compaction in the mammary gland;

- Concomitant use of other medications (see also “Interaction with other medications”);

- If prolonged immobility is expected (for example, a cast is applied to the lower limb), hospitalization or surgery is planned (at least four weeks before the proposed operation);

- Unusually heavy bleeding from the vagina;

- Missed a pill in the first week of taking the package and had sexual intercourse seven days or less before;

— Absence of regular menstrual-like bleeding two times in a row or suspicion of pregnancy (you should not start taking pills from the next package before consulting your doctor).

You should stop taking the tablets and consult your doctor immediately if there are possible signs of thrombosis, myocardial infarction or stroke: unusual cough; unusually severe pain behind the sternum, radiating to the left arm; unexpected shortness of breath, unusual, severe and prolonged headache or migraine attack; partial or complete loss of vision or double vision; slurred speech; sudden changes in hearing, smell, or taste; dizziness or fainting; weakness or loss of sensation in any part of the body; severe abdominal pain; severe pain in the lower limb or sudden swelling of any of the lower limbs.