Microgynon, 21 pcs., 150 mcg+30 mcg, film-coated tablets

Pharmacological properties of the drug Microgynon

The contraceptive effect of combined oral contraceptives (COCs) is based on the interaction of various factors, important among which are suppression of ovulation and changes in cervical secretion. In addition to preventing pregnancy, PDAs have a number of positive properties that can be used when choosing a method of contraception. The menstrual cycle becomes regular, menstruation is usually less painful, blood loss decreases (thereby reducing the incidence of iron deficiency anemia). There is evidence of a reduced risk of endometrial and ovarian cancer. In addition, when using high-dose COCs (50 mcg ethinyl estradiol), the risk of ovarian cysts, pelvic inflammatory diseases, benign breast diseases and ectopic pregnancy is reduced. Standard preclinical studies of repeated dose toxicity, genotoxicity, carcinogenicity and reproductive toxicity do not indicate any specific risk to humans. However, it should be noted that sex steroids can promote the growth of certain hormone-dependent tissues and pre-existing tumors. Levonorgestrel After oral administration, levonorgestrel is rapidly and completely absorbed. The peak concentration of the substance in the blood serum is about 3-4 ng/ml and is achieved approximately 1 hour after a single dose. The bioavailability of levonorgestrel after oral administration is almost complete. Levonorgestrel binds to plasma albumin and sex steroid binding globulin (SGBS). Only 1.3% of the total serum concentration is present as a free steroid, while about 64% is specifically bound to SHB and 35% is nonspecifically bound to albumin. Ethinyl estradiol-induced increase in SHPS levels affects the distribution between blood plasma proteins, causing an increase in the SHPS-bound fraction and a decrease in the albumin-bound fraction. The expected volume of distribution of levonorgestrel is 184 L after a single dose. Levonorgestrel is completely metabolized. Serum clearance is 1.3–1.6 ml/min/kg. The level of levonorgestrel in the blood serum decreases in 2 phases. Distribution in the final phase is characterized by a half-life of almost 20–23 hours. Levonorgestrel is not excreted in unchanged form. Metabolites are excreted in urine and bile in a 1:1 ratio. The half-life of metabolites is about 1 day. After daily use, the level of the drug in the blood serum increases approximately 3-4 times, reaching a state of equilibrium in the second half of the course of administration. The pharmacokinetics of levonorgestrel is affected by the level of SHPS, which increases approximately 1.7 times after oral administration of the drug Microgynon. This results in a decrease in clearance to approximately 0.7 ml/min/kg when equilibrium is reached. Ethinyl estradiol When administered orally, ethinyl estradiol is rapidly and completely absorbed. The maximum concentration is almost 95 pkg/ml and is achieved within 1–2 hours. During absorption and initial passage through the liver, ethinyl estradiol is significantly metabolized, resulting in an average oral bioavailability of about 45%. Ethinyl estradiol binds strongly and nonspecifically to plasma albumin (about 98%) and causes an increase in the concentration of GSPC. The volume of distribution is approximately 2.8–8.6 l/kg. Ethinyl estradiol is metabolized mainly by aromatic hydroxylation, however, a large number of hydroxyl and methyl metabolites are additionally formed, among which there are both free metabolites and conjugates with glucuronides and sulfates. Clearance is 2.3–7 ml/min/kg. Serum ethinyl estradiol levels decrease in 2 phases with half-lives of about an hour and 10–20 hours, respectively. The drug is not excreted from the body unchanged; ethinyl estradiol metabolites are excreted in urine and bile in a ratio of 4:6. The half-life of metabolites is about 1 day. Serum concentrations of ethinyl estradiol increase slightly after oral administration. The maximum concentration is about 114 pg/ml and is determined at the end of the cycle. Based on the variable serum half-life and daily dosing, the steady-state concentration of ethinyl estradiol in the serum is achieved in approximately one week.

Microgynon

When using a 2-phase drug, a reliable contraceptive effect occurs only in the second cycle of taking the drug, so other non-hormonal methods of contraception should be used in the first half of the cycle.

For teenage girls and women under 35 years of age, 3-phase low-dose drugs are recommended. 2-phase drugs are most suitable for women of a moderate gestagenic phenotype, and can also be used in young nulliparous women, because provide transformation of the uterine mucosa.

For therapeutic and prophylactic purposes, it is advisable to use monophasic drugs.

After stopping the drug, fertility is restored fairly quickly, within 1-3 menstrual cycles.

Prescription after childbirth or abortion (miscarriage) is recommended no earlier than the first normal menstrual cycle has passed.

Before starting contraception and every 6 months, a general medical and gynecological examination is recommended (including examination of the mammary glands, liver function, monitoring of blood pressure and cholesterol concentrations in the blood, urine analysis).

Excreted in small quantities into breast milk. Usually, taking oral contraceptives is indicated only during a long period of lactation, because During a short period of breastfeeding, the menstrual cycle, as a rule, is not restored. If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

Women who smoke and take hormonal contraceptive drugs have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk increases with age and depending on the number of cigarettes smoked (especially in women over 35 years of age).

With diarrhea and vomiting, the contraceptive effect is reduced (without stopping the drug, it is necessary to use additional non-hormonal methods of contraception).

Treatment should be stopped immediately if pregnancy occurs, migraine-like headaches develop (if they did not exist previously), early signs of phlebitis or phlebothrombosis appear (unusual pain or swelling of the veins in the legs), jaundice, visual impairment, cerebrovascular disorders, stabbing pain of unknown etiology. when breathing or coughing, pain and tightness in the chest, with increased blood pressure, as well as 3 months before a planned pregnancy and approximately 6 weeks before a planned surgical intervention, with prolonged immobilization.

Moderate bleeding during the course does not require discontinuation of use.

Use of the drug Microgynon

The pills should be taken every day according to the order indicated on the blister, at approximately the same time, with a small amount of liquid. The drug is taken 1 tablet per day for 21 days. Taking pills from each subsequent package should be started after the end of a 7-day break from taking the drug, during which menstrual-like bleeding usually occurs. As a rule, it begins on the 3rd day after taking the last pill and may not end by the time you start taking the pill from the next package. How to start taking Microgynon

1. No hormonal contraceptive drug was used in the previous period (last month). Taking the pills should begin on the 1st day of the patient’s menstrual cycle. You can start taking it from the 5th day, but in this case, during the first cycle, it is recommended to additionally use a barrier method of contraception in the first 7 days of using the drug.
2. Transfer from another combined PDA. It is advisable to start taking Microgynon the day after taking the last active pill of the previous COC, at least no later than the next day after a break in taking the pill or after taking the placebo pill of the patient's previous COC.
3. Transitioning from a progestogen-only method (mini-pills, injections, implants) or a progestogen-containing intrauterine system. You can start taking Microgynon any day after you stop taking the mini-pill (in the case of an implant or intrauterine system - on the day of their removal, in the case of an injection - instead of the next injection). However, in all cases it is recommended to additionally use a barrier method of contraception during the first 7 days of taking 1 tablet.
4. After an abortion in the first trimester of pregnancy. You can start taking Microgynon immediately after an abortion. In this case, there is no need to use additional contraception.
5. After childbirth or abortion in the second trimester of pregnancy. If you are breastfeeding, see the subsection Pregnancy and lactation.

It is recommended to start taking the drug Microgynon from the 21st to 28th day after childbirth or abortion in the second trimester of pregnancy. If you start taking the pill later, you must additionally use a barrier method of contraception during the first 7 days of taking the drug. However, if sexual intercourse has already taken place, then before starting to use the PDA, you need to exclude a possible pregnancy or wait for menstruation. What to do if you miss taking the pills If the delay in taking the pills does not exceed 12 hours, the contraceptive effect of the drug is not reduced. The missed pill should be taken as soon as possible. The next pill from this package should be taken at the usual time. If the delay in taking the missed pill exceeds 12 hours, contraceptive protection may decrease. In this case, you can follow two basic rules:

• a break in taking pills should never exceed 7 days;
• Adequate suppression of the hypothalamus-pituitary-ovarian system is achieved by continuously taking the pills for 7 days.

According to this, you must follow the recommendations below: 1st week You need to take the last missed pill as soon as possible, even if you have to take two pills at the same time. After this, continue to take the pills at the usual time. In addition, over the next 7 days you need to use a barrier method of contraception, such as a condom. If sexual intercourse took place in the previous 7 days, the possibility of pregnancy must be taken into account. The more pills you miss and the closer the break in taking the drug, the higher the risk of pregnancy. Week 2 You need to take the last missed pill as soon as possible, even if you have to take 2 pills at the same time. After this, continue to take the pills at the usual time. Provided you take the tablets correctly for 7 days before the first missed period, there is no need to use additional contraceptives. Otherwise, or if more than one pill is missed, it is recommended to additionally use a barrier method of contraception for 7 days. Week 3 The risk of decreased reliability increases as the break in taking the pill approaches. However, if you follow the regimen for taking pills, you can avoid a decrease in contraceptive protection. If you adhere to one of the following options, there will be no need to use additional contraceptives, provided you take the tablets correctly for 7 days before the missed period. If this is not the case, you need to stick to the first of the following options and use additional methods of contraception for the next 7 days.

1. It is advisable to take the last missed pill as soon as possible, even if you need to take 2 pills at the same time. After this, continue to take the pills at the usual time. The pills from the next package should be taken immediately after the end of the previous one, that is, there should be no break. It is unlikely that a woman will experience menstrual-like bleeding before finishing the second pack, although spotting or breakthrough bleeding may occur while taking the tablets.
2. You may also be advised to stop using the pills from the current package. In this case, the break in using the drug should be up to 7 days, including days of missing pills; You should start taking the drug from the next package.

If a tablet dose is missed and there is no menstrual bleeding during the first usual break in taking the drug, the possibility of pregnancy should be considered. Recommendations in case of gastrointestinal disorders In case of severe dysfunction, incomplete absorption of the drug is possible; in this case, you need to use additional contraception. If vomiting occurs within 3-4 hours after taking the pills, it is advisable to use the recommendations regarding skipping pills. If the patient does not want to change her usual regimen of using the drug, she needs to take additional tablet(s) from a different package. To delay the onset of menstruation, you need to continue taking Microgynon tablets from a new package and not take a break from taking the drug. If desired, the period of administration can be continued until the end of the second package. In this case, breakthrough bleeding or spotting cannot be ruled out. The usual use of the drug Microgynon continues after a 7-day break from taking the tablets. To shift the onset of menstruation to another day of the week, it is recommended to shorten the break in taking the pills by the required number of days. The shorter the break, the more often the absence of menstrual-like bleeding and breakthrough bleeding or spotting is noted while taking the pills from the second package (as in the case of a delay in the onset of menstruation).

Microgynon®

In case of planned surgery, it is recommended to stop taking the drug at least 4 weeks before the operation and not to resume taking it for 2 weeks after the end of immobilization.

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 (such as ampicillins and tetracyclines) 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 tablet in the package, you need to move on to the next package of Microgynon without the usual break in taking the tablet.

If any of the conditions/risk factors listed below currently exist, the potential risks and expected benefits of Microgynon treatment should be carefully weighed in each individual case and discussed with the woman before she decides to start taking the drug. If any of these conditions or risk factors worsen, intensify, or appear 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 evidence of an increased incidence of venous and arterial thrombosis and thromboembolism when taking combined oral contraceptives.

However, the incidence of venous thromboembolism (VTE) developing with combined oral contraceptives is less than the incidence associated with pregnancy (6 per 10,000 pregnant women per year).

In women taking combined oral contraceptives, extremely rare cases of thrombosis of other blood vessels, such as the hepatic, mesenteric, renal arteries and veins, the central retinal vein and its branches, have been described. The connection with the use of combined oral contraceptives has not been proven.

A woman should stop taking the drug and consult a doctor if symptoms of venous or arterial thrombosis or cerebrovascular disorders develop, which may include: unilateral leg pain and/or swelling; sudden severe chest pain, with or without radiation to the left arm; sudden shortness of breath; sudden attack of cough; any unusual, severe, prolonged headache; sudden partial or complete loss of vision; diplopia; slurred speech or aphasia; dizziness; loss of consciousness with/or without a seizure; weakness or very significant loss of sensation that suddenly appears on one side or in one part of the body; movement disorders; symptoms of "acute abdomen". The risk of thrombosis (venous and/or arterial) and thromboembolism increases:

- with age

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

in the presence of:

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

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

- dislipoproteinemia;

- arterial hypertension;

- migraine;

— diseases of the heart valves;

- atrial fibrillation;

- prolonged immobilization, major surgery, any leg surgery or major trauma. In these situations, it is advisable to stop using combined oral contraceptives (in the case of planned surgery, at least four weeks before it) and not to resume use for two weeks after the end of immobilization.

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

Circulatory abnormalities 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 migraines during the use of combined oral contraceptives (which may precede cerebrovascular events) may be grounds for immediate discontinuation of these drugs.

Biochemical parameters that may be indicative of hereditary or acquired susceptibility to venous or arterial thrombosis include activated protein C resistance, hyperhomocysteinemia, antithrombin-II deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

Tumors

There are reports of an increased risk of cervical cancer with long-term use of combined oral contraceptives. Its connection with the use of combined oral contraceptives has not been proven. Controversy remains regarding the extent to which these findings are attributable to sexual behavior and other factors such as human papillomavirus (HPV).

It was also found that there is a slightly increased relative risk of developing breast cancer diagnosed in women who used combined oral contraceptives. Its connection with the use of combined oral contraceptives has not been proven. The observed increased risk may be a consequence of earlier diagnosis of breast cancer in women using combined oral contraceptives.

In rare cases, the development of liver tumors has been observed during the use of combined oral contraceptives. 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 relationship with taking combined oral contraceptives 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 Crohn's disease and ulcerative colitis have also been described during the use of combined oral contraceptives.

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 (<0.05 mg ethinyl estradiol). However, women with diabetes mellitus should be carefully monitored while taking combined oral contraceptives.

Women prone to chloasma should avoid prolonged exposure to the sun and ultraviolet radiation while taking combined oral contraceptives.

Laboratory tests

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.

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.

Medical examinations

Before starting to use Microgynon, a woman is recommended to undergo 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 conduct control examinations every 6 months.

A woman should be warned that drugs like Microgynon do not protect against HIV infection (AIDS) and other sexually transmitted diseases!

Impact on the ability to drive a car and equipment

Not found.

Contraindications to the use of the drug Microgynon

The PDA should not be used if you have one of the following conditions or diseases. If any of these conditions or diseases occurs for the first time while using the COC, then the drug should be stopped immediately:

• venous or arterial thrombotic/thromboembolic events (eg deep vein thrombosis, pulmonary embolism, myocardial infarction) or cerebrovascular disorders, including a history;
• prodromal symptoms of thrombosis (for example, transient ischemic attack, angina), including a history;
• history of migraine with focal neurological symptoms;
• diabetes mellitus with vascular damage;
• the presence of severe or multiple risk factors for venous or arterial thrombosis may also be a contraindication (see section PECULIARITIES OF APPLICATION);
• pancreatitis (including a history) associated with severe hypertriglyceridemia;
• severe liver disease (until normalization of liver function indicators);
• liver tumors (benign or malignant), including history;
• known or suspected hormone-dependent malignant tumors (for example, genitals or mammary glands);
• vaginal bleeding of unknown etiology;
• pregnancy;
• hypersensitivity to the active substances or to any of the components of the drug.

Side effects of the drug Microgynon

Adverse effects have been reported with the use of COCs, but their relationship with the use of COCs has not been confirmed:

Special instructions for the use of Microgynon

If any of the following conditions/risk factors are present, it is necessary to weigh the benefits of using a COC against the possible risks, taking into account the individual characteristics of each patient, before prescribing a COC. If any of the following conditions or risk factors become worse, worse, or occur for the first time, it is recommended that you consult your doctor. The doctor must decide to stop using the COC. Based on the results of epidemiological studies, there is a possible connection between the use of COCs and an increased risk of venous and arterial thrombotic and thromboembolic diseases, such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism. The above conditions occur rarely. 1. Venous thromboembolism (VTE) - acute venous thrombosis and/or pulmonary embolism can occur when using any COC. The risk of VTE is very high during the first year of using COCs. The incidence of VTE in patients taking oral contraceptives with a low dose of estrogens (≤0.05 mg ethinyl estradiol) is up to 4 cases per 10,000 women/year compared with women not using oral contraceptives - 0.5–3 cases per 10,000 women/year The incidence of VTE associated with pregnancy is 6 cases per 10,000 women/year. Thrombosis of other blood vessels, such as arteries and veins of the liver, kidneys, mesenteric vessels, cerebral or retinal vessels, has been extremely rarely reported in women using COCs. There is no general conclusion regarding the connection of these complications with the use of PDAs. Symptoms of venous or arterial thrombotic/thromboembolic events or cerebrovascular disorders may include: unilateral lower extremity pain or swelling; sudden severe chest pain that may radiate to the left arm; sudden shortness of breath; sudden onset of cough; any unusual, severe, prolonged headache; sudden decrease or complete loss of vision; diplopia; speech impairment or aphasia; vertigo; collapse with or without partial epileptic seizure; weakness or very severe sudden numbness of one side or one part of the body; motor impairment; "acute" stomach. Factors that increase the risk of venous or arterial thrombotic/thromboembolic events or cerebrovascular events: age; smoking (with heavy smoking, the risk increases with age, especially in women over 35 years of age); family history (for example, cases of venous or arterial thromboembolism in siblings or parents at a relatively early age); obesity (body mass index more than 30 kg/m2); dyslipoproteinemia; arterial hypertension; migraine; heart valve disease; atrial fibrillation; prolonged immobilization, radical surgical interventions, any surgical operations on the lower extremities, significant injuries. In these cases, it is recommended to stop using the PDA (for elective operations at least 4 weeks before the procedure) and not restore it until 2 weeks after complete remobilization. It is necessary to take into account the increased risk of thromboembolism in the postpartum period. Other diseases that may be associated with circulatory disorders include: diabetes mellitus; systemic lupus erythematosus; hemolytic uremic syndrome; chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia. An increased incidence of migraine or its exacerbations during the use of COCs (which may predetermine cerebrovascular accidents) may require urgent cessation of COC use. Biochemical indicators that may be characteristic of a hereditary or acquired tendency to venous or arterial thrombosis include: activated protein C (APC) resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies). When analyzing the risk/benefit ratio, the physician should take into account the fact that adequate treatment of the conditions mentioned above may reduce the associated risk of thrombosis, and also that the risk of thrombosis associated with pregnancy is higher than with the use of low-dose COCs (≤0.05 mg ethinyl estradiol). 2. Tumors An important risk factor for the development of cervical cancer is the persistence of papillomavirus. Some epidemiological studies suggest an additional increase in this risk with long-term COC use, but this is controversial because the extent to which these data account for concomitant risk factors such as cervical screening and sexual behavior, including the use of barrier methods of contraception, is unclear. The results of 54 epidemiological studies indicate a slight increase in the risk (RR = 1.24) of developing breast cancer in women using COCs. The risk gradually decreases over 10 years after stopping taking COCs. Because breast cancer is rarely diagnosed in women under 40 years of age, the increase in breast cancer diagnosis among current or recent COC users is small relative to the overall risk of developing breast cancer. The results of these studies do not prove the existence of a causal relationship. The increased risk may be due to earlier diagnosis of breast cancer in women using COCs, the biological effects of COCs, or both. There was a tendency that breast cancer detected in patients who took COCs was clinically less severe than in those who never took COCs. In isolated cases, patients taking COCs were diagnosed with benign and, less frequently, malignant liver tumors, leading in some cases to life-threatening intra-abdominal bleeding. In case of complaints of severe pain in the epigastric region, enlarged liver size, or signs of intra-abdominal bleeding during differential diagnosis, the possibility of a liver tumor in women taking COCs should be taken into account. 3. Other conditions Women with hypertriglyceridemia (including a family history) are at risk of developing pancreatitis when using COCs. Slight increases in blood pressure have been reported in many women taking COCs, but clinically significant increases in blood pressure have been reported extremely rarely. However, if prolonged clinically significant hypertension (arterial hypertension) occurs while taking a COC, then it is necessary to discontinue the COC and direct treatment to the hypertension (arterial hypertension). If appropriate, the use of COCs can be resumed after normalization of blood pressure. The following diseases have been reported to occur or worsen during pregnancy and when using COCs, but their relationship is not completely clear: jaundice and/or skin itching associated with cholestasis, gallstone formation, porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, chorea Sydenham, herpes of pregnancy, hearing loss associated with otosclerosis. In case of acute or chronic liver dysfunction, it may be necessary to stop taking COCs until liver function tests normalize. If cholestatic jaundice relapses, which first occurred during pregnancy or previous use of sex hormones, the use of COCs should be discontinued. Although COCs may influence peripheral insulin resistance and glucose tolerance, there are no data regarding the need for changes in the therapeutic regimen in patients with diabetes mellitus taking low-dose COCs (≤0.05 mg ethinyl estradiol). However, patients with diabetes mellitus should be under medical supervision during the period of taking COCs. Crohn's disease and ulcerative colitis may be associated with COC use. Chloasma can sometimes occur, especially in patients with a history of chloasma during pregnancy. Patients predisposed to the development of chloasma should avoid exposure to direct sunlight or ultraviolet radiation while taking COCs. Medical examination Before starting or resuming taking the drug Microgynon, it is necessary to conduct a full medical examination and study the patient’s medical history in detail, taking into account contraindications (see CONTRAINDICATIONS) and warnings (see PECULIARITIES OF APPLICATION). When using COCs, it is recommended to conduct periodic examinations, since the conditions listed in the CONTRAINDICATIONS section (for example, transient circulatory disorders, etc.) or risk factors (for example, a family history of venous or arterial thrombosis) may appear for the first time while taking COCs. The frequency and nature of these examinations should be based on current standards of medical practice, taking into account the individual characteristics of each patient. Particular attention is paid to examination of the pelvic organs, including standard cytological analysis of the cervix, abdominal organs, mammary glands, and blood pressure control. The patient must be warned that oral contraceptives do not protect against HIV infection and other sexually transmitted diseases. Decreased effectiveness The effectiveness of combined oral contraceptives may be reduced if a pill is missed, gastrointestinal dysfunction or other medications are used. Monitoring your cycle When taking oral contraceptives, you may experience intermenstrual bleeding (spotting or breakthrough bleeding), especially during the first few months. Taking this into account, examination in the event of the appearance of any intermenstrual discharge should be carried out only after a period of adaptation of the body to the drug (about three cycles). If the cycle disorder continues or occurs after several normal cycles, non-hormonal causes of bleeding should be considered and appropriate examinations should be carried out to exclude the presence of tumors and pregnancy. Curettage can be included in the diagnosis. Some patients may not experience menstrual bleeding during a break in taking the drug. If you take your COC as directed, there is a low chance of pregnancy. However, if the contraceptive was taken irregularly, if menstrual-like bleeding is absent for two cycles, pregnancy must be excluded before continuing to take the COC. Pregnancy and lactation The drug is contraindicated for use during pregnancy. If pregnancy occurs while using the drug Microgynon, its use must be stopped. However, the results of epidemiological studies do not indicate an increased risk of congenital defects in children born to patients who took COCs before pregnancy, nor do they indicate the existence of a teratogenic effect when unintentionally taking COCs in early pregnancy. PDAs can affect lactation, since under their influence the amount of breast milk can decrease and also change its composition. Given this, COCs are not recommended for use during breastfeeding. The active substances included in the drug and/or their metabolites are excreted in small quantities into breast milk, although there is no evidence that this negatively affects the health of the infant. The drug does not affect the ability to drive vehicles or operate machinery.

Microgynon, 21 pcs., 150 mcg+30 mcg, film-coated tablets

In case of planned surgery, it is recommended to stop taking the drug at least 4 weeks before the operation and not to resume taking it for 2 weeks after the end of immobilization.

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 (such as ampicillins and tetracyclines) 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 tablet in the package, you need to move on to the next package of Microgynon without the usual break in taking the tablet.

If any of the conditions/risk factors listed below currently exist, the potential risks and expected benefits of Microgynon treatment should be carefully weighed in each individual case and discussed with the woman before she decides to start taking the drug. If any of these conditions or risk factors worsen, intensify, or appear 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 evidence of an increased incidence of venous and arterial thrombosis and thromboembolism when taking combined oral contraceptives.

However, the incidence of venous thromboembolism (VTE) developing with combined oral contraceptives is less than the incidence associated with pregnancy (6 per 10,000 pregnant women per year).

In women taking combined oral contraceptives, extremely rare cases of thrombosis of other blood vessels, such as the hepatic, mesenteric, renal arteries and veins, the central retinal vein and its branches, have been described. The connection with the use of combined oral contraceptives has not been proven.

A woman should stop taking the drug and consult a doctor if symptoms of venous or arterial thrombosis or cerebrovascular disorders develop, which may include: unilateral leg pain and/or swelling; sudden severe chest pain, with or without radiation to the left arm; sudden shortness of breath; sudden attack of cough; any unusual, severe, prolonged headache; sudden partial or complete loss of vision; diplopia; slurred speech or aphasia; dizziness; loss of consciousness with/or without a seizure; weakness or very significant loss of sensation that suddenly appears on one side or in one part of the body; movement disorders; symptoms of "acute abdomen". The risk of thrombosis (venous and/or arterial) and thromboembolism increases:

- with age

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

in the presence of:

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

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

- dislipoproteinemia;

- arterial hypertension;

- migraine;

— diseases of the heart valves;

- atrial fibrillation;

- prolonged immobilization, major surgery, any leg surgery or major trauma. In these situations, it is advisable to stop using combined oral contraceptives (in the case of planned surgery, at least four weeks before it) and not to resume use for two weeks after the end of immobilization.

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

Circulatory abnormalities 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 migraines during the use of combined oral contraceptives (which may precede cerebrovascular events) may be grounds for immediate discontinuation of these drugs.

Biochemical parameters that may be indicative of hereditary or acquired susceptibility to venous or arterial thrombosis include activated protein C resistance, hyperhomocysteinemia, antithrombin-II deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

Tumors

There are reports of an increased risk of cervical cancer with long-term use of combined oral contraceptives. Its connection with the use of combined oral contraceptives has not been proven. Controversy remains regarding the extent to which these findings are attributable to sexual behavior and other factors such as human papillomavirus (HPV).

It was also found that there is a slightly increased relative risk of developing breast cancer diagnosed in women who used combined oral contraceptives. Its connection with the use of combined oral contraceptives has not been proven. The observed increased risk may be a consequence of earlier diagnosis of breast cancer in women using combined oral contraceptives.

In rare cases, the development of liver tumors has been observed during the use of combined oral contraceptives. 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 relationship with taking combined oral contraceptives 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 Crohn's disease and ulcerative colitis have also been described during the use of combined oral contraceptives.

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 0.05 mg ethinyl estradiol). However, women with diabetes mellitus should be carefully monitored while taking combined oral contraceptives.

Women prone to chloasma should avoid prolonged exposure to the sun and ultraviolet radiation while taking combined oral contraceptives.

Laboratory tests

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.

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.

Medical examinations

Before starting to use Microgynon, a woman is recommended to undergo 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 conduct control examinations every 6 months.

A woman should be warned that drugs like Microgynon do not protect against HIV infection (AIDS) and other sexually transmitted diseases!

Impact on the ability to drive a car and equipment

Not found.

Interactions of the drug Microgynon

With other drugs may lead to breakthrough bleeding and/or loss of contraceptive effectiveness. Interactions with drugs that induce microsomal enzymes may occur. These include, for example, phenytoin, barbiturates, primidone, carbamazepine, rifampicin and (possibly) oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, as well as medicines containing St. John's wort. This interaction may cause an increase in the clearance of sex hormones. Some clinical studies suggest that ethinyl estradiol levels may be reduced by certain antibiotics (eg penicillin and tetracycline antibiotics). When treating with any of the above drugs, it is necessary to temporarily use a barrier method of contraception in addition to taking COCs or choose another method of contraception. When treating with drugs that induce microsomal enzymes, the barrier method should be used throughout the entire period of treatment with the corresponding drug and for another 28 days after stopping its use. When treating with an antibiotic (with the exception of rifampicin and griseofulvin), the barrier method should be used for another 7 days after its discontinuation. If the barrier method is still being used, and the tablets in the PDA package have already run out, taking the tablets from the next package should be started without the usual break. Oral contraceptives may affect the metabolism of other drugs. Taking this into account, the concentrations of active substances in blood plasma and tissues (for example, cyclosporine) may change. Note: to determine the potential for interaction with drugs that are taken concomitantly with COCs, it is recommended that you read the instructions for medical use of these drugs. Impact on laboratory results Taking contraceptives may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, plasma levels of proteins (carriers), such as sex hormone-binding globulin and fractions lipids/lipoproteins, parameters of carbohydrate metabolism, as well as parameters of coagulation and fibrinolysis. Usually such changes are within normal limits.

Microgynon®

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

Diseases of the cardiovascular system

The results of epidemiological studies indicate a relationship between the use of COCs and an increased incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders). 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 COCs or resumption of use of the same or different COCs (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 COCs (containing less than 0.05 mg ethinyl estradiol) is two to three times higher than in non-pregnant patients not taking COCs, however, this risk remains lower than the risk of VTE with 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 any COC.

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 (DVT)

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

Symptoms of pulmonary embolism (PE)

: 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 or less severe complications (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, limbs, especially on one side of the body, sudden confusion, problems with speech and understanding; 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, 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 Microgynon® 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);

- 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 COCs;

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

- with dislipoproteinemia;

- for arterial hypertension;

- for migraine;

- for diseases of the heart valves;

- with atrial fibrillation;

- in case of prolonged immobilization, major surgery, any operation on the lower extremities or major trauma.

In these situations, it is recommended to stop using COCs (in the case of planned surgery, at least four weeks before it) and not to resume use for two weeks after the end of immobilization. Temporary immobilization (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.

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.

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 (which may precede cerebrovascular events) during the use of COCs may be grounds for immediate discontinuation of these drugs.

Biochemical indicators indicating a hereditary or acquired predisposition to the development of 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 can 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 COCs (containing less than 0.05 mg ethinyl estradiol).

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. 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 the incidence of breast cancer in women who are currently or recently taking COCs 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 who use COCs (they are diagnosed with earlier clinical forms of breast cancer than women who do not use COCs), the biological effects of COCs, or a combination of both.

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. In case of severe abdominal pain, liver enlargement or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.

Other states

In women with hypertriglyceridemia (or a family history of this condition), the risk of developing pancreatitis may increase 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. COCs can be continued if normal blood pressure levels 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: cholestatic 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 Crohn's disease and ulcerative colitis have also been described with the use of COCs.

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 generally no need for dose adjustment of hypoglycemic agents in diabetic patients using low-dose COCs (containing less than 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 should avoid prolonged exposure to the sun and exposure to ultraviolet radiation while taking COCs.

Laboratory tests

The use of drugs such as Microgynon® may affect the results of some laboratory tests, including biochemical indicators of liver, thyroid, kidney and adrenal function, plasma concentrations of transport proteins (for example, corticosteroid binding globulin, lipid/lipoprotein fractions, parameters of carbohydrate metabolism , coagulation and fibrinolysis). These changes usually remain within normal physiological values.

Reduced efficiency

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

Effect on bleeding pattern

While taking COCs, irregular bleeding may occur (“spotting” and/or “breakthrough” 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.

Some women may not develop bleeding during a break in taking pills; “ooContraindications” and “Use with caution”;

— Local compaction in the mammary gland;

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

- If prolonged immobilization 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 drug 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.