Modell Pro tablets 3 mg +0.03 mg 21 pcs. in Stupino

MODELL PRO (form - tablets) belongs to the group of sex hormones and modulators of the reproductive system. The instructions for use highlight the following features of the medicine:

How to dissolve vascular plaques, normalize blood circulation, blood pressure and forget the way to the pharmacy

• Sold only with a doctor's prescription
• During pregnancy: contraindicated
• When breastfeeding: contraindicated
• In childhood: with caution
• For liver dysfunction: with caution
• If renal function is impaired: with caution
• In old age: with caution

Compound

Directions for use and doses

Inside.

The tablets should be taken in the order indicated on the package, at approximately the same time every day, with a small amount of water.

You should take 1 tablet. continuously for 21 days. Taking the tablets from the next package begins after a 7-day break, during which menstrual-like bleeding (withdrawal bleeding) is usually observed. As a rule, it begins on the 2-3rd day after taking the last tablet and may not end until you start taking tablets from a new package.

Start taking MODELL® PRO.

If you have not taken any hormonal contraceptives in the previous month, use of MODELL® PRO should begin 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 2nd–5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the tablets from the first package.

Switching from other COCs, vaginal ring or contraceptive patch.

It is preferable to start taking MODELL PRO the day after taking the last tablet from the previous package, but in no case later than the next day after the usual 7-day break. Taking MODELL® PRO should begin on the day the vaginal ring or patch is removed, but no later than the day when a new ring is to be inserted or a new patch is applied.

Switching from contraceptives containing only gestagens (mini-pills, injectable forms, implant or IUD with controlled release of gestagen).

You can switch from a mini-pill to taking MODELL® PRO on any day (without a break), from an implant or IUD on the day of their 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 pills.

After an abortion in the first trimester of pregnancy, you can start taking the drug immediately—on the day of the abortion.

If this condition is met, 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 21st–28th day after childbirth (in the absence of breastfeeding) 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 pills. If sexual contact has taken place, then before starting to take the drug MODELL® PRO, you should exclude pregnancy or wait until your first menstruation.

Taking missed pills.

If the delay in taking the drug is less than 12 hours, contraceptive protection is not reduced.

You should take the tablet as soon as possible, and take the next tablet at the usual time. If the delay in taking the drug is more than 12 hours, contraceptive protection may be reduced. The more pills are missed and the closer the missed pill is to the 7-day break in taking pills, the greater the likelihood of pregnancy. 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 pill taking are required. Accordingly, if the delay in taking the pills is more than 12 hours (the interval since the last pill was taken is more than 36 hours), the woman should follow the recommendations given below.

The first week of using the drug.

The last missed pill should be taken as soon as possible, as soon as the woman remembers (even if this means taking two pills at the same time). The next tablet is taken at the usual time. Additionally, you should use a barrier method of contraception (such as a condom) for the next 7 days. If sexual intercourse took place during the week before missing the pill, the possibility of pregnancy must be taken into account.

Second week of using the drug.

The last missed pill should be taken as soon as possible, as soon as the woman remembers (even if this means taking two pills at the same time). The next tablet is taken at the usual time. Provided that the woman has taken the pills correctly for the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures.

Otherwise, or if you miss two or more tablets, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.

Third week of using the drug.

The risk of pregnancy increases due to the upcoming break in taking the pills. You should strictly adhere to one of the following two options. However, if during the 7 days preceding the first missed pill, all pills were taken correctly, there is no need to use additional contraceptive methods. Otherwise, you must use the first of the following regimens and additionally use a barrier method of contraception (for example, a condom) for 7 days.

1. It is necessary to take the last missed pill as soon as possible, as soon as the woman remembers it (even if this means taking two pills at the same time). The next tablets are taken at the usual time until the tablets in the current pack 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 tablets.

2. You can also stop taking tablets from the current package, thus starting a 7-day break (including the day you missed tablets), and then start taking tablets from a new package. If a woman misses taking pills and then does not have withdrawal bleeding during the break, pregnancy must be ruled out.

Recommendations in case of gastrointestinal disorders.

In case of severe gastrointestinal disorders (vomiting, diarrhea), absorption may be incomplete, so additional methods of contraception should be used. If vomiting occurs within 3-4 hours after taking the tablet, you should follow the recommendations for skipping tablets. If a woman does not want to change her usual dosing regimen and move her menstrual cycle to another day of the week, an additional tablet should be taken from a different package.

Changing the day the menstrual cycle begins.

In order to delay the onset of menstruation, it is necessary to continue taking tablets from the new MODELL® PRO package without a 7-day break. Tablets from the new package can be taken for as long as necessary, incl. until the packaging runs out. While taking the drug from the second package, spotting from the vagina or breakthrough uterine bleeding are possible. You should resume regular use of MODELL® PRO from the next package after the usual 7-day break. In order to postpone the onset of menstruation to another day of the week, a woman should shorten the next break in taking pills by the desired number of days. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and will subsequently experience spotting and breakthrough bleeding while taking the second pack (just as if she would like to delay the onset of menstruation).

Additional information for special categories of patients

Use in children.

The effectiveness and safety of the drug as a contraceptive have been studied in women of reproductive age. It is assumed that the effectiveness and safety of the drug in post-pubertal age up to 18 years are similar to those in women after 18 years. The use of the drug before menarche is not indicated.

Use in old age.

After menopause, MODELL® PRO is not indicated.

Use for liver dysfunction.

The use of the drug is contraindicated if you currently have or have a history of severe liver disease (until normalization of liver test results), or if you currently have or have a history of benign or malignant liver tumors.

Use for renal impairment.

The use of the drug is contraindicated in acute renal failure and severe renal failure.

Modell® PRO (Modelle PRO)

If any of the conditions, diseases or risk factors listed below currently exist, the potential risks and expected benefits of using COCs, including the combination of drospirenone + ethinyl estradiol, should be carefully weighed in each individual case and discussed with the woman before starting taking the drug. If any of these conditions, diseases 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.

Risk of developing VTE and ATE

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 DVT, PE, myocardial infarction, cerebrovascular disorders). These diseases are rarely reported.

The increased risk of developing VTE associated with the use of COCs is due to the presence of estrogen in its composition. Drugs containing levonorgestrel, norgestimate, or norethisterone as a progestogen component are associated with the lowest risk of VTE.

When using other COCs, such as the combination of drospirenone + ethinyl estradiol, the risk of developing VTE is 2 times higher. The choice of a COC with a higher risk of VTE should only be made after consultation with the woman to ensure that she fully understands the risk of VTE associated with the contraceptive, the effect of the drug on her existing risk factors and that the risk of developing VTE maximum in the first year of taking COCs (mainly during the first 3 months). An increased risk is also observed when COC use is resumed (after a break between doses of the drug of 4 weeks or more). VTE can be life-threatening or lead to death (in 1-2% of cases). VTE, manifested as DVT and/or PE, can occur with 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 DVT:

unilateral swelling of the lower limb or along the vein, pain or discomfort 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:

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).

ATE 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, severe or prolonged headache for no apparent reason, one- or two-sided loss of vision; problems with speech and understanding; sudden disturbance in gait, dizziness, loss of balance or coordination; sudden loss of consciousness or fainting with or without a seizure. Other signs of vascular occlusion: sudden pain, swelling and slight cyanosis of the extremities, “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.

ATE can be life-threatening and lead to death.

In women with a combination of several risk factors or high severity of one of the factors, 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, the combination of drospirenone + ethinyl estradiol is contraindicated.

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 smoked or an increase in age, the risk increases, especially over the age of 35 years);

- if there is a family history (for example, VTE or ATE in close relatives or parents aged less than 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 COCs;

— for obesity (with a BMI 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, pelvis or major trauma: in these cases, the use of COCs should be stopped (in the case of planned surgery, at least four weeks before it) and not restarted within two weeks after the woman’s mobility is completely restored.

Temporary immobilization (eg, air travel lasting more than 4 hours) may also be a risk factor for the development of VTE, especially in the presence of other risk factors.

The possible role of varicose veins and superficial thrombophlebitis in the development of TVE 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 is 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 therapy for the relevant condition/disease can reduce the associated risk of thrombosis.

Tumors

The most significant risk factor for the development of cervical cancer (CC) is persistent human papillomavirus infection. There are reports of a slight increase in the risk of developing breast cancer with long-term use of COCs, but the connection with COC use has not been proven. Controversy remains regarding the extent to which these findings are related to screening for cervical pathology or to women's sexual behavior (lower use of barrier methods of contraception, greater number of sexual partners).

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. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the incidence of breast cancer in women who are currently taking COCs or have recently taken it is insignificant in relation to the overall risk of this disease. Its connection with COC use has not been proven. The observed increase in risk may be a consequence of earlier diagnosis of breast cancer in women taking COCs (they are diagnosed with earlier clinical forms of breast cancer than women not taking COCs), the biological effect of COCs, or a combination of both of these factors.

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

Drospirenone is an aldosterone antagonist with potassium-sparing properties. In most cases, there should be no increase in plasma potassium concentration. In clinical studies in some patients with mild to moderate renal impairment and concomitant use of potassium-sparing drugs, plasma potassium concentrations were slightly increased while taking drospirenone. Therefore, it is necessary to monitor the concentration of potassium in the blood plasma during the first cycle of taking the drug in patients with renal failure and when the initial potassium concentration is at the upper limit of normal, especially when taking potassium-sparing drugs concomitantly.

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 (BP) 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 during the use of COCs, the COC should be discontinued and treatment of arterial hypertension should be initiated. If normal blood pressure values ​​are achieved with antihypertensive therapy, COC use can be continued.

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; gestational herpes; hearing loss associated with otosclerosis. Cases of Crohn's disease or ulcerative colitis have also been described during 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 normalize. 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, in patients with diabetes mellitus using low-dose COCs (containing less than 50 mcg ethinyl estradiol), as a rule, no dose adjustment of hypoglycemic drugs is required. 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 ultraviolet radiation while taking COCs.

Low mood and depression are known adverse reactions when using hormonal contraceptives. Depression can be serious and is a known risk factor for suicidal behavior and suicide. Women should be advised to consult a doctor if mood changes or symptoms of depression occur, including soon after starting contraception.

Effect on liver function tests

In clinical trials of hepatitis C viral therapy with drugs containing ombitasvir/paritaprevir/ritonavir and dasabuvir (with or without ribavirin), increases in ALT levels greater than 5 times the upper limit of normal were significantly more common in patients using ethinyl estradiol-containing drugs such as like COC. Women taking MODELL® PRO should switch to an alternative method of contraception (progestogen only or non-hormonal methods of contraception). Taking MODELL® PRO should be discontinued before starting antiviral therapy and can be resumed no earlier than 2 weeks after completion of therapy with a combination of antiviral drugs.

Laboratory tests

The use of drugs such as drospirenone + ethinyl estradiol may affect the results of some laboratory tests, including biochemical indicators of liver, thyroid, kidney and adrenal function, the concentration of transport proteins in plasma (for example, transcortin, lipid / lipoprotein fractions, parameters of carbohydrate metabolism, coagulation and fibrinolysis ). These changes usually remain within normal physiological values. Drospirenone increases plasma renin activity and aldosterone concentrations, which is associated with its antimineralocorticoid effect.

Reduced efficiency

The effectiveness of COCs may be reduced in the following cases: in case of 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, assessment of any irregular bleeding should be carried out after an adaptation period of approximately three cycles of dosing.

If irregular bleeding recurs or develops after previous regular cycles, the woman should be carefully examined to rule out malignancy or pregnancy.

Some women may not develop withdrawal bleeding during a break in taking contraceptive pills; pregnancy should be excluded before continuing to take it.

Medical examinations

Before starting or resuming taking the drug drospirenone + ethinyl estradiol, it is necessary to familiarize yourself with the woman’s life history and family history, conduct a thorough general medical examination (including changes in blood pressure, determination of BMI) and gynecological examination (with mandatory examination of the mammary glands and cytological examination of the cervical epithelium), and exclude pregnancy. The scope of additional studies and frequency of follow-up examinations are determined individually. Typically, follow-up examinations should be carried out at least once every 6 months. It must be remembered that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases!

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.

Special precautions when disposing of unused drugs

No special precautions are required when disposing of unused medicinal products.

Synonyms of nosological groups

MODELL PRO

special instructions

Before starting or resuming the use of the drug MODELL PRO, 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 uterus (Papanicolaou test), exclude pregnancy.
The scope of additional studies and frequency of follow-up examinations are determined individually. Typically, follow-up examinations should be carried out at least once every 6 months. A woman should be informed that MODELL PRO does not protect against HIV infection (acquired immunodeficiency syndrome - 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 using COCs should be carefully weighed in each individual case and discussed with the woman before she decides to start taking the drug. If risk factors become more severe, intensify, or when risk factors first appear, it may be necessary to discontinue the drug.

Diseases of 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, and cerebrovascular diseases. 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 suggest that this increased risk is predominantly present during the first 3 months.

The overall risk of VTE in patients taking low-dose COCs (containing <50 mcg ethinyl estradiol) is 2-3 times higher than in non-pregnant patients not taking COCs, although the risk remains lower than the risk of VTE in pregnancy and childbirth VTE can be fatal (in 1-2% of cases).

VTE, manifested as deep vein thrombosis or pulmonary embolism, can develop 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. There is no consensus regarding the relationship between the occurrence of these events and the use of COCs. Symptoms of deep vein thrombosis (DVT) include: unilateral swelling of the lower extremity or along a vein in the lower extremity, pain or discomfort in the lower extremity only when standing or walking, localized warmth in the affected lower extremity, redness or discoloration of the skin on the lower extremity limbs.

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, 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 include: pain; discomfort; a feeling of pressure, heaviness, a feeling of squeezing or fullness in the chest, in the arm or behind the sternum; discomfort in the left half of the chest radiating to the back, cheekbone, larynx, arm, epigastric region; 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 an increase in the number of cigarettes or an increase in 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 COCs;

- with prolonged immobilization, major surgery, any operation on the lower extremities or major trauma. In these situations, it is advisable to stop using COCs (in the case of a planned operation, at least four weeks before it) and not resume use for two weeks after the end of immobilization;

- with dislipoproteinemia;

- for arterial hypertension;

- for migraine;

- 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, SLE, 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 attacks during the use of COCs (which may precede cerebrovascular events) should 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, the presence of antibodies to phospholipids (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 50 mcg ethinyl estradiol). Medicines containing levonorgestrel, norgestimate, or norethindrone. have a low risk of developing venous thromboembolism. In drugs that include drospirenone, the risk of developing thromboembolic complications is 2 times higher, therefore, before a woman is recommended to take MODELL PRO, she should be warned about this increased risk.

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. There remains conflicting evidence 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. The relationship between the development of breast cancer and COC use has not been proven. The observed increased risk may also be a consequence of careful monitoring and earlier diagnosis of breast cancer in women using COCs. Women who have ever used COCs are diagnosed with earlier stages of breast cancer than 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 condition.

Clinical studies have shown no effect of drospirenone on serum potassium concentrations in patients with mild to moderate renal failure. Theoretically, there is a risk of developing hyperkalemia in patients with impaired renal function and initial potassium levels at the upper limit of normal or while taking medications that lead to potassium retention in the body.

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 hypertension has been reported rarely. However, if a persistent, clinically significant increase in blood pressure develops while taking COCs, these drugs should be discontinued and treatment of 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 during both pregnancy and COC use, but their association with COC use has not been proven: jaundice and/or pruritus associated with cholestasis; formation of gallstones; porphyria; SLE; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis. Cases of Crohn's disease or ulcerative colitis have also been described during the use of COCs.

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

In case of acute or chronic liver dysfunction, it may be necessary to discontinue the drug 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 COC use.

Although COCs 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 COCs (containing less than 50 mcg ethinyl estradiol). However, women with diabetes need careful monitoring of blood glucose concentrations while using the drug.

When using the drug, chloasma may develop. especially in women with a history of chloasma during pregnancy. Women with a tendency to chloasma should avoid prolonged exposure to the sun and exposure to ultraviolet radiation while taking COCs.

The effectiveness of COCs may be reduced by missed pills, vomiting and diarrhea, or as a result of drug interactions.

Effect on the menstrual cycle.

While using COCs, irregular (acyclic) bleeding may occur (“spotting” or “breakthrough” bleeding), especially during the first months of use. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately 3 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 in taking the pills; pregnancy must be ruled out before continuing to take the drug.

Influence neither indicators of laboratory tests.

Taking COCs may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma transport proteins, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond normal values. Drospirenone increases plasma renin and aldosterone activity, which is associated with its antimineralocorticoid effect.