Index of drugs

Hormonal contraception. The decision to prescribe the preparation should be made on the basis of an individual assessment of risk factors in women, in particular the risk of venous thromboembolism and the risk of venous thromboembolism associated with the use of the preparation in relation to other combined hormonal contraceptives.

1 tabl powl. contains 0.03 mg ethinyl estradiol and 2 mg chlormadinone acetate. The preparation contains lactose.

A complex oral contraceptive. The use of the preparation inhibits the secretion of FSH and LH in the pituitary gland and, therefore, inhibition of ovulation. There are changes in the proliferation and endocrine secretion activity. The consistency of the cervical mucus changes. After oral administration, chlormadinone acetate is absorbed quickly and almost completely. Systemic bioavailability is high because it is not subject to first pass metabolism. The maximum plasma concentration is achieved after 1-2 h. In> 95%, it binds to plasma proteins, mainly to albumin. It has no affinity for sex hormone binding globulin (SHBG) or corticosteroid binding globulin (CBG). It is mainly stored in adipose tissue. As a result of various reduction and oxidation processes and conjugation to glucuronides and sulfates, many different metabolites of chlormadinone acetate are formed. 3-Hydroxymetabolite has similar antiandrogenic effects as the parent compound. T_0,5 chlormadinone acetate in the elimination phase is approx. 34 h (after a single dose) and on average 36-39 h (after multiple doses). Chlormadinone acetate and its metabolites are excreted in almost equal amounts by the kidneys and stools. Ethinylestradiol is rapidly and completely absorbed after oral administration, reaching an average concentration of 1.5 hours. Absolute bioavailability is about 40%, due to the phenomenon of pre-systemic conjugation and the first pass effect in the liver and subject to significant individual variability (20-65% ). It is 98% bound to plasma proteins, almost entirely to albumin. It is metabolized by hydroxylation of the aromatic ring (with the participation of cytochrome P-450). The main metabolite is 2-hydroxyethynyl estradiol, which is metabolized to further metabolites and conjugates. Ethinyl estradiol undergoes pre-systemic transformation in both the duodenal and hepatic mucosa. Medium T_0,5 ethinyl estradiol in plasma is about 12-14 h. It is excreted in the form of metabolites through the kidneys and in the faeces in a 2: 3 ratio. Ethinyl estradiol sulphate is excreted into the bile after hydrolysis by intestinal bacteria and undergoes enterohepatic circulation.

Hypersensitivity to the active substances or to any of the excipients. Occurrence or risk of venous thromboembolism (VTE): venous thromboembolism - active (treated with anticoagulants) or history of venous thromboembolism, e.g. deep vein thrombosis (DVT), pulmonary embolism (PE); known hereditary or acquired predisposition for venous thromboembolism, e.g. resistance to active C protein (APC) (including V Leiden factor), antithrombin III deficiency, protein C deficiency, protein S deficiency; extensive surgery associated with long-term immobilization; high risk of venous thromboembolism due to multiple risk factors. Occurrence or risk of arterial thromboembolism (ATE): arterial thromboembolic events - active (eg myocardial infarction) or prodromal symptoms (eg angina pectoris); cerebrovascular diseases - active stroke, previous stroke or prodromal symptoms (eg transient ischemic attack - TIA); confirmed hereditary or acquired propensity for arterial thromboembolic events, e.g. hyperhomocysteinemia and the presence of anti-phospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant); migraine with focal neurological symptoms in an interview; high risk of arterial thromboembolic events due to the presence of multiple risk factors or the presence of one of the major risk factors, such as: diabetes with vascular complications, severe hypertension, severe dyslipoproteinaemia. Insufficiently controlled diabetes. Uncontrolled hypertension or significant increase in blood pressure (permanently maintained blood pressure values ​​above 140/90 mmHg). Hepatitis, jaundice, abnormal liver function, until the liver function parameters have not returned to normal.Generalized pruritus, cholestasis, especially when it occurred during the last pregnancy or during estrogen therapy. Dubin-Johnson syndrome, Rotor syndrome, biliary disorders. Occurrence of liver tumors in the past or present. Severe epigastric pain, enlargement of the liver or symptoms of bleeding into the abdomen. The first or the Next porphyria attack (all 3 types, especially acquired porphyria). The presence of or in the past of hormone-dependent tumors such as breast or uterine tumors. Severe disorders of lipid metabolism. Occurrence of pancreatitis in the past or in the past if severe hypertriglyceridemia has occurred. Severe sensory disorder, e.g. visual or hearing impairment. Motor disorders (especially paresis). Increased frequency of epileptic seizures. Severe depression. Severity of otosclerosis during the last pregnancy. No menstrual bleeding with undetermined etiology. Hypertrophy of the endometrium. Bleeding from the genital tract of undetermined etiology. A contraindication may also be the presence of one serious or several risk factors for arterial or venous thrombosis.

Cigarette smoking increases the risk of serious cardiovascular side effects associated with the use of combined hormonal contraceptives. This risk increases with age and the number of cigarettes smoked, and is particularly marked in women over the age of 35. Women over the age of 35 who smoke cigarettes should use other methods of contraception. The use of combined hormonal contraceptives is associated with an increased risk of venous thromboembolism compared to when the therapy is not used. The use of preparations containing levonorgestrel, norgestimate or norethisterone is associated with the lowest risk of venous thromboembolism. The risk of using Belara has not been established as compared to these low-risk medicines. The decision to use the preparation from outside the group of preparations known for the lowest risk of venous thromboembolism should only be taken after talking to the patient, to ensure that she understands the risk of venous thromboembolism, how current risk factors affect this risk, and that the risk of venous thromboembolism is the highest in the first year of use. There is some evidence that the risk increases when combined hormonal contraceptives are taken again after a break in use for 4 weeks or longer. It has not yet been established how the risk of venous thromboembolism is associated with the use of the combined hormonal contraceptives containing chlormadinone for the risks associated with the use of levonorgestrel-containing combined hormonal contraceptives. In patients using combined hormonal contraceptives, cases of thrombosis in other blood vessels, such as the hepatic, mesenteric, renal, or retinal veins and arteries, have been reported very rarely. Risk factors for venous thromboembolism: obesity (BMI body mass index over 30 kg / m²) - the risk increases significantly with the increase in BMI, this is especially important for women who also have other risk factors; long-term immobilization, extensive surgery, any surgical operation in the lower limbs or pelvis, neurosurgical surgery or serious trauma - it is recommended to stop using the tablets for at least 4 weeks before the planned surgery and not to resume use within 2 weeks from the time of return for motor function (another method of contraception should be used), anticoagulant therapy should be considered if the preparation has not been discontinued early (temporary immobilization, including air travel> 4 h, may also be a risk factor for venous thromboembolism, especially in women with co-existing other risk factors); positive family history (occurrence of venous thromboembolism in siblings or parents, especially at a relatively young age, e.g. before 50) - if genetic predisposition is suspected, a woman should be referred for a decision to use a combined hormonal contraceptive consultation with a specialist; other diseases associated with venous thromboembolism (cancer, systemic lupus erythematosus, haemolytic-uremic syndrome, chronic inflammatory bowel diseases (eg Crohn's disease or ulcerative colitis) and sickle-cell anemia); age - especially at the age of over 35 years. If the patient has several VTE risk factors at the same time, the use of the preparation is contraindicated.If a woman has more than one risk factor, it is possible that the risk increase is greater than the sum of single factors - in this case, the overall risk of venous thromboembolism should be assessed - if the benefit-risk assessment is negative, complex hormonal measures should not be prescribed contraceptives. There was no consensus on the possible effect of varicose veins and thrombophlebitis on the occurrence or progression of venous thromboembolism. The increased risk of thromboembolism during pregnancy and in particular in the 6th week should be considered. postpartum period. Patients should be advised that if symptoms of venous thromboembolism occur, see a doctor immediately and tell the healthcare professional that they use a combined hormonal contraceptive. Epidemiological studies have shown a relationship between the use of hormonal contraceptives and an increased risk of arterial thromboembolism (myocardial infarction) or cerebrovascular events (eg, transient ischemic attack, stroke); cases of arterial thromboembolic events can be fatal. Risk factors for arterial thromboembolic events: age - especially those over 35 years of age; smoking - women should be carefully instructed not to smoke if they intend to use a combined hormonal contraceptive, women over the age of 35 who have not stopped smoking should be carefully instructed to use a different method of contraception; hypertension; obesity (body mass index (BMI) over 30 kg / m²) - the risk increases significantly with the increase in BMI, this is especially important for women who also have other risk factors; positive family history (occurrence of arterial thromboembolism in siblings or parents, especially at a relatively young age, eg before 50) - if genetic predisposition is suspected, before a decision to use a combined hormonal contraceptive is made, the woman should be referred for consultation with a specialist; migraine - an increase in the frequency or severity of migraine during use of combined hormonal contraceptives (which may indicate the occurrence of a cerebrovascular event) may be a reason to discontinue use immediately; other conditions associated with adverse events within the vessels (diabetes, hyperhomocysteinemia, valvular heart disease, atrial fibrillation, dyslipoproteinemia and systemic lupus erythematosus). The use of the preparation is contraindicated if the patient has one serious or several risk factors for arterial thromboembolic events that place the patient at high risk of arterial thrombosis. If a woman has more than one risk factor, it is possible that the risk increase is greater than the sum of individual factors - in this case, the total risk should be assessed - if the benefit-risk assessment is negative, the combined hormonal contraceptives should not be prescribed. Patients should be advised that if signs of arterial thromboembolism occur, immediately seek medical attention and tell the healthcare professional that they are using combined hormonal contraceptives. The results of some epidemiological studies indicate that long-term use of combined oral contraceptives may increase the risk of cervical cancer in women infected with human papillomavirus (HPV). There are ongoing disputes regarding the impact of additional factors (e.g., a different number of sexual partners and the use of mechanical contraception) on the development of these changes. In women taking combined oral contraceptives, the relative risk of breast cancer slightly increases. this risk decreases within 10 years of discontinuation of these measures. In rare cases, there have been reports of benign and, even more rarely, malignant liver tumors in women using oral contraceptives. In individual cases, these tumors have led to life-threatening haemorrhages in the abdominal cavity.In the event of severe, unremarkable abdominal pain, hepatomegaly or abdominal haemorrhage in women using oral contraceptives, the liver tumor should be considered for differential diagnosis and discontinued. If clinically significant hypertension develops while taking the preparation, the preparation should be discontinued and treatment should be initiated. You can return to use when antihypertensive therapy will normalize your blood pressure. In women who have herpes simplex, combined oral contraceptives may cause her recurrence. Women with hypertriglyceridemia or anamnesis indicating the occurrence of such disorders in the family may be at an increased risk of developing pancreatitis while taking combined oral contraceptives. In the case of acute or chronic hepatic dysfunction, the preparation should be discontinued until normalization of liver function parameters. Recurrence of jaundice associated with bile stasis, which occurred during pregnancy or when receiving sex hormones requires discontinuation of the use of combined oral contraceptives. Combined oral contraceptives may change peripheral insulin resistance and Glucose tolerance - women with diabetes should be carefully monitored during oral contraception. Women with a tendency to have chloasma should avoid exposure to sunlight or ultraviolet radiation when taking oral contraceptives. The use of estrogens or the combination of estrogen and progestagen may have a negative effect on certain diseases or conditions. Special clinical supervision is required for: epilepsy, multiple sclerosis, tetany, migraine, asthma, heart or kidney failure, minor chorea, diabetes, liver disorders, dyslipoproteinemia, autoimmune diseases (including systemic lupus erythematosus), obesity, hypertension, endometriosis , varicose veins, phlebitis, blood coagulation disorders, mastopathy, uterine leiomyomas, herpes simplex, depression, chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis). The decrease in the effectiveness of oral contraceptives may occur if the tablet is omitted or vomiting or intestinal disorders occur, including severe diarrhea, or during long-term use of certain medicines and, in very rare cases, metabolic disorders. When taking combined oral contraceptives, irregular bleeding may occur during the cycle (bleeding or intermenstrual staining), especially in the first months of using the tablets. Therefore, performing tests to explain the causes of any such bleeding should be considered only after the adaptation period, which should be about 3 cycles. In the event of persistent or irregular bleeding after regular cycles during use, appropriate examinations should be performed to exclude pregnancy or organic disorders. If these conditions are excluded, you can continue taking the preparation or convert it to another contraceptive. BMS may indicate a reduction in the effectiveness of contraceptive protection. In isolated cases, especially in the first months of using the tablets, the withdrawal bleeding may not occur. However, it does not have to be a symptom of reducing the effectiveness of contraceptive protection. If the withdrawal bleed does not occur after one cycle of using tablets, during which no tablet was missed, the tablet was not longer than 7 days, no other medicines were used and no vomiting or diarrhea were present, the patient was unlikely to be pregnant and the preparation can be continued. However, if the recommendations for use were not followed before the first absence of withdrawal bleeding or if the bleeding did not occur in two consecutive cycles, pregnancy should be excluded before continuing oral contraception. During the use of the preparation, herbal preparations containing St John's wort should not be taken.The preparation contains lactose - should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.

The use of the preparation is contraindicated during pregnancy. The pregnancy should be ruled out before use. If the patient becomes pregnant while using the medicine, stop using it immediately. The results of extensive epidemiological studies do not indicate a teratogenic effect or a toxic effect on the fetus in the event of accidental co-administration of estrogens in combination with other progestagens in doses similar to those contained in the preparation Belara. The risk of venous thromboembolism in women in the postpartum period should be taken into account when deciding whether to restart the treatment. It should not be used during breast-feeding. Estrogens can affect lactation because they can reduce the amount and change the composition of breast milk. Small amounts of contraceptive steroids and / or their metabolites can pass into breast milk and affect the baby.

Very common: nausea, discharge from the vagina, dysmenorrhea, lack of menstruation. Common: depressed mood, nervousness, dizziness, migraine and / or aggravation of migraines, blurred vision, vomiting, acne, heaviness, abdominal pain, irritability, fatigue, edema, weight gain, increased blood pressure. Uncommon: hypersensitivity reactions (including allergic skin reactions), abdominal pain, distension, diarrhea, pigmentation disorders, chloasma, alopecia, dry skin, back pain, muscle disorders, galactorrhoea, breast fibroids, vaginal candidiasis, decreased libido, excessive sweating , changes in blood lipids (including hypertriglyceridemia). Rare: conjunctivitis, contact lens intolerance, sudden loss of hearing, tinnitus, hypertension, hypotension, cardiovascular collapse, venous thromboembolism, arterial thromboembolism, urticaria, eczema, erythema, pruritus, worsening of psoriasis , hirsutism, breast enlargement, vaginal and vulvar inflammation, menorrhagia, premenstrual syndrome, increased appetite. Very rare: erythema nodosum. When using combined hormonal contraceptives, including those containing 0.03 mg ethinyl estradiol and 2 mg chlormadinone acetate, the following side effects were also observed: increased risk of venous and arterial thrombosis and thromboembolic events including myocardial infarction, stroke, transient ischemic attack, thrombosis venous and pulmonary embolism; increasing the risk of disorders in the bile ducts (long-term use); in rare cases, the occurrence of benign and, more rarely, malignant liver tumors (in individual cases, lead to life-threatening bleeding into the abdominal cavity); severity of chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis). The results of some epidemiological studies indicate that long-term use of combined oral contraceptives may increase the risk of cervical cancer in women infected with human papillomavirus (HPV). In women taking combined oral contraceptives, the relative risk of breast cancer slightly increases.

Orally. Take 1 tabl. powl. every day, at the same time of the day (preferably in the evening) for 21 consecutive days, with a 7-day break in taking the tablets. After 2-4 days after taking the last tablet you should have withdrawal bleeding similar to menstrual bleeding. The next pack should be started after a 7-day break in taking the tablets, regardless of whether the withdrawal bleed is over or continues. The tablet should be squeezed from the blister from the place marked with the appropriate day of the week and swallowed whole with a small amount of liquid, if necessary. The tablets are taken in the order indicated by the arrow.Beginning of the preparation. No hormonal contraception during the last menstrual cycle: first tabl. should be taken on the 1st day of the normal menstrual cycle, ie on the first day of menstruation. If the first tabl.taken on the first day of the cycle, contraceptive protection is already on the first day after taking the tablet and persists during a 7-day break in taking tablets. The first tabl. can also be taken between the 2nd and 5th day, regardless of whether the withdrawal bleed is over or continues. In this case, additional mechanical contraception should be used during the first 7 days of taking the tablets. If more than 5 days have passed since the menstrual bleeding started, the patient should be advised to wait until the next menstrual bleeding begins.A change from another contraceptive.A change from the use of another combined hormonal contraceptive. The patient should start the treatment on the first day after the end of the tablet-free period or the placebo-taking period of the previously used combined hormonal contraceptive.Change from a preparation containing only progestagen (POP). The first tablet of the preparation should be taken on the day after the end of the use of progestogen-only tablets. During the first 7 days of taking tablets, additional barrier methods of contraception should be used.Change from hormonal contraception in the form of injections or implant. The preparation can be started on the day the implant is removed or on the day the next injection should be made. During the first 7 days of taking tablets, additional barrier contraceptive methods should be used.After miscarriage or termination of pregnancy in the first trimester of pregnancy: the patient can start taking the product immediately. In this case, it is not necessary to use additional mechanical methods of contraception.After childbirth or miscarriage or termination of pregnancy in the second trimester of pregnancy: women who do not breastfeed can start using the product between 21 and 28 days after delivery. In this case, an additional mechanical contraceptive method is not necessary. If the use of the preparation is started later than 28 days after delivery, additional mechanical contraception is required during the first 7 days of taking the tablets. If the patient has already had sexual intercourse, pregnancy should be ruled out before starting the use of the tablets or wait until the first menstrual bleeding begins.Discontinuation of the preparation. After discontinuation of the preparation, the current cycle may be extended by about a week.Irregular tablet intake. If the patient forgets to take the tablet, but takes it within 12 hours, it is not necessary to use additional barrier methods of contraception. You should continue taking the tablets as before. If more than 12 hours have elapsed since the planned tablet was taken, the effectiveness of contraceptive protection may be reduced. The procedure for omitting the tablet should be in accordance with the following two basic principles: 1. Never stop taking tablets for more than 7 days. 2. It is necessary 7 days of uninterrupted taking of tablets to maintain the proper degree of inhibition of the hypothalamo-pituitary-ovary axis. Take the last missed tablet immediately, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time. In addition, a barrier method of contraception such as a condom should be used for the next 7 days. If the patient omitted taking the tablets in the first week of the cycle and during the previous 7 days (including during the period of the break in the use of tablets) there was sexual intercourse, the possibility of pregnancy should be considered. The more tablets are missed and the shorter the interval to the period of tablet use, the greater the risk of getting pregnant. If the packaging currently in use contains less than 7 tablets, start taking the product from the next pack immediately after taking the last tablet from the currently used pack, i.e. without storing the tablet in between packagings. It is likely that until the end of the second pack, no withdrawal bleeding occurs, however, there may be some minor bleeding or menstrual staining on the days of taking the tablets. If no withdrawal bleeding occurs after the end of the second pack, a pregnancy test should be performed.Proceedings in case of vomiting or diarrhea. If vomiting or severe diarrhea occurs within 4 hours after taking the tablet, absorption may be reduced and the effectiveness of contraceptive protection can not be guaranteed. In this case, follow the instructions for irregularly taking tablets.Delay of withdrawal bleeding. To delay the onset of menses, the patient should continue taking the tablets from the next blister pack without keeping the period of interruption. The extended tablet period can be continued for as long as needed until the contents of the second pack are exhausted. During the extended cycle, slight bleeding or intermenstrual staining may occur. Then, after a 7-day break, you can return to regular taking of the preparation. In order to move the moment of menstruation to a different day of the week than the one in which the bleeding occurs during the current taking of tablets, the patient may be advised to shorten the next period of their use by any number of days. The shorter this period, the greater the risk that no withdrawal bleeding will occur and that minor bleeding or intermenstrual staining may occur during the use of the contents of the next pack (similar to the case of postponing menstruation at a later date).