Belara, 63 pcs., 2 mg+0.03 mg, film-coated tablets

Compound

Pharmacodynamics

Long-term use of the drug Belara® leads to a decrease in the secretion of FSH and LH and, consequently, suppression of ovulation. At the same time, proliferation of the endometrium and its secretory transformation occur, preventing the implantation of a fertilized egg, the viscosity of the mucous secretion of the cervix increases, which is accompanied by difficulty in the passage of sperm through the cervical canal and a violation of their motility.

To completely suppress ovulation, 1.7 mg of chlormadinone acetate (CMA) is required daily. The required dose per cycle is 25 mg.

The composition of the drug Belara® XMA is a gestagen with antiandrogenic properties. Its action is based on the ability to replace androgens on specific receptors, eliminating and weakening the effect of endogenous and exogenous androgens. The Pearl index is 0.291–0.698, depending on how carefully the woman follows the drug regimen.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

A combined contraceptive drug taken orally.

Long-term use of the drug leads to a decrease in the secretion of follicle-stimulating hormone and luteinizing hormone , and, consequently, to suppression of the ovulation process. of the endometrium occurs , preventing the fixation of the fertilized egg. The viscosity of mucous secretions from the cervix increases, which causes difficulty in the passage of male germ cells through the cervical canal and inhibition of their mobility.

Chlormadinone acetate included in the drug is a gestagen with antiandrogenic properties. Its effect is based on the ability to compete with androgens at specific receptors, weakening the effect of androgens . The Pearl index (the probability of getting pregnant in 12 months) ranges from 0.291-0.698 and depends on how carefully the woman follows the medication regimen.

To completely block ovulation, approximately 1.7 mg of chlormadinone daily. The required dosage per cycle is 25 mg.

Pharmacokinetics

Chlormadinone acetate . Quickly and completely absorbed. The maximum concentration occurs in an hour and a half. 95% binds to human blood proteins, mainly albumin.

During the transformation process, many metabolites are formed, the main of which are 3-beta and 3-alpha-hydroxy-chlormadinone acetate.

The average half-life from the blood is 34 hours. Chlormadinone acetate and its metabolites are excreted in approximately equal quantities in the urine and through the intestines.

Ethinyl estradiol. It is quickly and almost completely absorbed from the intestine, reaching maximum concentration in plasma after an hour and a half. Absolute bioavailability is about 40%.

About 98% of the substance binds to blood proteins. Ethinyl estradiol is transformed through hydroxylation of the aromatic ring. The main derivative is 2-hydroxy-ethinyl estradiol.

The average half-life of ethinyl estradiol from the blood is 13 hours. Excreted by the kidneys and feces in a ratio of 2:3.

Pharmacokinetics

KhMA

Suction. When the drug is taken orally, CMA is quickly and completely absorbed.

Tmax CMA - 1–2 hours.

Distribution. More than 95% of CMA binds to human plasma proteins, mainly albumin.

Metabolism. Various processes of reduction, oxidation and binding with glucuronides and sulfates lead to the formation of many metabolites. The main metabolites in blood plasma are 3-alpha and 3-beta-hydroxy-CMA with a half-life not significantly different from unmetabolized CMA. 3-hydroxy metabolites have antiandrogenic activity similar to that of CMA itself. In urine, metabolites are contained mainly in the form of conjugates. After enzymatic cleavage, 2-alpha-hydroxy-CMA becomes the main metabolite, and 3-hydroxy metabolites and dihydroxy metabolites are also formed.

Excretion. The average T1/2 of CMA from blood plasma is approximately 34 hours (after a single dose) and about 36–39 hours (with multiple doses). When taking the drug orally, CMA and its metabolites are excreted in approximately equal proportions by the kidneys and through the intestines.

Ethinyl estradiol (EE)

Suction. When taking the drug orally, EE is quickly and almost completely absorbed.

Tmax in blood plasma is 1.5 hours.

Due to presystemic binding and metabolism in the liver, absolute bioavailability is approximately 40% and is subject to strong individual variability (20–65%).

Distribution. The information available in the literature on the concentration of EE in blood plasma varies greatly. About 98% of EE is bound to plasma proteins, almost exclusively to albumin.

Metabolism. Like natural estrogens, EE is biotransformed through hydroxylation of the aromatic ring (the mediator is the cytochrome P450 system). The main metabolite is 2-hydroxy-EE, which is transformed into other metabolites and conjugates. EE undergoes presystemic binding both in the mucous membrane of the small intestine and in the liver. Mainly glucuronides are found in urine, and sulfates are found in bile and blood plasma.

Excretion. The average T1/2 of EE from blood plasma is approximately 12–14 hours. EE is excreted by the kidneys and through the intestines in a ratio of 2:3. EE sulfate, excreted in bile after hydrolysis by intestinal bacteria, undergoes enterohepatic recirculation.

Contraindications

Taking Belara® is contraindicated for the following diseases/conditions:

hypersensitivity to the components of the drug;

the presence of thrombosis (venous and arterial) currently or in history (for example, deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke);

the presence of the first signs of thrombosis, thrombophlebitis or symptoms of embolism (for example, transient ischemic attacks, angina pectoris, see “Special Instructions”);

planned surgical intervention (at least 4 weeks before it) and a period of immobilization, for example after injury (including after applying plaster casts);

diabetes mellitus with vascular complications;

diabetes mellitus that is not adequately controlled;

uncontrolled hypertension or a significant increase in blood pressure (over 140/90 mm Hg, see “Special Instructions”);

hereditary or acquired predisposition to the development of venous or arterial thrombosis, such as increased body resistance to activated protein C (APC resistance); antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant);

acute or chronic severe liver diseases (until normalization of liver function indicators);

generalized itching, cholestasis, especially during a previous pregnancy or a history of taking sex hormones;

Dubin-Johnson syndrome, Rotor syndrome; violation of the outflow of bile;

the presence of liver tumors currently or in history;

severe epigastric pain, liver enlargement or symptoms of intra-abdominal bleeding;

newly diagnosed porphyria or its relapse (all three forms, especially acquired porphyria);

the presence of hormone-dependent malignant diseases, incl. history (for example, breast or uterus) or suspicion of them;

severe disorders of lipid metabolism;

pancreatitis currently or in history, in combination with severe forms of hypertriglyceridemia;

new attacks of migraine pain or frequent severe headaches;

migraine in combination with local neurological symptoms (associated migraine);

acute sensory impairment, such as visual or hearing impairment;

motor disorders (in particular paresis);

an increase in the number of epileptic attacks;

severe depression;

worsening otosclerosis during previous pregnancies;

amenorrhea of ​​unknown etiology;

endometrial hyperplasia;

bleeding from the vagina of unknown etiology;

smoking over the age of 35 (see “Special Instructions”);

lactose intolerance, lactase deficiency, glucose-galactose malabsorption;

the presence of pronounced or multiple factors of arterial or venous thrombosis (increasing age, smoking, especially over the age of 35 years, obesity (<30 kg/m2); dyslipoproteinemia; a family history of venous or arterial insufficiency in 1st degree relatives; diseases heart valves; atrial fibrillation; bacterial endocarditis; any surgery on the lower extremities; major trauma).

pregnancy or suspicion of it;

breastfeeding period.

With caution: If you have the following conditions/diseases/risk factors, currently or in history, the use of Belara® requires careful medical supervision and assessment of the potential risk and expected benefit: epilepsy; multiple sclerosis; convulsive syndrome (tetany); migraine (without focal neurological symptoms); bronchial asthma; heart or kidney failure; chorea; uncomplicated diabetes mellitus; acute and chronic liver diseases of mild and moderate severity (with normal liver function tests); lipid metabolism disorders, dyslipoproteinemia (see also “Contraindications”); autoimmune diseases (including systemic lupus erythematosus); obesity (<30 kg/m2); controlled arterial hypertension; endometriosis; varicose veins, phlebitis of the superficial veins of the lower extremities (see also “Contraindications”); blood coagulation disorder; mastopathy; uterine fibroids; herpes during pregnancy; depression (see also “Contraindications”); chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis).

Instructions for use BELARA®

Smoking increases the risk of serious cardiovascular complications associated with COC use. The risk increases with age and the number of cigarettes smoked and is highest in women over 35 years of age. Women over 35 who smoke should use other methods of contraception.

The use of COCs is associated with an increased risk of various serious diseases, such as myocardial infarction, thromboembolism, stroke or liver tumors. Other risk factors such as hypertension, hyperlipidemia, obesity and diabetes significantly increase the risk of complications and mortality.

If one of the following diseases/risk factors is present, the acceptability of using Belara® should be discussed with the woman. If these diseases or risk factors progress or occur for the first time, the patient should be advised to contact her physician. The doctor must decide whether to continue or stop using Belara®.

Thromboembolism and other vascular complications

Epidemiological studies indicate that there is an association between COC use and an increased risk of venous or arterial thromboembolic disease, such as myocardial infarction, cerebral hemorrhage, deep vein thrombosis or pulmonary embolism. These diseases develop rarely. Thrombosis of other blood vessels, such as hepatic, mesenteric, renal or retinal veins and arteries, has been extremely rarely reported in patients taking COCs.

Risk of venous thromboembolism (VTE)

The use of combined hormonal contraceptives increases the risk of VTE in patients taking them compared to those not taking these drugs. Drugs containing levonorgestrel, norgestimate, or norethisterone are associated with the lowest risk of VTE. The risk of Belara® compared to these low-risk drugs is unknown. The decision to use a drug that is not on the list with the lowest risk of VTE should be made only after a conversation with the woman. Make sure she understands the risk of VTE when taking Belara®, how it is affected by her risk factors, and that the greatest risk of developing VTE is observed in the first year of using the drug. In addition, there is evidence that the risk increases when you resume taking COCs after a break of 4 weeks or more.

Over the course of a year, VTE develops in approximately 2 in 10,000 women who are not pregnant and not taking combined hormonal contraceptives. However, a woman's individual risk may be much higher, given her risk factors (see below).

Epidemiological studies conducted in women using low-dose combined hormonal contraceptives (<50 mcg ethinyl estradiol) showed that out of 10,000 women, 6-12 cases of VTE develop per year.

Of 10,000 women taking levonorgestrel-containing COCs, about 61 develop VTE per year.

The risk of chlormadinone-containing COCs compared with the risk of levonorgestrel-containing COCs is unknown.

In both cases, the number of VTEs per year is less than the number expected during pregnancy or the postpartum period.

VTE can be fatal in 1–2% of cases.

1 The median range of 5–7 per 10,000 woman-years, based on the relative risk for levonorgestrel-containing COCs compared with no use, is approximately 2.3–3.6.

Risk factors for developing VTE

The risk of developing venous thromboembolic complications when using COCs may increase significantly in women with additional risk factors, in particular, with multiple risk factors (see table).

Belara® is contraindicated in women with multiple risk factors that place the patient at high risk of developing venous thrombosis. If a woman has more than one risk factor, a situation may arise in which the risk increases to a greater extent than with a simple summation of individual factors:

• in this case, the overall risk of developing VTE should be taken into account. If the benefit-risk ratio when assessed is unfavorable, the use of a COC should be abandoned.

Table. Risk factors for developing VTE

There is no consensus on the possible role of varicose veins and superficial vein thrombophlebitis in the development or progression of venous thrombosis.

The increased risk of thromboembolism during pregnancy and especially in the first 6 weeks of the postpartum period should be taken into account.

Symptoms of VTE (deep vein thrombosis and pulmonary embolism)

Women should be informed that if symptoms occur, they should seek emergency medical attention and tell a health care professional about the use of COCs.

Symptoms of deep vein thrombosis (DVT) may include:

• unilateral swelling of the lower extremities and/or feet, or swelling along the vein of the lower extremity;
• pain or tenderness in the lower extremity that is felt only when standing or while walking;
• increased temperature of the affected lower limb; redness or discoloration of the skin of the lower limb.

Symptoms of pulmonary embolism (PE) may include:

• sudden onset of causeless shortness of breath or rapid breathing;
• sudden cough for no obvious reason, possibly with blood;
• sharp chest pain;
• severe feeling of lightheadedness or dizziness;
• fast or irregular heartbeat.

Some of the symptoms listed (eg, shortness of breath, cough) are nonspecific and may be mistaken for more common or less severe conditions (eg, respiratory tract infections).

Other signs of blockage may include sudden pain, swelling, and mild cyanosis of the limb.

If a blockage develops in the eye, symptoms can range from blurred vision (without pain) to (as it progresses) vision loss. In some cases, vision loss can develop almost immediately.

Risk of developing arterial thromboembolism (ATE)

The results of epidemiological studies have linked the use of COCs with an increased risk of arterial thromboembolism (myocardial infarction) or cerebrovascular accident (for example, transient cerebrovascular accident, stroke). Cases of arterial thromboembolism can be fatal.

Risk factors for developing ATE

The risk of developing arterial thromboembolic complications or cerebrovascular accidents when using COCs increases in women with risk factors (see table). Belara® is contraindicated in women with one serious risk factor or multiple risk factors for the development of ATE, which place the patient at a high risk of developing arterial thrombosis. If a woman has more than one risk factor, a situation may arise in which the risk increases to a greater extent than with a simple summation of individual factors:

• in such a case the overall risk must be taken into account. If the benefit-risk ratio when assessed is unfavorable, the use of a COC should be abandoned.

Table. Risk factors for developing ATE

Symptoms of ATE

Women should be informed that if symptoms occur, they should seek emergency medical attention and tell a health care professional about the use of COCs.

Symptoms of a cerebrovascular accident may include:

• sudden weakness or numbness of the face, upper or lower limbs, especially on one side of the body;
• sudden difficulty walking, dizziness, loss of balance or coordination;
• sudden confusion, disturbances in speech or speech perception;
• sudden loss of vision in one or both eyes;
• sudden, severe or prolonged headache without known cause;
• loss of consciousness or fainting with or without convulsions.

The temporary nature of symptoms suggests a transient ischemic attack (TIA).

Symptoms of myocardial infarction (MI) may include:

• pain, discomfort, pressure, heaviness, a feeling of tightness or fullness in the chest, upper limb or behind the sternum;
• discomfort radiating to the back, lower jaw, throat, arm, stomach;
• feeling of fullness, indigestion, or suffocation;
• sweating, nausea, vomiting, or dizziness;
• extreme weakness, anxiety, or shortness of breath;
• fast or irregular heartbeat.

Patients taking COCs should be informed that if possible symptoms of thrombosis occur, they should consult a doctor. If thrombosis is suspected or confirmed, taking Belara® should be discontinued.

Tumors

Some epidemiological studies suggest that long-term use of oral contraceptives is a risk factor for the development of cervical cancer in women infected with human papillomavirus (HPV). However, this issue is controversial, because It is unclear to what extent other factors influence the results (for example, differences in the number of sexual partners or the use of barrier methods of contraception) (see section "Medical examination").

A meta-analysis of 54 epidemiological studies showed that the relative risk of developing breast cancer is slightly higher in women taking COCs (RR=1.24). This increased risk gradually decreases over 10 years after stopping COC use. However, these studies did not confirm the presence of a cause-and-effect relationship between the disease and taking the drug. The observed increased risk may be due to the fact that women who use COCs are diagnosed with breast cancer at an earlier stage than those who do not use them, the biological effects of COCs, or a combination of both factors.

In rare cases, cases of benign liver tumors have been reported after taking oral contraceptives, and malignant tumors have been reported even more rarely. In some cases, these tumors can cause life-threatening intra-abdominal bleeding. In case of severe abdominal pain that does not disappear on its own, hepatomegaly or signs of intra-abdominal bleeding, the possibility of developing a liver tumor should be considered, and Belara should be discontinued.

Other diseases

Many women taking oral contraceptives experience a slight increase in blood pressure. Clinically significant increases in blood pressure are rare. The relationship between the use of hormonal contraceptives and clinically manifested hypertension has not yet been confirmed. If a clinically significant increase in blood pressure is observed while taking Belara®, you should stop taking the drug and treat arterial hypertension. As soon as blood pressure levels normalize after antihypertensive therapy, taking Belara® can be continued.

In women with a history of herpes during pregnancy, a recurrence of this disease is possible while taking COCs.

Women with a history or family history of hypertriglyceridemia while taking COCs have an increased risk of developing pancreatitis.

In case of acute or chronic liver dysfunction, it may be necessary to stop taking COCs until liver function parameters normalize.

If cholestatic jaundice relapses, first diagnosed during pregnancy or taking sex hormones, it is necessary to stop taking COCs.

Taking COCs may affect peripheral insulin resistance or glucose tolerance. Therefore, the condition of patients with diabetes and taking oral contraceptives should be carefully monitored.

In rare cases, chloasma may occur, especially in women with a history of chloasma during pregnancy. Women predisposed to chloasma should avoid exposure to the sun, as well as ultraviolet radiation while taking oral contraceptives.

Precautionary measures

Taking medications that contain estrogen or estrogen/progestin may adversely affect certain diseases/conditions. In the following cases, careful medical supervision is necessary:

• epilepsy;
• multiple sclerosis;
• tetany;
• migraine (also see section “Contraindications”);
• asthma;
• heart or kidney failure;
• chorea;
• diabetes mellitus (see section “Contraindications”);
• liver diseases (see section “Contraindications”);
• dyslipoproteinemia (see section “Contraindications”);
• autoimmune diseases (including systemic lupus erythematosus);
• obesity;
• arterial hypertension (see section “Contraindications”);
• endometriosis;
• phlebeurysm;
• thrombophlebitis (see section “Contraindications”);
• bleeding disorders (see section “Contraindications”);
• mastopathy;
• uterine fibroids;
• herpes during pregnancy;
• depression (see section “Contraindications”);
• chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis; see section "Side effects").

Medical examination

Before starting or re-prescribing Belara®, a thorough medical history (including family history) should be taken and pregnancy should be excluded. Blood pressure should be measured and a physical examination should be performed, guided by information on contraindications, special instructions and precautions. This should be repeated while using Belara®. Regular medical examination is also necessary because... It is possible that some contraindications (eg, transient ischemic attacks) or risk factors (eg, family history of venous or arterial thrombosis) arise for the first time or become apparent during the use of hormonal contraceptives. The medical examination should include blood pressure measurement, examination of the mammary glands, abdominal cavity, internal and external genitalia, cytological examination of the cervical smear and relevant laboratory tests.

It is important to draw a woman’s attention to the risk of venous and arterial thrombosis, including the risk from the use of Belara® compared to other COCs, to the symptoms of VTE and ATE, as well as to established risk factors and actions taken in case of suspected thrombosis.

It is important that the woman read the patient information leaflet carefully and follow the recommendations contained therein. The frequency and type of examinations should be based on developed practical recommendations with their adaptation for each individual woman.

The woman should be informed that taking oral contraceptives, including Belara®, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Reduced efficiency

Missing a pill, vomiting or intestinal problems including diarrhea, prolonged use of certain concomitant medications or, in very rare cases, metabolic disorders may reduce the contraceptive effectiveness of the drug.

Effect on menstrual cycle control

Breakthrough bleeding and minor spotting

The use of all oral contraceptives may lead to vaginal bleeding (breakthrough bleeding and light spotting), especially during the first cycles of taking the drug. Therefore, medical evaluation of irregular cycles should only be carried out after an adaptation period of about three cycles. If, while taking Belar®, breakthrough bleeding is constantly observed or appears for the first time, although the cycle was previously regular, an examination should be carried out to exclude pregnancy or organic diseases. After ruling out pregnancy or an organic disease, you can continue taking Belara® or switch to another drug.

Intermenstrual bleeding may be a sign of decreased contraceptive effectiveness (see section “Irregular use of the drug”, “Recommendations in case of vomiting or diarrhea” and section “Drug interactions”).

No withdrawal bleeding

As a rule, withdrawal bleeding occurs after 21 days of taking the drug. Sometimes, especially during the first months of taking the drug, there may be no withdrawal bleeding. However, this does not necessarily indicate a decrease in contraceptive effect. If there is no bleeding after one cycle of dosing, during which the patient did not forget to take the pills, the seven-day period of break in taking the pills was not extended, and the patient did not have vomiting or diarrhea, then fertilization of the egg is unlikely and taking Belara® can be continued. If, before the first absence of withdrawal bleeding, Belara® was taken in violation of the instructions or the absence of withdrawal bleeding is observed within two cycles, pregnancy should be excluded before continuing to take the drug.

Together with the drug Belara®, you should not take herbal medicines containing St. John's wort (Hypericum perforatum).

Increased ALT

In clinical trials in patients treated with ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin, transaminase (ALT) levels greater than 5 times the ULN were observed in patients treated with hepatitis C virus (HCV) infections. , and occurs more often in women using ethinyl estradiol-containing drugs, such as combined hormonal contraceptives.

This medicine contains lactose (as lactose monohydrate). Patients with rare hereditary diseases such as galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption syndrome should not take this drug.

Impact on the ability to drive vehicles and operate machinery

There is no evidence that combined oral contraceptives have a negative effect on the ability to drive a car or use machinery.

Use during pregnancy and breastfeeding

The use of Belara® during pregnancy is contraindicated. Before you start using it, you must rule out pregnancy. If pregnancy occurs while taking Belara®, it should be stopped immediately. Existing epidemiological data do not contain information about the development of teratogenic or embryotoxic effects in women who accidentally took during pregnancy drugs containing estrogens and gestagens in the same combination as in Belara®.

It is contraindicated to use Belara® during breastfeeding, since the drug reduces the amount of milk produced and changes its composition. Small amounts of the hormones included in the contraceptive and/or their metabolites are excreted in breast milk and may affect the baby.

Side effects

When taking Belara®, the most common adverse reactions (>20% of cases) are breakthrough bleeding, spotting from the vagina, headache and discomfort in the mammary glands. Intermenstrual bleeding usually decreases as the duration of taking Belara® increases.

The frequency of occurrence of adverse reactions is determined as follows: very often - ≥1/10; often - ≥1/100, <1/10; uncommon - ≥1/1000, <1/100; rarely - ≥1/10,000, <1/1000; very rarely - <1/10,000.

Adverse reactions from the following organs and systems may occur.

From the immune system: rarely - hypersensitivity to the components of the drug, including allergic reactions from the skin.

Metabolism and nutrition: rarely - increased appetite.

Mental disorders: often - depressed mood, nervousness, irritability.

From the nervous system: often - dizziness, migraine (and/or its intensification).

From the organs of vision: often - visual disturbances; rarely - conjunctivitis, intolerance to contact lenses.

From the organ of hearing and labyrinthine disorders: rarely - sudden hearing loss, tinnitus.

From the cardiovascular system: rarely - increased blood pressure, arterial hypotension, cardiovascular collapse, varicose veins, vein thrombosis.

From the gastrointestinal tract: very often - nausea; often - vomiting; infrequently - abdominal pain, flatulence, diarrhea.

From the skin and subcutaneous tissues: often - acne; uncommon - pigmentation disorders, chloasma, hair loss, dry skin; rarely - urticaria, eczema, erythema, skin itching, increased psoriasis, hypertrichosis; very rarely - erythema nodosum.

From the musculoskeletal and connective tissue side: often - a feeling of heaviness in the lower extremities; Uncommon: back pain, muscle disorders.

From the genital organs and mammary gland: very often - increased vaginal discharge, painful menstrual-like bleeding from the vagina, absence of menstrual-like bleeding; often - pain in the lower abdomen; uncommon - galactorrhea, breast fibroadenoma, vaginal candidiasis; rarely - breast enlargement, vulvovaginitis, menorrhagia, premenstrual-like syndrome.

General disorders and disorders at the injection site: often - fatigue, swelling, weight gain; uncommon - decreased libido, hyperhidrosis; rarely - increased appetite.

Impact on the results of laboratory and instrumental examinations: infrequently - changes in lipid levels in the blood plasma, including hypertriglyceridemia.

When using combined oral contraceptives (COCs), including those containing 0.03 mg EE and 2 mg CMA, the following undesirable effects were also observed:

- increased risk of venous and arterial thromboembolism (for example, venous thrombosis, pulmonary embolism, stroke, myocardial infarction). The risk may be increased by additional factors (see “Special Instructions”);

- increased risk of biliary tract diseases;

- in rare cases - an increased risk of developing benign liver tumors (and even less often - malignant liver tumors); isolated cases can lead to life-threatening intra-abdominal bleeding (see also “Special instructions”);

- exacerbation of chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis, see also “Special Instructions”).

Belara, 63 pcs., 2 mg+0.03 mg, film-coated tablets

Smoking increases the risk of developing severe cardiovascular side effects of COCs, the risk increases with age and depending on the number of cigarettes smoked and is more pronounced in women over 35 years of age; women over 35 years of age who smoke should use other methods of contraception. When using COCs, the risk of developing serious diseases increases: myocardial infarction, thrombosis/thromboembolism, stroke and liver tumors. Other risk factors such as hypertension, hyperlipidemia, obesity and diabetes mellitus clearly increase the risk of morbidity and mortality. If one of the above diseases/risk factors is present, it is necessary to weigh the possible benefits of prescribing Belara® against the risks, and this should be discussed with the woman before she starts taking the drug. If these diseases or risk factors begin to appear or progress while taking the drug, you should consult your doctor. Your doctor must decide whether to stop taking this drug. Thromboembolism and other vascular diseases It has been noted that there is a relationship between taking COCs and an increased risk of diseases caused by venous or arterial thromboembolism, for example, myocardial infarction, cerebral stroke, deep vein thrombosis or pulmonary embolism. These complications are rare. Taking COCs leads to an increased risk of venous thromboembolism (VTE). The risk of VTE is greatest during the first year of use. This risk is less than during pregnancy, where the incidence of VTE is 60 cases per 100,000 pregnancies. VTE is fatal in 1–2% of cases. There is no data on assessing the development of the risk of VTE when taking Belara® in comparison with other COCs. The risk of developing venous thromboembolic complications when taking COCs increases:

• with age
• in the presence of thromboembolism in relatives (venous thromboembolism in one of the siblings or parents at a relatively young age). If a hereditary predisposition is suspected, it is recommended that the woman be referred for consultation with a specialist before deciding to prescribe COCs.
• with long-term decreased mobility
• for obesity (body mass index > 30 kg/m2). The risk of developing arterial thromboembolic complications when taking COCs increases:
• with age
• in smokers
• for dyslipoproteinemia
• for obesity (body mass index > 30 kg/m2)
• for hypertension
• for heart defects
• with atrial fibrillation in the presence of thromboembolism in relatives (arterial thromboembolism in one of the siblings or parents at a relatively young age). If there is chronic inflammation of the intestines (Crohn's disease and ulcerative colitis), sickle anemia. When assessing the risk/benefit, it should be remembered that adequate treatment of the above diseases can reduce the risk of thrombosis. It is necessary to take into account the increased risk of thromboembolic complications in the postpartum period. There is no consensus on whether there is a relationship between superficial vein thrombophlebitis and/or varicose veins and the etiology of venous thromboembolism. With the development of venous or arterial thrombosis, the following symptoms may occur:
• leg pain and/or swelling
• sudden severe pain in the chest, with or without radiation to the left arm
• sudden shortness of breath, cough for no apparent reason
• sudden, severe, prolonged headache
• partial or complete loss of vision, diplopia/speech impairment, or aphasia
• dizziness, collapse, in some cases accompanied by a focal epileptic seizure
• sudden weakness or dysesthesia (distortion of sensation) on one side or in one part of the body
• movement disorders
• acute pain in the abdomen.

Women taking COCs should be informed that if symptoms resembling those of thrombosis appear, they should consult their doctor. Belara® should be discontinued if a diagnosis of thrombosis is suspected or confirmed. An increase in the frequency or severity of migraine attacks while taking COCs (which may be a harbinger of the development or symptom of cerebrovascular disease) may be a reason for their discontinuation.

Tumors It has been noted that the use of COCs is a risk factor for the development of cervical cancer in women infected with the human papillomavirus (HPV). However, the extent to which other confounding factors (such as number of sexual partners or use of mechanical contraceptives) influence this observation remains controversial (see also Medical Examination). There is evidence that the relative risk (RR=1.24) of developing breast cancer in women who take COCs is slightly higher. Within 10 years after stopping taking COCs, the risk level gradually decreases and returns to the age level. Because breast cancer is rare in women under 40 years of age, there is little difference between the risk of breast cancer in current and recent COC users and the overall risk of developing the disease.

There are reports of the development in rare cases of benign, and in even more rare cases of malignant liver tumors while taking COCs. In some cases, these tumors are the cause of life-threatening intra-abdominal bleeding. In case of severe abdominal pain that does not go away on its own, hepatomegaly or signs of intra-abdominal bleeding, it is necessary to take into account the possibility of a liver tumor and discontinue Belara®.

Other diseases Many women taking oral contraceptives experience a slight increase in blood pressure; however, clinically significant increases are rare. The relationship between the prescription of oral contraceptives and the clinical manifestation of hypertension has not yet been confirmed. If a clinically significant increase in blood pressure occurs while taking Belara®, the drug should be discontinued and hypertension treated. As soon as blood pressure levels return to normal against the background of antihypertensive therapy, taking Belara® can be continued. Women with a history of herpes during pregnancy may experience a relapse of the disease while taking COCs. Women with a history or family history of hypertriglyceridemia are at increased risk of developing pancreatitis while taking COCs. Acute or chronic liver dysfunction may require discontinuation of COCs until liver function tests normalize. Recurrence of cholestatic jaundice, which first occurred during pregnancy or previous use of sex hormones, requires discontinuation of the COC.

COCs may have effects on peripheral tissue insulin resistance or glucose tolerance. Therefore, patients with diabetes should be under constant supervision while taking oral contraceptives. In rare cases, chloasma may develop, especially in women who have had chloasma during pregnancy. Women at risk of developing chloasma should avoid sun exposure and ultraviolet radiation while taking oral contraceptives. Patients with rare congenital conditions such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome should not take this drug.

Medical examination Before prescribing oral contraceptives, it is necessary to collect complete data on the health of the woman and her relatives in order to identify contraindications (see section “Contraindications”) and risk factors (see section “With caution”). The woman must undergo a medical examination. A medical examination should be carried out annually while taking Belara®. Regular medical examination is also necessary due to the fact that diseases that are contraindications (for example, transient ischemic attacks) or risk factors (for example, venous or arterial thrombosis in relatives) may first occur while taking oral contraceptives. The medical examination should include measuring blood pressure, examining the breasts, abdomen, internal and external genitalia, taking a smear from the cervix and conducting appropriate laboratory tests. A woman should be warned that the prescription of oral contraceptives, including Belara®, does not protect her from infection with HIV infection (AIDS) or other sexually transmitted diseases.

Lack of effectiveness Missing a pill (see section “Method of administration and dosage”, “Skipping a drug dose”), nausea or symptoms of digestive disorders, including diarrhea, long-term concomitant use of certain medications (see section “Use in case of diarrhea, vomiting", "Interaction with other medicinal products") or, in very rare cases, metabolic disorders may reduce the effectiveness of contraception.

Effect on the menstrual cycle Bleeding or breakthrough spotting (intermenstrual) All oral contraceptives may cause irregular vaginal bleeding (breakthrough bleeding/spotting), especially during the first few cycles while taking the drug. Therefore, a medical examination for irregular cycles should be carried out only after an adaptation period, which usually lasts for 3 cycles. If, while taking Belar®, the appearance of extraordinary bleeding continues or appears for the first time in a woman with a regular cycle, it is necessary to conduct an examination to exclude pregnancy or organic pathology; After excluding pregnancy and organic pathology, you can continue taking Belara® or switch to taking another drug. Bleeding that occurs between cycles may be a sign of insufficient contraceptive effectiveness.

Absence of menstrual-like bleeding (withdrawal bleeding) 21 days after taking the drug, withdrawal bleeding usually occurs. Sometimes, especially in the first few months of taking the drug, withdrawal bleeding may be absent. However, this is not evidence of insufficient contraceptive effect. If bleeding does not occur after taking the drug for one cycle, provided that no doses of the film-coated tablet were missed, the period after completion of the drug did not exceed 7 days, no other drugs were taken at the same time, there was no nausea or diarrhea, fertilization is unlikely whether pregnancy or organic pathology occurred and taking Belara®. After excluding pregnancy and organic pathology, taking Belara® can be continued. If, when taking Belara®, the instructions were not followed before the first absence of withdrawal bleeding, or withdrawal bleeding was absent for two consecutive cycles, it is necessary to exclude the presence of pregnancy to decide whether to continue taking the drug. While taking Belara, you should not take herbal remedies containing St. John's wort (Hypericum perforatum).

Laboratory parameters: While taking COCs, changes in some laboratory parameters may occur, including the functional activity of the liver, adrenal glands and thyroid gland, the level of bound proteins in the plasma (for example, SHBG (SHBG), lipoproteins), indicators of carbohydrate metabolism, coagulation and fibrinolysis. The nature and extent of changes are determined in part by the nature and dose of hormones taken.

INFLUENCE ON THE ABILITY TO DRIVE A VEHICLE OR WORK WITH PRECISION INSTRUMENTS No effect.

Interaction

The interaction of EE, the estrogenic component of Belar®, with other drugs may cause an increase or decrease in the concentration of ethinyl estradiol in the blood serum. If long-term treatment with these medications is necessary, you should switch to non-hormonal contraception. A decrease in the concentration of EE in the blood serum can lead to more frequent episodes of breakthrough bleeding, cycle disruption and a decrease in the contraceptive effectiveness of Belara®. Increasing serum EE concentrations may increase the frequency and severity of side effects.

The following drugs/active substances can reduce the concentration of EE in the blood serum:

- all drugs that increase gastrointestinal motility (for example, metoclopramide) or impair absorption (for example, activated charcoal);

- substances that induce liver microsomal enzymes, such as rifampicin, rifabutin, barbiturates, anticonvulsants (for example, carbamazepine, phenytoin or topiramate), griseofulvin, barbexaclone, primidone, modafinil, some protease inhibitors (for example, ritonavir) and St. John's wort preparations;

- some antibiotics (eg ampicillin, tetracycline) in some women, possibly due to a decrease in enterohepatic recirculation of estrogens.

When using such drugs/active substances simultaneously with Belara®, it is necessary to use additional barrier methods of contraception, both during treatment and for 7 days after it. When taking active substances that reduce the concentration of EE in the blood plasma due to the induction of microsomal liver enzymes, additional barrier methods should be used within 28 days after the end of treatment.

If taking a concomitant drug needs to be continued after the end of the tablets in the Belara® package, then you should start taking the tablets from the next package without taking the usual 7-day break.

The following drugs/active substances can increase the concentration of EE in the blood serum:

- active substances that suppress sulfation of EE in the intestinal wall (for example, ascorbic acid or paracetamol);

— atorvastatin (increases the AUC of EE by 20%);

- active substances that inhibit the activity of microsomal liver enzymes, such as imidazole-derived antifungals (for example fluconazole), indinavir or troleandomycin.

EE may affect the metabolism of other substances:

- suppress the activity of hepatic microsomal enzymes and, accordingly, increase the concentration in the blood serum of such active substances as diazepam (and other benzodiazepines, the metabolism of which is carried out through hydroxylation), cyclosporine, theophylline and prednisolone;

- induce glucuronidation in the liver and, accordingly, reduce the concentration in the blood serum of substances such as clofibrate, paracetamol, morphine and lorazepam.

While taking Belara®, the need for insulin and oral hypoglycemic drugs may change, because the drug affects glucose tolerance.

This may also apply to medications that were taken shortly before taking Belara®.

Before prescribing any drug, you should study its summary characteristics to identify possible interactions with Belara®.

Belara price, where to buy

The price of Belara in Russian pharmacies (21 tablets per package) is 491-536 rubles. The price of tablets No. 63 starts from 710 rubles.

Buying similar contraceptive pills No. 21 in Ukraine will cost 250-650 hryvnia, and the minimum cost of package No. 61 will be 910 hryvnia.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine
• Online pharmacies in KazakhstanKazakhstan

ZdravCity

• Belara tablets 21 pcs. Grunenthal GmbH/Gedeon Richter OJSC
  RUB 762 order
• Belara tablets 63 pcs. Grunenthal GmbH/Gedeon Richter OJSC

  RUB 1,957 order

Pharmacy Dialogue

• Belara (tab.p/v. No. 21x3)Gedeon-Richter

  RUB 1,973 order

• Belara (table no. 21x3)Grunenthal GmbH

  RUB 2,052 order

• Belara (tab. No. 21)Gedeon-Richter

  RUR 795 order

show more

Pharmacy24

• Belara No. 21 tablets VAT "Gedeon Richter", Ugorshchina
  279 UAH. order

PaniPharmacy

• Belara tablets Belara tablets. No. 21 Hungary, Gedeon Richter

  290 UAH. order

show more

Directions for use and doses

Inside. The tablets marked with the corresponding day of the week should be removed from the blister pack and swallowed whole, with a small amount of water if necessary. One tablet should be taken every day at the same time (preferably in the evening) for 21 days in a row, then a 7-day break from taking the tablets should be taken; two to four days after taking the last tablet, withdrawal bleeding will occur, similar to menstrual bleeding.

After the end of the 7-day break, you should start taking Belara® from the next pack, regardless of whether the bleeding has stopped or not.

Starting to take pills

If hormonal contraceptives have not been used previously (during the last menstrual cycle). The first tablet should be taken on the first day of a woman’s natural cycle, i.e. on the first day of the next menstrual bleeding. If the first tablet is taken on the first day of menstrual bleeding, the contraceptive effect of the drug begins on the first day of administration and continues during the 7-day break in taking tablets.

The first tablet can also be taken on the 2nd to 5th day of menstrual bleeding, regardless of whether the bleeding has stopped or not. In this case, during the first seven days of admission it is necessary to use additional barrier methods of contraception.

If menstrual bleeding began more than five days ago, the woman should be advised to wait until the next menstrual bleeding begins before taking Belara®.

Switching from another hormonal contraceptive to taking Belara®

Switching from another combined oral contraceptive.

Switching from drugs containing 21 or 22 active tablets. You should stop taking all tablets in the old pack. The first tablet of Belar® should be taken the next day. There should be no break in taking the pills, and the patient should not wait for the next menstrual cycle. Additional contraceptive measures are not required.

When switching from another drug containing 28 tablets: the first tablet of Belara® should be taken the next day after taking the last active tablet from the package of the previous contraceptive drug containing 28 tablets. (i.e. after taking 21 active tablets). There should be no break in taking the pills, and the patient should not wait for the next menstrual cycle. Additional contraceptive measures are not required.

Transition from drugs containing only gestagen (mini-pills). The first tablet of Belara® must be taken the day after taking the last tablet containing only a progestogen. During the first seven days, additional barrier methods of contraception must be used.

Switching from hormonal injectable contraceptives or a contraceptive implant. You can start taking Belara® on the day of implant removal or on the day of the originally planned injection. During the first seven days, additional barrier methods of contraception must be used.

After spontaneous or medical abortion in the first trimester of pregnancy. You can start taking Belara® immediately after a spontaneous or medical abortion in the first trimester of pregnancy. In this case, there is no need to use additional contraceptive measures.

After childbirth, spontaneous or medical abortion in the second trimester of pregnancy. It is recommended to start taking Belara® on the 21st - 28th day after birth, if the woman is not breastfeeding, or after an abortion in the second trimester of pregnancy. In this case, there is no need to use additional barrier methods of contraception.

If the drug was started more than 28 days after childbirth or abortion, then additional barrier methods of contraception should be used during the first seven days.

If a woman has already had sexual intercourse, pregnancy should be excluded or wait until the start of the next menstrual cycle before starting to take the drug.

Breastfeeding period. During breastfeeding, it is contraindicated to take Belara®.

After stopping taking Belara®. After you stop taking Belara®, your current cycle may lengthen by approximately one week.

Irregular taking of pills. If the patient forgot to take the pill, but took it within the next 12 hours, no additional contraceptive measures are required. The patient should continue taking the drug as usual.

If the patient forgot to take the pill, but took it after 12 hours, contraceptive protection may be reduced. If you miss a pill, you should act according to the following two basic rules:

1. You should never stop taking pills for more than 7 days.

2. 7 days of continuous use of tablets is necessary to achieve adequate suppression of the regulation of the hypothalamic-pituitary-ovarian system.

The last missed tablet should be taken immediately, even if this means taking 2 tablets. simultaneously. The following tablets should be taken as usual. Over the next 7 days, you must additionally use barrier methods of contraception, such as condoms. If taking pills was missed during the 1st week of the cycle, and there was sexual intercourse within 7 days before the missed pills (including a 7-day break in taking pills), the possibility of pregnancy should be taken into account. The more pills were missed, and the closer they were to the usual break in taking pills, the higher the likelihood of pregnancy.

Skipping pills on the 2nd and 3rd weeks of taking the drug. You should take the missed tablet immediately, even if this means taking 2 tablets. simultaneously. Take the next tablet as usual. You should use additional methods of contraception, such as condoms, for the next seven days.

If there are less than 7 tablets left in the used pack, immediately after finishing taking the tablets from the used pack, you should start taking tablets from the new pack of Belara®, i.e. there should be no break between two packages. It is likely that normal withdrawal bleeding will not occur until the second pack of tablets is gone; however, while taking tablets from a new package, breakthrough bleeding or spotting from the vagina may occur. If withdrawal bleeding does not occur after finishing taking the tablets from the second package, you should take a pregnancy test.

Recommendations for gastrointestinal disorders

If vomiting or severe diarrhea occurs within 4 hours after taking the tablet, absorption of the drug may be incomplete and the reliability of contraception cannot be guaranteed. In this case, you should act in accordance with the recommendations given in the section “Irregular use of tablets” (see above). You should continue taking Belara®.

How to Delay Withdrawal Bleeding

To delay bleeding, a woman should continue taking tablets from the next package of Belara® without taking a break. You can continue taking tablets if you wish until the tablets from the second package run out. While taking tablets from the second package, minor spotting or breakthrough bleeding may occur. After the usual 7-day break from taking tablets, you should resume regular use of Belara®. To shift the onset of bleeding to another day of the week, different from the day the bleeding began according to the current regimen, a woman can be advised to shorten the next 7-day break by the desired number of days. The shorter the break from taking the pills, the higher the likelihood of no withdrawal bleeding and no breakthrough bleeding or minor spotting while taking the next pill pack (as well as with delayed bleeding).

Analogs

Level 4 ATC code matches:
Ovidon

Rigevidon

Non-Ovlon

Mercilon

Yarina Plus

Yarina

Miniziston 20 fem

Novinet

Microgynon

Janine

Lindineth

Cyclo-Proginova

Regulon

Logest

Midiana

Femoden

Jess Plus

Jess

Zoely

Analogs of Belara: Vidora, Vidora Micro, Dayla, Darilia, Jess, Jess Plus, Difenda, Evra, Janine, Jastinda, Lindinet 20, Lindinet 30, Logest, Marvelon, Mercilon, Midiana, Milanda, Modell Anti, Modell Tin, Naadin, Novinet , Regulon, Rigevidon 21 +7, Silest, Simitsia, Femoden, Yarina, Yarina Plus.