Belara - instructions for use, analogs, reviews and release forms (birth control pills 2 mg + 30 μg) of a drug for contraception and prevention of unwanted pregnancy in women. Composition and side effects

In this article, you can read the instructions for using the drug Belara. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Belara in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Belara in the presence of existing structural analogues. Use for contraception and prevention of unwanted pregnancy in women. Composition of the contraceptive.

Belara - Combined contraceptive for oral administration.

Long-term (more than 21 days) application of the drug leads to a decrease in the secretion of follicle-stimulating and luteinizing hormones and, consequently, to suppression of ovulation, endometrial proliferation and its secretory transformation. At the same time, the properties of the mucus of the cervical canal change, which is accompanied by a difficulty in the passage of spermatozoa through the cervical canal and a violation of their mobility.

The chloromadinone acetate-progestagen with anti-androgenic properties is part of the drug. The daily dose of chloromadinone, which provides complete suppression of ovulation, is 1.7 mg. The required dose per cycle is 25 mg.

Ethinyl estradiol is a synthetic estrogen. Significantly increases the production of globulin, binding sex hormones, thereby reducing the amount of free testosterone in the blood plasma. Interacts with specialized estrogen receptors in target organs (in the fallopian tubes, cervix, vagina, external genitalia that lead to the ducts of the mammary glands), causes proliferation of the endometrium. Inhibits the secretion of cutaneous sweat glands.

In addition to reliable contraceptive action, the positive effect of the Belar drug is manifested in the normalization of the menstrual cycle, the decrease in the manifestation of premenstrual syndrome, the frequency of iron deficiency anemia, dysmenorrhea, functional ovarian cysts, ectopic pregnancy, malignant endometrial and ovarian formations, some forms of benign breast diseases and inflammatory diseases organs of the small pelvis.

Composition

Ethinyl estradiol + Chlormadinone acetate + excipients.

Pharmacokinetics

After taking the drug inside chloromidinone, acetate and ethinyl estradiol are quickly and completely absorbed from the digestive tract. Metabolites of chloromadinone acetate are excreted by the kidneys and through the intestine in a ratio of 2: 3. Metabolites ethinyl estradiol - water-soluble derivatives of sulfate or glucuron conjugation - are excreted by the kidneys and through the intestine in a ratio of 4: 6.

Indications

• oral contraception.

Forms of release

Tablets coated with 2 mg + 30 μg.

Instructions for use and reception scheme

The drug should be taken orally (preferably at the same time).It is necessary to take the first pill on the 1st day of the menstrual cycle and continue their daily intake of 1 tablet per day for 21 days. Then a 7-day break should be done, during which menstrual bleeding should begin. After a 7-day break, you should resume taking the pills from the next blister, regardless of whether menstrual bleeding has stopped or not.

Tablets must be squeezed out from the blister and swallowed whole, choosing that pill that is marked with the corresponding day of the week. The choice of tablets is determined by the direction of the arrow on the package.

If hormonal contraceptives are not used during the previous menstrual cycle, taking the tablets should begin on the first day of the normal menstrual cycle (the first day of menstruation). In this case, the contraceptive effect starts from the first day of taking the drug Belar and is maintained during the 7-day break, when the tablets are not taken. In addition, the first tablet of Belar can be taken on the 2nd-5th day of menstruation, regardless of whether bleeding has stopped or not.However, in this case, in the first 7 days of taking the tablets, additional barrier means of contraception must be used.

If the menstruation has begun prematurely (more than for 5 days), it should be recommended to the woman to postpone the start of taking the drug Belara until the next menstrual cycle.

When switching from another hormonal contraceptive containing 21 or 22 active tablets, you should end up taking all the pills of the old package. The first tablet of the drug Belar must be taken the next day. There should not be a break in taking the pills; The patient should not wait for the next menstrual cycle. Additional contraceptive measures are not required.

When switching from another hormonal contraceptive containing 28 tablets, the first tablet of the drug Belar should be taken the next day after taking the last active tablet from the packaging of the previous contraceptive (ie after taking 21 active tablets). There should not be a break in taking the pills; The patient should not wait for the next menstrual cycle. Additional contraceptive measures are not required.

When switching from contraceptives containing only gestagen (mini-pili), a woman can start taking the drug Belar any day (without interruption); when switching from using an implant containing gestagen, on the day of its removal; when switching from gestagens in the injection form - from the day when the next injection was to be made. In all cases it is necessary to use additional barrier methods of contraception during the first 7 days of taking the drug Belar.

After an abortion in the first trimester of pregnancy, you should start taking the medication immediately after the abortion. Additional methods of contraception are not necessary.

After childbirth or abortion in the 2nd trimester of pregnancy, women who are not breastfeeding can start taking the drug Belar on the 21-28th day of the postpartum period. In this case, additional contraceptive measures should not be taken. If the use of the drug in the postpartum period is started 28 days after the birth, additional contraceptive measures must be taken within 7 days. If a woman has had sexual intercourse, then before starting the use of the drug it is necessary to exclude pregnancy and wait for the next menstrual cycle.

If the patient did not take the drug at the usual time and after less than 12 hours after the prescribed time, the contraceptive effect of the drug is preserved, and the missed tablet should be taken as soon as possible. The next tablet should be taken at the set time.

In the event that more than 12 hours have elapsed since the prescribed time of admission, it is possible to reduce the contraceptive effect of the drug. It is necessary to immediately take the missed tablet and continue taking the drug at the usual time. It is necessary to use additional barrier methods of contraception during the next 7 days. If during these 7 days the tablets in the package have run out, then taking the tablets from the next package should begin immediately after the completion of the tablets in the previous package, i.e. Do not take a break between taking tablets from different packages. If there was no menstrual bleeding after taking the second package, pregnancy should be excluded.

If there is vomiting or diarrhea, it is recommended to use additional methods of contraception against the background of taking the drug Belar.The contraceptive effect of the drug may decrease due to incomplete absorption of the drug's active ingredients in the intestine.

Side effect

• bleeding breakthrough;
• bloody discharge from the vagina;
• headache;
• unpleasant sensations in the area of ​​the mammary glands;
• intermenstrual bleeding (usually decreasing with increasing duration of reception of Belara);
• hypersensitivity to the components of the drug, including allergic reactions from the skin;
• increased appetite;
• depressive state;
• nervousness;
• irritability;
• decreased libido;
• dizziness;
• migraine (and / or its enhancement);
• visual impairment;
• conjunctivitis;
• intolerance to contact lenses;
• unexpected hearing loss;
• noise in ears;
• increased blood pressure;
• hypertension;
• hypotension;
• cardiovascular collapse;
• varicose veins;
• vein thrombosis;
• nausea, vomiting;
• stomach ache;
• flatulence;
• diarrhea;
• acne;
• disorders of pigmentation;
• Chloasma;
• hair loss;
• dry skin;
• hyperhidrosis;
• hives;
• eczema;
• erythema;
• itching of the skin;
• increased psoriasis;
• hypertrichosis;
• erythema nodosum;
• feeling of heaviness;
• backache;
• muscle disorders;
• increased mucosal discharge from the vagina;
• dysmenorrhea;
• amenorrhea;
• pain in the lower abdomen;
• fibroadenoma of the breast;
• vaginal candidiasis;
• increased mammary glands;
• vulvovaginitis;
• menorrhagia;
• premenstrual syndrome;
• fatigue;
• edema;
• increase in body weight.

When using combined oral contraceptives, including Belarus, the following undesirable effects were also noted:

• increased risk of venous and arterial thromboembolism (eg, venous thrombosis, pulmonary embolism, stroke, myocardial infarction). Risk can be exacerbated by additional factors;
• increased risk of bile duct disease;
• in rare cases, an increased risk of developing benign neoplasms of the liver (and even less often - malignant neoplasms of the liver); Single cases can lead to life-threatening intra-abdominal bleeding;
• exacerbation of chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis).

Contraindications

Combined oral contraception (CPC) is contraindicated in the cases listed below. Reception of Belara should be stopped immediately if any of the following symptoms appear:

• presence of thrombosis (venous and arterial) currently or history (e.g., deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke);
• presence of the first signs of thrombosis, thrombophlebitis or symptoms of embolism (eg, transient ischemic attacks, angina);
• planned surgical intervention (at least 4 weeks before) and the period of immobilization, for example, after trauma (including after the application of plaster bandages);
• diabetes mellitus with vascular complications;
• diabetes mellitus, which can not be adequately controlled;
• uncontrolled hypertension or significant increase in blood pressure (above 140/90 mm Hg);
• hereditary or acquired predisposition to the development of venous or arterial thrombosis, such as: increased resistance of the organism to activated C-protein (APC-resistance); deficiency of antithrombin III, protein C deficiency, protein S-deficiency, hyperhomocysteinemia and antiphospholipid antibody (anticardiolipin antibodies, lupus anticoagulant);
• hepatitis, jaundice, a violation of the function of the liver at present or in anamnesis (before the normalization of liver tests);
• generalized pruritus and jaundice (cholestasis), especially during a previous pregnancy or estrogen therapy;
• Dubin-Johnson syndrome, Rotor syndrome, conditions / diseases, accompanied by a violation of bile outflow;
• the presence at the present time or in an anamnesis of liver tumors;
• severe epigastric pain, enlarged liver, or symptoms of intra-abdominal hemorrhage;
• manifestation for the first time or relapse of porphyria (all three forms, especially acquired porphyria);
• presence of hormone-dependent malignant diseases, incl. in the anamnesis (for example, a uterus or mammary glands) or suspicion on them;
• pronounced disorders of lipid metabolism;
• pancreatitis (currently or in anamnesis) in combination with severe forms of hypertriglyceridemia;
• first attacks of migraine pain or frequent severe headaches;
• Migraine in combination with local neurologic symptoms (associated migraines);
• acute sensory disorders, such as visual and hearing impairment;
• motor disorders (especially paresis);
• weighting of the course of epilepsy;
• severe depression;
• otosclerosis during previous pregnancies;
• bleeding from the vagina of an unclear etiology;
• endometrial hyperplasia;
• amenorrhea of ​​unclear etiology;
• smoking over the age of 35;
• pregnancy or suspected of it;
• lactation (the period of breastfeeding);
• hypersensitivity to the components of the drug.

Application in pregnancy and lactation

The use of the drug Belar during pregnancy is contraindicated. Before you start using the drug Belara, you must exclude the presence of pregnancy. At the onset of pregnancy during the reception of Belara, the drug should be stopped immediately. The data available to date do not contain information on the development of teratogenic or embryotoxic effects in women who accidentally took during pregnancy preparations containing estrogens and progesterones in the same combination as in the preparation of Belar,

It is not recommended to use the drug Belara during breastfeeding, as the drug reduces the amount of milk produced and changes its composition. Small amounts of hormones that make up the contraceptive and / or their metabolites are excreted in breast milk and can affect the baby.

Use in children

It is not used until the onset of menarche.

special instructions

Smoking increases the risk of developing severe adverse reactions from the cardiovascular system when using CPC. The risk rises with age and depends on the number of cigarettes smoked. The risk is more pronounced in women over the age of 35. Smoking women over the age of 35 should use other methods of contraception.

When using CPC, 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. In the presence of one of the above diseases / risk factors, it is necessary to weigh the possible benefits of using the drug Belar against risks, and this should be discussed with the woman before she starts taking her drug. If these diseases or risk factors start to appear or progress during the administration of the drug, you should consult a doctor. The doctor must decide whether or not to take this medication.

Thromboembolism and other vascular diseases

It was noted that there is a correlation between the administration of CPC and the 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.

Reception of CPC leads to an increased risk of venous thromboembolism (VTE). The risk of VTE is greatest during the first year of admission. The degree of such risk is less than in pregnancy, when the frequency of VTE is 60 cases per 100,000 pregnancies. VTE leads to death in 1-2% of cases. There is no data on development evaluation; risk of VTE when taking the drug Belara in comparison with other PDAs.

The risk of developing venous thromboembolic complications with the use of PDA increases:

• with age;
• in the presence of thromboembolism in relatives (venous thromboembolism in siblings, sisters or parents at a relatively young age). If hereditary predisposition is assumed, it is recommended that a woman be referred for consultation to a specialist before the appointment of the drug Belar;
• with prolonged decreased mobility;
• with obesity (body mass index more than 30 kg / m2).

The risk of developing arterial thromboembolic complications when taking PDA increases:

• with age;
• smokers;
• with dyslipoproteinemia;
• with obesity (body mass index more than 30 kg / m2);
• with hypertension;
• with heart diseases;
• with atrial fibrillation;
• in the presence of thromboembolism in relatives (arterial thromboembolism in siblings, sisters or parents at a relatively young age). If hereditary predisposition is assumed, it is recommended that a woman be referred for consultation to a specialist before the appointment of the drug Belar.

Other diseases affecting blood circulation are: diabetes mellitus, systemic lupus erythematosus, haemolytic uremic syndrome, chronic intestinal inflammations (Crohn's disease and ulcerative colitis), sickle cell 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 as to whether there is a relationship between venous thrombophlebitis and / or varicose veins and the etiology of venous thromboembolism. With the development of venous or arterial thrombosis, the following symptoms may occur:

• pain in lower limbs and / or swelling;
• sudden severe pain in the chest, with irradiation or without irradiation in the left arm;
• sudden shortness of breath, cough for no apparent reason;
• unexpected severe prolonged headache;
• partial or complete loss of vision;
• diplopia / speech disorders or aphasia;
• dizziness, collapse, in some cases accompanied by a focal epileptic seizure;
• sudden weakness or dysesthesia (perversion of sensitivity) on one side or in one part of the body;
• motor disorders;
• acute pain in the abdomen.

Women taking the drug Belara, should be informed that when symptoms appear resembling symptoms of thrombosis, you need to contact your doctor. The preparation of Belar should be canceled if there is a suspicion or confirmation of the diagnosis of thrombosis.

The increase or increase in the severity of migraine attacks during the administration of the drug Belara (which may bea harbinger of development or a symptom of cerebrovascular disease) is an indication for the immediate withdrawal of the drug Belar.

Tumors

It is noted that the use of CPC is a risk factor for the development of cervical cancer in women infected with human papillomavirus (HPV). However, the question of the degree of influence on the results of this observation of other concomitant factors (for example, the number of sexual partners or the use of mechanical contraceptives) remains controversial.

There is evidence that the relative risk (RR = 1.24) of breast cancer in women who take CPC is slightly higher. Within 10 years after the cessation of taking the CPC, the risk level gradually decreases and returns to the age. Because breast cancer is rare in women under the age of 40, the difference between the risk of breast cancer in current and recently accepted CCPs and the general risk of developing the disease is low.

There are reports of the development in rare cases of benign, even more rare cases of malignant liver tumors during the reception of the PDA.In some cases, these tumors are the causes of life-threatening intraabdominal bleeding. In case of severe pain in the abdomen, which does not pass by itself, hepatomegaly or signs of intraabdominal bleeding, it is necessary to take into account the possibility of a liver tumor, and to cancel the preparation of Belar.

Other diseases

Many women taking oral contraceptives have a slight increase in blood pressure; however, a clinically significant increase is rare. The relationship between the appointment of oral contraceptives and the clinical manifestation of hypertension has not been confirmed to date. If during the reception of the drug Belar appears clinically significant increase in blood pressure, then the drug should be canceled and the treatment of hypertension. As soon as the blood pressure returns to normal against a background of antihypertensive therapy, you can continue taking the drug Belar.

In women with herpes of pregnant women in an anamnesis against the background of taking the drug Belara can be a relapse of the disease. In women with hypertriglyceridemia in a history or a family history, the risk of developing pancreatitis during the administration of the drug Belara increases.Acute or chronic liver dysfunction may require the cancellation of the drug Belara before the normalization of liver function. The recurrence of cholestatic jaundice, which first arose during pregnancy or previous reception of sex hormones, requires the withdrawal of the drug Belar.

PDA can have an effect on the resistance of peripheral tissues to insulin or glucose tolerance. Therefore, patients with diabetes mellitus during the reception of the drug Belara should be under constant supervision.

In rare cases, chloasma may develop, especially in women who have undergone the chloasma of pregnant women. Women with a risk of developing chloasma should avoid exposure to sunlight and ultraviolet radiation while taking the drug Belar.

Patients with a rare congenital pathology - intolerance to galactose, deficiency of lactase lapp or malabsorption syndrome of glucose-galactose - use of the drug Belar is contraindicated.

Medical examination

Before the appointment of the drug Belar it is necessary to collect complete data on the health of the woman and her relatives in order to identify contraindications and risk factors. A woman must undergo a medical examination.Medical examination should be carried out once in 6 months during the reception of the drug Belar. Regular medical examination is also necessary due to the fact that diseases that are contraindications (eg, transient ischemic attacks) or risk factors, can occur for the first time against the background of taking the drug Belar.

The medical examination should include measurement of blood pressure, examination of the mammary glands, abdominal and pelvic organs, including cytological examination of the cervical epithelium and appropriate laboratory tests.

A woman should be warned that the appointment of oral contraceptives, incl. and the drug Belara, does not protect her from becoming infected with HIV (AIDS) or other sexually transmitted diseases.

Insufficient efficiency

Passing the pill, vomiting and diarrhea, prolonged simultaneous use of certain medications or, in very rare cases, metabolic disorders can reduce the effectiveness of contraception.

Effects on the menstrual cycle

Bleeding "breakthrough" or acyclic spotting

All oral contraceptives can cause irregular vaginal bleeding (bleeding "breakthrough" or acyclic spotting), especially during the first few cycles against the background of taking the drug. Therefore, a medical examination for irregular cycles should be conducted only after the adaptation period, which usually lasts for 3 cycles. If during the reception of the drug Belar the emergence of extraordinary bleeding continues or appeared for the first time in a woman with a regular cycle, it is necessary to conduct a survey to exclude pregnancy or organic pathology. After the exclusion of pregnancy and organic pathology, the drug Belara can be continued or switch to another drug.

Bleeding, appearing between cycles, may be a sign of insufficient contraceptive effectiveness.

Absence of menstrual bleeding (bleeding "withdrawal")

After 21 days after taking the drug, bleeding "cancellation" usually occurs. Sometimes, especially in the first few months of taking the drug, bleeding "cancellation" may be absent.However, this is not evidence of an insufficient contraceptive effect. If bleeding does not occur after taking the drug for one cycle, provided that no ingestion of the film-coated tablet was allowed, the period after completion of taking the drug did not exceed 7 days, no other medications were taken at the same time, there was no vomiting or diarrhea, pregnancy unlikely. After the exclusion of pregnancy and organic pathology, the drug Belara can be continued. If the instructions were not followed before the first absence of bleeding from the "Belar" administration, or bleeding "withdrawal" was absent for two consecutive cycles, it is necessary to exclude the presence of pregnancy to decide whether to continue taking the drug.

Simultaneously with the use of the drug Belara, do not take herbal medicines containing St. John's wort (Hypericum perforatum).

Laboratory indicators

During the reception of the drug Belar may change some of the laboratory indicators, including. functional activity of the liver, adrenal and thyroid gland,concentration of bound proteins in the plasma (eg, globulin, binding sex hormones, lipoproteins), carbohydrate metabolism, coagulation and fibrinolysis. The nature and extent of changes are partly determined by the nature and dose of hormones taken.

Drug Interactions

The interaction of ethinyl estradiol, the estrogen component of the drug Belar with other drugs can cause an increase or decrease in the concentration of ethinyl estradiol in the serum. If long-term treatment with these medicines is necessary, then non-hormonal contraceptives should be switched. Reducing the concentration of ethinyl estradiol in the blood serum can lead to an increase in episodes of breakthrough bleeding, disruption of the cycle and a decrease in the contraceptive efficacy of the drug Belar. Increasing the concentration of ethinyl estradiol in the serum can increase the frequency and severity of side effects.

The following medicines / active ingredients can reduce the concentration of ethinylestradiol in serum:

• all drugs that enhance the motility of the gastrointestinal tract (eg metoclopramide) or impair absorption (for example, activated charcoal);
• active substances that induce microsomal liver enzymes such as rifampicin, rifabutin, barbiturates, anticonvulsants (e.g., carbamazepine, oxcarbazepine, phenytoin, topiramate, felbamate), phenylbutazone, griseofulvin, barbeksaklon, primidone, modafinil, some protease inhibitors (e.g., ritonavir) and preparations of St. John's wort;
• some antibiotics (for example, ampicillin, tetracycline, rifampicin) - due to a decrease in enterohepatic circulation of estrogens.

With the simultaneous use of such drugs / active substances with the drug Belara, additional barrier methods of contraception should be used, both during treatment and within 7 days after it. When receiving the active substances that reduce the concentration of ethinyl estradiol in serum by induction of hepatic microsomal enzymes, additional barrier methods (condoms, spermicides) should be used within 28 days after treatment.

The following medicines / active ingredients may increase the concentration of ethinylestradiol in serum:

• active substances that suppress the sulfation of ethinylestradiol in the intestinal wall, for example, ascorbic acid or paracetamol;
• atorvastatin;
• substances that inhibit the activity of hepatic microsomal enzymes, such as antifungal imidazoles (eg, fluconazole), indinavir or trolleandomycin.

Ethinyl estradiol can affect the metabolism of other substances:

• suppress the activity of hepatic microsomal enzymes and, accordingly, increase the concentration in the serum of active substances such as diazepam (and other benzodiazepines metabolized through hydroxylation), cyclosporine, theophylline and prednisolone;
• induce glucuronization in the liver and, accordingly, reduce the concentration in the blood serum, for example, clofibrate, paracetamol, morphine and lorazepam.

The need for insulin and oral antidiabetics may change due to the effect of the drug on glucose tolerance.

Analogues of the drug Belara

The drug does not have structural analogs for the active substance. The combination of active ingredients in the formulation is unique.

Analogues for the pharmacological group (estrogens and gestagens):

• Antotevin;
• Artisia;
• Gynodian Depot;
• Gynoflor E;
• Demulen;
• Jess;
• Diane 35;
• Divina;
• Divertrain;
• Evra;
• Janine;
• Clira;
• Klimen;
• Klimodien;
• Clinonorm;
• Cliogest;
• Lindineth;
• Logest;
• Marvelon;
• Midian;
• Microinon;
• NovaRing;
• Novinet;
• Non Ovlon;
• Ovidon;
• Pausogest;
• Revmelid;
• Regulon;
• Rigevidone;
• Silestus;
• Silhouettes;
• Three Mercy;
• Three regol;
• Trikwilar;
• Trisequence;
• Femaflor;
• Femoden;
• Femoston;
• Cyclo Proginova;
• Evian;
• Egestenol;
• Escapel;
• Yarina;
• Yarina Plus.

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