Belara

Pharmacy sales terms

According to the recipe.

Special instructions

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

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

If you have one of the following diseases/risk factors, you should weigh the potential risk and the expected benefit of using Belara®, and also discuss this with the woman before she starts taking this drug. If these diseases or risk factors occur or progress during the use of the drug, the patient should consult with her doctor. The doctor must decide whether to continue or stop the treatment.

Thromboembolism or other vascular diseases. The results of epidemiological studies show that there is a relationship between the use of oral contraceptives and an increased risk of venous and arterial thromboembolic diseases, such as myocardial infarction, brain hemorrhage, deep vein thrombosis and pulmonary embolism. These diseases develop rarely.

The use of COC entails a higher risk of VTE than with abstinence from taking them. This risk of VTE is highest in women during the first year of combined oral contraceptive use. This risk is less than the risk of VTE associated with pregnancy, which is 60 cases per 100,000 pregnancies, VTE leads to death in 1-2% of cases. It is not known how to take the drug Belara® affects the risk of VTE compared to other COCs.

The risk of developing venous thromboembolism in women taking COC increases in the following cases: with age, in the presence of a hereditary predisposition (for example, venous thromboembolism in siblings or parents at a relatively young age). If there is a suspicion of a hereditary predisposition, a woman should be referred to a specialist before making a decision on taking COC, with prolonged immobilization, with obesity (body mass index more than 30 kg/m2).

The risk of developing arterial thromboembolism increases in the following cases: with age, smoking, dyslipoproteinemia, obesity (body mass index more than 30 kg / m2), arterial hypertension, the presence of a heart valve defect, atrial fibrillation, the presence of a hereditary predisposition (for example, arterial thromboembolism in siblings or parents at a relatively young age). If there is a suspicion of a hereditary predisposition, a woman should be referred to a specialist before making a decision on taking a COC.

Other diseases that affect blood circulation are diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, chronic inflammatory bowel diseases (Crohn's disease and ulcerative colitis), and sickle cell anemia.

When assessing the benefit / risk ratio of the drug, it should be remembered that adequate treatment of the above diseases can reduce the risk of thrombosis. It should also be taken into account that the risk of thromboembolic complications increases in the postpartum period.

There is no consensus on whether there is a relationship between superficial thrombophlebitis and/or varicose veins and the etiology of venous thromboembolism.

Possible symptoms of venous and arterial thrombosis are: pain and/or swelling in the lower extremity, sudden severe chest pain, whether it radiates to the left arm or not, sudden shortness of breath, sudden cough for an unknown reason, unexpectedly severe and prolonged headache, partial or complete loss of vision, diplopia/speech disorders or aphasia, dizziness, fainting, in some cases including focal epileptic seizures, sudden weakness or sensitivity disorders in one side of the body or part of the body.body disorders, motor disorders, acute abdominal pain.

Patients taking Belara® They should be informed that if they experience possible symptoms of thrombosis, they should consult a doctor. In case of suspicion or confirmation of thrombosis of the drug Belar® it should be stopped.

Increased frequency and intensity of migraine attacks on the background of the use of the drug Belara® it may indicate the prodromal phase of a violation of the blood supply to the brain and be an indication for immediate discontinuation of the drug.

Tumors. Some epidemiological studies suggest that long-term use of COC is a risk factor for cervical cancer in women infected with the human papillomavirus (HPV). However, this issue is controversial, as it is not clear to what extent other factors affect the results (for example, differences in the number of sexual partners or the use of barrier methods of contraception).

The relative risk of developing breast cancer is slightly higher in women taking COC (relative risk (RR) = 1.24), but gradually decreases over 10 years after discontinuation of COC. However, there is no causal relationship between the disease and taking the drug. The observed increased risk may be due to the fact that women who take COC are diagnosed with breast cancer at an earlier stage than those who do not use them, as well as the biological effect of COC or a combination of both factors.

In rare cases, after taking COC, cases of benign liver tumors were recorded, and even less often, malignant tumors were recorded. In some cases, such tumors can cause life-threatening intra-abdominal bleeding. In the case of severe abdominal pain that does not disappear on its own, an increase in the liver or signs of intra-abdominal bleeding, the probability of developing a liver tumor and taking Belara should be taken into account® it should be stopped.

Other diseases. Many women taking oral contraceptives have a slight increase in blood pressure. Clinically significant increase in blood pressure is rarely observed. The relationship between the use of oral contraceptives and arterial hypertension with clinical manifestations is currently not confirmed. If against the background of taking the drug Belara® there is a clinically significant increase in blood pressure, you should stop taking the drug and treat hypertension. As soon as blood pressure levels normalize after antihypertensive therapy, taking the drug Belara® can be continued.

In women with herpes of pregnant women against the background of taking COCs in the anamnesis, a relapse of this disease is possible. Women who have a history or family history of hypertriglyceridemia while taking COC have an increased risk of developing pancreatitis.

In acute or chronic liver function disorders, it may be necessary to stop taking COC until the functional parameters of the liver are normalized. In case of a relapse of cholestatic jaundice, first diagnosed during pregnancy or taking sex hormones, it is necessary to stop taking COC.

Taking COC may affect peripheral insulin resistance or glucose tolerance. Therefore, patients with diabetes mellitus and taking oral contraceptives should be carefully monitored.

In rare cases, chloasma may occur, especially in women with a history of pregnancy chloasma. Women who are predisposed to chloasma should avoid exposure to the sun, as well as UV radiation while taking COC.

Patients with rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption receive Belara® contraindicated.

Safety precautions. Taking medications containing estrogen or estrogen / progestogen can negatively affect certain diseases and conditions. In the following cases, careful medical supervision is necessary: epilepsy, multiple sclerosis, tetany, migraine, asthma, heart or kidney failure, chorea, diabetes mellitus, liver disease, dyslipoproteinemia, autoimmune diseases (including systemic lupus erythematosus), obesity, hypertension, endometriosis, varicose veins, thrombophlebitis, blood clotting disorders, mastopathy, uterine fibroids, herpes of pregnant women, depression, chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis).

Medical examination. Before the appointment of the drug Belar® It is necessary to conduct a medical examination and collect a complete family and personal history of the patient in order to identify contraindications and risk factors. When taking the drug Belara® this procedure should be repeated once every six months. Regular medical examinations are also necessary because contraindications (for example, a transient ischemic attack) or risk factors (for example, a personal or family history of venous or arterial thrombosis) may first appear while taking oral contraceptives. The medical examination should include blood pressure measurement, examination of the mammary glands, abdominal organs, internal and external genitalia, including cytological examination of the cervical epithelium, and the performance of appropriate laboratory tests.

You should inform the woman that taking oral contraceptives, including the drug Belara®, does not protect against HIV infection (AIDS), as well as other sexually transmitted diseases.

Laboratory tests. Indicators of some laboratory tests may change against the background of taking COC, for example, indicators of liver function, thyroid gland, adrenal glands, the content of carrier proteins in plasma (for example, SHBG, lipoproteins), as well as parameters of carbohydrate metabolism, coagulation and fibrinolysis. The nature and extent of changes in laboratory parameters depend on what hormones are prescribed and in what doses.

The loss of efficiency. Missed use of a film-coated tablet, vomiting or intestinal disorders, including diarrhea, prolonged use of certain concomitant medications, or, in very rare cases, metabolic disorders can reduce the contraceptive effectiveness of Belara®.

Effects on menstrual cycle control. Breakthrough bleeding and minor spotting.

The use of all oral contraceptives can lead to bleeding from the vagina (breakthrough bleeding and minor spotting), especially during the first cycles of taking the drug.

Therefore, the medical assessment of irregular cycles should be carried out only after an adaptation period equal to the first three cycles. If against the background of taking the drug Belara® breakthrough bleeding is constantly observed or appears for the first time, although previously the cycle was regular, an examination should be conducted to exclude pregnancy or organic diseases. After the exclusion of pregnancy or organic disease, you can continue taking the drug Belara® or navigate to the administration of other drugs. Acyclic bleeding can be a sign of decreased contraceptive effectiveness.

The absence of withdrawal bleeding. As a rule, after 21 days of taking the drug, withdrawal bleeding occurs. Sometimes, especially during the first months of taking the drug, withdrawal bleeding may be absent. However, this does not necessarily indicate a decrease in the contraceptive effect. If there was no bleeding after one cycle of administration, during which the patient did not forget to take the drug Belara®, the 7-day pill break period was not prolonged, the patient did not have vomiting or diarrhea, pregnancy is unlikely, and taking Belara® can be continued. If prior to the first absence of bleeding discontinuation of the drug Belara® if there is a violation of the instructions or the absence of withdrawal bleeding is observed for two cycles, then it is necessary to exclude pregnancy before continuing to take the drug.

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

Influence on the ability to drive vehicles and work with mechanisms. Does not affect.

Nosological classification (ICD-10)

  • Z30 Monitoring the use of contraceptives
  • Z30. 0 General tips and advice on contraception

ATC - Anatomical and therapeutic chemical classification

G03AA Progestogens and estrogens (fixed combinations)