Components:
Method of action:
Medically reviewed by Fedorchenko Olga Valeryevna, PharmD. Last updated on 31.03.2022
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Oral contraception.
Inside. Tablets marked with the appropriate day of the week should be removed from the blister pack and swallowed whole, if necessary, washed down with a small amount of water. One tablet should be taken every day at the same time (preferably in the evening) for 21 consecutive days, then a 7-day break should be taken, two to four days after taking the last tablet, withdrawal bleeding similar to menstrual bleeding will occur.
After the end of the 7-day break, you should start taking the drug Belara® from the next pack, regardless of whether the bleeding has stopped or not.
Start taking pills
If hormonal contraceptives have not been used before (during the last menstrual cycle). The first pill 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 pill is taken on the first day of menstrual bleeding, the contraceptive effect of the drug begins on the first day of administration and continues for a 7-day break in taking the pills.
The first pill can also be taken on the 2nd-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 has started more than five days ago, the woman should be advised to wait until the beginning of the next menstrual bleeding to start taking the drug Belara®.
Switching from another hormonal contraceptive to taking Belara®
Switching from another combined oral contraceptive.
Transition from drugs containing 21 or 22 active tablets. You should finish taking all the tablets of the old package. The first tablet of the drug Belara® it must be taken the next day. There should be no interruption 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 tab.: the first tablet of the drug Belara® it 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 interruption in taking the pills, and the patient should not wait for the next menstrual cycle. Additional contraceptive measures are not required.
The transition from products containing only progestogen (minipill). The first tablet of the drug Belara® it should be taken the next day after taking the last tablet containing only gestagen. During the first seven days, it is necessary to use additional barrier methods of contraception.
Transition from hormonal injectable contraceptives or a contraceptive implant. Taking the drug Belara® you can start on the day of the implant removal or on the day of the originally planned injection. During the first seven days, it is necessary to use additional barrier methods of contraception.
After a spontaneous or medical abortion in the first trimester of pregnancy. Taking the drug Belara® you can start immediately after a spontaneous or medical abortion in the first trimester of pregnancy. In this case, there is no need to apply additional contraceptive measures.
After childbirth, spontaneous or medical abortion in the second trimester of pregnancy. Taking the drug Belara® it is recommended to start on the 21st-28th day after delivery, 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 delivery or abortion, then additional barrier methods of contraception should be used during the first seven days.
If a woman has already had sexual intercourse, then you should exclude the presence of pregnancy or wait for the beginning of the next menstrual cycle before starting taking the drug.
The period of breastfeeding. During breastfeeding, it is contraindicated to take the drug Belara®.
After stopping taking the drug Belara®. After stopping taking the drug Belara® the current cycle can be extended by about one week.
Irregular pill intake. 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. In the case of skipping the pill, you should act according to the following two basic rules:
1. Never stop taking pills for more than 7 days.
2. 7 days of continuous tablet administration 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 it means that you need to take 2 tablets.. at the same time. The following tablets should be taken as usual. During the next 7 days, it is necessary to additionally use barrier methods of contraception, such as condoms. If the pills were missed during the 1st week of the cycle, and within 7 days before the missed pills there was sexual intercourse (including a 7-day break in taking the pills), the probability of pregnancy should be considered. The more pills that were missed, and the closer they were to the usual pill break, the higher the chance of pregnancy.
Skipping tablets on the 2nd and 3rd week of taking the drug. You should immediately take the missed tablet, even if it means taking 2 tablets at the same time. The next pill is taken as usual. During the next seven days, you must use additional methods of contraception, such as condoms.
If your pack has less than 7 tab., immediately after taking the pill used the pack to start taking pills from a new package of the drug Belar®, i.e. there should be no break between the two packages. It is likely that the usual withdrawal bleeding will not occur until the tablets from the second package run out, but while taking the tablets from the new package, breakthrough bleeding or spotting bloody discharge from the vagina may occur. If withdrawal bleeding does not occur after the end of taking the tablets from the second package, then a pregnancy test should be performed.
Recommendations for gastrointestinal disorders
If vomiting or severe diarrhea occurs within 4 hours after taking the pill, the absorption of the drug may be incomplete and the reliability of contraception cannot be guaranteed. In this case, you should follow the recommendations given in the section "Irregular pill intake» (see above). You should continue taking the drug Belara®.
How to delay withdrawal bleeding
To delay the bleeding, the woman should continue taking the tablets from the next package of the drug Belara® without taking a break. You can continue taking the tablets at will until you run out of tablets from the second package. While taking the tablets from the second package, minor spotting or breakthrough bleeding may occur. After the usual 7-day break in taking tablets, you should resume regular use of the drug Belara®. To move the beginning of bleeding to another day of the week, different from the day of the beginning of bleeding according to the current scheme, a woman can be recommended to reduce the next 7-day break by the desired number of days. The shorter the pill break, the higher the chance of no withdrawal bleeding and breakthrough bleeding or minor spotting while taking the pills from the next package (as well as when delaying bleeding).
Taking the drug Belara® contraindicated in the following diseases/conditions:
hypersensitivity to the components of the drug,
the presence of thrombosis (venous and arterial) at the present time or in the anamnesis (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, see " Special instructions»),
planned surgical intervention (at least 4 weeks before it) and the period of immobilization, for example, after an injury (including after applying plaster dressings),
diabetes mellitus with vascular complications,
diabetes mellitus that cannot be adequately controlled,
uncontrolled hypertension or a significant increase in blood pressure (above 140/90 mm Hg, see " Special instructions»),
hereditary or acquired predisposition to the development of venous or arterial thrombosis, such as increased resistance of the body to activated protein C (activated protein C resistance - ARS-resistance), antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant),
acute or chronic liver diseases of severe degree (before normalization of liver function indicators),
generalized itching, cholestasis, especially during a previous pregnancy or a history of taking sex hormones,
syndrome Dubin-Johnson syndrome Rotor, a violation of the outflow of bile,
the presence of liver tumors at present or in the anamnesis,
severe epigastric pain, enlarged liver, or symptoms of intra-abdominal bleeding,
first-time porphyria or its relapse (all three forms, especially acquired porphyria),
the presence of hormone-dependent malignant diseases, including in the anamnesis (for example, breast or uterus) or suspicion of them,
severe disorders of lipid metabolism,
pancreatitis currently or in anamnesis, in combination with severe forms of hypertriglyceridemia,
first-time migraine attacks or frequent severe headaches,
migraine in combination with local neurological symptoms (associated migraine),
acute sensory impairments, such as visual or hearing impairments,
motor disorders (in particular, paresis),
an increase in the number of epilepsy attacks,
severe depression,
worsening of the course of otosclerosis during previous pregnancies,
amenorrhea of unclear etiology,
endometrial hyperplasia,
vaginal bleeding 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 (age increase, smoking, especially over the age of 35 years, obesity (<30 kg / m2), dyslipoproteinemia, the presence of a family history of venous or arterial insufficiency in relatives of the 1st line of kinship, heart valve diseases, atrial fibrillation, bacterial endocarditis, any operations on the lower extremities, extensive trauma).
pregnancy or suspected pregnancy,
breast-feeding period.
With caution: In the presence of the following conditions/diseases/risk factors, currently or in the anamnesis, the use of the drug Belara® requires careful medical monitoring 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 minor, diabetes mellitus with uncomplicated course, acute and chronic liver diseases of mild and moderate severity (with normal liver function tests), impaired lipid metabolism, 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"), violation of the blood clotting system, mastopathy, uterine fibroids, herpes of pregnant women, depression (see also "Contraindications"), chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis).
When taking the drug Belara® the most common adverse reactions (>20% of cases) are breakthrough bleeding, vaginal bleeding, headache, and discomfort in the mammary glands. Intermenstrual bleeding usually decreases as the duration of taking Belara increases®.
The frequency of adverse reactions is determined as follows: very often - ≥1/10, often - ≥1/100, <1/10, infrequently - ≥1/1000, <1/100, rarely - ≥1/10 000, <1/1000, very rarely - <1/10 000.
There may be adverse reactions from the following organs and systems.
On the part of the immune system: infrequently-hypersensitivity to the components of the drug, including allergic reactions from the skin.
From the side of metabolism and nutrition: rarely-increased appetite.
Mental disorders: often-depressed mood, nervousness, irritability.
From the nervous system: often-dizziness, migraine (and / or its increase).
On the part of the visual organs: often-visual disorders, rarely-conjunctivitis, contact lens intolerance.
On the part of the organ of hearing and labyrinth disorders: rarely, sudden hearing loss, ringing in the ears.
From the CCC side: rarely-increased blood pressure, hypotension, cardiovascular collapse, varicose veins, venous thrombosis.
From the gastrointestinal tract: very often-nausea, often-vomiting, infrequently-abdominal pain, flatulence, diarrhea.
From the skin and subcutaneous tissues: often-acne, infrequently-pigmentation disorders, chloasma, hair loss, dry skin, rarely-urticaria, eczema, erythema, itching of the skin, increased psoriasis, hypertrichosis, very rarely-erythema nodosum.
Musculoskeletal and connective tissue disorders: often-a feeling of heaviness in the lower extremities, infrequently-back pain, muscle disorders.
From the genitals and breast: very often-increased vaginal discharge, painful menstrual-like spotting from the vagina, absence of menstrual-like spotting, often-pain in the lower abdomen, infrequently-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, infrequently-decreased libido, hyperhidrosis, rarely-increased appetite.
Influence on the results of laboratory and instrumental examinations: infrequently-changes in the content of lipids in the blood plasma, including hypertriglyceridemia.
When using combined oral contraceptives (COC), including those containing 0.03 mg of EE and 2 mg of 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 neoplasms (and even less often - malignant liver neoplasms), 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").
Symptoms: no severe toxic reactions are observed, nausea, vomiting (especially in young girls), bloody discharge/bleeding from the vagina may develop.
Treatment: symptomatic. There is no specific antidote. In rare cases, it is necessary to monitor the indicators of water-electrolyte metabolism and liver function.
Long-term use of the drug Belara® leads to a decrease in the secretion of FSH and LH and, consequently, the suppression of ovulation. At the same time, endometrial proliferation and secretory transformation occur, which prevent the implantation of a fertilized egg, the viscosity of the mucous secretion of the cervix increases, which is accompanied by difficulty in passing spermatozoa through the cervical canal and a violation of their mobility.
For the complete suppression of ovulation requires 1.7 mg of chlormadinone acetate (CMA) on a daily basis. The required dose per cycle is 25 mg.
Part of the preparation Belara® CMA is a progestogen with antiandrogenic properties. Its action is based on the ability to replace androgens at specific receptors, eliminating and weakening the effect of endogenous and exogenous androgens. The Pearl index is equal to 0.291–0.698, depending on how carefully the woman follows the regimen of taking the drug.
HMA
Suction. When taking the drug inside, CMA is quickly and completely absorbed.
Tmax HMA — 1-2 hours.
Distribution. More than 95% of CMA binds to human plasma proteins, mainly albumin.
Metabolism. Various processes of reduction, oxidation and binding to 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 non-metabolized CMA. 3-hydroxy-metabolites have antiandrogenic activity similar to that of CMA itself. In the urine, the metabolites are mainly contained in the form of conjugates. After enzymatic cleavage, 2-alpha-hydroxy-CMA becomes the main metabolite, and 3-hydroxy-metabolites and dihydroxymetabolites are also formed.
Output. Average T1/2 CMA from the blood plasma is approximately 34 hours (after taking a single dose) and about 36-39 hours (with repeated use). When the drug is taken orally, CMA and its metabolites are excreted in approximately equal proportions by the kidneys and through the intestine.
Ethinyl estradiol (EE)
Suction. When taking the drug inside, EE is quickly and almost completely absorbed.
Tmax in the blood plasma is 1.5 hours.
Due to presystemic binding and liver metabolism, absolute bioavailability is about 40% and is subject to strong individual variability (20-65%).
Distribution. The data available in the literature on the concentration of EE in blood plasma vary greatly. About 98% of EE binds to plasma proteins, almost exclusively to albumin.
Metabolism. Like natural estrogens, EE is biotransformed through the hydroxylation of the aromatic ring (the mediator is the cytochrome P450 system). The main metabolite is 2-hydroxy-EE, which is transformed to other metabolites and conjugates. EE undergoes presystemic binding both in the mucosa of the small intestine and in the liver. In the urine, glucuronides are found mainly, and in bile and blood plasma — sulfates.
Output. Average T1/2 EE from the blood plasma is approximately 12-14 hours. EE is excreted by the kidneys and through the intestine in a ratio of 2:3. EE sulfate, which is excreted with bile after hydrolysis by intestinal bacteria, is subjected to intestinal-hepatic recirculation.
- Combined contraceptive (estrogen progestogen) [Estrogens, progestogens, their homologs and antagonists in combinations]
Interaction of EE, the estrogenic component of the drug Belara®, with other drugs may cause an increase or decrease in the concentration of ethinyl estradiol in the blood serum. If you need long-term treatment with these drugs, you should switch to non-hormonal contraceptives. A decrease in the concentration of EE in the blood serum can lead to an increase in episodes of breakthrough bleeding, a violation of the cycle and a decrease in the contraceptive effectiveness of the drug Belara®. Increased 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 enhance gastrointestinal motility (for example, metoclopramide) or interfere with absorption (for example, activated carbon),
- substances that induce microsomal liver enzymes, such as rifampicin, rifabutin, barbiturates, anticonvulsants (e.g. carbamazepine, phenytoin or topiramate), griseofulvin, roxaclon, primidone, modafinil, certain protease inhibitors (e.g. ritonavir) and St. John's wort preparations,
- some antibiotics (e.g. ampicillin, tetracycline) in selected women, possibly due to reduced intestinal-hepatic estrogen recycling.
With the simultaneous use of such drugs/active substances with the drug 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 you need to continue taking concomitant drugs after the end of the tablets in the package of the drug Belara® then you should start taking the tablets from the next package, without taking the usual 7-day break.
The following drugs / active substances may increase the concentration of EE in the blood serum:
- active substances that inhibit the sulfation of EE in the intestinal wall (for example, ascorbic acid or paracetamol),
- atorvastatin (increases the EE AUC by 20%),
- active substances that inhibit the activity of microsomal liver enzymes, such as antifungal agents that are imidazole derivatives (for example, fluconazole), indinavir or troleandomycin.
EE can affect the metabolism of other substances:
- inhibit the activity of hepatic microsomal enzymes and, accordingly, increase the concentration in the blood serum of such active substances as diazepam (and other benzodiazepines, which are metabolized through hydroxylation), cyclosporine, theophylline and prednisone,
- induce glucuronidation in the liver and, accordingly, reduce the concentration in the blood serum of substances such as clofibrate, paracetamol, morphine and lorazepam.
Against the background of taking the drug Belara® the need for insulin and oral hypoglycemic drugs may change, as 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 brief characteristics to identify possible interactions with the drug Belara®.
At a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf life of the drug Belara®film-coated tablets 2 mg 0.03 mg 2 mg 0.03-3 years.
film-coated tablets 30 mcg 2 mg 30 mcg 2-2 years.
Do not use after the expiration date indicated on the package.
Film-coated tablets | 1 table. |
active substance: | |
chlormadinone acetate | 2 mg |
ethinyl estradiol | 0.03 mg |
excipients: povidone K30-4.5 mg, corn starch-9 mg, lactose monohydrate-68.97 mg, magnesium stearate-0.5 mg | |
the shell film: hypromellose 6 MPa * s-1.115 mg, lactose monohydrate-0.575 mg, macrogol 6000-0.279 mg, propylene glycol-0.093 mg, talc-0.371 mg, titanium dioxide (E171) - 0.557 mg, iron (III) oxide red dye (E172) - 0.01 mg |
Film-coated tablets, 2 mg 0.03 mg. In a PVC blister/PVDH / aluminum foil according to 21 tables. 1 or 3 blisters are placed in a cardboard pack.
Application of the drug Belara® during pregnancy, it is contraindicated. Before you start using it, you must exclude the presence of pregnancy. When pregnancy occurs while taking the drug Belara® its use 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 progestogens in the same combination as in the drug Belara®.
It is contraindicated to use the drug Belara® in the period of breast-feeding, since the drug decreases the amount of milk produced and changes its composition. Small amounts of the hormones and/or their metabolites that make up the contraceptive are excreted in breast milk and may affect the baby.
According to the recipe.
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.
G03AA Progestogens and estrogens (fixed combinations)
- Z30 Monitoring the use of contraceptives
- Z30. 0 General tips and advice on contraception
Round biconvex tablets, covered with a film shell of light pink color.
Core Color: from white to almost white.