Belara - instructions for use, doses, side effects, contraindications

Active substanceChlormadinone + EthinylestradiolChlormadinone + Ethinylestradiol

Similar drugsTo uncover

Belara®

pills inwards

GEDEON RICHTER, OJSC Hungary

Dosage form: & nbspfilm-coated tablets

Composition:

One tablet, film-coated, contains:

active ingredients: Chlormadinone acetate 2 mg and ethinylestradiol 0.03 mg;

Excipients: povidone-KZO 4.5 mg, corn starch 9.0 mg, lactose monohydrate 68.97 mg, magnesium stearate 0.5 mg;

film sheath: hypromellose-6 mPa.s - 1,115 mg, lactose monohydrate 0.575 mg, macrogol-6000 0.275 mg, propylene glycol 0.093 mg, talc 0.341 mg, titanium dioxide 0.557 mg, iron oxide red oxide 0.01 mg.

Description:

Round biconvex tablets, covered with a film coat of light pink color.

The color of the tablet core is white or almost white.

Pharmacotherapeutic group:Contraceptive agent combined (estrogen + progestogen)

ATX: & nbsp

G.03.A.A Progestogens and estrogens (fixed combinations)

Pharmacodynamics:

Prolonged use of the drug Belara ® leads to a decrease in the secretion of follicle-stimulating hormone (FSH) and luteinizing hormone (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 the difficulty of passage of spermatozoa through the cervical canal and a violation of their mobility.

To completely suppress ovulation, 1.7 mg of chloromadinone acetate is required daily. The required dose per cycle is 25 mg.

It is part of the drug Belara ® chloromadinone acetate - gestagen, which possesses antiandrogenic properties. Its action is based on the ability to replace androgens at specific receptors, excluding and weakening the effect of endogenous and exogenous androgens. The Perl index is 0.291-0.698, depending on how thoroughly a woman observes the regimen of taking the drug.

Pharmacokinetics:

Chlormadinone acetate

Suction

After ingestion of chloromadinone, acetate (XMA) is rapidly and completely absorbed. The maximum concentration (C_mOh) XMA is achieved after 1 -2 h.

Distribution

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

Metabolism

Various processes of reduction, oxidation and binding with glucuronides and sulfates lead to the formation of a variety of metabolites.The main metabolites in blood plasma are 3-alpha and 3-beta-hydroxy-XMA with a half-life period, which does not differ significantly from nonmetabolized XMA. 3-hydroxy metabolites have antiandrogenic activity, similar to the activity of the XMA itself. In the urine, metabolites are mainly contained in the form of conjugates. After enzymatic cleavage, the main metabolite becomes 2-alpha-hydroxy-CMA, 3-hydroxy metabolites and dihydroximetabolites are also formed.

Excretion

The mean half-life (T1/2) XMA from the blood plasma is approximately 34 hours (after taking a single dose) and about 36-39 hours (with repeated use). When administered orally, XMA and its metabolites are excreted in approximately equal amounts by the kidneys and through the intestine.

Ethinylestradiol

Suction

Ethinyl estradiol (EE) is rapidly and almost completely absorbed after ingestion, reaching CmOh in the blood plasma after 1.5 hours. Due to presystemic binding and metabolism in the liver, absolute bioavailability is about 40% and is subject to strong individual variability (20-65%).

Distribution

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

Metabolism

Like natural estrogens, EE biotransformed by hydroxylation of the aromatic ring (mediator is cytochrome P450 system). The main metabolite is 2-hydroxy-EE, which is transformed to other metabolites and conjugates. EE is subjected to presystemic binding both in the mucosa of the small intestine and in the liver. In the urine are found, mainly, glucuronides, and in the bile and blood plasma - sulfates.

Excretion

The mean half-life of EE from plasma is approximately 12-14 hours. EE is excreted by the kidneys and through the intestine in a ratio of 2: 3. EE sulphate, excreted with bile after hydrolysis by intestinal bacteria, undergoes enterohepatic recirculation.

Indications:

Oral contraception.

Contraindications:

Acceptance of the drug Belar® is contraindicated in the following diseases / conditions:

- thromboses (venous and arterial) and thromboembolism now or in the anamnesis (for example, deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);

- 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 arterial hypertension or significant increase in blood pressure (BP) (over 140/90 mm Hg, see section "Special instructions");

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

- acute or chronic liver disease of a severe degree (before the normalization of liver function);

- generalized pruritus, cholestasis, especially during a previous pregnancy or taking a sex hormone in an anamnesis;

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

- the presence of liver tumors at present or in the anamnesis;

- severe pain in epigastrium, enlarged liver or symptoms of intra-abdominal bleeding;

- the newly discovered porphyria or its relapse (all three forms, especially acquired porphyria);

- presence of hormonal-dependent malignant diseases, including in the anamnesis (for example, a breast or a uterus), or suspicion on them;

- pronounced disorders of lipid metabolism;

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

- the first occurrence of attacks of migraine pain or frequent severe headaches;

- Migraine in combination with local neurologic symptoms (associated migraines);

- acute sensory disturbances, such as visual or hearing impairment;

- motor disorders (in particular, paresis);

- increased number of epileptic seizures;

- severe depression;

- deterioration of the course of otosclerosis during previous pregnancies;

- amenorrhea of unclear etiology;

- endometrial hyperplasia;

- bleeding from the vagina of an unclear etiology;

- hypersensitivity to the components of the drug;

- pregnancy or suspected of it;

- the period of breastfeeding;

- smoking over the age of 35;

- lactose intolerance, lactase deficiency, glucose-galactose malabsorption;

- presence of expressed or multiple factors of arterial or venous thrombosis (increase in age, smoking, especially over the age of 35, obesity> 30 kg / m2, dyslipoproteinemia, family history of venous or arterial insufficiency in relatives of the first line of kinship, heart valve disease atrial fibrillation, bacterial endocarditis, any operations on the lower limbs, extensive trauma).

Carefully:In the presence of the following conditions / diseases / risk factors, at present or in the past, the use of the drug Belara® requires careful medical supervision and evaluation of the potential risk and expected benefits: epilepsy, multiple sclerosis; convulsive syndrome (tetany); migraine without focal neurological symptoms; bronchial asthma; heart or kidney failure; chorea; diabetes mellitus with uncomplicated course; acute and chronic liver diseases of mild and moderate severity (with normal indicators of functional liver samples); disturbance of lipid metabolism, dyslipoproteinemia (see.also the section "Contraindications"); autoimmune diseases (including systemic lupus erythematosus); obesity (<30 kg / m2); controlled arterial hypertension; endometriosis; varicose veins, phlebitis of superficial veins of the lower extremities (see also the section "Contraindications"); violation of the blood coagulation system; mastopathy; uterine myoma; herpes pregnant; depression (see also the section "Contraindications"); chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis).

Pregnancy and lactation:

Pregnancy: the use of the drug Belara ® during pregnancy is contraindicated. Before starting the use of the drug Belara ®, it is necessary to exclude the presence of pregnancy. When pregnancy occurs while taking the drug Belara ®, the drug should be stopped immediately. Existing epidemiological data do not contain data on the development of teratogenic or embryotoxic effects in women who accidentally took during pregnancy preparations containing estrogens and gestagens in the same combination as in the preparation Belara®.

Breastfeeding period: It is contraindicated to use the drug Belara ® during breastfeeding, as the drug reduces the amount of milk produced and changes its composition. Small amounts of hormones included in the contraceptive and / or their metabolites penetrate into breast milk and can affect the baby.

Dosing and Administration:

For ingestion. The tablet, indicated by the corresponding day of the week, should be removed from the blister pack and swallowed whole, without chewing and washing 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 in taking the tablets; after two to four days after taking the last pill, there will be a bleeding "withdrawal", similar to menstrual bleeding. After the end of the seven-day break, you should start taking Bedar® from the next pack, regardless of whether the bleeding has stopped or not.

The beginning of taking tablets

If hormonal contraceptives have not previously been applied (during the last menstrual cycle).

The first pill should be taken on the first day of a woman's natural cycle, i.e. 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 taking and continues for a seven-day break in taking the tablets. The first tablet can also be taken on the 2nd-5th day of menstrual bleeding, regardless of whether bleeding has stopped or not. In this case, during the first seven days of admission, additional barrier methods of contraception must be used. If menstrual bleeding began more than five days ago, a woman should be advised to wait for the onset of the next menstrual bleeding, to start receiving the drug Belara ®.

Transition from another hormonal contraceptive to taking Belara ®.

Transition from another combined oral contraceptive.

Transition from preparations containing 21 or 22 active tablets: you should finish taking all the pills of the old package. The first tablet of the drug Belara®need to take the next day.There should not be a break in the taking of tablets, and the patient should not wait for the next menstrual cycle to come. Additional contraceptive measures are not required.

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

Transition from preparations containing only gestagen ("mini-drank")

The first tablet of the preparation Belara® should be taken the next day after taking the last tablet containing only gestagen. During The first seven days need to use additional barrier methods of contraception.

Transition from hormonal injectable contraceptives or contraceptive implants.

You can start taking Belara ® on the day you remove the implant or on the day of the initial injection.During the first seven days, additional barrier methods of contraception must be used.

After a spontaneous or medical abortion in the first trimester of pregnancy.

Reception of the drug Belar®you can start immediately after a spontaneous or medical abortion in the first trimester of pregnancy. In this case, there is no need for additional contraceptive measures.

After childbirth, spontaneous or medical abortion in the second trimester of pregnancy.

It is recommended to start taking Belara ® on the 21-28th day after giving birth, if the woman does not breast-feed, or after an abortion in the second trimester of pregnancy. In this case, there is no need for additional barrier methods of contraception. If the drug was started more than 28 days after childbirth or abortion, additional barrier methods of contraception should be used within the first seven days. If a woman has already had sexual intercourse, then you should exclude the presence of pregnancy or wait for the start of the next menstrual cycle before you start taking the drug.

Breastfeeding period.

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

After discontinuation of the drug Belara ®.

After discontinuation of the preparation of the drug Belara®, the current cycle may extend for about one week.

Irregular intake of tablets.

If the patient has forgotten to take the pill, but has taken it within the next 12 hours, no additional contraceptive measures are required. The patient should continue taking the drug as usual. If the patient has forgotten to take the pill, but has taken it after 12 hours, the contraceptive protection may be reduced. In case of missing the tablet, you should act on the basis of the following two basic rules:

1. Never take pills for more than 7 days.

2. 7 days of continuous taking 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 it means taking 2 tablets at a time. The following tablets should be taken as usual. In the next 7 days, barrier methods of contraception, for example, condoms, need to be used additionally.If the intake of tablets was missed during the 1st week of the cycle, and within 7 days before the missed tablets there was a sexual intercourse (including a seven-day break in taking the tablets), the probability of developing a pregnancy should be taken into account. The more pills were missed, and the closer they were to the usual pause in taking pills, the higher the probability of pregnancy.

Skipping pills at 2 and 3 week of taking the drug.

You should immediately take the missed pill, even if it means taking two tablets at the same time. The next tablet is taken as usual. During the next seven days, additional contraceptive methods, such as condoms, should be used. If less than 7 tablets remain in the used pack, immediately after the end of taking the tablets from the used pack, you should start taking the tablets from a new package of the preparation Belara®, i.e. there should not be a break between the two packages. Probably, the usual bleeding of "cancellation" does not occur until the tablets from the second package run out; However, during the reception of tablets from a new package, there may be a "breakthrough" bleeding or "smearing" bloody discharge from the vagina.If bleeding "cancellation" does not occur after the end of taking tablets from the second package, then you should make a pregnancy test.

Recommendations for gastrointestinal disorders

If vomiting or severe diarrhea has occurred within 4 hours after taking the pill, then the absorption of the drug may be incomplete and the reliability of contraception is not can be guaranteed. In this case should be act according to the recommendations given in the section "Irregular intake of tablets" (see above). You should continue taking the drug Belara®.

How to delay bleeding "cancellation".

To delay bleeding, a woman should continue taking the tablets from the next package of the Belar® preparation without taking a break. Continue taking the tablets at will, as long as the tablets from the second package do not run out. During the reception of tablets from the second package, there may be minor bleeding or "breakthrough" bleeding. After an ordinary 7-day break in admission Tablets should resume regular use of the drug Belara®. To shift the onset 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 seven-day break for the desired number of days. The shorter the break in taking the tablets, the higher the likelihood of no bleeding from the "cancellation" and "breakthrough" bleeding or minor bleeding at the time of taking the tablets from the next package (as well as delaying the bleeding).

Side effects:

When receiving the drug Belara ® the most common adverse reactions (more than 20% of cases) are "breakthrough" bleeding, spotting from the vagina, headache and discomfort in the mammary glands. The frequency of acyclic bleeding usually decreases as the duration of administration of the drug Belara® increases.

The incidence of adverse reactions is determined as follows:

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:

Immune system disorders

Infrequent: increased sensitivity to the components of the drug, including allergic reactions from the skin.

Disorders from the metabolism and nutrition

Rarely: increased appetite.

Disorders of the psyche

Often: depressed mood, nervousness.

Disturbances from the nervous system

Often: dizziness, migraine (and / or her gain).

Disturbances on the part of the organ of sight

Often: a disorder of vision. Rare: conjunctivitis, intolerance to contact lenses.

Hearing disorders and labyrinthine disorders

Rarely: sudden loss of hearing, tinnitus.

Violations from the heart and blood vessels

Rarely: increased blood pressure, arterial hypotension, cardiovascular collapse, varicose veins, thrombosis of veins.

Disorders from the gastrointestinal tract

Very often: nausea. Often: vomiting. Infrequent: abdominal pain, flatulence, diarrhea.

Disturbances from the skin and subcutaneous tissues

Often: acne. Infrequent: disorders of pigmentation, chloasma, hair loss, dry skin. Rarely: urticaria, eczema, erythema, pruritus, psoriasis, hypertrichosis. Very rarely: erythema nodosum.

Disturbances from musculoskeletal and connective tissue

Often: a feeling of heaviness in the lower limbs.Infrequent: back pain, muscle disorders.

Violations of the genitals and mammary gland

Very often: increased vaginal discharge, painful menstrual bloody discharge from the vagina, absence of menstrual bloody discharge. Often: pain in the lower abdomen. Infrequently: galactorrhea, fibroadenoma of the breast, candidiasis of the vagina. Rarely: mammary gland enlargement, vulvovaginitis, copious menstrual bleeding or spotting from the vagina, premenstrual-like syndrome.

General disorders and disorders at the site of administration

Often: irritability, fatigue, swelling, weight gain. Infrequently: decreased libido, hyperhidrosis. Rarely: increased appetite.

Impact on the results of laboratory and instrumental examinations

Infrequently: changes in lipid levels in blood plasma, including hypertriglyceridemia.

When combined oral contraceptives (COCs) were used, including those containing 0.03 mg of ethinylestradiol and 2 mg of chloromadinone acetate, the following undesirable effects:

- Increased risk of venous and arterial thromboembolism (eg, venous thrombosis, pulmonary embolism, stroke, myocardial infarction). The risk may be exacerbated by additional factors, see the "Special instructions" section.

- Increased risk of bile duct disease.

- In rare cases, an increased risk of developing benign liver tumors (and even less often, malignant liver tumors) and single cases can lead to life-threatening intraabdominal bleeding (see also "Special instructions").

- Exacerbation of chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis, see also "Special instructions").

Overdose:

When an overdose of the drug does not observe any severe toxic reactions. At casual reception of a plenty of tablets development of a nausea, vomiting, especially at young girls, krovjanisty vydaleny from a vagina is possible. There is no specific antidote. Treatment is symptomatic. In rare cases, it is necessary to monitor the parameters of water-electrolyte metabolism and liver function.

Interaction:

The interaction of EE, the estrogen component of the drug Belar, with other drugs can cause an increase or decrease in the concentration of EE in the blood plasma.If long-term treatment with these substances is necessary, non-hormonal methods of contraception should be used. Reducing the concentration of EE in the blood plasma can lead to an increase in episodes of breakthrough bleeding, disruption of the cycle and a decrease in the contraceptive efficacy of the preparation Belara®; an increase in the concentration of EE in the blood plasma can lead to an increase in the frequency and severity of side effects. The following drugs / active ingredients can reduce the concentration of EE in the blood plasma:

- all drugs that enhance the motility of the gastrointestinal tract (for example, metoclopramide) or disturbing absorption (for example, Activated carbon);

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

- some antibiotics (for example, ampicillin, tetracycline) in individual women, possibly due to a decrease in intestinal hepatic recirculation of estrogens.

At the simultaneous short-term use of these drugs / active substances with the drug Belara®, additional barrier methods of contraception should be used both during treatment and within the first 7 days after its termination. 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 applied within 28 days after the end of treatment.

If the concomitant medication is to be continued after the completion of the tablets in the package of the preparation Belara®, you should start taking the tablets from the next package without doing an ordinary 7-day break.

The following drugs / active ingredients can increase the concentration of EE in the blood plasma:

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

- atorvastatin (increases the area under the EE concentration-time curve by 20%);

- active substances that inhibit the activity of microsomal liver enzymes, such as antifungal agents, which are imidazole derivatives (for example, fluconazole), indinavir or trolandomycin.

Ethinyl estradiol can affect the metabolism of other substances:

- suppress the activity of microsomal liver enzymes and, accordingly, increase the concentration in the blood plasma of such active substances as diazepam (and other benzodiazepines, metabolized by hydroxylation), ciclosporin, theophylline and prednisolone;

- to induce glucuronization in the liver and, accordingly, to reduce the concentration in the blood plasma 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 has an effect on glucose tolerance.

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

Before prescribing any medication, its brief description should be studied to identify possible interactions with the Belara® preparation.

Special instructions:

Smoking

Smoking increases the risk of serious cardiovascular complications associated with taking combined oral contraceptives (COCs).Risk increases with age, with an increase in the number of cigarettes smoked and is high in women older than 35 years. Smoking women older than 35 years 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 malignancy. 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 benefits of using the Belara® drug, and discuss this with the woman before she starts taking the 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 correlation between the intake of oral contraceptives and an increased risk of venous and arterial thromboembolic diseases, for example, myocardial infarction,hemorrhages in the brain, deep vein thrombosis and pulmonary embolism. These diseases rarely develop.

The use of combined oral contraceptives (COCs) entails a higher risk of venous thromboembolism (VTE) than with abstinence from their admission. This risk of VTE is highest in women during the first year of combined oral contraceptives. 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 the administration of the Belara drug affects the risk of VTE compared to other combined oral contraceptives.

The risk of venous thromboembolism in women taking COC increases in the following cases:

- With age.

- In the presence of hereditary predisposition (for example, venous thromboembolism in brothers and sisters or parents at a relatively young age). If there is a suspicion of a hereditary predisposition, the woman should be referred to a specialist before taking a decision on taking COC.

- With prolonged immobilization.

- With obesity (body mass index more than 30 kg / m).

The risk of developing arterial thromboembolism increases in the following cases:

- With age.

- Smoking.

- Dislipoproteinemia.

- Obesity (body mass index more than 30 kg / m).

- Arterial hypertension.

- Heart valve flaw.

- Atrial fibrillation.

- Presence of hereditary predisposition (eg, arterial thromboembolism in brothers and sisters or parents at a relatively young age). If there is a suspicion of a hereditary predisposition, the woman should be referred to a specialist before taking a decision on taking COC.

Other diseases affecting blood circulation are diabetes, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel diseases (Crohn's disease and ulcerative colitis), as well as 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 vein thrombosis and arteries are the following:

- pain and / or swelling in the lower limb;

- sudden severe pain in the chest, regardless of whether it is given to the left arm or not;

- a sudden onset of shortness of breath, a 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 impaired sensation in one side of the body or part of the body;

- motor disorders;

- acute pain in the abdomen.

Patients taking Belara® should be informed that if they have any possible symptoms of thrombosis, they should consult a doctor. If you suspect or confirm thrombosis, you should stop taking Belara ®.

An increase in the frequency and intensity of migraine attacks with the use of the preparation Belara® may indicate a prodromal phase of the disorderblood supply to the brain and may be an indication for an immediate discontinuation of taking the drug.

Tumors

Some epidemiological studies indicate that prolonged intake of oral contraceptives is a risk factor for cervical cancer in women infected with human papillomavirus (HPV). However, this question is controversial, since it is unclear to what extent other factors influence the results obtained (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 within 10 years after cessation of COC administration. At the same time, there is no causal link between the disease and the drug intake. The observed increased risk may be due to the fact that in women taking COC breast cancer is diagnosed at an earlier stage than those who do not use them, as well as the biological effect of COCs or a combination of both.

In rare cases, after the administration of COC, cases of benign liver tumors were registered, and malignant tumors were even more rarely recorded.In some cases, such tumors can provoke life-threatening intraabdominal bleeding. In case of severe pain in the abdomen, which does not disappear on its own, liver enlargement or signs of intraabdominal bleeding, the probability of developing a liver tumor should be considered and the drug should be discontinued.

Other diseases

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

In women with an anamnesis of herpes of pregnant women on the background of taking COC, a relapse of this disease is possible. Women who have a history or family history of whom there are indications of hypertriglyceridemia when taking COCs increase the risk of developing pancreatitis.With acute or chronic violations of liver function, it may be necessary to stop taking COCs before normalizing the liver's functional parameters. In case of recurrence of cholestatic jaundice, first diagnosed during pregnancy or admission of sex hormones, it is necessary to stop taking COC.

The administration of COC can affect peripheral insulin resistance or glucose tolerance. Therefore, patients with diabetes mellitus and those taking oral contraceptives should be carefully monitored.

In rare cases, the appearance of chloasma, especially in women with a history of pregnant women, is possible. Women who are predisposed to chloasma should avoid exposure to sunlight, as well as ultraviolet radiation during oral contraceptives.

Patients with rare hereditary intolerance to galactose, lactase deficiency, or glucose-galactose malabsorption are not allowed to take Belara®.

Precautionary measures

Taking medications containing estrogen or estrogen / progestogen may adversely 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;

- liver disease;

- dyslipoproteinemia;

- autoimmune diseases (including systemic lupus erythematosus);

- obesity;

- arterial hypertension;

- endometriosis;

- phlebeurysm;

- thrombophlebitis;

- bleeding disorders;

- mastopathy;

- uterine myoma;

- herpes pregnant;

- depression;

- chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis).

Medical examination

Before the appointment of the drug Belara®, a medical examination should be conducted and a complete family and personal history of the patient should be collected in order to identify contraindications and risk factors. When taking the drug Belar, this procedure should be repeated 1 time in six months. Regular medical examinations are also necessary because contraindications (eg, transient ischemic attack) or risk factors (for example, a personal or family history of vein or arterial thrombosis) may first appear against the background of oral contraceptives. The medical examination should include measurement of blood pressure, examination of the mammary glands,abdominal organs, internal and external genital organs, including cytological examination of the cervical epithelium, and the performance of appropriate laboratory tests.

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

Laboratory research

Indicators of some laboratory studies may change with the use of COCs, for example, indicators of liver function, thyroid gland, adrenal gland, plasma proteins in the plasma (for example, globulin binding sex hormones (SHBG); lipoproteins), as well as parameters of carbohydrate metabolism, coagulation and fibrinolysis. The nature and extent of changes in laboratory parameters depend on which hormones are prescribed and in what doses.

Decreased efficiency

A missed film-coated tablet, vomiting or intestinal disorders, including diarrhea, prolonged use of certain concomitant medications, or, in very rare cases, metabolic disorders, may reduce the contraceptive efficacy of the Belara® preparation.

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 insignificant bleeding), especially during the first cycles of taking the drug. Therefore, the medical evaluation of irregular cycles should be carried out only after an adaptation period equal to the first three cycles. If the "Belar" drug is constantly observed or appears for the first time "breakthrough" bleeding, although the cycle was previously regular, a survey should be conducted to exclude pregnancy or organic diseases. After excluding pregnancy or organic disease, you can continue taking Belara® or switch to another drug. Acyclic bleeding may be a sign of a decrease in contraceptive effectiveness.

No bleeding "cancellation"

As a rule, after 21 days of taking the drug there is a bleeding "cancellation". Sometimes, especially during the first months of taking the drug, bleeding "cancellation" may be absent.Nevertheless, this does not necessarily indicate a decrease in the contraceptive effect. If there was no bleeding after a single cycle of admission, during which the patient did not forget to take Belara®, the 7-day period of interruption in taking the tablets did not increase, the patient did not have vomiting or diarrhea, pregnancy is unlikely and the preparation of Belara® can be continued. If before the first absence of bleeding "withdrawal" reception of the drug Belara® occurred with a violation of the instructions or the absence of bleeding "cancellation" is observed for two cycles, then it is necessary to exclude pregnancy, before than to continue taking the drug.

Together with the drug Belara ® should not take medicinal products of plant origin, containing St. John's Wort (Hypericum perforatum).

Effect on the ability to drive transp. cf. and fur:

Does not affect.

Form release / dosage:

Tablets, film-coated, 2 mg + 0.03 mg.

Packaging:

For 21 tablets in a blister of PVC / PVDC / aluminum foil. For 1 or 3 blisters together with instructions for use are placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N014429 / 01

Date of registration:24.12.2008 / 30.11.2015

Expiration Date:Unlimited

The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary

Manufacturer: & nbsp

GEDEON RICHTER OJSC Hungary

Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary

Information update date: & nbsp21.01.2017

Illustrated instructions

Instructions

Belara® (Belara®)