Belara

General characteristics. Structure:

Active agents: hlormadinona acetate of 2 mg and ethinylestradiol of 0,03 mg.

Excipients: povidone To 30 — 4,5 mg, starch corn — 9,0 mg, lactoses monohydrate — 68,97 mg, magnesium stearate — 0,5 mg
film cover: a gipromelloza 6 мПа.с — 1,115 mg, lactoses monohydrate — 0,575 mg, a macrogoal of 6000 — 0,279 mg, propylene glycol — 0,093 mg, talc — 0,371 mg, titanium dye dioxide, E 171 — 0,557 mg, dye ferrous oxide of red (III), E 172 — 0,01 mg.

Pharmacological properties:

Pharmacodynamics. Long (more than 21 day) use of the drug BELARA® leads to reduction of secretion of follicle-stimulating hormone and luteinizing hormone, and, therefore, suppression of an ovulation, proliferation of an endometria and its secretory transformation. At the same time properties of slime of the cervical channel change that is followed by difficulty of passing of spermatozoa via the cervical channel and disturbance of their mobility.
The acetate which is part БЕЛАРЫ® хлормадинон — the progestogen having anti-androgenic properties. Its action is based on ability to replace androgens on specific receptors, excluding and weakening effect of endogenous and exogenous androgens. Full suppression of an ovulation requires 1,7 mg of a hlormadinon of acetate daily. A necessary dose on a cycle — 25 mg.
Other BELARY® active component — ethinylestradiol — inhibits secretion of skin sweat glands. It also significantly increases products of the globulin connecting sex hormones, thereby, reducing amount of free testosterone in a blood plasma. Interacts with specialized receptors of estrogen in target organs (in uterine tubes, a neck of uterus, a vagina, external genitals, the removing channels of mammary glands), causes proliferation of an endometria.
In addition to reliable contraceptive action, positive effect of the drug BELARY® is shown in normalization of a menstrual cycle, decrease in expressiveness of manifestation of a premenstrual syndrome, frequency of emergence of an iron deficiency anemia, dysmenorrhea, functional cysts of ovaries, ectopic pregnancy, malignancies of an endometria and ovaries, some forms of benign diseases of mammary glands and inflammatory diseases of bodies of a small pelvis.

Pharmacokinetics. At intake of drug of a hlormadinon acetate and ethinylestradiol are quickly and completely absorbed. The maximum concentration of ethinylestradiol is reached in 1,5 h. The maximum concentration of a hlormadinon of acetate is reached in 1–2 h.
The elimination half-life of a hlormadinon of acetate makes about 34-39 h, ethinylestradiol — 12–14 h. Metabolites of a hlormadinon of acetate are removed by kidneys and through intestines in the ratio 2:3. The elimination half-life of ethinylestradiol makes about 12-14 h.
Ethinylestradiol metabolites — soluble derivatives of sulphatic or glucuronic conjugation in water. Metabolites of ethinylestradiol are removed by kidneys and through intestines in the ratio 4:6.

Indications to use:

Peroral contraception.

Route of administration and doses:

The pill BELARA® should be taken inside (preferably at the same time).
It is necessary to take the first pill in the 1st day of a menstrual cycle and to continue their reception daily on the 1st tablet in day within 21 days. Then to take the 7th a dnevny break during which menstrualnopodobny bleeding has to begin.
After the 7 a day break it is necessary to resume reception of the tablets BELARA® from the following blister irrespective of, menstrualnopodobny bleeding stopped or not.
Tablets need to be squeezed out from the blister and to swallow entirely, choosing that tablet which is marked by the corresponding day of the week. The choice of tablets is defined by the direction of an arrow on packaging.

Beginning of reception of tablets. Earlier hormonal contraceptives were not applied (during the previous menstrual cycle).
The first pill should be taken in the first day of periods. In that case contraceptive action begins from the first day of administration of drug БЕЛАРА® and remains during a 7-day break when a pill is not taken.
Besides, the first pill BELARA® can be taken for 2-y-5-y day of periods irrespective of, bleeding stopped or not. However, in this case in the first 7 days of reception of tablets it is necessary to apply additional barrier contraceptives.
If the periods began prematurely (more, than for 5 days), it is necessary to recommend to the woman to postpone the beginning of administration of drug БЕЛАРА® until the following bleeding.

Transition from other hormonal contraceptive to the drug BELARA®.
Transition from the drugs containing 21 or 22 active tablets: it is necessary to finish reception of all tablets of old packaging. The first pill of the drug BELARA® needs to be taken next day. There should not be a break in reception of tablets, and the patient should not wait for approach of the following menstrual cycle. Additional contraceptive measures at the same time are not required.
28 tablets: the first pill of the drug BELARA® should be taken next day after reception of the last active tablet from packaging of the previous contraceptive drug containing 28 tablets (i.e. after reception of 21 active tablets). There should not be a break in reception of tablets, and the patient should not wait for approach of the following menstrual cycle. Additional contraceptive measures at the same time are not required.

Transition from the contraceptives containing only гестаген (pass saw, injection forms, an implant). The woman can pass with pass saw on the drug BELARA® in any day (without interruption), from an implant — in day of its removal, from an injection form — from the date of when the following injection would have to be made. In all cases it is necessary to use additional barrier methods of contraception during the first 7 days of administration of drug БЕЛАРА®.

After abortion in the first trimester of pregnancy. It is necessary to begin administration of drug БЕЛАРА® right after abortion in the first trimester of pregnancy. Additional methods of contraceptions are not obligatory.
After the delivery or abortion in the second trimester of pregnancy.
After the delivery drug use by the women who are not nursing can be begun for 21–28 day of a puerperal period. In this case it is not necessary to undertake additional measures of contraception.
If use of drug in a puerperal period is begun 28 days later after the delivery, it is necessary to take additional measures of contraception within 7 days. If the woman had a sexual contact, then prior to use of drug it is necessary to exclude pregnancy and to wait for the following menstrual cycle.

Admission of reception of a tablet. If there passed less than 12 h after reception of a tablet was forgotten, contraceptive effect of the drug BELARA® remains. The passed pill has to be taken at once as soon as the woman remembers it, and the following pill has to be taken in usual time. If there passed more than 12 h after the admission of reception of a tablet, decrease in contraceptive effect of drug is possible. It is necessary to take immediately passed pill. The subsequent pill has to be taken in usual time, however it is necessary to apply additional barrier methods of contraception (condom) during the next 7 days. If during these 7 days of a tablet in packaging did not end, then reception of tablets from the following packaging needs to be begun at once after end of tablets in the previous packaging, i.e. the break between reception of tablets is not made of various packagings. If there was no menstrualnopodobny bleeding after reception of the second packaging, it is necessary to exclude pregnancy.

Use in case of diarrhea, vomiting. When developing vomiting or diarrhea against the background of reception of the tablets BELARA® it is recommended to use additional barrier methods of contraception since contraceptive effect of drug can decrease because of incomplete absorption of drug in intestines.

Features of use:

Smoking increases risk of development of heavy cardiovascular side effects of the CPC, the risk increases with age and depending on quantity of the smoked cigarettes and is more expressed at women aged 35 years are more senior, the smoking women at the age of more than 35 years should use other methods of contraception.
At use of the CPC the risk of development of serious diseases increases: myocardial infarction, thromboses/thromboembolisms, stroke and new growths of a liver.
Other risk factors, such as hypertensia, lipidemia, obesity and diabetes mellitus clearly increase risk of incidence and mortality.
In the presence of one of above-mentioned diseases / risk factors it is necessary to weigh possible advantage of purpose of the drug Belara® against risks, and it should be discussed with the woman before reception of drug by it. If these diseases or risk factors begin to be shown or progress during administration of drug, it is necessary to see a doctor.
The doctor has to make the decision on whether it is necessary to stop reception of this drug.
Thromboembolisms and other vascular diseases
It is noted that there is an interrelation between reception of the CPC and the increased risk of developing of the diseases caused by venous or arterial thromboembolisms, for example, of a myocardial infarction, a stroke of a brain, a deep vein thrombosis or an embolism of a pulmonary artery. These complications meet seldom.
Reception of the CPC leads to increase in risk of emergence of venous thromboembolisms (VTE). Risk of VTE the greatest within the first year of reception. Degree of such risk is less, than at pregnancy when the frequency of VTE makes 60 cases on 100000 pregnancies. VTE leads to death in 1–2% of cases. There are no data on assessment of development of risk of VTE at reception of Belary® in comparison with other PDA.

The risk of development of venous tromboembolic episodes at reception of the CPC increases:

- with age
- in the presence of thromboembolisms at relatives (venous thromboembolisms at one of brothers, sisters or parents at rather young age). If existence, genetic predisposition is supposed, it is recommended to direct the woman to consultation to the specialist before making decision on purpose of the CPC
- at the long lowered mobility
- at obesity (a body weight index> of 30 kg/sq.m).
The risk of development of arterial tromboembolic episodes at reception of the CPC increases:
- with age
- at smokers
- at a dislipoproteinemiya
- at obesity (a body weight index> of 30 kg/sq.m)
- at hypertensia
- at heart diseases
- at fibrillation of auricles
in the presence of thromboembolisms at relatives (arterial thromboembolisms at one of brothers, sisters or parents at rather young age). If chronic inflammations of intestines (disease krone and ulcer colitis), crescent anemia. At assessment risk/advantage it is necessary to remember that adequate treatment above the listed diseases can reduce risk of thrombosis. It is necessary to take into account the increased risk of development of tromboembolic episodes in a puerperal period.
There is no consensus about whether there is an interrelation between thrombophlebitis of superficial veins and / or a varicosity and an etiology of venous thromboembolisms.
At development of venous or arterial thrombosis there can be following symptoms:
- onychalgia and/or hypostasis
- sudden severe pain in a thorax, with irradiation or without irradiation in the left hand
- sudden asthma, cough for no apparent reason
- unexpected severe long headache
- partial or total loss of sight, diplopia/disturbance of the speech or aphasia
- the dizziness, a collapse which in certain cases are followed by a focal epileptic attack
- sudden weakness or a dizesteziya (a sensitivity perversion) on the one hand or in one part of a body
- motive disturbances
- an acute pain in a stomach.
The women accepting the CPC have to be informed that at emergence of the symptoms reminding thrombosis symptoms it is necessary to see the attending physician. Белара® it has to be cancelled at suspicion or confirmation of the diagnosis of thrombosis.
Increase or increase of weight of attacks of migraine during reception of the CPC (which can be a harbinger of development or a symptom of a cerebrovascular disease) can be the cause for their cancellation.

Tumors. It is noted that use of the CPC is: risk factor of development of cancer of neck of uterus in the women infected with the virus of papilloma of the person (VPP). However so far there is disputable a question of extent of influence on results of this observation of other concurrent factors (for example, numbers of sexual partners or use of mechanical contraceptive means) (see also "Medical examination").
There are data that relative risk (RR=1.24) of development of a breast cancer in women who accept the CPC insignificantly above. Within 10 years after the termination of reception of the CPC risk level gradually decreases and returned to age. As the breast cancer occurs seldom at women aged up to 40 years a difference between a risk degree of a breast cancer at the PDA of women accepting now and recently accepting and degree of the general risk of development of a disease is small.
There are messages on development in rare instances high-quality, in more exceptional cases of malignant tumors of a liver during reception of the CPC. In some cases these tumors are the reasons of development of life-threatening vnutibryushny bleedings. In case of severe pain in a stomach which does not pass independently of a hepatomegalia or symptoms of intra belly bleeding, it is necessary to take a possibility of a tumor of a liver into account and to cancel Belaru®.

Other diseases. Many women accepting oral contraceptives have a slight increase of arterial pressure; however, clinically significant increase meets seldom. The interrelation between purpose of oral contraceptives and clinical manifestation of hypertensia is not confirmed so far. If during reception of Belary® there is clinically significant increase in arterial pressure, then drug should be cancelled and carried out treatment of hypertensia. As soon as indicators of arterial pressure are returned to norm against the background of hypotensive therapy, reception of Belary® can be continued.
Women, with pregnancy herpes in the anamnesis, against the background of reception of the CPC can have a disease recurrence. At women with a gipertriglitseridemiya in the anamnesis or that the family anamnesis the risk of development of pancreatitis increases during reception of the CPC. Acute or chronic abnormal liver functions can demand cancellation of the CPC before normalization of indicators of function of a liver. The recurrence of holestatachesky jaundice which for the first time arose in time of pregnancy or the previous reception of sex hormones, demands cancellation of the CPC.
PDA can have effect on resistance of peripheral fabrics to insulin or tolerance to glucose.
Therefore patients with diabetes during reception of oral contraceptives have to be under constant observation.
In rare instances the hloazma, first of all at the women who transferred a hloazma of pregnant women can develop. Women with risk of development of a hloazma should avoid stay in the sun and ultraviolet radiation during reception of oral contraceptives.
Patients with rare inborn pathology — intolerance of a galactose, deficit of lactase of Lapp or a sprue of glucose galactose — should not accept this drug.

Medical examination. Before purpose of oral contraceptives it is necessary to collect complete data about health of the woman and her relatives to reveal contraindications (see the section "Contraindications") and risk factors (cm the section "With Care"). The woman has to undergo medical examination.
Medical examination has to be conducted annually during administration of drug of Belara®. Regular medical examination is also necessary because the diseases which are contraindications (for example, the tranzitorny ischemic attacks), or risk factors (for example, venous or arterial fibrinferments at relatives), can occur for the first time against the background of reception of oral contraceptives. Medical examination has to include measurement of arterial pressure, survey of mammary glands, a stomach, internal and external genitals, capture of a smear about necks of uterus and conducting the corresponding laboratory tests.
The woman has to be warned that purpose of oral contraceptives including the drug Belara®, does not protect her from infection with HIV infection (AIDS) or other diseases, sexually transmitted.
Insufficient efficiency
The admission of reception of a tablet (see the section "Route of Administration and Doses", "Admission of Administration of Drug"), nausea or symptoms of disturbance of digestion, including diarrhea, a long concomitant use of certain medicines (see the section "Use in Case of Diarrhea, Vomiting", "Interaction with Other Medicines") or, seldom or never, metabolic disturbances can reduce efficiency of contraception.

Influence on a menstrual cycle. Bleedings or bloody allocations of "break" (intermenstrual)
All oral contraceptives can cause irregular vaginal bleedings (bleedings / bloody allocations of "break"), especially during the first several cycles against the background of administration of drug. Therefore performing medical examination concerning irregular cycles has to be conducted only after the adaptation period which proceeds usually during 3 cycles. If during reception of Belara® emergence of extraordinary bleedings proceeds or appeared for the first time at the woman with a regular cycle, it is necessary to conduct examination for an exception of pregnancy or organic pathology; After an exception of pregnancy and organic pathology reception of Belary® can be continued or passed to reception of other drug.
The bleedings developing between cycles can be a sign of insufficient contraceptive efficiency, (see. "The admission of administration of drug", "Use in case of diarrhea, vomiting").

Absence of menstrualnopodobny bleeding (cancellation bleeding). In 21 days after administration of drug usually there is cancellation bleeding. Sometimes, especially in the first, several months of administration of drug, bleeding of cancellation can be absent. However it is not the evidence of insufficient contraceptive effect. If bleeding does not come after administration of drug during one cycle provided that any reception of a tablet with a film covering was not missed, the period after completion of administration of drug did not exceed 7 days, other medicines were not accepted at the same time, there was no nausea or diarrhea, fertilization hardly happened, and reception of Belary® of pregnancy or organic pathology. After an exception of pregnancy and organic pathology reception of Belary® can be continued. If at reception of Belary® instructions were not carried out before the first absence of bleeding of cancellation, or bleeding of cancellation was absent during two consecutive cycles, it is necessary to exclude existence of pregnancy for the solution of a question of continuation of administration of drug.
Along with administration of drug of Belar it is not necessary to accept the herbal remedies containing a St. John's Wort (Hypericum perforatum).

Laboratory indicators. During reception of the CPC there can be changes of some laboratory indicators, including functional activity of a liver, adrenal glands and a thyroid gland, level of the connected proteins in plasma (for example, SHBG (GSPG), lipoproteins), indicators of carbohydrate metabolism, coagulation and fibrinolysis.
Character and extent of changes partially are defined by character and a dose of the accepted hormones.

INFLUENCE ON ABILITY TO DRIVE THE CAR OR TO WORK AT PRECISION INSTRUMENTS
Does not influence.

Side effects:

At administration of drug of Belara® the most often found side reactions (more than 20% of cases) are break bleedings, bloody allocations from a vagina, a headache and unpleasant feelings in mammary glands. Intermenstrual bleedings usually decrease in process of increase in duration of reception of Belary®.
Frequency of occurrence of side reactions is defined as follows:
Very Often: ≥ 1/10
Often: ≥ 1/100, <1/10
Infrequently: ≥ 1/1000; <1/100
Seldom: ≥ 1/10 000, <1/1000
Very seldom: <1/10 000
Side reactions from the following bodies and systems can be observed:
- Immune system.
Infrequently: hypersensitivity to drug components including allergic reactions from skin.
- Metabolism.
Infrequently: changes of lipidic composition of blood including a gipertriglitseridemiya.
Seldom: increase in appetite.
- Psychoemotional sphere.
Often: depression, nervousness, irritability.
Infrequently: decrease in a libido.
- Nervous system.
Often: dizziness, migraine (and/or its strengthening).
- Organs of sight.
Often: visual disturbances.
Seldom: conjunctivitis, intolerance of contact lenses.
- Acoustic organs and vestibular mechanism.
Seldom: unexpected hearing loss, sonitus.
- Cardiovascular system.
Often: increase arterial, pressure.
Seldom: hypertensia, hypotension, cardiovascular collapse, varicose vein disease, vein thrombosis.
- Alimentary system.
Very Often: nausea.
Often: vomiting.
Infrequently: abdominal pains, meteorism, diarrhea.
- Skin and hypodermic cellulose.
Often: acne rash.
Infrequently: disturbances of pigmentation, hloazm, hair loss, xeroderma, hyperhidrosis.
Seldom: urticaria, eczema, erythema, skin itch, strengthening of psoriasis, hypertrichosis.
Very seldom: knotty erythema.
- Musculoskeletal system.
Often: feeling of weight.
Infrequently: dorsodynia, muscular frustration.
- Reproductive system and mammary glands.
Very Often: strengthening of mucous allocations from a vagina, a dysmenorrhea, an amenorrhea.
Often: pains in the lower part of a stomach.
Infrequently: galactorrhoea, fibroadenoma of a mammary gland, vaginal candidiasis.
Seldom: increase in mammary glands, vulvovaginitis, menorrhagia, premenstrual syndrome.
- General frustration.
Often: fatigue, hypostases, increase in body weight.
At use of the combined oral contraceptives (COC), including containing 0,03 mg of ethinylestradiol and 2 mg of a hlormadinon of acetate, were also noted the following undesirable effects:
— increase in risk of a venous and arterial thromboembolism (for example vein thrombosis, pulmonary embolism, stroke, myocardial infarction). The risk can amplify accessory factors, see the section "Special Instructions".
— increase in risk of a disease of biliary tract,
— in rare instances increase in risk of development of high-quality new growths of a liver (and is even more rare — malignant new growths of a liver) and isolated cases can lead to life-threatening intra belly bleedings (see also "Special instructions"),
— an exacerbation of chronic inflammatory diseases of intestines (a disease Krone, ulcer colitis, see so "Special instructions").

Interaction with other medicines:

Interaction of ethinylestradiol, oestrogenic component of the drug BELARA®, with other medicines can cause increase or decrease in concentration of ethinylestradiol in blood serum. If prolonged treatment by these drugs is necessary, it is necessary to pass to non-hormonal contraceptives.
Decrease in concentration of ethinylestradiol in blood serum can lead to increase of episodes of breakthrough bleedings, disturbance of a cycle and decrease in contraceptive efficiency of the drug BELARA®. Increase in concentration of ethinylestradiol in blood serum can increase the frequency and weight of side effects.
The following medicines / active agents can reduce concentration of ethinylestradiol in blood serum:
— all medicines increasing motility of digestive tract (for example, Metoclopramidum) or breaking adsorption (for example, absorbent carbon);
— the active agents inducing microsomal enzymes of a liver such as rifampicin, рифабутин, barbiturates, antiepileptic means (for example, carbamazepine, окскарбазепин, Phenytoinum and топирамат) an anticonvulsant фелбамат, phenylbutazone, griseofulvin, барбексаклон, Primidonum, modafinit, some inhibitors of proteases (for example, ритонавир) and St. John's Wort drugs;
— some antibiotics (for example, ampicillin, tetracycline, rifampicin) — because of decrease in enteropechenochny circulation of estrogen.
At simultaneous use of such medicines / active agents with the tablets BELARA® it is necessary to use additional barrier methods of contraception, both during treatment, and within 7 days after it. At reception of the active agents reducing concentration of ethinylestradiol in blood serum due to induction of liver microsomal enzymes, additional barrier methods (condom, spermitsida) should be applied within 28 days after the end of treatment.

The following medicines / active agents can increase concentration of ethinylestradiol in blood serum:
— the active agents suppressing sulphation of ethinylestradiol in an intestinal wall, for example, ascorbic acid or paracetamol;
— аторвастатин;
— the substances suppressing activity of liver microsomal enzymes such as antifungal imidazoles (for example, fluconazole), индинавир or тролеандомицин.
Ethinylestradiol can influence metabolism of other substances:
— to suppress activity of liver microsomal enzymes and, respectively, to increase concentration in blood serum of such active agents as diazepam (and other benzodiazepines which metabolism is carried out through a hydroxylation), cyclosporine, theophylline and Prednisolonum;
— to induce a glyukuronidation in a liver and, respectively, to reduce concentration in blood serum, for example, of Clofibratum, paracetamol, morphine and lorazepam.
The need for insulin and peroral antidiabetic means can change because of influence of drug on tolerance to glucose.

Contraindications:

The Combined Peroral Contraception (CPC) is contraindicated in the listed below cases. It is necessary to stop reception of Belary® immediately in case of emergence at least one of below the listed symptoms:
— existence of thromboses (venous and arterial) now or in the anamnesis (for example, deep vein thrombosis, a pulmonary embolism, a myocardial infarction, a stroke);
— also existence of the first symptoms of thrombosis, thrombophlebitis or symptoms of an embolism (for example, the tranzitorny ischemic attacks, stenocardia see the section "Special Instructions");
— the planned surgical intervention (at least in 4 weeks prior to it) and the immobilization period, for example, after an injury (including after imposing of plaster bandages);
— a diabetes mellitus with vascular complications;
— the diabetes mellitus which is not giving in to adequate control;
— uncontrollable hypertensia or significant increase in blood pressure (over 140/90 mm Hg, see the section "Special Instructions");
— the hereditary or acquired predisposition to development of venous or arterial thromboses, as that the increased stability, an organism to the activated S-protein (ARS-resistance);
— insufficiency of antithrombin III, insufficiency of S-protein, insufficiency of S-protein, gipergomotsisteinemiya and anti-phospholipidic antibodies (anti-cardiolipin antibodies, lupoid anticoagulant);
— hepatitises, jaundice, an abnormal liver function (before normalization of indicators of hepatic tests);
— a generalized itch, a cholestasia, especially during the previous pregnancy or therapy by estrogen;
— syndrome Cudgel Johnson, Rotor syndrome; the states / diseases which are followed by bile outflow disturbance;
— existence now or in the anamnesis of tumors of a liver;
— the expressed pains in epigastriums, increase in a liver or. symptoms of intra belly bleeding (see the section "Side effect");
— manifestation for the first time or a porphyria recurrence (all three forms, in particular the acquired porphyria);
— existence of hormonedependent malignant diseases, including in the anamnesis, (for example, a mammary gland or a uterus) or suspicion on them;
— the expressed disturbances of metabolism of lipids;
— pancreatitis now or in the anamnesis, in a combination to severe forms of a gipertriglitseridemiya;
— first attacks of migrenozny pain or frequent heavy headaches;
— migraine in combination with local neurologic symptomatology (the associated migraine);
— acute touch disorders, for example, vision disorder or hearing;
— motive disturbances (in particular paresis);
— weighting of a course of epilepsy;
— heavy depression;
— an otosclerosis during previous, pregnancies;
— amenorrhea of not clear etiology;
— endometria hyperplasia;
— bleeding from a vagina of not clear etiology;
— hypersensitivity to drug components;
— pregnancy or suspicion on it;
— feeding period breast;
— smoking is aged more senior than 35 years (see the section "Special Instructions").

WITH CARE.
The use of a combination it is oestrogenic / прогестаген can make negative impact on the course of some diseases / states.
Special medical observation is required in the following cases: epilepsy, multiple sclerosis; convulsive syndrome (tetany); migraine; bronchial asthma; heart or renal failure; hysterical chorea; a diabetes mellitus with an uncomplicated current; a diabetes mellitus (see also section "Contraindications"); liver diseases (see also section "Contraindications"); disturbance of metabolism of lipids, a dislipoproteinemiya (see also section "Contraindications"); autoimmune diseases (including a system lupus erythematosus); obesity; arterial hypertension (see also section "Contraindications"); endometriosis; varicose diseases; phlebitis (see also section "Contraindications"); disturbance of coagulant system of blood; mastopathy; hysteromyoma; herpes of pregnant women; a depression (see also section "Contraindications"); chronic inflammatory diseases of intestines (disease Krone, nonspecific ulcer colitis).

USE AT PREGNANCY AND THE LACTATION.
Pregnancy: use of the drug Belara® during pregnancy is contraindicated. Before beginning drug Belara® use, it is necessary to exclude pregnancy existence. At approach of pregnancy during reception of Belary®, administration of drug should be stopped immediately. The data which are available so far do not contain data on development of teratogenic or embriotoksichesky action in women which accidentally accepted during pregnancy the drugs containing estrogen and progesterona in the same combination as well as in the drug Belara®.
Lactation period: Belara during breastfeeding as drug reduces amount of the produced milk is not recommended to use drug and changes its structure. Small amounts of the hormones which are a part of a contraceptive and/or their metabolites are allocated with breast milk and can influence the raised child.

Overdose:

At overdose drug does not observe any heavy toxic reactions. At accidental reception of a large number of tablets development of nausea, vomiting, bloody allocations / bleedings from a vagina is possible.
There is no specific antidote. Symptomatic treatment. Control of indicators of water and electrolytic exchange and function of a liver is in rare instances necessary.

 

Storage conditions:

At a temperature not above 30 °C.
To store in the place, unavailable to children!

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated. On 21 tablets in the blister from PVC/PVDH / aluminum foil or polypropylene / aluminum foil. 1, 3 or 6 blisters together with the application instruction place in a cardboard pack.