Belara

Белара Drug photo

The description is actual on 08.01.2015

  • Latin name: Belara
  • ATH code: G03AA
  • Active ingredient: Ethinylestradiol + Hlormadinon (Ethinylestradiol + Chlormadinone)
  • Producer: GEDEON RICHTER (Hungary)

Structure

2 mg of acetate of a hlormadinon and 30 mkg of ethinylestradiol are a part of one tablet of Belara.

Additional components: monohydrate of lactose, K30 povidone, corn starch, magnesium stearate.

Structure of a film cover: macrogoal 6000, gipromelloza, talc, monohydrate of lactose, propylene glycol, titanium dioxide, dye red iron oxide.

Release form

Contraceptive tablets of Belar are covered with a light pink cover, round, biconvex about color a white kernel. 21 such tablets in the blister, one or three blisters in a pack from a cardboard.

Pharmacological action

Contraceptive action.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

The combined drug for contraception accepted inside.

Long use of drug leads to decrease in secretion of follicle-stimulating hormone and lyuteniziruyushchy hormone, and, therefore, to suppression of process of an ovulation. At the same time the proliferation and secretory transformation of an endometria interfering fixing of an oospore takes place. Viscosity of mucous allocations from a neck of uterus increases that passes with difficulty of passing of man's sex cells through the channel of a neck and braking of their mobility.

The acetate of a hlormadinon entering drug is gestageny, possessing antiandrogenic properties. Its effect is based on ability to compete with androgens in specific receptors, weakening effect of androgens. Perl's index (probability to become pregnant in 12 months) fluctuates within 0.291-0.698 and depends on care of observance by the woman of the mode of reception of means.

Full blocking of an ovulation requires about 1.7 mg of acetate of a hlormadinon daily. The necessary dosage on a cycle makes 25 mg.

Pharmacokinetics

Hlormadinona acetate. It is quickly and completely absorbed. The maximum concentration comes an hour and a half. 95% contact blood proteins of the person, generally albumine.

In the course of transformation the set of metabolites is formed, basic of which are 3-beta and 3 - alpha hydroxy-hlormadinona acetate.

The average elimination half-life makes 34 hours of blood. Acetate of a hlormadinon and its metabolites are emitted in approximately identical quantities with urine and through intestines.

Ethinylestradiol. It is quickly and almost completely soaked up from intestines, reaching the maximum concentration in plasma through an hour and a half. Absolute bioavailability – about 40%.

About 98% of substance contact blood proteins. Ethinylestradiol is transformed by means of a hydroxylation of an aromatic ring. To the main derivatives 2-hydroxy-ethinylestradiol is.

The average elimination half-life of ethinylestradiol makes 13 hours of blood. It is removed by kidneys and with excrements in a proportion 2:3.

Indications to use

Need of peroral contraception.

Contraindications

Use of drug is contraindicated at following diseases:

  • existence of initial symptoms of thrombophlebitis, thrombosis or symptoms of an embolism (including, temporary ischemic attacks);
  • fibrinferments and thromboembolisms in the course or in the anamnesis (a myocardial infarction, an embolism of a pulmonary artery, vein thromboses, cerebrovascular changes);
  • the planned operative measure (in 4 weeks before) and the immobilization period;
  • uncontrollable arterial hypertension;
  • acute or chronic severe damages of a liver (before normalization of function of a liver);
  • uncontrollable diabetes mellitus;
  • predisposition to emergence of venous and arterial thromboses: ARS-resistance, deficit of a protein of S, deficit of a protein With, deficit of antithrombin 3, anti-phospholipidic antibodies and a gipergomotsisteinemiya;
  • itch of all body, cholestasia, especially during the previous pregnancy or use of sex hormones in the past;
  • liver tumors, including in the anamnesis;
  • severe pain in epigastriums, a hepatomegalia or symptoms of intra belly bleeding;
  • Rotor syndrome, syndrome Cudgel Johnson, bile outflow delay;
  • porphyria in any forms and manifestations;
  • hormonedependent malignant tumors or suspicion on their existence;
  • pancreatitis, in combination with a heavy gipertriglitseridemiya;
  • the expressed changes of a metabolism of lipids;
  • migraine attacks;
  • touch disturbances of acuity;
  • increase in frequency of attacks of epilepsy;
  • motive disturbances;
  • heavy depression;
  • complication of a current of an otosclerosis during the previous pregnancies;
  • endometria hyperplasia;
  • cryptogenic amenorrhea;
  • vulval bleeding of not clear etiology;
  • lactation period;
  • pregnancy and suspicion on it;
  • addiction to smoking aged from 35 flyings;
  • deficit of lactase, lactose intolerance, glyukozo-galaktozny malabsorption;
  • presence of multiple factors of risk of arterial or venous thrombosis;
  • sensitization to drug components.

It is necessary to appoint with care drug in the presence of following diseases (including in the anamnesis):

  • multiple sclerosis, epilepsy;
  • bronchial asthma;
  • convulsive syndrome;
  • migraine without neurologic symptomatology;
  • renal or heart failure;
  • uncomplicated diabetes mellitus;
  • hysterical chorea;
  • not serious illness of a liver;
  • dislipoproteinemiya, lipid metabolism disturbance;
  • autoimmune diseases;
  • obesity;
  • endometriosis;
  • controlled arterial hypertension;
  • phlebitis of superficial veins of legs, varicosis;
  • blood coagulation change;
  • hysteromyoma;
  • mastopathy;
  • herpes of pregnant women;
  • chronic diseases of intestines of inflammatory character;
  • depression.

Side effects

  • Reactions from mentality: nervousness, the suppressed mood, irritability, weakening of a libido.
  • Reactions from immunity: hypersensitivity to drug components.
  • Reactions from a metabolism: changes of fatty composition of blood, appetite increase.
  • Reactions from a nervous system: migrenozny pains, dizziness.
  • Reactions from sense bodys: intolerance of contact lenses, conjunctivitis, visual disturbances, hearing loss, sonitus.
  • Reactions from the blood circulatory system: increase of pressure, arterial hypotension, arterial hypertension, varicosis, collapse, vein thrombosis.
  • Reactions from system of digestion: meteorism, nausea, vomiting, abdominal pains, diarrhea.
  • Reactions from skin: eels, hloazma, pigmentation disturbances, hair loss, hyperhidrosis, xeroderma, small tortoiseshell, erythema, eczema, itch, hypertrichosis, knotty erythema.
  • Reactions from a musculoskeletal system: feeling of weight, lyumbalgiya, muscular frustration.
  • Reactions from urinogenital system: a dysmenorrhea, strengthening of allocations from a vagina, an amenorrhea, pains in the bottom of a stomach, a fibroadenoma of a mammary gland, a galactorrhoea, vaginal candidiasis, a menorrhagia, a vulvovaginitis, a premenstrual syndrome.
  • Reactions of the general character: hypostases, fatigue, increase in weight.

At Belara's use the following side effects were also revealed:

  • increase of risk of emergence of diseases of zhelchevyvodyashchy ways;
  • increase in risk of an arterial and venous thromboembolism;
  • increase of risk of emergence of benign tumors in a liver; in isolated cases development of intra belly bleedings is possible;
  • exacerbation of chronic diseases of intestines of inflammatory character.

Belara, application instruction (Way and dosage)

The application instruction of Belara orders to take a contraceptive pill inside. They should be taken from the blister and to swallow entirely if it is necessary having washed down with small amount of liquid. Tablets should be used every day in identical time (better in the evening) 21 days in a row, then it is necessary to interrupt reception for 7 days; approximately in 2-4 days after the use of the last tablet the cancellation bleeding similar to menstrual develops.

After end of a 7-day break it is necessary to start use of drug from the following pack, regardless of whether bleeding stopped.

The first medicine needs to be taken in the first day of a physiological cycle of the woman (the first days of the following periods). In this case the contraceptive effect begins from first days of reception and lasts during a week break in reception.

The first medicine can be taken for 1-5 days of menstrual bleeding (bleeding not very well stopped or not). In this case during the first seven days of reception it is necessary to use also barrier ways of contraception.

If menstrual bleeding developed more than 5 days ago, it is recommended to wait for the beginning of the following periods, and then to start a cycle of administration of drug.

Transition from other hormonal contraceptive (combined) to Belara

Transition from the means containing 21-22 tablets. It is necessary to finish use of all tablets from last packaging. Further the first medicine of Belara needs to be taken the next days. There should not be a break in use of tablets, and to the woman approach of the following periods does not consult. Additional ways of contraception in this case are not required.

Transition from the means containing one gestagen (mini-drank)

In this case the first medicine of Belara should be taken the next days after use of the last tablet including only gestagen. During the first seven days it is recommended to use also barrier ways of contraception.

Transition from hormonal contraceptives of injection introduction or an implant

Belara's reception can be begun in the first days of removal of an implant or in the first days of the planned injection. During the first seven days consults to use barrier contraceptive ways.

After abortion (spontaneous or medical) in the first 3 months of pregnancy

Belara's use can be begun in day of abortion. In this case it is possible not to apply the additional ways preventing pregnancy.

After the delivery or abortion (spontaneous or medical) on 3-6 month of pregnancy

Belara's reception is recommended to be begun on the fourth week after the delivery if the lactation, or after abortion on the second trimester of pregnancy is not made. In this case use of additional methods of contraception is not obligatory.

If use of drug is begun after the fourth week after the delivery or abortion, then it is recommended to use additional ways of contraception during the first week.

If sexual intercourse already was, then it is desirable to exclude pregnancy or to wait the following menstrual cycle before administration of drug.

If the woman forgot to take a medicine, but accepted it in 12 hours, the contraceptive effect can be weakened.

If reception of a tablet was missed, then it is necessary to conform to the stated below rules:

  • it is impossible to stop drug intake more than for a week;
  • 7 days of continuous drug intake are necessary for achievement of sure suppression of regulation of system a hypothalamus-hypophyses-ovaries.

The passed tablet consults to accept immediately, even if it means that it is necessary to take two medicines once. Then to be guided by the standard scheme. Within the next week it is necessary to use barrier ways of contraception.

If in a pack there were less than seven tablets, at once after the end of the use of tablets from this pack it is necessary to begin to use tablets from new packaging – there should be no break between packagings. Cancellation bleeding usually will not arise, all tablets from the second packaging will not be used yet, however exceptions are possible. If bleeding of cancellation does not develop after the termination of a cycle of reception of the second packaging, then it is necessary to execute the test for pregnancy.

Overdose

Usually at overdose the heavy toxic phenomena are not observed. Symptoms: vomiting, nausea, allocations of bloody character from a vagina are possible.

Treatment: symptomatic. There is no selection antidote.

Interaction

The following substances can lower concentration of ethinylestradiol in blood and weaken contraceptive activity:

  • all medicines which are increasing motility of intestines or slowing down absorption;
  • the substances activating microsomal liver enzymes such as Rifabutin, Rifampicin, barbiturates, Griseofulvin, anticonvulsants, Barbeksaklon, Modafinil, inhibitors of proteases, Primidonum, St. John's Wort drugs;
  • number of antibiotics (for example, Tetracycline, Ampicillin).

At simultaneous use of similar drugs it is necessary to apply additional barrier ways of contraception during therapy and within a week after it. At reception of the substances lowering concentration of ethinylestradiol in blood due to activation of microsomal enzymes of a liver, additional barrier ways should be used within four weeks after the end of therapy.

The following substances can increase concentration of ethinylestradiol in blood:

  • the substances which are slowing down sulphation of ethinylestradiol in intestines (Ascorbic acid, Paracetamol);
  • the substances blocking activity of microsomal enzymes of a liver (antifungal imidazoles, indinavir, troleandomitsin);
  • atorvastatin.

Terms of sale

According to the recipe.

Storage conditions

To protect from children and to store at a temperature up to 25 degrees.

Period of validity

Two years.

Special instructions

Drug does not influence ability to driving.

Analogs

Belara's analogs: Vidora, Vidor Mikro, Dayla, Dariliya, Jes, Jes Plus, Difenda, Evra, Jeanine, Zhastinda, Lindinet 20, Lindinet 30, Logest, Marvelon, Mersilon, Midiana, Milanda, Modell Anti, Modell Ting, Naadin, Novinet, Regulon, Rigevidonum 21 +7, Silest, Simitsia, Femoden, Yarina, Yarina Plus.

Zdravzona

  • Belara No. 21 of AG tabletkiberlin-Hema
  • Belara No. 21х3 of AG tabletkiberlin-Hema

Drugstore of IFC

  • Belara tbl p / about No. 21, Gedeon Richtervengriya
  • Belara tbl p / about No. 21, Grunenthalgermaniya
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Apteka24

  • Belara tab. p / about No. 21gryunental (Germany)

BIOSPHERE

  • Belara of 2 mg / 0.03 mg No. 21 tabl.p.o.
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Section: Hormonal Contraceptives
in more detail

Education: Graduated from the Vitebsk state medical university majoring in "Surgery". At university headed Council of students' scientific society. Professional development in 2010 - in "Oncology" and in 2011 - in "A mammology, visual forms of oncology".

Experience: Work in an all-medical network 3 years the surgeon (The Vitebsk hospital of an emergency medical service, Lioznensky TsRB) and in combination the regional oncologist and the traumatologist. Work farm the representative within a year in the Rubicon company.

Provided 3 improvement suggestions on the subject "Optimization of an Antibioticotherapia depending on Species Composition of Microflora", 2 works took prizes in a republican competition review of student's scientific works (1 and 3 categories).
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