Klayra

Klayra – the combined hormonal contraceptive applied to the prevention of undesirable pregnancy.

Form of release and structure

Klayra is let out in the form of five types of tablets, film coated: biconvex, round, on cross section – from almost white till white color a kernel and dark yellow, pink, pale yellow, red or white color a cover (on 28 pieces in blisters from an aluminum foil / polyvinylchloride, on 1 or 3 blisters in the book folding bed with a reception calendar).

Tablets, film coated – 2 pieces: dark yellow, with a text of "DD" on one of the parties in the correct hexagon.

Active agent is a part of 1 tablet: oestradiol valerate, micro 20 – 3 mg.

Tablets, film coated – 5 pieces: pink, with a text of "DJ" on one of the parties in the correct hexagon.

Active agents are a part of 1 tablet:

• Oestradiol valerate, micro 20 – 2 mg;
• Диеногест, micro – 2 mg.

Tablets, film coated – 17 pieces: pale yellow, with a text of "DH" on one of the parties in the correct hexagon.

Active agents are a part of 1 tablet:

• Oestradiol valerate, micro 20 – 2 mg;
• Диеногест, micro – 3 mg.

Tablets, film coated – 2 pieces: red, with a text of "DN" on one of the parties in the correct hexagon.

Active agent is a part of 1 tablet: oestradiol valerate, micro 20 – 1 mg.

Tablets (placebo), film coated – 2 pieces: white, on one of the parties in the correct hexagon a text of "DT".

Auxiliary components (темно-желтые/розовые/бледно-желтые/красные/белые tablets respectively): monohydrate of lactose – 48,36/47,36/46,36/50,36/52,1455 mg; mg povidone 25 - 4/4/4/4/3,0545; prezhelatinizirovanny corn starch – 9,6/9,6/9,6/9,6/0 mg; corn starch – 14,4/14,4/14,4/14,4/24 mg; magnesium stearate – 0,64/0,64/0,64/0,64/0,8 mg.

Cover (темно-желтые/розовые/бледно-желтые/красные/белые tablets respectively): a gipromelloza – 1,5168/1,5168/1,5168/1,5168/1,0112 mg; a macrogoal 6000 – 0,3036/0,3036/0,3036/0,3036/0 mg; talc – 0,3036/0,3036/0,3036/0,3036/0,2024 mg; titanium dioxide – 0,584/0,83694/0,83694/0,5109/0,7864 mg; dye yellow iron oxide – 0,292/0,03906 mg (dark yellow/pale yellow tablets respectively); dye red iron oxide – 0,03906/0,3651 mg (pink/red tablets respectively).

Indications to use

Klayra is appointed for peroral contraception.

Contraindications

• Thromboembolisms and fibrinferments (arterial and venous) now or in the presence in the anamnesis (including a myocardial infarction, a thrombembolia of a pulmonary artery, a deep vein thrombosis, a stroke now or in the anamnesis);
• Existence of risk factors (multiple or expressed) arterial or venous thrombosis (including extensive surgical interventions with a long immobilization, the complicated diseases of the valve device of heart, uncontrollable arterial hypertension);
• The states preceding development of thrombosis (including stenocardia, the tranzitorny ischemic attacks) now or in the presence in the anamnesis;
• The diabetes mellitus proceeding with vascular complications;
• Bleeding from a vagina of the obscure genesis;
• Migraine with focal neurologic signs, including in the presence in the anamnesis;
• The pancreatitis which is followed by the expressed gipertriglitseridemiya (now or in the presence in the anamnesis);
• Hormonedependent malignant tumors, including the tumors of mammary glands or generative organs (confirmed or in the presence of suspicion of them);
• Malignant and benign tumors of a liver (now or in the presence in the anamnesis);
• Serious illnesses of a liver and liver failure (Klayra's use can be begun after normalization of indicators of function of a liver);
• Pregnancy or at suspicion on it;
• Hypersensitivity to drug components.

Drug should not be used in the presence of any of the specified diseases/states, in cases of their development during therapy Klayr should cancel.

In the presence of risks/states, any of diseases/factors, before Klayra's reception it is necessary to correlate to care potential risk with the expected advantage of its use (each case in an individual order):

• Hereditary Quincke's disease;
• Arterial hypertension, smoking, extensive injuries and surgical interventions, dislipoproteinemiya, obesity, disturbance of a cordial rhythm, migraine, diseases of valves of heart, long immobilization and other risk factors of developing of a thrombembolia and thrombosis;
• System lupus erythematosus, diabetes mellitus, gemolitiko-uraemic syndrome, disease Krone and ulcer colitis, drepanocytic anemia and other diseases at which disturbances of peripheric circulation can be observed;
• Diseases which arose for the first time or were aggravated during pregnancy or at the previous use of sex hormones, including cholestatic jaundice, herpes of pregnant women, a cholestatic itch, a chorea of Sidenkhem, a cholelithiasis, a porphyria, an otosclerosis with deterioration in hearing;
• Gipertriglitseridemiya;
• Puerperal period.

Route of administration and dosage

Klayra is accepted inside, washing down if necessary with water or other liquid, regardless of meal. Drug needs to be accepted every day (continuously) on 1 tablet a day approximately in at one time in the order specified in a calendar for 28 days then begin reception of tablets from new packaging.

As a rule, menstrualnopodobny bleedings begin during reception of the last tablets of calendar packaging. At some women they begin after the beginning of reception of tablets from new packaging.

If the woman did not use hormonal contraception earlier, Klayra begins to be accepted in the first day of a natural menstrual cycle.

Upon transition from other combined hormonal contraceptive, tablets begin to accept Klayra next day after reception of the last active (with the content of active agent). When using a transdermalny plaster or vaginal ring Klayra's reception needs to be begun in day of their removal.

Transition from use mini-was drunk it is possible to carry out in any day, from an injection method – in day of purpose of the next injection, from intrauterine system with release of progestogen or an implant – in day of their removal. During the first 9 days of reception of Klayra it is recommended to use in addition barrier method of contraception.

After the abortion which is carried out in the first trimester of pregnancy it is possible to apply Klayra at once without use of additional measures of contraception.

After the abortion which is carried out in the second trimester of pregnancy and after the delivery drug begins to be accepted for 21-28 day. If Klayra's reception is begun later, during the first 9 days it is necessary to use in addition barrier method of contraception. In cases if already the sexual contact took place, before therapy it is necessary to exclude pregnancy or to wait for approach of the first periods.

The passed inactive (white) tablets can be neglected. At the admission during 12 reception hours of active tablets contraceptive protection does not go down, and the passed medicine needs to be taken at once as soon as the woman remembers it. Further Klayra's reception is continued according to the usual scheme.

At a delay of reception of an active tablet longer than 12 hours, contraceptive protection can decrease. The passed pill needs to be taken at once as soon as the woman remembers it even if it means that it is necessary to take at the same time 2 pill. Further Klayra's reception is continued according to the usual scheme.

Depending on day in which the woman missed reception of 1 tablet longer than for 12 hours, it is necessary to follow the following rules:

• 1-2 day (tablet of dark yellow color): the passed pill should be taken immediately, and following – according to the usual scheme (even at reception of 2 tablets in one day);
• 3-7 day (tablet of pink color): within 9 next days it is necessary to use additional measures of contraception, method of tablets is continued according to the usual scheme;
• 8-17 day (tablet of pale yellow color): within 9 next days it is necessary to apply additional measures of contraception;
• 18-24 day (tablet of pale yellow color): it is necessary to begin administration of drug from new calendar packaging at once (with the first tablet), within 9 next days it is necessary to apply additional measures of contraception;
• 25-26 day (tablet of red color): the passed pill should be taken immediately, and following – in usual time (even at reception of 2 tablets in one day);
• 27-28 day (tablets of white color – placebo): it is necessary to continue Klayra's reception according to the usual scheme, having thrown out the passed tablet.

In one day it is allowed to take no more than 2 pill.

What more tablets (during the period from 3 to 24 day, especially with the maintenance of a combination of two active components) were passed by, and than day of the admission of administration of drug is closer to a phase of reception of inactive tablets, subjects a pregnancy high probability (in cases if within 7 days before the admission of a tablet there was a sexual contact).

In the absence of menstrualnopodobny bleeding at the end of the current calendar packaging / at the beginning of new calendar packaging, it is necessary to consider probability of pregnancy.

Absorption of active agents of drug at heavy gastrointestinal disturbances can be incomplete therefore it is recommended to apply additional contraceptive measures.

In cases if in 3-4 hours after reception of a tablet with the content of active agent vomiting develops, the recommendations relating to the passed tablets work. If the woman does not want to change the usual scheme of reception of Klayra, it is necessary to take the corresponding additional pill (tablets) from new packaging.

Klayra should not be accepted to women after approach of a menopause.

Side effects

At Klayra's use the following side effects can develop:

• Nervous system: often – a headache, including tension headache; infrequently – dizziness, decrease a mood/depression, decrease in a libido, mental disturbances, changes of mood; seldom – aggression, affective lability, nervousness, uneasiness, increase in a libido, disturbance of attention, a dysphoria, sleep disorders, a stress, concern, вертиго, paresthesias;
• Alimentary system: often – pains in a stomach (including swelling); infrequently – nausea, diarrhea, vomiting; seldom – a gastroesophageal reflux;
• Cardiovascular system: infrequently – increase in arterial pressure, migraine (with aura and without it); seldom – inflows of heat to the person, bleeding from varicose expanded veins, pains on the course of veins, lowering of arterial pressure;
• Reproductive system: often – discomfort and mammary gland pains, an amenorrhea, disturbances in nipples, a dysmenorrhea, nipple pains, a metrorrhagia; infrequently – increase and diffusion consolidation of mammary glands, a fibrous and cystous mastopathy, a dysplasia of an epithelium of a neck of uterus, a dispareuniya, dysfunctional uterine bleeding, a menorrhagia, pains in pelvic area, cysts in ovaries, a premenstrual syndrome, a leiomyoma of a uterus, allocation from a vagina, uterus spasms, dryness in vulvovaginal area; seldom – high-quality new growths in a mammary gland, a galactorrhoea, a lactocele, bleeding during the sexual intercourse, bleeding from a vagina, a delay of menstrualnopodobny bleeding, a hypomenorrhea, a rupture of an oothecoma, burning sensation in a vagina, vulval/uterine bleeding (including the vulvovaginal discomfort, a smell from a vagina smearing allocations);
• Liver: seldom – a focal nodular hyperplasia of a liver, increase in activity of alaninaminotranspherase;
• Musculoskeletal system: seldom – feeling of weight, muscular spasms, dorsodynias;
• Hypodermic cellulose and skin: often – an acne; infrequently – an alopecia, rash (including a menocelis), an itch (including pruritic rash, a generalized itch); seldom – neurodermatitis, allergic skin reactions (including urticaria, allergic dermatitis), dermatitis, a hloazma, a hirsutism, a hypertrichosis, seborrhea, pigmentation disturbance, not specified damages of skin, including feeling of stiffness of skin;
• Organ of sight: seldom – intolerance of contact lenses;
• Invasions and infections: infrequently – fungal infections, vagina candidiasis, not specified vagina infections; seldom – vulvovaginal fungal infections, multi-colored deprive, herpes, candidiasis, a syndrome of estimated histoplasmosis of eyes, a bacterial vaginosis, infections of urinary tract;
• Alimentary disturbances and metabolism: infrequently – increase in appetite; seldom – a gipertriglitseridemiya, a liquid delay;
• General symptoms: often – increase in body weight; infrequently – a body degrowth, hypostasis, irritability; seldom – an indisposition, pain behind a breast, a lymphadenopathy, fatigue.

Special instructions

Before Klayra's use it is necessary to estimate carefully contraindications to her appointment on the basis of the family anamnesis of the woman, the anamnesis of life, and also gynecologic and all-medical examination.

The maximum risk of developing of a venous thrombembolia is noted in the first year of reception of Klayra (preferential – for the first 3 months).

Thrombosis of other blood vessels (for example, mesenteric, hepatic, renal, vessels of a retina, brain veins and arteries) develops extremely seldom.

The risk of developing of a thrombembolia and thrombosis (arterial and/or venous) increases at smokers, with age, and also in the presence of the following diseases / states:

• Existence in the family anamnesis of instructions on a venous or arterial thromboembolism;
• Obesity (index of body weight more than 30 kg/m ²);
• Fibrillation of auricles;
• Dislipoproteinemiya;
• Arterial hypertension;
• Diseases of valves of heart;
• Migraine;
• Long immobilization;
• Extensive surgical interventions, any operations performed on the lower extremities, extensive injuries.

It is necessary to consider the increased risk of development of a thromboembolism during the puerperal period. Development of disturbances of peripheric circulation in women with a diabetes mellitus, a system lupus erythematosus, a gemolitiko-uraemic syndrome, chronic inflammatory diseases of intestines (a disease Krone or ulcer colitis) and a sickemia is also possible.

Increase in weight and frequency of migraine can be the basis for the immediate termination of reception of Klayra.

In rare instances at use of drug developed high-quality, and in extremely exceptional cases – malignant tumors of a liver. When developing severe pains in upper parts of a stomach, increase in the sizes of a liver or symptoms of intra belly bleeding when carrying out differential diagnosis it is necessary to exclude liver tumors.

The risk of development of pancreatitis is higher at women with a gipertriglitseridemiya.

At development of permanent, clinically significant increase in arterial pressure Klayra's reception needs to be cancelled.

In the presence of hereditary forms of a Quincke's disease drug can worsen or induce symptoms of a Quincke's disease.

Klayra's reception can influence results of some laboratory researches, including biochemical parameters of a thyroid gland, function of a liver, kidneys and adrenal glands, concentration of transport proteins in plasma, parameters of carbohydrate metabolism, a fibrinolysis and coagulation.

During Klayra's use, in particular in the first months of therapy, development of irregular menstrualnopodobny bleedings in the form of the smearing allocations or breakthrough uterine bleedings is possible. It is necessary to carry out assessment of any irregular menstrualnopodobny bleedings only later 3 menstrualnopodobny cycles (after the adaptation period).

At repetition of irregular menstrualnopodobny bleedings or if they arise for the first time after the previous regular cycles, it is necessary to conduct careful examination to exclude malignant new growths or pregnancy.

Klayra's efficiency can decrease at gastrointestinal disturbances, the admission of tablets with the content of active components, and also because of the accompanying medicinal therapy.

Medicinal interaction

Klayra's interaction with some other medicines can result in lack of contraceptive effect and/or development of breakthrough uterine bleedings. In particular, it is necessary to consider effect of simultaneous use of Klayra with such drugs as:

• Rifampicin, carbamazepine, Phenytoinum, Primidonum, barbiturates and, perhaps, also окскарбазепин, griseofulvin, топирамат, ритонавир, фелбамат, and also drugs with the maintenance of the St. John's Wort which is made a hole: increase in clearance of sex hormones;
• Nenukleozidny inhibitors of the return transcriptase (for example, not Virapinum) and their combinations, HIV protease inhibitors (for example, ритонавир): influence on hepatic metabolism;
• The drugs inducing microsomal enzymes, antibiotics: decrease in enterogepatichesky circulation of estrogen and, respectively, reduction of concentration of oestradiol (it is recommended for use of these drugs and within 28 days after their cancellation to apply other method of contraception or to use barrier methods of contraception);
• Grapefruit juice, azolny antifungal drugs, verapamil, Cimetidinum, diltiazem, antidepressants, macroleads: increase in concentration of a diyenogest in a blood plasma.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature up to 30 °C.

Period of validity – 4 years.