Klayra of the tab. of p/o No. 28

tablets "Klayra" are applied at the following indications:

• oral contraception;
• treatment of heavy menstrual bleedings at women without organic pathology which appointed oral contraception.

Structure

Active ingredients - estradiol valerate, dienogest.

:

• 2 of dark yellow color of a tablet, each of which contains 3 mg of oestradiol valerate;
• 5 of red color of tablets, each of which contains 2 mg of oestradiol valerate and 2 mg of the diyenogest;
• 17 of light yellow color of tablets, each of which contains 2 mg of oestradiol valerate and 3 mg of the diyenogest;
• 2 of dark red color of a tablet, each of which contains 1 mg of oestradiol valerate;
• 2 of white color of a tablet of placebo.

Excipients: lactoses monohydrate, starch corn, starch prezhelatinizirovanny, povidone, magnesium stearate, gipromelloza, macrogoal 6000, talc, titan dioxide (E 171), ferrous oxide yellow (E172) or ferrous oxide red (E172).

Placebo: lactoses monohydrate, starch corn, povidone, magnesium stearate, gipromelloza, talc, titan dioxide (E 171).

Contraindication

should not apply KGK in the presence of any of the states provided below. If any of them developed for the first time during application of KGK, it is necessary to stop administration of medicament immediately.

Existence or risk of developing venous thrombembolia (VTE):

• presence of a venous thrombembolia now (during therapy by anticoagulants) or in the anamnesis (for example the deep vein thrombosis (DVT), a pulmonary embolism (TELA);
hereditary or acquired tendency to a venous thrombembolia, such as resistance to the activated protein With (including a mutation of a factor of the V Leiden), deficiency of antithrombin-III, deficiency of a protein With, deficiency of S protein is known to
• ;
• big surgeries with a long immobilization;
• high risk of a venous thrombembolia because of existence of multiple factors of risk.

Existence or risk of developing arterial thrombembolia (ATE):

• arterial thrombembolia: presence of an arterial thrombembolia in the anamnesis (for example myocardial infarction) or existence of prodromal symptoms (for example stenocardias);
• violation of cerebral circulation: a stroke in the anamnesis, existence of prodromal symptoms (for example the tranzitorny ischemic attack (TIA));
• known hereditary or acquired tendency to an arterial thrombembolia, such as gipergomotsisteinemiya and antibodies to phospholipids (antibodies to cardiolipins, lupoid anticoagulant);
• migraine with focal neurologic symptoms in the anamnesis;
• high risk of an arterial thrombembolia because of existence of multiple factors of risk or because of existence of one serious risk factor, such, as: diabetes with vascular complications; heavy arterial hypertension; heavy dislipoproteinemiya.

Serious illness of a liver in the anamnesis, so far indicators of function of a liver did not return to norm limits.

Benign or malignant tumor of a liver now or in the past.

Expected malignant tumors (for example, genitals or mammary glands), dependent on sex hormones.

Vaginal bleeding of not clear etiology.

Hypersensitivity to active ingredients or to any of medicine components.

Route of administration

Way of use - orally.

should take the Pill in the order specified on packing, every day approximately at the same time, washing down if necessary with liquid. A pill should be taken continuously. To accept on one tablet daily within 28 days in a row. Each following packing should be begun next day after reception of the last tablet from the previous packing. Cancellation bleeding usually begins during reception of the last tablets from packing and can not come to an end at the time of the beginning of reception of tablets from the following packing. At some women the bleeding begins after reception of the first tablets from new packing.

How to begin administration of medicament of Klayr

If any hormonal contraceptive was not used (last month) method of tablets should be begun in the 1st day of a natural cycle of the woman (that is the first day of her menstrual bleeding).

Upon transition from other hormonal contraceptive for oral administration, a vaginal ring or a transdermalny plaster. It is necessary to begin use of the medicine "Klayra" next day after took the last pill containing hormones, preliminary the COOK. In case of application of a vaginal ring or a transdermalny plaster it is necessary to begin administration of medicament of Klayr in day of removal of means.

Upon transition from a progestagenovy method (the oral contraceptive containing only progestogen, an injection contraceptive, an implant) or an intrauterine system (Naval Forces) with progestogen). The woman can pass to use of the medicine "Klayra" from the oral contraceptive containing only progestogen in any day (from an implant or Naval Forces - in day of removal, from an injection - in day in which the following injection has to be made), but anyway in the first 9 days of use of the medicine "Klayra" it is necessary to use additional barrier contraceptive resources.

After abortion use of the medicine "Klayra" at once. If administration of medicament is begun, the woman does not demand application of additional methods of contraception.

After the delivery or abortion in ΙΙ a pregnancy trimester. It is recommended to begin administration of medicament for 21-28 day after the delivery or abortion in ΙΙ a pregnancy trimester. At later application the woman needs to recommend additional barrier methods of contraception during the first 9 days of administration of drug. However, if sexual intercourse already took place, prior to application the COOK it is necessary to exclude pregnancy or to wait for the first menstrual period.

Feature of application

Pregnant

Drug cannot be used during pregnancy.

Use the COOK can influence a lactation as the quantity can decrease and be changed players of milk. Thus, application the COOK generally is not recommended while the child is nursed still. A small amount of contraceptive steroids and/or their metabolites can get into breast milk and have negative effect on health of the child.

Drivers

it was Not established influences on ability to steer motor transport or other mechanisms at the patients receiving the medicine "Klayra".

Overdose

Is not present messages about serious consequences of overdose of Klayr.

Symptoms which can be observed at overdose of the tablets containing hormones: nausea, vomiting, young girls have an insignificant vaginal bleeding. There are no specific antidotes, and further treatment has to be symptomatic.

Side effects

Most frequent side reactions which were observed at use of the medicine "Klayra" as an oral contraceptive or as therapies of heavy menstrual bleedings women without organic pathology which appointed orally contraceptions had an acne, discomfort in mammary glands, a headache, intermenstrual bleedings, nausea and increase in body weight. Serious side reactions are an arterial and venous thrombembolia.

to Store

at a temperature not above 30 °C, out of children's reach.

Expiration date - 5 years.