Klayra tablets 3mg, No. 84

oral contraception;

oral contraception and treatment of heavy and / or prolonged menstrual bleeding without organic pathology.

Inside, regardless of the meal.

The tablets should be taken in the order indicated on the package every day at approximately the same time, with water or other liquid if necessary. The pills are taken continuously. It should be taken one tablet a day consecutively for 28 days. Each new pack is started after the last tablet from the previous calendar pack is taken. Menstrual bleeding usually begins while taking the last pills of the calendar pack and may not end until the next calendar pack starts. In some women, menstrual bleeding begins after taking the first pills from a new calendar pack.

Preparing a clamshell book

In order to monitor the intake of pills, 7 stickers with the names of 7 days of the week are attached to the package.

It is necessary to choose a sticker that begins on the day of the week on which the woman starts taking the pills. For example, if your appointment starts on Wednesday, you should use a sticker that starts with the word 'CP'.

The sticker is applied to the upper part of the folding package of the KlayraЃ preparation, where the inscription 'Stick the calendar here' is located, so that the name of the first day is above the tablet with the number '1'.

Now, above each pill, there is the name of the corresponding day of the week, and you can see whether the pill has already been taken on a particular day or not. It is necessary to follow the direction of the arrow on the clamshell book until all 28 tables are accepted.

Usually, the so-called menstrual bleeding begins during the period of taking the second dark red pill or white pills and may not be over before the next pack is started. For some women, bleeding continues after taking the first pills from a new package.

The next package is started without interruption, i.e. the day after the current packaging is finished, even if the bleeding has not stopped. This means that the next pack should start on the same day of the week as the current one, and that menstrual bleeding should occur every month on the same days of the week.

If the drug KlayraЃ is used as indicated in the description, the woman is protected from unwanted pregnancy even during those 2 days when she takes inactive pills.

If hormonal contraception has not been used previously (in the previous month)

The tablets begin to be taken on the 1st day of a woman's natural menstrual cycle (i.e., the 1st day of menstrual bleeding).

Changing from another combined hormonal contraceptive (another PDA, vaginal ring, or transdermal patch)

A woman should start taking KlayraЃ the next day after the last active tablet (tablet containing active substances) from the package of the previous PDA has been drunk. When using a vaginal ring or transdermal patch, a woman should start taking KlayraЃ on the day they are removed.

When switching from contraceptives containing only progestogen (mini-pills, injection, implant) or progestogen-releasing intrauterine system (IUD)

A woman can switch to taking KlayraЃ from a mini-drink on any day (from an implant or IUD - on the day of their removal; from an injection method - on the day on which the next injection is scheduled), but in all cases during the first 9 days of admission tablets, it is recommended to additionally use a barrier method of contraception.

After an abortion in the first trimester of pregnancy

The woman can start taking the pills immediately. In this case, there is no need for additional contraceptive measures.

After childbirth, in the absence of breastfeeding or abortion in the second trimester of pregnancy

A woman should be advised to start taking pills on the 21-28th day after childbirth, in the absence of breastfeeding or abortion in the second trimester of pregnancy. If a woman started taking pills later, then she is recommended to additionally use a barrier method of contraception during the first 9 days of taking the pills. However, if sexual intercourse has already taken place, pregnancy must be excluded before the actual start of taking KlayraЃ, or the woman should wait for the onset of the first menstruation.

Taking missed pills

The missed (white) inactive tablets are negligible. However, they should be thrown away to avoid unintentionally prolonging the interval between taking active pills.

The following tips are solely for skipping active pills

If the delay in taking any of the tablets is less than 12 hours, contraceptive protection is not reduced. A woman should take the missed pill as soon as she remembers it, and take the rest of the pills at the usual time.

If the delay in taking any of the pills is more than 12 hours, contraceptive protection may be reduced. A woman should take the last missed pill as soon as she remembers this, even if it means that she will have to drink 2 tablets. at the same time. Then you must continue to take the pills at the usual time.

Depending on the day of the menstrual cycle in which the pill was missed (see table 1 for more details), additional contraceptive measures are required (for example, a barrier method of contraception, in particular condoms) in accordance with the following recommendations:

Table 1

Principles for handling missed pills

It is allowed to take no more than 2 tables. one day.

If a woman forgot to start a new calendar pack or missed one or more tablets from the 3rd to the 9th day of the calendar pack, she may already be pregnant (if she had sexual intercourse within 7 days before the tablet was missed). The more pills (especially with a combination of two active ingredients on days 3 to 24) are missed and the closer they are to the inactive pill phase, the higher the likelihood of pregnancy.

If a woman missed pills and then had no menstrual bleeding at the end of the calendar pack / at the beginning of the new calendar pack, the likelihood of pregnancy should be considered.

Recommendations for gastrointestinal disorders

If, after taking any of the 26 active tablets of KlairaЃ, a woman begins to vomit or severe diarrhea, the absorption of the active substances may be incomplete. If vomiting occurs 3-4 hours after taking the pill, it is tantamount to missing the pill. Therefore, in this case, you should take into account the information specified in the section Taking missed pills. Vomiting or diarrhea on the days of taking the last 2 inactive pills do not have any effect on the effectiveness of contraception.

How to stop taking KlayraЃ

You can stop taking KlayraЃ at any time. If a woman is not planning a pregnancy, other methods of contraception should be taken care of. If pregnancy is planned, you should simply stop taking KlayraЃ.

Additional information for specific patient groups

Application in children and adolescents. There are no data on the efficacy and safety on the use of the drug in girls under the age of 18 years.

Elderly patients. Not applicable. KlayraЃ is not indicated after menopause.

Patients with impaired liver function. The drug KlayraЃ is contraindicated in women with severe liver disease until the liver function indicators return to normal (see 'Contraindications').

Patients with impaired renal function. The drug KlayraЃ has not been specifically studied in patients with impaired renal function. The available data do not suggest a dosage adjustment in these patients.

KlayraЃ should not be used in the presence of any of the conditions listed below. The drug should be stopped immediately if any of these conditions develop for the first time while taking it:

hypersensitivity to active substances or any of the excipients;

thrombosis (venous and arterial) and thromboembolism currently or in history (including deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction (MI), current or history of stroke);

conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history;

identified acquired or hereditary predisposition to venous or arterial thrombosis, including resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant);

the presence of a high risk of venous or arterial thrombosis (see 'Special instructions');

migraine with focal neurological symptoms, incl. history;

diabetes mellitus with vascular complications;

pancreatitis with severe hypertriglyceridemia at present or in history;

liver failure and severe liver disease (before normalization of liver function indicators);

liver tumors (benign and malignant), currently or in history;

identified hormone-dependent malignant tumors (including genitals or mammary glands) or suspicion of them;

vaginal bleeding of unknown origin;

pregnancy or suspicion of it;

breastfeeding period;

lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

WITH CAUTION

If any of the diseases / conditions / risk factors listed below are currently available, then the potential risk and the expected benefit of using the KlayraЃ drug in each individual case should be carefully correlated:

risk factors for the development of thrombosis and thromboembolism (smoking; obesity; dyslipoproteinemia; arterial hypertension; migraine; heart valve disease; heart rhythm disturbances; extensive surgical interventions without prolonged immobilization);

other diseases in which peripheral circulation disorders may occur (diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia);

hereditary angioedema;

hypertriglyceridemia;

diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (for example, cholestatic jaundice, cholestatic pruritus, cholelithiasis, otosclerosis with hearing impairment, porphyria, herpes of pregnant women, Sydenham's chorea);

postpartum period.