Leia tablets 3 + 0.02mg, No. 84

contraception;

contraception and treatment of moderate acne (acne vulgaris);

contraception and treatment of severe premenstrual syndrome (PMS).

Inside, daily for 28 days without interruption, at approximately the same time, with a little water, in the order indicated on the blister package. Taking pills from a new package begins the day after taking the last tablet from the previous package.

How to take LeiaЃ

If you have not taken any hormonal contraceptives in the previous month. Taking LeiaЃ begins on the first day of the menstrual cycle (i.e. the first day of menstrual bleeding). It is allowed to start taking on the 2-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the pills from a new package. Withdrawal bleeding usually begins 2Ц3 days after you start taking the inactive pills and may not end before you start taking the pills from the new pack.

When switching from other combined oral contraceptives (COCs, vaginal rings or transdermal patch). It is preferable to start taking LeiaЃ the next day after taking the last active tablet from the previous package, but in no case later than the next day after the usual 7-day break (for drugs containing 21 active tablets) or after taking the last inactive tablet ( for preparations containing 28 tablets per package). Taking LeiaЃ should be started on the day the vaginal ring or contraceptive patch is removed, but no later than the day when a new ring is to be inserted or a new patch is glued on.

When switching from contraceptives containing only gestagens (mini-pills, injectable forms, implant or intrauterine contraceptive). A woman can switch from a mini-drink to taking LeiaЃ any day (without a break); from an implant or intrauterine therapeutic system that releases progestogen on the day of its removal; from an injectable contraceptive - on the day the next injection is to be made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills.

After an abortion in the first trimester of pregnancy A woman can start taking LeiaЃ from the first day after the abortion. If this condition is met, a woman does not need additional contraceptive measures.

After childbirth or abortion in the second trimester of pregnancy. It is recommended to start taking LeiaЃ on the 21-28th day after childbirth, in the absence of breastfeeding, or abortion in the second trimester of pregnancy. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills. However, if a woman has already had a sex life, pregnancy should be excluded before taking LeiaЃ.

Taking the missed pills. Skipping inactive pills can be ignored. However, they should be thrown away so as not to accidentally extend the period of taking inactive pills.

The following recommendations apply only to taking active tablets:

If the delay in taking the drug is less than 24 hours, contraceptive protection is not reduced. A woman should take the missed pill as soon as possible, and take the next at the usual time.

If the delay in taking the pills is more than 24 hours, contraceptive protection may be reduced. The more pills are missed and the closer the skip is to the inactive pill phase, the higher the likelihood of pregnancy.

In this case, you can be guided by the following basic rules:

- taking the drug should never be interrupted for more than 7 days (the recommended interval for taking inactive tablets is 4 days);

- to achieve adequate suppression of the gyrothalamic-pituitary-ovarian system, 7 days of continuous pill intake are required.

Thus, if the delay in taking the active tablets is more than 24 hours, the following can be recommended:

- from the 1st to the 7th day. A woman should take the last missed pill as soon as she remembers it, even if it means taking two pills at the same time. She continues to take the next pills at the usual time. In addition, over the next 7 days, you must additionally use a barrier method of contraception (for example, a condom). If sexual intercourse took place within 7 days before skipping the pill, the possibility of pregnancy should be taken into account;

- from the 8th to the 14th day. A woman should take the last missed pill as soon as she remembers it, even if it means taking two pills at the same time. The following tablets should be taken at the usual time. Provided that the woman took the pills correctly within 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as when skipping two or more pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days;

- from the 15th to the 24th day. The risk of reduced reliability is inevitable due to the approaching phase of taking inactive pills. A woman must strictly adhere to one of the following two options. Moreover, if in 7 days preceding the first missed pill, all pills were taken correctly, there is no need to use additional contraceptive methods. Otherwise, she needs to use the first of the following regimens and additionally use a barrier method of contraception (such as a condom) for 7 days:

- 1st option. The woman should take the last missed pill as soon as possible, as soon as she remembers (even if that means taking two pills at the same time). The next tablets are taken at the usual time, until the active tablets in the package run out. Discard the four inactive tablets and start taking the tablets from the next pack immediately. Withdrawal bleeding is unlikely until the active tablets in the second pack run out, but spotting and breakthrough bleeding may occur while taking the tablets.

- 2nd option. The woman can also stop taking the pills from the current pack. Then she should take a break for no more than 4 days, including the days of missing pills, and then start taking pills from a new package. If a woman missed taking active pills and while taking inactive pills there was no withdrawal bleeding, pregnancy must be excluded.

Recommendations for gastrointestinal disorders

In severe gastrointestinal disorders, the absorption of the drug may be incomplete, therefore additional contraceptive measures should be taken. If vomiting occurs within 4 hours after taking the active pill, you should be guided by the recommendations when skipping pills. If a woman does not want to change her usual dosage regimen and postpone the onset of menstruation to another day of the week, the additional active tablet should be taken from a different package.

Change in day of onset of menstrual bleeding

In order to delay the onset of menstrual bleeding, the woman should continue taking the tablets from the next package, skipping the inactive tablets from the current package. Thus, the cycle can be extended, if desired, for any period until the active tablets from the second pack run out. While taking pills from the second package, a woman may experience spotting or breakthrough uterine bleeding. Regular use of LeiaЃ is resumed after the end of the inactive pill phase.

In order to postpone the onset of menstrual bleeding to another day of the week, a woman should shorten the next phase of taking inactive pills by the desired number of days. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and will subsequently have spotting spotting and breakthrough bleeding while taking the second pack (as well as in the case when she would like to delay the onset of menstrual bleeding).

How to delay withdrawal bleeding

To delay the onset of menstruation, the woman should switch to taking the pills from the new LeiaЃ pack without taking the placebo pills.

This prolongation of the cycle can be continued until the active tablets of the second pack run out. During this extension, the woman may experience breakthrough bleeding or spotting. In the future, you should resume regular use of LeiaЃ after the usual interval without taking pills, which is 7 days. To move the onset of menstruation to another day more suitable for a woman's usual schedule, you can shorten the second phase of taking placebo pills for as many days as necessary. The shorter this phase, the higher the risk that withdrawal bleeding will not develop and breakthrough bleeding or spotting will occur while taking the pills from the second pack (as well as when menstruation is delayed).

Special patient groups

Children and adolescents. LeiaЃ is indicated only after the onset of menarche. Available data do not suggest dose adjustment in this patient population.

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

Liver disorders. LeiaЃ is contraindicated in women with severe liver disease until the liver function indicators return to normal (see 'Contraindications' and 'Pharmacodynamics').

Kidney disorders. LeiaЃ is contraindicated in women with severe renal failure or acute renal failure. (See 'Contraindications' and 'Pharmacodynamics').

Taking LeiaЃ is contraindicated in the presence of any of the conditions listed below; if any of these conditions occurs for the first time during treatment with COCs, they should be stopped immediately.

hypersensitivity to any component of LeiaЃ;

lactose intolerance, lactase deficiency, glucose-galactose malabsorption (contains lactose monohydrate);

thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction), cerebrovascular disorders (including history);

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

hereditary or acquired predisposition to the development of venous or arterial thrombosis, such as resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, and antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant);

migraine with focal neurological symptoms at present or in history;

multiple or severe risk factors for venous or arterial thrombosis, incl. complicated lesions of the valvular apparatus of the heart, atrial fibrillation; diseases of the vessels of the brain or coronary arteries: uncontrolled arterial hypertension; severe dyslipoproteinemia, diabetes mellitus with vascular complications, serious surgery with prolonged immobilization; smoking and over 35 years of age; obesity with a body mass index (BMI) over 30 kg / m2; extensive trauma;

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

liver tumors (benign or malignant), incl. history;

severe renal failure, acute renal failure;

adrenal insufficiency;

pancreatitis, incl. a history of severe triglyceridemia;

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

vaginal bleeding of unspecified etiology;

pregnancy or suspicion of it;

period of breastfeeding.

Carefully:

If the patient has any of the conditions / risk factors listed below, the potential risk and the expected benefit of using COCs, including LeiaЃ, should be carefully weighed.

risk factors for the development of thrombosis and thromboembolism: smoking, thrombosis (including in history), myocardial infarction or cerebrovascular accident at a young age in one of the closest relatives; obesity with a BMI less than 30 kg / m2; dyslipoproteinemia; controlled arterial hypertension; migraine without focal neurological symptoms; heart valve disease without complications; violation of the heart rhythm;

other diseases in which peripheral circulatory disorders may occur: diabetes mellitus; systemic lupus erythematosus; hemolytic uremic syndrome; Crohn's disease and ulcerative colitis; sickle cell anemia; as well as phlebitis of superficial veins;

hereditary angioedema;

hypertriglyceridemia;

liver disease;

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

postpartum period.