tablets "Espa-tibol" are applied to treatment of symptoms of deficiency of estrogen at women in a postmenopause if the menopause came more than a 1 years ago.

Decision on purpose of a tibolon has to be based on assessment of individual risk factors; appointing patients aged from 60 years, it is necessary to take risk of developing of a stroke into account.

Structure

Active ingredient - tibolon (one tablet supports a tibolon of 2.5 mg).

Excipients: potato starch, magnesium stearate, ascorbyl palmitate, lactoses monohydrate.

Contraindication

• hypersensitivity to active agent or to any of excipients;
• pregnancy and period of feeding by a breast;
• suspicion of a breast cancer, its existence now or in the anamnesis (medicament increased risk of a recurrence of a breast cancer in placebo - a controlled research);
• suspected or available estrogenzavisimy tumors (for example endometrial cancer);
• vaginal bleeding of not clear etiology;
• not treated hyperplasia of endometrium;
• a venous thrombembolia in the anamnesis or now (a deep vein thrombosis, an embolism of pulmonary vessels);
• arterial thromboembolic diseases in the anamnesis (for example stenocardia, a myocardial infarction, a stroke or tranzitorny ischemic disturbance of cerebral circulation);
• an acute disease of a liver or a disease of a liver in the anamnesis, before normalization of indicators of hepatic tests;
• porphyria.

Route of administration

Recommended dose makes one tablet a day. There is no need for dose adjustment for patients of advanced age. To take a pill, washing down with a small amount of water or other drinks, it is desirable at the same time day. For a start and continuations of treatment at symptoms of a postmenopause it is necessary to apply the smallest effective dose during the short span. At the Espa-tibol medicament treatment it is not necessary to apply progestogens separately.

Beginning of use of the medicament "Espa-tibol". Women with a natural menopause are recommended to begin the Espa-tibol medicament treatment not earlier than in 12 months after the last natural bleeding. In case of the menopause which came after surgical intervention, the Espa-tibol medicament treatment can be begun at once.

before administration of medicament of Espa-tibol for an exception of a malignant new growth.

Feature of use

Drivers

Drug does not influence speed of response at control of motor transport or work with other mechanisms.

Overdose

Acute toxicity of a tibolon at animals very low. Therefore emergence of symptoms of toxicity, even is expected at reception of several tablets at the same time. At acute overdose the woman can have a nausea, vomiting and vaginal bleeding. Specific antidote does not exist. If necessary it is necessary to carry out symptomatic therapy.

undesirable reactions Provided below were registered by

during the 21st placebo - a controlled research (including the researches LIFT), with the assistance of 4079 women receiving therapeutic doses of a tibolon (1.25 or 2.5 mg) and also 3476 women receiving placebo. Treatment duration at these researches fluctuated from 2 months to 4.5 years.

is given Below the undesirable reactions arising at treatment tibolon are given it is considerable more often than at intake of placebo.

from digestive tract: often (> 1%, <10%) - pain in the lower part of a stomach.

from skin and hypodermic fabric: often (> 1%, <10%) - the pathological growth of hair.

from a reproductive system and mammary glands: often (> 1%, <10%) - vaginal discharges, a thickening of walls of endometrium, post-menopausal bleeding, sensation of discomfort in mammary glands, an itching of genitals, vaginal candidiasis, vaginal bleeding, pain in the field of a basin, a dysplasia of a neck of the uterus, a vulvovaginitis.

Inspection: often (> 1%, <10%) - increase in body weight, pathological results of a smear from a neck of the uterus.

Storage conditions

to Store

at a temperature not above 25 °C, out of children's reach.

Expiration date - 30 months.