Livial

Livial – anticlimacteric means.

Form of release and structure

Dosage form – tablets: a round flat form with slanted edges, almost white or white color, with an engraving on both parties: on one – figure "2" under the MK code, on another – a five-pointed star with a text of "ORGANON" (on 28 pieces in blisters, and in a cardboard pack 1 or 3 blisters).

Active ingredient of Livial – тиболон, in 1 tablet – 2,5 mg.

Auxiliary components: potato starch, lactose, offended palmitate, the water purified (in the course of production is removed), magnesium stearate.

Indications to use

Livial's use is shown to women in the postmenopause period:

• Treatment of signs of oestrogenic insufficiency;
• Prevention of osteoporosis at patients with high risk of developing of fractures at intolerance of medicines of other groups intended for the prevention of osteoporosis.

Contraindications

• The breast cancer, malignant estrogenzavisimy tumors, including endometrial cancer (diagnosed, including the anamnesis or assumed);
• Endometria hyperplasia in not treated state;
• Vulval bleedings of not clear etiology;
• Trombofilichesky states, including deficit of antithrombin, a protein of C or a protein of S;
• Arterial or venous fibrinferments, thromboembolisms, including in the anamnesis (including thrombophlebitis and a deep vein thrombosis, a myocardial infarction, hemorrhagic or ischemic cerebrovascular disturbances, a thromboembolism of a pulmonary artery);
• The stenocardia, the tranzitorny ischemic attacks and other states preceding thrombosis (now or in the anamnesis);
• Cardiovascular insufficiency in a decompensation stage;
• Uncontrollable arterial hypertension, fibrillation of auricles, subacute bacterial endocarditis and the complicated defeats of the valve device of heart, severe injury, long immobilization after an extensive operative measure, obesity (the index of body weight exceeds 30 kg on ^sq.m) and other numerous or expressed risk factors of emergence of arterial or venous thrombosis;
• The expressed disease of a liver or abnormal liver function;
• Liver new growths (including adenoma of a liver of a malignant or high-quality etiology, including the anamnesis);
• Liver failure;
• The otosclerosis which arose against the background of reception of hormonal contraceptives or during the previous pregnancy in the anamnesis;
• Porphyria;
• Intolerance of a galactose, glyukozo-galaktozny malabsorption, insufficiency of lactase;
• Period of pregnancy and breastfeeding;
• The period from the moment of the last periods less than 1 year;
• The confirmed hypersensitivity to drug components.

With care it is necessary to appoint Livial at bronchial asthma, fibroma of a uterus (leiomyoma) and/or endometriosis, controlled arterial hypertension, cardiovascular insufficiency without signs of a decompensation, cholelithiasis, existence of risk factors of estrogenzavisimy tumors (a breast cancer at mother or the sister), a renal failure, increase in level of concentration of cholesterol in blood, disturbance of carbohydrate metabolism, a diabetes mellitus (with complications or without), a system lupus erythematosus, migraine or a severe headache, an endometria hyperplasia in the anamnesis, epilepsy, the otosclerosis which is not connected with pregnancy or reception of hormonal contraceptives.

Careful observation of the doctor is necessary if the specified pathologies took place in the anamnesis of the patient or recured and became aggravated during Livial's reception.

Route of administration and dosage

It is impossible to begin Livial's use before the 12-month period from the moment of the last menstrual bleeding! If at the woman against the background of reception of other hormonal drug or without it bloody allocations take place, then prior to therapy it is necessary to be convinced of lack of malignant new growths of generative organs.

If the previous zamenitelny hormonal therapy had the cyclic mode of use, Livial's reception is begun next day after end of the previous scheme of treatment. Upon transition from the combined means for zamenitelny hormonal therapy with the continuous mode of reception therapy can be begun at any convenient time.

Pill is taken inside, swallowing entirely and washing down with a small amount of water.

The drug dosing makes 1 tablet a day which should be accepted every day in at one time. Use is begun with a tablet in the blister of the week corresponding to the present day and further follow on the days of the week specified on packaging. Reception from the new blister needs to be begun next day after the termination of tablets in previous. It is impossible to allow the admission in reception of the following tablet or delay in time.

At accidental delay of reception of the next tablet less than for 12 hours drug should be accepted urgently. If delay makes more than 12 hours, then reception it is necessary to pass and take the following pill from the blister at the scheduled time. It is impossible to accept a double dose of drug.

During treatment it is not necessary to appoint reception of gestagen in addition.

Side effects

Livial's use has the following side effects:

• Reproductive system and mammary glands: often – mammary gland pain, allocations (including bloody) or bleedings from a vagina, an endometria thickening, a vulvovaginitis and a candidosis vulvovaginitis, a genital itch, pain in pelvic area, a dysplasia of a neck of uterus; infrequently – a nagrubaniye of mammary glands, mycosis, morbidity of nipples;
• Digestive tract: often – pain in the bottom of a stomach;
• Skin and hypodermic fabrics: often – strengthening of growth of hair, including on a face; infrequently – an acne;
• Laboratory and tool indicators: often – disturbance of cytologic characteristics of a cervical epithelium, increase in body weight;
• Others: frequency is unknown – a depression, a headache, dizziness, migraine, a skin itch and rashes, seborrheal dermatitis, gastrointestinal frustration (a meteorism, diarrhea), vision disorders (including a sight illegibility), peripheral hypostases, a liquid delay in an organism, joint and muscular hurt, functional disturbances of a liver, increase in activity of liver enzymes.

Therapy by the drugs containing only тиболон or it is oestrogenic, it is accompanied by the increased risk of development in women of a breast cancer, but it is much lower, than in case of use of the combined hormonal means. The risk degree depends on therapy duration. Reception estrogen-gestagenykh of drugs increases more than 5 years the frequency of development of a breast cancer twice.

Livial's influence on increase in probability of development of endometrial cancer is confirmed.

Against the background of hormonal therapy the risk of emergence of an ischemic stroke increases more than twice, and degree of its probability raises in process of aging of the patient.

At patients, especially in the first year of treatment, development of a venous thromboembolism, including a deep vein thrombosis and a thromboembolism of a pulmonary artery is possible.

At long reception of a tibolon there is a relative risk of diagnosing of ovarian cancer.

Use of drug can lead to emergence of coronary heart disease (at women 60 years are more senior), a myocardial infarction, cholelithiasis, cholecystitis, skin pathologies in the form of a hloazma, a mnogoformny and knotty erythema, a vascular purpura; dementias – at an initiation of treatment after 65 years.

Special instructions

Livial is not contraceptive means.

The decision on use of drug has to be made taking into account all risk factors and on condition of considerable exceeding of advantage of therapy in the ratio to big risk of development of side effects, including at women 60 years are more senior than strokes.

Only in case of negative influence of symptoms of oestrogenic insufficiency on quality of life purpose of drug is made.

At purpose of drug the doctor has to inform in detail the woman on all risks connected with administration of drug including probability of oncological pathologies.

Assessment of advantage and risk of therapy should be carried out once a year. On the basis of results of assessment make the decision on the termination or continuation of further use of drug as development of side effects, including oncological diseases, is in direct dependence on duration of therapy and age of the woman.

Primary purpose or resuming of therapy is made on the basis of the detailed family and individual anamnesis of the woman, physical inspection of mammary glands and bodies of a small pelvis, taking into account all contraindications. Routine inspections (including mammography) during treatment are performed 2 times a year. The patient has to inform the doctor on the slightest changes in mammary glands.

Livial it is necessary to cancel in case of detection of contraindications, and also at jaundice and an abnormal liver function, sudden increase in arterial pressure to indicators uncharacteristic for the patient, a severe headache similar to migraine.

The probability of development of cancer and hyperplasia of an endometria increases in proportion to duration of reception of a tibolon. In case of emergence against the background of administration of drug long (up to 6 months) the bloody allocations or bleedings proceeding even after phase-out of Livial it is necessary to conduct examination of the woman regarding an endometria hyperplasia.

The risk of development of a breast cancer becomes explicit after several years of therapy, increases in process of increase in its duration and is returned to initial level after phase-out in 5 years (these data demand carrying out further researches).

At appointment it is necessary to consider the existing relative risk of development of ovarian cancer.

The doctor has to pay special attention at purpose of drug to women who in the absence of a venous thromboembolism in the anamnesis have relatives of the first degree of relationship with this pathology. If against the background of treatment development of a venous thromboembolism is noted, it is necessary to stop administration of drug. The doctor has to warn the patient about need of the immediate appeal to medical institution at emergence of unilateral hypostasis and pain of the lower extremities, an asthma, a stethalgia.

Against the background of therapy there is a potential threat of a myocardial infarction both at women with coronary heart disease, and without it.

The threat of an ischemic stroke arises from first year of therapy, the risk depends on age of the patient. Therefore at emergence of a migrenepodobny headache with a vision disorder or without it it is necessary to stop temporarily Livial's reception and to see urgently a doctor for confirmation of safety of further therapy.

Administration of drug within 2 years leads to considerable decrease in cholesterol of lipoproteins of high density, triglycerides and a lipoprotein.

At treatment of patients with renal or heart failure it is necessary to consider that effect of drug causes a liquid delay in an organism.

Exceptional cases of essential growth of level of triglycerides in a blood plasma are celebrated, it should be considered at purpose of drug to patients with a gipertriglitseridemiya and to carefully control their state regarding possible development of pancreatitis.

Livial reduces the level of the tiroksinsvyazyvayushchy globulin, the general T4 hormone and globulin connecting sex hormones.

Influence of drug on cognitive function increases risk of development of dementia, especially at women 65 years are more senior.

Medicinal interaction

In need of simultaneous use of Livial with other drugs it is necessary to consult with the attending physician to avoid development of undesirable effects.

Terms and storage conditions

To store in the place protected from light at a temperature from 2 to 25 °C. To protect from children.

Period of validity – 2 years.