Livial, pills 2.5mg, 28pcs

Composition

Active ingredient:

Tibolone 2.5 mg;

Auxiliary substances:

Potato starch;

Magnesium stearate;

Ascorbyl palmitate;

Lactose;

Purified water.

Pharmacological action

With the cessation of menstruation, both due to natural causes and after removal of the ovaries, the postmenopausal period begins, characterized by a significant decrease in the body of female sex hormones, primarily estrogens. In turn, estrogen deficiency causes the appearance of such postmenopausal (climacteric) symptoms as, for example, hot flashes, night sweats, mood changes, depression, irritability, dryness and discomfort in the vagina, decreased libido, etc. The consequence of estrogen deficiency is also accelerated bone loss during postmenopause – osteoporosis develops, resulting in more frequent fractures. To a greater extent, this applies to the spine, femur, forearm and wrist bones. In addition, osteoporosis can also cause back pain, weight loss, and curvature of the spine. The drug Livial belongs to the group of drugs used in the so-called hormone replacement therapy (HRT) and is used to treat postmenopausal symptoms. If you are 60 years old or older, you should only use Livial if you cannot use other HRT medications. Relief of symptoms usually begins within a few weeks, but optimal results are achieved after three months of treatment. If your risk of developing postmenopausal osteoporosis increases when other drugs for treating osteoporosis are not suitable for you, you can also use Livial. Unlike other types of hormone replacement therapy, the drug Livial does not have a stimulating effect on the endometrium. Therefore, treatment with Livial does not lead to monthly bleeding from the vagina.

Indications

Contraindications

• Hormone-dependent tumor;
• Thrombophlebitis;
• Vaginal bleeding.

Side effects

Often observed in clinical studies, side effects (occurring in 1-10% of women taking Livial) may include: :

• Pain in the lower abdomen;
• Spotting/ bleeding from the vagina;
• Increased mucosal discharge from the vagina;
• Weight gain;
• Soreness in the mammary glands;
• Increased hair growth, including on the face;
• Vaginal discomfort, such as discharge, itching, and irritation.

An infrequent side effect (which occurred in 0.1-1% of women taking Livial) is:

• Acne;
• Mastodynia.

Other possible side effects may include:

• Dizziness, headache, and migraines.
• Depression.
• Skin rashes or itchy skin.
• Vision disorders;
• Gastrointestinal disorders (diarrhea, flatulence);
• Fluid retention in the body, the appearance of puffiness;
• Joint pain, muscle pain;
• Impaired liver function.

Interaction

Concomitant use of Livial with anticoagulants may increase the effect of the latter (a decrease in the level of fibrinogen, an increase in the concentration of antithrombin III, plasminogen, and an increase in plasma fibrinolytic activity).

The metabolism of Livial may be accelerated, and therefore its activity may decrease with simultaneous use of drugs that induce enzymatic systems.

How to take, course of use and dosage

Inside, at the same time, with water or a drink.

The drug Livial® is taken 1 tablet 1 time a day. Blisters are marked with days of the week. You should start taking the drug by taking the pill marked on the current day.

For example, if the day of admission coincides with Monday, then you need to take the pill marked Monday from the top row of the blister. Then you should take the pills according to the days of the week. From the next blister, tablets are taken without skipping or interruptions.

Do not skip taking tablets between blisters or packages!

The drug Livial® it should not be taken in the period before 12 months after the last natural menstruation. If you start taking Livial® earlier than the indicated time, the likelihood of irregular spotting/bleeding from the vagina increases.

In case of any side effects, you should immediately consult a doctor.

If the woman forgot to take the drug Livial®

If a woman has forgotten to take a pill, then you should take it as soon as she remembers, but not later than 12 hours. If the pill is overdue for more than 12 hours, then you must skip it.

Do not take a double dose to make up for a missed individual dose.

Overdose

Possible symptoms include feeling unwell, nausea, and vaginal bleeding.

Special instructions

The drug Livial is not intended for use as a contraceptive and does not protect against unwanted pregnancy.

The decision to start taking Livial should be based on an assessment of the benefit/risk ratio, taking into account all individual risk factors, and in women over 60 years of age, an increased risk of stroke should also be taken into account.

For the treatment of postmenopausal symptoms, the drug Livial should be prescribed only for symptoms that adversely affect the quality of life. In all cases, a thorough assessment of the risk and benefit of therapy should be carried out at least once a year, and therapy with Livial should be continued only during the time period when the benefit of therapy exceeds the risk.

The risk of stroke, breast cancer, and endometrial cancer should be carefully evaluated for each woman with an intact uterus, taking into account all individual risk factors, the frequency of occurrence, and the characteristics of both cancers and stroke in terms of curability, morbidity, and mortality.

Evidence for the relative risk associated with HRT or the use of tibolone to treat premature menopause is limited. However, the benefit / risk ratio in women with premature menopause may be more favorable than in older women, due to the low absolute risk level in younger women.

Medical examination/follow-up

Before starting or resuming therapy with Livial, an individual and family medical history should be collected.

Physical examination (including examination of the pelvic organs and mammary glands) should be carried out taking into account the anamnesis, absolute and relative contraindications. During therapy, preventive repeated examinations are recommended, the frequency and nature of which are determined by the individual characteristics of the patient, but at least once every 6 months. In particular, the woman should be informed about the need to inform the doctor about changes in the mammary glands.

Examinations, including appropriate imaging techniques, such as mammography, should be performed in accordance with the currently accepted examination scheme, adapted to the clinical needs of each patient, but at least once every 6 months.

Reasons for immediate discontinuation of therapy and immediate medical attention

Therapy should be discontinued if a contraindication is detected and/or if the following conditions/diseases occur: :

• jaundice or deterioration of liver function;
• sudden increase in blood pressure, which differs from the usual blood pressure indicators characteristic of the patient;
• the occurrence of a migraine-type headache.

Endometrial hyperplasia and cancer

Data from randomized controlled clinical trials are contradictory, but observational studies have shown an increased risk of endometrial hyperplasia or cancer in women taking Livial. These studies have shown that the risk of developing endometrial cancer increases with increasing duration of use of the drug. Tibolone can increase the thickness measured by transvaginal ultrasound.

Breakthrough bleeding and spotting may occur during the first months of treatment.

If you experience spotting/bleeding during the use of the drug Livial, which lasts more than 6 months from the start of taking the drug or begins 6 months after the start of using the drug Livial and continues even after the patient has stopped using the drug Livial, you should consult a doctor – this may be a sign of endometrial hyperplasia.

Breast cancer

Data from various clinical studies from the point of view of evidence-based medicine regarding the risk of developing breast cancer when taking tibolone are contradictory, and further research is required.

According to the Million Women Study, a significant increase in the risk of breast cancer was found with a 2.5 mg dose. This risk became apparent after several years of use of the drug and increased with increasing duration of use, returning to the baseline level several years (more often 5 years) after discontinuation of the drug.

These results were not confirmed in a study using the General Practice Research Database (GPRD).

Ovarian cancer

Ovarian cancer is significantly less common than breast cancer. Long-term (at least 5-10 years) estrogen replacement monotherapy was associated with a slight increase in the risk of ovarian cancer.

Some studies, including the Women’s Health Initiative (WHI) study, suggest that long-term therapy with combination medications for HRT may have a similar or slightly lower risk.

In the” Million Women Study”, it was shown that the relative risk of developing ovarian cancer with tibolone was similar to the risk associated with other types of HRT.

Venous thromboembolism

Oestrogen-only HRT medications, or combined HRT medications containing oestrogen and progestogen, may increase the risk of venous thromboembolism (VTE) (i. e. deep vein thrombosis or pulmonary embolism) by 1.3-3 times, especially during the first year of using HRT medications.

According to an epidemiological study using UK databases, the risk of developing VTE associated with taking tibolone was lower than the risk associated with conventional HRT, but since only a small proportion of women were taking tibolone at that time, a slight increase in risk cannot be excluded compared to women who did not take tibolone.

Patients with known thrombophilic conditions have an increased risk of developing VTE, and taking Livial may increase this risk, so the use of the drug in this patient population is contraindicated.

Risk factors for VTE include estrogen use, advanced age, extensive surgery, prolonged immobilization, obesity (body mass index (BMI) > 30 kg/m2), pregnancy and the postpartum period, systemic lupus erythematosus, and cancer.

In patients after surgical interventions, special attention should be paid to preventive measures to prevent VTE in the postoperative period. If prolonged immobilization is necessary after surgery, it is recommended to temporarily stop taking Livial 4-6 weeks before surgery. Treatment should not be resumed until the woman regains motor activity.

Women who do not have a history of VTE, but who have first-degree relatives who have a history of thrombosis at a young age, may be offered screening (the woman should be informed that screening reveals only a fraction of thrombophilic conditions). If a thrombophilic condition is detected that is separate from thrombosis in relatives, or a serious disorder (for example, a deficiency of antithrombin, protein S, protein C, or a combination of disorders), taking Livial is contraindicated.

For women who are already receiving anticoagulant treatment, careful consideration should be given to the benefit/risk ratio of HRT or tibolone.

If VTE develops after starting treatment, the drug should be discontinued. Patients should be informed about the need to see a doctor immediately if symptoms of potential thromboembolism appear (for example, pain and unilateral swelling of the lower limb, sudden chest pain, shortness of breath).

Coronary heart disease (CHD)

In randomized controlled trials, there was no evidence of protection against myocardial infarction in women with or without CHD who received HRT with combined medications (oestrogen/progestogen) or oestrogen-only HRT medications.

Epidemiological studies using the GPRD database did not provide evidence of protection against myocardial infarction in postmenopausal women treated with tibolone.

Ischemic stroke

Therapy with Livial increases the risk of ischemic stroke, starting from the first year of use. The absolute risk of stroke strictly depends on age, and, therefore, the greater the effect of tibolone, the greater the age.

If you experience unexplained migraine-like headaches with or without visual impairment, you should consult a doctor as soon as possible. In this case, you should not take the drug until the doctor confirms the safety of continuing HRT, since such headaches can be an early diagnostic sign of a possible stroke.

Other states

According to available data, treatment with Livial resulted in a significant dose-dependent reduction in HDL cholesterol (from -16.7% at a dose of 1.25 mg to -21.8% at a dose of 2.5 mg after 2 years of use).

Total triglyceride and lipoprotein concentrations also decreased. The decrease in total cholesterol and VLDL cholesterol was not dose-dependent. LDL cholesterol concentrations did not change. The clinical significance of these data is still unknown.

Estrogens can cause fluid retention, so patients with heart or kidney failure should be carefully monitored by a doctor.

Women with pre-existing hypertriglyceridemia should be carefully monitored by a doctor during therapy with Livial, as rare cases of significant increases in plasma triglycerides that contribute to the development of pancreatitis have been reported during estrogen therapy for this condition.

Treatment with Livial leads to a very small decrease in thyroxine-binding globulin (TSG) and total T4. The level of total T3 does not change. Livial reduces the level of sex hormone binding globulin (SHBG), while the levels of corticosteroid-binding globulin (CSG) and circulating cortisol do not change.

The use of HRT medications does not improve cognitive function. There is evidence of an increased risk of possible dementia in women who start continuous therapy with combined HRT medications or oestrogen-only HRT medications after the age of 65.

Form of production

Pills.

Storage conditions

The drug should be stored in a dry place protected from light at a temperature of 2° to 25°C.

Shelf

life is 2 years.

Active ingredient

Tibolon

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For postmenopausal women

Indications

From estrogen deficiency