Livial, tablets 2.5mg 28 pcs

With the cessation of menstruation, both due to natural causes and after removal of the ovaries, the period of postmenopause begins, characterized by a significant decrease in the female sex hormones in the body, especially estrogens. In turn, estrogen deficiency causes postmenopausal (menopausal) symptoms such as hot flashes, night sweats, mood changes, depression, irritability, vaginal dryness and discomfort, decreased libido, etc.

A consequence of estrogen deficiency is the accelerated loss of bone tissue during postmenopause – osteoporosis develops, resulting in more frequent fractures. This affects the spine, femur, forearm and wrist bones to a greater extent. In addition, osteoporosis may also cause back pain, weight loss and curvature of the spine.

Livial belongs to a group of drugs used in so-called hormone replacement therapy (HRT) and is used to treat postmenopausal symptoms. If you are 60 or older, you should use Livial only if other OHT drugs are not available. Relief of symptoms usually begins after several weeks, but optimal results are achieved after three months of treatment.

If there is an increased risk of osteoporosis in postmenopause in cases when other osteoporosis drugs are not suitable for you, Livial can also be used.

Unlike other types of hormone replacement therapy, Livial has no stimulating effect on the endometrium. That is why treatment with Livial does not cause monthly bleeding from the vagina.

Indications

Active ingredient

Composition

Active ingredient:

Tibolone 2.5 mg;

Associates:

Potato starch;

Magnesium stearate;

Ascorbyl palmitate;

Lactose;

Purified water.

How to take, the dosage

To be taken by mouth at the same time with water or a drink.

Livial® is taken 1 tablet once a day. The blisters are labeled with the days of the week. You should start taking the drug with the tablet marked for the current day.

For example, if the day of taking the drug is Monday, you need to take the tablet marked Monday, from the top row of the blister. Then take the tablets according to the days of the week. From the next blister, the tablets are taken without skipping or interruption.

The tablets should not be skipped between blisters or packs!

Livial® should not be taken until 12 months after your last natural menstrual period. If Livial® is started before this time, there is an increased chance of irregular bleeding/bleeding from the vagina.

If any side effects occur, consult a physician immediately.

If a woman forgets to take Livial®

If a woman forgets to take a pill, she should take it as soon as she remembers, but no later than 12 hours later. If the pill is more than 12 hours overdue, it should be skipped.

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

Interaction

In concomitant administration of Livial with anticoagulants, the effect of the latter may be enhanced (decreased fibrinogen levels, increased concentration of antithrombin III, plasminogen and increased plasma fibrinolytic activity).

Livial metabolism may be accelerated, and, consequently, its activity may be reduced when concomitant administration of drugs that induce enzyme systems.

Special Instructions

Livial is not intended for use as a contraceptive and does not protect against unintended pregnancy.

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

For the treatment of postmenopausal symptoms, Livial should be prescribed only for symptoms that adversely affect quality of life. In all cases, the risks and benefits of therapy should be carefully evaluated at least once a year, and therapy with Livial should be continued only for as long as the benefit of therapy is greater than the risk.

The risk of stroke, breast cancer, and endometrial cancer in every woman with an intact uterus should be carefully evaluated, considering all individual risk factors, incidence, and characteristics of both cancers and stroke in terms of cure rate, morbidity, and mortality.

The evidence for the relative risk associated with MHT or the use of tibolone for the treatment of premature menopause is limited. However, the benefit/risk ratio in women with premature menopause may be more favorable than in older women because of the low absolute risk in younger women.

Medical examination/surveillance

A personal and family medical history should be taken before starting or resuming therapy with Livial.

The physical examination (including pelvic and mammary gland examinations) must take into account medical history and absolute and relative contraindications. During therapy, preventive follow-up 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 must be informed about the need to report changes in the mammary glands to the doctor.

The examinations, including appropriate imaging modalities such as mammography, should be performed according to a currently accepted examination regimen tailored to each patient’s clinical needs, but at least once every 6 months.

Reasons to immediately discontinue therapy and seek immediate medical attention

The therapy should be discontinued if a contraindication is found and/or the following conditions/diseases are present:

Hyperplasia and endometrial cancer

The data from randomized controlled clinical trials are inconsistent, but data from observational studies showed 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 thickness as measured by transvaginal ultrasound.

In the first months of treatment, breakthrough bleeding and bloody discharge may occur.

If bleeding/bleeding occurs after starting Livial for more than 6 months after starting treatment, or if it starts 6 months after starting Livial and continues even after you stop taking Livial, you should see a doctor because this could be a sign of endometrial hyperplasia.

Breast cancer

The evidence from various clinical studies about the risk of breast cancer with Tibolone is inconsistent, and more research is needed.

The Million Woman Study found a significant increase in breast cancer risk with the 2.5 mg dose. This risk was evident after a few years of use and increased with duration of use, returning to baseline levels several years (often 5 years) after discontinuation.

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

Ovarian cancer

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

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

The Million Woman Study showed that the relative risk of ovarian cancer with tibolone was similar to that of other types of HRT.

Venous thromboembolism

The estrogen-only OST medications or combined OST medications containing estrogen and gestagen may increase the risk of venous thromboembolism (VTE) (i.e.i.e., deep vein thrombosis or pulmonary embolism) by a factor of 1.3 to 3, especially during the first year of MHT use.

The risk of VTE associated with taking tibolone was lower than the risk associated with conventional MST, but because only a small proportion of women were taking tibolone at that time, a small increase in risk compared with women who were not taking tibolone cannot be ruled out.

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

The risk factors for VTE include estrogen use, older age, major surgery, prolonged immobilization, obesity (body mass index (BMI) > 30 kg/m2), pregnancy and postpartum, systemic lupus erythematosus, and cancer.

In female patients after surgical interventions, special attention should be paid to preventive measures to prevent VTE in the postoperative period. If long-term immobilization after the operation is necessary it is recommended to stop taking Livial 4-6 weeks prior to the operation. The treatment should not be resumed until the woman regains motor activity.

Women with no history of VTE but who have first-degree relatives with a history of thrombosis at a young age may be offered screening (women should be informed that screening identifies only a portion of thrombophiliac conditions). If a thrombophilic condition, which is isolated from thrombosis in relatives, or a serious disorder (e.g. deficiency of antithrombin, protein S, protein C or a combination of disorders) is identified, Livial is contraindicated.

In women who are already being treated with anticoagulants, careful consideration of the benefit/risk ratio of using ZHT or tibolone is required.

If VTE develops after starting treatment, the drug should be discontinued. Patients should be advised to seek immediate medical attention if symptoms of a potential thromboembolism occur (e.g., pain and unilateral swelling of the lower extremity, sudden chest pain, dyspnea).

Ischemic heart disease (IHD)

. There is no evidence of protection against myocardial infarction in women with or without CHD who received MHT with a combination (estrogen/gestagen) or with MHT products containing only estrogen in randomized controlled trials.

There was no evidence of protection against myocardial infarction in postmenopausal women who received tibolone in epidemiologic studies using the GPRD database.

Ischemic stroke

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

In case of unexplained migraine-like headaches with or without visual impairment, a physician should be consulted as soon as possible. In this case, do not take the medication until your doctor has confirmed that it is safe to continue on MHT, because these headaches may be an early diagnostic sign of a possible stroke.

Other conditions

Livial treatment has been reported to result in a significant dose-dependent decrease 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 triglycerides and lipoprotein concentrations were also reduced. The decrease in total cholesterol and LDL cholesterol concentrations was not dose-dependent. LDL cholesterol concentrations did not change. The clinical significance of these data is not yet known.

Estrogens can cause fluid retention, so patients with cardiac or renal insufficiency should be closely monitored by a physician.

Women with pre-existing hypertriglyceridemia should be closely monitored by a physician during therapy with Livial, because rare cases of significant increases in plasma triglyceride levels contributing to pancreatitis have been noted during estrogen therapy for this condition.

The treatment with Livial leads to a very small decrease in thyroxine-binding globulin (TSH) and total T4. The level of total T3 does not change. Livial reduces levels of sex hormone-binding globulin (hGHB), while levels of corticosteroid-binding globulin (CRBG) and circulating cortisol are unchanged.

The use of MHT drugs does not improve cognitive function. There is evidence for an increased risk of possible dementia in women who start continuous therapy with combination MHT or estrogen-only MHT medications after age 65.

Contraindications

Side effects

Frequently observed side effects in clinical trials (occurring in 1-10% of women who have taken Livial) may include:

Infrequent side effects (occurring in 0.1-1% of women who have taken Livial) are:

Other possible side effects may be:

Overdose