Leatrisa^® (Tablets) Instructions for Use

Marketing Authorization Holder

Aristo Pharma, GmbH (Germany)

Manufactured By

Lindopharm, GmbH (Germany)

ATC Code

G03CX01 (Tibolone)

Active Substance

Tibolone (Rec.INN registered by WHO)

Dosage Form

Leatrisa®

Tablets 2.5 mg: 28 or 84 pcs.

Dosage Form, Packaging, and Composition

Tablets are round, slightly biconvex, white or almost white in color.

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

28 pcs. – blisters (1) – cardboard packs.
28 pcs. – blisters (3) – cardboard packs.

Clinical-Pharmacological Group

Anticlimacteric estrogenic drug

Pharmacotherapeutic Group

Sex hormones and modulators of the genital system, estrogens, other estrogens

Pharmacological Action

It is an anabolic steroid. It has estrogenic, progestogenic, and weak androgenic activity, stabilizes the hypothalamic-pituitary system after the cessation of ovarian function, and causes a decrease in the secretion of gonadotropic hormones.

It inhibits bone resorption in the postmenopausal period, alleviates such manifestations of menopausal syndrome as hot flashes, increased sweating, and headaches.

It has a positive effect on libido and mood (increases the concentration of central and peripheral opioids). It has a stimulating effect on the vaginal mucosa without stimulating endometrial proliferation. In fertile women, it suppresses ovulation.

It prevents the development of osteoporosis and reduces the concentration of phosphates and calcium in the blood serum.

Pharmacokinetics

Absorption is high. It is metabolized in the liver to form hydrophilic products, some of which are pharmacologically active.

It is excreted by the kidneys (including in the form of metabolites) and through the intestines.

Indications

Menopause (natural or due to oophorectomy).

Prevention of menopausal osteoporosis.

ICD codes

Dosage Regimen

Administer orally at a dose of 2.5 mg once daily.

Take the tablet at the same time each day to maintain stable plasma concentrations.

Initiate therapy at least one year after the last spontaneous menstruation.

Begin treatment immediately following surgical menopause induced by oophorectomy.

The minimum duration of continuous treatment for achieving therapeutic effect is three months.

Continue therapy for as long as the therapeutic benefit persists and the treatment remains well-tolerated.

Do not use this medication for contraceptive purposes.

Swallow the tablet whole with a sufficient amount of water; it can be taken with or without food.

If a dose is missed and remembered within 12 hours, take it immediately. If more than 12 hours have passed, skip the missed dose and continue the regular schedule; do not double the dose.

Adverse Reactions

From the central nervous system: dizziness, headache.

From the digestive system: diarrhea, increased activity of liver transaminases, change in body weight.

From the endocrine system: increased facial hair growth, metrorrhagia, endometrial proliferation.

Other: swelling of the legs, seborrheic dermatosis, pain in the back, arms, and legs.

Contraindications

Pregnancy, hormone-dependent tumors (including suspected ones), thrombophlebitis, thromboembolism (including in history), vaginal bleeding of unknown etiology, hepatic insufficiency, cardiovascular insufficiency, cerebrovascular disorders, otosclerosis that occurred during pregnancy or during treatment with steroids, period less than 1 year after the last menstruation.

Use in Pregnancy and Lactation

Contraindicated during pregnancy.

Use in Hepatic Impairment

Contraindicated in hepatic insufficiency.

Use in Renal Impairment

Use with caution in renal insufficiency.

Special Precautions

Use with caution in renal insufficiency, carbohydrate metabolism disorders, hypercholesterolemia, epilepsy.

It is not intended for use as a contraceptive. During treatment, an increase in the sensitivity of patients to anticoagulants may occur due to an increase in the fibrinolytic activity of the blood.

If symptoms of thromboembolism, jaundice, or persistent pathological changes in liver function tests appear, treatment should be discontinued.

During treatment, regular monitoring of relevant laboratory parameters is necessary in patients with hypercholesterolemia, renal insufficiency, and diabetes mellitus. During treatment, a decrease in the concentrations of total and free T₄ and thyroxine-binding globulin is possible.

Drug Interactions

It enhances the effect of anticoagulants.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.