Valgestril 21 tablets

Description:

Combined hormone replacement therapy (HRT) for peri- and postmenopausal women. Contains estrogen (estradiol valerate) and progestogen (norgestrel). Alleviates menopausal symptoms and prevents osteoporosis.

Indications:

– Menopausal symptoms: hot flashes, night sweats, sleep disturbances, mood swings.

– Urogenital atrophy (vaginal dryness, dyspareunia).

– Prevention of osteoporosis in high-risk women.

– Menstrual disorders (amenorrhea, dysmenorrhea) in women with intact uterus.

Dosage and Administration:

Initiation:

With cyclic menstruation: on day 5 of the cycle.

With amenorrhea: any day.

Regimen: 1 tablet daily for 21 days (white then brown), then 7-day break.

Time: Same time daily, with or without food.

Contraindications:

– Breast cancer or estrogen-dependent tumors (including history).

– Undiagnosed vaginal bleeding.

– History of thrombosis (venous/arterial).

– Severe liver disease.

– Porphyria, hypertriglyceridemia.

– Pregnancy, lactation.

– Hypersensitivity to ingredients.

Precautions:

– Cancer risk: Regular breast monitoring (mammography every 1-2 years).

– Thrombosis: Assess benefits/risks in high-risk patients (obesity, smoking, thrombophilia).

– Pre-treatment screening: BP, lipids, glucose, liver function.

Interactions:

Reduce efficacy: barbiturates, rifampicin, St. John’s wort.

Increase efficacy: ketoconazole, antidepressants.

Lactose: Contains lactose — contraindicated in intolerance.

Adverse Effects:

Common (>1%):

Breast tenderness, headache, nausea, breakthrough bleeding.

Mood swings, weight gain.

Rare (<0.1%):

Thrombosis, hypertriglyceridemia, chloasma (skin pigmentation).

Increased growth of uterine fibroids.

Discontinue immediately if: Migraine, jaundice, chest pain.

Pregnancy and Lactation:

Contraindicated. Discontinue immediately if pregnancy occurs.

Storage:

Store below 30°C in a dry place.

Package:

A carton box containing a blister of 21 tablets (11 white + 10 brown) + leaflet.