Renorma 2.5 mg (Tablet)

Indications

• Treatment of symptoms resulting from natural or surgical menopause in postmenopausal women
• Prevention of osteoporosis in postmenopausal women at high risk of fractures

Pharmacology

• Tibolone is a synthetic steroid with estrogenic, androgenic, and progestagenic properties
• Rapid metabolism into three compounds contributing to pharmacological effects
• Estrogenic effects on vagina, bone, and thermoregulatory centers in the brain
• Prevents bone loss following menopause or ovariectomy
• Improves vaginal dryness and atrophy
• Affects mood and libido

Dosage & Administration

• One Tibolone tablet per day (2.5 mg daily)
• Improvement of symptoms within a few weeks, optimal results after at least 3 months
• Commencement of treatment based on natural or surgical menopause
• Instructions for switching from other hormone replacement therapy regimens
• Guidelines for missed dose

Interaction

• No reported interactions with other medicines in clinical practice
• Theoretical considerations of interactions with enzyme-inducing compounds and anticoagulants

Contraindications

• Pregnancy and lactation
• Hormone-dependent tumors
• Cardiovascular or cerebrovascular disorders
• Active deep vein thrombosis
• Vaginal bleeding of unknown etiology
• Severe liver disorders

Side Effects

• Occasional vaginal bleeding or spotting
• Headache and migraine
• Edema
• Dizziness
• Pruritus
• Increase in body weight
• Nausea
• Abdominal pain
• Rash
• Depression

Pregnancy & Lactation

• Contraindicated during pregnancy
• Immediate withdrawal of treatment if pregnancy occurs during medication
• No clinical data available on exposed pregnancies
• Contraindicated in lactating women

Precautions & Warnings

• Relevant for patients with renal dysfunction, history of liver disease, epilepsy, migraine, hypercholesterolemia, impaired carbohydrate metabolism, diabetes mellitus, and cholestatic jaundice

Overdose Effects

• Low acute toxicity in animals
• Symptoms may include nausea, vomiting, and withdrawal bleeding in females
• Symptomatic treatment if necessary

Therapeutic Class

• Drugs for menopausal symptoms: Hormone replacement therapy

Storage Conditions

• Keep in a cool and dry place
• Protect from light
• Keep out of the reach of children

Related Brands

• Menorest 2.5 mg (Tablet) - renata-limited