Uses of Tibofem: - Hormone replacement therapy - Post menopausal osteoporosis Menopausal vasomotor symptoms, [hot flushes, sweating, vaginal dryness & less elasticity, mood disorders, anxiety etc.], postmenopausal and post oophorectomy osteoporosis, improvement of bone-mineral density, Vaginal atrophy, Prevention of frequent UTI, urinary incontinence in postmenopausal women. Known or suspected oestrogen dependent tumours in women, present or history of breast cancer, undiagnosed vaginal bleeding, severe liver disease, history or current CV or cerebrovascular disorders, untreated endometrial hyperplasia, porphyria, pregnancy and lactation, premenopausal women.

Drugs for menopausal symptoms: Hormone replacement therapy

Tibolone is a synthetic steroid that has estrogenic, androgenic and progestagenic properties. After oral administration, Tibolone is rapidly metabolized into three compounds which contribute to the pharmacological effects of Tibolone. Two of these metabolites (the 3α−OH and 3β−OH metabolite) have predominantly estrogenic activity; a third metabolite (δ4-isomer of Tibolone) and the parent compound have predominantly progestagenic and androgenic activities. Tibolone substitutes for the loss of estrogen production in postmenopausal women and alleviates menopausal symptoms. It prevents bone loss following menopause or ovariectomy. It has estrogenic effects on the vagina, on bone and on the thermoregulatory centers in the brain (hot flushes). It improves vaginal dryness and vaginal atrophy. Tibolone has also effects on mood and libido.

How to use Tibolone: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Tibolone may be taken with or without food, but it is better to take it at a fixed time. Administration: May be taken with or without food. Adult Dose: Oral Menopausal vasomotor symptoms; Adult: 2.5 mg daily. Symptomatic relief occurs within few days, but optimal results are obtained minimum after 3 months. Prophylaxis of postmenopausal osteoporosis Adult: 2.5 mg daily. To prevent osteoporosis in post-menopausal women or after oophorectomy an uninterrupted longer (5-10 years) therapy is needed. Starting Tibolone: In case of natural menopause: To avoid irregular & abnormal bleeding, Tibolone should be started at least 12 months after last natural bleeding. In case of artificial menopause: Treatment should be started immediately. In case of switching over from other conventional HRT: If someone switches from estrogen-only preparation, she should start after a withdrawal bleeding. If someone switches from sequential HRT preparation she should wait for the completion of the progestogen phase. If someone switches from continuous combined HRT, she can start any time. In case of missed pill: If no more than 12 hours have passed, the pill should be taken immediately. Otherwise the next dose should be continued as before.

Enzyme inducers eg, barbiturates, phenytoin, carbamazepine and rifampicin may accelerate tibolone metabolism. Increased anticoagulant effects of warfarin.

Known or suspected oestrogen dependent tumours in women, present or history of breast cancer, undiagnosed vaginal bleeding, severe liver disease, history or current CV or cerebrovascular disorders, untreated endometrial hyperplasia, porphyria, pregnancy and lactation, premenopausal women.

Common - Breast pain - Stomach pain - Vaginal bleeding - Vaginal inflammation - Vaginal spotting - Irritation - Itching - Weight gain Weight gain; dizziness; rash; pruritus; headache; migraine; visual disturbances; GI symptoms; facial hair growth; altered liver function; ankle oedema; depression; arthralgia or myalgia; irregular vaginal bleeding. Potentially Fatal: Breast or endometrial cancer and stroke.

Tibolone tablet is contraindicated during pregnancy. If pregnancy occurs during medication with this tablet, treatment should be withdrawn immediately. For this tablet no clinical data on exposed pregnancies are available. Tibolone tablet is contraindicated in lactating women.

Precaution: Liver disease, history or risk factors of thromboembolic disorder, impaired glucose tolerance, hypercholesterolaemia, hypertriglyceridaemia, hypertension, cholelithiasis, SLE, uterine fibroids, endometriosis and history of endometrial hyperplasia. Disorders that may be worsened by fluid retention, eg. renal dysfunction, migraine, epilepsy. Discontinue in the event of thromboembolic or abnormal liver function results, significant increase in BP, new onset of migraine-type headache. Not recommended in women within 1 yr of menopause because of irregular vaginal bleeding. Stop tibolone 4 wk before elective surgery especially when prolonged immobilisation after surgery is expected. Adjustment of antidiabetic medications may be needed.

The acute toxicity of Tibolone in animals is very low. Therefore, toxic symptoms are not expected to occur if several tablets are taken simultaneously. In cases of acute overdose - nausea, vomiting, and withdrawal bleeding in females may develop. Symptomatic treatment can be given if necessary.

Keep in a cool & dry place. Protect from light. Keep out of the reach of children.

Drugs for menopausal symptoms: Hormone replacement therapy

Tibolone is a steroid that possesses oestrogenic, progestogenic and weak androgenic properties.

Tibolone tablet is contraindicated during pregnancy. If pregnancy occurs during medication with this tablet, treatment should be withdrawn immediately. For this tablet no clinical data on exposed pregnancies are available. Tibolone tablet is contraindicated in lactating women.