Tibofem 

Presentation: Tibofem is presented as tablets, each containing 2.5mg of tibolone. The tablets are usually available in blister packs.

Indications: Tibofem (tibolone) is indicated for:

• Relief of menopausal symptoms such as hot flushes, night sweats, and vaginal dryness in postmenopausal women.
• Prevention of osteoporosis in postmenopausal women at high risk of fractures.

Dosage and Administration: The recommended dose of Tibofem is one tablet (2.5mg) once daily, taken orally preferably at the same time each day with some water or other drink.

For the treatment of menopausal symptoms, improvement usually occurs within a few weeks, but optimal results are obtained when therapy is continued for at least 3 months. The need for continuation of treatment should be reviewed after 6 months taking into account the risk-benefit ratio for the individualuser.

For the prevention of postmenopausal bone mineral density loss, the recommended dose is also one tablet (2.5mg) once daily.

Women experiencing a natural menopause should commence treatment with Tibofem at least 12 months after their last natural bleed.In case of a surgical menopause, treatment may commence immediately.

If a dose is missed and it is more than 12 hours overdue, the missed dose should be skipped, and the next dose should be taken at the normal time. Missing a dose may increase the likelihood of breakthrough bleeding and spotting.  

Side Effects: Common side effects may include lower abdominal pain, abnormal hair growth, endometrial hyperplasia, vaginal discharge, breast tenderness, genital itching, vaginal bleeding, pelvic pain, cervical thickening, and weightgain.

Less common side effects may include headache, pre-tibial edema, dizziness, rash, changes in body mass.

Rare side effects may include vaginal bleeding mainly during the first 1-3 months of treatment.

Patients should report any unusual vaginal bleeding that continues after the first 6 months of treatment, starts after that time, or continues after stopping treatment. Signs of blood clots (painful swelling and redness of the legs, sudden chest pain, difficulty breathing), severe headaches, and changes in breasts should also be reported immediately.

Precautions: Tibofem (tibolone) is contraindicated in pre-menopausal women, pregnant and lactating women, patients with known or suspected hormone-dependent tumors (e.g., breast cancer, endometrial cancer), undiagnosed genital bleeding, untreated endometrial hyperplasia, a history of cardiovascular or cerebrovascular disorders such as thrombophlebitis, thromboembolic diseases, angina, myocardial infarction, stroke or transient ischemic attack, acute liver disease or a history of liver disease as long as liver function tests have not returned to normal, and porphyria.

Caution should be exercised in patients with leiomyoma (uterine fibroids) or endometriosis, risk factors for thromboembolic disorders or estrogen-dependent tumors, hypertension, liver disorders, diabetes mellitus with or without vascular involvement, cholelithiasis, migraine or (severe) headache, systemic lupuserythematosus, a history of endometrial hyperplasia,⁶epilepsy, asthma, and otosclerosis.

The need for continuation of treatment should be reviewed after 6 months. Regular breast screening and cervical smear tests are recommended.

Storage: Store below 30°C in a dry place, protected from light. Keep out of reach of children.

Important Note: This information is for general knowledge and informational purposes only, and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication. They can assess your individual medical condition and provide the most appropriate advice.