• Tibolone is indicated for the treatment of menopausal symptoms in postmenopausal women who have at least 12 months since their last natural menstrual bleeding.
• It can also be used for the prevention of osteoporosis in postmenopausal women at high risk of fractures and who cannot tolerate or are contraindicated for other approved osteoporosis treatments.

Menopause

Post Menopausal Osteoporosis (Brittle Bone)

• The dosage of tibolone should be individualized based on the patient's symptoms and response to treatment.
• The usual starting dose is 2.5 mg once daily.
• The treatment duration should be determined on an individual basis and regularly reviewed.

Common adverse reactions include:

• Breast pain or tenderness
• Vaginal bleeding or spotting
• Headache
• Abdominal pain or discomfort
• Mood changes
• Weight changes

Breast Tenderness

Vaginal bleeding

Headache

Abdominal Cramp

• For the treatment of postmenopausal symptoms, tibolone should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and tibolone should only be continued as long as the benefit outweighs the risk.
• The risks of stroke, breast cancer and, in women with an intact uterus, endometrial cancer (see below and section 4.8) for each woman should be carefully assessed, in the light of her individual risk factors and bearing in mind the frequency and characteristics of both cancers and stroke, in terms of their response to treatment, morbidity and mortality.
• Evidence regarding the risks associated with HRT or tibolone in the treatment of premature menopause is limited. Due to the low level of absolute risk in younger women, however, the balance of benefits and risks for these women may be more favorable than in older women.