Active Ingredient: Tibolone
Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
2.5 - 2.5 mg
From 2.5 To 2.5 mg once every day
The dosage is 2.5 mg per day.
For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used.
A separate progestogen should not be added with Tibolone treatment.
Women experiencing a natural menopause should commence treatment with Tibolone at least 12 months after their last natural bleed. In case of a surgical menopause, treatment with Tibolone may commence immediately. Women being treated with gonadotrophin releasing hormone (GnRH) analogues, for example, for endometriosis, may commence treatment with Tibolone immediately.
Any irregular/unscheduled vaginal bleeding, either on or off HRT, should be investigated to exclude malignancy before starting Tibolone.
If changing from a sequential HRT preparation, treatment with Tibolone should start the day following completion of the prior regimen. If changing from a continuous combined HRT preparation, treatment can start at any time.
A missed dose should be taken as soon as remembered, unless it is more than 12 hours overdue. In the latter case, 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.
The tablets should be swallowed with some water or other drink, preferably at the same time every day.
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