Prevention of osteoporosis in postmenopausal women

Active Ingredient: Tibolone

Indication for Tibolone

Population group: women, only adults (18 years old or older)

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:

2.5 mg once daily

Route of admnistration


Defined daily dose

2.5 - 2.5 mg

Dosage regimen

From 2.5 To 2.5 mg once every day

Detailed description

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.

Starting Tibolone

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.

Switching from a sequential or continuous combined HRT preparation

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.

Missed dose

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.

Dosage considerations

The tablets should be swallowed with some water or other drink, preferably at the same time every day.

Active ingredient


Tibolone is rapidly metabolised into three compounds, which all contribute to the pharmacodynamic profile of tibolone. Two of the metabolites (3α-OH-tibolone and 3β-OH-tibolone) have oestrogenic-like activities, whereas the third metabolite (4Δ-isomer of tibolone) has progestogenic and androgenic-like activities.

Read more about Tibolone

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