Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Mercury Pharmaceuticals Limited, Capital House, 85 King William Street, London, EC4N 7BL
For all women the decision to prescribe Tibolone should be based on an assessment of the individual patient’s overall risks and, particularly in the over 60s, should include consideration of the risk of stroke (see sections 4.4 and 4.8).
The dosage is one tablet per day. The tablets should be swallowed with some water or other drink, preferably at the same time every day.
For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) 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 (see section 4.3)
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.
There is no relevant use of Tibolone in the paediatric population.
No dose adjustment is necessary for the elderly. There is limited experience in treating women over age 65 years.
For oral use.
The acute toxicity of tibolone in animals is very low. Therefore, toxic symptoms are not expected to occur, even when several tablets are taken simultaneously. In cases of acute overdose, nausea, vomiting and vaginal bleeding in females may occur. No specific antidote is known. Symptomatic treatment can be given if necessary.
Shelf life: 3 years.
This medicinal product does not require any special temperature storage conditions.
Store in the original package, in order to protect from light and moisture.
Push-through pack of transparent PVC-Alu tablets pack sizes: cardboard boxes containing 1, 3 or 6 blisters with 28 or 30 tablets.
Not all pack size may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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