Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Mercury Pharmaceuticals Limited, Capital House, 85 King William Street, London, EC4N 7BL
Tibolone 2.5 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. White to off-white round uncoated tablets of 6 mm diameter with bevelled edge without any marking. |
Each tablet contain contains 2.5 mg tibolone.
Excipient(s) with known effect: each tablet contains 43.2 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tibolone |
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. |
| List of Excipients |
|---|
|
Tibolone contains: Lactose monohydrate |
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.
Mercury Pharmaceuticals Limited, Capital House, 85 King William Street, London, EC4N 7BL
PL 12762/0528
24/03/2016
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