Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Takeda Pharma A/S, Delta Park 45, 2665 Vallensbaek Strand, Denmark
Vipdomet 12.5 mg/850 mg film-coated tablets.
Vipdomet 12.5 mg/1,000 mg film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablet (tablet). Vipdomet 12.5 mg/850 mg film-coated tablets: Light yellow, oblong (approximately 21.0 mm long by 10.1 mm wide), biconvex, film-coated tablets with “12.5/850” debossed on one side and “322M” debossed on the other side. Vipdomet 12.5 mg/1,000 mg film-coated tablets: Pale yellow, oblong (approximately 22.3 mm long by 10.7 mm wide), biconvex, film-coated tablets with “12.5/1000” debossed on one side and “322M” debossed on the other side. |
Vipdomet 12.5 mg/850 mg film-coated tablets: Each tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin and 850 mg metformin hydrochloride.
Vipdomet 12.5 mg/1,000 mg film-coated tablets: Each tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin and 1000 mg metformin hydrochloride.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Alogliptin |
Alogliptin is a potent and highly selective inhibitor of DPP-4, >10,000-fold more selective for DPP-4 than other related enzymes including DPP-8 and DPP-9. Alogliptin improves glycaemic control via a glucose-dependent mechanism, whereby insulin release is enhanced and glucagon levels are suppressed when glucose levels are high. |
|
| Metformin |
Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia. |
|
| Metformin and Alogliptin |
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| List of Excipients |
|---|
|
Tablet core: Mannitol Film-coating: Hypromellose |
Polychlorotrifluoroethylene (PCTFE)/polyvinyl chloride (PVC) blisters with push through aluminium lidding foil. Pack sizes of 10, 14, 20, 28, 56, 60, 98, 112, 120, 180, 196, 200 or multipacks containing 196 (2 packs of 98) film-coated tablets.
Not all pack sizes may be marketed.
Takeda Pharma A/S, Delta Park 45, 2665 Vallensbaek Strand, Denmark
EU/1/13/843/001-026
Date of first authorisation: 19 September 2013
Date of latest renewal: 24 May 2018
| Drug | Countries | |
|---|---|---|
| VIPDOMET | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom |
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