Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Eucreas 50 mg/850 mg film-coated tablets.
Eucreas 50 mg/1000 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Eucreas 50 mg/850 mg film-coated tablets: Yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “NVR” on one side and “SEH” on the other side. Eucreas 50 mg/1000 mg film-coated tablets: Dark yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “NVR” on one side and “FLO” on the other side. |
Eucreas 50 mg/850 mg film-coated tablets: Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (corresponding to 660 mg of metformin).
Eucreas 50 mg/1000 mg film-coated tablets: Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (corresponding to 780 mg of metformin).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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 Vildagliptin |
Combination of two antihyperglycaemic agents with complimentary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: vildagliptin, a member of the islet enhancer class, and metformin hydrochloride, a member of the biguanide class. |
|
| Vildagliptin |
Vildagliptin enhances the sensitivity of beta cells to glucose, resulting in improved glucose-dependent insulin secretion by increasing the endogenous levels of these incretin hormones. The administration of vildagliptin results in a rapid and complete inhibition of DPP-4 activity, resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide). |
| List of Excipients |
|---|
|
Tablet core: Hydroxypropylcellulose Film-coating: Hypromellose |
Aluminium/Aluminium (PA/alu/PVC/alu) blister: Available in packs containing 10, 30, 60, 120,180 or 360 film-coated tablets and in multi-packs containing 120 (2 packs of 60), 180 (3 packs of 60) or 360 (6 packs of 60) film-coated tablets.
Polychlorotrifluoroethylene (PCTFE/PVC/alu) blister: Available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multi-packs containing 120 (2 packs of 60), 180 (3 packs of 60) or 360 (6 packs of 60) film-coated tablets.
Polyvinylchloride/Polyethylene/Polyvinylidene chloride/Aluminium (PVC/PE/PVDC/alu) blister: Available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multi-packs containing 120 (2 packs of 60), 180 (3 packs of 60) or 360 (6 packs of 60) film-coated tablets.
Not all pack sizes and tablet strengths may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Eucreas 50 mg/850 mg film-coated tablets:
EU/1/07/425/001–006
EU/1/07/425/013–015
EU/1/07/425/019–024
EU/1/07/425/031–033
EU/1/07/425/037–045
Eucreas 50 mg/1000 mg film-coated tablets:
EU/1/07/425/007–012
EU/1/07/425/016–018
EU/1/07/425/025–030
EU/1/07/425/034–036
EU/1/07/425/046–054
Date of first authorisation: 14 November 2007
Date of latest renewal: 23 July 2012
| Drug | Countries | |
|---|---|---|
| EUCREAS | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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