Leading the way to safer medication
 Crosscheck  Recommender

EUCREAS Film-coated tablet (2020)

Active ingredients: Vildagliptin Metformin

Product Name and Form

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.

Qualitative and Quantitative Composition

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.

Chemical substance
Description
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).

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.

List of excipients

Tablet core:

Hydroxypropylcellulose
Magnesium stearate

Film-coating:

Hypromellose
Titanium dioxide (E171)
Iron oxide, yellow (E172)
Macrogol 4000
Talc

Pack sizes and Marketing

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.

Marketing authorization holder
Authorization dates

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Date of first authorisation: 14 November 2007

Date of latest renewal: 23 July 2012

Marketing authorization number:

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