GLUCOPHAGE Film-coated tablet Ref.[50677] Active ingredients: Metformin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Merck Serono Limited, 5 New Square, Bedfont Lakes Business Park, Feltham, Middlesex, TW14 8HA, UK

Product name and form

GLUCOPHAGE 500 mg film-coated tablets.

GLUCOPHAGE 850 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Glucophage 500 mg: White, circular, convex film-coated tablets 11 mm in diameter and 5.7 mm high, engraved with GL 500.

Glucophage 850 mg: White, circular, convex film-coated tablets 13.5 mm in diameter and 6.6 mm high, engraved with GL 850.

Qualitative and quantitative composition

Glucophage 500 mg: One film-coated tablet contains 500 mg metformin hydrochloride corresponding to 390 mg metformin base.

Glucophage 850 mg: One film-coated tablet contains 850 mg metformin hydrochloride corresponding to 662.9 mg metformin base.

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.

List of Excipients

Tablet core:

Povidone K 30
Magnesium stearate

Film-coating:

Hypromellose

Pack sizes and marketing

500 mg tablets

1 (x100), 9, 20, 21, 30, 40, 50, 56, 60, 84, 90, 100, 120, 200, 500, 600 or 1000 tablets in blister packs (PVC-aluminium)

21, 30, 40, 50, 60, 100, 120, 300, 400, 500, 600 or 1000 tablets in plastic bottles (high-density polyethylene) with child-resistant caps (polypropylene).

Not all pack sizes may be marketed.

850mg tablets

1 (x 100), 8, 9, 10,14, 20, 21, 30, 40, 50, 56, 60, 84, 90, 100, 120, 300, 600 or 1000 tablets in blister packs (PVC-aluminium)

30, 60, 200, 300 or 600 tablets in plastic bottles (high-density polyethylene) with caps (polypropylene),

Not all pack sizes may be marketed.

Marketing authorization holder

Merck Serono Limited, 5 New Square, Bedfont Lakes Business Park, Feltham, Middlesex, TW14 8HA, UK

Marketing authorization dates and numbers

PL 11648/0085-86

17 January 2015

Drugs

Drug Countries
GLUCOPHAGE Albania, Austria, Canada, Cyprus, Germany, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Italy, Malta, Nigeria, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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