BROT Film-coated tablet Ref.[28148] Active ingredients: Metformin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Brot 850mg film-coated tablet.

Pharmaceutical Form

Film-coated tablet.

White, oblong, convex, scored, film coated tablets, embossed “MC” with dimension of nucleus 17.5 × 8.0 mm.

Qualitative and quantitative composition

Each tablet contains metformin hydrochloride 850mg corresponding to metformin base 662.9mg.

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:

Macrogol 4000
Povidone K25
Powdered cellulose
Calcium stearate

Film-coating:

Opadry White OY-B-28920 (polyvinyl alcohol, titanium dioxide (E171), purified talc, lecithin, xanthan gum)
Macrogol 6000
Purified talc

Pack sizes and marketing

Blister packs (PVC-aluminium): 10 tablets/blister and 5 and 10 blisters/pack.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

18506

Date of first authorisation: 30.9.1999
Date of latest renewal: 05.07.2013

Drugs

Drug Countries
BROT Cyprus, Hong Kong, Tunisia

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