METFORAL Film-coated tablet Ref.[28189] Active ingredients: Metformin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: Laboratori Guidotti S.p.A, Via Livornese 897, La Vettola 56122, PISA, Italy Local Representative, Menarini Hellas S.A., An. Damvergi 7, Athens, Greece, Τel.: 210-8316111

Product name and form

METFORAL 500 mg film-coated tablets.

METFORAL 850 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

METFORAL 500 mg film-coated tablets:

White, round film-coated tablet, shallow biconvex, beveled edges.

METFORAL 850 mg film-coated tablets:

White, oblong film-coated tablet with a break-mark on both sides.

The break-mark is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

METFORAL 500 mg film-coated tablets

Each film-coated tablet contains:

500 mg of metformin hydrochloride, equivalent to 390 mg of metformin.

METFORAL 850 mg film-coated tablets

Each film-coated tablet contains:

850 mg of metformin hydrochloride, equivalent to 662.9 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.

List of Excipients

Colloidal anhydrous silica
Povidone
Macrogol 4000
Magnesium stearate
Opadry II 85F29116 Clear (polyvinyl alcohol, macrogol 3350, talc)

Pack sizes and marketing

Rigid thermoformed PVC/PVDC/aluminium blister strips, thermo-sealed with thermoforming resin-lacquered aluminium film, packed in lithographed cardboard packets.

METFORAL 500 mg film-coated tablets: 50 film-coated tablets.

METFORAL 850 mg film-coated tablets: 30 film-coated tablets.

Marketing authorization holder

Laboratori Guidotti S.p.A, Via Livornese 897, La Vettola 56122, PISA, Italy

Local Representative, Menarini Hellas S.A., An. Damvergi 7, Athens, Greece, Τel.: 210-8316111

Marketing authorization dates and numbers

Metforal 500 mg: 017499
Metforal 850 mg: 018663

Date of first authorisation:

Metforal 500 mg: 11/12/1997
Metforal 850 mg: 15/02/2000

Drugs

Drug Countries
METFORAL Cyprus, Estonia, Hong Kong, Italy, Lithuania, Malta, Singapore, Tunisia, South Africa

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