DIAFORMIN Film-coated tablet Ref.[50318] Active ingredients: Metformin

Source: Pharmaceutical Benefits Scheme (AU)  Revision Year: 2022  Publisher: Alphapharm Pty Ltd trading as Viatris, Level 1, 30 The Bond, 30-34 Hickson Road, Millers Point NSW 2000, www.viatris.com.au, Phone: 1800 274 276

Product name and form

DIAFORMIN – Metformin hydrochloride.

Pharmaceutical Form

500 mg tablet: 15.65 mm x 7.25 mm, oblong, white, clear coated, tablet debossed “MF/1” on one side and blank on the other.

850 mg tablet: 12.5 mm normal convex, white, clear film-coated tablet, debossed “MF” over “2” on one side and “G” on the other.

1000 mg tablet: 19 mm x 10.5 mm, oval, film coated white tablet, debossed “MF/3” on one side and “G” on the other side.

Qualitative and quantitative composition

The tablets contain metformin hydrochloride as the active ingredient and are available in three strengths 500 mg, 850 mg and 1000 mg.

Excipients with known effect: trace quantities of sulfites.

For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.

Chemical structure

Metformin hydrochloride is a white, crystalline powder which is odourless or almost odourless and hygroscopic. It is freely soluble in water, slightly soluble in ethanol (96%), and practically insoluble in chloroform and in ether.

Chemical name: 1,1-dimethylbiguanide hydrochloride

Molecular formula: C4H11N5, HCl

Molecular weight: 165.6

CAS number: 1115-70-4

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

The tablets contain the following excipients: povidone and magnesium stearate, and are film-coated with a proprietary coating ingredient, OPADRY complete film coating system 20C59060 Clear (ARTG PI No: 106044).

Pack sizes and marketing

DIAFORMIN 500: Aluminium/PVC Blister packs of 10 (sample) and 100 tablets.

DIAFORMIN: PP pails packs* of 22700 tablets and 4540 tablets.

DIAFORMIN 850: Aluminium/PVC Blister packs and HDPE bottles of 60 tablets.

DIAFORMIN 1000: Aluminium/PVC Blister packs of 10, 30, 60 and 90 tablets. PP pails packs* of 11380 tablets and 2276 tablets.

* Bulk pack for dose administration to aid Packers

Some strengths, pack sizes and/or pack types may not be marketed.

Australian Register of Therapeutic Goods (ARTG)

AUST R 73806 – DIAFORMIN 500 metformin hydrochloride 500mg tablet blister pack.
AUST R 299825 – DIAFORMIN metformin hydrochloride 500 mg tablet bulk pack.
AUST R 73808 – DIAFORMIN 850 metformin hydrochloride 850mg tablet blister pack.
AUST R 73807 – DIAFORMIN 850 metformin hydrochloride 850mg tablet bottle.
AUST R 82207 – DIAFORMIN 1000 metformin hydrochloride 1000mg tablet blister pack.
AUST R 294057 – DIAFORMIN 1000 metformin 1000mg (as hydrochloride) tablet bulk pack.

Marketing authorization holder

Alphapharm Pty Ltd trading as Viatris, Level 1, 30 The Bond, 30-34 Hickson Road, Millers Point NSW 2000, www.viatris.com.au, Phone: 1800 274 276

Marketing authorization dates and numbers

05/04/2000 (DIAFORMIN)
05/04/2000 (DIAFORMIN 850)
23/08/2002 (DIAFORMIN 1000)

Drugs

Drug Countries
DIAFORMIN Australia, Brazil, Hong Kong, Turkey, South Africa

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