DIAFORMIN Film-coated tablet (2022)

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Περιεχόμενα

1. Name of the medicinal product

DIAFORMIN Metformin hydrochloride.

2. 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. ...

3. 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, ...

4.1. Therapeutic indications

Metformin is indicated in the treatment of type 2 diabetes mellitus in adults, children from 10 years of age and adolescents, particularly in overweight patients, when dietary management and exercise alone ...

4.2. Posology and method of administration

Life threatening lactic acidosis can occur due to accumulation of metformin. The main risk factor is renal impairment, other risk factors include old age associated with reduced renal function and high ...

4.3. Contraindications

Juvenile diabetes mellitus that is uncomplicated and well regulated on insulin Diabetes mellitus regulated by diet alone Hypersensitivity to metformin hydrochloride or any of the excipients in DIAFORMIN ...

4.4. Special warnings and precautions for use

Lactic acidosis Lactic acidosis is a rare but serious (high mortality in the absence of prompt treatment), metabolic complication that can occur due to metformin accumulation. Reported cases of lactic ...

4.5. Interaction with other medicinal products and other forms of interaction

Contraindicated combinations Iodinated contrast materials Metformin must be discontinued either 48 hours before the test when renal function is known to be impaired, or from the time of the test when renal ...

4.6. Fertility, pregnancy and lactation

Effects on fertility Fertility of male or female rats was unaffected by metformin administration at doses up to 600 mg/kg/day, or approximately twice the maximum recommended daily dose on a body surface ...

4.7. Effects on ability to drive and use machines

Metformin monotherapy does not cause hypoglycaemia and therefore has no effect on the ability to drive or to use machinery. However, patients should be alerted to the risk of hypoglycaemia when metformin ...

4.8. Undesirable effects

The following undesirable effects may occur under treatment with metformin hydrochloride. Frequencies are defined as follows: very common: ≥1/10; common ≥1/100, <1/10; uncommon ≥1/1,000, <1/100; rare ≥1/10,000, ...

4.9. Overdose

Symptoms Hypoglycaemia has not been seen with ingestion of up to 85 g of metformin alone, although lactic acidosis has occurred in such circumstances. This disorder is a medical emergency and must be treated ...

5.1. Pharmacodynamic properties

Mechanism of action 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 ...

5.2. Pharmacokinetic properties

Absorption After oral administration, metformin hydrochloride is absorbed along the entire gastrointestinal mucosa. Studies using single oral doses of metformin tablets indicate that there is a lack of ...

5.3. Preclinical safety data

Carcinogenicity Long term carcinogenicity studies have been performed in rats (dosing duration of 104 weeks) and mice (dosing duration of 91 weeks) at doses up to and including 900 mg/kg/day and 1500 mg/kg/day, ...

6.1. 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: ...

6.2. Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3. Shelf life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4. Special precautions for storage

Store below 30°C (blisters and bottles). Store below 25°C (pails only).

6.5. Nature and contents of container

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 ...

6.6. Special precautions for disposal and other handling

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

7. 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

9. Date of first authorization / renewal of the authorization

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

10. Date of revision of the text

28/09/2022

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