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
Treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone do not result in adequate blood glucose control.
A reduction in the complications of diabetes has been demonstrated in overweight adult patients with Type 2 diabetes treated with metformin as a first-line therapy after lack of success with diet (see section 5.1).
The usual starting dose is 500 mg or 850 mg metformin hydrochloride 2 or 3 times daily given during or after meals.
After 10 to 15 days, the dose should be adjusted on the basis of blood glucose measurements. A slow increase of the dose may improve gastrointestinal tolerability.
In patients receiving a high metformin hydrochloride dose (2 to 3 grams per day), it is possible to replace two metformin hydrochloride 500 mg film-coated tablets with one Metformin Hydrochloride 1000 mg film-coated tablet.
The maximum recommended dose of metformin hydrochloride is 3 g daily, taken as 3 divided doses.
If transfer from another oral anti-diabetic medicinal product is intended: discontinue the other medicinal product and initiate metformin hydrochloride at the dose indicated above.
Metformin hydrochloride and insulin may be used in combination therapy to achieve a better control of the blood glucose level. Metformin hydrochloride is given at the usual starting dose of 500 mg or 850 mg 2 or 3 times daily, while insulin dosage is adjusted on the basis of the blood glucose values.
Due to the potential decrease of renal function in elderly patients, the metformin hydrochloride dosage should be adjustedbased on renal function.. Regular assessment of the renal function is therefore required (see “Renal impairment” in sections 4.2 and 4.4).
A GFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter. In patients at an increased risk of further progression of renal impairment and in elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
| GFR mL/min | Total maximum daily dose (to be divided into 2-3 daily doses) | Additional considerations |
|---|---|---|
| 60-89 | 3000 mg | Dose reduction may be considered in relation to a declining renal function. |
| 45-59 | 2000 mg | Factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of metformin. The starting dose is at most half of the maximum dose. |
| 30-44 | 1000 mg | |
| <30 | Metformin is contraindicated. |
METFORAL 500 mg/METFORAL 850 mg can be used in children from 10 years of age and adolescents.
The usual starting dose is 500 mg o 850 mg of metformin hydrochloride once daily, given during or after meals.
After 10 to 15 days, the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability.
In case of normal renal function, the maximum recommended dose of metformin hydrochloride is 2 g daily, taken as 2 or 3 divided doses.
For oral use.
Due to the snap-tab form, the film-coated tablets can alternatively be divided, like other tablets as well, with two hands, or by placing them with the larger break-mark facing downwards on a hard, flat surface and applying thumb pressure. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Hypoglycaemia has not been seen with metformin hydrochloride doses of up to 85 g, although lactic acidosis has occurred in such circumstances. High overdose of metformin hydrochloride or concomitant risk factors may lead to lactic acidosis. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and metformin is haemodialysis.
5 years.
Store in a dry place.
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.
Any unused medicinal product or waste materials deriving from the same must be disposed of in compliance with local regulations.
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