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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gerformin 500mg Film-coated Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 500mg metformin hydrochloride corresponding to 390 mg metformin base.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, circular convex film-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary managements and exercise
alone does not result in adequate glycaemic control.
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In adults, Gerformin 500mg film-coated tablets may be used as monotherapy or in combination with other oral
anti-diabetic agents or with insulin.
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In Children form 10 years of aged and adolescents, Gerformin 500mg film-coated tablets may be used as
monotherapy or in combination with insulin.
A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with
metformin hydrochloride as first-line therapy after diet failure (_see section 5.1, Pharmacodynamic properties_).
A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with
metformin hydrochloride as first-line therapy after diet failure (_see section 5.1, Pharmacodynamic properties _).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS:
_Monotherapy and combination with other oral antidiabetic agents:_
The usual starting dose is one tablet 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 dose may improve gastrointestinal
tolerability. The maximum recommended dose of metformin hydrochloride is 3 g daily, taken as 3 divided doses.
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