Metfogamma 1000

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

metformin (metformin hydrochloride)

Available from:

Dragenopharm Apotheker Puschl GmbH

INN (International Name):

metformin (metformin hydrochloride)

Dosage:

1000mg

Pharmaceutical form:

tablets film-coated

Prescription type:

Prescription

Summary of Product characteristics

MODULE 1.3.1 SPC
DE/H/745/01/MR
Version 20.10.2010
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Metfogamma® 1000
Metfogamma 1000 mg, film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 1000 mg metformin hydrochloride
corresponding to 780 mg
metformin base.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, oblong film-coated tablets with scoreline on one side and a
deep breakline on the other (snap-
tab shaped). The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of type 2 diabetes mellitus, particularly in overweight
patients when dietary management
and exercise alone does not result in adequate glycaemic control.
•
In adults, Metfogamma 1000 mg, film-coated tablets may be used as
monotherapy or in
combination with other oral anti-diabetic agents or with insulin.
•
In children from 10 years of age and adolescents, Metfogamma 1000 mg,
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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
_Monotherapy and combination with other oral antidiabetic agents: _
_ _
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 dose may improve the 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 Metfogamma 1000 mg,
film-coated tablet. The maximum recommended daily dose of metformin
hydrochloride is 3 g daily,
taken as 3 divided doses.
If transfer from another oral antidiab