Glucophage

Land: Armenien

Sprog: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv bestanddel:

metformin (metformin hydrochloride)

Tilgængelig fra:

Merck Sante s.a.s.

INN (International Name):

metformin (metformin hydrochloride)

Dosering:

1000mg

Lægemiddelform:

tablets film-coated

Recept type:

Prescription

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1
1.
NAME OF THE MEDICINAL PRODUCT
GLUCOPHAGE 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 the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, oval, biconvex film-coated tablets with a score line on both
sides with « 1000 » engraved on
one side. 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, Glucophage may be used as monotherapy or in combination
with other oral
antidiabetic agents or with insulin.



In children from 10 years of age and adolescents, Glucophage 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 as first-line therapy after diet failure (see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_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 gastrointestinal tolerability.
In patients receiving a high metformin hydrochloride dose (2 to 3
grams per day), it is possible to
replace two Glucophage 500 mg film-coated tablets with one Glucophage
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 antidiabetic agent is intended:
discontinue the other agent and initiate
metformin at the dose indicated above.
2
COMBINATION WITH INSULIN
Metformin and insul