Glucophage

Country: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Virkt innihaldsefni:

metformin (metformin hydrochloride)

Fáanlegur frá:

Merck Sante s.a.s.

INN (Alþjóðlegt nafn):

metformin (metformin hydrochloride)

Skammtar:

850mg

Lyfjaform:

tablets film-coated

Gerð lyfseðils:

Prescription

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
1.
NAME OF THE MEDICINAL PRODUCT
GLUCOPHAGE 850 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 850 mg metformin hydrochloride
corresponding to 662.9 mg
metformin base.
For the 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 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. 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.
_Combination with insulin_
Metformin and insulin may be used in combination therapy to achieve
better blood glucose control.
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 blood glucose
measurements.
2
_Elderly_
Due to the potential for decreased renal fun