Metformin

Land: Armenien

Sprache: Englisch

Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Wirkstoff:

metformin (metformin hydrochloride)

Verfügbar ab:

Arpimed LLC

INN (Internationale Bezeichnung):

metformin (metformin hydrochloride)

Dosierung:

1000mg

Darreichungsform:

tablets film-coated

Verschreibungstyp:

Prescription

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS METFORMIN 1000 MG COATED TABLETS
1. NAME OF THE MEDICINAL PRODUCT - Metformin
NON-PROPRIETARY NAME - Metformin
2. QUANTITATIVE AND QUALITATIVE COMPOSITION
Each coated tablet contains:
ACTIVE INGREDIENT: Metformin hydrochloride - 1000 mg (equivalent to
780 mg of metformin);
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
White round biconvex coated tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of type 2 diabetes mellitus in adults, particularly in
overweight patients, when dietary
management and exercise alone does not result in adequate glycemic
control.
In adults, Metformin 1000 mg coated tablets 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, Metformin 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
A dose of 850 mg is not possible with Metformin 1000 mg. Another
appropriate formulation
should be used for a dose of 850 mg.
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 gastro-intestinal
tolerability.
In patients receiving a high metformin hydrochloride dose (2 to 3
grams per day), it is possible to
replace two Metformin 500 mg coated tablets with one Metformin 1000 mg
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,
the other agent should be
discontinued and metformin initiated at the dose indicated above.
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