Glucophage Tab 1 g

Land: Jordan

Sprog: engelsk

Kilde: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Aktiv bestanddel:

Metformin Hcl 1 g

Tilgængelig fra:

مستودع ادوية النابلسي - Nabulsi Drug Store

ATC-kode:

A10BA02

INN (International Name):

Metformin Hcl 1 g

Dosering:

1 g

Enheder i pakken:

30

Fremstillet af:

MERCK SANTE S.A.S(SEMOY)/FRANCE (فرنسا)

Produkt oversigt:

2.25 :سعر الجمهور + الضريبة

Indlægsseddel

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FR2586021
1000 MG
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 with normal renal function (GFR≥ 90 mL/min)_
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.
COMBINATION WITH INSULIN