GLUCOPHAGE TABLET 1000 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Metformin hydrochloride

Available from:

MERCK PTE. LTD.

ATC code:

A10BA02

Dosage:

1000mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Metformin hydrochloride 1000mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Merck Santé s.a.s.

Authorization status:

ACTIVE

Authorization date:

2002-05-21

Patient Information leaflet

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1.  NAME OF THE MEDICINAL PRODUCT
GLUCOPHAGE 500 mg, film-coated tablet.
GLUCOPHAGE 850 mg, film-coated tablet.
GLUCOPHAGE 1000 mg, film-coated tablet.
2.  QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Glucophage 500 mg film-coated tablet contains 500 mg 
metformin hydrochloride corresponding to 390 mg metformin 
base.
Each Glucophage 850 mg film-coated tablet contains 
850 mg metformin hydrochloride corresponding to 662.9 mg 
metformin base.
Each Glucophage 1000 mg 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.
Glucophage 500 mg and Glucophage 850 mg tablets are white, 
circular, convex and film-coated.
Glucophage 1000 mg tablets are white, oval, biconvex and 
film-coated with a 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 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, Glucophage 
film-coated tablets may be used as monotherapy or in 

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
GLUCOPHAGE 500 mg, film-coated tablet.
GLUCOPHAGE 850 mg, film-coated tablet.
GLUCOPHAGE 1000 mg, film-coated tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Glucophage 500 mg film-coated tablet contains 500 mg metformin
hydrochloride
corresponding to 390 mg metformin base.
Each Glucophage 850 mg film-coated tablet contains 850 mg metformin
hydrochloride
corresponding to 662.9 mg metformin base.
Each Glucophage 1000 mg 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.
Glucophage 500 mg and Glucophage 850 mg tablets are white, circular,
convex and film-
coated.
Glucophage 1000 mg tablets are white, oval, biconvex and film-coated
with a 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
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, Glucophage
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 as first-line therapy after diet
failure (see section 5.1).
4.2. Posology and method of administration
Oral route
Adults with normal renal function (GFR > 90mL/min):
Monotherapy and combination with other oral antidiabetic agents:

The usual starting dose is one tablet of Glucophage 500 mg or 850 mg 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 gastro