GLUCOPHAGE TABLET 850 mg

Țară: Singapore

Limbă: engleză

Sursă: HSA (Health Sciences Authority)

Ingredient activ:

Metformin hydrochloride

Disponibil de la:

MERCK PTE. LTD.

Codul ATC:

A10BA02

Dozare:

850 mg

Forma farmaceutică:

TABLET, FILM COATED

Compoziție:

Metformin hydrochloride 850 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

Prescription Only

Produs de:

MERCK SANTE SAS

Statutul autorizaţiei:

ACTIVE

Data de autorizare:

1992-05-04

Prospect

21
0
65
35
M
C-
15
21
-2
01
4
10
1 mini
10
12
12
170
170
170
170
12
12
Page 2
Page 3
Page 4
Page 1
2
1
1
1 mini
CODE 128A SUR COTE EXT BOBINE (CENTRE)
CODE 128A ON OUTSIDE BOBBIN (CENTER)
12
65
35
21
0
10
10
10
12
12
10
21
0
12
10
21
0
M
C-1
52
1-2
01
4
Co
de a
rtic
le
Le
afl
et co
de
CODE 128A SUR COTE EXT BOBINE (CENTRE)
CODE 128A ON OUTSIDE BOBBIN (CENTER)
CODE 128A SUR COTE INT BOBINE (CENTRE)
CODE 128A ON INSIDE BOBBIN (CENTER)
Code article
Leaflet code
Page 1
Page 1
Page 1
170
12
12
82.6
2
210
±0.5
70
-7
6
MAX. 600
35
35
21
0
65
65
M
C-
152
1-
20
14
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 

Caracteristicilor produsului

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