Glucophage XR 500 mg Extended Release Tablet

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Metformin hydrochloride

Available from:

MERCK PTE. LTD.

ATC code:

A10BA02

Dosage:

500 mg

Pharmaceutical form:

TABLET, EXTENDED RELEASE

Composition:

Metformin hydrochloride 500 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Merck Sante sas (Semoy)

Authorization status:

ACTIVE

Authorization date:

2007-04-12

Patient Information leaflet

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1.  NAME OF THE MEDICINAL PRODUCT
Glucophage XR 500 mg extended release tablet
Glucophage XR 750 mg extended release tablet
Glucophage XR 1000 mg extended release tablet
2.  QUALITATIVE AND QUANTITATIVE COMPOSITION
One Glucophage XR 500 mg extended release tablet contains 500 mg 
metformin hydrochloride corresponding to 390 mg metformin base.
One Glucophage XR 750 mg extended release tablet contains 750 mg 
metformin hydrochloride corresponding to 585 mg metformin base.
One Glucophage XR 1000 mg extended release tablet contains 1000 mg 
metformin hydrochloride corresponding to 780 mg metformin base.
For excipients, see section 6.1.
3.  PHARMACEUTICAL FORM
Extended release tablet
Glucophage XR 500 mg : White to off-white, capsule-shaped, biconvex 
tablet, debossed on one side with “500”
Glucophage XR 750 mg: White to off-white,capsule-shaped, biconvex 
tablet, debossed on one side with '750' and on
the other side with 
'Merck'.
Glucophage XR 1000 mg: White to off-white, capsule-shaped, biconvex 
tablet, debossed on one side with “1000” and on the other side
with 
'Merck'.
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 glycaemic control.
Glucophage XR may be used as monotherapy or in combination with 
other oral antidiabetic agents, or with insulin.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Monotherapy and combination with other oral antidiabetic agents._
Glucophage XR 500 mg
•  The usual starting dose of Glucophage XR 500 mg is one tablet 
once daily with the evening meal.
•  Glucophage XR tablets must be swallowed whole and never 
crushed or chewed.
•  After 10 to 15 days the dose should be adjusted on the basis
of 
blood glucose measurements. 
•  To improve gastrointestinal

Summary of Product characteristics

MERCK
GLUCOPHAGE XR 500MG – 750MG – 1000MG EXTENDED RELEASE TABLETS
METFORMIN HYDROCHLORIDE
1. NAME OF THE MEDICINAL PRODUCT
Glucophage XR 500 mg extended release tablet
Glucophage XR 750 mg extended release tablet
Glucophage XR 1000 mg extended release tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One Glucophage XR 500 mg extended release tablet contains 500 mg
metformin hydrochloride corresponding to 390 mg
metformin base.
One Glucophage XR 750 mg extended release tablet contains 750 mg
metformin hydrochloride corresponding to 585 mg
metformin base.
One Glucophage XR 1000 mg extended release tablet contains 1000 mg
metformin hydrochloride corresponding to 780 mg
metformin base.
For excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Extended release tablet
Glucophage XR 500 mg: White to off-white, round shaped, biconvex
tablet, debossed on one side with “500”
Glucophage XR 750 mg: White to off-white, capsule-shaped, biconvex
tablet, debossed on one side with '750' and on the other
side with 'Merck'.
Glucophage XR 1000 mg: White to off-white, capsule-shaped, biconvex
tablet, debossed on one side with “1000” and on the
other side with 'Merck'.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Reduction in the risk or delay of the onset of type 2 diabetes
mellitus in adult, overweight patients with IGT* and/or IFG* who
are:
- at high risk for developing overt type 2 diabetes mellitus (see
section 5.1) and
- not suitable for intensive lifestyle modifications.
Treatment with Glucophage XR must be based on a risk score
incorporating appropriate measures of glycaemic control and
including evidence of high cardiovascular risk (see section 5.1).
*IGT: Impaired Glucose Tolerance; IFG: Impaired Fasting Glucose
•
Treatment of type 2 diabetes mellitus in adults, particularly in
overweight patients, when dietary management and exercise
alone does not result in adequate glycaemic control.
Glucophage XR may be used as monotherapy or in combination with other
oral antidiabetic agents, or with insulin.
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