Glucophage XR 750mg Tablet

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

METFORMIN HYDROCHLORIDE

Available from:

MERCK SDN. BHD.

INN (International Name):

METFORMIN HYDROCHLORIDE

Units in package:

60Tablet Tablets; 30Tablet Tablets

Manufactured by:

MERCK SANTE S.A.S.

Patient Information leaflet

Consumer Medication Information Leaflet (RiMUP)
GLUCOPHAGE XR TABLET
Metformin Hydrochloride (500mg, 750mg & 1000mg)
What is in this leaflet
1.
What Glucophage XR is used for
2.
How Glucophage XR works
3.
Before you use Glucophage XR
4.
How to take Glucophage XR
5.
While you are using Glucophage
XR
6.
Side effects
7.
Storage and disposal of
Glucophage XR
8.
Product description
9.
Manufacturer and product
registration holder
10.
Date of revision
What Glucophage XR is used for
Glucophage XR prolonged release
tablets contain the active ingredient
metformin hydrochloride and belong
to a group of medicines called
biguanides, used in the treatment of
diabetes. Glucophage XR is used to
delay the onset and treat Type 2 (non-
insulin dependent) diabetes mellitus
when diet and exercise changes alone
have not been enough to control blood
glucose (sugar).
How Glucophage XR work
Insulin is a hormone produced by the
pancreas that makes your body take in
glucose (sugar) from the blood. Your
body uses glucose to produce energy
or stores it for future use.
If you have diabetes, your pancreas
does not make enough insulin or your
body is not able to use properly the
insulin it produces. This leads to a
high level of glucose in your blood.
Glucophage XR makes the body more
sensitive to insulin and helps return to
normal the way your body uses
glucose.
Glucophage XR is associated with
either a stable body weight or modest
weight loss.
Glucophage XR Prolonged Release
Tablets are specially made to release
the drug slowly in your body and
therefore are different to many other
types of tablet containing metformin.
Before you take Glucophage XR
When you must not take it
Do not take Glucophage XR if:

you are allergic to metformin or to
any of the other ingredients which
are listed later on in the leaflet.

If you have lactic acidosis [too
much lactic acid in the blood (see
“Risk of lactic acidosis”)] or
ketoacidosis. Ketoacidosis is a
condition in which substances
called 'ketone bodies' accumulate
in the blood and which can lead

Summary of Product characteristics

NAME OF THE MEDICINAL PRODUCT
Glucophage XR 750mg extended release tablet
Metformin hydrochloride
QUALITATIVE AND QUANTITATIVE COMPOSITION
One extended release tablet contains 750 mg metformin hydrochloride
corresponding to
585 mg metformin base.
For a full list of excipients, see List of excipients.
PHARMACEUTICAL FORM
Extended release tablet
White to off-white capsule-shaped, biconvex tablet, debossed on one
side with '750' and on
the other side with 'Merck'.
ROUTE OF ADMINISTRATION
Oral
CLINICAL PARTICULARS
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*, and/or increased HbA1C who
are:
-
at high risk for developing overt type 2 diabetes mellitus (see
section
Pharmacodynamic properties) and
-
still progressing towards type 2 diabetes mellitus despite
implementation of
intensive lifestyle change for 3 to 6 months
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 Pharmacodynamic properties).
Lifestyle modifications should be continued when metformin is
initiated, unless the
patient is unable to do so because of medical reasons.
*IGT: Impaired Glucose Tolerance; IFG: Impaired Fasting Glucose

Treatment of type 2 diabetes mellitus in adults, 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.
A reduction of diabetic complications has been shown in overweight
type 2 diabetic
patients treated with immediate release metformin as first-line
therapy after diet failure
(see Pharmacodynamic properties).
Posology and method of administration
Adults with normal renal function (GFR≥ 90 mL/min)
Reduction in the risk or delay of the onset of type 2 diabetes

Metformin should only be considered where intensive lifestyle
modifications for 3 to