GLUCOPHAGE 500MG 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:

120 Tablets

Manufactured by:

MERCK SANTE S.A.S.

Patient Information leaflet

Consumer Medication Information Leaflet (RiMUP)
1
GLUCOPHAGE
®
FILM-COATED TABLET
Metformin hydrochloride (500mg, 850mg, 1000mg)
What is in this leaflet
1.
What Glucophage is used for
2.
How Glucophage works
3.
Before you take Glucophage
4.
How to take Glucophage
5.
While you are taking it
6.
Side effects
7.
Storage and Disposal of
Glucophage
8.
Product Description
9.
Manufacturer and Product
registration holder
10. Date of revision
What Glucophage is used for
Glucophage contains metformin, a
medicine to treat diabetes. It belongs
to a group of medicines called
biguanides.
Glucophage is used to treat patients
with type 2 diabetes (also called
'non-insulin dependent diabetes')
when diet and exercise alone have
not been enough to control your
blood glucose levels. It is used
particularly in overweight patients.
Adults can take Glucophage on its
own or together with other medicines
to treat diabetes (medicines taken by
mouth or insulin).
Children 10 years and over and
adolescents can take Glucophage on
its own or together with insulin.
How Glucophage works
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 helps to lower your
blood glucose to as normal a level as
possible.
If you are an overweight adult,
taking Glucophage over a long
period of time also helps to lower the
risk of complications associated with
diabetes. Glucophage is associated
with either a stable body weight or
modest weight loss.
Before you take Glucophage
- When you must not take it
Do not take Glucophage
 if you are allergic
(hypersensitive) to metformin or
any of the other ingredients of
this medicine (see Product
Description, Ingredients)
 if you have severely
reduced kidney function
 if you have uncontrolled diabetes,

Summary of Product characteristics

Classification: INTERNAL
NAME OF THE MEDICINAL PRODUCT
GLUCOPHAGE 500 mg film-coated tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 500 mg metformin hydrochloride
corresponding to 390 mg
metformin base.
For a full list of excipients, see section List of excipients.
PHARMACEUTICAL FORM
Film-coated tablet.
White, circular, convex film-coated tablets.
ROUTE OF ADMINISTRATION
Oral
CLINICAL PARTICULARS
Therapeutic indications
Treatment of type 2 diabetes mellitus, when dietary management and
exercise alone does not result
in adequate glycaemic control.
-
In adults, GLUCOPHAGE® 500 mg film-coated tablet 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® 500 mg
film-coated tablet 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
Pharmacodynamic properties).
Posology and method of administration
Adults with normal renal function (GFR≥ 90 mL/min):
Monotherapy and combination with other oral antidiabetic agents:
-
The usual starting dose is one tablet 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.
-
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:
Metformin and insulin may be used in combination therapy to achieve
better blood glucose control.
Metformin hydrochloride is given at the usual starting dose of one
tablet 2 or 3 times daily, while
insulin dosage is adjusted on the basis of blood glucose measurements.
Classification: INTERN