Glucophage XR 1000mg Extended release tablet

Nazione: Malesia

Lingua: inglese

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

Principio attivo:

METFORMIN HYDROCHLORIDE

Commercializzato da:

MERCK SDN. BHD.

INN (Nome Internazionale):

METFORMIN HYDROCHLORIDE

Confezione:

30tablet Tablets; 60tablet Tablets

Prodotto da:

MERCK SANTE S.A.S.

Foglio illustrativo

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

Scheda tecnica

1
1.
NAME OF THE MEDICINAL PRODUCT
GLUCOPHAGE XR 1000 mg Extended release tablet
Metformin hydrochloride
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each extended release tablet of Glucophage XR 1000mg contains 1000 mg
metformin hydrochloride
corresponding to 780 mg metformin base.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Extended release tablet.
White to off-white, capsule shaped, biconvex tablet, debossed on one
side with ‘1000’ and on the other
side with ‘Merck’.
Route of Administration
Oral
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*, 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 anti-diabetic agents or with insulin.
2
4.2 Posology and method of administration
Posology
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 6 months
have not resulted in adequate glycaemic control.
•
The therapy should be initiated with one tablet Glucophage XR 500 mg
once dail