METKEM XR 1000 mg (Metformin Hydrochloride Extended Release Tablets 1000 mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

METFORMIN HYDROCHLORIDE

Boleh didapati daripada:

Ascend Laboratories Sdn Bhd

INN (Nama Antarabangsa):

METFORMIN HYDROCHLORIDE

Unit dalam pakej:

3 x 10 Tablets; 6 x 10 Tablets

Dikeluarkan oleh:

Alkem Laboratories Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
METKEM XR 1000MG (METFORMIN HYDROCHLORIDE
EXTENDED RELEASE TABLETS 1000 MG)
Metformin Hydrochloride (1000mg)
1
WHAT IS IN THIS LEAFLET
1.
What METKEM XR is used for
2.
How METKEM XR works
3.
Before you use METKEM XR
4.
How to take METKEM XR
5.
While you are using METKEM XR
6.
Side effects
7.
Storage and disposal of METKEM
XR
8.
Product description
9.
Manufacturer and product
registration holder
10.
Date of revision
11.
Serial Number
WHAT METKEM XR IS USED FOR
METKEM 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. METKEM 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 METKEM 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.
METKEM XR makes the body more
sensitive to insulin and helps return to
normal the way your body uses
glucose.
METKEM XR is associated with either
a stable body weight or modest weight
loss.
METKEM 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 USE METKEM XR
-
_When you must not use it _
Do not take METKEM XR if:
□
You have severely-reduced kidney
function.
□
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 to diabetic pre-coma. Symptoms of
acidosis may include st

Ciri produk

1
1.
NAME OF THE MEDICINAL PRODUCT
METKEM XR 1000mg (Metformin Hydrochloride Extended Release Tablets
1000 mg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each extended release tablet of METKEM XR 1000mg contains 1000 mg
metformin hydrochloride
corresponding to 779.88mg metformin base.
3.
PHARMACEUTICAL FORM
Extended release tablet.
White to off-white, oval shaped, uncoated tablet, debossed with
‘PR’ on one side and “1000
on the other side.
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 and
-
still progressing towards type 2 diabetes mellitus despite
implementation of intensive
lifestyle change for 3 to 6 months
Treatment with METKEM XR must be based on a risk score incorporating
appropriate measures
of glycaemic control and including evidence of high cardiovascular
risk.
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. METKEM XR may be used
as monotherapy or
in combination with other oral anti-diabetic agents or with insulin.
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 Metformin
Hydrochloride Extended Release
Tablets 500 mg once daily with the evening meal.
•
After
10
to
15
days
dose
adjustment
on
the
basis
of
blood
glucose
measurements
is
recommended (OGTT and/or FP