DIAMICRON MR 60MG MODIFIED RELEASED TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

GLICLAZIDE

Boleh didapati daripada:

SERVIER MALAYSIA SDN BHD

INN (Nama Antarabangsa):

GLICLAZIDE

Unit dalam pakej:

60tablet Tablets

Dikeluarkan oleh:

KOTRA PHARMA (M) SDN. BHD.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
DIAMICRON
® MR 60 MG
MODIFIED RELEASE TABLET_ _
_Gliclazide_
60mg WHAT IS IN THIS LEAFLET
1.
What DIAMICRON MR 60 mg
is used for
2.
How DIAMICRON MR 60 mg
works
3.
Before you use DIAMICRON
MR 60 mg
4.
How to use DIAMICRON MR
60 mg
5.
While
you
are
using
DIAMICRON MR 60 mg
6.
Side effects
7.
Storage
and
Disposal
of
DIAMICRON MR 60 mg
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DIAMICRON MR 60MG
IS USED FOR
DIAMICRON MR 60 mg is used in
a certain form of diabetes (type 2
diabetes mellitus) in adults, when
diet, exercise and weight loss alone
do not have an adequate effect on
keeping blood sugar at the correct
level.
HOW
DIAMICRON MR 60MG
WORKS
DIAMICRON
MR
60
mg
is
a
medicine that reduces blood sugar
levels
(oral
antidiabetic
medicine
belonging
to
the
sulfonylurea
group).
BEFORE YOU USE DIAMICRON
MR 60 MG
-
_When you must not use it _
_ _
DO NOT TAKE DIAMICRON MR
60 MG:
-
if you are allergic to gliclazide or
any of the other ingredients of
DIAMICRON MR 60 mg, or to
other
medicines
of
the
same
group (sulfonylurea), or to other
related
medicines
(hypoglycaemic sulfonamides);
-
if
you
have
insulin-dependent
diabetes (type 1);
-
if you have ketone bodies and
sugar in your urine (this may
mean
you
have
diabetic
ketoacidosis),
a
diabetic
pre-
coma or coma;
-
if you have severe kidney or liver
disease;
-
if you are taking medicines to
treat
fungal
infections
(miconazole, see Section
“Taking other medicines”);
-
if
you
are
breastfeeding
(see
Section
“Pregnancy
and
breastfeeding”).
-
_Before you start to use it _
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking
DIAMICRON
MR
60
mg.
You
should observe the treatment plan
prescribed by your doctor to achieve
proper
blood
sugar
levels.
This
means,
apart
from
regular
tablet
intake,
to
observe
the
dietary
regimen, have physical exercise and,
where necessary, reduce weight.
During gliclazide treatment regular
monitoring
of
your
blood
(and
possibly urine) sugar

Ciri produk

Final PI_Diamicron_MR_60mg_Kotra_17.05.2022
1
DIAMICRON MR 60 MG
MODIFIED RELEASE TABLET
1.
NAME OF THE MEDICINAL PRODUCT
DIAMICRON 60 mg, modified release tablet.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One modified release tablet contains gliclazide 60 mg
Excipient with known effect: lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified release tablet.
White, oblong, tablet,
15 mm long and 7 mm wide, scored and engraved, with ‘DIA 60’ on
both faces.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non insulin-dependent diabetes (type 2) in adults when dietary
measures, physical exercise and weight
loss alone are not sufficient to control blood glucose.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The daily dose of DIAMICRON 60 mg may vary from one half to 2 tablets
per day,
_i.e_
.from 30 to
120 mg taken orally in a single intake at breakfast time.
It is recommended to swallow the dose without crushing or chewing.
If a dose is forgotten, there must be no increase in the dose taken
the next day.
As with any hypoglycaemic agent, the dose should be adjusted according
to the individual patient's
metabolic response (blood glucose, HbAlc).
•
Initial dose
The recommended starting dose is 30 mg daily (half a tablet of
DIAMICRON 60 mg). If blood
glucose is effectively controlled, this dose may be used for
maintenance treatment.
If blood glucose is not adequately controlled, the dose may be
increased to 60, 90 or 120 mg daily, in
successive steps. The interval between each dose increment should be
at least 1 month except in
patients whose blood glucose has not reduced after two weeks of
treatment. In such cases, the dose
may be increased at the end of the second week of treatment.
The maximum recommended daily dose is 120 mg.
Final PI_Diamicron_MR_60mg_Kotra_17.05.2022
2
One DIAMICRON 60 mg modified release tablet is equivalent to two
DIAMICRON 30 mg modified
release tablets. The breakability of the DIAMICRON 60