DIAMICRON MR TABLET 30MG

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:

LES LABS SERVIER INDUSTRIE

Risalah maklumat

_Consumer Medication Information Leaflet (RIMUP) _
1
DIAMICRON
® MR MODIFIED RELEASE TABLET_ _
Gliclazide 30mg
WHAT IS IN THIS LEAFLET
1.
What DIAMICRON MR 30
mg is used for
2.
How
DIAMICRON
MR
30
mg works
3.
Before you use DIAMICRON
MR 30 mg
4.
How to use DIAMICRON MR
30 mg
5.
While
you
are
using
DIAMICRON MR 30 mg
6.
Side effects
7.
Storage
and
Disposal
of
DIAMICRON MR 30 mg
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10. Date of revisión
11. Serial number
WHAT DIAMICRON MR 30MG
IS USED FOR
DIAMICRON MR 30 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
30MG
WORKS
DIAMICRON
MR
30
mg
is
a
medicine that reduces blood sugar
levels (oral antidiabetic medicine
belonging
to
the
sulfonylurea
group).
BEFORE
YOU
USE
DIAMICRON
MR 30 MG
-
_When you must not use it _
_ _
DO NOT TAKE DIAMICRON MR
30 MG:
-
if
you
are
allergic
(hypersensitive) to gliclazide or
any of the other ingredients of
DIAMICRON MR 30 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 keto-
acidosis), 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 30 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

Ciri produk

Final PI_Diamicron MR 30mg_Gidy_17.05.2022
1
DIAMICRON MR
MODIFIED RELEASE TABLET
1.
NAME OF THE MEDICINAL PRODUCT
DIAMICRON 30 MG
, modified release tablet.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains gliclazide 30 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified release tablet.
White, oblong tablet engraved on both faces, ‘DIA 30’ on one face
and
on the other.
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 may vary from 1 to 4 tablets per day,
_i.e_
. from 30 to 120 mg taken orally in a
single intake at breakfast time.
It is recommended that the tablet(s) be swallowed whole.
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.
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.
•
Switching from Diamicron 80 mg tablets to Diamicron 30 mg modified
release tablets:
1 tablet of Diamicron 80 mg is comparable to 1 tablet of Diamicron 30
mg. Consequently
the switch can be performed provided a careful blood monitoring.
Final PI_Diamicron MR 30mg_Gidy_17.05.2022
2
•
Switching from another oral antidiabetic agent to Diamicron 30 mg:
Diamicron 30 mg can be used to repl