DIAMICRON TABLET 0.08G

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
® 80 MG_ _
_Gliclazide 80mg _
WHAT IS IN THIS LEAFLET
1.
What DIAMICRON 80 mg is
used for
2.
Before you use DIAMICRON
80 mg
3.
How to use DIAMICRON 80
mg
4.
While you are using it
5.
Side effects
6.
Storage
and
Disposal
of
DIAMICRON 80 mg
7.
Product Description
8.
Manufacturer
and
Product
Registration Holder
9.
Date of revision
10. Serial number
WHAT
DIAMICRON
80
MG
IS
USED FOR
This medicine is intended for use
in cases of non-insulin-dependent
diabetes, when it is not controlled
by diet.
BEFORE YOU USE DIAMICRON 80
MG
- _When you must not use it_
DO
NOT
TAKE
DIAMICRON
80
MG:
-
if
you
are
allergic
to
gliclazide, or any of the other
ingredients of DIAMICRON
80 mg (listed in excipients),
or to other medicines of the
same group (sulphonylureas),
or to other related medicines
(hypoglycaemic
sulphonamides)
-
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 suffer from severe liver
or kidney disease,
-
if you are taking medicines to
treat
fungal
infections
(miconazole,
see
section
“Taking other medicines”);
-
if you are breast-feeding (see
section
“Pregnancy,
breast-
feeding and fertility”).
Ask
your
doctor
or
your
pharmacist
for
advice
before
taking any medicine.
-
_Before you start to use it _
Talk to your doctor or pharmacist
before
taking
DIAMICRON
80
mg.
You should observe the treatment
plan prescribed by your doctor to
achieve proper blood sugar levels.
This
means,
apart
from
regular
tablet
intake,
you
observe
the
dietary
regimen,
have
physical
exercise
and,
where
necessary,
reduce weight.
During
gliclazide
treatment
regular monitoring of your blood
(and
possibly
urine)
sugar
level
and
also
your
glycated
haemoglobin
(HbA1c)
is
necessary.
In the first few weeks of treatment
the risk of having reduced blood
sugar levels (hypoglycaemia) may
be increased. So particularly close
medical monitoring is necessary.
L

Ciri produk

_Final PI_Diamicron 80mg_17.05.2022_
1
Diamicron
DIAMICRON
INN: Gliclazide
1.
NAME OF THE MEDICINAL PRODUCT
DIAMICRON 80 MG
, scored tablet.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gliclazide……………………………………………………………………………………...........80
mg
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Scored tablet.
Round, flat, white tablets, cross-scored on one face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC I
NDICATIONS
Non-insulin dependent diabetes, in association with an adapted diet,
in cases where dietary measures
alone provide inadequate control blood glucose levels
.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
RESTRICTED TO ADULTS.
As with any hypoglycaemic agent, the dosages should be adjusted to the
particular circumstances.
In the event of a transitory loss of blood glucose control in a
patient where good control is usually achieved
by diet, it may be sufficient to administer this product for a short
period.
_Patients under the age of 65 _
INITIAL DOSE:
The recommended initial dose is one
tablet per day.
DOSAGE STEPS:
Adjustments in posology are usually made in steps of one tablet at a
time, depending on the response in
blood glucose. At least 14 days should separate successive steps in
the dose.
MAINTENANCE TREATMENT:
The posology can vary from 1 to 3, or rarely 4, tablets per day.
The standard dosage is 2 tablets a day, as 2 daily doses.
_Final PI_Diamicron 80mg_17.05.2022_
2
_Patients at particular risk _
PATIENTS OVER THE AGE OF 65:
Begin the treatment with a half-tablet once a day.
The dose can be progressively increased until the patient's blood
glucose is satisfactorily controlled, while
keeping to steps of at least 14 days between successive levels, and
with close monitoring of blood glucose.
OTHER PATIENTS AT PARTICULAR RISK:
In patients who are malnourished or showing markedly poor general
state of health, or whose calorie intake
is irregular, or whose kidney or liver fun