IDAMAN PHARMA GLICLAZIDE TABLET 80MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

GLICLAZIDE

Boleh didapati daripada:

IDAMAN PHARMA MANUFACTURING SDN BHD

INN (Nama Antarabangsa):

GLICLAZIDE

Unit dalam pakej:

6 x 10’s Tablets; 10 x 10’s Tablets; 50 x 10’s Tablets

Dikeluarkan oleh:

IDAMAN PHARMA MANUFACTURING SDN BHD

Risalah maklumat

Page 1 of 2
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
IDAMAN PHARMA GLICLAZIDE TABLET 80MG
Gliclazide (80mg)
WHAT IS IN THIS LEAFLET
1.
What Idaman Pharma Gliclazide Tablet
is used for
2.
How Idaman Pharma Gliclazide Tablet
works
3.
Before
you
use
Idaman
Pharma
Gliclazide Tablet
4.
How to use Idaman Pharma Gliclazide
Tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Idaman Pharma
Gliclazide Tablet
8.
Product Description
9.
Product
Registration
Holder
&
Manufacturer
10.
Date of Revision
WHAT IDAMAN PHARMA GLICLAZIDE TABLET IS
USED FOR
This medicine used for adults with type 2
diabetes, when diet, exercise and weight
loss alone do not have an adequate effect on
keeping blood sugar at the correct level.
HOW IDAMAN PHARMA GLICLAZIDE TABLET
WORKS
Gliclazide is an oral antidiabetic medicine
belonging to the sulfonylurea group, which
reduces
blood
glucose
levels
by
stimulating the secretion of insulin.
BEFORE
YOU
USE
IDAMAN
PHARMA
GLICLAZIDE TABLET
-
_When you must not use it_
_ _
Do not take:
-
If you are allergic to Gliclazide or other
sulfonylureas or sulfonamides or to any
of excipients as listed at the end of this
leaflet
-
If you have diabetes
requiring
treatment with insulin,
-
In
case
of
diabetes
complicated
by
keto- acidosis, diabetic pre-coma,
-
If you suffer from severe liver or kidney
disease,
-
If
you
are
in
a
treatment
with
miconazole,
phenylbutazone,
danazol
or medicine containing alcohol
-
If you are breast-feeding
_Pregnancy and breast-feeding _
There is no data concerning the use of
Gliclazide in pregnant woman; even though
there are few data with other sulfonylurea.
Studies
in
animals
have
shown
reproductive toxicity. As a precautionary
measure, it is preferable to avoid the use of
Gliclazide during pregnancy.
Control of diabetes should be obtained
before the time of conception to reduce the
risk
of
congenital
abnormalities
due
to
uncontrolled diabetes.
During
pregnancy,
oral
hypoglycemic
agents are not suitable, so insulin is the first
choice for the treatmen

Ciri produk

IDAMAN PHARMA MANUFACTURING
IDAMAN PHARMA GLICLAZIDE TABLET 80MG
DESCRIPTION
White
to
off
white,
round,
flat,
bevelled-
edge
tablet
and
scored on one side.
EACH TABLET CONTAINS: Gliclazide 80mg
ROUTE OF ADM
I
N
I
STRAT
I
ON
Oral
PHARMACODYNAM
I
CS
Pharmacotherapeutic group: sulphonamides, urea derivatives.
ATC code: A10BB09
_MECHANISM OF ACTION _
Gliclazide is a hypoglycaemic sulfonylurea antidiabetic active
substance differing from other related compounds by an N-
containing heterocyclic ring with an endocyclic bond.
Gliclazide reduces blood glucose levels by stimulating insulin
secretion from the β-cells of the islets of Langerhans. Increase
in postprandial insulin and C-peptide secretion persists after
two
years
of
treatment.
In
addition
to
these
metabolic
properties, gliclazide has haemovascular properties.
_EFFECTS ON INSULIN RELEASE _
In type 2 diabetics, gliclazide restores the first peak of insulin
secretion
in
response
to
glucose
and
increases
the
second
phase
of
insulin
secretion.
A
significant
increase
in
insulin
response is seen in response to stimulation induced by a meal
or glucose.
_HAEMOVASCULAR PROPERTIES _
Gliclazide
decreases
microthrombosis
by
two
mechanisms
which may be involved in complications of diabetes:
• A partial inhibition of platelet aggregation and adhesion, with
a
decrease
in
the
markers
of
platelet
activation
(beta
thromboglobulin, thromboxane B2),
• An action on the vascular endothelium fibrinolytic activity
with an increase in tPA activity.
PHARMACOK
I
NET
I
CS
_ABSORPTION _
Plasma
levels
increase
reaching
maximal
concentrations
between 2 and 6 hours. Gliclazide is well absorbed. Food intake
does not affect the rate or degree of absorption.
_DISTRIBUTION _
Plasma protein binding is approximately 95%. The volume of
distribution is around 19 liters.
_BIOTRANSFORMATION _
Gliclazide is mainly metabolised in the liver and excreted in the
urine; less than 1% of the dose is excreted unchanged in the
urine. No active metabolites have been detected in plasma.
_ELIMINATION _
The elim