APO-GLICLAZIDE MR 60 mg tablets

Country: Malaysia

Language: English

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

Active ingredient:

GLICLAZIDE

Available from:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (International Name):

GLICLAZIDE

Units in package:

100 Tablets; 30 Tablets

Manufactured by:

APOTEX INC

Patient Information leaflet

APO-GLICLAZIDE MR TABLETS
Gliclazide (30mg, 60mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Apo-Gliclazide is used for
2.
How Apo-Gliclazide works
3.
Before you use Apo-Gliclazide
4.
How to use Apo-Gliclazide
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Apo-
Gliclazide
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT APO-GLICLAZIDE
IS USED FOR
Apo-Gliclazide consist the active
ingredient gliclazide, which 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 APO-GLICLAZIDE WORKS
Gliclazide is a medicine that reduces
blood sugar levels (oral antidiabetic
medicine belonging to the sulphonylurea
group).
BEFORE YOU USE APO-GLICLAZIDE
-
_When you must not use it_
_ _
You should not take Apo-Gliclazide:
- if you have any allergies to
gliclazide, or any ingredients in this
medication.
- if you have insulin-dependent
diabetes (type 1)
- if you have ketone bodies and sugar
in your urine, a diabetic pre-coma, or
coma
- if you have severe kidney and liver
diseases
- if you are under treatment with
miconazole (for fungal).
_ _
_Pregnancy and lactation _
Do not take Apo-Gliclazide if you are
pregnant, trying to get pregnant or
think you may be pregnant.
Do not take Apo-Gliclazide if you are
breast-feeding. Ask your doctor or
pharmacist for advice before taking
any medicine.
_ _
-
_Before you start to use it_
_ _
Before you start to use this medication,
make sure that your doctor knows that:
- if you have any other medical
conditions, including kidney and liver
diseases.
- if you have low blood glucose
- if you have G6PD-deficiency with
sulphonylurea agents (medicine used
for blood glucose)
-
_Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that
you buy without a prescription from a
pharmacy, supermarket or health food
shop.
So

Summary of Product characteristics

APO‐GLICLAZIDE MR 60MG TABLETS
GLICLAZIDE MODIFIED RELEASE TABLETS
GLICLAZIDE 60MG
HYPOGLYCEMIC SULFONYLUREA ‐ ORAL ANTIDIABETIC AGENT
PRODUCT DESCRIPTION
APO‐GLICLAZIDE MR 60 mg tablets: White to off‐white, oval shaped
biconvex
tablets. Engraved “GL” bisect “60” on one side, “APO”
bisect “APO” on the
other side.
PHARMACOLOGY
Pharmacodynamics
Gliclazide is a hypoglycaemic sulphonylurea oral 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
B
2
).
• An action on the vascular endothelium fibrinolytic activity with
an increase
in tPA activity.
Pharmacokinetics
Absorption: Plasma levels increase progressively during the first 6
hours,
reaching a plateau which is maintained from the sixth to the twelfth
hour
after
administration.
Intra‐individual
variability
is
low.
Gliclazide
is
completely 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 30 litres. A single daily intake of Bilxona
maintains
effective gliclazide plasma concent