Plecaz MR Tablet 60mg

Country: Malaysia

Language: English

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

Active ingredient:

GLICLAZIDE

Available from:

PHARMANIAGA MANUFACTURING BERHAD

INN (International Name):

GLICLAZIDE

Units in package:

3 x10 Tablets

Manufactured by:

PHARMANIAGA MANUFACTURING BERHAD

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
PLECAZ MR TABLET 60MG
Gliclazide 60mg
Page 1
of
3
WHAT IS IN THIS LEAFLET
1.
What Plecaz MR 60mg is used
for
2.
How Plecaz MR 60mg works
3.
Before you use Plecaz MR 60mg
4.
How to use Plecaz MR 60mg
5.
While you are using Plecaz MR
60mg
6.
Side Effects
7.
Storage and Disposal of Plecaz
MR 60mg
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT PLECAZ MR 60MG IS USED FOR
_Plecaz MR _
is a tablet that contains
gliclazide as the active ingredient.
_Plecaz MR _
is used for 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 PLECAZ MR 60MG WORKS
_Plecaz MR _
is a medicine that reduces
blood
sugar
levels
(oral
antidiabetic
medicine
belonging
to
the
sulfonylurea group).
BEFORE YOU USE PLECAZ MR 60MG
_-When you must not use it_
Do not take
_Plecaz MR _
if you:
▪
if you are allergic to gliclazide or
any
of
the
other
ingredients
of
_Plecaz MR_
, 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.
▪
if you are breastfeeding.
_- Before you start to use it_
If you are not sure if any of these
apply to you, talk to your doctor or
pharmacist before taking
_Plecaz MR_
.
Low blood sugar (Hypoglycaemia)
may occur:
▪
if you take meals irregularly or
skip meals altogether
▪
if you are fasting
▪
if you are malnourished
▪
if you change your diet
▪
if you increase your physical
activity
and
carbohydrate
intake
does not match this increase
▪
if you refuse to co-operate
especially in elderly patient.
▪
if you take other medicines or
natural remedies at the same time
▪
i

Summary of Product characteristics

Gliclazide
_PLECAZ MR_
PRODUCT NAME:
Plecaz MR Tablet 60 mg
DESCRIPTION
15 mm length, white to off white uncoated oblong tablet, plain on one
side and Pharmaniaga
logo on the other side. PLECAZ MR 60 mg should not be split into half.
COMPOSITION
Each modified release tablet contains Gliclazide 60 mg.
PHARMACODYNAMICS
Gliclazide is a hypoglycaemic sulphonylurea oral antidiabetic active
substances 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 in insulin release response to stimulation induced by a meal
or glucose.
In type 2 diabetics, gliclazide restores the first peak of insulin
secretion in response to glucose
and increase 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
compilations 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.
PHARMACOKINETICS
Absorption
Plasma levels increase progressively during the first 6 hours,
reaching a plateau which is
maintained from the 6 to 12 hours 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 Plecaz MR Tablet maintains effective gliclazide
plasma concentrations
over 24 hou