GLUCODEX TABLET

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:

100Tablet Tablets

Manufactured by:

PT DEXA MEDICA

Patient Information leaflet

GLUCODEX TABLET
Gliclazide (80mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What GLUCODEX is used for
2.
How GLUCODEX works
3.
Before you use GLUCODEX
4.
How to use GLUCODEX
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
GLUCODEX
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT GLUCODEX
IS USED FOR
GLUCODEX is a medicine used to
lower blood glucose level in adult
patients with type 2 diabetes mellitus
when proper diet, physical exercise, and
weight loss are not sufficient to control
blood glucose.
HOW GLUCODEX WORKS
GLUCODEX
is
an
antidiabetic
agent
belongs
to
a
subfamily
of
medicines
called sulfonylureas. It stimulates insulin
secretion by the pancreas in the body.
Insulin is made by special cells in the
pancreas known as beta cells. In type 2
diabetes you either do not make enough
insulin for your body`s needs, and/or the
cells in your body are not able to use the
insulin properly.
By
stimulating
the
beta
cells
in
the
pancreas,
GLUCODEX
causing
more
insulin to be produced and this helps to
decrease the amount of sugar in
your
blood.
BEFORE YOU USE GLUCODEX
-
_When you must not use it_
_ _
Do not take GLUCODEX if:
_ _
•
You have insulin-dependent diabetes
or experienced of diabetes coma.
•
You are diabetic patients with acidosis
(an accumulation of acid in the body)
and ketosis (where the body converts
fat into energy) complications.
•
You are about to undergo surgery, or if
you have severe trauma or infection.
•
You have diabetes mellitus which
occurred during childhood or growing
period.
•
You have ever had an allergic or
hypersensitivity reaction to gliclazide
or to other sulfonylureas.
_ _
_Pregnancy and lactation _
Do not take GLUCODEX if you are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not take GLUCODEX if you are
breast-feeding. Ask your doctor or
pharmacist for advice before taking any
medicine.
_ _
-
_Before you start use it _
_ _
Talk to your doctor or pharmacist

Summary of Product characteristics

C. LEAFLET GLUCODEX
DESCRIPTION :
Round, white tablet, flat bevelled edge surfaces, odorless, tasteless,
printed a break-line on side I and
“DEXA” on side II.
COMPOSITION :
Each tablet contains
:Gliclazide........................................................80
mg
ACTION/PHARMACOLOGY :
Gliclazide is a hypoglycaemic sulfonylurea which stimulates insulin
secretion by the pancreas. Its action on
insulin secretation is mainly due to the restoration of the early
phase, resulting in a physiological release of
insulin.Gliclazide
has
been
reported
to
increase
glucose
metabolism
at
a
peripheral
level.
This
extrapancreatic action is not due to a modification in the number of
insulin receptor, but may be due to the
potentiation of the “post-receptor pathway”. Therefore, gliclazide
improves glycaemic control throughout 24
hours.
This
can
normalize
fasting
and
post-prandial
blood
sugar.
In
human,
apart
from
having
hypoglycaemic
effect,
gliclazide
has
been
reported
to
reduce
platelet
hyperadhesiveness
and
hyperaggregation and to increase fibrinolytic activity. These factors
are important in diabetes mellitus
patients with vascular complications. Study in patients with diabetes
retinopathy shows that gliclazide can
slow down the progression of retinopathy.
PHARMACOKINETICS
Oral absorption of gliclazide is similar in patients and healthy
volunteers, although intersubject variation in
time to reach peak plasma concentrations (t
max
) and age-related differences in peak plasma concentrations
(C
max
) and t
max
have been observed. Single-dose oral administration of gliclazide 40
to 120 mg results in a
C
max
of 2.2 to 8 mg/L within 2 to 8 hours. C
max
and t
max
are increased after repeated gliclazide
administration, although drug accumulation has not been observed.
Steady-state concentrations are
achieved after 2 days administration of gliclazide 40 to 120 mg. The
volume of distribution of gliclazide in
healthy volunteers and patients is low (13 to 24L) which may be
partially explained by extensive protein
binding (85 to 9