GLUCOSENSE MR 60mg Tablet

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

GLICLAZIDE

Διαθέσιμο από:

MEDISPEC (M) SDN.BHD

INN (Διεθνής Όνομα):

GLICLAZIDE

Μονάδες σε πακέτο:

6x10 Tablets; 3x10 Tablets; 10x10 Tablets

Κατασκευάζεται από:

Unison Laboratories Co. Ltd.

Φύλλο οδηγιών χρήσης

_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
GLUCOSENSE MR 60 MG TABLET
Gliclazide (60 mg) 1
WHAT IS IN THIS LEAFLET
1.
What
Glucosense
MR
60mg
is
used for
2.
How Glucosense MR 60mg works
3.
Before
you
use
Glucosense
MR
60mg
4.
How to use Glucosense MR 60mg
5.
While you are using it
6.
Side effects
7.
Storage and Disposal
of Glucosense MR 60mg
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT GLUCOSENSE MR 60MG
IS USED
FOR
Glucosense
MR
60mg,
modified
release tablet 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 GLUCOSENSE MR 60MG WORKS
Glucosense
MR
60mg,
modified
release
tablet
is
a
medicine
that
contains
Gliclazide
which
reduces
blood sugar levels (oral antidiabetic
medicine
belonging
to
the
sulfonylurea group).
BEFORE
YOU
USE
GLUCOSENSE
MR
60MG
_- When you must not use it _
•
if you are allergic to Gliclazide or
any
of
the
other
ingredients
of
Glucosense MR 60mg (listed in
_Ingredients_
),
or
to
other
medicines
of
the
same
group
(sulfonylurea), or to other related
medicines
(hypoglycemic
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
ketoacidosis), a diabetic pre-coma
or coma
•
if you have severe kidney or liver
disease
•
if
you
are
taking
medicines
to
treat
fungal
infections
(Miconazole)
_Pregnancy and breastfeeding _
Glucosense
MR
60mg
is
not
recommended
for
use
during
pregnancy.
If you are pregnant, think you may be
pregnant
or
are planning
to
have
a
baby,
ask
your
doctor
for
advice
before taking this medicine.
•
You must not take Glucosense MR
60mg while you are breastfeeding.
_ _
_Glucosense MR 60mg_
_contains lactose _
If you have been told by your doctor
that you have an intolerance to some
sugars,
contact
your
doctor
before
taking this

Αρχείο Π.Χ.Π.

1 of 3
GLUCOSENSE MR 60 MG TABLET
ANTIDIABETIC
Each modified release tablet contains:
GLICLAZIDE 60 MG

PRODUCT DESCRIPTION:
White, oblong, biconvex tablet with plain on one side and engraved GZ
60 on the other

MECHANISM OF ACTION:
_PHARMACOLOGY_
Gliclazide is a hypoglycemic sulfonylurea 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 hemovascular properties.
_ _
_Pharmacodynamic effects_
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.
Hemovascular 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
_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 Liters. A single daily intake of Gliclazide
MR 60 mg maintains effective Gliclazide plasma
concentrations over 24 hours.
Biotransformation
Gliclazide is mainly metabolized in the liver and excre