OZICLIDE MR TABLETS 60 mg

Ország: Malajzia

Nyelv: angol

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

Aktív összetevők:

GLICLAZIDE

Beszerezhető a:

RANBAXY (MALAYSIA) SDN. BHD.

INN (nemzetközi neve):

GLICLAZIDE

db csomag:

10x10tablet Tablets; 10X10tablet Tablets; 3x10 Tablets; 3x10 Tablets; 6x10 Tablets; 6x10 Tablets

Gyártó:

RANBAXY (MALAYSIA) SDN. BHD.

Betegtájékoztató

_CONSUMER MEDICATION INFORMATION LEAFLET _
OZICLIDE MR
_ _
Gliclazide Modified Release (60 mg)
_ _
Page
1
of
4
WHAT IS IN THIS LEAFLET
1.
What
OZICLIDE MR
is used for
2.
How
OZICLIDE MR
works
3.
Before you use
OZICLIDE MR
4.
How to use
OZICLIDE MR
5.
While you are using
OZICLIDE MR
6.
Side Effects
7.
Storage and Disposal of
OZICLIDE
MR
8.
Product Description
9.
Manufacturer & Product Registration
Holder
10.
Date of revision
11.
Serial Number
WHAT OZICLIDE MR IS USED FOR
OZICLIDE MR
is used to control blood
sugar level 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.
Follow all directions given to you by your
doctor carefully.
HOW OZICLIDE MR WORKS
OZICLIDE
MR
contains
gliclazide
which belongs to a group of medicines
called
sulphonylureas.
Sulphonylureas
work by reducing blood sugar levels.
Gliclazide in
OZICLIDE MR
is in a
“modified release” form. This means the
tablet releases active ingredient gradually
and therefore you only have to take the
tablet once a day
BEFORE YOU USE OZICLIDE MR S
-
_When you must not use it _
DO NOT USE OZICLIDE MR :

If you are allergic to gliclazide or any
of
the
other
ingredients
of
OZICLIDE
MR
,
or
to
other
medicines
of
the
same
group
(sulphonylureas)
or
to
other
related
medicines (sulphonamides).

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 (miconazole)

If you are breastfeeding
Do not take this medicine after the expiry
date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to
your pharmacist for disposal.
-
_Before you start to use it _
Tell your doctor if you have allergies to
any other medicines, foods, preservatives
or dyes.

Termékjellemzők

PRESCRIBING INFORMATION
FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER
OZICLIDE MR TABLETS
(Gliclazide Modified Release Tablets 60 mg)
COMPOSITION
Each modified release tablet contains:
Gliclazide …………60 mg
Excipients: Magnesium Stearate, Hypromellose, Pregelatinized starch,
Sodium citrate, Lactose, Purified
Water.
PRODUCT DESRIPTION
White to off white oblong tablets, engraved with ‘Z’ and ‘I’
on one side and plain on the other side.
DESCRIPTION
OZICLIDE MR TABLETS contain gliclazide. Gliclazide is a hypoglycaemic
sulfonylurea oral antidiabetic
drug.
It
is
chemically
designated
as
1-(hexahydrocyclopenta[c]pyrrol-2(1H)-yl)-3-[(4-
methylphenyl)sulphonyl]urea. The molecular formula of gliclazide is
C15H21N3O3S and its molecular
weight 323.4.
STRUCTURAL FOMULA
GLICLAZIDE
PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES
PHARMACODYNAMICS
Gliclazide is a hypoglycaemic 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 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.
PHARMACOKINETICS
Absorp