ARDIX GLICLAZIDE 60 mg MR gliclazide 60 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gliclazide, Quantity: 60 mg

Available from:

Servier Laboratories (Aust) Pty Ltd

INN (International Name):

Gliclazide

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: magnesium stearate; lactose monohydrate; colloidal anhydrous silica; maltodextrin; hypromellose

Administration route:

Oral

Units in package:

60, 20

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Type II Diabetes in association with dietary measures when dietary measures alone are inadequate to control blood glucose. During controlled clinical trials in patients with type II diabetes, a modified release formulation of gliclazide (30 mg-120 mg), taken as a single daily dose, was shown to be effective long term in controlling blood glucose levels, based on monitoring of HbA1c.

Product summary:

Visual Identification: White oblong tablets. Break bar. DIA 60 on both faces; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2009-11-11

Patient Information leaflet

ARDIX
® GLICLAZIDE 60
MG MR
_Modified Release tablets containing gliclazide (pronounced
gli-cla-zide)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about ARDIX
GLICLAZIDE 60 mg MR.
It does not contain all the available
information
Reading this leaflet does not take the
place of talking to your doctor,
pharmacist, or diabetes educator.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking ARDIX
GLICLAZIDE 60 mg MR against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR, PHARMACIST, OR DIABETES
EDUCATOR.
KEEP THIS LEAFLET WITH THE MEDICINE.
YOU MAY NEED TO READ IT AGAIN.
WHAT ARDIX
GLICLAZIDE 60 MG
MR IS
The name of your medicine is
ARDIX GLICLAZIDE 60 mg MR.
ARDIX GLICLAZIDE 60 mg MR
contains the active ingredient
'gliclazide'.
Gliclazide belongs to a group of
medicines called sulphonylureas. The
medicine releases the active
ingredient gliclazide progressively
over 24 hours.
WHAT ARDIX
GLICLAZIDE 60 MG
MR IS USED FOR
ARDIX GLICLAZIDE 60 mg MR is
used to control blood glucose (sugar)
in patients with Type II diabetes
mellitus. This type of diabetes is also
known as non-insulin-dependent
diabetes (NIDDM), or maturity-onset
diabetes).
_WHY ARDIX GLICLAZIDE 60_
_MG MR IS USED FOR TYPE II_
_DIABETES MELLITUS_
ARDIX GLICLAZIDE 60 mg MR is
used when diet and exercise are not
enough to control your blood
glucose.
ARDIX GLICLAZIDE 60 mg MR
can be used alone or together with
insulin or other medicines for
treating diabetes.
_HOW IT WORKS_
Glucose is used by the body as fuel,
and all people have glucose
circulating in their blood. In diabetes,
levels of blood glucose are higher
than is needed, which is also known
as hyperglycaemia.
If your blood glucose is not properly
controlled, you may experience
hypoglycaemia (low blood glucose)
or hyperglycaemia (high blood
glucose). High blood glucose can
lead to serious problems with our
heart, circulation and/or kidneys.
It is very

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ARDIX
® GLICLAZIDE 60 MG MR TABLET, MODIFIED RELEASE
Version: 8
1/14
AUSTRALIAN PRODUCT INFORMATION
ARDIX
® GLICLAZIDE 60 MG MR
1
NAME OF THE MEDICINE
Gliclazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ARDIX GLICLAZIDE 60 mg MR tablet contains 60 mg of gliclazide.
Gliclazide is an oral hypoglycaemic sulphonylurea which differs from
other related compounds by
an N-containing heterocyclic ring with an endocyclic bond.
Excipient with known effect: each tablet contains 71.36 mg of lactose
monohydrate.
For the full list of excipients, see _section 6.1 - List of
excipients_.
3
PHARMACEUTICAL FORM
Tablet, modified release: white, oblong, scored with a break bar on
both sides with an engraving of
"DIA 60" on both faces.
4 CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Type II diabetes in association with dietary measures when dietary
measures alone are inadequate
to control blood glucose.
During controlled clinical trials in patients with type II diabetes, a
modified release formulation of
gliclazide (30 mg - 120 mg), taken as a single daily dose, was shown
to be effective long term in
controlling blood glucose levels, based on monitoring of HbA1c.
4.2
D
OSE AND METHOD OF ADMINISTRATION
For adult use only.
ARDIX GLICLAZIDE 60 mg MR tablets have a break bar and may be
administered as whole or as
half tablets (see _section 5.2 – Pharmacokinetic properties_). So
that the modified release properties
of the product can be maintained, tablets should not be chewed or
crushed.
Whole or half tablets of ARDIX GLICLAZIDE 60 mg MR should be taken
with food because there is
an increased risk of hypoglycaemia if a meal is taken late, if an
inadequate amount of food is
consumed or if the food is low in carbohydrate. It is recommended that
the medication be taken at
breakfast time. If a dose is forgotten, the dose taken on the next day
should not be increased.
A single daily dose provides an effective blood glucose control. The
daily dose may vary from half
a tablet to two tablets per day i.