GLYADE (Servier Formulation) gliclazide 80mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gliclazide, Quantity: 80 mg

Available from:

Servier Laboratories (Aust) Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: pregelatinised maize starch; maize starch; magnesium stearate; lactose monohydrate; purified talc

Administration route:

Oral

Units in package:

100 tablets, 20 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 3 November 1999: Diabetes mellitus of the maturity onset type, which cannot be controlled by diet alone.

Product summary:

Visual Identification: 8 mm, round white tablet, cross-scored on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1999-11-19

Patient Information leaflet

GLYADE
®
_Immediate release tablets containing gliclazide (pronounced
gli-cla-zide)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about GLYADE.
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 GLYADE
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 GLYADE IS
The name of your medicine is
GLYADE.
GLYADE contains the active
ingredient 'gliclazide'.
Gliclazide belongs to a group of
medicines called sulphonylureas.
WHAT GLYADE IS USED
FOR
GLYADE 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 GLYADE IS USED FOR_
_TYPE II DIABETES MELLITUS_
GLYADE is used when diet and
exercise are not enough to control
your blood glucose.
GLYADE 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 important to control high
blood glucose whether or not you
feel unwell. This really helps to
avoid serious long-term health
problems, which can involve the
heart, eyes, circulation, and/or
kidneys.
A SECTION AT THE END OF THIS LEAFLET
CONTAINS ADVICE ABOUT RECOGNISING
AND TREATING HYPERGLYCAE

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
GLYADE
® TABLET, FILM COATED
Version: 11a
1/12
AUSTRALIAN PRODUCT INFORMATION
GLYADE
® TABLET, FILM COATED
1
NAME OF THE MEDICINE
Gliclazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each GLYADE tablet contains 80 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 45 mg of lactose
monohydrate.
For the full list of excipients, see _section 6.1 - List of
excipients_.
3
PHARMACEUTICAL FORM
Film-coated tablet: white, round, cross-scored on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Diabetes mellitus of the maturity onset type, which cannot be
controlled by diet alone.
4.2
D
OSE AND METHOD OF ADMINISTRATION
For adult use only.
GLYADE should be taken with food because there is increased risk of
hypoglycemia 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.
The daily dose may vary from 40 to 320 mg taken orally. The initial
recommended dose is 40 mg
(half tablet) daily, even in elderly patients (≥ 65 years) and may
be increased if necessary up to
320 mg (four tablets) daily. Doses up to 160 mg daily may be taken in
a single dose but preferably
at the same time each morning. Doses in excess of 160 mg should be
taken in divided doses in the
morning and evening.
In general, the dosage will depend on the severity of the glycaemia
with ongoing adjustments
made in order to obtain the optimal response at the lowest dosage.
Treatment with gliclazide does not obviate the necessity of
maintaining standard dietary
regulations.
4.3
C
ONTRAINDICATIONS
This medication is contra-indicated in the following cases:
AUSTRALIAN PRODUCT INFORMATION
GLYADE
® TABLET, FILM COATED
Version: 11a
2/12
−
hypersensitivity t