APO-GLICLAZIDE gliclazide 80mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gliclazide, Quantity: 80 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; croscarmellose sodium; magnesium stearate; colloidal anhydrous silica

Administration route:

Oral

Units in package:

100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Indicated for the treatment of diabetes mellitus of the maturity onset type, which cannot be controlled by diet alone.

Product summary:

Visual Identification: WHITE, ROUND FLAT-SIDED TABLETS WITH BEVELLED EDGES, ENGRAVED 'APO' OVER '80' ON ONE SIDE, CROSS-SCORED ON THE OTHER SIDE.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2002-06-17

Patient Information leaflet

APO-GLICLAZIDE TABLETS
1
APO-GLICLAZIDE
UNCOATED TABLETS
_Gliclazide _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about gliclazide. It does not
contain all the available information.
It 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 using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Gliclazide belongs to a group of
medicines called sulfonylureas.
It 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 mellitus
(NIDDM) or maturity onset diabetes.
Gliclazide is used when diet and
exercise are not enough to control
your blood glucose.
Gliclazide can be used alone or
together with 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. This is called
hyperglycaemia.
Gliclazide lowers high blood glucose
by increasing the amount of insulin
produced by your pancreas.
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 HYPERGLYCAEMIA.
As with many medicines used for the
tre

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – APO-GLICLAZIDE
(GLICLAZIDE) UNCOATED TABLET
1
NAME OF THE MEDICINE
Gliclazide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains gliclazide 80 mg, as the active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients
3
PHARMACEUTICAL FORM
Uncoated tablet:
Round, white, flat-sided tablets with bevelled edges, engraved
“APO” over “80” on one side,
cross-scored on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Diabetes mellitus of the maturity onset type, which cannot be
controlled by diet alone.
4.2
DOSE AND METHOD OF ADMINISTRATION
For adult use only.
Gliclazide 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 and 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 (4 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
should be 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.
2
4.3
CONTRAINDICATIONS
This medication is contraindicated in the following cases:
•
Hypersensitivity to gliclazide, other sulphonylureas, sulfonamides, or
to any of the
excipients
(see
2
AND
3
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
AND
PHARMACEUTICALS FORM).
•
Type I diabetes, diabetic keto-acidosis, diabet