GLICLAZIDE LUPIN MR gliclazide 60 mg modified release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gliclazide, Quantity: 60 mg

Available from:

Lupin Australia Pty Limited

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: povidone; calcium hydrogen phosphate dihydrate; hypromellose; magnesium stearate

Administration route:

Oral

Units in package:

20 tablets, 60 tablets

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 to off-white oval shaped, bioconvex, uncoated tablet with a break line on both sides and debossed wtih 60 on one side of the break line on one surface.and plain on the other side; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-11-14

Patient Information leaflet

Gliclazide Lupin MR V1
1
GLICLAZIDE LUPIN MR
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING GLICLAZIDE LUPIN MR?
Gliclazide Lupin MR contains the active ingredient gliclazide.
Gliclazide Lupin MR is used to control blood glucose (sugar) in
patients with type II diabetes mellitus when diet and exercise are not
enough to control your blood glucose.
For more information, see Section 1. Why am I using Gliclazide Lupin
MR?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE GLICLAZIDE LUPIN MR?
Do not use if you have ever had an allergic reaction to gliclazide or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Gliclazide Lupin MR?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Gliclazide Lupin MR and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE GLICLAZIDE LUPIN MR?
Swallow the tablet(s) as prescribed by your physician with a glass of
water at the same time-usually with breakfast.
More instructions can be found in Section 4. How do I use Gliclazide
Lupin
MR? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING GLICLAZIDE LUPIN MR?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, pharmacist, or diabetes educator you visit
that you are using gliclazide.
•
Check your blood glucose levels regularly to know if your diabetes is
being controlled properly.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine or change the dosage, without checking
with your doctor.
•
Do not skip meals while taking Gliclazide Lupin MR.
DRIVING OR USING
MACHINES
•
Gliclazide Lupin MR may cause dizziness and drowsiness in some people.
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Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – GLICLAZIDE LUPIN MR
(GLICLAZIDE) MODIFIED RELEASE TABLET
1
NAME OF THE MEDICINE
Gliclazide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Gliclazide Lupin MR tablet contains 60 mg gliclazide.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Modified release tablet:
Gliclazide Lupin MR 60 mg tablets: White to off white, oval shaped,
biconvex, uncoated tablet with a
breakline on both sides and debossed with ’60’ on one side of the
breakline on one surface and plain on
the other side.
4
CLINICAL PARTICULARS
4.1 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.
4.2 DOSE AND METHOD OF ADMINISTRATION
For adult use only.
Gliclazide Lupin MR 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 Gliclazide Lupin 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.
Gliclazide Lupin MR v1
Page 2 of 14
(gliclazide) modified release tablet
A single daily dose provides an effective blood glucose control. The
daily dose may vary from half a tablet
to two tablets per day, ie. 30 mg to 120 mg taken orally. The initial
recommended dose is half a tablet
(30 mg), even in elderly patients (≥65 years). The daily dose should