PHARMACOR GLICLARON gliclazide 30 mg modified release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gliclazide, Quantity: 30 mg

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: hypromellose; mannitol; lactose monohydrate; sodium acetate; silicon dioxide; magnesium stearate

Administration route:

Oral

Units in package:

100's, 30's, 60's, 10's, 20's

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, round tablets, engraved with G3 on one face and plain on the other face.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-04-29

Patient Information leaflet

_PHARMACOR GLICLARON _
_Ver 00 _
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PHARMACOR GLICLARON TABLETS
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
PHARMACOR GLICLARON contains the active ingredient gliclazide.
PHARMACOR GLICLARON is used so control blood glucose (sugar) in
patients with Type II diabetes mellitus. For more information,
see Section 1. Why am I using PHARMACOR GLICLARON? in the full CMI.
Do not use if you have ever had an allergic reaction to PHARMACOR
GLICLARON, macrolide antibiotics, 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
PHARMACOR GLICLARON ? in the full CMI.
Some medicines may interfere with PHARMACOR GLICLARON and affect how
it works.
Tell your doctor, pharmacist or diabetes educator if you are taking
any other medicines, including medicines you buy without a
prescription
from a pharmacy, supermarket or health food shop.
See Section 3. What if I am taking other medicines? in the full CMI
for information.
Your doctor will tell you how many tablets to take each day. They may
increase or decrease the dose, depending on your blood glucose
levels.
More instructions can be found in Section 4. How do I use PHARMACOR
GLICLARON? in the full CMI.
Tell all doctors, dentists, pharmacists and diabetes educators who are
involved with your treatment that you are taking PHARMACOR
GLICLARON.
If you are about to start taking any new medicines, tell you doctor
and pharmacist that you are taking.
For more information, see Section 5. What should I know while using
PHARMACOR GLICLARON? in the full CMI.
There are a number of side effects associated with this medicine. It
is important to be aware of them so that you can identify any symptoms
if
they occur (see the full CMI for more details). The serious side
effects are:
Back pain, ar

Summary of Product characteristics

PHARMACOR GLICLARON
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Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
PHARMACOR GLICLARON TABLETS
(GLICLAZIDE)
1.
NAME OF THE MEDICINE
Gliclazide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PHARMACOR GLICLARON 30 mg: Each modified release tablet contain 30 mg
Gliclazide._ _
Excipient with known effect: Lactose Monohydrate 39 mg
PHARMACOR GLICLARON 60 mg: Each modified release tablet contain 60 mg
Gliclazide._ _
Excipient with known effect: Lactose Monohydrate 78 mg
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Tablet, Modified Release
PHARMACOR GLICLARON 30 mg: White to off-white, round tablets, engraved
with “G3”
on one face and plain on the other face.
PHARMACOR GLICLARON 60 mg: White to off-white, oblong shaped tablets,
scored with
a break bar on both sides, engraved with “G L” on one face and
plain on the other face.
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
DOSAGE
For adult use only.
PHARMACOR GLICLARON
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Page 2 of 14
PHARMACOR GLICLARON 60 mg have a break bar and may be administered as
whole or
as half tablets (see section 5.2 Pharmacokinetic properties).
PHARMACOR GLICLARON are modified release tablets; tablets should not
be chewed or
crushed to maintain the modified release properties of the product.
A single daily dose provides an effective blood glucose control. The
daily dose may vary
from 30 mg to 120 mg taken orally. The initial recommended dose is 30
mg, even in elderly
patients (≥ 65 years). The daily dose should not exceed 120 mg.
As with all hypoglycaemic agents, the dose should be titrated
according to the