PHARMACOR GLICLAZIDE 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: mannitol; hypromellose; sodium acetate; magnesium stearate; lactose monohydrate; silicon dioxide

Administration route:

Oral

Units in package:

10's, 20's, 60's, 30's, 100'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 GLICLAZIDE MR
Ver 01
Page 1 of 9
PHARMACOR GLICLAZIDE MR TABLETS 30 MG &
60 MG
GLICLAZIDE
CONSUMER MEDICINE INFORMATION(CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
PHARMACOR GLICLAZIDE
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
PHARMACOR GLICLAZIDE
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 PHARMACOR
GLICLAZIDE MR IS
The name of your medicine is
PHARMACOR GLICLAZIDE
MR.
PHARMACOR GLICLAZIDE
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 PHARMACOR
GLICLAZIDE MR IS USED
FOR
PHARMACOR GLICLAZIDE
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 PHARMACOR
GLICLAZIDE MR IS USED
FOR TYPE II DIABETES MELLITUS
_ _
PHARMACOR GLICLAZIDE
MR is used when diet and
exercise are not enough to
control your blood glucose.
PHARMACOR GLICLAZIDE
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 important to control
hig

Summary of Product characteristics

PHARMACOR GLICLAZIDE MR
Ver 03
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
PHARMACOR GLICLAZIDE MR TABLETS
(GLICLAZIDE)
1.
NAME OF THE MEDICINE
Gliclazide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PHARMACOR GLICLAZIDE MR 30 mg: Each modified release tablet contain 30
mg
Gliclazide._ _
Excipient with known effect: Lactose Monohydrate 39 mg
PHARMACOR GLICLAZIDE MR 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 GLICLAZIDE MR 30 mg: White to off-white, round tablets,
engraved with
“G3” on one face and plain on the other face.
PHARMACOR GLICLAZIDE MR 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 GLICLAZIDE MR
Ver 03
Page 2 of 14
PHARMACOR GLICLAZIDE MR 60 mg have a break bar and may be administered
as
whole or as half tablets (see section 5.2 Pharmacokinetic properties).
PHARMACOR GLICLAZIDE MR 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