TERRY WHITE CHEMISTS GLICLAZIDE MR 30mg tablets, blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Gliclazide

Available from:

Apotex Pty Ltd

INN (International Name):

Gliclazide

Patient Information leaflet

TERRY WHITE CHEMISTS
GLICLAZIDE MR TABLETS
_30 MG TABLETS_
_Modified Release tablets containing the active ingredient gliclazide_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
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.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
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.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is Terry
White Chemists Gliclazide MR. It
contains the active ingredient
gliclazide.
The tablets release the gliclazide
gradually over 24 hours.
The medicine is used to control,
blood glucose 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
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
Gliclazide

Summary of Product characteristics

Product Information – Australia
Terry White Chemists Gliclazide MR Tablets
Page 1/11
TERRY WHITE CHEMISTS GLICLAZIDE MR 30 MG TABLETS
NAME OF THE MEDICINE
Gliclazide
Chemical Name :
1-(3-azabicyclo[3.3.0]oct-3-yl)-3-_p_-tolylsulphonylurea.
Structural Formula
Molecular Formula:
C
15
H
21
N
3
O
3
S
Molecular Weight:
323.4
CAS Registry Number:
21187-98-4
DESCRIPTION
Gliclazide is a white or almost white powder which is practically
insoluble in water. Freely soluble in
dichloromethane, sparingly soluble in acetone and slightly soluble in
ethanol 96%. The melting point of
gliclazide is approximately 168 °C.
Gliclazide MR 30 mg tablets are intended for oral administration. Each
tablet contains gliclazide 30 mg, as
the active ingredient.
In addition to gliclazide, each tablet contains the following inactive
ingredients: hypromellose, stearic acid
and silica-colloidal anhydrous.
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
Gliclazide is an oral hypoglycaemic sulfonylurea which differs from
other related compounds. It has an
N-containing heterocyclic ring with an endocyclic bond. Gliclazide
reduces blood glucose levels by
stimulating insulin secretion from the beta-cells of the Islets of
Langerhans. Gliclazide shows high
affinity, strong selectivity and reversible binding to the β-cell K
ATP
channels with a low affinity for cardiac
and vascular K
ATP
channels. Increased postprandial insulin and C-peptide secretion
persists after two
years of treatment.
In type II diabetes, gliclazide restores the first peak of insulin
secretion in response to glucose and
increases the second phase of insulin secretion. A significant
increase in insulin release is seen in
response to stimulation induced by a meal or glucose.
Gliclazide also has extra-pancreatic effects and haemovascular
properties.
Product Information – Australia
Terry White Chemists Gliclazide MR Tablets
Page 2/11
It has been shown to increase peripheral insulin sensitivity:
-
In muscle, euglycaemic hyperinsulinaemic clamp studies with gliclazide
have demonstrated
significa