APO-GLICLAZIDE MR 30mg tablets, bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gliclazide, Quantity: 30 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Gliclazide

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: stearic acid; hypromellose; colloidal anhydrous silica

Administration route:

Oral

Units in package:

100 (bottle)

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, Gliclazide MR 30 mg Tablets, 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, flat faced, radial edge capsule shaped tablet, engraved "APO 30" on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2009-05-20

Patient Information leaflet

APO-GLICLAZIDE MR TABLETS
1
APO-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.arrotex.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 APO-
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

1
AUSTRALIAN PRODUCT INFORMATION – APO- GLICLAZIDE
(GLICLAZIDE) MODIFIED RELEASE TABLETS
1
NAME OF THE MEDICINE
Gliclazide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gliclazide MR 30 mg tablets are intended for oral administration. Each
tablet contains gliclazide
30 mg, as the active ingredient.
For full list of excipients, see section 6.1 List of excipients
3
PHARMACEUTICAL FORM
Modified release tablets:
White to off-white, flat faced, radial edge, capsule shaped tablets,
engraved “APO 30” on one side
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,
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
Gliclazide MR 30 mg Tablets are for adult use only.
The daily dose may vary from 30 mg to 120 mg taken orally, once daily.
Gliclazide MR 30 mg Tablets
should be taken with food because there is an 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
should not be increased.
Gliclazide MR 30 mg Tablets are modified release tablets and therefore
should be neither broken
nor chewed.
As with all hypoglycaemic agents, the dose should be titrated
according to the individual patient's
response.
The initial recommended dose is 30 mg daily, even in elderly patients
(≥ 65 years).
Dose titration should be carried out in steps of 30 mg, according to
the fasting blood glucose
response. Each step should last for at least two weeks. A single daily
dose provides an effective
blood glucose control. The single daily dose may b