APX-GLICLAZIDE gliclazide 80 mg tablet blister pack

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

gliclazide, Quantity: 80 mg

Saatavilla:

Arrotex Pharmaceuticals Pty Ltd

Lääkemuoto:

Tablet, uncoated

Koostumus:

Excipient Ingredients: sodium starch glycollate type A; purified talc; magnesium stearate; povidone; lactose monohydrate; microcrystalline cellulose; purified water

Antoreitti:

Oral

Kpl paketissa:

100 tablets

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

INDICATIONS: Diabetes mellitus of the maturity onset type, which cannot be controlled by diet alone.

Tuoteyhteenveto:

Visual Identification: A white to off white round, bevel-edged, uncoated tablet with cross score (+) on one face and plain on the other; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2020-06-23

Pakkausseloste

Page 1 of 6
APX-GLICLAZIDE
gliclazide
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APX-GLICLAZIDE.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor, pharmacist or diabetes
educator.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking APX-
GLICLAZIDE against the benefits
they expect it will have for you
.
TALK TO YOUR DOCTOR, PHARMACIST
OR DIABETES EDUCATOR IF YOU HAVE
ANY CONCERNS ABOUT TAKING THIS
MEDICINE.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT APX-GLICLAZIDE IS
USED FOR
APX-GLICLAZIDE is used to
control blood glucose in people
with Type 2 diabetes mellitus.
This type of diabetes is also
called non-insulin dependent
diabetes mellitus (NIDDM) or
maturity onset diabetes.
APX-GLICLAZIDE is used when diet
and exercise are not enough to
control your blood glucose levels. It
can be used alone, or in
combination with other medicines
for treating diabetes.
APX-GLICLAZIDE is available only
with a doctor's prescription.
HOW APX-GLICLAZIDE
WORKS
APX-GLICLAZIDE belongs to a
group of medicines called
sulphonylureas. These
medicines lower blood glucose
by increasing the amount of
insulin produced by your
pancreas.
If your blood glucose is not properly
controlled, you may experience
hypoglycaemia (low blood glucose)
or hyperglycaemia (high blood
glucose).
HYPOGLYCAEMIA
Hypoglycaemia (low blood glucose)
can occur suddenly. Signs may
include:
•
weakness, trembling or shaking
•
sweating
•
lightheadedness, dizziness,
headache or lack of
concentration
•
irritability, tearfulness or crying
•
hunger
•
numbness around the lips and
tongue.
If not treated promptly, these may
progress to:
•
loss of co-ordination
•
slurred speech
•
confusion
•
fits or loss of consciousness
HYPERGLYCAEMIA
Hyperglycaemia (high blood
glucose)
usually occurs more
slowly than hypoglycaemia. Signs
of hyperglycaemia may include:
•
lethargy or tirednes

Valmisteyhteenveto

APX-GLICLAZIDE product Information
1
AUSTRALIAN PRODUCT INFORMATION
APX-GLICLAZIDE (GLICLAZIDE) TABLET
S
1
NAME OF THE MEDICINE
Gliclazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APX-GLICLAZIDE tablets contain 80 mg of gliclazide.
EXCIPIENTS WITH KNOWN EFFECT: lactose monohydrate.
For the full list of excipients, see Section 6.1 L
IST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Uncoated tablets
A white to off white round, bevel-edged, uncoated tablet with cross
score (+) on one face and plain
on the other
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Diabetes mellitus of the maturity onset type, which cannot be
controlled by diet alone.
4.2
D
OSE AND METHOD OF ADMINISTRATION
For adult use only.
The dosage of gliclazide should be carefully titrated to maintain
optimal control at the various
possible dose levels. Dosage should be initiated at 40 mg (1/2 tablet)
daily and may be increased
if necessary up to 320 mg (four tablets) daily. Doses up to 160 mg
daily may be taken in a single
dose but preferably at the same time each morning. Doses in excess of
160 mg should be taken in
divided doses in the morning and evening.
In general, the dosage will depend on the severity of the glycaemia
with ongoing adjustments
made in order to obtain the optimal response at the lowest dosage.
Treatment
with
gliclazide
does
not
obviate
the
necessity
of
maintaining
standard
dietary
regulations.
4.3
C
ONTRAINDICATIONS
Gliclazide should not be used in diabetes complicated by acidosis,
ketosis or coma, or in patients
with a history of repeated episodes of ketoacidosis or coma.
APX-GLICLAZIDE product Information
2
Juvenile onset diabetes and unstable or brittle diabetes. As
sulfonylurea hypoglycaemic agents are
not effective in juvenile onset, unstable or brittle diabetes,
gliclazide should not be used in these
conditions.
Hypersensitivity:
Gliclazide
should
not
be
used
with
patients
with
known
sensitivity
to
sulfonylureas.
Impaired renal function: Gliclazide is contraindicated in severe renal
insufficiency. Caution should
be exercise