ARX-GLIMEPIRIDE glimepiride 3mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

glimepiride, Quantity: 3 mg

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

Glimepiride

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; povidone; lactose monohydrate; iron oxide yellow; sodium starch glycollate type A

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

GLIMEPIRIDE APOTEX is indicated as an adjunct to diet, exercise and weight loss to lower the blood glucose in patients with non-insulin-dependent diabetes mellitus (Type 2)

Product summary:

Visual Identification: Pale yellow oval shaped uncoated tablets with breakline on one side and plain on the other side of the tablet; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-03-17

Patient Information leaflet

_GLIMEPIRIDE APOTEX – Consumer Medicine Information _
_ _
_Version: 1.0 _
_ _
_ _
_Page 1 _
GLIMEPIRIDE APOTEX TABLETS
_Glimepiride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
GLIMEPIRIDE APOTEX.
It does not contain all the
available information. It does not
take the place of talking to your
doctor or, pharmacist
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
GLIMEPIRIDE APOTEX against
the
benefits it is expected to have for
you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again
WHAT GLIMEPIRIDE
APOTEX IS USED FOR
The name of your medicine is
GLIMEPIRIDE APOTEX. It
contains the
active ingredient glimepiride.
GLIMEPIRIDE APOTEX is used
to control
blood glucose in patients with
type 2 diabetes mellitus.
GLIMEPIRIDE APOTEX is used
when
healthy eating and increased
physical activity are not enough
to control your blood glucose.
GLIMEPIRIDE APOTEX can be
used
alone, or together with insulin or
other medicines for treating
diabetes.
_HOW IT WORKS _
GLIMEPIRIDE APOTEX lowers
high blood glucose by increasing
the amount of insulin produced
by your pancreas.
GLIMEPIRIDE APOTEX tablets
belong to
a group of medicines called
sulfonylureas.
If your blood glucose is not
controlled properly, you may
experience hypoglycaemia (low
blood glucose - a "hypo") or
hyperglycaemia (high blood
glucose).
Low blood glucose can occur
suddenly. Signs may include:
• weakness, trembling or
shaking
• sweating
• lightheadedness, dizziness,
headache or lack of
concentration
• tearfulness or crying
• irritability
• hunger
• numbness around the lips and
tongue
If not treated promptly, these
may progress to:
• loss of co-ordination
• slurred speech
• confusion
• loss of consciousness or
seizures
Hypoglycaemia can be very
dangerous so make sure that
you and your family can
recognize its symptoms and
know how to react.
High blood

Summary of Product characteristics

3
AUSTRALIAN PRODUCT INFORMATION
GLIMEPIRIDE APOTEX (GLIMEPIRIDE) TABLETS
1
NAME OF THE MEDICINE
Glimepiride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glimepiride
GLIMEPIRIDE APOTEX Tablets are available in four strengths 1 mg, 2 mg,
3 mg and 4 mg.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
GLIMEPIRIDE APOTEX Tablets 1 mg: Pink coloured round, flat uncoated
tablets with bevelled
edges and score-line on one side and plain on other side of tablet.
GLIMEPIRIDE APOTEX Tablets 2 mg: Light pink coloured oval shaped,
uncoated tablets with
score-line on one side and plain on other side of tablet.
GLIMEPIRIDE APOTEX Tablets 3 mg: Pale yellow, oval shaped, uncoated
tablets with break-
line on one side and plain on other side of tablet.
GLIMEPIRIDE APOTEX Tablets 4 mg: White, oval shaped, uncoated tablets
with score-line
on one side and plain on other side of tablet.
_The Score line is only to facilitate breaking for ease of swallowing
and not to divide into the _
_equal doses _
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As an adjunct to diet, exercise and weight loss, to lower the blood
glucose in patients with non-
insulin-dependent (type 2) diabetes mellitus.
3
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
In the management of type 2 diabetes mellitus, administration of an
oral antidiabetic agent is
not a substitute for appropriate dietary control.
In initiating treatment for type 2 diabetes mellitus, diet should be
emphasised as the primary
form of treatment. Caloric restriction and weight loss are essential
in the obese diabetic patient.
Proper dietary management alone may be effective in controlling the
blood glucose and
symptoms of hyperglycaemia. The importance of regular physical
activity should also be
stressed, and cardiovascular risk factors should be identified and
corrective measures taken
where possible.
If this treatment program fails to reduce symptoms and/or blood
glucose, the use of an oral
sulfonylurea