AMARYL glimepiride 3mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

glimepiride, Quantity: 3 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; magnesium stearate; iron oxide yellow; sodium starch glycollate; microcrystalline cellulose; povidone

Administration route:

Oral

Units in package:

10 tablets, 30 tablets, 100 tablets, 50 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS: Amaryl is indicated as an adjunct to diet, exercise and weight loss to lower the blood glucose in patients with non-insulin-dependent (type 2) diabetes mellitus.

Product summary:

Visual Identification: Pale yellow oblong, bi-planar tablets with a score line and debossed with "NMN" and the Hoechst logo on each side.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2001-08-21

Patient Information leaflet

AMARYL
®
_(AM-A(R)-RILL)_
_glimepiride (glim-epi-RIDE)_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Amaryl.
It does not contain all the available
information. It 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 Amaryl
against the benefits they expect it
will 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 AMARYL IS USED
FOR
Amaryl is used to control blood
glucose in patients with type 2
diabetes mellitus.
Amaryl is used when healthy eating
and increased physical activity are
not enough to control your blood
glucose.
Amaryl can be used alone, or
together with insulin or other
medicines for treating diabetes.
_HOW IT WORKS_
Amaryl lowers high blood glucose by
increasing the amount of insulin
produced by your pancreas.
Amaryl belongs to a group of
medicines called sulfonylureas.
If your blood glucose in 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
High blood glucose usually occurs
more slowly than low blood glucose.
Signs of high blood glucose may
include:
•
lethargy or tiredness
•
headache
•
thirst
•
passing large amounts of urine
•
blurred vision
High blood glucose can lead to
serious problems with your heart,
eyes, circulation or kidneys.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN P

Summary of Product characteristics

amaryl-ccdsv14-piv12-23jun20
Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION AMARYL (GLIMEPIRIDE)
TABLET
1
NAME OF THE MEDICINE
Glimepiride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amaryl tablets contain 1 mg, 2 mg, 3 mg or 4 mg of glimepiride.
Excipients with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1, List of Excipients.
3
PHARMACEUTICAL FORM
Tablet, uncoated
1 mg: Pink, oblong, scored tablets debossed with “NMK” and the
Hoechst logo on both sides.
2 mg: Green, oblong, scored tablets debossed with “NMM” and the
Hoechst logo on both
sides.
3 mg: Pale yellow, oblong, scored tablets debossed with “NMN” and
the Hoechst logo on
both sides.
4 mg: Light blue, oblong, scored tablets debossed with “NMO” and
the Hoechst logo on both
sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amaryl is indicated as an adjunct to diet, exercise and weight loss,
to lower the blood glucose
in patients with non-insulin-dependent (type 2) diabetes mellitus.
4.2
DOSE AND METHOD OF ADMINISTRATION
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
amaryl-ccdsv14-piv12-23jun20
Page 2 of 15
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 should be considered. Use of Amaryl must be viewed by
both the physician and
patient as a treatment in addition to diet, and not as a substitute
for diet or as a convenient
mechanism for avoiding dietary restraint. Furthermore, lo