APO-METFORMIN 1000 metformin hydrochloride 1000 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metformin hydrochloride, Quantity: 1000 mg

Available from:

Cipla Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: maize starch; povidone; colloidal anhydrous silica; magnesium stearate; hypromellose; titanium dioxide; propylene glycol; macrogol 6000; purified talc; sodium starch glycollate type A

Administration route:

Oral

Units in package:

20, 28, 30, 56, 60, 100, 10, 14, 90

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Metformin is indicated in the treatment of type 2 diabetes mellitus in adults, children from 10 years of age and adolescents, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. For adult patients, metformin may be used as initial treatment or in sulfonylurea failures either alone or in combination with a sulfonylurea and other oral agents or as adjuvant therapy in insulin requiring type 2 diabetes.

Product summary:

Visual Identification: White to off white, oval shaped, biconvex tablets debossed with '10' and '00' on either side of deep notch on one side and breakline on other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2019-03-29

Patient Information leaflet

APO METFORMIN
_contains the active ingredient metformin hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about medicine.
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 benefits and
risks. Your doctor has weighed the
risks of you taking this medicine
against the benefits expected for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR, PHARMACIST OR DIABETES
EDUCATOR.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT IT IS USED FOR
It is used to control blood glucose
(the amount of sugar in the
blood) in people with diabetes
mellitus.
It can be used in type 2 diabetes in
adults and children over 10 years
of age. It is especially useful in
those who are overweight, when
diet and exercise are not enough to
lower high blood glucose levels.
(hyperglycaemia). For adult
patients, APO Metformin be used
alone, or in combination with other
oral diabetic medicines or in
combination with insulin in insulin
requiring type 2 diabetes.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
it for another reason.
It is available only with a
doctor's prescription.
There is no evidence it is
addictive.
_ _
_HOW IT WORKS _
_ _
It belongs to a group of
medicines called biguanides. It
lowers high blood glucose
(hyperglycaemia) by helping your
body make better use of the insulin
produced by your pancreas.
People with type 2 diabetes are
unable to make enough insulin or
their body does not respond
properly to the insulin it does
make. This causes a build up of
glucose in the blood, which can
lead to serious medical problems.
Long-term hyperglycaemia can
lead to heart disease, blindness,
kidney damage, poor blood
circulation and gangrene.
Signs of hyperglycaemia may
include:
•
tiredness or lack of energy
•
headache
•
thirst
•
passing large amounts of

Summary of Product characteristics

PRODUCT INFORMATION-AUSTRALIA
APO METFORMIN (REV-01/03-2020)
1
AUSTRALIAN PRODUCT INFORMATION - APO-METFORMIN 500, 850 & 1000
(METFORMIN
HYDROCHLORIDE)
1 NAME OF THE MEDICINE
Metformin hydrochloride.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Metformin Hydrochloride 500 mg tablet contains 500 mg of
metformin hydrochloride.
Each Metformin Hydrochloride 850 mg contains 850 mg of metformin
hydrochloride. Each
Metformin Hydrochloride 1000 mg contains 1000 mg of metformin
hydrochloride.
The tablets are gluten free.
For full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
METFORMIN 500 MG, 850 MG AND 1000 MG
500 MG:
Metformin hydrochloride 500 mg tablet: White coloured film coated
round biconvex tablets
with “500” debossing.
850 MG:
Metformin hydrochloride 850 mg tablet: White coloured film coated
round biconvex tablets
with “850” debossing.
1000 MG:
Metformin hydrochloride 1000 mg tablet: White to off white film
coated, oval shaped,
biconvex tablets debossed with ‘C’ and ‘36’ on either side of
deep notch on one side and
breakline on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Metformin is indicated in the treatment of type 2 diabetes mellitus in
adults, children from 10
years of age and adolescents, particularly in overweight patients,
when dietary management
and exercise alone does not result in adequate glycaemic control.
For adult patients, metformin may be used as initial treatment or in
sulfonylurea failures either
alone or in combination with a sulfonylurea and other oral agents or
as adjuvant therapy in
insulin requiring type 2 diabetes.
4.2 DOSE AND METHOD OF ADMINISTRATION
LIFE THREATENING LACTIC ACIDOSIS CAN OCCUR DUE TO ACCUMULATION OF
METFORMIN. RISK
FACTORS INCLUDE RENAL IMPAIRMENT, OLD AGE AND THE USE OF HIGH DOSES OF
METFORMIN
ABOVE 2 G PER DAY. PRODUCT INFORMATION-AUSTRALIA
APO METFORMIN (REV-01/03-2020)
2
It is important that the tablets are taken in divided doses with
meals.
Half tablet doses of the 1000 mg tablet may be administer