METFORMIN MYLAN metformin hydrochloride 500mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metformin hydrochloride, Quantity: 500 mg

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; povidone; hypromellose; macrogol 8000; hyprolose; macrogol 400

Administration route:

Oral

Units in package:

10 tablets (sample), 100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Metformin is indicated for 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: 15.65mm x 7.25mm, oblong, white, clear coated, tablet debossed "MF/1" on one side and blank on the other.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2000-04-14

Patient Information leaflet

DIAFORMIN
®
_metformin hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DIAFORMIN.
It does not contain all the available
information. It does not take the
place of talking to your doctor,
diabetes educator or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking DIAFORMIN
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 DIAFORMIN IS
USED FOR
DIAFORMIN is used to control
blood glucose (the amount of sugar
in the blood) in people with diabetes
mellitus.
DIAFORMIN 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,
metformin can 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 DIAFORMIN
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
DIAFORMIN for another reason.
DIAFORMIN is available only with
a doctor's prescription.
There is no evidence that
DIAFORMIN is addictive.
_HOW DIAFORMIN WORKS_
DIAFORMIN belongs to a group of
medicines called biguanides.
DIAFORMIN 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
•
thirs

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
DIAFORMIN
®
_ _
_Metformin hydrochloride film-coated tablets _
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.
1
NAME OF THE MEDICINE
Metformin hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The tablets contain metformin hydrochloride as the active ingredient
and are available in three strengths 500 mg,
850 mg and 1000 mg.
Excipients with known effect: trace quantities of sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
500 MG TABLET
:
15.65 mm x 7.25 mm, oblong, white, clear coated, tablet debossed
"MF/1" on
one side and blank on the other.
850 MG TABLET
:
12.5 mm normal convex, white, clear film-coated tablet, debossed "MF"
over
"2" on one side and "G" on the other.
1000 MG TABLET
:
19 mm x 10.5 mm, oval, film coated white tablet, debossed "MF/3" on
one side
and "G" on the 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. THE MAIN RISK
FACTOR IS RENAL IMPAIRMENT, OTHER RISK FACTORS INCLUDE OLD AGE
ASSOCIATED WITH REDUCED RENAL
FUNCTION AND HIGH DOSES OF METFORMIN ABOVE 2 G PER DAY.
It is important that the tablets are taken in divided doses with
meals.
DIAFORMIN
®
– AUSTRALIAN PRODUCT INFORMATION
2
Initially 500 mg should be taken once or twice a day and if necessary
increased over a few w