METMIN metformin hydrochloride 500 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metformin hydrochloride, Quantity: 500 mg

Available from:

Ipca Pharma (Australia) Pty Ltd

INN (International Name):

Metformin hydrochloride

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:

1000 (hospital only pack), 100

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 coloured, film coated, round, biconvex tablets with 500 debossing; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2017-07-19

Patient Information leaflet

METMIN
_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, 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 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 urine