Glucophage

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Metformin hydrochloride

Available from:

Alphapharm Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

GLUCOPHAGE

_contains the active ingredient metformin hydrochloride_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Glucophage.
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 Glucophage
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 GLUCOPHAGE IS
USED FOR
Glucophage is used to control blood
glucose (the amount of sugar in the
blood) in people with diabetes
mellitus.
Glucophage can be used in:
•
type 1 diabetes, also called
insulin dependent diabetes or
juvenile onset diabetes, when
insulin alone is not enough to
control blood glucose levels
•
type 2 diabetes, also called non-
insulin dependent diabetes
mellitus (NIDDM) or maturity
onset diabetes. It is especially
useful in those who are
overweight, when diet and
exercise are not enough to lower
high blood glucose levels
(hyperglycaemia)
Glucophage can be used alone, or in
combination with other medicines for
treating diabetes.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY GLUCOPHAGE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Glucophage for another reason.
Glucophage is not recommended for
use in children, except for those with
insulin-resistant diabetes who are
being treated in hospital.
Glucophage is available only with a
doctor's prescription.
There is no evidence that
Glucophage is addictive.
_HOW GLUCOPHAGE WORKS_
Glucophage belongs to a group of
medicines called biguanides.
Glucophage 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 insul

Summary of Product characteristics

GLUCOPHAGE 
_Metformin hydrochloride _

PRODUCT INFORMATION 
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. 
NAME OF THE MEDICINE 
Active ingredient: 
Metformin hydrochloride 
Chemical name: 
1,1 dimethyl biguanide hydrochloride 
Structural formula: 

Molecular Formula: 
C
4
H
11
N
5
.HCl 

Molecular weight: 
165.6 

CAS Registry No.: 
1115-70-4 
DESCRIPTION 
Metformin hydrochloride is a white, crystalline
powder which is odourless or almost odourless and 
hygroscopic.  It is freely soluble in
water, slightly soluble in ethanol (96%), and
practically insoluble in 
chloroform and ether. 
Glucophage tablets come in two strengths and contain either 500
mg or 850 mg of metformin 
hydrochloride.  The tablets also contain
the following excipients: povidone, magnesium stearate and 
hypromellose.  The tablets are gluten free. 
PHARMACOLOGY 
Glucophage is an oral anti-diabetic

agent.  Metformin is a biguanide with antihyperglycaemic
effects, 
lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore 
does not produce hypoglycaemia. 
Metformin may act via 3 mechanisms: 
  Me
2
H 
 H 
 N 
 NH
2 
  NH 
  NH 
,HCl 
GLUCOPHAGE – Product Information 
2 

1) 
Reduction
of hepatic glucose production by inhibiting gluconeogenesis and
glycogenolysis 
2) 
In muscle, by increasing insulin sensitivity, improving
peripheral glucose uptake and utilisation 
3) 
Delay of intestinal glucose absorption. 
Metformin stimulates intracellular glycogen synthesis
by acting on glycogen synthase. 
Metformin increases the transport capacity of all types of membrane
glucose transporters (GLUT). 
In humans, independe