GLUCOPHAGE 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; hypromellose; povidone

Administration route:

Oral

Units in package:

20 tablets, 100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Metformin is indicated in the treatment of type 2 diabetes mellitus not satisfactorily controlled by diet, where the risk of lactic acidosis is minimised by excluding predisposing factors, especially impaired renal, hepatic or cardiovascular function. Metformin may be used as initial therapy or in sulphonylurea failure, either alone or in combination with a sulphonylurea or as adjuvant therapy in insulin-dependent diabetes.

Product summary:

Visual Identification: White, oblong, convex, film-coated tablet. The tablet is embossed "GL500" on the scored face.; Container Type: Blister Pack; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-10-14

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 insulin it does make.

Summary of Product characteristics

PRODUCT INFORMATION
GLUCOPHAGE
_Metformin hydrochloride_
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:

Reduction of hepatic glucose production by inhibiting gluconeogenesis
and glycogenolysis

In muscle, by increasing insulin sensitivity, improving peripheral
glucose uptake and utilisation

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).
GLUCOPHAGE – Product Information
2
In humans, independently of its action on glycaemia, metformin has
favourable effects on lipid metabolism.
This has been shown at therapeutic doses in controlled, medium-term or
long-term clinical studies: metformin
reduces total cholesterol, LDL cholesterol and triglyceride levels.
PHARMACOKINETICS
ABSORPTION
After oral administration, metformin hydrochl