APO-Metformin XR 1000 metformin hydrochloride 1000 mg modified release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metformin hydrochloride

Available from:

Apotex Pty Ltd

INN (International Name):

Metformin hydrochloride

Authorization status:

Registered

Patient Information leaflet

APO-METFORMIN XR
_Contains the active ingredient metformin hydrochloride_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about metformin. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
APO-Metformin XR Tablets is used
to control blood glucose (sugar) in
people with Type 2 diabetes mellitus,
especially in those who are
overweight. It is used when diet and
exercise are not enough to control
high levels of blood glucose.
Metformin XR can be used alone, or
in combination with other medicines
for treating diabetes.
Metformin belongs to a group of
medicines called biguanides. It
lowers high blood glucose levels by:
•
improving your body's sensitivity
to insulin and restoring the way it
normally uses glucose
•
reducing the amount of glucose
your liver makes
•
delaying the amount of glucose
your intestine absorbs.
This medicine is available only with
a doctor's prescription.
_TYPE 2 DIABETES MELLITUS_
Type 2 diabetes mellitus is also
called Non-Insulin Dependent
Diabetes Mellitus (NIDDM) or
Maturity Onset Diabetes.
Insulin is a hormone that enab

Summary of Product characteristics

Product Information – Australia
APO- Metformin XR tablets
Page 1
APO- METFORMIN XR (500 & 1000) TABLETS
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 HYDROCHLORIDE (≥ 2 G PER DAY).
NAME OF THE MEDICINE
Metformin hydrochloride.
Chemical Name:
1,1-dimethylbiguanide hydrochloride
Structural Formula:
. HCl
Molecular Formula:
C
4
H
12
ClN
5
Molecular Weight:
165.62
CAS Registry Number:
1115-70-4
DESCRIPTION
White crystals easily soluble in water, sparingly soluble in alcohol
and practically insoluble in acetone
and methylene chloride.
Metformin is a strong base with a pKa greater than 12. At pH < 12,
which is always the case in the
body, metformin is very hydrophilic: the octanol/water partition
coefficient is 0.05. The melting point of
metformin hydrochloride is 224°C. Metformin hydrochloride is a very
stable molecule.
Each modified release tablet contains either 500 mg or 1000 mg
metformin hydrochloride (HCl). The
tablets also contain the following excipients: hypromellose, povidone,
colloidal anhydrous silica and
magnesium stearate.
Tablet shells may be present in the faeces (see PRECAUTIONS, OTHER
PRECAUTIONS).
PHARMACOLOGY
PHARMACODYNAMICS
Metformin is an oral hypoglycaemic agent; it 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 three mechanisms:

Reduction of hepatic glucose production by inhibiting gluconeogenesis
and glycogenolysis.

In muscle, by increasing insulin sensitivity, improving peripheral
glucose uptake and utilization.

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.
Product Information �