Avandamet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Rosiglitazone maleate; Metformin hydrochloride

Available from:

GlaxoSmithKline Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

AVANDAMET
®
TABLETS

_Rosiglitazone (as maleate) and Metformin hydrochloride_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET?
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU TAKE AVANDAMET. IF
YOU ARE HELPING SOMEONE ELSE TO
TAKE AVANDAMET, PLEASE READ
THIS LEAFLET CAREFULLY BEFORE YOU
GIVE THE FIRST DOSE.
This leaflet answers some common
questions about AVANDAMET. It
does not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Sometimes new risks are
found even when a medicine has
been used for many years. Your
doctor has weighed the expected
benefits of you taking
AVANDAMET against the risks this
medicine could 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 IS AVANDAMET
USED FOR?
AVANDAMET is used to treat
patients with type 2 diabetes mellitus.
This is also called non-insulin
dependent diabetes (NIDDM) or
maturity onset diabetes.
Type 2 diabetes mellitus is a
condition in which your body does
not make enough insulin or where the
insulin that your body produces does
not work as well as it should. Insulin
is a natural body chemical that helps
the body's cells use the sugar from
the blood and so stops your blood
sugar levels from rising too high.
High blood sugar levels can cause
damage to the body's cells.
AVANDAMET contains two active
ingredients; namely rosiglitazone (as
maleate), which belongs to a group
of medicines called glitazones, and
metformin hydrochloride which
belongs to a group of medicines
called biguanides.
AVANDAMET acts by making your
body more sensitive to insulin. It
therefore helps your body make
better use of the insulin it produces
and thus helps to restore your blood
sugar towards a normal level.
AVANDAMET can be used alone
(when diet and exercise is not enough
to treat your diabetes) or together
with other anti-diabetic medicines.
Your doctor may have

Summary of Product characteristics

                                                                   
1                     
AVANDAMET
®
 PRODUCT INFORMATION  
(ROSIGLITAZONE & METFORMIN HYDROCHLORIDE) 
2/500, 4/500, 2/1000 & 4/1000 

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  
2000 mg per day. 

The use of AVANDAMET is not recommended in patients with known
ischaemic heart 
disease, particularly those
taking nitrates. Rosiglitazone has been shown to be associated 
with
an increased risk of myocardial ischaemia (angina, infarction) in
pooled short-term 
clinical studies compared
to combined active/placebo control (2.00% versus 1.53%, 
respectively), particularly
in those who needed several antidiabetic
drugs or nitrates. See 
PRECAUTIONS.  

NAME OF THE MEDICINE 

AVANDAMET (rosiglitazone maleate and metformin
hydrochloride) contains two oral 
antihyperglycaemic drugs used in the management of type 2
diabetes, rosiglitazone maleate 
and metformin hydrochloride.  Rosiglitazone maleate
is chemically designated as (

)-5-[[4-
[2-(methyl-2-pyridinylamino) ethoxy]phenyl]methyl]-2,4-thiazolidinedione, (_Z_)-2-butenedioate 
(1:1).  

The structural formula is: 
CO
2
H
CO
2
H
N
CH
3
N
O
S
NH
O
O
.

Molecular weight: 473.52 (357.44 free base) 
CAS number : 0155141-29-0 

Metformin
hydrochloride (1,1-dimethylbiguanide hydrochloride) has a molecular formula of  
C 
4 
H 
11 
N 
5 

HCl. The structural formula is as shown below: 

Molecular weight: 165.63 (129.16 free base) 
CAS number : 1115-70-4 

DESCRIPTION 

Rosiglitazone maleate is a white to off-white solid with
a melting range of 122

 to 123

C. It is 
readily soluble in ethano