AVANDAMET 4/500 tablet blister pack

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

metformin hydrochloride,rosiglitazone maleate

Boleh didapati daripada:

GlaxoSmithKline Australia Pty Ltd

INN (Nama Antarabangsa):

Metformin hydrochloride,Rosiglitazone maleate

Status kebenaran:

Registered

Risalah maklumat

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 prescribed
AVANDAM

Ciri produk

1
This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report
any suspected adverse events at www.tga.gov.au/reporting-problems. _ _
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
Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
AUSTRALIAN PRODUCT INFORMATION
AVANDAMET (ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE)
FILM COATED TABLETS
1
NAME OF THE MEDICINE
Rosiglitazone (as maleate) and metformin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Avandamet film coated tablets contain 2 mg/500 mg, 4 mg/500 mg, 2
mg/1000 mg or 4
mg/1000 mg rosiglitazone (as maleate) and metformin hydrochloride as
the active
ingredients.
LIST OF EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Film-coated oval tablets, debossed with gsk on one side, and the
following debossing on the
reverse side. The tablets are also distinguished by colour
2mg/500mg – 2/500 (pale pink)
4mg/500mg – 4/500 (orange)
2mg/1000mg – 2/1000 (yellow)
4mg/1000mg – 4/1000 (pink)_ _
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
▼

2
AVANDAMET is indicated as an adjunct to diet and exercise to improve
glycaemic control in
patients with Type 2 diabetes mellitus (non-insulin dependent diabetes
mellitus), as dual
combination therapy in patients who are already