AURO-ONDANSETRON ODT 8 ondansetron 8 mg orally disintegrating tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ondansetron, Quantity: 8 mg

Available from:

Strides Pharma Science Pty Ltd

INN (International Name):

Ondansetron

Pharmaceutical form:

Tablet, orally disintegrating

Composition:

Excipient Ingredients: mannitol; colloidal anhydrous silica; aspartame; microcrystalline cellulose; lactose monohydrate; magnesium stearate; crospovidone; Flavour

Administration route:

Oral

Units in package:

4, 10, 20

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ondansetron is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy.

Product summary:

Visual Identification: White to off-white, round tablets debossed with '7' on one side and 'E' on the other side with an embossed circular edge; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-04-02

Patient Information leaflet

AURO-ONDANSETRON ODT
CONSUMER MEDICINE INFORMATION
Ver 1.2
Page 1 of 3
AURO-ONDANSETRON ODT 4 & 8
Ondansetron
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please
read
this
leaflet
carefully
before
you
start
taking
AURO-
ONDANSETRON ODT.
This leaflet answers some common
questions
about
AURO-
ONDANSETRON ODT. 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. Your doctor has weighed
the
risks
of
you
taking
AURO-
ONDANSETRON ODT against the
benefits this medicine is expected to
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 AURO-
ONDANSETRON ODT ARE
USED FOR
AURO-ONDANSETRON
ODT
belong
to
a
group
of
medicines
called antiemetics.
AURO-ONDANSETRON
ODT
work by helping to stop the nausea
(sick
feeling)
and
vomiting
which
can occur after certain treatments.
AURO-ONDANSETRON
ODT
should
only
be
used
to
treat
the
nausea and vomiting for which they
have been prescribed.
Your
doctor
may
have
prescribed
AURO-ONDANSETRON ODT for
another reason.
Ask
your
doctor
if
you
have
any
questions
about
why
AURO-
ONDANSETRON ODT have been
prescribed for you.
AURO-ONDANSETRON
ODT
is
not addictive.
BEFORE YOU TAKE AURO-
ONDANSETRON ODT
WHEN YOU MUST NOT TAKE
THEM
•
DO
NOT
TAKE
AURO-
ONDANSETRON
ODT
IF
YOU
ARE TAKING APOMORPHINE (USED TO
TREAT PARKINSON'S DISEASE)
•
DO
NOT
TAKE
AURO-
ONDANSETRON
ODT
IF
YOU
HAVE
EVER
HAD
AN
ALLERGIC
REACTION TO ONDANSETRON OR ANY
OF THE INGREDIENTS LISTED AT THE
END OF THIS LEAFLET.
Symptoms of an allergic reaction
may
be
mild
or
severe.
They
usually include some or all of the
following: wheezing, swelling of
the
lips/mouth,
difficulty
in
breathing,
hayfever,
lumpy
rash
("hives") or fainting.
•
DO
NOT
TAKE
AURO-
ONDANSETRON
ODT
IF
YOU
ARE PREGNANT,
TRYING TO BECOME
PREGNANT
OR
BREASTFEEDING,
UNLESS
YOUR
DOCTOR
SAYS
YOU
SHOULD.
Your doctor will discuss the risks
and