APO-ONDANSETRON ODT ondansetron 4 mg orally disintegrating tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ondansetron

Available from:

Apotex Pty Ltd

Authorization status:

Registered

Patient Information leaflet

APO-ONDANSETRON ODT orally disintegrating tablets
1
APO-ONDANSETRON
ODT ORALLY
DISINTEGRATING TABLETS
_Contains the active ingredient ondansetron _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all 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 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-ONDANSETRON ODT orally
disintegrating tablets are used to treat
the nausea and vomiting.
Ondansetron belongs to a group of
medicines called antiemetics.
It works by helping to stop the
nausea (sick feeling) and vomiting
which can occur after certain
treatments.
ODT refers to a special type of tablet
which dissolves in a few seconds
when placed on the tongue. It is
easier to swallow than ordinary
tablets.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend the use of ondansetron
for children under the age of 4 years.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
ARE TAKING APOMORPHINE (USED TO
TREAT PARKINSON'S DISEASE).
DO NOT TAKE THIS MEDICINE IF YOU
ARE PREGNANT, TRYING TO BECOME
PREGNANT OR BREAST FEEDING, UNLESS
YOUR DOCTOR SAYS IT IS SAFE.
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
ondansetron
•
any of the ingredients listed at the
end of this leaflet
•
any other similar medicines (such
as medicines of the same class or
with a similar structure).
Some of the symptoms of an a

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
APO-ONDANSETRON ODT (ONDANSETRON)
1
NAME OF THE MEDICINE
Ondansetron
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orally disintegrating tablet contains 4 mg or 8 mg ondansetron,
as the active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Aspartame (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE);
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
4 MG ORALLY DISINTEGRATING TABLETS:
White, round shaped, flat faced bevelled edge tablets debossed with
‘P’ on one side and ‘92’
on the other side.
8 MG ORALLY DISINTEGRATING TABLETS:
White, round shaped, flat faced bevelled edge tablets debossed with
‘P’ on one side and ‘91’
on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ondansetron is indicated for the prevention and treatment of nausea
and vomiting induced by
cytotoxic therapy and radiotherapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
Ondansetron tablets, injections and suppositories are unavailable in
this brand, however these
dosage forms are available in other brands. Dosage, pharmacokinetic,
clinical trial and adverse
effect
information
obtained
using
ondansetron
tablet,
injection
and/or
suppository
formulations have been retained in the relevant sections for
prescriber information.
The emetogenic potential of cancer treatment varies according to the
doses and combinations
of chemotherapy and radiotherapy regimens used. The dose of
ondansetron should be flexible
in the range of 8 to 32 mg a day and selected as shown below. The
lowest effective dose
should be used.
The ondansetron orally disintegrating tablet is administered by
placing on top of the tongue
where it dissolves within seconds, and is swallowed.
2
USE IN ADULTS
_EMETOGENIC CHEMOTHERAPY AND RADIOTHERAPY _
For the control of chemotherapy or radiotherapy induced emesis or
nausea in adults, two oral
doses of 8 mg each at 12 HOURLY INTERVALS may be given, the first dose
being administered 2
hours prior to chemotherapy or radiotherapy.
To