ONDANSETRON ODT-DRLA ondansetron 8 mg orally disintegrating tablet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ondansetron, Quantity: 8 mg

Available from:

Dr Reddys Laboratories Australia Pty Ltd

INN (International Name):

Ondansetron

Pharmaceutical form:

Tablet, orally disintegrating

Composition:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; Guar Gum; crospovidone; sodium lauryl sulfate; colloidal anhydrous silica; mannitol; aspartame; pregelatinised maize starch; Flavour

Administration route:

Oral

Units in package:

10 tablet, 6 tablets, 4 tablet

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy.

Product summary:

Visual Identification: White to off-white, round, biconvex, uncoated tablets embossed '8' on one side and 'O' on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2010-11-22

Patient Information leaflet

ONDANSETRON ODT-DRLA
ORALLY DISINTEGRATING TABLETS
_Ondansetron _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully before
you start taking Ondansetron ODT-DRLA
orally disintegrating tablets.
This leaflet answers some common
questions about Ondansetron ODT-DRLA
orally disintegrating tablets. 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 Ondansetron ODT-DRLA orally
disintegrating tablets 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 ONDANSETRON ODT-DRLA
ORALLY DISINTEGRATING TABLETS ARE
USED FOR
Ondansetron ODT-DRLA orally
disintegrating tablets belong to a group of
medicines called antiemetics.
Ondansetron ODT-DRLA orally
disintegrating tablets work by helping to
stop the nausea (sick feeling) and
vomiting which can occur after certain
treatments.
'Orally disintegrating' used in the product
name, is the word used for the special
type of tablet which dissolves in a few
seconds when placed on the tongue. It is
easier to swallow than ordinary tablets.
Ondansetron ODT-DRLA orally
disintegrating tablets should only be used
to treat the nausea and vomiting for which
they have been prescribed.
Your doctor may have prescribed
Ondansetron ODT-DRLA orally
disintegrating tablets for another reason.
Ask your doctor if you have any questions
about why Ondansetron ODT-DRLA orally
disintegrating tablets have been
prescribed for you.
Ondansetron ODT-DRLA orally
disintegrating tablets are not addictive.
BEFORE YOU TAKE ONDANSETRON
ODT-DRLA ORALLY DISINTEGRATING
TABLETS
_ _
_WHEN YOU MUST NOT TAKE THEM _

DO NOT TAKE ONDANSETRON ODT-
DRLA ORALLY DISINTEGRATING
TABLETS IF YOU ARE TAKING
APOMORPHINE (USED TO TREAT
PARKINSON’S DISEASE)

DO NOT TAKE ON

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – ONDANSETRON ODT-DRLA
(ONDANSETRON) ORALLY-DISINTEGRATING TABLETS
1
NAME OF THE MEDICINE
Ondansetron
2
& 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Ondansetron ODT-DRLA 4 mg and 8 mg tablets contain the following
excipients:
Microcrystalline cellulose, mannitol, pregelatinised maize starch,
crospovidone, aspartame, guar
gum, colloidal anhydrous silica, magnesium stearate, sodium lauryl
sulphate, Strawberry
Guarana 586997 AP0551
Ondansetron ODT-DRLA 4 mg orally disintegrating tablets: White to
off-white, round, biconvex,
uncoated tablets embossed ‘4’ on one side and ‘O’ on the other
side.
Ondansetron ODT-DRLA 8 mg orally disintegrating tablets: White to
off-white, round, biconvex,
uncoated tablets embossed ‘8’ on one side and ‘O’ on the other
side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Prevention and treatment of nausea and vomiting induced by cytotoxic
therapy and
radiotherapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The emetogenic potential of cancer treatment varies according to the
doses and combinations of
chemotherapy and radiotherapy regimens used. The route of
administration and 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 ODT-DRLA orally disintegrating tablet is administered
by placing it on top of
the tongue where it dissolves within seconds, and is swallowed.
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 (tablets or orally disintegrating tablets), the
first dose being
administered two hours prior to chemotherapy or radiotherapy. To
protect against delayed
emesis after the first 24 hours, ondansetron should be continued
orally at a dosage of 8 mg
twice daily, for up to five days after a course of treatment.
USE IN CHILDREN. EMETOGENIC CHEMOTHERAPY AND RADIOTH