ONDANSETRON ODT GH ondansetron 4 mg orally disintegrating tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ondansetron, Quantity: 4 mg

Available from:

Dr Reddys Laboratories Australia Pty Ltd

INN (International Name):

Ondansetron

Pharmaceutical form:

Tablet, orally disintegrating

Composition:

Excipient Ingredients: crospovidone; magnesium stearate; sodium lauryl sulfate; mannitol; colloidal anhydrous silica; pregelatinised maize starch; microcrystalline cellulose; aspartame; Guar Gum; 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 '4' 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:

Registered

Authorization date:

2016-01-18

Patient Information leaflet

Ondansetron ODT GH CMI V1
Page 1 of 5
CONSUMER MEDICINE INFORMATION
ONDANSETRON ODT GH
ORALLY DISINTEGRATING TABLETS
_Ondansetron _
WHAT IS IN THIS LEAFLET?
Please read this leaflet
carefully before you start
taking Ondansetron ODT
GH orally disintegrating
tablets.
This leaflet answers some
common questions about
Ondansetron ODT GH 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
GH 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 GH ORALLY
DISINTEGRATING TABLETS
ARE USED FOR
Ondansetron ODT GH orally
disintegrating tablets
belong to a group of
medicines called
antiemetics.
Ondansetron ODT GH 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 GH 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 GH orally
disintegrating tablets for
another reason.
Ask your doctor if you have
any questions about why
Ondansetron ODT GH orally
disintegrating tablets have
been prescribed for you.
Ondansetron ODT GH orally
disintegrating tablets are
not addictive.
BEFORE YOU TAKE
ONDANSETRON ODT GH
ORALLY DISINTEGRATING
TABLETS
_ _
_WHEN YOU MUST NOT TAKE _
_THEM _

DO NOT TAKE
ONDANSETRON ODT GH
ORALLY DISINTEGRATING
TABLETS IF YOU ARE TAKING
APOMORPHINE (USED TO
TREAT PARKINSON'S
DISEASE)

DO NOT

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – ONDANSETRON ODT GH
(ONDANSETRON) ORALLY-DISINTEGRATING TABLETS
1
NAME OF THE MEDICINE
Ondansetron
2
& 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Ondansetron ODT GH 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 GH orally disintegrating tablets do not contain gluten
or lactose.
Ondansetron ODT GH 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 GH 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 GH 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