ZOFRAN ORAL LIQUID ondansetron (as hydrochloride dihydrate) 4mg/5mL oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ondansetron hydrochloride dihydrate, Quantity: 1 mg/mL (Equivalent: ondansetron, Qty 0.8 mg/mL)

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Oral Liquid, solution

Composition:

Excipient Ingredients: citric acid; sodium citrate dihydrate; sodium benzoate; sorbitol solution (70 per cent) (crystallising); purified water; Flavour

Administration route:

Oral

Units in package:

1 X 50mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ondansetron (tablets, syrup and injection) is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy. Ondansetron (injection) is also indicated for the prevention and treatment of post-operative nausea and vomiting.

Product summary:

Visual Identification: A clear, colourless to light yellow liquid.; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

1997-02-28

Patient Information leaflet

ZOFRAN
®
SYRUP
1
ZOFRAN
® SYRUP
_Ondansetron hydrochloride dihydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you start taking Zofran Syrup.
This leaflet answers some common
questions about Zofran Syrup. 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 Zofran Syrup
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 ZOFRAN SYRUP IS
USED FOR
Zofran syrup contains ondansetron
which is used to help stop the nausea
(sick feeling) and vomiting which
can occur after certain treatments.
Zofran syrup should only be used to
treat the nausea and vomiting for
which it has been prescribed.
Your doctor may have prescribed
Zofran syrup for another reason.
Ask your doctor if you have any
questions about why Zofran syrup
has been prescribed for you.
Zofran syrup is not addictive.
BEFORE YOU TAKE
ZOFRAN SYRUP
_WHEN YOU MUST NOT TAKE IT _
•
DO NOT TAKE ZOFRAN SYRUP IF YOU
ARE TAKING APOMORPHINE (USED
TO TREAT PARKINSON'S DISEASE)
•
DO NOT TAKE ZOFRAN SYRUP IF YOU
HAVE EVER HAD AN ALLERGIC
REACTION TO ONDANSETRON
HYDROCHLORIDE DIHYDRATE 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 ZOFRAN SYRUP IF YOU
ARE PREGNANT, TRYING TO BECOME
PREGNANT OR BREASTFEEDING,
UNLESS YOUR DOCTOR SAYS YOU
SHOULD.
Your doctor will discuss the risks
and benefits of using Zofran
Syrup if you are pregnant or
breastfeeding.
•
DO NOT TAKE ZOFRAN SYRUP AFTER
THE EXPIRY DATE (EXP) PRINTED
ON THE PACK.
If you take it after the expir

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
ZOFRAN (ONDANSETRON HYDROCHLORIDE DIHYDRATE) INJECTIONS, TABLETS AND
ORAL LIQUID, ZOFRAN (ONDANSETRON) SUPPOSITORIES AND
ZOFRAN ZYDIS (ONDANSETRON) WAFERS
1 NAME OF THE MEDICINE
Ondansetron hydrochloride dihydrate is the therapeutically active
ingredient in
Zofran injections, Zofran tablets and Zofran oral liquid.
Ondansetron is the therapeutically active ingredient in Zofran
suppositories and in
Zofran Zydis wafers.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Zofran 4 mg and 8 mg tablets contain 4 and 8 mg of ondansetron (as
ondansetron
hydrochloride dihydrate) and the following excipients: lactose
monohydrate,
microcrystalline cellulose, pregelatinised maize starch, magnesium
stearate,
hypromellose, titanium dioxide and iron oxide yellow.
Excipients with known effect: sugars as lactose
Zofran 24 mg tablets contain 24 mg of ondansetron (as ondansetron
hydrochloride
dihydrate) and the following excipients: lactose, microcrystalline
cellulose,
pregelatinised maize starch, magnesium stearate and Opadry Pink
YS-1-14593-A
(ARTG PI No: 3522).
Excipients with known effect: sugars as lactose
Zofran oral liquid contains 0.8 mg/mL of ondansetron (as ondansetron
hydrochloride
dihydrate) and the following excipients: citric acid, sodium citrate
dihydrate, sodium
benzoate, sorbitol solution (70 percent) (crystallising), purified
water and Strawberry
Flavouring Liquid SC887891 (ARTG PI No: 140281).
Excipients with known effect: benzoates and sorbitol (12.6g per
recommended
maximum daily dose) which may have a laxative effect or cause
diarrhoea
Zofran Zydis wafers contain 4 and 8 mg of ondansetron and the
following excipients:
gelatin, mannitol, aspartame, sodium methyl hydroxybenzoate, sodium
propyl
hydroxybenzoate and Strawberry Flavouring Liquid SC887891 (ARTG PI No:
140281).
Excipients with known effect: aspartame, hydroxybenzoates and
sulphites.
Each 2 mL Zofran injection contains 4 mg of ondansetron (as
ondansetron
hydrochloride dihydrate) and the following excipients: citric acid
monohydr