ZOFRAN ondansetron 16mg suppository blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ondansetron, Quantity: 16 mg

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Suppository, moulded

Composition:

Excipient Ingredients: Hard fat; cetomacrogol 1000; glyceryl ricinoleate

Administration route:

Rectal

Units in package:

5 x 1g

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ondansetron (tablets, syrup, injection and suppository) 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: White, smooth homogenous suppository with a torpedo shape; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1997-08-20

Patient Information leaflet

ZOFRAN
®
SUPPOSITORIES
1
ZOFRAN
® SUPPOSITORIES
_Ondansetron _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you start using Zofran
Suppositories.
This leaflet answers some common
questions about Zofran
Suppositories. 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
Suppositories 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
SUPPOSITORIES ARE
USED FOR
Zofran suppositories contain
ondansetron which is used to help
stop the nausea (sick feeling) and
vomiting which can occur after
certain treatments. Zofran
suppositories should only be used to
treat the nausea and vomiting for
which they have been prescribed.
Your doctor may have prescribed
Zofran suppositories for another
reason.
Ask your doctor if you have any
questions about why Zofran
suppositories have been prescribed
for you.
Zofran suppositories are not
addictive.
BEFORE YOU USE ZOFRAN
SUPPOSITORIES
_WHEN YOU MUST NOT USE _
_THEM _
•
DO NOT USE ZOFRAN SUPPOSITORIES
IF YOU ARE TAKING APOMORPHINE
(USED TO TREAT PARKINSON'S
DISEASE)
•
DO NOT USE ZOFRAN SUPPOSITORIES
IF YOU ARE ALLERGIC TO
ONDANSETRON OR WITEPSOL S58.
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 USE ZOFRAN SUPPOSITORIES
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
suppositories if you are pregnant
or breastfeeding.
•
DO NOT USE ZOFRAN SUPPOSITORIES
AFTER THE EXPIRY DATE (EXP)
PRINTED ON THE PACK.
If yo

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