ZOFRAN ZYDIS ondansetron 8 mg wafer blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ondansetron, Quantity: 8 mg

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Wafer

Composition:

Excipient Ingredients: Gelatin; mannitol; aspartame; sodium methyl hydroxybenzoate; sodium propyl hydroxybenzoate; Flavour

Administration route:

Oral

Units in package:

4 wafers, 10 wafers

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ondansetron (tablets, syrup, wafers, suppository and injection) is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy.

Product summary:

Visual Identification: White, round and plano-convex, no markings on either 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:

1998-02-16

Patient Information leaflet

ZOFRAN
®
ZYDIS
®
WAFERS
1
ZOFRAN
® ZYDIS
® WAFERS
_Ondansetron _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you start taking Zofran Zydis
wafers.
This leaflet answers some common
questions about Zofran Zydis wafers.
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 Zydis
wafers 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 ZYDIS
WAFERS ARE USED FOR
Zofran Zydis wafers belong to a
group of medicines called
antiemetics.
Zofran Zydis wafers work by helping
to stop the nausea (sick feeling) and
vomiting which can occur after
certain treatments. 'Wafer' 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.
Zofran Zydis wafers should only be
used to treat the nausea and vomiting
for which they have been prescribed.
Your doctor may have prescribed
Zofran Zydis wafers for another
reason.
Ask your doctor if you have any
questions about why Zofran Zydis
wafers have been prescribed for you.
Zofran Zydis wafers are not
addictive.
BEFORE YOU TAKE
ZOFRAN ZYDIS WAFERS
_WHEN YOU MUST NOT TAKE _
_THEM _
•
DO NOT TAKE ZOFRAN ZYDIS
WAFERS IF YOU ARE TAKING
APOMORPHINE (USED TO TREAT
PARKINSON'S DISEASE)
•
DO NOT TAKE ZOFRAN ZYDIS
WAFERS IF YOU HAVE EVER HAD AN
ALLERGIC REACTION TO ONDANSETRON
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 ZYDIS
WAFERS IF YOU

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