ZOFRAN 4 mg/5 ml MG/5ml Syrup

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ONDANSETRON HYDROCHLORIDE DIHYDRATE

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

A04AA01

INN (International Name):

ONDANSETRON HYDROCHLORIDE DIHYDRATE

Dosage:

4 mg/5 ml MG/5ml

Pharmaceutical form:

Syrup

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Serotonin (5HT3) antagonists

Authorization status:

Authorised

Authorization date:

2016-01-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 
ZOFRAN® 4 MG/5 ML SYRUP 

ONDANSETRON  

READ  ALL  OF  THIS  LEAFLET  CAREFULLY  BEFORE  YOU  START  TAKING  THIS  MEDICINE  BECAUSE  IT 
CONTAINS IMPORTANT INFORMATION FOR YOU. 

  Keep this leaflet. You may need to read it again. 

  If  you  have  any  further  questions  about  your  illness  or  your  medicine,  ask  your  doctor, 
nurse or pharmacist. 

  This medicine has been prescribed for you only. Do not pass it on to others. It may harm 
them, even if their signs of illness are the same as yours. 

  If  you  get  any  side  effects,  talk  to  your  doctor,  nurse  or  pharmacist.  This  includes  any 
possible side effects not listed in this leaflet. 

WHAT IS IN THIS LEAFLET: 
1 
What Zofran syrup is and what it is used for 
2 
What you need to know before you take Zofran syrup  
3 
How to take Zofran syrup 
4 
Possible side effects 
5 
How to store Zofran syrup 
6 
Contents of the pack and other information 

1  WHAT ZOFRAN SYRUP IS AND WHAT IT IS USED FOR  

Zofran syrup contains a medicine called ondansetron. This belongs to a group of medicines 
called anti-emetics.   

Zofran syrup is used for: 

  preventing  nausea  and  vomiting  caused  by  chemotherapy  
[http://www.netdoctor.co.uk/medicines/effect/cancer.shtml]or  radiotherapy  for  cancer  
[http://www.netdoctor.co.uk/cancer/index.shtml]in 
ADULTS 

  preventing nausea and vomiting after surgery in ADULTS 

  preventing  nausea  and  vomiting  caused  by  chemotherapy  
[http://www.netdoctor.co.uk/medicines/effect/cancer.shtml]for  cancer  
[http://www.netdoctor.co.uk/cancer/index.shtml]in  CHILDREN  AND 
ADOLESCENTS aged 6 months to 17 years 

Ask  your  doctor,  nurse  or  pha

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zofran 4mg/5ml Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains 4mg ondansetron (as ondansetron hydrochloride
dihydrate).
Each 5ml also contains 2.1g of Sorbitol (E420) and 3mg of ethanol.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution.
Clear, colourless to light yellow liquid with characteristic
strawberry odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS
Zofran Syrup is indicated for the management of nausea and vomiting
induced by cytotoxic chemotherapy and
radiotherapy. Zofran Syrup is also indicated for the prevention of
post-operative nausea and vomiting.
PAEDIATRIC POPULATION
Orally administered Zofran is indicated for the management of nausea
and vomiting induced by cytotoxic
chemotherapy in children and adolescents aged from 6 months to 17
years.
No studies have been conducted in children on the use of orally
administered Zofran in the prevention or treatment of
post-operative nausea and vomiting; IV injection may be recommended
for this purpose.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Zofran is also available for parenteral and rectal use to allow the
route of administration and dosing to be flexible.
CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING (CINV AND
RINV):
The emetogenic potential of cancer treatment varies according to the
doses and combinations of chemotherapy and
radiotherapy regimens used. The selection of dose regimen should be
determined by the severity of the emetogenic
challenge.
_CINV AND RINV IN ADULTS:_
The recommended oral dose is 8 mg (two 5 ml spoonfuls) 1-2 hours
before treatment, followed by 8 mg (two 5 ml
spoonfuls) orally 12 hours later.
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