ZOFRAN ZYDIS 8mg Milligram Oral Lyophilisate

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

ONDANSETRON

Fáanlegur frá:

Novartis Pharmaceuticals UK Ltd

ATC númer:

A04AA01

INN (Alþjóðlegt nafn):

ONDANSETRON

Skammtar:

8mg Milligram

Lyfjaform:

Oral Lyophilisate

Gerð lyfseðils:

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

Lækningarsvæði:

Serotonin (5HT3) antagonists

Leyfisstaða:

Authorised

Leyfisdagur:

2016-01-29

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER 
ZOFRAN® ZYDIS 4 MG AND 8 MG ORAL LYOPHILISATE

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 Zydis is and what it is used for 
2 
What you need to know before you take Zofran Zydis  
3 
How to take Zofran Zydis 
4 
Possible side effects 
5 
How to store Zofran Zydis 
6 
Contents of the pack and other information 

1  WHAT ZOFRAN ZYDIS IS AND WHAT IT IS USED FOR  

Zofran Zydis contains a medicine called ondansetron. This belongs to a group of medicines 
called anti-emetics. Zofran Zydis is a special type of Zofran tablet that dissolves very quickly 
when put on top of the tongue.   

Zofran Zydis 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/i

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zofran Zydis 8 mg Oral Lyophilisate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Zofran Zydis oral lyophilisate contains ondansetron 8 mg.
Each 8mg Oral Lyophilisate contains 1.25 mg of aspartame (E951), 110
micrograms sodium
methylparahydroxybenzoate (E219) and 14 micrograms of sodium
propylparahydroxybenzoate (E217).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral lyophilisate.
White round tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
Zofran Zydis is indicated for the management of nausea and vomiting
induced by cytotoxic chemotherapy and
radiotherapy. Zofran Zydis 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.
Place the Zofran Zydis on top of the tongue, where it will disperse
within seconds, then swallow.
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 8mg taken 1-2 hours before chemotherapy
or radiation treatment, followed by 8mg
orally every 12 hours for a maximum of 5 days.
_Highly emetogenic chemotherapy:_
For patients receiving highly emetogenic chemotherapy a single oral
dose of up to 24 mg ondan