ZOFRAN 8 Milligram Film Coated Tablet

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

ONDANSETRON HYDROCHLORIDE

Dostupno od:

Novartis Pharmaceuticals UK Ltd

ATC koda:

A04AA01

INN (International ime):

ONDANSETRON HYDROCHLORIDE

Doziranje:

8 Milligram

Farmaceutski oblik:

Film Coated Tablet

Tip recepta:

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

Područje terapije:

Serotonin (5HT3) antagonists

Status autorizacije:

Authorised

Datum autorizacije:

2016-01-22

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER 
ZOFRAN® 4 MG OR 8 MG FILM COATED TABLETS  
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 tablets are and what they are used for 
2 
What you need to know before you take Zofran tablets 
3 
How to take Zofran tablets 
4 
Possible side effects 
5 
How to store Zofran tablets 
6 
Contents of the pack and other information 

1  WHAT ZOFRAN TABLETS ARE AND WHAT THEY ARE USED FOR  

Zofran tablets contain a medicine called ondansetron. This belongs to a group of medicines 
called anti-emetics.  

Zofran tablets are 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  in  CHILDREN  AND 
ADOLESCENTS aged 6 months to 17 years 

Ask  your  doctor,  nurse  or  pharmacis

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zofran 8mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains ondansetron 8mg as ondansetron hydrochloride
dihydrate.
Excipients: Contains Lactose Anhydrous 163.75mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, oval, biconvex tablets engraved "GXET5" on one face and plain
on the other face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS
Zofran tablets are indicated for the management of nausea and vomiting
induced by cytotoxic chemotherapy and
radiotherapy. Zofran tablets are 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 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 ondansetron taken together
with 12 mg oral dexamethasone sodium phosphate, 1 to 2 hours before
chemotherapy, may be used. After the first 24
hours, oral