ZOFRAN 4 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ONDANSETRON HYDROCHLORIDE DIHYDRATE

Available from:

B & S Healthcare

ATC code:

A04AA01

INN (International Name):

ONDANSETRON HYDROCHLORIDE DIHYDRATE

Dosage:

4 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

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

Therapeutic area:

Serotonin (5HT3) antagonists

Authorization status:

Authorised

Authorization date:

2011-05-03

Patient Information leaflet

LEAFLET: INFORMATION FOR THE USER 
ZOFRAN
®
 4MG 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.  

The name of your medicine is Zofran 4mg Film-coated 
Tablets but will be referred to as Zofran tablets 
throughout 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 or radiotherapy for cancer  
  preventing nausea and vomiting after surgery  

Ask your doctor, nurse or pharmacist if you would like any 
further explanation about these uses.  

Zofran tablets should start to work within one or two 
hours of taking a dose. You must talk to a doctor if you do 
not feel better or if you feel worse. 

2  WHAT YOU NEED TO KNOW BEFORE YOU TAKE 
ZOFRAN TABLETS  

DO NOT TAKE ZOFRAN TABLETS IF:  
  if you ar

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zofran 4 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains ondansetron 4mg as ondansetron hydrochloride dihydrate.
Excipient: contains lactose anhydrous.
For a full list of excipients, see _Section 6.1_.
3 PHARMACEUTICAL FORM
Film coated tablet.
_Product imported from Poland:_
Yellow, biconvex, oval film-coated tablet engraved ‘GXET3’ on one face and plain on the other.
4 CLINICAL PARTICULARS
As per PA1077/016/005.
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/016/005.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Core_
Lactose anhydrous
Microcrystalline cellulose
Pregelatinised maize starch
Magnesium stearate
_Film-coating_
Hypromellose
Titanium dioxide (E171)
Iron oxide yellow (E172)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on the blister and outer package of the product on the
market in the country of origin.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 31/03/2015_
_CRN 2158627_
_page number: 1_
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
6.5 NATURE AND CONTENTS OF CONTAINER
Zofran tablets are available in double foil blister packs containing 5 tablets per strip in a cardboard carton. Total pack
size 10 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Swallow whole with a glass of water.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
B&S Healthcare
Unit 4, Bradfield Road
Ruislip
Middlesex
HA4 0NU
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1328/148/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 3rd May 2011
10 DATE OF REVISION OF