Zofran 4 mg film-coated tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
25-11-2019
Summary of Product characteristics
(SPC)
25-11-2019
Active ingredient:
Ondansetron
Available from:
IMED Healthcare Ltd.
ATC code:
A04AA; A04AA01
INN (International Name):
Ondansetron
Dosage:
4 milligram(s)
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Serotonin (5HT3) antagonists; ondansetron
Authorization status:
Authorised
Authorization date:
2012-06-22
Patient Information leaflet
PACKAGE 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.
See
section 4.
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 in ADULTS
preventing nausea and vomiting after surgery in ADULTS
preventing nausea and vomiting caused by chemotherapy for cancer
in CHILDREN AND ADOLESCENTS aged 6 months to 17 years
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 are taking apomorphine (used to treat Parkinson’s Disease)
you are allergic (hypersensitive) to ondansetron or any of the other
ingredients in Zofran tablets (listed in Section 6).
If you are not sure, talk to your doctor, nurse or pharmacist before
taking
Zofran table
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
24 November 2019
CRN0096QZ
Page 1 of 2
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 with known effect: lactose
For a full list of exciptents, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Poland_
Yellow, oval, biconvex tablets GXET3 on the face and plain on the
other face
4 CLINICAL PARTICULARS
As per PA0896/036/005
5 PHARMACOLOGICAL PROPERTIES
As per PA0896/036/005
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Core
Lactose Anhydrous
Microcrystalline cellulose
Pregelatanised 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 is the date shown on the
container and outer carton of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Health Products Regulatory Authority
24 November 2019
CRN0096QZ
Page 2 of 2
Do not store above 30°C.
6.5 NATURE AND CONTENTS OF CONTAINER
Zofran film-coated tablets are available in blister packs containing
10 tablets in an over-labelled outer carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
Swallow whole with a glass of water.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/062/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 22
nd
June 2012
10 DATE OF REVISION OF THE TEXT
November 2019
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