Zofran 4 mg film-coated tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Ondansetron

Disponible desde:

PCO Manufacturing Ltd.

Código ATC:

A04AA; A04AA01

Designación común internacional (DCI):

Ondansetron

Dosis:

4 milligram(s)

formulario farmacéutico:

Film-coated tablet

tipo de receta:

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

Área terapéutica:

Serotonin (5HT3) antagonists; ondansetron

Estado de Autorización:

Authorised

Fecha de autorización:

2003-10-17

Información para el usuario

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOFRAN
® 4 MG FILM-COATED TABLETS
ZOFRAN
® 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 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

Ficha técnica

Health Products Regulatory Authority
04 April 2023
CRN00DHPR
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 4 mg as ondansetron hydrochloride
dihydrate.
Excipient(s) with known effect: Lactose
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
_Product imported from Greece or Poland_
_Film-coated tablets_
Yellow, oval, film coated tablet engraved "GLAXO" on one face and "4"
on the other
or
Yellow, oval, film-coated tablet engraved 'GX ET 3' on one face and
blank on the other.
4 CLINICAL PARTICULARS
As per PA0711/327/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0711/327/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Core:_
Lactose
Microcrystalline cellulose
Maize starch
Magnesium stearate
_Film-coating:_
Hypromellose
Titanium dioxide (E171)
Iron oxide (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 package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
Health Products Regulatory Authority
04 April 2023
CRN00DHPR
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs containing 10, 15 or 30 tablets in an outer cardboard
carton.
Not all pack sizes may be marketed.
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
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/113/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 17 October 2003
Date of last renewal: 17 October 2008
10 DATE OF REVISION OF THE TEXT
April 2023