Zofran 4 mg film-coated tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Ondansetron

Tilgjengelig fra:

IMED Healthcare Ltd.

ATC-kode:

A04AA; A04AA01

INN (International Name):

Ondansetron

Legemiddelform:

Film-coated tablet

Terapeutisk område:

Serotonin (5HT3) antagonists; ondansetron

Autorisasjon dato:

2022-03-25

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE
USER
ZOFRAN
® 4 MG FILM-COATED T
ABLETS
ZOFRAN
® 8 MG FILM-COATED T
ABLETS
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 or pharmacist

Preparatomtale

Health Products Regulatory Authority
11 April 2023
CRN00DHVS
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 film-coated tablet contains 4 mg ondansetron (as hydrochloride
dihydrate).
Excipient(s) with known effect: lactose anhydrous
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Greece_
Yellow, oval, biconvex tablets engraved GXET3 on one face and plain on
the other face.
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 anhydrous
Microcrystalline cellulose
Pregelatinised maize starch
Magnesium stearate
Film Coating
Hypromellose
Opaspray Yellow M-1-8429
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
blister and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 30°C.
6.5 NATURE AND CONTENTS OF CONTAINER
Health Products Regulatory Authority
11 April 2023
CRN00DHVS
Page 2 of 2
Blister packs of PVC/aluminium containing 15 film-coated tablets.
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
PPA1463/158/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 25
th
March 2022
10 DATE OF REVISION OF THE TEXT
April 2023