Zofran 8 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ondansetron

Available from:

Novartis Ireland Limited

ATC code:

A04AA; A04AA01

INN (International Name):

Ondansetron

Dosage:

8 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:

Marketed

Authorization date:

1990-06-27

Patient Information leaflet

1
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 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 tablets.
WARNINGS AN

Summary of Product characteristics

Health Products Regulatory Authority
15 December 2021
CRN00CN3K
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zofran 8 mg 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