Zofran Tablets 8mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ONDANSETRON

Available from:

Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland

ATC code:

A04AA01

INN (International Name):

ONDANSETRON 8 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ONDANSETRON 8 mg

Prescription type:

POM

Therapeutic area:

ANTIEMETICS AND ANTINAUSEANTS

Authorization status:

Withdrawn

Authorization date:

2006-09-18

Patient Information leaflet

- 1 -
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZOFRAN® TABLETS 8 MG
ondansetron (as hydrochloride dihydrate)
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, ask your doctor 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 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 (in adults and
children) or radiotherapy
for cancer (adults only)
•
preventing nausea and vomiting after surgery (adults only).
Ask your doctor, nurse or pharmacist if you would like any further
explanation about these
uses.
HOW ZOFRAN WORKS
Ondansetron is a 5HT
3
receptor antagonist. It works by inhibiting the 5HT
3
receptors on neurons located
in peripheral and central nervous system of the body
.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOFRAN TABLETS
DO NOT TAKE ZOFRAN TABLETS:
•
if you are taking apomorphine (used to treat Parkinson’s disease)
•
if you are allergic (hypersensitive) to ondansetron or any of the
other ingredients in Zofran
tablets (listed in Section 6). If any of these applies to you, do not
take ZOFRAN and tell your
doctor.
WARNINGS AND PRECAUTIONS
Talk your doctor or pharmacist before using Zofran tablets:
•
if you have

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zofran Tablets 8mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Zofran Tablet 8mg is a yellow, oval, film coated tablet engraved
"GXET5" on one face and plain on the other. Each tablet contains
ondansetron 8mg (as hydrochloride dihydrate).
3.
PHARMACEUTICAL FORM
Film coated tablet.
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 indicated for the prevention of post-operative
nausea and
vomiting(PONV).
For treatment of established PONV, administration by injection is
recommended.
_PAEDIATRIC POPULATION: _
Zofran is indicated for the management of chemotherapy-induced nausea
and
vomiting (CINV) in children aged ≥6 months.
For the prevention and treatment of PONV in children aged ≥1 month
administration by injection is recommended.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING
ADULTS:
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.
_Emetogenic Chemotherapy and Radiotherapy: _
Zofran can be given either by
rectal, oral (tablets or syrup), intravenous or intramuscular
administration.
For oral administration: 8mg taken 1 to 2 hours before chemotherapy or
radiation treatment, followed by 8mg every 12 hours for a maximum of 5
days
to protect against delayed or prolonged emesis.
_For highly emetogenic chemotherapy: _
a single dose of up to 24mg Zofran
taken with 12mg oral dexamethasone sodium phosphate, 1 to 2 hours
before
chemotherapy, may be used.
To protect against delayed or prolonged emesis after the first 24
hours, oral or
rectal treatment with Zofran may be continued for up to 5 days after a
course
of treatment.
The recommended dose for oral admin