Zofran 4 mg/5 ml syrup

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Ondansetron

Fáanlegur frá:

Rowex Ltd

ATC númer:

A04AA; A04AA01

INN (Alþjóðlegt nafn):

Ondansetron

Lyfjaform:

Syrup

Lækningarsvæði:

Serotonin (5HT3) antagonists; ondansetron

Leyfisstaða:

Not marketed

Leyfisdagur:

1998-04-17

Upplýsingar fylgiseðill

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOFRAN® 4 MG/5 ML SYRUP
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 syrup is and what it is used for
2
What you need to know before you take Zofran syrup
3
How to take Zofran syrup
4
Possible side effects
5
How to store Zofran syrup
6
Contents of the pack and other information
1.
WHAT ZOFRAN SYRUP IS AND WHAT IT IS USED FOR
Zofran syrup contains a medicine called ondansetron. This belongs to a
group of medicines called anti-
emetics.
Zofran syrup is 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 syrup 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 SYRUP
DO NOT TAKE ZOFRAN SYRUP 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 syrup
(listed in Section 6).
If you are not sure, talk to your doctor, nurse or pharmacist before
taking Zofran syrup.
WARNINGS AND PRECAUTIONS
Check with your doctor or pharmacis

Vara einkenni

Health Products Regulatory Authority
23 February 2023
CRN00DC7H
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zofran 4 mg/5 ml syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains 4mg ondansetron (as ondansetron hydrochloride
dihydrate).
Excipients with known effect:
Each 5 ml also contains 2.1g of Sorbitol (E420) and 3.75mg of ethanol,
and 10mg of sodium benzoate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution.
Clear, colourless to light yellow liquid with characteristic
strawberry odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS
Zofran Syrup is indicated for the management of nausea and vomiting
induced by cytotoxic chemotherapy and radiotherapy.
Zofran Syrup is 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 8 mg (two 5 ml spoonfuls) 1-2 hours
before treatment, followed by 8 mg (two 5 ml spoonfuls)
orally 12 hours later.
_Highly emetogenic chemotherapy:_
For patients receiving highly emetogenic chemotherapy a single oral
dose of up to 24 mg (six 5 ml spoonfuls) ondansetron
t