Zofran 4 mg/5 ml syrup

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ondansetron

Available from:

PCO Manufacturing Ltd.

ATC code:

A04AA01

INN (International Name):

Ondansetron

Dosage:

4 mg/5ml

Pharmaceutical form:

Syrup

Therapeutic area:

ondansetron

Authorization date:

2021-04-16

Patient Information leaflet

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 pharm

Summary of Product characteristics

Health Products Regulatory Authority
15 May 2023
CRN00DKQ4
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zofran 4 mg/5 ml syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 4 mg ondansetron (as ondansetron hydrochloride
dihydrate).
Excipients with known effect: Sorbitol, ethanol and sodium benzoate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution.
_Product imported from Poland:_
Clear, colourless to light yellow liquid with characteristic
strawberry odour.
4 CLINICAL PARTICULARS
As per PA0711/327/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0711/327/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Citric acid anhydrous (E330)
Sodium citrate dihydrate
Sodium benzoate (E211)
Sorbitol 70% (crystallising) (E420)
Strawberry flavour*
Purified Water
*Strawberry flavour contains small amounts of ethanol (alcohol)
6.2 INCOMPATIBILITIES
Due to the lack of available data, Zofran Syrup should not be diluted
or admixed with any other liquid preparation.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the bottle and outer package of the product on the market
in the country of origin. The product should be used within 28 days
after first opening.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Zofran Syrup should be stored upright. Do not store above 25°C. Do
not refrigerate or freeze.
Health Products Regulatory Authority
15 May 2023
CRN00DKQ4
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Zofran Syrup is packed into a 60 ml amber glass bottle, with a child
resistant cap. Bottles contain 50 ml.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements. Any unused product or waste material should
be disposed of in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/113/005
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first author