Zofran 16 mg Suppositories

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:

16 milligram(s)

Pharmaceutical form:

Suppository

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Serotonin (5HT3) antagonists; ondansetron

Authorization status:

Not marketed

Authorization date:

1998-05-01

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOFRAN® 16 MG SUPPOSITORIES
ondansetron
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 suppositories are and what they are used for
2
What you need to know before you use Zofran suppositories
3
How to use Zofran suppositories
4
Possible side effects
5
How to store Zofran suppositories
6
Contents of the pack and other information
1.
WHAT ZOFRAN SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR
Zofran suppositories contain a medicine called ondansetron. This
belongs to a group of medicines
called anti-emetics.
ZOFRAN SUPPOSITORIES ARE FOR USE IN YOUR BACK PASSAGE ONLY (RECTAL
USE).
THEY SHOULD NOT BE SWALLOWED.
Zofran suppositories are used for:
•
preventing nausea and vomiting caused by chemotherapy or radiotherapy
for cancer
Ask your doctor, nurse or pharmacist if you would like any further
explanation about these uses.
Zofran suppositories 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 USE ZOFRAN SUPPOSITORIES
DO NOT USE ZOFRAN SUPPOSITORIES 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
suppositories (listed in section 6).
If you are not sure, talk to your doctor, nurse or pharmacist before
using Zofran suppositories.
WARNINGS AND PRECAUTIONS
Check with your doctor

Summary of Product characteristics

Health Products Regulatory Authority
15 December 2021
CRN00CN3K
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zofran 16 mg Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 16.00 mg of ondansetron.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suppositories.
White, smooth, homogeneous suppository with a torpedo shape.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zofran Suppositories are indicated for the management of nausea and
vomiting induced by cytotoxic chemotherapy and
radiotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Zofran is also available for parenteral and oral 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 dose of Zofran Suppositories is one 16mg suppository
given 1-2 hours before treatment.
To protect against delayed or prolonged emesis after the first 24
hours, rectal treatment with Zofran should be continued for
up to 3 days, or oral treatment for up to 5 days after a course of
treatment. The recommended daily dose of Zofran
Suppositories is one 16mg suppository.
_PAEDIATRIC POPULATION: _
CINV IN CHILDREN AND ADOLESCENTS (AGED 6 MONTHS TO 17 YEARS)
The use of Zofran Suppositories in children is not recommended.
The usual method of administration is a single intravenous dose
immediately before chemotherapy, followed by an oral dose
twelve hours later. Oral therapy should be continued for up to 5 days
after a course of treatment.
In paediatric clinical studies, ondansetron was given by IV infusion
diluted in 25 to 50 ml of saline or other compatible infusion
fluid (see section 6.6 Instructions for Use and Handling) and infused
over n