Zofran 16mg suppositories

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ondansetron

Available from:

CST Pharma Ltd

ATC code:

A04AA01

INN (International Name):

Ondansetron

Dosage:

16mg

Pharmaceutical form:

Suppository

Administration route:

Rectal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000; GTIN: 5055946806266

Patient Information leaflet

ZOFRAN
® 16MG
SUPPOSITORIES
(ondansetron)
PACKAGE LEAFLET: INFORMATION FOR THE USER
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. Do not pass it on to
others. It
may harm them, even if their symptoms are the same as yours.
-
If any of the side effects get serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor, nurse or pharmacist.
This
includes any other side effects not listed in this leaflet. See
section 4.
The name of your medicine is Zofran 16mg Suppositories but will be
referred to as Zofran suppositories throughout 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ZOFRAN
SUPPOSITORIES
DO NOT USE ZOFRAN SUPPOSITORIES IF:
-
you are taking apomorphine (used to treat Parkinson’s disease)
-
you are allergic (hypersensitive) to ondansetron or Witespol S58 in
Zofran
suppositories
If you are not sure, talk to your doctor, nurse or pharmacist before
using
Zofran suppositories.
WARNINGS AND PRECAUTIONS
Check with your doc

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zofran Suppositories 16 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 16 mg of ondansetron.
3
PHARMACEUTICAL FORM
White torpedo shaped suppositories.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults: _
Zofran Suppositories are indicated for the management of nausea and
vomiting induced by cytotoxic chemotherapy and radiotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_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 rectal administration: The recommended dose of Zofran
(ondansetron)
Suppositories is one 16 mg suppository given 1 to 2 hours before
treatment.
To protect against delayed or prolonged emesis after the first 24
hours, oral or
rectal treatment with Zofran should be continued for up to 5 days
after a
course of treatment. The recommended daily dose for rectal
administration is
one 16 mg suppository.
_Highly emetogenic chemotherapy (e.g. high dose cisplatin):_ Zofran
can be
given either by oral, rectal, intravenous or intramuscular
administration.
For rectal administration: The recommended dose of Zofran
(ondansetron)
Suppositories is one 16 mg suppository given 1 to 2 hours before
treatment.
The efficacy of Zofran in highly emetogenic chemotherapy may be
enhanced
by the addition of a single intravenous dose of dexamethasone sodium
phosphate 20 mg, administered prior to chemotherapy.
To protect against delayed or prolonged emesis after the first 24
hours, oral or
rectal treatment with Zofran should be continued for up to 5 days
after a
course of treatment. The recommended daily dose for rectal
administration is
one 16 mg suppository.
_Paediatric Population