Zofran 16mg suppositories

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Ondansetron

Fáanlegur frá:

Novartis Pharmaceuticals UK Ltd

ATC númer:

A04AA01

INN (Alþjóðlegt nafn):

Ondansetron

Skammtar:

16mg

Lyfjaform:

Suppository

Stjórnsýsluleið:

Rectal

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 04060000; GTIN: 5000123108824

Upplýsingar fylgiseðill

NOVARTIS (LOGO)
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOFRAN® SUPPOSITORIES 16 MG
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 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
possible side effects not listed in
this leaflet. See section 4.
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 doctor, nurse or pharmacist before using Zofran
suppositories if:
•
you have ever had heart proble

Vara einkenni

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
Posology
_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 Po