Zofran 4mg/5ml syrup

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Ondansetron hydrochloride

Dostępny od:

Novartis Pharmaceuticals UK Ltd

Kod ATC:

A04AA01

INN (International Nazwa):

Ondansetron hydrochloride

Dawkowanie:

800microgram/1ml

Forma farmaceutyczna:

Oral solution

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 04060000; GTIN: 5000123108541

Ulotka dla pacjenta

- 1 -
NOVARTIS (LOGO)
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOFRAN® SYRUP 4 MG/5 ML
ONDANSETRON (AS HYDROCHLORIDE DIHYDRATE)
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 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 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 (in adults and
children) or radiotherapy
for cancer (adults only)

preventing nausea and vomiting after surgery (adults only).
Ask your doctor, nurse or pharmacist if you would like any further
explanation about these uses.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOFRAN SYRUP
DO NOT TAKE ZOFRAN SYRUP 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, nurse or pharmacist before taking Zofran syrup
if:

you have ever had heart problems (e.g. congestive heart fail

Charakterystyka produktu

OBJECT 1
ZOFRAN SYRUP
Summary of Product Characteristics Updated 13-Oct-2017 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Zofran
®
Syrup 4 mg/5 ml
2. Qualitative and quantitative composition
Each 5 ml contains 4 mg of ondansetron as the hydrochloride dihydrate.
Excipients with known effect: Each 5 ml also contain 2.1 g of sorbitol
(E420) and 3 mg of ethanol (see
section 4.4).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution.
Sugar-free strawberry flavoured liquid.
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 indicated for the prevention of post-operative nausea
and vomiting (PONV).
For treatment of established PONV, administration by injection is
recommended.
_Paediatric Population:_
Zofran is indicated for the management of chemotherapy-induced nausea
and vomiting (CINV) in
children aged ≥6 months.
No studies have been conducted on the use of orally administered
ondansetron in the prevention and
treatment of PONV in children aged ≥1 month administration by IV
injection is recommended for this
purpose.
4.2 Posology and method of administration
Chemotherapy and radiotherapy induced nausea and vomiting.
_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 oral administration: 8 mg taken 1 to 2 hours before chemotherapy
or radiation treatment, followed by
8 mg every 12 hours for a maximum of 5 days to protect against delayed
or prolonged emesis.
_For highly emetogenic chemotherapy_: a single dose of up to 24 mg
Zofran taken with 12 mg oral
dexameth