Zofran Melt 4mg oral lyophilisates

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Ondansetron

Dostupné z:

Novartis Pharmaceuticals UK Ltd

ATC kód:

A04AA01

INN (Medzinárodný Name):

Ondansetron

Dávkovanie:

4mg

Forma lieku:

Oral lyophilisate

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 04060000; GTIN: 5000123109043

Príbalový leták

Package Leaflet: Information for the User
ZOFRAN
® MELT 4MG
(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 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.

The name of this medicine is Zofran melt 4mg but will be referred to
as
Zofran melt throughout the remainder of this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Zofran melt is and what it is used for
2. What you need to know before you take Zofran melt
3. How to take Zofran melt
4. Possible side effects
5. How to store Zofran melt
6. Contents of the pack and other information
Zofran melt contains a medicine called ondansetron. This belongs to a
group of medicines called anti-emetics. Zofran melt is a special type
of
Zofran tablet that dissolves very quickly when put on top of the
tongue.
Zofran melt 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.
DO NOT TAKE ZOFRAN MELT 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 melt (listed in Section 6).
If you are not sure, talk to your doctor, nurse or pharmacist before
taking
Zofran melt.
WARNINGS AND PRECAUTIONS
Check with your doctor, nurse or pharmacist before taking Zof

Súhrn charakteristických

OBJECT 1
ZOFRAN MELT 4MG
Summary of Product Characteristics Updated 13-Oct-2017 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Zofran Melt 4 mg
Zofran Melt 8 mg
2. Qualitative and quantitative composition
Zofran Melt 4 mg
Each Melt contains ondansetron 4 mg.
Excipients with known effect: Each 4 mg Melt contains 625 micrograms
of aspartame (E951), 56
micrograms sodium methyl para-hydroxybenzoate (E219) and 6.9
micrograms of sodium propyl para-
hydroxybenzoate (E217).
Zofran Melt 8 mg
Each Melt contains ondansetron 8 mg.
Excipients with known effect: Each 8 mg Melt contains 1.25 mg of
aspartame (E951), 110 micrograms
sodium methyl para hydroxybenzoate (E219) and 14 micrograms of sodium
propyl para hydroxybenzoate
(E217).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral lyophilisate.
White, round, plano-convex, freeze dried, fast dispersing oral dosage
form.
4. Clinical particulars
4.1 Therapeutic indications
_Adults:_
Zofran Melt is indicated for the management of nausea and vomiting
induced by cytotoxic chemotherapy
and radiotherapy.
Zofran Melt 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
Place the Melt on top of the tongue, where it will disperse within
seconds, then swallow.
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 cha