Setofilm 4 mg Orodispersible Films

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ondansetron

Available from:

Norgine B.V.

ATC code:

A04AA; A04AA01

INN (International Name):

Ondansetron

Dosage:

4 milligram(s)

Pharmaceutical form:

Orodispersible film

Prescription type:

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

Therapeutic area:

Serotonin (5HT3) antagonists; ondansetron

Authorization status:

Not marketed

Authorization date:

2010-08-20

Patient Information leaflet

Page 1/7
PACKAGE LEAFLET: INFORMATION FOR THE USER
SETOFILM
® 4 MG, ORODISPERSIBLE FILMS
SETOFILM
® 8 MG, ORODISPERSIBLE FILMS
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, 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 you get any side effects, talk to 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 SETOFILM is and what it is used for
2.
What you need to know before you use SETOFILM
3.
How to use SETOFILM
4.
Possible side effects
5.
How to store SETOFILM
6.
Contents of the pack and other information
1.
WHAT SETOFILM IS AND WHAT IT IS USED FOR
Setofilm contains a medicine called ondansetron. This belongs to a
group of drugs called
antiemetics.
Setofilm is used to treat and prevent nausea (feeling sick) and
vomiting (being sick) caused by
chemotherapy or radiotherapy. It can also be used after an operation
to prevent and treat
nausea and vomiting.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SETOFILM
DO NOT USE SETOFILM

if you are allergic (hypersensitive) to ondansetron or any of the
other ingredients of
Setofilm listed in section 6,
if you are allergic (hypersensitive) to other drugs belonging to the
group of selective
serotonin (5-HT
3
)-receptor antagonists (eg. granisetron, dolasetron). If you are
taking
apomorphine (used to treat Parkinson’s disease). For further
information see section
“Other medicines and Setofilm”.
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist before taking Setofilm if:

you have ever had heart problems

you have an irregular or uneven heart beat (arrhythmia)

you have liver problems
Page 2/7

you have a blockage in your gut or bowel or

Summary of Product characteristics

HealthProductsRegulatoryAuthority
27February2019
CRN008S2H
Page1of9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Setofilm4mgOrodispersibleFilms
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachfilmcontains4mgofondansetron(asbase)
Forafulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
OrodispersibleFilm.
White,rectangular(size3cm
2
),orodispersiblefilm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS:

-Prophylaxisofacutenauseaandvomitinginducedbymoderatelyemetogenicchemotherapy.

-Prophylaxisandtreatmentofdelayednauseaandvomitinginducedbymoderatelytohighlyemetogenic
chemotherapy.

-Prophylaxisandtreatmentofacuteanddelayednauseaandvomitinginducedbyhighlyemetogenic
radiotherapy.

-Prophylaxisandtreatmentofpost-operativenauseaandvomiting(PONV).
PAEDIATRIC POPULATION:

-Managementofchemotherapy-inducednauseaandvomitinginchildrenaged≥6months.

-Prophylaxisandtreatmentofpost-operativenauseaandvomiting(PONV)inchildrenaged≥4years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
SETOFILMisonlyindicatedfororaluse.PleaserefertotherelevantSmPCforotherdosageformsofondansetron.
SETOFILMmayberecommendedinpatientswithanenhancedriskofaspiration.
Itcanbeusefulforpatientsthatexperience
difficultiesinswallowing,e.g.,childrenortheelderly.
METHOD OF ADMINISTRATION:

-SETOFILMorodispersiblefilmshouldberemovedfromeachindividualsachettakingcarenottodamagethefilm.

-Openthesachetonlyattheteartagandtearthisoffslowly.
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