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SETOFILM 8 MG ORODISPERSIBLE FILMS

Active substance(s): ONDANSETRON / ONDANSETRON / ONDANSETRON

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22205303
3
2605
SETOFILM

SETOFILM Orodispersible Films
®

Ondansetron

FRONTSIDE
18/11/16
UK/Ireland
PIL
LTS
NOR-LFT22-V1
100x560mm
3737
6511494-3737
N/A

530445A03

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, 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

Black

1 What Setofilm is and what it is used for
Digitally signed by Wendy Worthy
DN: cn=Wendy Worthy, o=Schawk,
ou=Newcastle,
email=wendy.worthy@schawk.com, c=GB
Date: 2016.11.18 12:26:11 Z

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

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Page 1 of 2

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-HT3)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
• you have a blockage in your gut or bowel or if you
suffer from severe constipation
• you have problems with the levels of salts in your blood,
such as potassium, sodium and magnesium
• you are going to have or have recently had your tonsils
or adenoids removed, because treatment with Setofilm
may hide symptoms of internal bleeding
• this medicine is prescribed for a child below the
age of 2 years or with a body surface of less than
0.6m2 and / or weighing 10kg and below
If you need to have a blood or urine test, you should
tell the person performing the test that you are taking
Setofilm.
If you are not sure if any of the above apply to you, talk to
your doctor, nurse or pharmacist before taking Setofilm.
Other medicines and Setofilm
Please tell your doctor, nurse or pharmacist if you
are taking or have recently taken or might take other
medicines. This includes medicines that you buy without
a prescription and herbal medicines. This is because
Setofilm can affect the way some medicines work. Also
some other medicines can affect the way Setofilm works.
In particular, tell your doctor, nurse or pharmacist if
you are taking any of the following medicines:
• Apomorphine (a medical substance for the treatment
of Parkinson’s disease), as excessive drop in blood
pressure and loss of consciousness have been
reported when administering Setofilm (Ondansetron)
concomitantly with apomorphine.
• phenytoin, carbamazepine (medicines used to treat
epilepsy)
• rifampicin (for treating serious bacterial infections,
like TB)
• antibiotics such as erythromycin
• antifungal agents such as ketoconazole
• tramadol (for managing pain)
• anti-arrhythmics (used to treat irregular or fast heart
beat)
• beta-blockers (used to treat certain heart or eye
problems, anxiety or prevent migraines)
• medicines that can affect the heart (such as haloperidol
or methadone)
• cancer medicines (especially anthracyclines and
trastuzumab)
• SSRIs (selective serotonin reuptake inhibitors) used to
treat depression and/or anxiety including fluoxetine,
paroxetine, sertraline, fluvoxamine, citalopram,
escitalopram
• SNRIs (serotonin noradrenaline reuptake inhibitors)
used to treat depression and/or anxiety including
venlafaxine, duloxetine.
If you are not sure if any of the above applies to
you, talk to your doctor, nurse or pharmacist before
having Setofilm.
Setofilm with food and drink
You may take Setofilm with food and drink.
Pregnancy and breast-feeding
If you are pregnant or breast feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
Pregnancy:
It is not known if Setofilm is safe during pregnancy. You
should only use Setofilm if your doctor has told you to.
Breast-feeding:
You should not breast-feed whilst using Setofilm as it
can pass into your breast milk.
Driving and using machines
Setofilm has little or no effect on your ability to drive or
use machines.

3 How to use Setofilm
Always use Setofilm exactly as your doctor or
pharmacist has told you. Check with your doctor, or
pharmacist if you are not sure.
Setofilm is for oral use only. It may be recommended
for patients who may have problems with taking or
swallowing tablets; for example children or elderly.
• Remove Setofilm orodispersible film from each
individual sachet taking care not to damage the film as
follows: Open the sachet only at the tear tag and tear
this off slowly. Do not cut the sachet.
• Before use check the film for damage as you should
only use undamaged films.
• Ensure the mouth is empty (and your fingers are dry)
before placing Setofilm orodispersible film on to the
tongue.
• The film should disintegrate on your tongue without
water in a few seconds (in saliva which can be
subsequently swallowed).
Treatment and prevention of sickness (nausea and
vomiting) in patients receiving chemotherapy or
radiotherapy
Elderly:
Setofilm is well tolerated by elderly patients. They may
take the same dosage as adults (see below).
Adults:
8 mg 1-2 hours before chemotherapy or radiotherapy,
followed by 8 mg every 12 hours for up to 5 days. Your
doctor may recommend that your first dose is given by
injection.
Children (aged 6 months and over) and adolescents
(<18 years):
Your doctor will recommend what dose of ondansetron
should be given. The individualised dose will depend on
the weight or body surface area of the child.
Prevention and Treatment of post-operative sickness
(nausea and vomiting).
Elderly:
Ondansetron is well tolerated by elderly patients. They
may take the same dosage as adults; see below.

22205303
3
2605
SETOFILM
BACKSIDE
18/11/16
UK/Ireland
PIL
LTS
NOR-LFT22-V1
100x560mm
3737
6511494-3737
N/A

530445A03

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Adults:
Take 16 mg of Setofilm 1 hour before your operation
or 8 mg administered one hour before your operation,
followed by two further doses of 8 mg 8 hours apart
as directed by your doctor.
Children aged over 4 years and adolescents:
In children weighing 40 kg and above, take 4mg of
Setofilm 1 hour before your operation, followed by one
further dose of 4 mg after 12 hours.
Liver dysfunction:
Do not take more than 8 mg of ondansetron daily if your
liver does not work properly (moderate to severe liver
problems).
If you take more Setofilm than you should
Contact your doctor, or go to the hospital immediately
if you or your child have taken more Setofilm than
recommended in this package leaflet or than prescribed
by your doctor. Take the medicine pack with you.
If you forget to take Setofilm
If you forget to take Setofilm and feel sick or vomit
• Take a dose of Setofilm as soon as possible
• Take your next dose of Setofilm at the usual time
• Do not take a double dose to make up for a forgotten
dose
If you miss a dose but do not feel sick or vomit
• Take the next dose
• Do not take a double dose to make up for the forgotten
dose
If you stop taking Setofilm
If you feel unwell and stop taking Setofilm tell your
doctor or nurse as soon as possible.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.

4 Possible side effects

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Helvetica Neue LT Std-55 Roman
Helvetica Neue LT Std-75 Bold
Helvetica Neue LT Std-76 Bold Italic
Helvetica Neue LT Std-95 Black
Average Text Size (Body Text):
9.0 pt

Page 2 of 2

Like all medicines, Setofilm can cause side effects,
although not everybody gets them.
Allergic reactions:
If you have an allergic reaction, stop taking Setofilm and
immediately contact your doctor or go to the nearest
hospital. The signs of an allergic reaction may include:
• Sudden wheezing and chest pain or chest tightness
• Severe itching of the skin
• Skin rash - red spots or lumps under your skin (hives)
anywhere on your body
• Swelling of the eyelids, throat, face, lips, tongue
or mouth
• Difficulty in breathing or swallowing
• Collapse
Other side effects include:
Very common side effects (affects more than 1 in
10 people)
• Headache
Common side effects (affects less than 1 in 10 people)
• Sensation of warmth or flushing
• Constipation; tell your doctor, if you have crampy
abdominal pain or difficulty in passing stools. They
will need to monitor you carefully to see how the
treatment is affecting you.
Uncommon side effects (affects less than 1 in
100 people)
• Hiccups
• Low blood pressure, which may make you feel faint
or dizzy
• Palpitations (conscious awareness of heart beat)
or irregular or slow heart beat
• Chest pain
• Fits (convulsions)
• Unusual unintentional eye or body movements
or shaking
• Changes to liver function test results (changes
are more common if you take ondansetron with
a medicine called Cisplatin)
Rare (affects less than 1 in 1,000 people)
• Allergic reactions, sometimes severe, including
anaphylaxis
• Feeling dizzy or lightheaded [when ondansetron is
given intravenously (i.e. through a tube in your vein)]
• Blurred vision or temporary loss of eyesight,
(predominantly
when
ondansetron
is given
intravenously ) which normally comes back within
20 minutes
• Disturbance in heart rhythm and ECG changes,
including a special form of heart rhythm disorder
called Torsade de Pointes,
(sometimes causing
sudden loss of consciousness)
Very rare (affects less than 1 in 10,000 people):
• Temporary
visual
disturbances
e.g.
blurred
vision (predominantly when ondansetron is given
intravenously)
Reporting of side effects
If you get any side effects, talk to your doctor,
nurse or pharmacist. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via Yellow Card Scheme:
www.mhra.gov.uk/yellowcard.
By
reporting
side
effects you can help provide more information on the
safety of this medicine.

5 How to store Setofilm
Keep this medicine out of the sight and reach of children.
Keep the sachet tightly closed in order to protect
from moisture.
Do not use Setofilm after the expiry date (EXP) which is
stated on the carton. The expiry date refers to the last
day of that month.
Do not use Setofilm if you notice that it is damaged.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

6 Contents of the pack and other information
What Setofilm contains
The active substance is ondansetron. Each film contains
4 mg or 8 mg of ondansetron.
The other ingredients are: poly (vinyl alcohol), Macrogol
1000, acesulfame potassium E950, glycerol E422,
titanium dioxide E171, rice starch, levomenthol and
polysorbate 80 E433.
What Setofilm looks like and contents of the pack
Setofilm 4 mg are white and rectangular (size 3 cm2)
orodispersible films.
Setofilm 8 mg are white and rectangular (size 6 cm2)
orodispersible films.
Setofilm 4 mg Orodispersible Film is placed into sachets.
Each carton contains 2, 4, 6, 10, 30 or 50 sachets.
Setofilm 8 mg Orodispersible Film is placed into sachets.
Each carton contains 2, 4, 6, 10, 30 or 50 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Norgine B.V.
Hogehilweg 7,
1101CA Amsterdam ZO,
The Netherlands
Manufacturer:
LTS Lohmann Therapie-Systeme AG
Lohmannstrasse 2
D-56626 Andernach
GERMANY
This medicinal product is authorised in the Member
States of the EEA under the following names:
Setofilm: France, Ireland, UK, Belgium, Luxemburg,
Portugal, Spain, Sweden, Finland, Denmark, Netherlands,
Italy, Germany
Setofim: Norway
Product under license of APR Applied Pharma
Research S.A. SETOFILM and the SETOFILM logo
are registered trademarks of APR Applied Pharma
Research S.A., exclusively licensed to the Norgine group
of companies in the EU.
This leaflet was last revised in November 2016.

6511494-3737

22205303

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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