ZOFRAN SUPPOSITORIES 16MG

Active substance: ONDANSETRON

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8N654D00

5 How to store Zofran suppositories

GSK-ContractMfg-Eur-UK-France-Farmaclair-Herouville
United Kingdom-GBR
Zofran
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• eep out of the sight and reach of children.
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• o not use Zofran suppositories after the expiry date
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which is stated on the pack after ‘Exp’. The expiry date
refers to the last day of that month.
• tore Zofran suppositories below 30°C.
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• ofran suppositories should only be taken out of the
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blister immediately before use.
• o not throw away any medicines via wastewater or
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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

125x40-PD315-100_Ed2

What Zofran suppositories contain
• he active ingredient is ondansetron. Each Zofran
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suppository contains ondansetron 16 mg.
• he other ingredient is Witespol S58
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What Zofran suppositories look like and contents of the pack
Zofran suppository is white and torpedo shaped. Each
suppository is in an individually sealed cavity enclosed in a
perforated cardboard mount and packed into a carton.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder:
Glaxo Wellcome UK Ltd,
Stockley Park West, Uxbridge, Middlesex UB11 1BT
Manufacturer:
Farmaclair, Herouville Saint-Clair, France
Other formats:
To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:

0800 198 5000 (UK only).
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PHARMA CODE N° 1057

PHARMA CODE N° 1057

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Please be ready to give the following information:
Product name
Zofran suppositories
Reference number 0949/0247
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This is a service provided by the Royal National Institute of
Blind People.
This leaflet was last revised in August 2014
Zofran is a registered trademark of the GlaxoSmithKline
group of companies
© 2014 GlaxoSmithKline group of companies.
All rights reserved

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.
• eep this leaflet. You may need to read it again.
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• f you have any further questions about your illness or
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your medicine, ask your doctor, nurse or pharmacist.
• his medicine has been prescribed for you. Do not pass it
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on to others. It may harm them, even if their symptoms
are the same as yours.
• f any of the side effects get serious, or if you notice
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any side effects not listed in this leaflet, please tell your
doctor, nurse or pharmacist (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:
• reventing nausea and vomiting caused by chemotherapy
p
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:
• ou are taking apomorphine (used to treat Parkinson’s
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disease)
• ou are allergic (hypersensitive) to ondansetron or
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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 or pharmacist before using Zofran
suppositories if:
• ou have ever had heart problems (e.g. congestive heart
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failure which causes shortness of breath and swollen
ankles)
• ou have an uneven heart beat (arrhythmias)
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• ou are allergic to medicines similar to ondansetron, such
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as granisetron or palonosetron
• ou have liver problems
y
• ou have a blockage in your gut
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• ou have problems with the levels of salts in your blood,
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such as potassium, sodium and magnesium.
If you are not sure if any of the above apply to you, talk
to your doctor, nurse or pharmacist before using Zofran
suppositories.
Other medicines and Zofran
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.
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GSK-ContractMfg-Eur-UK-France-Farmaclair-Herouville
United Kingdom-GBR
Zofran
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125x40-PD315-100_Ed2

This is because Zofran can affect the way some medicines
work. Also some other medicines can affect the way Zofran
works.
In particular, tell your doctor, nurse or pharmacist if you are
taking any of the following medicines:
• arbamazepine or phenytoin used to treat epilepsy
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• ifampicin used to treat infections such as tuberculosis (TB)
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• ntibiotics such as erythromycin or ketoconazole
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• nti-arrhythmic medicines used to treat an uneven heart
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beat
• eta-blocker medicines used to treat certain heart or eye
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problems, anxiety or prevent migraines
• ramadol, a pain killer
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• edicines that affect the heart (such as haloperidol or
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methadone)
• ancer medicines (especially anthracyclines and
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trastuzumab).
• SSRIs (selective serotonin reuptake inhibitors) used to treat

depression and/or anxiety including fluoxetine, paroxetine,
sertraline, fluvoxamine, citalopram, escitalopram
• NRIs (serotonin noradrenaline reuptake inhibitors) used
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to treat depression and/or anxiety including venlafaxine,
duloxetine.

If you keep feeling or being sick
Zofran suppositories should start to work within one or two
hours of using a dose.
If you continue to feel sick or are sick then tell your doctor
or nurse. Do not use the suppositories more often than the
label says.
If you use more Zofran suppositories than you should
If you use more Zofran suppositories than you should, or
accidentally swallow one, talk to a doctor or go to a
hospital straight away. Take the medicine pack with you.
If you forget to use Zofran suppositories
If you miss a dose and feel sick or vomit:
• se a Zofran suppository as soon as possible, then
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• se your next suppository at the usual time (as shown on
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the label)
• o not use a double dose to make up for a forgotten
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dose.
If you miss a dose but do not feel sick
• se the next dose as shown on the label
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• o not use a double dose to make up for a forgotten
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dose.
4 Possible side effects

If you are not sure if any of the above applies to you, talk
to your doctor, nurse or pharmacist before using Zofran
suppositories.

Like all medicines, Zofran suppositories can cause side
effects, although not everybody gets them.

Pregnancy and breast-feeding
It is not known if Zofran is safe during pregnancy. If you are
pregnant, think you are pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before using
Zofran suppositories.
Do not breast-feed if you are using Zofran. This is because
small amounts pass into the mother’s milk. Ask your doctor
or midwife for advice.

Allergic reactions
If you have an allergic reaction, stop using it and see a
doctor straight away. The signs may include:
• udden wheezing and chest pain or chest tightness
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• welling of your eyelids, face, lips, mouth or tongue
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• kin rash - red spots or lumps under your skin (hives)
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anywhere on your body
• ollapse.
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3 How to use Zofran suppositories

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Always use Zofran suppositories exactly as your doctor
has told you. You should check with your doctor, nurse or
pharmacist if you are not sure.
Dosage
On the day of chemotherapy or radiotherapy:
• he usual dose is one suppository (16 mg) to be inserted
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1 to 2 hours before treatment.
On the following days:
• he usual dose is one suppository (16 mg) each day
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• his may be repeated for up to 5 days.
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Children
Zofran suppositories are not recommended for children.
Patients with moderate or severe liver problems
You should use Zofran as injection or tablets because the
total daily dose should not be more than 8 mg.

Using Zofran suppositories
1. mpty your bowels if you need to. Wash your hands.
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2. emove the suppository from its packaging by tearing
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the foil (see illustration on pack)
3. ou may find that inserting the suppository is easier if
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you squat or bend forward
4. ently push the pointed end of the suppository into the
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back passage (rectum)
5. ush the suppository in as far as possible and remain still
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for a little while. This allows the suppository to melt so
the medicine will work
6. ash your hands
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7. ry not to empty your bowels within 1 hour of inserting
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the suppository.
8. f your suppository comes out of your back passage, push
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it back in as far as possible and remain still for a while.
Wash your hands again.
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Other side effects include:
Very common (affects more than 1 in 10 people)
• eadache.
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Common (affects less than 1 in 10 people)
• feeling of warmth or flushing
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• onstipation
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• hanges to liver function test results (if you use Zofran
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suppositories with a medicine called cisplatin, otherwise
this side effect is uncommon).
Uncommon (affects less than 1 in 100 people)
• iccups
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• ow blood pressure, which can make you feel faint or
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dizzy
• neven heart beat
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• hest pain
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• its
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• nusual body movements or shaking.
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Rare (affects less than 1 in 1,000 people)
• feeling dizzy or light headed
• blurred vision
• isturbance in heart rhythm (sometimes causing a sudden
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loss of consciousness).
Very rare (affects less than 1 in 10,000 people)
• oor vision or temporary loss of eyesight, which usually
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comes back within 20 minutes.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

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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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