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ZOFRAN SUPPOSITORIES 16MG

Active substance(s): ONDANSETRON

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5 How to store Zofran suppositories
• Keep this medicine out of the sight and reach of children.
• Do not use Zofran suppositories after the expiry date
which is stated on the pack after ‘Exp’. The expiry date
refers to the last day of that month.
• Store Zofran suppositories below 30°C.
• Zofran suppositories should only be taken out of the
blister immediately before use.
• 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.

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.
• 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.

6 Contents of the pack and other information
What Zofran suppositories contain
• The active ingredient is ondansetron. Each Zofran
suppository contains ondansetron 16 mg.
• The other ingredient is Witespol S58
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.

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder:
Novartis Pharmaceuticals UK Ltd, Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR, United Kingdom
Manufacturer:
Farmaclair, Herouville Saint Clair, France
This leaflet was last revised in May 2015

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:
• preventing nausea and vomiting caused by chemotherapy
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:
• you are taking apomorphine (used to treat Parkinson’s
disease)
• you are allergic (hypersensitive) to ondansetron or
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, nurse or pharmacist before using
Zofran suppositories if:
• you have ever had heart problems (e.g. congestive heart
failure which causes shortness of breath and swollen
ankles)
• you have an uneven heart beat (arrhythmias)
• you are allergic to medicines similar to ondansetron, such
as granisetron or palonosetron
• you have liver problems
• you have a blockage in your gut
• you have problems with the levels of salts in your blood,
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.
TURN OVER
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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:
• carbamazepine or phenytoin used to treat epilepsy
• rifampicin used to treat infections such as tuberculosis (TB)
• antibiotics such as erythromycin or ketoconazole
• anti-arrhythmic medicines used to treat an uneven heart
beat
• beta-blocker medicines used to treat certain heart or eye
problems, anxiety or prevent migraines
• tramadol, a pain killer
• medicines that 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 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:
• use a Zofran suppository as soon as possible, then
• use your next suppository at the usual time (as shown on
the label)
• do not use a double dose to make up for a forgotten
dose.
If you miss a dose but do not feel sick
• use the next dose as shown on the label
• do not use a double dose to make up for a forgotten
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:
• sudden wheezing and chest pain or chest tightness
• swelling of your eyelids, face, lips, mouth or tongue
• skin rash - red spots or lumps under your skin (hives)
anywhere on your body
• collapse.
Other side effects include:
Very common (may affect more than 1 in 10 people)
• headache.

3 How to use Zofran suppositories
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.

Common (may affect up to 1 in 10 people)
• a feeling of warmth or flushing
• constipation
• changes to liver function test results (if you use Zofran
suppositories with a medicine called cisplatin, otherwise
this side effect is uncommon).

Dosage
On the day of chemotherapy or radiotherapy:
• the usual dose is one suppository (16 mg) to be
inserted 1 to 2 hours before treatment.
On the following days:
• the usual dose is one suppository (16 mg) each day
• this may be repeated for up to 5 days.

Uncommon (may affect up to 1 in 100 people)
• hiccups
• low blood pressure, which can make you feel faint or
dizzy
• uneven heart beat
• chest pain
• fits
• unusual body movements or shaking.

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.

Rare (may affect up to 1 in 1,000 people)
• feeling dizzy or light headed
• blurred vision
• disturbance in heart rhythm (sometimes causing a sudden
loss of consciousness).

Using Zofran suppositories
1. Empty your bowels if you need to. Wash your hands.
2. Remove the suppository from its packaging by tearing
the foil (see illustration on pack)
3. You may find that inserting the suppository is easier if
you squat or bend forward
4. Gently push the pointed end of the suppository into the
back passage (rectum)
5. Push the suppository in as far as possible and remain still
for a little while. This allows the suppository to melt so
the medicine will work
6. Wash your hands
7. Try not to empty your bowels within 1 hour of inserting
the suppository.
8. If your suppository comes out of your back passage, push
it back in as far as possible and remain still for a while.
Wash your hands again.

Very rare (may affect up to 1 in 10,000 people)
• poor vision or temporary loss of eyesight, which usually
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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HU1 3HA
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x Yes
Live Text:
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No
WO:
1395602
Comp. Description: Leaflet_ZOFRAN_SUP_16MG_GB
Comp. Number New: 1395602 GB
Comp. Number Old: N/A
Format/Dimension: 250 x 315 mm
Tech. Drawing No.: 125x40-PD315-100_Ed2

/

Both

Production Site:
CTM:
Printing Colours:

Checking against manuscript according to
SOP-0022667. To be signed by AwOps.

France, TPO, Farmaclair, Herouville
Stone, Christina
Black

Technical Colours: Cutting
Dimensions

Technical approval. To be signed by Manufacturing Site.

Minimum Font Size: 6.0pt
Font Type: Frutiger LT Std
Proof Number: 2
Braille:

05/06/2015

Laura Broadbent

! PL E ASE TU R N OVE R P R I NT I N G O N !
632106_0

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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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