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ZOFRAN 16MG SUPPOSITORIES

Active substance(s): ONDANSETRON

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Zofran® 16mg Suppositories

2121
01.02.16[13]

(ondansetron)
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 about your illness or your medicine, 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 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 other side effects not listed in this leaflet. See section 4.
The name of your medicine is Zofran 16mg Suppositories but will be
referred to as Zofran suppositories throughout this leaflet.
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:
- 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.
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 are not sure if any of the above applies to you, talk to your doctor,
nurse or pharmacist before using Zofran suppositories.
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.
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.
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.
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. 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.
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
Like all medicines, Zofran suppositories can cause side effects, although not
everybody gets them.
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.

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).
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.
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).
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.
5. HOW TO STORE ZOFRAN SUPPOSITORIES
Keep 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'.
Do not store above 30°C.
Zofran suppositories should only be taken out of the blister immediately
before use.
If your doctor tells you to stop using Zofran suppositories, it is important to
return any which are left over to your pharmacist.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Zofran suppositories contain
The active ingredient is ondansetron. Each suppository contains 16mg
ondansetron.
Also contains the excipients 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 cartons of 1 or 2 suppositories.
PRODUCT LICENCE HOLDER AND MANUFACTURER
Manufactured by Farmaclair, 440 avenue du General de Gaulle, Herouville
Saint Clair, F-14200, France. Procured from within the EU by Product
Licence holder: Tenolol Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL 30900/2121

Leaflet revision and issue date (Ref) 01.02.16[13]
Zofran is trademark of the Glaxo Group Ltd.

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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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