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ZOFRAN MELT 4MG

Active substance: ONDANSETRON

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Package Leaflet: Information for the User
GSK-ContractMfg-Eur-Deu-Germany-Aspen-Bad Oldesloe

Zofran melt 4 mg and 8 mg
®

United Kingdom-GBR

ondansetron
Read all of this leaflet carefully before you start taking 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. (see section 4).

Zofran
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What is in this leaflet:
1
2
3
4
5
6

What Zofran melt is and what it is used for
What you need to know before you take Zofran melt
How to take Zofran melt
Possible side effects
How to store Zofran melt
Contents of the pack and other information

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1 What Zofran melt is and what it is used for
Zofran melt contains a medicine called ondansetron. This belongs to a group of medicines called
anti-emetics. Zofran melt is a special type of Zofran tablet that dissolves very quickly when put on top of the
tongue.
Zofran melt is used for:
• preventing nausea and vomiting caused by chemotherapy (in adults and children) or radiotherapy for
cancer (adults only)
• preventing nausea and vomiting after surgery (adults only).
Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses.

2 What you need to know before you take Zofran melt
Do not take Zofran melt if:

• you are taking apomorphine (used to treat Parkinson’s disease)
• you are allergic (hypersensitive) to ondansetron or any of the other ingredients in Zofran melt (listed in
Section 6).
If you are not sure, talk to your doctor, nurse or pharmacist before taking Zofran melt.

Warnings and precautions

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Page 1 of 2

Check with your doctor or pharmacist before taking Zofran melt 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 taking
Zofran melt.

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 having
Zofran melt.

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 taking Zofran melt.
Do not breast-feed if you are taking Zofran. This is because small amounts pass into the mother’s milk. Ask
your doctor or midwife for advice.

Important information about some of the ingredients of Zofran melt

• This medicine contains aspartame (which is a source of phenylalanine). If you have an inherited illness
called phenylketonuria speak to your doctor before taking this medicine.
• This medicine contains sodium methylparahydroxybenzoate and sodium propylparahydroxybenzoate. This
may cause allergic reactions (which could be delayed).

3 How to take Zofran melt
Always take Zofran melt exactly as your doctor has told you. You should check with your doctor, nurse or
pharmacist if you are not sure. The dose you have been prescribed will depend on the treatment you are having.

To prevent nausea and vomiting from chemotherapy or radiotherapy

On the day of chemotherapy or radiotherapy
• the usual adult dose is 8 mg taken one or two hours before treatment and another 8 mg twelve hours after.
On the following days
• the usual adult dose is 8 mg twice a day
• this may be given for up to 5 days.
Children aged over 6 months and adolescents:
The doctor will decide the dose depending on the child’s size (body surface area) or weight. Look at the label
for more information.
• the usual dose for a child is up to 4 mg twice a day
• this can be given for up to 5 days.

To prevent nausea and vomiting after an operation
The usual adult dose is 16 mg before your operation

Children aged over 1 month and adolescents:
It is recommended that Zofran is given as an injection.

Patients with moderate or severe liver problems
The total daily dose should not be more than 8 mg.

How to remove Zofran melt from the blister and take the medicine

• Do not take a Zofran melt tablet out from its blister until you are ready to take it.
• Before you take the Zofran melt make sure the foil packaging has not been pierced.
• Important: Do not try to push Zofran melt through the foil top like a usual tablet. This is because Zofran
melt is fragile and will break.

1

Tear off one
Zofran melt in its
blister.

2

Peel back the
foil, as shown by
the arrow.

3

Gently push out
the Zofran melt
tablet.

4

Place the Zofran
melt on top of the
tongue. It will dissolve
very quickly. Then
you can swallow as
normal.

Zofran melt should start to work within one or two hours of taking a dose.

If you are sick (vomit) within one hour of taking a dose
• take the same dose again
• otherwise, do not take more Zofran melt than the label says.
If you continue to feel sick, tell your doctor or nurse.

If you take more Zofran melt than you should

If you take more Zofran than you should, talk to a doctor or go to a hospital straight away. Take the
medicine pack with you.

Aspen Bad Oldesloe
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If you forget to take Zofran melt

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If you miss a dose and feel sick or vomit:
• take a Zofran melt as soon as possible, then
• take your next tablet at the usual time (as shown on the label)
• do not take a double dose to make up for a forgotten dose.

GSK-ContractMfg-Eur-Deu-Germany-Aspen-Bad Oldesloe

If you miss a dose but do not feel sick
• take the next dose as shown on the label
• do not take a double dose to make up for a forgotten dose.

United Kingdom-GBR
Zofran

4 Possible side effects

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

Allergic reactions

If you have an allergic reaction, stop taking 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 (affects more than 1 in 10 people)

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• headache.

Common (affects less than 1 in 10 people)

• a feeling of warmth or flushing
• constipation
• changes to liver function test results (if you take Zofran melt with a medicine called cisplatin, otherwise
this side effect is uncommon).

Uncommon (affects less than 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 (affects less than 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 (affects less than 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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5 How to store Zofran melt
• Keep out of the sight and reach of children.
• Do not use Zofran melt 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 melt below 30°C
• Zofran melt should only be taken out of the blister immediately before taking it.
• 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 Zofran melt contains

• The active ingredient is ondansetron. Each Zofran melt contains ondansetron 4 mg or 8 mg.
• The other ingredients are gelatin, mannitol, aspartame, sodium methylhydroxybenzoate, sodium
propylhydroxybenzoate, strawberry flavour.

What Zofran melt looks like and contents of the pack

Zofran melt is a white round oral lyophilisate. Each pack contains 10 Zofran melt units.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder:
Glaxo Wellcome UK Ltd, Stockley Park West, Uxbridge, Middlesex UB11 1BT
Manufacturer:
Aspen Bad Oldesloe GmbH, 23843 Bad Oldesloe, Germany

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).
Please be ready to give the following information:

Product name

Reference number

Aspen Bad Oldesloe
Additional Information Panel

Zofran melt

10949/0263 / 0264

Replacement: 12000000104061

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

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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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