ZOFRAN MELT 4 MG, ONDANSETRON 4 MG ORAL LYOPHILISATES - patient leaflet, side effects, dosage

Patient leaflet - ZOFRAN MELT 4 MG, ONDANSETRON 4 MG ORAL LYOPHILISATES

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 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.

What is in this leaflet:

1 What Zofran® is and what it is used for

2 What you need to know before you take Zofran®

3 How to take Zofran®

4 Possible side effects

5 How to store Zofran®

6 Contents of the pack and other information

1 what zofran® is and what it is used for

Zofran® contains a medicine called ondansetron. This belongs to a group of medicines called anti-emetics. Zofran® is a special type of Zofran® tablet that dissolves very quickly when put on top of the tongue.

Zofran® 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®

Do not take Zofran® 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® (listed in Section 6).

If you are not sure, talk to your doctor, nurse or pharmacist before taking Zofran®.

Warnings and precautions

Check with your doctor, nurse or pharmacist before taking Zofran® 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®.

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®.

Tell your doctor or pharmacist immediately if you get any of these symptoms during and after the treatment with Zofran

if you experience sudden chest pain or chest tightness (myocardial ischemia).

Pregnancy and breast-feeding

Only use during the first trimester of pregnancy after discussion with your doctor of the potential benefits and risks to you and your unborn baby of the different treatment options. This is because Zofran® can slightly increase the risk of a baby being born with cleft lip and/or cleft palate (openings or splits in the upper lip and/or the roof of the mouth). If you are already pregnant, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Zofran®. If you are a woman of childbearing potential you may be advised to use effective contraception.

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®

Zofran Melt 4 mg contains 0.625 mg aspartame per tablet; Zofran Melt 8 mg contains 1.25 mg aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly. Speak to your doctor before taking this medicine.
This medicine contains sodium methyl para-hydroxybenzoate and sodium propyl para-hydroxybenzoate. This may cause allergic reactions (possibly delayed).
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3 how to take zofran®

Always take Zofran® 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® from the blister and take the medicine

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

I.Tear off one Zofran melt in 2. Peel back the foil, as its blister. shown by the arrow.

3. Gently push out the Zofran 4. Place the Zofran melt on melt tablet. top of the tongue. It will

dissolve very quickly. Then you can swallow as normal.

Zofran® 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® than the label says.

If you continue to feel sick, tell your doctor or nurse.

If you take more Zofran® than you should

If you or your child take more Zofran® than you should, talk to a doctor or go to a hospital straight away.

Take the medicine pack with you.

If you forget to take Zofran®

If you miss a dose and feel sick or vomit:

take a Zofran® 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.

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.

4 POSSIBLE SIDE EFFECTS

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

Some side effects could be serious

Stop taking Zofran and seek medical help immediately if you or your child experience any of the following:

Allergic reactions

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.

Myocardial ischemia:

sudden chest pain or
chest tightness

Other side effects include:

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 take Zofran® 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5 HOW TO STORE ZOFRAN®

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C
Zofran® should only be taken out of the blister immediately before taking it.
If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste. These measures will help protect the environment.

6 CONTENTS OF THE PACK AND OTHER INFORMATION

What Zofran® contains

The active ingredient is ondansetron. Each oral lyophilisate contains 4 mg ondansetron.
The other ingredients are gelatin, mannitol, aspartame (E951), sodium propyl para-hydroxybenzoate (E217), sodium methyl parahydroxybenzoate (E219), and strawberry flavour.
The strawberry flavour has the following composition: artificial and natural flavouring substances and propylene glycol (E1520).

What Zofran® looks like and contents of the pack

Zofran® is a white round oral lyophilisate, with no markings. Each pack contains 10 oral lyophilisate.

Manufactured by Novartis Farmaceutica, S.A. Ronda de Santa Maria, 158– Barbera del Valles, 08210 Barcelona, Spain.

Procured from within the EU and repackaged by the Product Licence Holder Beachcourse Ltd., Unit 2–3, Townsend Industrial Estate, Waxlow Road, London, NW10 7NU.

Revision date: 25.02.2022

PLGB 16378/0731 |POM|

Zofran® is a registered trademark of Novartis AG.

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Phone Beachcourse,

Tel: 020 8896 9054 for help.

Ref. number: 0731