PACKAGE LEAFLET: INFORMATION FOR THE USER ZOFRAN® melt 4mg ZOFRAN® melt 8mg (ondansetron)

This product is available in the above name and strength but will be referred to as Zofran Melt throughout this leaflet.

This product is available in multiple strengths and all strengths will be referred to throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine.

•    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.

In this leaflet:

1.    What Zofran melt is and what it is used for

2.    Before you take Zofran melt

3.    How to take Zofran melt

4.    Possible side effects

5.    How to store Zofran melt

6.    Further information

Pregnancy and breast-feeding

It is not known if Zofran is safe during pregnancy. Talk to your doctor before taking Zofran melt if you are pregnant or might become pregnant. 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

1. What Zofran melt is and what it is used for

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.

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 or radiotherapy for cancer (in adults and children)

•    preventing nausea and vomiting after surgery (adults only).

Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses.

Children aged over 6 months and adolescents

The doctor will decide the dose. 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 or

•    8 mg before the operation, then

•    8 mg after the operation, then

•    8 mg after a further eight hours.

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2. 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.

Take special care with Zofran melt

Check with your doctor or pharmacist before taking Zofran melt if:

•    you have ever had heart problems

•    you have an uneven heart beat (arrhythmias)

•    you are allergic to medicines similar to ondansetron, such as granisetron (known as ‘Kytril')

•    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.

Taking other medicines

Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any 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)

•    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.

Please also tell your doctor if you are taking these medicines:

•    medicines that affect the heart (such as haloperidol or methadone)

•    cancer medicines (especially anthracyclines and trastuzumab).

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

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.

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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.

4. Possible side effects

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6. Further information

5. How to store Zofran melt