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ZOFRAN SYRUP 4 MG/5 ML

Active substance(s): ONDANSETRON HYDROCHLORIDE DIHYDRATE

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Zofran® syrup 4 mg/5 ml

ondansetron (as hydrochloride dihydrate)
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.

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Package Leaflet: Information for the User

What is in this leaflet:

1 What Zofran syrup is and what it is used for
2 What you need to know before you take Zofran syrup
3 How to take Zofran syrup
4 Possible side effects
5 How to store Zofran syrup
6 Contents of the pack and other information

1 What Zofran syrup is and what it is used for
Zofran syrup contains a medicine called ondansetron. This belongs to a group of medicines called anti-emetics.
Zofran syrup 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 syrup
Do not take Zofran syrup 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 syrup (listed in Section 6).
If you are not sure, talk to your doctor, nurse or pharmacist before taking Zofran syrup.

Warnings and precautions

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

Other medicines and Zofran

Read Direction
(Dummy Code)

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 syrup.

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 syrup.
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 syrup

This medicine contains sorbitol (E420). Calorific value 2.6 kcal/g sorbitol. If you have been told by your doctor that you have an
intolerance to some sugars, speak to your doctor before taking this medicine. Sorbitol may have a mild laxative effect.
This medicinal product contains small amounts of ethanol (alcohol), less than 0.004 ml in a 5 ml spoonful.

3 How to take Zofran syrup
Always take Zofran syrup 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.
Do not mix Zofran syrup with anything (not even water) before swallowing it.

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 to two hours before treatment and another 8 mg twelve hours after.
On the following days
• the usual adult dose is two 5 ml spoonfuls 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 one 5 ml spoonful 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 four 5 ml spoonfuls before your operation.
Children aged over 1 month and adolescents:
It is recommended that Zofran is given as an injection.

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Patients with moderate or severe liver problems

The total daily dose should not be more than 8 mg (two 5 ml spoonfuls).
Zofran syrup 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 syrup than the label says.
If you continue to feel sick, tell your doctor or nurse.

If you take more Zofran syrup 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 syrup

If you miss a dose and feel sick or vomit:
• take Zofran syrup as soon as possible, then
• take your next dose 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 syrup 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 (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 take Zofran syrup 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.

Read Direction
(Dummy Code)

5 How to store Zofran syrup
• Keep this medicine out of the sight and reach of children.
• Do not use Zofran syrup after the expiry date which is stated on the bottle and carton after ‘Exp’. The expiry date refers to
the last day of that month.
• Store Zofran syrup below 30°C.
• Do not refrigerate. Keep the bottle upright.
• 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 syrup contains

• The active ingredient is ondansetron. Each 5 ml spoonful of Zofran syrup contains ondansetron 4 mg.
• The other ingredients are citric acid (E330), sodium citrate (E331), sodium benzoate (E211), sorbitol (E420), strawberry
flavour and water. This medicinal product also contains very small amounts of ethanol (please see Section 2 above).

What Zofran syrup looks like and contents of the pack

Zofran syrup is a sugar-free, strawberry flavoured liquid. It is packed in 60 ml amber glass bottles with a child resistant cap
containing 50 ml of Zofran syrup.

Marketing Authorisation Holder and Manufacturer

Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom
This leaflet was last revised in February 2016.

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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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