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ZOFRAN 4MG/5ML SYRUP

Active substance(s): ONDANSETRON HYDROCHLORIDE DIHYDRATE

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Zofran® 4 mg/5 ml Syrup

2097
16.08.16[13]

(ondansetron hydrochloride dihydrate)
PATIENT INFORMATION LEAFLET
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.
The name of your medicine is Zofran 4 mg/5 ml Syrup but will be referred to
as Zofran syrup throughout this leaflet.
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

Pregnancy and breast-feeding
It is not known if Zofran syrup 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 syrup. 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 0.004ml in a 5ml 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.

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.

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.

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).

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.

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 syrup
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
syrup can affect the way some medicines work. Also some other medicines
can affect the way Zofran syrup 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.

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.
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 syrup 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.
5. HOW TO STORE ZOFRAN SYRUP
- Keep 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’.
- Do not store Zofran syrup above 30°C.
- Do not refrigerate. Keep the bottle upright.
- If your doctor tells you to stop taking Zofran syrup, it is important to return
any which is left over to your pharmacist.
- If the syrup becomes discoloured or shows any other signs of
deterioration, consult your doctor or pharmacist who will tell you what to
do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Zofran syrup contains
- The active ingredient is ondansetron. Each 5 ml spoonful of syrup
contains 4mg ondansetron (as hydrochloride dihydrate).
- The other ingredients are sodium citrate dihydrate, citric acid anhydrous,
sodium benzoate (E211), sorbitol liquid crystallising (E420), strawberry
flavour and purified water.
What Zofran syrup looks like and contents of the pack
Zofran syrup is clear, colourless to light yellow liquid with characteristic
strawberry odour. It is packed amber glass bottles with a child resistant cap
containing 50 ml.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, Bad
Oldesloe, 23843 Germany. Procured from within the EU by Product Licence
holder: Tenolol Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 30900/2097

Leaflet revision and issue date (Ref) 16.08.16[13]
Zofran is a 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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