ZOFRAN TABLETS 4MG

Active substance: ONDANSETRON HYDROCHLORIDE DIHYDRATE

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12000000101137

Package Leaflet: Information for the User

Zofran® tablets 4 mg and 8 mg
ondansetron hydrochloride dihydrate

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 tablets are and what they are used for
2 Before you take Zofran tablets
3 How to take Zofran tablets
4 Possible side effects
5 How to store Zofran tablets
6 Further information

1 What Zofran tablets are and what they are used for
Zofran tablets contain a medicine called ondansetron. This belongs to a group of medicines called anti-emetics.
Zofran tablets are 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.

2 Before you take Zofran tablets
Do not take Zofran tablets 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 tablets (listed in Section 6).
If you are not sure, talk to your doctor, nurse or pharmacist before taking Zofran tablets.
Take special care with Zofran tablets
Check with your doctor or pharmacist before taking Zofran tablets 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 tablets.
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
• 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 tablets.
Pregnancy and breast-feeding
It is not known if Zofran is safe during pregnancy. Talk to your doctor before taking Zofran tablets 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 tablets
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, speak to your doctor
before taking this medicine.

3 How to take Zofran tablets
Always take Zofran tablets 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. 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
• 8mg before the operation, then
• 8mg after the operation, then
• 8mg after a further eight hours.
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.
Zofran tablets 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 tablets than the label says.
If you continue to feel sick, tell your doctor or nurse.
If you take more Zofran tablets 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.
If you forget to take Zofran tablets
If you miss a dose and feel sick or vomit:
• take Zofran tablets 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 tablets 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)
• 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 tablets 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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

5 How to store Zofran tablets





Keep out of the reach and sight of children.
Do not use Zofran tablets after the expiry date which is stated on the pack after ‘Exp’.
Do not store Zofran tablets above 30°C.
If your doctor tells you to stop taking Zofran tablets, it is important to return any which are left over to your pharmacist.

6 Further information
What Zofran tablets contain
• The active ingredient is ondansetron. Each Zofran tablet contains ondansetron 4 mg or 8 mg.
• The other ingredients are lactose, microcrystalline cellulose, pre-gelatinised maize starch, magnesium stearate,
methylhydroxypropylcellulose, titanium dioxide(E171) and iron oxide (E172).
What Zofran tablets look like and contents of the pack
• Zofran tablets are yellow, oval, film coated tablets and come in two strengths.
• The 4 mg tablets contain 4 mg of the active ingredient ondansetron and are marked with “GXET3” on one face and plain on the
other.
• The 8 mg tablets contain 8 mg of the active ingredient ondansetron and are marked with “GXET5” on one face and plain on the
other.
Zofran tablets come in:
• blister packs of 10 or 30 tablets. The 8 mg tablets also come in blister packs of 15 tablets.
• Containers of 30 or 100 tablets.
Not all packs may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder:
Glaxo Wellcome UK Ltd, trading as GlaxoSmithKline UK, 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
Zofran tablets
Reference number
10949/0110 / 0111
This is a service provided by the Royal National Institute of Blind People.
Leaflet date: April 2012
Zofran is a registered trademark of the GlaxoSmithKline group of companies
© 2012 GlaxoSmithKline group of companies

12000000101137

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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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