Medication Guide App

ZOFRAN TABLETS 4MG

Active substance: ONDANSETRON HYDROCHLORIDE DIHYDRATE

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GSK-ContractMfg-Eur-Deu-Germany-Aspen-Bad Oldesloe
Package Leaflet: Information for the User

Zofran® tablets 4 mg and 8 mg

United Kingdom-GBR

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. 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. (see section 4).

Zofran

ondansetron (as hydrochloride dihydrate)

What is in this leaflet:
1 What Zofran tablets are and what they are used for
2 What you need to know before you take Zofran tablets
3 How to take Zofran tablets
4 Possible side effects
5 How to store Zofran tablets
6 Contents of the pack and other information

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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 (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.

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2 What you need to know 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.
Warnings and precautions
Check with your doctor or pharmacist before taking Zofran tablets 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 tablets.
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 tablets.
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 tablets.
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.

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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 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.
Zofran tablets should start to work within one or two hours of taking a dose.

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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.

GSK-ContractMfg-Eur-Deu-Germany-Aspen-Bad Oldesloe

United Kingdom-GBR
Zofran
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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.
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.

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5 How to store Zofran tablets





Keep out of the sight and reach of children.
Do not use Zofran tablets after the expiry date which is stated on the pack after ‘Exp’. The expiry date refers to the last day of that month.
Store Zofran tablets below 30°C
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 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, 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:

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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.
This leaflet was last revised in August 2014
Zofran is a registered trademark of the GlaxoSmithKline group of companies
© 2014 GlaxoSmithKline group of companies. All rights reserved
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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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