ZOFRAN 4MG TABLETS

Active substance: ONDANSETRON

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Zofran 4mg Tablets/Ondansetron 4mg Tablets
Zofran 8mg Tablets/Ondansetron 8mg Tablets
(ondansetron hydrochloride)
Patient Information Leaflet
Your medicine is known by either of the above names but will be referred to
as Zofran Tablets 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 illness or your medicine, ask your doctor
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 gets troublesome or serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor 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 Tablets can affect
the way some medicines work. Also some other medicines can affect the way
Zofran Tablets 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 Tablets are 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 Tablets. 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 Tablets 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 Tablets 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 all medicines 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 above 30°C.
 If your doctor tells you to stop taking the tablets, please take them back to
the pharmacist for safe disposal. Only keep the tablets if your doctor tells
you to.
 If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to do.

6) Further information
What Zofran Tablets contains
 The active ingredient is ondansetron.
 Each film coated tablet contains ondansetron 4mg (as ondansetron
hydrochloride dihydrate)
 Each film coated tablet contains ondansetron 8mg (as ondansetron
hydrochloride dihydrate)
 Zofran Tablets also contain the following ingredients; lactose, maize starch
pregelatinised, microcrystalline cellulose, magnesium stearate,
hypromellose and opaspray Yellow M-1-8429.
What Zofran Tablets looks like and contents of the pack
Zofran 4mg Tablets are yellow, oval, film coated tablet engraved “GLAXO” on
one face and “4” on the other.
Zofran 8mg Tablets are yellow, oval, film coated tablet engraved “GLAXO” on
one face and “8” on the other.
Zofran 4mg Tablets packs contain 10 tablets in a carton.
Zofran 8mg Tablets packs contain 10 tablets in a carton.
PL 10383/1790
PL 10383/1791

Zofran 4mg Tablets/Ondansetron 4mg Tablets
Zofran 8mg Tablets/Ondansetron 8mg Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by GlaxoSmithkline Pharmaceuticals S.A. ul.
Grunwaldzka, 189 60-322 Poland. Procured from within the EU and
repackaged by the Product Licence Holder: Primecrown Ltd, 4/5 Northolt
Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 17.05.2012

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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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