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ZOFRAN 8MG TABLETS

Active substance(s): ONDANSETRON

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

ZOFRAN 8MG TABLETS /
ONDANSETRON 8MG TABLETS
(ondansetron hydrochloride dihydrate)

Your tablets are available using the above names, but will be
referred to as Zofran Tablets throughout this leaflet. Zofran
Tablets are available in the following strengths: 4mg & 8mg.

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.

What is in this leaflet:

1.
2.
3.
4.
5.
6.

What Zofran Tablets are and what they are used for
What you need to know before you take Zofran Tablets
How to take Zofran Tablets
Possible side effects
How to store Zofran Tablets
Contents of the pack and other 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 (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 Tablets
Do not take Zofran Tablets if:



If you are not sure, talk to your doctor, nurse or pharmacist
before taking Zofran Tablets.

Warnings and precautions

Check with your doctor, nurse 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 Tablets

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

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).

Pregnancy and breast-feeding

It is not known if Zofran Tablets are 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 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 8mg taken one to two hours
before treatment and another 8mg twelve hours after.
On the following days

the usual adult dose is 8mg 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 4mg 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 16mg before your operation

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 8mg.
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.



Page 1 of 2

If you take more Zofran Tablets than you should

If you or your child 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

Very rare (may affect up to 1 in 10,000 people)

Product Licence holder:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.

Reporting of side effects

PL: 04423/0531



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 Tablets




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 (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
Tablets 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).

poor vision or temporary loss of eyesight, which usually
comes back within 20 minutes.



Keep out of the sight and reach of children.
Do not store above 30°C.
If your tablets appear discoloured or show any other
signs of deterioration, take them to your pharmacist
who will advise you.
If your doctor stops your treatment, do not keep any
leftover tablets unless your doctor tells you to. Return
any unused tablets to your pharmacist.
Do not use the tablets after the expiry date on the tablet
foil or carton. The expiry date refers to the last day of
that month.
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

Active ingredient: ondansetron 8mg (as ondansetron
hydrochloride dihydrate).
Other ingredients: lactose anhydrous,
pregelatinised maize starch, microcrystalline cellulose,
magnesium stearate, hypromellose, titanium dioxide (E171)
and iron oxide (E172).

What Zofran Tablets look like and contents of the
pack
Each Zofran Tablet is yellow, oval, film coated, and is
engraved “Glaxo” on one face and “8” on the reverse.
Packs contain 15 x 8mg tablets.

Manufacturer

Your medicine is manufactured by:
Glaxo Operations UK Ltd., England.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.

Page 2 of 2

POM

Leaflet issue and revision date (Ref): 13.05.16
Zofran® is a registered trademark of Novartis AG.

Other formats:

To listen to or request a copy of this leaflet in Braille, large
print or audio please call: 01302 365000. Please be ready to
give the following information:
Product name
Zofran 8mg Tablets or
Ondansetron 8mg Tablets

Reference number
04423/0531

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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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