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TEVA ONDANSETRON 8 MG FILM-COATED TABLETS

Active substance(s): ONDANSETRON HYDROCHLORIDE DIHYDRATE

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Package leaflet: Information for the user
Teva Ondansetron 4 mg & 8 mg Film Coated Tablets
Ondansetron
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, please ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as yours.
If you get any side effects talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See Section 4

What is in this leaflet
1.

What Ondansetron is and what it is used for.

2.

What you need to know before you take Ondansetron.

3.

How to take Ondansetron.

4.

Possible side effects.

5.

How to store Ondansetron.

6.

Contents of the pack and other information.

1.

What Ondansetron is and what it is used for

Ondansetron belongs to a group of drugs called anti-emetics, which prevent nausea and
vomiting (feeling sick or being sick)
Ondansetron is used:



to treat nausea (feeling sick) and vomiting (being sick) caused by receiving
chemotherapy or radiotherapy.
to prevent and treat nausea and vomiting following surgical operations.

2.

What you need to know before you take Ondansetron

Do not take Ondansetron:


if you are allergic (hypersensitive) to ondansetron or any of the other ingredients of this
medicine (listed in section 6).




if you have ever suffered an allergic reaction to other similar medicines e.g. granisetron,
tropisetron or dolasetron.
if you use apomorphine (used to treat Parkinson’s disease)

Warnings and precautions
Talk to your doctor or pharmacist before taking Ondansetron if you:







have liver problems.
have a blockage in your gut or if you suffer from severe constipation.
have had surgery on your gut
have had surgery on your adenoids or tonsils
have had heart problems, including an uneven heart beat (arrhytmias)
have problems with the levels of salts in your blood, such as potassium, sodium and
magnesium
Other medicines and Ondansetron
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Tell your doctor if you are taking any of the following medicines:










Phenytoin (used in the treatment of epilepsy).
Carbamazepine (used in the treatment of epilepsy).
Rifampicin (used in the treatment of tuberculosis).
Tramadol (used to relieve moderate to moderately severe pain).
Medicines that affect the heart (such as haloperidol or methadone)
Medicines used to treat an uneven heart beat (anti-arrhytmics)
Beta-blocking medicines (used to treat heart problems, eye problems, anxiety or for
prevention of migraines)
Cancer medicines (especially anthracyclines)
Medicines used to treat infections (erythromycin, ketoconazole)

If you have a blood test to check how your liver is working while you are taking
Ondansetron, please make sure the doctor knows you are taking this medicine, as it may
affect the results of these tests.
Pregnancy and breast-feeding:


Ondansetron is not recommended if you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your doctor for advice before taking this
medicine.

Do not breast-feed if you are taking Ondansetron. This is because small amounts pass
into mother’s milk. Ask your doctor for advice.
Driving and using machines

Ondansetron is not expected to affect your ability to drive or operate machinery.
Ondansetron contains lactose



Patients who are intolerant to lactose should note that Ondansetron tablets contain a
small amount of lactose. If your doctor has told you that you have an intolerance to
some sugars, contact your doctor before taking this medicine.

3.

How to take Ondansetron

Always take this medicine exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
The tablets should be swallowed whole preferably with a drink of water. The recommended
dose is:
To treat nausea and vomiting caused by receiving chemotherapy or radiotherapy:

Adults (including the elderly):
8 mg taken 1 to 2 hours before chemotherapy or radiotherapy, followed by 8 mg 12 hours
later. 24 hours after chemotherapy or radiotherapy, 8 mg twice a day may be taken for up to 5
days.

Use in children (aged over 6 months) and adolescents
Ondansetron may be given initially by a single injection into the vein over 15 minutes before
chemotherapy, followed by tablets which may be given two to three times a day for up to 5
days following chemotherapy. The dose of tablets will depend on your body size and will be
calculated by your doctor.
To prevent nausea and vomiting after an operation:

Adults (including the elderly):
A dose of 16 mg can be taken one hour before the anaesthesia.
Alternatively, a dose of 8 mg can be taken one hour before the anaesthesia, followed by two
further 8 mg doses as eight hourly intervals.

Use in children (aged over 1 month) and adolescents
It is recommended that an intravenous injection containing Ondansetron should be given.
Patients with Liver Problems:
The total daily dose should not exceed 8 mg.
Ondansetron should start to work within one to two hours of taking the dose. If you vomit the
dose back within one hour, take another dose. Otherwise, continue to take your tablets as on
the label, but do not take more than your doctor has recommended. If you continue to feel
sick then you should tell the doctor.
If you take more Ondansetron than you should
If you or your child take more Ondansetron than you should, talk to a doctor or go to a
hospital straight away. Take the medicine pack with you.
An overdose can cause temporary problem with your sight, severe constipation, feeling dizzy
or faint.

If you forget to take Ondansetron
If you forget to take a tablet and feel sick or vomit, take one as soon as you remember and
then carry on as before. If you forget to take a tablet and do not feel sick, then wait until the
next dose as on the label. Take the remaining doses at the correct time.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Ondansetron
Do not stop taking you medicine without talking to your doctor first even if you feel better.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the following happens, stop taking the tablets and tell your doctor immediately or go to the
casualty department at your nearest hospital:
Uncommon (may affect up to 1 in 100 people)
 fits.
Rare (may affect up to 1 in 1,000 people)




an allergic reaction causing (swelling of the face, lips, tongue or throat, difficulty in
breathing or swallowing, skin rash).
collapse
disturbances in heart rhythm (sometimes causing a sudden loss of consciousness).

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 Ondansetron 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 or chest pain
unusual body movements or shaking.

Rare (may affect up to 1 in 1,000 people)



feeling dizzy or light headed
blurred vision

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 or pharmacist. 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 Ondansetron

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton. The
expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 Ondansetron tablets contain:


The active substance is Ondansetron. Each film-coated tablet contains 4 mg & 8 mg of
Ondansetron (as ondansetron hydrochloride dihydrate).



The other ingredients are:
o

tablet core: lactose monohydrate, sodium starch glycolate, microcrystalline
cellulose, pregelatinised starch, magnesium stearate,

o

coating: hypromellose, titanium dioxide (E171), macrogol (400 & 6000) and
yellow iron oxide (E172).

What Ondansetron tablets looks like and contents of the pack:


Ondansetron 4 mg tablets are yellow, oblong film-coated tablets engraved “4” on one side
and plain on the other.



Ondansetron 8 mg tablets are yellow, oblong film-coated tablets engraved “8” on one side
and scoreline on the other.



Ondansetron 4 mg tablets are available in pack sizes of 2, 4, 5, 6, 10, 15, 30, 100 & 500
film-coated tablets



Ondansetron 8 mg tablets are available in pack sizes of 2, 4, 5, 6, 9, 10, 15, 18, 50, 100 &
500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharma BV
Computerweg 10
3542 Dr Utrecht
The Netherlands
Manufacturer:
Teva UK Limited,
Brampton Road,
Hampden Park,
Eastbourne,
East Sussex, BN22 9AG,
United Kingdom

Pharmachemie B.V.,
Swensweg 5,
Postbus 522
2003 RN Haarlem,
The Netherlands

Teva Pharmaceutical Works Co. Ltd.
Pallagi Street 13
4042 Debrecen

Hungary

Teva UK Limited
18 Bruntcliffe Way
Morley, Leeds,
West Yorkshire LS27 0JG
United Kingdom

Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren
Germany

This leaflet was last revised in: April 2016

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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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