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Package leaflet: Information for the user
Ondansetron 4 mg Film-coated Tablets
Ondansetron 8 mg Film-coated Tablets
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, 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
- If you get any of the 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 Tablet is and what it is used for
2. What you need to know before you take
Ondansetron Tablets
3. How to take Ondansetron Tablets
4. Possible side effects
5. How to store Ondansetron Tablets
6. Contents of the pack and other information

1 What Ondansetron Tablet is and what
it is used for
Ondansetron belongs to a group of medicines
known as ‘antiemetics and antinauseants’. These
prevent feelings of sickness (nausea) or being sick
(vomiting) that may occur after certain medical or
surgical treatments.
Your doctor or nurse may give you Ondansetron
Tablets to prevent you from or to treat you for
feeling or being sick when you:
- are on chemotherapy and radiotherapy that can
cause nausea and vomiting.
- undergo surgical treatment.

After the first 24 hours following chemotherapy,
Ondansetron Tablets can be given to prevent further
nausea or vomiting. The usual dose for oral
administration is 8 mg twice daily, which can be
given for up to 5 days.
Use in children aged over 6 months and adolescents
The doctor will decide the dose.
• the usual dose for child 4 mg,twice a day
• this can be given for up to 5 days
To prevent nausea and vomiting after an operation
The usual dose is 16 mg taken one hour before the
operation or 8 mg taken one hour before the
operation followed by two further doses of 8 mg at
eight hourly intervals.
Use in children (aged 2 years or over)
Ondansetron Tablets are not suitable for use in
children following abdominal surgery.
A slow intravenous injection is recommended.
Patients with liver disease
In patients with moderate or severe liver problems a
total daily dose of 8 mg should not be exceeded.
If you take more Ondansetron Tablets than you should
It is important to stick to the dose on the label of
your medicine. Taking more than this could make
you ill.
If you or your child take more Ondansetron 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 Ondansetron Tablets
If you forget to take a dose and do not feel sick
take the next day’s tablet at the usual time. If you
forget to take a dose, and feel sick or are sick, take
a tablet as soon as possible. Do not take a double
dose to make up for a forgotten dose.
If you stop taking Ondansetron Tablets
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4 Possible side effects

Please take the time to read the following
information carefully as this may stop you from
being able to take Ondansetron Tablets.
Do not take Ondansetron Tablets:
- If you are allergic to ondansetron or any of the
other ingredients of this medicine (listed in
section 6).
- If you are taking apomorphine (used to treat
Parkinson’s disease)
Warnings and precautions
Talk to your doctor or pharmacist before taking
Ondansetron Tablets if you:
- have ever been allergic (hypersensitive) to similar
medicines known as 5HT3 receptor antagonists
- have liver disease
- are suffering from severe constipation or have a
blockage in your gut
- have had surgery on your gut
- have had surgery on your adenoids or tonsils
- have had heart problems, including an uneven
heart beat (arrhythmias)
- have problems with the levels of salts in your
blood, such as potassium, sodium and magnesium
If any of the above apply to you, talk to your doctor
who will decide what to do.
Other medicines and Ondansetron Tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. The following medicines may interact
with Ondansetron Tablets:
• Tramadol. The effect of pain relief from Tramadol
may be reduced whilst you are taking
Ondansetron Tablets.
• Phenytoin and carbamazepine (usually used to
treat epilepsy)
• Rifampicin (a type of antibiotic, often used for
the treatment of tuberculosis)
• Medicines that affect the heart (such as
haloperidol or methadone)
• Medicines used to treat an uneven heart beat

and tell your doctor immediately or go to the
casualty department at your nearest hospital:
• An allergic reaction causing swelling of the face,
lips, tongue or throat, difficulting in breathing or
swallowing, skin rash
• 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
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
• Fits
• Unusual body movement or shaking
Rare (may affect up to 1 in 1000 people)
• Feeling dizzy or lightheaded
• Blurred vision
• Disturbances in heart rhythm (sometimes causing a
sudden loss of consciousness)
Very rare (may affect up to 1 in 10000 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:
By reporting side effects you can help provide more
information on the safety of this medicine.

5 How to store Ondansetron Tablets

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If the following happens, stop taking the tablets


2 What you need to know before you
take Ondansetron Tablets

Version 5.4

Keep this medicine out of the sight and reach of
Do not use this medicine after the expiry date




18 January 2016

• Beta-blocking medicines (used to treat heart
problems, eye problems, anxiety or for prevention
of migranes)
• Cancer medicines (especially anthracyclines and
• Medicines used to treat infections (erythromycin,
• Medicines used to treat depression (SSRIs and
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking
this medicine. Ondansetron may pass into mothers’
milk, therefore breast-feeding is not recommended
in mothers taking Ondansetron Tablets.
Driving and using machines
Ondansetron Tablets should not affect your ability
to drive or use machinery.
Ondansetron Tablets contain lactose
Ondansetron Tablets contain lactose monohydrate,
a type of sugar. If you have been told by your doctor
that you have an intolerance to some sugars,
contact your doctor before taking this medicine.

3 How to take Ondansetron Tablets
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure. Ondansetron Tablets
should be swallowed whole with a little water.
Ondansetron Tablets should start to work within 1
to 2 hours of taking a dose. If you are sick within
1 hour of taking Ondansetron Tablets you should
talk to your doctor who will tell you what you should
do. If you continue to feel or be sick whilst taking
the tablets, tell your doctor.
For patients receiving chemotherapy and/or
radiotherapy that causes nausea or vomiting
Adults (including the elderly)
The usual dose is 8 mg 1-2 hours before you are
treated with chemotherapy or radiotherapy, followed
by 8 mg 12 hours later.

which is stated on the carton after EXP. The expiry
date refers to the last day of that month.
Do not store above 30°C. Store your tablets in the
original package in order to protect from light.
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
What Ondansetron Tablets contains
- The active substance is ondansetron (as
hydrochloride dihydrate). Each tablet contains
4 mg or 8 mg of ondansetron.
- The other ingredients are microcrystalline cellulose,
lactose monohydrate, maize starch, magnesium
stearate. The ingredients of the film-coating on the
tablets are lactose monohydrate, hypromellose,
titanium dioxide E171, macrogol and sodium
citrate dihydrate E331.
What Ondansetron Tablets look like and contents of
the pack
Ondasetron Tablets are white to off-white, round
biconvex film-coated tablets with PA engraved on
one side and 933 (4 mg tablets) or 934 (8 mg
tablets) on the other side.
Ondansetron Tablets are available in blister packs
containing 6, 10, 15 or 30 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
PLIVA Pharma Ltd., Ridings Point, Whistler Drive,
Castleford, West Yorkshire, WF10 5HX,
Teva Operations Poland Sp. z.o.o., Ul. Mogilska 80,
31-456 Krakow, Poland.
This leaflet was last revised in January 2016
PL 10622/0100
PL 10622/0101

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Teva Pharmaceuticals Europe B.V

Signed by
Madhavarao Thakallapally


Meaning of Signature
Regulatory Affairs Approval

Version 5.4


Server Date
20-Jan-2016 03:24:52 PM

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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.