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231-30-40212-A LEA ONDANSETRON A/S TAB PLIVA Dimensions:

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 yours.
- 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


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.


What you need to know before you take Ondansetron Tablets

Please take the time to read the following information carefully as this may stop
you from being able to take Ondansetron Tablets.

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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
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
• 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 (anti-arrhytmics)
• Beta-blocking medicines (used to treat heart problems, eye problems, anxiety or
for prevention of migranes)
• Cancer medicines (especially anthracyclines and trastuzumab).
• Medicines used to treat infections (erythromycin, ketoconazole)
• Medicines used to treat depression (SSRIs and SNRIs).
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.


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
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.
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
Use in children (aged 2 years or over)
Ondansetron Tablets are not suitable for use in children following abdominal surgery.


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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


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:
• 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).

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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
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.


How to store Ondansetron Tablets

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 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.


Contents of the pack and other information

What Ondansetron Tablets contains
- The active substance is ondansetron (as hydrochloride dihydrate). Each tablet
contains 4 mg or 8 mg of ondansetron.


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- 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,
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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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.