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Patient Information Leaflet

ONDANSETRON 4mg & 8mg FILM-COATED TABLETS

Please read this leaflet carefully before you take these tablets. It briefly outlines the most important things you need to know. If you want to know more about this medicine, or you are not sure about anything, ask your doctor or your pharmacist.

IN THIS LEAFLET:

1.    WHAT IS ONDANSETRON?

2.    WHAT IS ONDANSETRON USED FOR?

3.    BEFORE YOU TAKE ONDANSETRON TABLETS.

4.    HOW TO TAKE ONDANSETRON TABLETS

5.    SIDE EFFECTS

6.    STORING ONDANSETRON TABLETS

7.    FURTHER INFORMATION

1.    WHAT IS ONDANSETRON?

The name of your tablet is:

Ondansetron 4mg film-coated Tablets Ondansetron 8mg film-coated Tablets

Ondansetron 4mg tablet is a film coated, yellow-pale brown, oval tablet marked FW631. Ondansetron 8mg tablet is a film coated, yellow-pale brown, oval tablet marked FW641.

Ondansetron tablets are available in two strengths containing either 4mg or 8mg of the active, ondansetron, as ondansetron hydrochloride dihydrate.

The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, magnesium stearate, hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172).

Each pack contains 15, 30 or 60 tablets.

The Marketing Authorisation holder and company responsible for manufacture is Mercury Pharmaceuticals Ltd, No.1 Croydon,

12-16 Addiscombe Road, Croydon CR0 0XT, UK.

2.    WHAT IS ONDANSETRON USED FOR?

Ondansetron belongs to a group of medicines called anti-emetics. Some medical and surgical treatments can make you feel sick or be sick (nausea and vomiting). These tablets may stop these effects. Ask your doctor or pharmacist if you need additional information.

3.    BEFORE YOU TAKE ONDANSETRON TABLETS:

Do not take Ondansetron 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 Ondansetron listed in section 1.

If you are unsure, talk to your doctor or pharmacist before taking this tablet.

Take special care with Ondansetron Tablets:

•    If you been told that you have a blockage in your gut or you suffer from severe constipation

•    If you have ever had heart problems

•    If you have a problem of uneven heart beat (arrhythmias)

•    If you have liver problems

•    If you are suffering with severe electrolyte disturbance (imbalance in the level of sodium, potassium and/or calcium).

•    You are allergic to medicines similar to ondansetron

•    If you have an intolerance to some sugars (such as lactose)

•    If you have undergone surgery of the tonsils.

Please consult your doctor, even if these statements were applicable to you at any time in the past.

Your doctor will advise you about taking the medicine.

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 Ondansetron can affect the way some medicines work. Also some other medicines can affect the way Ondansetron 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

•    Cancer medicines (especially anthracyclines).

If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before having Ondansetron tablets.

It is not known if Ondansetron is safe during pregnancy.

Talk to your doctor before taking ondansetron tablets if you are pregnant or might become pregnant. Ondansetron may pass into the mother’s milk. It is better therefore that mothers taking these tablets do not breast-feed.

4. HOW TO TAKE ONDANSETRON TABLETS:

Ondansetron tablets can be prescribed for two reasons:

•    To prevent feelings of sickness (nausea) and sickness (vomiting), or

•    To treat nausea and vomiting.

Always take ondansetron tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

Swallow each tablet whole with a little water.

For patients receiving chemotherapy and/or radiotherapy that causes nausea and vomiting: The recommended dose is 8 mg, 1 to 2 hours before chemotherapy followed by 8 mg 12 hours later.

After the first 24 hours following chemotherapy, ondansetron tablets can be given to prevent nausea and vomiting. The usual adult dose is 8 mg twice a day, which can be given for up to 5 days. The usual dose for children aged over 6 months and adolescents is up to 4 mg twice a day, which can be given for up to 5 days, following chemotherapy.

To prevent nausea and vomiting after an operation: The usual adult dose is 16 mg before the operation, or 8 mg before the operation followed by two further doses of 8mg at eight hourly intervals.

Children aged over 1 month and adolescents: It is recommended that ondansetron is given as an injection.

Patients with moderate or severe liver disease: the total daily dose should not be more than 8 mg.

•    Your doctor will tell you how long to take ondansetron tablets. Do not stop taking the tablets early

•    If you have the impression that the effect of ondansetron tablets is too strong or too weak, talk to your doctor or pharmacist

•    If you see another doctor or go into hospital, tell the doctor or hospital staff that you are taking ondansetron tablets.

What to do if you miss a dose:

If you miss a dose and feel sick or vomit, take a tablet as soon as possible and then carry on as before. If you miss a dose but do not feel sick take the next dose as on the label.

Do not take double the dose if you miss a dose.

What to do if you take too many tablets:

It is important to stick to the dose on the label. Taking more than this could make you ill. If an overdose is taken, don’t delay; ask your doctor what to do or contact your nearest hospital casualty department.

After starting to take your tablets:

Ondansetron tablets should start to work within one or two hours of taking a dose. If you vomit a dose back within one hour then take the same dose again, otherwise do not take more tablets or take them more often than the label says. If you continue to feel sick then tell your doctor.

5. SIDE EFFECTS:

Along with the desirable effects, a medicine may cause unwanted effects. Most people taking this medicine find it causes no problems. A few people can be allergic to some medicines.

If any of the following rare side effects (occur in between 1 and 10 of 10,000 treated) come on soon after taking these tablets, do not take any more tablets and tell your doctor immediately:

•    Sudden chest tightness or wheeziness

•    Swelling of eyelids, face or lips

•    Skin rash - red spots or hives (skin lumps) Collapse.

Very common side effects (occur in more than 1 of 10 treated):

•    Headache.

Common side effects (occur in between 1 and 10 of 100 treated):

•    Feeling of warmth in the head or stomach

•    Upset bowels - constipation

•    Irritation and redness at the site of injection.

•    Asymptomatic increases in liver function tests (if you take Ondansetron with a cisplatine chemotherapy, otherwise uncommon).

•    Hiccups

•    Slow or irregular heartbeat

•    Chest pain

•    Involuntary movements of the limbs or eyes.

•    Low blood pressure, which can make you feel faint or dizzy

•    Fits.

Rare side effects (occur in between 1 and 10 of 10,000 treated):

•    Dizziness or lightheaded feeling

•    Problems with your eye sight

•    Disturbance in heart rhythm (can sometimes cause 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 you have any blood tests to check how your liver is working, this medicine may affect the results.

If you feel unwell or have any other unusual discomfort you don’t understand, it is important to tell your doctor as soon as possible.

If you don’t feel better:

If your sickliness does not get better while taking ondansetron then tell your doctor.

Reporting of suspected adverse reactions:

You can help to make sure that medicines remain safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form avaible from your local pharmacy.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

6.    STORING ONDANSETRON TABLETS:

Keep ondansetron tablets and all medicines out of the reach and sight of children.

Do not store above 25°C. Store in the original packaging. Do not use the tablets after the expiry/use before date on the blister pack or carton.

What to do with any unused tablets:

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.

7.    FURTHER INFORMATION:

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was updated: August 2013.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only)

Please be ready to give the following information:

Product Name	Reference No.
Ondansetron 4mg film-coated tablet	12762/0163
Ondansetron 8mg film-coated tablet	12762/0164

This is a service provided by the Royal National Institute of the Blind.