Ondansetron 4 mg film-coated tablets

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Ondansetron Tablets are and what they are 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

• you are taking apomorphine (used to treat Parkinson's disease).
• you are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6).

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

Talk to your doctor, pharmacist or nurse before taking Ondansetron Tablets if:

• you are allergic to medicines similar to ondansetron such as granisetron or palonosetron.
• you have a blockage in your gut or suffer from severe constipation.
• if you are due to have surgery to the adenoids or tonsils
• 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 suffer from any liver problems.
• 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 Ondansetron Tablets.

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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

Ondansetron Tablets may have an effect on other drugs or other drugs may have an effect on Ondansetron Tablets.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

• Anti-arrhythmic medicines such as amiodarone used to treat an uneven heartbeat.
• Medicines used to treat heart problems such as abnormal heart beats (anti-arrhythmics like amiodarone) and/or high blood pressure (beta-blockers like atenolol, timolol)
• Phenytoin or carbamazepine, used to treat epilepsy.
• Rifampicin, an antibiotic used to treat infections such as tuberculosis (TB).
• Antibiotics such as erythromycin or ketoconazole.
• Tramadol, a pain relieving medicine.
• Beta-blocker medicines used to treat certain heart or eye problems, anxiety or prevent migraines.
• Medicines that affect the heart (such as haloperidol or methadone).
• Cancer medicines (especially anthracyclines as doxorubicin, daunorubicin and monoclonal antibodies such as trastuzumab) as these may interact with Ondansetron to cause heart arrhythmias).
• 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 or pharmacist before having ondansetron tablets.

If you are already pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you are a woman of childbearing potential you may be advised to use effective contraception (methods resulting in less than 1% pregnancy rate) during treatment with ondansetron.

Pregnancy

Only use Ondansetron Tablets during the first trimester of pregnancy after discussion with your doctor of the potential benefits and risks to you and your unborn baby of the different treatment options. This is because Ondansetron Tablets can slightly increase the risk of a baby being born with cleft lip and/or cleft palate (openings or splits in the upper lip and/or the roof of the mouth).

Breast-feeding

Do not take Ondansetron Tablet if you are breast-feeding, because small amounts pass into the mother’s milk.

Fertility

There are no data on the effects of ondansetron on fertility in humans.

Ondansetron is unlikely to affect your ability to drive or operate machinery.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

On the day of chemotherapy or radiotherapy

• the recommended adult dose is 8 mg taken one to two hours before treatment and another 8 mg twelve hours after.

On the following days

• the recommended adult dose is 8 mg 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 recommended dose for a child is up to 4 mg twice a day.
• This can be given for up to 5 days.

The usual adult dose is 16 mg before your operation

Children aged over 1 month and adolescents.

It is recommended that ondansetron is given as an injection.

The total daily dose should not be more than 8 mg.

Ondansetron Tablets should start to work within one or two hours of taking a dose.

• take the same dose again
• otherwise, do not take more Ondanseron Tablets than the label says.

If you continue to feel sick, tell your doctor or nurse.

If you have taken too many tablets it is important to contact your doctor as soon as possible or go to your nearest hospital casualty department immediately. Take the medicine packet with you, even if there are no tablets left, so that the doctor knows which tablets were taken.

If an overdose has been taken, symptoms may include problems with vision, low blood pressure (which could cause dizziness or faintness) or irregular heart beat.

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 miss a dose and feel sick or vomit:

• take Ondansetron 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.

Do not stop taking your tablets, even if you are feeling well, without consulting a doctor.

Stop taking this medicine and seek medical help immediately if you or your child experience any of the following:

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

Myocardial ischemia:

Signs include:

• sudden chest pain or
• chest tightness

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
• 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)

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

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: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active ingredient in Ondansetron Tablets is ondansetron hydrochloride dihydrate. Each Ondansetron film-coated tablet contains ondansetron 4 mg or 8 mg.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, maize starch, magnesium stearate, hypromellose, titanium dioxide E171, macrogol.

• Ondansetron 4 mg Tablets are white, circular, biconvex, film coated tablet marked '4' on one side, plain on the other
• Ondansetron 8 mg Tablets are white, circular, biconvex, film coated tablet marked '8' on one side and with a deep breakline on the other.

Ondansetron Tablets come in:

• Blister strips comprising PVC/PVdC/Aluminium foil enclosed in an outer carton. Pack sizes of 10, 30, or 100 tablets. Not all pack sizes may be marketed.