Ondansetron 4mg/5ml Syrup

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet (See section 4).

1. What Ondansetron Syrup is and what it is used for
2. What you need to know before you take Ondansetron Syrup
3. How to take Ondansetron Syrup
4. Possible side effects
5. How to store Ondansetron Syrup
6. Contents of the pack and other information

• 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).

Talk to your doctor, pharmacist or nurse before taking Ondansetron Syrup

• if you are allergic (hypersensitivity) to medicines similar to ondansetron such as dolasetron, granisetron and palonosetron;
• if you have a blockage in your gut or bowel or if you have constipation;
• if you have ever had heart problems (e.g. congestive heart failure which causes shortness of breath and swollen ankles);
• if you have an uneven heart beat (arrhythmias);
• if you have problems with your liver;
• if you know that the levels of sodium, potassium, magnesium or chloride in your body are very low or very high.

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

Make sure your doctor knows if you are taking a medicine listed here:

• Beta blockers (used to treat certain heart or eye problems, anxiety or prevent migraines);
• Atenolol to treat high blood pressure or angina (pains in your chest): use with ondansetron may cause a change to your heart rate;
• Anti-arrhythmics such as amiodarone to control your heart rate: use with ondansetron may cause a change to your heart rate;
• Phenytoin and carbamazepine to treat epilepsy, or rifampicin to treat tuberculosis: ondansetron may not work as well;
• Tramadol a strong painkiller: ondansetron may stop the tramadol working properly;
• Haloperidol or Methadone medicines that affect the heart;
• Antibiotics such as erythromycin to treat bacterial infections and Antifungals such as ketoconazole to treat fungal infections: use with ondansetron may increase the risk of irregular heartbeats or changes to your heart rate;
• Cardiotoxic drugs such as some cancer medicines including anthracyclines (e.g. doxorubicin and daunorubicin) and trastuzumab: use with ondansetron may increase the risk of irregular heartbeats or changes to your heart rate;
• SSRIs (selective serotonin re-uptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram;
• SNRIs (serotonin noradrenaline re-uptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine: use with ondansetron may cause side effects to get worse.

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.

Pregnancy

Only use Ondansetron Syrup 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 Syrup 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). If you are already pregnant, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Ondansetron Syrup. If you are a woman of childbearing potential you may be advised to use effective contraception.

Breast-feeding

Do not breast-feed if you are taking Ondansetron. This is because small amounts pass into the mother’s milk. Ask your doctor or midwife for advice.

Ondansetron Syrup does not affect your ability to drive or use machines.

This medicine contains 2 mg sodium benzoate in 1 ml, which is equivalent to 2 mg/ml. Benzoic salt may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

This medicine contains Xylitol (E 967) which may have a laxative effect and has a calorific value of 2.4 kcal/g xylitol.

This medicine contains 13.5 mg propylene glycol in each 5ml which is equivalent to 2.7 mg/ml.

Adults and the elderly

During chemotherapy or radiotherapy

• the usual dose is two 5ml spoonfuls (8mg ondansetron);
• this is taken 1 to 2 hours before your therapy starts;
• take two 5ml spoonfuls (8mg ondansetron) 12 hours later;
• take two 5ml spoonfuls (8mg ondansetron) twice a day for up to five days after the day of your chemo- or radiotherapy;
• if your chemotherapy is expected to make you feel, or be, very sick take 6 spoonfuls (24mg ondansetron) before therapy. Your doctor may recommend taking 12mg of dexamethasone at the same time;
• you should not take more than 32mg over a 24 hour period.

• either take four 5ml spoonfuls (16mg ondansetron) one hour before your anaesthetic, or two 5ml spoonfuls (8mg ondansetron) one hour before your anaesthetic followed by two 5ml spoonfuls at 8 hours and 16 hours after your first dose.

During chemotherapy or radiotherapy

• The dose depends on the weight or body surface area of the child;
• Your doctor will tell you the actual dose for your child;
• Make sure the child takes the medicine as the doctor says;
• A dose range of half a 5ml spoonful (2mg ondansetron) to two 5 ml spoonfuls (8mg ondansetron) every 12 hours for up to five days is permitted.

• Ondansetron Syrup is not normally given to children before an operation.

• The maximum dose is two 5ml spoonfuls (8mg ondansetron) each day.

If you or your child take more Ondansetron Syrup than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. In an event of overdose you may experience constipation, difficulty in seeing, low blood pressure, feeling dizzy, feeling sick, loss of consciousness, abnormal changes to ECG.

If you forget to take a dose, take another as soon as you remember. Then take your next dose at the normal time.

Do not take a double dose to make up for a forgotten dose.

Very common (may affect more than 1 in 10 people)

• headache.

Common (may affect up to 1 in 10 people)

• constipation;
• flushing or feeling warm.

Uncommon (may affect up to 1 in 100 people)

• fits (seizures);
• muscle weakness;
• problems controlling movement or problems with the movement of your eyes;
• hiccups;
• low blood pressure, which can make you feel faint or dizzy;
• uneven heart beat;
• chest pain;
• changes to liver function test results (if you take Ondansetron syrup with a medicine called cisplatin).

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

• feeling dizzy or light headed (usually when given by injection);
• changes to your vision such as blurred vision (usually when given by injection);
• 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, especially if you are also having chemotherapy (usually when given by injection).

If you need a blood test tell your doctor you are taking this medicine as it may affect the results.

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: www.mhra.gov.uk/yellowcard 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 substance is ondansetron (as the hydrochloride dihydrate). Each 5ml spoonful contains 4mg of ondansetron.
• The other ingredients are citric acid anhydrous, sodium citrate dihydrate, sodium benzoate (E211), xylitol (E967), strawberry flavour (containing propylene glycol (E1520)) and purified water.

Ondansetron Syrup is a clear solution in a brown glass bottle containing 50ml of the solution.