Ondansetron 4mg/5ml Syrup
Read all of this leaflet carefully before you
start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
In this leaflet:
1. What Ondansetron Syrup is and what it is used for
2. Before you take Ondansetron Syrup
3. How to take Ondansetron Syrup
4. Possible side effects
5. How to store Ondansetron Syrup
6. Further information
1. What Ondansetron Syrup is and what it is used for
Ondansetron 4mg/5ml Syrup belongs to a group of medicines called anti-emetics, also known as serotonin 5HT3 antagonists (called Ondansetron Syrup throughout the rest of this leaflet).
What this medicine does
Ondansetron Syrup is taken if you are feeling sick (nausea) or being sick (vomiting) after you have had chemotherapy, radiotherapy, or an operation.
2. Before you take Ondansetron Syrup
Do not take Ondansetron syrup
• if you are allergic (hypersensitive) to ondansetron or any of the other ingredients of Ondansetron Syrup (see section 6).
Tell your doctor or nurse if any of the
following apply to you:
• if you have previously had allergic (hypersensitivity) reactions to other 5HT3 antagonists taken to stop you feeling and being sick such as dolasetron;
• if you have a blockage in your gut or bowel or if you have constipation;
• if you have problems with your heart;
• if you have problems with your liver;
• if you know that the levels of sodium, potassium or chloride in your body are very low or very high.
Using other medicines
Make sure your doctor knows if you are
taking a medicine listed here:
• beta blockers such as 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.
• Cardiotoxic drugs such as some cancer medicines including anthracyclines (e.g. Doxorubicin) and Trastuzumab: use with ondansetron may increase the risk of irregular heart beats or changes to your heart rate.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
• If you are pregnant, thinking of getting pregnant or breast-feeding ask your doctor, pharmacist or nurse for advice before taking Ondansetron Syrup.
Driving and using machines
Ondansetron Syrup does not affect your
ability to drive or use machines.
Important information about some of the other ingredients in Ondansetron Syrup
• Your medicine contains a very small amount of alcohol, less than 3mg per 5ml spoonful dose.
Always take Ondansetron Syrup exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure how much to take.
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 you are having an operation
• either take four 5ml spoonfuls (16mg ondansetron) one hour before your anaesthetic;
• ortwo5ml spoonfuls (8mg ondansetron) one hour before your anaesthetic followed by two 5ml spoonfuls at 8 hours and 16 hours after your first dose.
Children and adolescents (aged 6 months
and above)
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 one 5 ml spoonful (4mg ondansetron) every 12 hours for up to five days is permitted.
If your child is having an operation
• Ondansetron Syrup is not normally given to children before an operation.
Patients with liver disease
• The maximum dose is two 5ml spoonfuls (8mg ondansetron) each day.
If you take more Ondansetron Syrup than
you should
• If you take more Ondansetron Syrup than your doctor has prescribed, or you think a child has accidentally swallowed any, contact the nearest hospital Accident and Emergency Department or a doctor.
• Take this leaflet and any Ondansetron Syrup that you still have to show the doctor.
If you forget to take Ondansetron Syrup
• 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 double the amount to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Ondansetron Syrup can cause side effects, although not everybody gets them.
If you have any of the following rare side effects while taking your medicine tell your doctor immediately or go to hospital straight away:
• severe allergic reaction which may include a red and lumpy skin rash, difficulty with breathing, swelling of your face, mouth, lips or eyelids, a high temperature (fever) and feeling faint. If the swelling affects your throat and makes breathing and swallowing difficult, go to hospital straight away.
• uneven, fast or slow heartbeat (palpitations)
• chest pain
Other effects which may occur
Very common side effects (affecting more than 1 in 10 people)
• headache
Common side effects (affecting up to 1 in 10 people)
• constipation
• flushing or feeling warm
Uncommon side effects (affecting fewer than 1 in 100 people)
• fits (seizures)
• muscle weakness
• problems controlling movement or problems with the movement of your eyes
• hiccups
Rare side effects (affecting fewer than 1 in 1,000 people)
• low blood pressure making you feel giddy or light headed
• uncontrolled movements
• dizziness (usually when given by injection)
• changes to your vision such as blurred vision (usually when given by injection)
Very rare side effects (affecting fewer than 1 in 10,000 people)
• short term blindness, 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. This effect is more common if you are also on chemotherapy with cisplatin.
See section 2 of this leaflet for side effects that may be caused by ethanol, one of the ingredients in your medicine ('Important information about some of the ingredients in Ondansetron Syrup').
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: www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.
5. How to store Ondansetron Syrup
Keep out of the sight and reach of children.
Do not use after the expiry date stated on the carton and bottle.
Once opened, use within 28 days.
There are no special storage conditions for your medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Ondansetron Syrup contains
• 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 and ethanol) and purified water.
What Ondansetron Syrup looks like and contents of the pack
Ondansetron Syrup is a clear solution in a brown glass bottle containing 50ml of the solution.
Marketing Authorisation Holder
Focus Pharmaceuticals Limited,
Capital House, 1st Floor, 85 King William Street, London EC4N 7BL, UK.
Tel: 01283 495 280
Fax: 01283 495 290
Email: medinfo@focuspharma.co.uk
Manufacturer
Penn Pharmaceutical Services Ltd, Tredegar, Gwent, NP22 3AA.
For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.
For information in large print, audio CD or Braille please telephone 01283 495 280 or email M medinfo@focuspharma.co.uk. £
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This leaflet was last revised in 06/2015 oo
