Ondansetron 4mg/5ml Syrup
Patient Information Leaflet
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 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 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Zofran 4mg/5ml syrup, but will be referred to as Zofran syrup throughout the remainder of this leaflet.
What is in this leaflet:
What Zofran syrup is and what it is used for
r2^ What you need to know before you take Zofran syrup
3 How to take Zofran syrup Possible side effects ^ How to store Zofran syrup
Contents of the pack and other information
M What Zofran syrup is and what it is used for
Zofran syrup contains a medicine called ondansetron. This belongs to a group of medicines called anti-emetics.
Zofran syrup is used for:
• preventing nausea and vomiting caused by chemotherapy (in adults and children) or radiotherapy for cancer (adults only)
• preventing nausea and vomiting after surgery (adults only).
Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses.
[2) What you need to know before you take Zofran syrup
Do not take Zofran syrup if:
• you are taking apomorphine (used to treat Parkinson's disease)
• you are allergic (hypersensitive) to ondansetron or any of the other ingredients in Zofran syrup (listed in Section 6).
If you are not sure, talk to your doctor, nurse or pharmacist before taking Zofran syrup.
Warnings and precautions
Check with your doctor, nurse or pharmacist before taking Zofran syrup if:
• 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 are allergic to medicines similar to ondansetron, such as granisetron or palonosetron
• you have liver problems
• you have a blockage in your gut
• 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 Zofran syrup.
Other medicines and Zofran
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken or might take other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Zofran can affect the way some medicines work. Also some other medicines can affect the way Zofran 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)
• antibiotics such as erythromycin or ketoconazole
• 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
• medicines that affect the heart (such as haloperidol or methadone)
• cancer medicines (especially anthracyclines and trastuzumab).
• 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, nurse or pharmacist before having Zofran syrup.
Pregnancy and breast-feeding
It is not known if Zofran is safe during pregnancy. If you are pregnant, think you are pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Zofran syrup.
Do not breast-feed if you are taking Zofran. This is because small amounts pass into the mother's milk. Ask your doctor or midwife for advice.
Important information about some of the ingredients of Zofran syrup
This medicine contains sorbitol (E420). Calorific value 2.6 kcal/g sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, speak to your doctor before taking this medicine. Sorbitol may have a mild laxative effect. This medicinal product contains small amounts of ethanol (alcohol), less than 0.004 ml in a 5 ml spoonful.
How to take Zofran syrup
Always take Zofran syrup exactly as your doctor has told you. You should check with your doctor, nurse or pharmacist if you are not sure. The dose you have been prescribed will depend on the treatment you are having.
Do not mix Zofran syrup with anything (not even water) before swallowing it.
To prevent nausea and vomiting from chemotherapy or radiotherapy
On the day of chemotherapy or radiotherapy
• the usual adult dose is 8 mg taken one to two hours before treatment and another 8 mg twelve hours after.
On the following days
• the usual adult dose is two 5 ml spoonfuls 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 usual dose for a child is up to one 5 ml spoonful twice a day
• this can be given for up to 5 days.
To prevent nausea and vomiting after an operation
The usual adult dose is four 5 ml spoonfuls before your operation
Children aged over 1 month and adolescents It is recommended that Zofran is given as an injection.
Patients with moderate or severe liver problems
The total daily dose should not be more than 8 mg (two 5 ml spoonfuls).
Zofran syrup should start to work within one or two hours of taking a dose.
If you are sick (vomit) within one hour of taking a dose
• take the same dose again
• otherwise, do not take more Zofran syrup than the label says.
If you continue to feel sick, tell your doctor or nurse.
If you take more Zofran syrup than you should
If you or your child take more Zofran 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 Zofran syrup If you miss a dose and feel sick or vomit:
• take Zofran syrup as soon as possible, then
• take your next dose 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.
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.
Reporting of side effects
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.
By reporting side effects you can help provide more information on the safety of this medicine.
[ft How to store Zofran syrup
• Do not store above 30°C.
• Do not refrigerate. Keep the bottle upright.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and blister label. The expiry date refers to the last day of the month.
• If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist who will tell you what to do.
• Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Possible side effects
Like all medicines, Zofran syrup can cause side effects, although not everybody gets them.
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.
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 Zofran syrup 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.
^6 Contents of the pack and other infromation
What Zofran syrup contains
Each 5ml contains 4mg ondansetron in a sugar-free syrup. Also contains anhydrous citric acid, sodium citrate dihydrate, sodium benzoate E211, sorbitol liquid, crystallising, strawberry flavour and purified water.
What Zofran syrup looks like and contents of the pack
Zofran syrup is a clear strawberry flavoured liquid. It comes in a 50ml amber glass bottle with a child resistant cap and a measuring spoon.
Manufacturer and Licence Holder
Zofran syrup is manufactured by Glaxo Wellcome GmbH & Co. KG, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany and is procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE and repackaged by Lexon (UK) Limited, B98 0RE.
Zofran is a registered trademark of the GlaxoSmithKline Group of companies.
POM PL 33723/0148
Leaflet revision date: 23/03/16
Blind or partially sighted?
Is this leaflet hard to see or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
Ref: LTT0148/230316/1 /B
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 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 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Ondansetron 4mg/5ml syrup, but will be referred to as Ondansetron syrup throughout the remainder of this leaflet.
What is in this leaflet:
^ What Ondansetron syrup is and what it is used for
^ What you need to know before you take Ondansetron syrup
How to take Ondansetron syrup Possible side effects How to store Ondansetron syrup Contents of the pack and other information
What Ondansetron syrup is and what it is used for
Ondansetron syrup contains a medicine called ondansetron. This belongs to a group of medicines called anti-emetics.
Ondansetron syrup is used for:
• preventing nausea and vomiting caused by chemotherapy (in adults and children) or radiotherapy for cancer (adults only)
• preventing nausea and vomiting after surgery (adults only).
Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses.
^2 What you need to know before you take Ondansetron syrup
Do not take Ondansetron syrup if:
• are taking apomorphine (used to treat Parkinson's disease)
• you are allergic (hypersensitive) to ondansetron or any of the other ingredients in Ondansetron syrup (listed in Section 6).
If you are not sure, talk to your doctor, nurse or pharmacist before taking Ondansetron syrup.
Warnings and precautions
Check with your doctor, nurse or pharmacist before taking Ondansetron syrup if:
• 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 are allergic to medicines similar to ondansetron, such as granisetron or palonosetron
• you have liver problems
• you have a blockage in your gut
• 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 syrup.
Other medicines and Ondansetron
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken or might take 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)
• antibiotics such as erythromycin or ketoconazole
• 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
• medicines that affect the heart (such as haloperidol or methadone)
• cancer medicines (especially anthracyclines and trastuzumab).
• 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, nurse or pharmacist before having Ondansetron Syrup.
Pregnancy and breast-feeding
It is not known if Ondansetron is safe during pregnancy. If you are pregnant, think you are pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Ondansetron syrup.
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.
Important information about some of the ingredients of Ondansetron syrup
This medicine contains sorbitol (E420). Calorific value 2.6 kcal/g sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, speak to your doctor before taking this medicine. Sorbitol may have a mild laxative effect. This medicinal product contains small amounts of ethanol (alcohol), less than 0.004 ml in a 5 ml spoonful.
How to take Ondansetron syrup
Always take Ondansetron syrup exactly as your doctor has told you. You should check with your doctor, nurse or pharmacist if you are not sure. The dose you have been prescribed will depend on the treatment you are having.
Do not mix Ondansetron syrup with anything (not even water) before swallowing it.
To prevent nausea and vomiting from chemotherapy or radiotherapy
On the day of chemotherapy or radiotherapy
• the usual adult dose is 8 mg taken one to two hours before treatment and another 8 mg twelve hours after.
On the following days
• the usual adult dose is two 5 ml spoonfuls 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 usual dose for a child is up to one 5 ml spoonful twice a day
• this can be given for up to 5 days.
To prevent nausea and vomiting after an operation
The usual adult dose is four 5 ml spoonfuls before your operation.
Children aged over 1 month and adolescents
It is recommended that Ondansetron is given as an
injection.
Patients with moderate or severe liver problems
The total daily dose should not be more than 8 mg (two 5 ml spoonfuls).
Ondansetron syrup should start to work within one or two hours of taking a dose.
If you are sick (vomit) within one hour of taking a dose
• take the same dose again
• otherwise, do not take more Ondansetron syrup than the label says.
If you continue to feel sick, tell your doctor or nurse.
If you take more Ondansetron syrup than you should
If you or your child take more Ondansetron 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 Syrup
If you miss a dose and feel sick or vomit:
• take Ondansetron syrup as soon as possible, then
• take your next dose 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.
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.
Reporting of side effects
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.
By reporting side effects you can help provide more information on the safety of this medicine.
How to store Ondansetron syrup
• Do not store above 30°C.
• Do not refrigerate. Keep the bottle upright.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and blister label. The expiry date refers to the last day of the month.
• If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist who will tell you what to do.
• Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Possible side effects
Like all medicines, Ondansetron syrup can cause side effects, although not everybody gets them.
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.
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 syrup 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.
^6) Contents of the pack and other infromation
What Ondansetron syrup contains
Each 5ml contains 4mg ondansetron in a sugar-free syrup. Also contains anhydrous citric acid, sodium citrate dihydrate, sodium benzoate E211, sorbitol liquid, crystallising, strawberry flavour and purified water.
What Ondansetron syrup looks like and contents of the pack
Ondansetron syrup is a clear strawberry flavoured liquid. It comes in a 50ml amber glass bottle with a child resistant cap and a measuring spoon.
Manufacturer and Licence Holder
Ondansetron syrup is manufactured by Glaxo Wellcome GmbH & Co. KG, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany and is procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE and repackaged by Lexon (UK) Limited, B98 0RE.
POM PL 33723/0148
Leaflet revision date: 23/03/16
Blind or partially sighted?
Is this leaflet hard to see or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
Ref: LTT0148/230316/2/B