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ONDANSETRON 4MG/5ML SYRUP

Active substance(s): ONDANSETRON HYDROCHLORIDE DIHYDRATE

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Zofran ® 4mg/5ml Syrup

Ref: LTT0148/230316/1/F

(ondansetron hydrochloride dihydrate)
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:
1 What Zofran syrup is and what it is used for
2

What you need to know before you take Zofran
syrup

3

How to take Zofran syrup

4

Possible side effects

5

How to store Zofran syrup

6

Contents of the pack and other information

1

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.
3 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.
4

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.

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.

5








6

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.

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

Ondansetron 4mg/5ml Syrup

Ref: LTT0148/230316/2/F

(ondansetron hydrochloride dihydrate)
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 Ondansetron 4mg/5ml
syrup, but will be referred to as Ondansetron syrup
throughout the remainder of this leaflet.
What is in this leaflet:
1
2

What Ondansetron syrup is and what it is
used for
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

1

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.
3 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.

4 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).

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.

5








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.

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.

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.
Ref: LTT0148/230316/2/B

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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