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ONDANSETRON 4MG/5ML ORAL SOLUTION

Active substance(s): ONDANSETRON HYDROCHLORIDE DIHYDRATE

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PACKAGE LEAFLET
INFORMATION FOR THE USER

Ondansetron 4mg/5ml
Oral Solution
(Ondansetron)

READ ALL 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, ask your doctor or your
pharmacist.
• This medicine has been prescribed only 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 these side effects become serious, or if you
notice any side effects not listed in this leaflet, please
tell your doctor, nurse or pharmacist (see section 4).
What is in this leaflet
1. What Ondansetron 4mg/5ml Oral Solution is and
what it is used for
2. What you need to know before you take
Ondansetron 4mg/5ml Oral Solution
3. How to take Ondansetron 4mg/5ml Oral Solution
4. Possible side effects
5. How to store Ondansetron 4mg/5ml Oral Solution
6. Contents of the pack and other information

1. What Ondansetron 4mg/5ml Oral
Solution is and what it is used for
Some medical and surgical treatments can make you
feel sick or be sick (nausea and vomiting). Ondansetron
4mg/5ml Oral Solution belongs to a group of medicines
called anti-emetics, which can stop these effects. This
medicine is used to stop nausea and vomiting after
• chemotherapy or radiotherapy for cancer (in adults
and children)
• an operation (adults only).
Ask your doctor, nurse or pharmacist if you would
like further explanation about these uses.

2. What you need to know before
you take Ondansetron 4mg/5ml
Oral Solution
Do not take Ondansetron 4mg/5ml Oral
Solution if you

• know you are allergic (hypersensitive) to, or have
ever had a bad reaction to ondansetron or any of the
other ingredients (see section 6)
• are taking apomorphine (used to treat Parkinson’s
disease).

Take special care and check with your doctor,
nurse or pharmacist before taking this
medicine if you:

• have ever had heart problems
• an uneven heartbeat (arrhythmias)
• are allergic to similar medicines, such as
granisetron (also known as “Kytril”)
• have liver problems
• have a blockage in your gut or you suffer from
severe constipation
• have a problem 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 this
medicine.

SO49796_TD0009_P2.indd 1

Taking other medicines

Please tell your doctor, nurse or pharmacist if
you are taking or have recently taken any other
medicines, including medicines obtained without a
prescription and herbal medicines. This is because
ondansetron can affect the way other medicines
work. Also, some other medicines can affect the way
ondansetron works. In particular, make sure your doctor
or pharmacist knows if you or your child are taking:
• carbamazepine or phenytoin (to treat epilepsy)
• rifampicin (to treat serious infections such as
tuberculosis (TB))
• tramadol (to control pain)
• medicines that affect the heart (such as haloperidol
or methadone)
• medicines to treat cancer (especially anthracyclines
or trastuzumab)
• anti-arrhythmic medicines (to treat an uneven
heartbeat)
• beta-blocker medicines (to treat certain heart or eye
problems, anxiety or prevent migraines).
• antibiotics such as erythromycin or ketoconazole
• SSRIs (selective serotonin reuptake inhibitors) used
to treat depression and/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 using
Ondansetron 4mg/5ml Oral Solution.

Pregnancy and breast-feeding

It is not known if Ondansetron is safe during pregnancy.
Therefore, talk to your doctor or pharmacist before taking
Ondansetron 4mg/5ml Oral Solution if you are pregnant,
might become pregnant or planning to have a baby.
Do not breast feed if you are taking Ondansetron, as
small amounts can pass into the breast milk. Ask your
doctor or midwife for advice.

Driving and using machines

Ondansetron 4mg/5ml Oral Solution should not affect
your ability to drive or to operate machinery, but if you
feel faint or dizzy, do not drive or operate machinery until
you feel better.

Important information about some of the
ingredients of Ondansetron Oral Solution

This medicine contains a sugar called sorbitol (E420).
If you have been told by your doctor that you have an
intolerance to some sugars, speak to your doctor before
taking this medicine.

3. How to take Ondansetron 4mg/5ml
Oral Solution
Always take Ondansetron 4mg/5ml Oral Solution exactly
as your doctor has told you. 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 your medicine 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 8mg taken one to two hours
before treatment and another 8mg twelve hours after.
On the following days
• the usual adult dose is two 5ml spoonfuls twice a day
• this may be given for up to 5 days

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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 5ml spoonfuls before your
operation.

Uncommon (affects less than 1 person in 100 people)
• hiccups
• low blood pressure, which can make you feel faint or
dizzy
• uneven heartbeat
• chest pain
• fits
• unusual body movement or shaking

For children aged over 1 month and
adolescents:

Rare (affects less than 1 in 1,000 people)
• feeling dizzy or light headed
• blurred vision
• disturbance in heart rhythm (sometimes causing a
sudden loss of consciousness)

Patients with moderate to severe liver
problems

Very rare (affects less than 1 in 10,000 people)
• poor vision or temporary loss of eyesight which usually
comes back within 20 minutes. This is much less likely
when ondansetron is given by mouth.

It is recommended that Ondansetron is given as an
injection.

The total daily dose should not be more than 8mg (two
5ml spoonfuls).
Ondansetron 4mg/5ml Oral Solution should start to work
within 1-2 hours of taking a dose.

If you are sick (vomit) a dose back within 1
hour of taking a dose

• then take the same dose again
• otherwise do not take more doses than the label says.
If you continue to be sick or feel sick, tell your doctor or
nurse.

If you take more than you should

If you take more than you should, talk to your doctor or go
to hospital straight away. Take the medicine pack with you.

If you forget to take

If you miss a dose and feel sick or vomit
• take a dose as soon as possible, then
• take the 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 when due (as shown on the label).
If you have any further questions on the use of this
product, ask your doctor, nurse or pharmacist.

4. Possible side effects
Like all medicines, Ondansetron 4mg/5ml Oral Solution
can cause side effects, although not everybody gets them.

Allergic reactions

A few people may be allergic to Ondansetron 4mg/5ml
Oral Solution, however this is rare, affecting less than 1
in 1000 patients.
If you have an allergic reaction stop taking this
medicine and seek medical attention immediately.
The signs may include:
• sudden wheeziness and chest pain or chest tightness
• difficulty breathing
• swelling of eyelids, face, lips, mouth or tongue
• skin rash - red spots or red spots or lumps under your
skin (hives) anywhere on your body
• feeling faint, especially when standing up
• collapse.

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
• Keep out of the sight and reach of children.
• Do not store above 30ºC.
• Do not refrigerate. Keep the bottle upright.
• Do not use after 28 days of first opening the bottle.
Do not use after the expiry date which is stated on the
label and carton after “EXP”. The expiry date
refers to the last day of the month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines you no longer use. These measures will help
to protect the environment.

6. Contents of the pack and other
information
What Ondansetron 4mg/5ml Oral Solution contains
• The active substance is ondansetron. Each 5 ml
spoonful contains 4mg ondansetron.
The other ingredients are sodium citrate (E331),
citric acid (E330), saccharin sodium, sorbitol (E420),
sodium benzoate (E221), strawberry flavour and
purified water.
What Ondansetron Oral Liquid 4mg/5ml looks like
and contents of the pack
Ondansetron 4mg/5ml Oral Solution is a clear, sucrosefree, strawberry flavoured solution. It is supplied in
a 50ml amber glass bottle, packed in a carton with a
double ended (5ml and 2.5ml) measuring spoon.

Very common (affects more than 1 in 10 people)
• headache.

Marketing Authorisation Holder
Transdermal Limited,
House, Avenue,
Brunel Road,
Limited, Merlin
35 Grimwade
Croydon,
CR0 5DJ,
UK
Theale,
Reading,
RG7 4AB, UK
Manufacturer:
Nupharm
Laboratories
Limited,
Manufacturer Nupharm
Laboratories
Limited,
2
Apollo
Pharma
Ltd, unit
1,
2
Newtech
Square,
Deeside
Industrial
Park,
Newtech
Square,
Deeside
Industrial
Deeside,
Irwell
Works,
Lower
Woodhill
Road,Park,
Flintshire,
CH5
UK 2NT, UK
Deeside,
Bury
BL8Flintshire,
1AA 2NT,CH5

Common (affects less than 1 in 10 people)
• a feeling of warmth or flushing
• constipation
• changes to liver function test results (if you take
Ondansetron 4mg/5ml Oral Solution with a medicine
called cisplatin, otherwise this side effect is uncommon).

PL 14308/0015
This leafl
et was
approved
in July 2014.
leaflet
waslast
approved
in December
2017.
TD0009

Other side effects include:

SO49796_TD0009_P2.indd 2

15/11/2017 15:08

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Further information

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