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ONDANSETRON 4MG FILM COATED TABLETS

Active substance(s): ONDANSETRON HYDROCHLORIDE DIHYDRATE / ONDANSETRON HYDROCHLORIDE DIHYDRATE / ONDANSETRON HYDROCHLORIDE DIHYDRATE

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Package leaflet: Information for the patient
Ondansetron 4 mg Film-coated Tablets
Ondansetron 8 mg Film-coated Tablets
Ondansetron
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, 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 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.
What is in this leaflet
1. What Ondansetron are and what they are used for
2. What you need to know before you take Ondansetron
3. How to take Ondansetron
4. Possible Side effects
5. How to store Ondansetron
6. Contents of the pack and other information

1.

What Ondansetron is and what it is used for

Ondansetron belongs to a group of medicines known as anti-emetics or anti-sickness medicines.
Ondansetron is used for:
- preventing nausea (feeling sick) and vomiting (being sick) caused by chemotherapy or
radiotherapy treatment for cancer (in adults and children aged 6 months or over).
- 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

Do not take Ondansetron:
- if you are allergic to ondansetron or any of the other ingredients of this medicine (listed in
section 6).
- if you are allergic to anti-sickness medicines belonging to the group selective serotonin (5HT3)-receptor antagonists (e.g. granisetron, dolasetron), because in such a case you may also
be allergic to ondansetron.
- if you are taking apomorphine (used to treat Parkinson’s disease).
If you are not sure, talk to your doctor, nurse or pharmacist before taking Ondansetron.
Warnings and precautions
Talk to your doctor, nurse or pharmacist before taking Ondansetron:
- if you have ever had heart problems or you have an uneven heart beat (arrhythmias)
if you have problems with the levels of salts in your blood such as potassium, sodium or
magnesium.
- if you have a blockage in your gut or you suffer from severe constipation.
- if you are going to have, or have recently had, your tonsils or adenoids removed, because
treatment with ondansetron may hide signs of internal bleeding.
- if you have liver problems.

If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before
taking Ondansetron.
Other medicines and Ondansetron
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any 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 Ondansetron.
In particular, tell your doctor, nurse or pharmacist if you are taking any of the following medicines:
 carbamazepine or phenytoin used to treat epilepsy. These medicines can reduce the effect of
ondansetron.
 rifampicin used to treat infections such as tuberculosis (TB). This can reduce the effect of
ondansetron.
 antibiotics such as erythromycin or ketoconazole used to treat fungal infections
 anti-arrhythmic medicines (such as amiodarone) use to treat an uneven heartbeat
 beta-blocker medicines (such as atenolol or timolol) used to treat certain heart or eye
problems, anxiety or prevent migraines
 tramadol, a pain killer. The effect of this medicine may be reduced.
 cancer medicines (especially anthracyclines and trastuzumab)
 certain types of medicines used to treat depression known as SSRIs (selective serotonin
reuptake inhibitors) or SNRIs (serotonin and noradrenaline reuptake inhibitors) as these may
cause serotonin syndrome, a potentially life-threatening reaction, when used together with
ondansetron. The symptoms of serotonin syndrome may include a combination of the
following: nausea (feeling sick), vomiting, agitation, diarrhoea, high temperature, increased
blood pressure, excessive sweating, rapid heartbeat, hallucinations, loss of coordination,
overactive reflexes and coma.
If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before
taking Ondansetron.
Pregnancy and breast-feeding
It is not known if Ondansetron is safe during pregnancy. Talk to your doctor before taking
Ondansetron if you are pregnant or might become pregnant.
Do not breast-feed if you are taking Ondansetron. This is because this medicine can pass into the
mother’s milk. Ask your doctor, pharmacist or midwife for advice.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor, nurse or pharmacist for advice before taking this medicine.
Driving and using machines
Ondansetron should not affect your ability to drive or use machines.
Ondansetron contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicine.
3.

How to take Ondansetron

Always take this medicine 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.

To prevent nausea and vomiting from chemotherapy and radiotherapy treatment
On the day of chemotherapy and radiotherapy
- the recommended adult dose is 8 mg taken one or two hours before treatment and another 8
mg twelve hours after.
On the following days
- the recommended adult dose is 8 mg twice a day
- this may be given for up to 5 days.
Use in children (aged 6 months or over) and adolescents
The doctor will decide the dose. See the label for more information.
- the recommended dose for a child is up to 8 mg twice a day depending on the weight of the
child.
- this can be given for up to 5 days.
To prevent nausea and vomiting after an operation
The recommended adult dose is 16 mg before your operation or
- 8 mg before an operation, then
- 8 mg after the operation, then
- 8 mg after further 8 hours.
Use in children (aged 1 month or over) and adolescents
It is recommended that Ondansetron is given as an injection. Other forms of this medicine are more
suitable for children; ask your doctor or pharmacist.
Elderly
There is limited experience with the use of ondansetron in elderly patients for the prevention of nausea
and vomiting after an operation. However ondansetron is well tolerated in patients over 65 years of
age receiving chemotherapy. Alteration to the dosage is not required.
Patients with moderate or severe liver problems
The total daily dose should not be more than 8 mg.
Ondansetron should start to work within one or two hours of taking a dose.
Patients with kidney problems or poor sparteine/debrisoquine metabolism
Patients with kidney problems or who cannot metabolise sparteine/debrisoquine well can take the
recommended doses of ondansetron, as detailed above.
If you are sick (vomit) within one hour of taking a dose
- take the same dose again
- otherwise do not take more Ondansetron tablets than the label says.
If you continue to feel sick, tell your doctor or nurse.
Method of administration
- Swallow the tablets with a glass of water.
- Ondansetron is also available as an injection.
If you take more Ondansetron 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 container and any remaining tablets with you.
There is limited information about overdose with ondansetron. Signs of overdose that have been
reported include disturbances of vision, severe constipation, low blood pressure, fainting and
disturbances in heart beat rhythm.
If you forget to take Ondansetron
If you miss a dose and feel sick or vomit:
- take Ondansetron as soon as possible, then

- take your next tablet 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, this medicine can cause side effects, although not everybody gets them.
The following serious side effects may occur when taking this medicine. If you notice any of
these, stop taking the medicine and see a doctor straight away or go to the nearest hospital
immediately.
Rare (may affect up to 1 in 1,000 people)
 If you have an allergic reaction, 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.
Uncommon (may affect up to 1 in 100 people)
 Involuntary eye movements (oculogyric crisis)
Other possible side effects
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
Uncommon (may affect up to 1 in 100 people)
 hiccups
 low blood pressure, which can make you feel faint or dizzy
 uneven heart beat or slow heart beat
 chest pain with or without ECG changes
 fits, unusual body movements or shaking
 changes to blood tests which show changes in the way the liver is working (most often in
patients receiving chemotherapy with cisplatin)
Rare (may affect up to 1 in 1,000 people)
 transient blurred vision
 disturbances in heart rhythm called QT prolongation (delayed conduction of electrical signals
which can be seen on an ECG, an electrical recording of the heart). In some people this can
develop into a potentially serious heart condition known as Torsades de Pointes. This can
result in a very fast heartbeat 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.
Side effects in children and adolescents
The side effects reported in children and adolescents were similar to that seen in adults, as listed
above.

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

Keep this medicine out of the sight and reach of children.
Do not store tablets above 30°C.
Do not use this medicine after the expiry date which is stated on the carton or blister foil after EXP.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6.

Contents of the pack and other information

What Ondansetron contains
The active substance is ondansetron hydrochloride dihydrate.
Each tablet contains either 4 mg or 8 mg of the active ingredient ondansetron (as the hydrochloride
dihydrate).
The other ingredients are lactose monohydrate (see section 2 “Ondansetron contains lactose”),
microcrystalline cellulose (E460), pregelatinised maize starch, magnesium stearate (E572). The
coating contains hypromellose (E464), titanium dioxide (E171), macrogol (E1520), hydroxypropyl
cellulose (E463), sorbitan oleate (E494), sorbic acid (E200), vanillin and Quinoline yellow (E104).
What Ondansetron looks like and contents of the pack
Ondansetron are round, pale yellow film-coated tablets. The 4 mg strength tablets are marked “41” on
one side and the 8 mg strength are marked “42” on one side.
Ondansetron is available in blister packs of 3, 6, 10, 14, 15, 20, 30, 40, 50, 60, 90, 100, 200, 300, 500
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, UK
Manufacturer
Mylan B.V., Dieselweg 25, 3752 LB Bunschoten, The Netherlands.
Generics [UK] Ltd, Potters Bar, Hertfordshire, EN6 1TL, UK.
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

This leaflet was last revised in 06/2017.

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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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