ONDEMET 8MG TABLETS

Active substance: ONDANSETRON HYDROCHLORIDE DIHYDRATE

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Package leaflet: Information for the user

Ondemet® 4mg and 8mg 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 or pharmacist or
nurse.
• 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, or 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 is and what it is 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 drugs called anti-emetics.
Ondansetron inhibits the effect of the neuro-transmitter serotonin
in the brain. Serotonin causes nausea and vomiting.
Ondansetron is used for:
Preventing and treating nausea and vomiting induced by cytotoxic
chemotherapy (CINV) and radiotherapy (adults and children aged
≥ 6 months).
Preventing and treating nausea and vomiting in patients following an
operation (PONV) (in adults and children aged ≥ 1 month).
Your doctor may have prescribed Ondansetron for another use. Always
follow your doctor's advice.

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 have previously experienced allergy to other drugs belonging
to the group of serotonin antagonists (e.g. granisetron, dolasetron). If
this is the case, it is possible that you are also allergic to Ondansetron
• if you are taking apomorphine (used to treat Parkinson's disease).
Warnings and precautions
Talk to your doctor or pharmacist before taking Ondansetron:
• if you have a blockage of your intestines or constipation, as you
will need to be closely monitored by your doctor
• if you are going to have or recently have had your tonsils removed,
because treatment with Ondansetron may hide symptoms of internal
bleeding
• if you have problems with the levels of salts in your blood such as
potassium and magnesium
• if you have heart problems, such as irregular heartbeat (with
arrhythmias or conduction disorders) and are being treated with other
medication such as anaesthetics, anti-arrhythmics or beta-blockers at
the same time, because of the limited experience hereby
• if it is for children below the age of 6 months or with a body surface
of less than 0.6 m2
• if you have liver problems
• if children or adolescents receive ondansetron together with drugs,
that may have a harmful effect on the liver. Careful monitoring of the
liver function is recommended
• if you take other serotonergic drugs (medicines of the type SSRI or
SNRI, used in the treatment of depressions).
Tell your doctor if any of the above warnings apply to you.

Please tell your doctor or nurse if you need to have blood or urine tests,
that you are being treated with Ondansetron.
Other medicines and Ondansetron
Ondansetron may have an effect on other drugs or other drugs may
have an effect on Ondansetron.
Tell your doctor or pharmacist if you are taking or have recently taken
or might take any other medicines.
You must tell your doctor that you are taking Ondansetron, if he/she
starts treating you with the following medicine:
• Drugs for epilepsy (phenytoin, carbamazepine), which may reduce the
effect of ondansetron
• Antibiotics and antifungal medicines (e.g. rifampicin, erythromycin or
ketoconazole)
• Pain relieving medicine (tramadol)
• Apomorphine (used to treat Parkinson’s disease)
• Medicines inducing heart damage (e.g. anthracyclines or trastuzumab)
• Serotonergic drugs (medicines of the type SSRI or SNRI, used in the
treatment of depressions)
• Anti-arrhythmic medicines used to treat an uneven heart beat
(e.g. amiodarone)
• Drugs which may result in QT prolongation (heart rhythm disorder)
• Beta-blocker medicines used to treat certain heart or eye problems,
anxiety or prevent migraines (e.g. atenolol or timolol).
Talk with your doctor or the healthcare staff if you are taking any of
these types of medicines. It may be necessary to adjust the dose.
Taking Ondansetron with food and drink
You may take Ondansetron with food and drinks. The tablets should
be taken with a glass of water.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
Pregnancy:
Use in pregnancy has not been established and is not recommended.
If it is absolutely necessary that ondansetron be given, caution should be
exercised when prescribing to pregnant women especially in the first
trimester. Your doctor should evaluate the risk/benefit balance.
Breast-feeding:
Do not take Ondansetron if you are breast-feeding, because it is
excreted into the milk.
Driving and using machines
Ondansetron does not affect the ability to use any tools or machines
or the ability to drive safely in traffic.
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 medicinal product.

3. How to take Ondansetron
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
Treatment and prevention of nausea and vomiting in connection
with chemotherapy or radiotherapy
Adults:
The recommended oral dose is 8 mg 1-2 hours before chemotherapy
or radiotherapy, followed by 8 mg every 12 hours for up to 5 days.
Your doctor may decide to give the first dose as an injection.
Elderly:
The same dose as for adults.

Continued overleaf.....

Treatment and prevention of post-operative nausea and vomiting
Adults:
The recommended oral dose is 16 mg one hour prior to anaesthesia
or alternatively, 8 mg taken one hour prior to anaesthesia followed by
an additional 8 mg after 8 and 16 hours. Your doctor may choose to give
you the medicine as injections.
Elderly:
There is limited experience with the use of ondansetron in elderly patients.
Ondansetron is however tolerated well by patients above 65 years in
chemotherapy (please refer to sections above).
Paediatric population (children aged ≥ 1 month and adolescents):
For prevention of PONV in paediatric patients having surgery performed
under general anaesthesia, a single dose of ondansetron may be given
by slow injection into a vein.

Rare side effects (may affect up to 1 in 1000 people):
• sudden skin rash, difficulty breathing, and fainting (within
minutes to hours) due to hypersensitivity (anaphylactic shock)
• dizziness (usually during rapid injection of Ondansetron)
• transient visual disturbances such as blurred vision (usually during
rapid injection of Ondansetron)
• Prolongation of QT-time in ECG, including abnormally rapid heart
rhythm called “Torsade des pointes”.
If any of these symptoms occur, immediately seek medical attention.
Very rare side effects (may affect up to 1 in 10,000 people):
• temporary blindness usually during injection of Ondansetron. Most
of these blindness cases were resolved 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 internet 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

For the treatment of PONV after surgery in paediatric patients having
surgery performed under general anaesthesia, a single dose of
ondansetron may be given by slow injection into a vein. There are no
data on the use of ondansetron in the treatment of PONV in children
below 2 years of age.





Insufficient function of the liver:
The daily dose should not exceed 8 mg if you have moderately to
severely reduced function of the liver.



The tablets should be taken with a glass of water.
Always follow your doctor's prescription. There are differences in what
the individual patients need. Changes in or discontinuation of treatment
should only occur in consultation with your doctor.
If you take more Ondansetron than you should
Contact your doctor, the hospital or the pharmacy if you have
taken more Ondansetron than recommended in this package leaflet or
than prescribed by your doctor and you feel uncomfortable.
The symptoms of overdose are disturbances of vision, severe
constipation, low blood pressure and disturbances in heart beat rhythm.
If you forget to take Ondansetron
Do not take a double dose to make up for a forgotten dose.

4. Possible side effects
Like all medicines, Ondansetron can cause side effects, although not
everybody gets them.
Very common side effects (may affect more than 1 in 10 people):
• headache.
Common side effects (may affect up to 1 in 10 people):
• a sensation of reddening and warmth
• constipation
• local injection site reactions (if you use Ondansetron injection).
Uncommon side effects (may affect up to 1 in 100 people):
• seizures
• hiccups
• low blood pressure
• irregular heartbeats
• heart pain and slow pulse
• involuntary movements
• sometimes changes in liver function have been observed.

Keep out of the sight and reach of children
Store in the original package
Do not use Ondansetron after the expiry date which is stated on
the blister and on the carton. 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 to protect the
environment.
6. Contents of the pack and other information

What Ondansetron contains
The active substance is ondansetron 4 mg or 8 mg as ondansetron
hydrochloride dihydrate.
The other ingredients are Cellulose, microcrystalline; Lactose
monohydrate; Starch, pregelatinised (maize); Magnesium stearate;
Hypromellose; Hydroxypropylcellulose; Propylene glycol; Sorbitane
oleate; Sorbic acid; Vanillin; Titanium dioxide (E171) and Quinoline
yellow (E104).
What Ondansetron looks like and contents of the pack
Ondemet 4 mg are yellow round, biconvex film-coated tablets with
a diameter of 7.2 mm and marked 41 on one side.
Ondemet 8 mg are yellow round, biconvex film-coated tablets with
a diameter of 9.2 mm and marked 42 on one side.
4 mg blister: 6, 10, 30, 50 and 100 film-coated tablets.
8 mg blister: 6, 10, 15, 30, 50 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road,
Chippenham, Wiltshire, SN15 2BB, UK
Manufacturer
Pharmathen S.A., 6. Dervenakion str., 15351 Pallini. Attikis, Greece
This leaflet was last revised in February 2014
Ondemet is a registered trademark in the United Kingdom of
Alliance Pharmaceuticals Limited.
Alliance and associated devices are registered trademarks of
Alliance Pharmaceuticals Limited.
© Alliance Pharmaceuticals Limited 2014

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Paediatric population (children aged ≥ 6 months and adolescents):
Ondansetron should be given immediately before chemotherapy as
a single dose given into a vein. Oral dosing can commence twelve
hours later and may be continued for up to 5 days. The total daily
dose must not exceed 32 mg.

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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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