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.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or
pharmacist.

This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.

If any side effects trouble you, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Ondansetron is and what it is used for
2. Before you take Ondansetron
3. How to take Ondansetron
4. Possible side effects
5. How to store Ondansetron
6. Further 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 to prevent or treat nausea and vomiting
induced by chemotherapy or radiotherapy. In addition it may be
used to prevent or treat post-operative nausea and vomiting.
Your doctor may have prescribed Ondansetron for another use.
Always follow your doctor's advice.
2. BEFORE YOU TAKE ONDANSETRON
Do Not take Ondansetron:

if you are allergic (hypersensitive) to Ondansetron or any of
the other ingredients of this medicine (listed in section 6)

if you have previously experienced allergy (hypersensitivity)
to other drugs belonging to the group of serotonin antagonists
used to prevent and treat nausea and vomiting (e.g.
granisetron, dolasetron). If this is the case, it is possible that
you are also allergic to Ondansetron

if you are pregnant or breastfeeding.
Take special care with Ondansetron
Tell your doctor:

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 had your tonsils removed,
as treatment with Ondansetron may hide symptoms of
internal bleeding

if you have heart problems (with arrhythmias or conduction
disorders) and are being treated with other medicines such
as anaesthetics, anti-arrhythmic or beta-blockers at the same
time.

if it is for a child under the age of 6 months

if you have liver problems.
Always tell the laboratory if you are having blood or urine tests, that
you are being treated with Ondansetron.

Taking other medicines
Ondansetron may have an effect on other drugs or other drugs
may have an effect on Ondansetron.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription, natural supplements or vitamins or minerals.
You must tell your doctor that you are taking Ondansetron, if
he/she starts treating you with any of the following medicines:

Phenytoin or carbamazepine, used to treat epilepsy

Rifampicin, an antibiotic used to treat infections

Tramadol, a pain relieving medicine

Cancer medicines (especially anthracyclines and trastuzumab).
Contact your doctor. 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
Ask your doctor or pharmacist for advice before taking any
medicine.
Pregnancy:
It is not known if ondansetron is safe during pregnancy. Talk to
your doctor before taking Ondansetron tablets if you are pregnant
or might become pregnant.
Breast-feeding:
Do not take Ondansetron if you are breast-feeding, because it is
excreted into the milk.
Driving and using machines
Ondansetron may cause problems with your vision. If affected do
not drive or operate machinery.
Important information about some of the ingredients of
Ondansetron
Ondansetron contains Lactose monohydrate. Contact your doctor
before taking this medicine if your doctor has told you that you do
not tolerate certain types of sugar.
3. HOW TO TAKE ONDANSETRON
Always take Ondansetron exactly as your doctor has told you. You
should 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 usual 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.
Children (aged over 6 months) and adolescents under the age
of 18 years:
The doctor will decide the dose. Look at the label for more
information. The usual dose for a child is up to 4mg twice a day.
This can be given for up to 5 days.
Continued overleaf.....

Treatment and prevention of post-operative nausea and
vomiting
Adults, prevention and treatment:
The usual dose is 16 mg one hour before anaesthesia or
alternatively, 8 mg taken one hour before anaesthesia followed by
an additional 8 mg after 8 and 16 hours. Your doctor may choose
to give you the medicine as injections.
Children aged over 1 month and adolescents under the age
of 18 years:
It is recommended that ondansetron is given as an injection.
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 advice. There are differences in
individual patients’ needs. Do not change or stop your treatment
without first talking to your doctor.
If you take more Ondansetron than you should
Contact your doctor, hospital casualty department 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.
Serious, rare side effects (occur in between 1 and 10 of 10,000
patients treated):
Tell your doctor or go to the nearest hospital casualty
department immediately if you experience any of the following
signs of a serious allergic reaction:

Swollen tongue or throat

Difficulty breathing

Hives (also known as nettle rash or urticaria).
Very common side effects (occur in more than 1 in 10 patients
treated):

Headache.
Common side effects (occur in between 1 and 10 of 100
patients treated):

A sensation of reddening and warmth

Constipation.
.
Uncommon side effects (occur in between1 and 10 of 1,000
patients treated):

Hiccups

Low blood pressure (you may feel dizzy or faint when you
stand up), irregular heart beats, chest pain and slow pulse

Involuntary movements

Changes in liver function

Seizures (fits).

Rare side effects (occur in between 1 and 10 of 10,000 patients
treated):

Temporary blurred vision.
Very rare side effects (occur in less than 1 of 10, 000 patients
treated):

Temporary blindness (usually following ondansetron
injection).

Abnormally rapid heart rhythm (Torsades de pointes).
If any of these side effects occur, immediately seek medical
attention.
Tell your doctor or pharmacist if you notice any other side effects
not listed in this package leaflet. This will ensure that side effects
are recorded by the National Drug regulatory authority, and help to
improve knowledge on side effects.
Tell your doctor or pharmacist if you experience side effects that
persist, bother or concern you in any way.
5. HOW TO STORE ONDANSETRON





Keep out of the reach and sight 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
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. FURTHER 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 (EI7l) and Quinoline
yellow (E I04).
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 Ltd, 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 January 2012
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 2012

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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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