ONDANSETRON 8MG FILM COATED TABLETS

Active substance: ONDANSETRON HYDROCHLORIDE DIHYDRATE

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PACKAGE LEAFLET: INFORMATION
FOR THE USER

Ondansetron 4mg and 8mg
Film-coated 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 of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Ondansetron Tablets are and what they are
used for
2. Before you take Ondansetron Tablets
3. How to take Ondansetron Tablets
4. Possible side effects
5. How to store Ondansetron Tablets
6. Further information

1 What Ondansetron tablets are and
what they are used for
Ondansetron belongs to a group of medicines
known as ‘antiemetics and antinauseants’. These
prevent feelings of sickness (nausea) or being sick
(vomiting) that may occur after certain medical or
surgical treatments.
Your doctor or nurse may give you Ondansetron
Tablets to prevent you from or to treat you for
feeling or being sick when you:
• are on chemotherapy and radiotherapy that can
cause nausea and vomiting.
• undergo surgical treatment.

Children (aged 2 years to 18 years)
Your doctor will decide on a suitable dose based on
body surface area. The usual doses for children are
4mg three times daily, or 8mg three times daily for
up to 5 days, after chemotherapy
To prevent nausea and vomiting after an operation
Adults
The usual dose is 16mg taken one hour before the
operation or 8mg taken one hour before the
operation followed by two further doses of 8mg at
eight hourly intervals.
Children (aged 2 years or over)
Ondansetron Tablets are not suitable for use in
children following abdominal surgery.
A slow intravenous injection is recommended.
Patients with liver disease
In patients with moderate or severe liver problems a
total daily dose of 8mg should not be exceeded.
If you take more Ondansetron Tablets than you should
It is important to stick to the dose on the label of your
medicine. Taking more than this could make you ill. If
you or someone else swallows several of these tablets
all together, contact your doctor, pharmacist or
hospital emergency department immediately. Always
take any tablets left over with you and also the box, as
this will allow easier identification of the tablets.
If you forget to take Ondansetron Tablets
If you forget to take a dose and do not feel sick
take the next day’s tablet at the usual time. If you
forget to take a dose, and feel sick or are sick, take
a tablet as soon as possible. Do not take a double
dose to make up for a forgotten dose.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, Ondansetron Tablets can cause
side effects, although not everybody gets them.

2 Before you take Ondansetron tablets
Please take the time to read the following
information carefully as this may stop you from
being able to take Ondansetron Tablets.
Do not take Ondansetron Tablets if you are
• allergic (hypersensitive) to ondansetron or any of
the other ingredients of Ondansetron Tablets.
Take special care with Ondansetron Tablets
Before you take Ondansetron Tablets you should tell
your doctor if you:
• have ever been allergic (hypersensitive) to similar
medicines known as 5HT³ receptor antagonists
• have liver diseases
• are suffering from severe constipation or have a
blockage in your gut
• have had surgery on your gut
• have had surgery on your adenoids or tonsils
• have had heart problems, including an uneven
heart beat (arrhythmias).
If any of the above apply to you, talk to your doctor
who will decide what to do.
Taking other medicines
You should tell your doctor if you are taking or have
taken any of the following medicines as they may
interact with Ondansetron Tablets:
• Tramadol. The effect of pain relief from Tramadol
may be reduced whilst you are taking
Ondansetron Tablets.
• Phenytoin and carbamazepine (usually used to
treat epilepsy)
• Rifampicin (a type of antibiotic, often used for
the treatment of tuberculosis)
• Medicines that affect the heart (such as
haloperidol or methadone)
• Medicines used to treat an uneven heart beat
(anti-arrhythmics)
• Beta-blocking medicines (used to treat heart
problems, eye problems, anxiety or for prevention
of migranes)
• Cancer medicines (especially anthracyclines).
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.

If the following happens, stop taking the tablets
and tell your doctor immediately or go to the
casualty department at your nearest hospital:
• An allergic reaction causing swelling of the face,
lips, tongue or throat, difficulty in breathing or
swallowing, skin rash
• Collapse
Other side effects include:
Very common (affects more than 1 in 10 people)
• Headache
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 tablets with a medicine called
cisplatin, otherwise this side effect is
uncommon).
Uncommon (affects less than 1 in 100 people)
• Hiccups
• Low blood pressure, which can make you feel
faint or dizzy
• Uneven heart beat or chest pain
• Fits
• Unusual body movement or shaking
Rare (affects less than 1 in 1000 people)
• Feeling dizzy or lightheaded
• Blurred vision
Very rare (affects less than 1 in 10000 people)
• Poor vision or temporary loss of eyesight, which
usually comes back within 20 minutes.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5 How to store Ondansetron tablets
Keep out of the reach and sight of children.
Do not use Ondansetron Tablets after the expiry
date which is stated on the carton after EXP:. The
expiry date refers to the last day of that month.

Pregnancy and breast-feeding
You should not take Ondansetron Tablets if you are
pregnant or there is a chance you may be pregnant.
Ondansetron may pass into mothers’ milk, therefore
breast-feeding is not recommended in mothers
taking Ondansetron Tablets
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
Ondansetron Tablets should not affect your ability
to drive or use machinery.
Important information about some of the
ingredients of Ondansetron Tablets
Ondansetron Tablets contain lactose monohydrate, a
type of sugar. 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 tablets
Always take Ondansetron Tablets exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure. Ondansetron
Tablets should be swallowed whole with a little water.
Ondansetron Tablets should start to work within 1
to 2 hours of taking a dose. If you are sick within 1
hour of taking Ondansetron Tablets you should talk
to your doctor who will tell you what you should do.
If you continue to feel or be sick whilst taking the
tablets, tell your doctor.
For patients receiving chemotherapy and/or
radiotherapy that causes nausea or vomiting
Adults (including the elderly)
The usual dose is 8mg 1-2 hours before you are
treated with chemotherapy or radiotherapy, followed
by 8mg 12 hours later.
After the first 24 hours following chemotherapy,
Ondansetron Tablets can be given to prevent further
nausea or vomiting. The usual dose for oral
administration is 8 mg twice daily, which can be
given for up to 5 days.

Do not store above 30°C. Store your tablets in the
original package in order to protect from light.
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 Tablets contain
• The active substance is ondansetron (as
hydrochloride dihydrate). Each tablet contains
4mg or 8mg of ondansetron.
• The other ingredients are microcrystalline
cellulose, lactose monohydrate, maize starch,
magnesium stearate. The ingredients of the
film-coating on the tablets are lactose
monohydrate, hypromellose, titanium
dioxide E171, macrogol and sodium citrate
dihydrate E331.
What Ondansetron Tablets look like and contents of
the pack
Ondasetron Tablets are white to off-white, round
biconvex film-coated tablets with PA engraved on
one side and 933 (4mg tablets) or 934 (8mg
tablets) on the other side.
Ondansetron Tablets are available in blister packs
containing 6, 10, 15 or 30 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
PLIVA Pharma Ltd., Ridings Point, Whistler Drive,
Castleford, West Yorkshire, WF10 5HX, United
Kingdom.
Manufacturer
Teva Operations Poland Sp. z.o.o., Ul.Mogilska 80,
31-456 Krakow, Poland.
This leaflet was last revised in July 2011
PL 10622/0100
PL 10622/0101
87335-C

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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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