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ONDANSETRON 4MG TABLETS

Active substance(s): ONDANSETRON HYDROCHLORIDE DIHYDRATE

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Package leaflet: information for the user

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Ondansetron 4 mg Tablets
Ondansetron 8 mg Tablets
Ondansetron Hydrochloride Dihydrate

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.
• 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. This includes any
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 medicines
called anti-emetics, drugs against feeling sick
(nausea) or being sick (vomiting).
This medicine is used for:
• preventing nausea (feeling sick) and vomiting
(being sick) caused by chemotherapy (in
adults and children) or radiotherapy for
cancer (adults only),
• preventing nausea and vomiting after surgery
(adults only).

2.

WHAT YOU NEED TO KNOW
BEFORE YOU TAKE
ONDANSETRON

Do not take Ondansetron
• if you are taking apomorphine, a medicine
used to treat Parkinson's disease,
• if you are allergic to ondansetron or any of the
other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Ondansetron:
• if you have ever had heart problems (e.g.
congestive heart failure which causes
shortness of breath and swollen ankles),
• if you have an uneven heart beat
(arrhythmias),
• if you are allergic to medicines similar to
ondansetron, such as granisetron or
palonosetron,
• if you have liver problems,
• if you suffer from any blockage in your gut or
if you have severe constipation,
• if your blood levels of potassium or
magnesium are reduced,
• if you are having your tonsils out.
Other medicines and Ondansetron
Tell your doctor 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 4 mg / 8 mg
Film-coated Tablets can affect the way some
medicines work. Also some other medicines can
affect the way Ondansetron 4 mg / 8 mg
Film-coated Tablets works.
In particular, tell your doctor or pharmacist:
• if you are taking phenytoin, carbamazepine










(used to treat epilepsy or other illnesses), or
rifampicin (used to treat certain infections):
the ondansetron blood concentrations are
decreased.
if you are taking tramadol (used to treat pain):
the effect of tramadol may be reduced.
if you are taking medicines used to treat heart
problems such as anti-arrhythmic medicines
(e.g. amiodarone) and beta-blockers
(e.g. timolol or atenolol).
if you are taking any cancer medicines which
are known to have toxic effects on the heart
(especially anthracyclines e.g. daunorubicin,
doxorubicin or trastuzumab). These
medicines may not be used together with
ondansetron as they may increase the risk of
irregular heartbeat.
if you are taking serotonergic drugs (including
SSRIs and SNRIs), used to treat major
depression and other mental disorders.
if you are taking apomorphine (a medicine
used to treat Parkinson's disease), because
severe drop in blood pressure and loss of
consciousness were reported when
Ondansetron was used with apomorphine.

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.
Because of insufficient experience the use of
ondansetron during pregnancy is not
recommended.
Do not breast-feed if you are taking this
medicine. This is because small amounts pass
into the mother’s milk.
Driving and using machines
Ondansetron has no or negligible effect on the
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 or
pharmacist if you are not sure.
• Swallow each tablet whole with a little water.
Your doctor will decide on the correct dose of
ondansetron therapy for you. The dose varies
depending on why you are being given
ondansetron and on your liver function.
Patients receiving chemotherapy and/or
radiotherapy that causes nausea and
vomiting:
• Adults (including the elderly):
The recommended dose is 8 mg 1 to 2 hours
before chemotherapy, followed by 8 mg
12 hours later.
After the first 24 hours following
chemotherapy, ondansetron tablets can be
given to prevent nausea and vomiting. The
usual dose is 8 mg twice a day, which can be
taken up to 5 days.
• Children aged over 6 months and
adolescents (less than 18 years of age):
The doctor will decided 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 4 mg twice a day.
This can be given for up to 5 days.

Continued over the page >>

To prevent nausea and vomiting after an
operation:
• Adults (including the elderly):
The usual adult dose is 16 mg before the
operation.
• Children aged over 1 month and
adolescents (less than 18 years of age):
It is recommended that ondansetron is given
as an intravenous injection.
Patients with moderate or severe liver
problems:
• The total daily dose should not be more than
8 mg.
If you notice that the effect of ondansetron is too
strong or too weak, talk to your doctor or
pharmacist.
If you take more Ondansetron than you should
If you take too many ondansetron tablets or if
someone else has taken some tablets by
accident, you should see a doctor at once or go
to the hospital emergency department. Take any
remaining tablets or the package with you to
show the doctor.
If you forget to take Ondansetron
If you forget a dose and feel sick or vomit, take
a tablet as soon as possible and then carry on
as before. 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 on the label.
If you stop taking Ondansetron
Do not stop taking your tablets, even if you are
feeling well, unless your doctor tells you.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Allergic reactions
If you have an allergic reaction, stop taking it
and see a doctor straight away. 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.
Other side effects include:
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
• changes to liver function test results (if you
take ondansetron tablets with a medicine
called cisplatin, otherwise this side effect is
uncommon)
Uncommon (may affect up to 1 in 100 people):
• hiccups
• low blood pressure, which can make you feel
faint or dizzy
• uneven heart beat
• chest pain
• fits
• unusual body movements or shaking

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any side effect not
listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme:
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 use Ondansetron after the expiry date
which is stated on the carton and blister after
EXP. The expiry date refers to the last day of
that month.
This medicinal product does not require any
special storage conditions.
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
Ondansetron 4 mg Tablets:
The active substance is ondansetron
hydrochloride dihydrate. Each film-coated tablet
contains ondansetron hydrochloride dihydrate
equivalent to 4 mg ondansetron.
Ondansetron 8 mg Tablets:
The active substance is ondansetron
hydrochloride dihydrate. Each film-coated tablet
contains ondansetron hydrochloride dihydrate
equivalent to 8 mg ondansetron.
• The other ingredients are:
Core:
lactose anhydrous, cellulose
microcrystalline, starch (maize)
pregelatinised, magnesium stearate.
Coating: hypromellose, lactose monohydrate,
titanium dioxide (E171), glycerol
triacetate, iron oxide yellow (E172).
What Ondansetron looks like and contents
of the pack
Ondansetron tablets are yellow, oval shaped,
film-coated tablets, plain on both sides.
Ondansetron tablets are packed in
PVC/PVDC//Aluminium blisters.
Pack sizes for 4 mg:
Blisters containing 2, 4, 6, 10, 15, 30, 50 and
100 film-coated tablets.
Unit dose blisters containing 10, 30 and 50
film-coated tablets.
Pack sizes for 8 mg:
Blisters containing 2, 4, 6, 10, 15, 30, 50 and
100 film-coated tablets.
Unit dose blisters containing 10, 30 and 50
film-coated tablets.
Hospital pack containing 20 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Rare (may affect up to 1 in 1,000 people):
• dizziness or light-headedness
• blurred vision
• disturbance in heart rhythm (sometimes
causing a sudden loss of consciousness)

Manufacturer
Salutas Pharma GmbH, Dieselstrasse 5, 70839
Gerlingen, Germany or Lek Pharmaceuticals
d.d., Verovśkova 57, 1526 Ljubljana, Slovenia
or Sandoz GmbH, Biochemiestrasse 10, A-6250
Kundl, Austria or Salutas Pharma GmbH, Ottovon-Guericke-Allee 1, 39179 Barleben, Germany
or S.C. Sandoz, S.R.L., Str. Livezeni nr 7A,
540472, Targu Mures, Jud. Mures, Romania.

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

This leaflet was last revised in 12/2015

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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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