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ONDANSETRON 4 MG ORODISPERSIBLE TABLETS

Active substance(s): ONDANSETRON

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150 mm

United Kingdom

Package leaflet: Information for the user
Ondansetron 4 mg orodispersible tablets
Ondansetron 8 mg orodispersible 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.

Ondansetron orodispersible tablets contain
glucose and sorbitol. If you have been told
by your doctor that you have intolerance to
some sugars, contact your doctor before
taking this medicinal product.
Ondansetron orodispersible tablets contain
sulphur dioxide which may rarely cause
severe hypersensitivity reactions and
bronchospasm.
3. How to take Ondansetron orodispersible
tablets
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.

What is in this leaflet:
1. What Ondansetron orodispersible tablets
is and what it is used for
2. What you need to know before you take
Ondansetron orodispersible tablets
3. How to take Ondansetron orodispersible
tablets
4. Possible side effects
5. How to store Ondansetron orodispersible
tablets
6. Contents of the pack and other information
1. What Ondansetron orodispersible tablets
are and what it is used for
Ondansetron orodispersible tablet is a fast
dissolving tablet when placed on top of the
tongue. Ondansetron orodispersible tablets
contains ondansetron which belongs to a
group of medicines that stop you feeling
sick or being sick, so called anti-emetics.
Ondansetron orodispersible tablets may:
 stop the effects of nausea and vomiting
caused by cytotoxic chemotherapy in
children and adults
 prevent post-operative nausea and
vomiting in children and adults
 stop the effects of nausea and vomiting
caused by radiotherapy in adults

520 mm

If you are not sure why they have been
prescribed for you, ask your doctor.
2. What you need to know before you take
before you take Ondansetron
orodispersible tablets
Do not take Ondansetron orodispersible
tablets
If you are allergicto ondansetron, or any of
the other ingredients of this medicine (listed
in section 6).
You are taking apomorphine (used to treat
Parkinson’s disease).
Warnings and precautions
Talk to your doctor or pharmacist or nurse
before taking Ondansetron orodispersible
tablets
- If you are pregnant or likey to become
pregnant soon.
- If you are breast-feeding.
- If you have liver disease.
- If you have a blockage in your gut or if
you suffer from severe constipation
- If you have been told by your doctor
that you have an intolerance to some
sugars, contact your doctor before
taking this medicinal product
- If you have phenylketonuria because
Ondansetron orodispersible tablets
contain a source of phenylalanine. May
be harmful for people with
phenylketonuria.
- If it is children below the age of 2 years
or with a body surface of less than 0.6 m2.
Other medicines and Ondansetron
orodispersible tablets
Tell your Doctor or pharmacist if you are
taking or have recently taken any other
medicines like phenytoin, carbamazepine,
rifampicin, tramadol and including
medicines obtained without a prescription.
Pregnancy and breast-feeding
Pregnancy
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.
Breast-feeding
Ondansetron probably passes into the
mother’s milk. Therefore it is recommended
that mothers taking Ondansetron
orodispersible tablets do not breast-feed.
Driving and using machines
Ondansetron orodispersible tablets has no
influence on the ability to drive and use
machines.
Important information about some of
the ingredients of Ondansetron
orodispersible tablets
Ondansetron orodispersible tablets contain
aspartame, a source of phenylalanine. This
may be harmful for people with
phenylketonuria.

After starting to take your medicine
Ondansetron orodispersible tablets should
start to work within one or two hours of
taking a dose. If you are sick within one
hour of taking a dose, then take the same
dose again – otherwise do not take more
Ondansetron orodispersible tablets than
the label says. If you continue to feel sick
then tell your doctor.
Treatment and prevention of nausea and
vomiting in connection with chemotherapy
or radiotherapy
Adults:
8 mg 1 to 2 hours before chemotherapy or
radiotherapy followed by 8 mg 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.
Use in Children (age 2 years and up) and
adolescents under the age of 18 years:
The dose is individual and depends on the
size/surface of the child. Ondansetron
Bluefish should not be used for children
with a total body surface of less than 0.6 m2.
Children aged over 6 months and
adolescents
• The usual dose for a child is up to 4 mg
twice a day
• This can be given up to 5 days
Treatment and prevention of
operative nausea and vomiting

post-

Adults, prevention and treatment:
16 mg one hour prior to anesthesia or
alternatively, 8 mg administered one hour
prior to anesthesia followed by an
additional 8 mg after 8 and 16 hours. Your
doctor may choose to give you the medicine
as injections.
Elderly, prevention and treatment:
There is limited experience with the use of
ondansetron to elderly patients.
Ondansetron is however tolerated well by
patients above 65 years in chemotherapy
(please refer to section above).
Patients with moderate or severe liver
disease: the total daily dose should not be
more than 8 mg.
Patients with poor sparteine/debrisoquine
metabolism: No alteration of daily dosage
or frequency of dosing is required. Do not
remove Ondansetron orodispersible tablets
from its blister or pierce the foil until you
are ready to take it.
The tablet(s) must be taken as follows:
In order to prevent the breakage of tablets,
it is important not to push the tablet out of
its recess (Figure A).
The tablets in each strip are separated from
each other by perforations. Detach one tablet
recess along the perforation (Figure 1). The
covering foil should be removed carefully.
Start with the corner that is marked with an
arrow (Figures 2 and 3).
The tablet must be taken from the
container with dry hands and placed on the
tongue (Figure 4). The tablet will
disintegrate, after which it can be
swallowed with water.
Figure A.

Figure 1.

Figure 3.

Figure 2.

Figure 4.

If you take more Ondansetron
orodispersible tablets than you should
If you or your child take more Ondansetron
orodispersible tablets than you should, talk
to a doctor or go to a hospital straight away.
Take the medicine pack with you.

150 mm

If you forget to take Ondansetron
orodispersible tablets
Do not take a double dose to make up for a
forgotten dose.
If you miss a dose and feel sick or vomit,
take an Ondansetron orodispersible tablet
as soon as possibe and then carry on as
before.
If you miss a dose but do not feel sick take
the next dose as on the label.
4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Some side effects are more likely to occur
than others. The possible side effects of
ondansetron are listed below and can be
divided as:
- Very common (affecting not more than
1 in 10 persons)
- Common (affecting less than 1 in 10,
but more than 1 in 100 persons)
- Uncommon (affecting less than 1 in
100, but more than 1 in 1,000 persons)
- Rare (affecting less than 1 in 1,000
persons, but more than 1 in 10,000
persons)
- Very rare (affecting less than 1 in 10,000
persons, including isolated reports)
A few people can be allergic to some
medicines; if any of the following side
effects come on soon after taking
Ondansetron orodispersible
tablets,
stop taking them and tell your doctor
immediately:





Sudden wheeziness and chest pain or
chest tightness
Swelling of eyelids, face, lips, mouth
or tongue
Skin rah - red spots or hives (skin
lumps) anywhere on the body
Collapse

Very common (affecting not more than 1 in
10 persons)
- Headache.

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Common (affecting less than 1 in 10, but
more than 1 in 100 persons)
- Constipation.
- Sensation of warmth or flushing.
Uncommon (affecting less than 1 in 100,
but more than 1 in 1,000 persons)
- Arrhythmias, chest pain with or without
ST segment depression, bradycardia.
- Asymptomatic increases in liver
function tests.
- Seizures, movement disorders including
extrapyramidal reactions such as
dystonic reactions, oculogyric crisis and
dyskinesia have been observed without
definitive evidence of persistent clinical
sequelae.
- Hiccups.
- Hypotension.
Rare (affecting less than 1 in 1,000
persons, but more than 1 in 10,000 persons)
- Immediate hypersensitivity reactions
sometimes
severe,
including
anaphylaxis.
- Dizziness during i.v. administration,
which in most cases is prevented or
resolved by lengthening the infusion
period.
- Transient visual disturbances (eg. blurred
vision) during i.v. administration.
Very rare (affecting less than 1 in 10,000
persons, including isolated reports):
Transient blindness predominantly during
intravenous administration
The majority of the blindness cases
reported resolved within 20 minutes. Most
patients had received chemotherapeutic
agents, which included cisplatin. Some
cases of transient blindness were reported
as cortical in origin.
Strawberry flavour contains sulphur
dioxide (E220) which may rarely cause
severe hypersensitivity reactions and
bronchospasm.
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.
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. You can also report side effects
directly via Yellow Card Scheme Website:
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 orodispersible
tablets
Keep this medicine out of the sight and
reach of children.
Store in the original package in order to
protect from light.
Store below 30°C.

Do not use this medicine after the expiry
date which is stated on the carton or foil
after EXP. The expiry date refers to the last
day of that month.
Do not use this medicine if you notice
signs of deterioration, such as
discolouration or broken tablets, are
observed.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away dispose of
medicines no longer required. These
measures will help to protect the
environment.
6. Contents of the pack and further
information
What Ondansetron orodispersible
tablets contains
The active substance is ondansetron. Each
orodispersible tablet contains 4 mg or 8 mg
ondansetron.
The other ingredients are: Aspartame
(E951), Crospovidone type B, Magnesium
stearate (E572), Microcrystalline cellulose
(E460), Pharmaburst TM C1, containing
mannitol (E421), sorbitol (E420),
crospovidone (type A) and colloidal
silicon dioxide); Strawberrry flavouring,
(containing dextrose, maltodextrin, gum
araibc E414 2.3% and sulphur dioxide
E220); Sodium stearyl fumarate.
What Ondansetron orodispersible
tablets looks like and contents of the
pack
Orodispersible tablets.
Ondansetron 4 mg and 8 mg orodispersible
tablets
White, flat, round, bevel-edged tablet.
Ondansetron orodispersible tablets is
provided in packs of 6x1, 10x1, 14x1,
20x1, 30x1, 50x1, 60x1, 100x1 tablets in
aluminium/OPA/PVC unit-dose blister
pack.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden
Manufacturer
Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm
Sweden
The package leaflet for the blind and
partially sighted in other formats is made
available on request.
This medicinal product is authorized in
the Member States of the EEA under the
following names:
Name of the Name of the medicinal
Member
product
State
Denmark
Ondansetron Bluefish
4 mg/8 mg smeltetabletter
Finland
Ondansetron Bluefish
4 mg/8 mg tabletti, suussa
hajoava
Ondansetron Bluefish
4 mg/8 mg
munsönderfallande
tabletter
Germany
Ondansetron Bluefish
4 mg/8 mg
schmelztabletten
Netherlands Ondansetron Bluefish
4 mg/8 mg smelttabletten
Norway
Ondansetron Bluefish
4 mg/8 mg smeltetabletter
Poland
Ondansetron Bluefish
Spain
Ondansetron Bluefish
4 mg/8 mg comprimidos
bucodispersibles EFG
Sweden
Ondansetron Bluefish
4 mg/8 mg
munsönderfallande
tabletter
United
Ondansetron 4 mg/8 mg
Kingdom
orodispersible tablets
This leaflet was last revised in 07/2016.

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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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