Package leaflet: Information for the user
Ondansetron Orifarm 4 mg orodispersible tablet
Ondansetron Orifarm 8 mg orodispersible tablet
Ondansetron
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
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Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, 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, 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 Orifarm is and what it is used for
2.
What you need to know before you take Ondansetron Orifarm
3.
How to take Ondansetron Orifarm
4.
Possible side effects
5.
How to store Ondansetron Orifarm
6.
Contents of the pack and other information
1.
What Ondansetron Orifarm is and what it is used for
Ondansetron Orifarm belongs to a group of medicinal products called anti emetics. Ondansetron inhibits the
effect of the neuro- transmittor 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.
An orodispersible tablet is a special type of tablet which dissolves very quickly when placed on top of the
tongue.
2.
What you need to know before you take Ondansetron Orifarm
Do not take Ondansetron Orifarm
if you are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6).
if you are using apomorphine (used in the treatment of Parkinson's disease)
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Ondansetron Orifarm:
if you have stricture of intestines or constipation, because you will need special surveillance by your
doctor.
if you are hypersensitive to other medicinal products belonging to the group of selective serotonin (5HT3)-receptor antagonists (e.g. granisetron, dolasetron). It is, in such case, possible that you are also
allergic to ondansetron.
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if you are going to have or recently have had your tonsils removed, because treatment with
Ondansetron Orifarm may hide symptoms of internal bleeding.
if you are heart patient (with arrythmias or conduction disorders) and are being treated with other
medication such as anesthetics, anti-arrythmics or beta-blockers at the same time, because of the
limited experience hereby.
if you have liver impairment.
Always inform the laboratory during tests of blood and urine that you are being treated with Ondansetron
Orifarm.
Other medicines and Ondansetron Orifarm
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is important to inform your doctor if you are being treated with:
 epilepsy medicine (phenytoin, carbamazepine)
 antibiotics (rifampicin, erythromycin, ketoconazole)
 pain-relieving medicine (tramadol)
 medicines used to treat heart problems such as abnormal heart beats (amiodarone) and high blood
pressure (atenolol, timolol)
 other medicines that, like Ondansetron Orifarm, affect the neuro-transmittor serotonin in the brain
for example medicines used to treat depresssion
 cancer medicine (doxorubicin, daunorubicin, trastuzimab)
Contact your doctor. It may be necessary to adjust the dose.
Ondansetron Orifarm with food and drink
Ondansetron Orifarm can be taken independently of meals.
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:
There is only limited experience with the use of Ondansetron Orifarm during pregnancy. If you are pregnant,
you should use Ondansetron Orifarm only if your doctor has told you to.
Breast-feeding:
You should not breast-feed your infant whilst taking Ondansetron Orifarm.
Driving and using machines
Ondansetron Orifarm has no or negligible influence on the ability to drive and use machines.
Ondansetron Orifarm contains aspartame and sorbitol
This medicine contains aspartame, a source of phenylalanine. May be harmful for people with
phenylketonuria.
This medicine contains sorbitol. If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medical product.
3.
How to take Ondansetron Orifarm
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Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure. The dose is always determined by your doctor who is adjusting the dose for
you so you will achieve optimal effect.
If you feel that the effect of Ondansetron Orifarm is too strong or too weak you should tell your doctor or
pharmacist.
Treatment and prevention of nausea and vomiting in connection with chemotherapy or radiotherapy
Adults and elderly:
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.
Use in Children (aged ≥ 6 month) and adolescents under the age of 18 years:
The dose is individual and depends on the size/surface of the child. Ondansetron Orifarm should not be used
for children with a total body surface of less than 0.6 m2.
Treatment and prevention of post-operative nausea and vomiting.
Adults
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.
Use in Children (aged ≥1 month) and adolescents under the age of 18 years:
No data available on prevention or treatment of post-operative nausea and vomiting.
Elderly:
There is limited experience with the use of ondansetron to elderly patients in prevention of post-operative nausea
and vomiting. Ondansetron is however tolerated well by patients above 65 years in chemotherapy (please refer to
sections above).
Insufficient function of the liver:
The daily dose should not exceed 8 mg if you have moderately to severely decreased function of the liver.
To remove the Ondansetron Orifarm unit:
Do not remove Ondansetron Orifarm from its blister or pierce the foil until you are ready to take it.
Important: Do not try to push Ondansetron Orifarm through the foil top, like a usual tablet, as the
Ondansetron Orifarm is fragile and will break.
Follow these instructions carefully:
1. Tear along perforations of the foil to separate off one unit.
2. Peel back the tab, to lift the foil top off of one blister.
3. Gently push the Ondansetron Orifarm out of the foil.
4. Place the Ondansetron Orifarm on top of the tongue. It will disperse very quickly, then swallow with or
without water.
If you take more Ondansetron Orifarm than you should
Contact your doctor, emergency room or pharmacist if you have taken more Ondansetron Orifarm than
stated in this leaflet or if a child accidentally has ingested the medicine.
The symptoms of overdose are disturbances of vision, severe constipation, low blood pressure and
disturbances in heart beat rhythm.
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If you forget to take Ondansetron Orifarm
Do not take a double dose to make up for a forgotten dose.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following allergic reactions happen, stop taking Ondansetron Orifarm and tell your doctor
immediately or go to the casualty department of the nearest hospital:
 Severe itching of the skin, rash.
 Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulties in
swallowing or breathing.
 Collapse.
Very common (may affect more than 1in 10 people):
Headache.
Common (may affect up to1 in 10 people):
A sensation of reddening and warmth. Constipation.
Uncommon (may affect up to 1 in 100 people):
Seizures. Hiccups. Low blood pressure, irregular heart beats, heart pain and slow pulse. Involuntary
movements. Involuntary eye movements. Changes in liver function.
Rare (may affect up to 1 in 1.000 people):
Nettle rash (urticaria). Dizziness, transient blurred vision predominantly during intravenous administration.
Severe allergic reactions, including swollen tongue, throat, trouble with breathing and anaphylactic shock
collapse. Serious heart rhythm disturbances with rapid, irregular pulse (sometimes causes a sudden loss of
consciousness).
Very rare (may affect up to 1in 10.000 people):
Transient blindness predominantly during intravenous administration. Most of these blindness cases were
resolved within 20 minutes.
Not known (frequency cannot be estimated from the available data):
Toxic epidermal necrolysis, which is a potentially serious skin condition with blistering and shedding of the
skin.
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 national reporting system listed in
Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
5.
How to store Ondansetron Orifarm
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the foil or carton after EXP. The expiry date
refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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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 Orifarm contains
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The active substance is ondansetron 4 mg or 8 mg.
The other ingredients are: mannitol (E421), sorbitol (E420), crospovidone, colloidal hydrated silica,
microcrystalline cellulose, aspartame (E951), sodium stearyl fumarate, magnesium stearate, strawberry
flavouring.
What Ondansetron Orifarm looks like and contents of the pack
4 mg: White, flat, round 7 mm orodispersible tablet.
8 mg: White, flat, round 10 mm orodispersible tablet.
Blister : 6, 7, 10, 14, 28, 30 tablets.
Unit-dose blister : 6x1, 7x1, 10x1, 14x1, 28x1, 30x1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
[To be completed nationally]
This medicinal product is authorised in the Member States of the EEA under the following names:
Denmark
Ondansetron Orifarm
Sweden
Ondansetron Orifarm
This leaflet was last revised in 2014-10-31
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