Patient leaflet - ONDANSETRON 8 MG ORODISPERSIBLE TABLETS
What you need to know before you take Ondansetron Orodispersible Tablets
Do not take Ondansetron Orodispersible Tablets:
if you are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6)
if you are taking apomorphine (used to treat Parkinson's disease).
Ondansetron Orodispersible Tablets contain sorbitol, aspartame and sulphur dioxide (E220), sodium and glucose Ondansetron 4 mg Orodispersible Tablets contain up to 8.44 mg sorbitol in each tablet. Ondansetron 8 mg Orodispersible Tablets contain up to 16.88 mg sorbitol in each tablet.
If you are not sure, talk to your doctor, pharmacist or nurse before taking Ondansetron Orodispersible Tablets.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Ondansetron Orodispersible Tablets:
Ondansetron 4 mg Orodispersible Tablets contain 0.88 mg aspartame in each tablet. Ondansetron 8 mg Orodispersible Tablets contain 1.76 mg aspartame in each tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
If
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 have a blockage in your gut
if you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium
if you have had an operation to remove both the adenoids and tonsils
(adenotonsillar surgery).
you are not sure if any of the above
Ondansetron 4 mg and 8 mg Orodispersible Tablets contain small amounts of sulphur dioxide that may rarely cause severe hypersensitivity reactions and bronchospasm.
Ondansetron 4mg and 8mg Orodispersible Tablets contain less than 1mmol sodium (23mg) per tablet, that is to say essentially ‚sodium-free‘.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
applies to you, talk to your doctor, pharmacist or nurse before taking Ondansetron Tablets.
3. How to take Ondansetron Orodispersible Tablets
Other medicines and Ondansetron Orodispersible Tablets
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines that you can buy without prescription and herbal medicines. This is because Ondansetron Orodispersible Tablets can affect the way some medicines work, and some medicines can affect the way Ondansetron Orodispersible Tablets work.
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 you have been prescribed will depend on the treatment you are having.
Place the tablet on top of your tongue, where it will disperse within seconds, and then swallow.
To prevent nausea and vomiting from chemotherapy or radiotherapy
In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines:
! carbamazepine or phenytoin used to treat epilepsy
On the day of chemotherapy or radiotherapy ! the usual adult dose is 8mg taken one or two hours before treatment and another 8mg twelve hours after.
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.
If you forget to take Ondansetron Orodispersible Tablets
If you miss a dose and feel sick or vomit:
! do not take a double dose to make up for a forgotten dose
! take a dose as soon as possible, then
! take your next tablet at the usual time (as
shown on the label).
If you miss a dose but do not feel sick:
! Do not take a double dose to make up for a forgotten dose.
! take the next dose as shown on the label If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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 this medicine 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 Orodispersible 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.
Rare (may affect up to 1 in 1,000 people)
! feeling dizzy or light headed
! blurred vision
! disturbance in heart rhythm (sometimes causing a sudden loss of consciousness).
! poor vision or temporary loss of eyesight, which usually comes back within 20 minutes.
Reporting of side effect
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 Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. 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.
! Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
! Store Ondansetron Orodispersible Tablets in the original blister to protect from light and moisture.
! Ondansetron Orodispersible Tablets should only be taken out of the blister immediately before taking them.
! 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 Orodispersible Tablets contains
! The active substance is ondansetron.
Each tablet contains either 4mg or 8mg ondanestron.
! The other ingredients are mannitol, sorbitol (see section 2), crospovidone, colloidal silicon dioxide, microcrystalline cellulose, aspartame (see section 2), strawberry flavouring (contains glucose and sulphur dioxide (E220) (see section 2)), sodium stearyl fumarate, magnesium stearate.
What Ondansetron Orodispersible Tablets looks like and contents of the pack
Ondansetron 4 mg Orodispersible Tablets are white, flat, round, 7 mm, bevel-edged tablets.
Ondansetron 8 mg Orodispersible Tablets are white, flat, round, 10 mm, bevel-edged tablets.
Ondansetron Orodispersible Tablets come in pack sizes of 2, 4 and 10 tablets. Not all pack sizes may be marketed.
Marketing Authoristaion Holder
Healthcare Pharma Limited
Longdene House
Hedgehog Lane Haslemere
Surrey
GU27 2PH
United Kingdom
Manufacturer
SOFARIMEX Industria Quimica e Farmaceutica, Lda.
Av. das Industrias- Alto de Colaride 2735–213 – CACEM- PORTUGAL
This leaflet was last revised in February 2021.
Very rare (may affect up to 1 in 10,000 people) ______________