Ondansetron 8mg Film-Coated Tablet.
Package leaflet: Information for the patient ONDANSETRON 4mg & 8mg FILM-COATED TABLETS
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, 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 tablets are and what they are used for
2. What you need to know before you take Ondansetron tablets
3. How to take Ondansetron tablets
4. Possible side effects
5. How to store Ondansetron tablets
6. Contents of the pack and other information
1. What Ondansetron tablets are and what they are used for
Ondansetron belongs to a group of medicines called anti-emetics.
Ondansetron tablets are used for:
1. preventing nausea and vomiting caused by chemotherapy (in adults and children) or radiotherapy for cancer (adults only)
2. preventing nausea and vomiting after surgery (adults only).
Ask your doctor or pharmacist if you need additional information.
2. What you need to know before you take Ondansetron tablets Do not take Ondansetron tablets:
• If you are allergic to ondansetron or any of the other ingredients in this medicine (listed in section 6)
• If you are taking apomorphine (used to treat Parkinson's disease).
If you are unsure, talk to your doctor or pharmacist before taking this tablet.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Ondansetron tablets
• If you been told that you have a blockage in your gut or you suffer from severe constipation
• If you have ever had heart problems (e.g. congestive heart failure which causes shortness of breath and swollen ankles)
• If you have a problem of uneven heart beat (arrhythmias)
• If you have liver problems
• If you are suffering with severe electrolyte disturbance (imbalance in the level of sodium, potassium and/or calcium).
• If you are allergic to medicines similar to ondansetron such as granisetron or palonosetron
• If you have undergone surgery of the tonsils.
Other medicines and Ondansetron tablets
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.
In particular, tell your doctor, nurse or pharmacist if you are taking any of the following medicines:
• Carbamazepine or phenytoin used to treat epilepsy
• Rifampicin used to treat infections such as tuberculosis (TB)
• Anti-arrhythmic medicines used to treat an uneven heart beat
• Beta-blocker medicines used to treat certain heart or eye problems, anxiety or prevent migraines
• Tramadol, a pain killer
• Cancer medicines (especially anthracyclines)
• Antibiotics such as erythromycin or ketoconazole
• Medicines that affect the heart (such as haloperidol or methadone)
• SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
• SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine.
If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before taking Ondansetron tablets.
Pregnancy, breast-feeding and fertility
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
It is not known if Ondansetron is safe during pregnancy.
Talk to your doctor before taking Ondansetron tablets if you are pregnant or might become pregnant.
Breast-feeding
Ondansetron may pass into the mother’s milk. It is better therefore that mothers taking these tablets do not breast-feed.
Driving and using machines
Ondansetron tablets are not known to cause any effect on the ability to drive or use machines. Ondansetron tablets contain Lactose:
Ondansetron tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, speak to your doctor before taking this medicine.
3. How to take Ondansetron 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.
Swallow each tablet whole with a little water.
For patients receiving chemotherapy and/or radiotherapy that causes nausea and vomiting:
The recommended dose is 8 mg, 1 to 2 hours before chemotherapy followed by 8 mg 12 hours later for a maximum of 5 days.
After the first 24 hours following chemotherapy, ondansetron tablets can be given to prevent nausea and vomiting. The recommended adult dose is 8 mg twice a day, which can be given for up to 5 days.
To prevent nausea and vomiting after an operation: The recommended adult dose is 16 mg one hour before the operation.
Use in children and adolescents
The recommended dose for children aged over 6 months and adolescents is up to 4 mg twice a day, which can be given for up to 5 days, following chemotherapy.
Children aged over 1 month and adolescents: It is recommended that ondansetron is given as an injection.
Patients with moderate or severe liver disease: the total daily dose should not be more than 8 mg.
• Your doctor will tell you how long to take ondansetron tablets. Do not stop taking the tablets early
• If you have the impression that the effect of ondansetron tablets is too strong or too weak, talk to your doctor or pharmacist
• If you see another doctor or go into hospital, tell the doctor or hospital staff that you are taking ondansetron tablets.
If you forget to take Ondansetron tablets
If you miss a dose and feel sick or vomit, take a tablet as soon as possible and then carry on as before. If you miss a dose but do not feel sick take the next dose at the usual time.
Do not take a double dose to make up for a forgotten tablet.
If you take more Ondansetron tablets than you should
If you or your child take more Ondansetron tablets than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
After starting to take your tablets:
Ondansetron tablets should start to work within one or two hours of taking a dose. If you vomit within one hour of taking a dose then take the same dose again, otherwise do not take more tablets or take them more often than the label says. If you continue to feel sick then tell your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects
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 melt 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)
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. 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 Yellow Card Scheme at: 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 tablets
Keep this medicine out of the sight and reach of children. Do not store above 25°C. Store in the original packaging. Do not use this medicine after the expiry date which is stated on the blister pack or carton. The expiry date refers to the last day of that month.
If your doctor stops your treatment, do not keep any leftover tablets unless your doctor tells you to.
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 tablets contain
The active substance is ondansetron as ondansetron hydrochloride dihydrate. Ondansetron tablets are available in two strengths, containing either 4mg or 8 mg ondansetron as ondansetron hydrochloride dihydrate.
The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, magnesium stearate, hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172).
What Ondansetron tablets look like and contents of the pack
Ondansetron 4mg tablet is a film coated, yellow-pale brown, oval tablet marked FW631. Ondansetron 8mg tablet is a film coated, yellow-pale brown, oval tablet marked FW641. Packaging: The tablets are available in blister packs of 15, 30 or 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Mercury Pharmaceuticals Ltd, No.1 Croydon,
12-16 Addiscombe Road, Croydon CR0 0XT, UK.
This leaflet was last revised in January 2016.