Ondansetron 8 Mg Film-Coated Tablets
Package leaflet: Information for the user Ondansetron 4 mg and 8 mg Film-coated 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.
- 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 possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Ondansetron Film-coated Tablets are and what they are used for
2. What you need to know before you take Ondansetron Film-coated Tablets
3. How to take Ondansetron Film-coated Tablets
4. Possible side effects
5. How to store Ondansetron Film-coated Tablets
6. Contents of the pack and other information
1. What Ondansetron film-coated tablets are and what they are used for
Ondansetron Film-coated Tablets contain ondansetron which belongs to a group of medicines called anti-emetics.
Some medical and surgical treatments make you feel sick or be sick.
Ondansetron Film-coated Tablets can be prescribed for two reasons:
• to prevent feelings of nausea (feeling sick) and vomiting (being sick)
• to treat nausea and vomiting
2. What you need to know before you take Ondansetron film-coated tablets
Do not take Ondansetron Film-coated 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)
- if you have ever had any allergic (hypersensitive) reaction with other anti-emetics (for example granisetron or dolasetron)
Warnings and precautions
Talk to your doctor or pharmacist before taking Ondansetron Film-coated Tablets,
- if you have ever had a heart problem
- if you have an uneven heart beat (arrhythmias)
- if your liver is not working as well as it should do
- if you have a blockage in your gut or if you suffer from severe constipation
- if you are due to have a surgery to the adenoids or tonsils
- if you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium
Other medicines and Ondansetron Film-coated Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Ondansetron Film-coated Tablets if you are taking apomorphine (used to treat Parkinson's disease)
It is particularly important to tell your doctor if you are taking, or are about to start treatment with any of the following medicines as the dose may need to be adjusted:
- Carbamazepine or phenytoin (used to treat epilepsy)
- Some antibiotic and antifungal medicines (e.g. rifampicin, erythromycin or ketoconazole)
- Tramadol (a pain killer)
- Beta-blocker medicines used to treat certain heart or eye problems, anxiety or prevent migraines (e.g. atenolol or timolol)
- Anti-arrhythmic medicines used to treat an uneven heart beat (e.g. amiodarone)
- Drugs which may result in QT prolongation (heart rhythm disorder)
- Medicines that may cause heart damage (e.g. trastuzimab, or anthracyclines such as doxorubicin and daunorubicin)
- Medicines used to treat depression and/or anxiety e.g. SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin noradrenaline reuptake inhibitors)
Children and adolescents
If children or adolescents receive ondansetron together with drugs that may have a harmful effect on the liver, careful monitoring of the liver function is recommended.
Ondansetron Film-coated Tablets with food and drink
Do not eat when you experience sickness after surgery.
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:
It is not recommended that Ondansetron Film-coated Tablets be taken during pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding:
If you are taking Ondansetron Film-coated Tablets you should not breast-feed your baby.
Driving and using machines
Ondansetron Film-coated Tablets is unlikely to affect your ability to drive or operate machinery.
Ondansetron Film-coated Tablets contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Ondansetron film-coated tablets
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 glass of water.
Tablets are available containing either 4 mg or 8 mg of Ondansetron.
Adults (including the elderly)
For patients receiving chemotherapy and/or radiotherapy that cause nausea and vomiting
The recommended dose is 8 mg 1 or 2 hours before chemotherapy or radiotherapy followed by 8 mg 12 hours later.
After the first 24 hours following chemotherapy or radiotherapy, Ondansetron Film-coated Tablets can be given to prevent nausea and vomiting. The usual 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 usual adult dose is 16 mg one hour before the operation, or 8 mg one hour before the operation followed by two further doses of 8 mg at eight hourly intervals.
Ondansetron Film-coated Tablets should start to work within one or two hours of taking a dose. If you vomit within one hour then take the same dose again - otherwise do not take more tablets but take your next dose at the right time. If you continue to feel sick then tell your doctor.
If your sickness does not get better while taking Ondansetron Film-coated Tablets then tell your doctor.
Children and adolescents
For patients receiving chemotherapy and/or radiotherapy that cause nausea and vomiting Children (aged 6 months and over) and adolescents (under 18 years old)
Your doctor will decide what dose of ondansetron should be given. This will depend on the age and size or body weight of the child.
To prevent nausea and vomiting after an operation
Children (aged 1 month and over) and adolescents (under 18 years old):
It is recommended to give ondansetron as an injection.
Patients with moderate or severe liver problems
The total daily dose should not be more than 8 mg.
If you take more Ondansetron Film-coated Tablets than you should
DO NOT take more Ondansetron Film-Coated Tablets than recommended on the package label. If you take more Ondansetron Film-Coated Tablets than you should, tell your doctor straight away or telephone your nearest hospital casualty department. You may need to be monitored via ECG.
If an overdose has been taken, symptoms may include problems with vision, severe constipation, low blood pressure (which could cause dizziness or faintness) and palpitations (irregular heart beat).
If you stop taking Ondansetron Film-coated Tablets
Do not stop taking your tablets, even if you are feeling well, without consulting a doctor.
If you forget to take Ondansetron Film-coated Tablets
If you miss a dose, 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 as on the label.
Do not take a double dose to make up for a forgotten dose.
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. Most people taking this medicine find it causes no problems.
Allergic reactions (Rare: may affect up to 1 in 1,000 people):
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, tongue or throat that may cause difficulty in breathing
- 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):
- sensation of flushing and warmth
- constipation
- an increase in liver function tests (common in patients receiving chemotherapy with cisplatin, otherwise this side effect is uncommon)
Uncommon (may affect up to 1 in 100 people):
- involuntary movements of the body, including upward movement of the eyes
- fits (seizures/convulsions)
- palpitations (Irregular heartbeat) or slow heart rate
- chest pain
- low blood pressure
- hiccups
Rare (may affect up to 1 of 1,000 people):
- Visual disturbances e.g. blurred vision (though this has almost always been associated with an ondansetron injection, rather than tablets).
- Dizziness has also been occurred when ondansetron was given through the veins.
Very rare (may affect up to 1 of 10,000 people):
- Temporary loss of vision (however, as with other visual disturbances, such as blurred vision, this has almost always been reported with an ondansetron injection, rather than tablets, and usually chemotherapy containing cisplatin).
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/vellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Ondansetron film-coated tablets
Keep this medicine out of the sight and reach of children. A child may be harmed by medicine prescribed for someone else.
This medicinal product does not require any special storage conditions
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.
Do not use this medicine if you notice any visible signs of deterioration in the tablets.
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 Film-coated Tablets contains
- The active substance is ondansetron (as ondansetron hydrochloride dihydrate)
- The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, magnesium stearate, hypromellose, macrogol, titanium dioxide (E171).
What Ondansetron Film-coated Tablets looks like and contents of the pack
Ondansetron 4 mg film-coated tablets
White coloured, circular, biconvex film-coated tablets debossed with ‘4’ on one side and plain on the other.
Ondansetron 8 mg film-coated tablets
White coloured, circular, biconvex film-coated tablets debossed with ‘8’ on one side and central breakline on the other. The tablets can be divided into two equal doses.
Ondansetron Film-coated tablets are available in blister packs of 2, 4, 6, 9, 10, 15, 30, 50, 100, 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder Actavis Group PTC ehf.
Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland
Manufacturer
Arrow Pharm (Malta) Ltd
HF 62, Hal Far Industrial Estate,
Birzebbugia BBG 3000 Malta
If you have any questions or are not sure about anything, ask your doctor or pharmacist who will advise you.
The information provided applies only to Ondansetron Film-coated Tablets.