Ondansetron 8mg Film Coated Tablets
Out of date information, search anotherRead all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.
In this leaflet:
1. What Ondansetron Tablets are and what they are used for
2. Before you take Ondansetron Tablets
3. How to take Ondansetron Tablets
4. Possible side effects
5. How to store Ondansetron Tablets
6. Further information
m' What Ondansetron tablets are and what they are used for
Ondansetron belongs to a group of medicines known as ‘antiemetics and antinauseants'. These prevent feelings of sickness (nausea) or being sick (vomiting) that may occur after certain medical or surgical treatments.
Your doctor or nurse may give you Ondansetron Tablets to prevent you from or to treat you for feeling or being sick when you:
• are on chemotherapy and radiotherapy that can cause nausea and vomiting.
• undergo surgical treatment.
Before you take Ondansetron tablets
Please take the time to read the following information carefully as this may stop you from being able to take Ondansetron Tablets.
Do not take Ondansetron Tablets if you are
• allergic (hypersensitive) to ondansetron or any of the other ingredients of Ondansetron Tablets.
Take special care with Ondansetron Tablets
Before you take Ondansetron Tablets you should tell your doctor if you:
• have ever been allergic (hypersensitive) to similar medicines known as 5HT3 receptor antagonists
• have liver diseases
• are suffering from severe constipation or have a blockage in your gut
• have had surgery on your gut
• have had surgery on your adenoids or tonsils
• have had heart problems, including an uneven heart beat (arrhythmias).
If any of the above apply to you, talk to your doctor who will decide what to do.
Taking other medicines
You should tell your doctor if you are taking or have taken any of the following medicines as they may interact with Ondansetron Tablets:
• Tramadol. The effect of pain relief from Tramadol may be reduced whilst you are taking Ondansetron Tablets.
• Phenytoin and carbamazepine (usually used to treat epilepsy)
• Rifampicin (a type of antibiotic, often used for the treatment of tuberculosis)
• Medicines that affect the heart (such as haloperidol or methadone)
• Medicines used to treat an uneven heart beat (anti-arrhythmics)
• Beta-blocking medicines (used to treat heart problems, eye problems, anxiety or for prevention of migranes)
• Cancer medicines (especially anthracyclines). Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
You should not take Ondansetron Tablets if you are pregnant or there is a chance you may be pregnant. Ondansetron may pass into mothers' milk, therefore breast-feeding is not recommended in mothers taking Ondansetron Tablets
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Ondansetron Tablets should not affect your ability to drive or use machinery.
Important information about some of the ingredients of Ondansetron Tablets
Ondansetron Tablets contain lactose monohydrate, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
^2 How to take Ondansetron tablets
Always take Ondansetron Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Ondansetron Tablets should be swallowed whole with a little water.
Ondansetron Tablets should start to work within 1 to 2 hours of taking a dose. If you are sick within 1 hour of taking Ondansetron Tablets you should talk to your doctor who will tell you what you should do. If you continue to feel or be sick whilst taking the tablets, tell your doctor.
For patients receiving chemotherapy and/or radiotherapy that causes nausea or vomiting Adults (including the elderly)
The usual dose is 8mg 1-2 hours before you are treated with chemotherapy or radiotherapy, followed by 8mg 12 hours later.
After the first 24 hours following chemotherapy, Ondansetron Tablets can be given to prevent further nausea or vomiting. The usual dose for oral administration is 8 mg twice daily, which can be given for up to 5 days.
Children (aged 2 years to 18 years)
Your doctor will decide on a suitable dose based on body surface area. The usual doses for children are 4mg three times daily, or 8mg three times daily for up to 5 days, after chemotherapy
To prevent nausea and vomiting after an operation Adults
The usual dose is 16mg taken one hour before the operation or 8mg taken one hour before the operation followed by two further doses of 8mg at eight hourly intervals.
Children (aged 2 years or over)
Ondansetron Tablets are not suitable for use in children following abdominal surgery.
A slow intravenous injection is recommended.
Patients with liver disease
In patients with moderate or severe liver problems a total daily dose of 8mg should not be exceeded.
If you take more Ondansetron Tablets than you should
It is important to stick to the dose on the label of your medicine. Taking more than this could make you ill. If you or someone else swallows several of these tablets all together, contact your doctor, pharmacist or hospital emergency department immediately. Always take any tablets left over with you and also the box, as this will allow easier identification of the tablets.
If you forget to take Ondansetron Tablets
If you forget to take a dose and do not feel sick take the next day's tablet at the usual time. If you forget to take a dose, and feel sick or are sick, take a tablet as soon as possible. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Ondansetron Tablets can cause side effects, although not everybody gets them.
If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:
• An allergic reaction causing swelling of the face, lips, tongue or throat, difficulty in breathing or swallowing, skin rash
• Collapse
Other side effects include:
Very common (affects more than 1 in 10 people)
• Headache
Common (affects less than 1 in 10 people)
• A feeling of warmth or flushing
• Constipation
• Changes to liver function test results (if you take Ondansetron tablets with a medicine called cisplatin, otherwise this side effect is uncommon).
Uncommon (affects less than 1 in 100 people)
• Hiccups
• Low blood pressure, which can make you feel faint or dizzy
• Uneven heart beat or chest pain
• Fits
• Unusual body movement or shaking
Rare (affects less than 1 in 1000 people)
• Feeling dizzy or lightheaded
• Blurred vision
Very rare (affects less than 1 in 10000 people)
• Poor vision or temporary loss of eyesight, which usually comes back within 20 minutes.
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.
^2 How to store Ondansetron tablets
Keep out of the reach and sight of children.
Do not use Ondansetron Tablets 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 store above 30°C. Store your tablets in the original package in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further information
What Ondansetron Tablets contain
• The active substance is ondansetron (as hydrochloride dihydrate). Each tablet contains 4mg or 8mg of ondansetron.
• The other ingredients are microcrystalline cellulose, lactose monohydrate, maize starch, magnesium stearate. The ingredients of the film-coating on the tablets are lactose monohydrate, hypromellose, titanium dioxide E171, macrogol and sodium citrate dihydrate E331.
What Ondansetron Tablets look like and contents of the pack
Ondasetron Tablets are white to off-white, round biconvex film-coated tablets with PA engraved on one side and 933 (4mg tablets) or 934 (8mg tablets) on the other side.
Ondansetron Tablets are available in blister packs containing 6, 10, 15 or 30 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
PLIVA Pharma Ltd., Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom.
Manufacturer
Teva Operations Poland Sp. z.o.o., Ul.Mogilska 80, 31-456 Krakow, Poland.
This leaflet was last revised in July 2011
PL 10622/0100 PL 10622/0101
87335-C (^)PLIVA