Ondansetron 8 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER Ondansetron 4 mg film-coated tablets Ondansetron 8 mg film-coated tablets
Ondansetron (as hydrochloride dihydrate)
This medicinal product is known as Ondansetron 4 mg / 8 mg film-coated tablets but will be known as Ondansetron throughout the leaflet.
Read all of this leaflet carefully before you start using 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 is and what it is used for
2. Before you take Ondansetron
3. How to take Ondansetron
4. Possible side effects
5. How to store Ondansetron
6. Further information
1. WHAT ONDANSETRON IS AND WHAT IT IS USED FOR
This medicine contains ondansetron, which belongs to a group of medicines called anti-emetics.
Ondansetron is used to treat nausea (feeling sick) and vomiting (being sick) caused by some medical treatments, such as chemotherapy or radiotherapy. It is also used to prevent nausea and vomiting in patients following an operation.
2. BEFORE YOU TAKE ONDANSETRON Do not take Ondansetron
• if you are allergic (hypersensitive) to ondansetron or any of the other ingredients of Ondansetron
• if you have ever had any allergic (hypersensitive) reaction with other anti-emetics (for example granisetron or dolasetron)
Take special care with Ondansetron
• if you have a blockage in your gut or suffer from severe constipation
• if you are due to have surgery to the adenoids or tonsils
• if you have a heart problem
• if you have liver problems
If any of the above apply, you should inform your doctor before beginning treatment with Ondansetron.
Using other medicines
Ondansetron may have an effect on other drugs and other drugs may have an effect on ondansetron.
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription, natural supplements or vitamins or minerals.
In particular it is 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:
• Medicines used to treat epilepsy (phenytoin, carbamazepine) - these medicines may reduce the effect of ondansetron
• Antibiotics (rifampicin) - these can reduce the effect of ondansetron
• Medicines used to treat pain (tramadol) - the effect of this medicine may be reduced by ondansetron
• Medicines used to treat heart problems (anti-arrhythmics and/or beta-blockers) Pregnancy:
It is not recommended that ondansetron be taken during pregnancy. If it is absolutely necessary it should be given with caution especially in the first trimester.
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding:
If you are taking ondansetron you should not breast-feed your baby.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Ondansetron is unlikely to affect your ability to drive or operate machinery.
Important information about some of the ingredients of Ondansetron Ondansetron contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE ONDANSETRON
Always take Ondansetron exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Treatment of sickness (nausea and vomiting) in patients receiving chemotherapy or radiotherapy:
Adults (including the elderly): The usual dose is 8 mg of Ondansetron 1 - 2 hours before chemotherapy or radiotherapy, followed by 8 mg of Ondansetron 12 hours later. To protect against delayed, or further, sickness a dose of 8 mg of Ondansetron may be continued twice a day for up to 5 days after treatment.
Children (aged 2 years 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 of the child.
Ondansetron should not be given to children below 2 years or children who are very small.
Prevention of sickness (nausea and vomiting) after an operation: Adults (including the elderly):
The usual dose is either 16 mg of Ondansetron one hour before the operation or 8 mg of Ondansetron one hour before the operation, followed by two further doses of 8 mg 8 hours apart.
Children (aged 2 years and over) and adolescents (under 18 years old):
The doctor may decide to give an injection rather than tablets.
Patients with liver problems:
The total daily dose should not be more than 8 mg.
If you take more Ondansetron than you should
Do not to exceed the stated dose as doing so could make you ill. If you have taken too many tablets it is important to ask your doctor or pharmacist what to do, or contact your nearest hospital casualty department, without delay. Take these tablets with you.
If an overdose has been taken, symptoms may include problems with vision, low blood pressure (which could cause dizziness or faintness) and palpitations (irregular heart beat).
If you forget to take Ondansetron
If you forget to take a dose, take it as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose.
If you stop using Ondansetron
Do not stop taking your tablets, even if you are feeling well, without consulting a doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ondansetron can cause side effects, although not everybody gets them.
Common side effects: at least 1 of 100 patients treated:
• Headache
• Sensation of flushing and warmth
• Constipation
Uncommon side effects: at least 1 of 1,000 patients treated:
• 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
• An increase in liver function tests (most often in patients receiving chemotherapy with cisplatin)
Rare side effects: at least 1 of 10,000 patients treated:
• An immediate allergic reaction, which may be serious and include symptoms such as swelling of the mouth, and throat causing difficulty in breathing. IF THIS SHOULD OCCUR, SEEK URGENT MEDICAL ATTENTION.
• Visual disturbances e.g. blurred vision (though this has almost always been associated with an ondansetron injection rather than tablets).
Very rare side effects: at least 1 of 10,000 patients treated:
• 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 with chemotherapy containing cisplatin).
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.
5. HOW TO STORE ONDANSETRON
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use Ondansetron after the expiry date, which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose off medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION What Ondansetron contains
The active substance is ondansetron hydrochloride dihydrate.
Each tablet contains 4 mg of ondansetron (as ondansetron hydrochloride dihydrate). Each tablet contains 8 mg of ondansetron (as ondansetron hydrochloride dihydrate).
The other ingredients are Tablet core:
Lactose anhydrous Cellulose,microcrystalline Starch, pregelatinised (maize)
Magnesium stearate
Film coat:
Triacetin Titanium dioxide Hypromellose
Iron oxide yellow (for 8 mg tablets only)
What Ondansetron looks like and contents of the pack Film-coated tablet.
White to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘01’ on the other side.
Yellow, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘02’ on the other side.
Ondansetron 4 mg film-coated tablets are available in packs of 4, 6, 7, 10, 14, 15, 28, 30, 49, 50 & 100 tablets.
Ondansetron 8 mg film-coated tablets are available in packs of 4, 5, 6, 10, 15, 30, 49, 50 & 100 tablets.
Not all pack sizes may be marketed.
Also leaflet is available in forms suitable for the partially sighted upon request.
Marketing Authorisation Holder
Amneal Pharma Europe Limited 70 Sir John Rogerson’s Quay Dublin 2 Ireland
Manufacturer
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000 Malta
This leaflet was last revised in 08/2014