Ondansetron 8mg Tablets
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Ondansetron 4 mg & 8 mg Tablets
Ondansetron hydrochloride dihydrate
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 about your illness or your medicine, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms 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
The active ingredient in your tablets is ondansetron. This belongs to a group of medicines known as anti-emetics.
Ondansetron Tablets are used for:
• preventing nausea and vomiting caused by chemotherapy or radiotherapy for cancer (in adults and children)
• preventing nausea and vomiting after surgery (adults only)
Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE ONDANSETRON TABLETS
Do not take Ondansetron tablets if you:
• are allergic to ondansetron, or to any of the other ingredients or of this medicines (listed in section 6).
• are taking apomorphine (used to treat Parkinson’s disease)
Warnings and precautions
Talk to your doctor or pharmacist before taking Ondansetron Tablets
• you have ever had heart problems
• you have an uneven heart beat (arrhythmias)
• you are allergic to medicines similar to ondansetron, such as granisetron (known as ‘Kytril’)
• you have liver problems
• you have a blockage in your gut
• you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium.
If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before taking Ondansetron Tablets
Children and Adolescents
The liver function for persons under 18 years of age taking Ondansetron Tablets should be regularly checked.
Other medicines and Ondansetron Tablets
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
There are known interaction between the following medications and Ondansetron therefore there use with Ondansetron Tablets is not recommended:
• carbamazepine or phenytoin used to treat epilepsy, as it lowers the concentration of ondansetron,
• rifampicin used to treat infections such as tuberculosis (TB), it lowers the concentration of ondansetron,
• anti-arrhythmic medicines used to treat an uneven heartbeat, as ondansetron prevents medication from working,
• beta-blocker medicines used to treat certain heart or eye problems, anxiety or prevent migraines as beta-blocker may not work properly,
• tramadol, a pain killer, as tramadol may not work properly
• medicines that affect the heart (such as haloperidol or methadone),
• cancer medicines (especially anthracyclines and trastuzumab).
Ondansetron Tablets with food, drink and alcohol
You can take your Ondansetron Tablets with or without food.
There are no interactions with alcohol.
Pregnancy, breast-feeding and fertility
Pregnancy:
There is insufficient experience of using Ondansetron Tablets during pregnancy therefore it is not recommended.
Breastfeeding:
The ondansetron in these tablets may pass into breast milk. Mothers taking Ondansetron Tablets should not therefore breast-feed.
Fertility:
No data available.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before taking this medicine.
Driving and using machines
Ondansetron can cause visual disturbances and dizziness. If you are affected do not drive or operate machinery.
Ondansetron Tablets contain 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 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.
Ondansetron Tablets are an oral medicine and the recommended dose you are prescribed by your doctor will be dependent on your treatment.
To prevention of Chemotherapy and radiotherapy induced nausea and vomiting
On the day of chemotherapy or radiotherapy:
• the usual adult dose is 8mg one - two hours before treatment, followed by another 8mg twelve hours later.
On following days:
• the usual adult dose is 8mg twice a day.
• this may be given up to 5 days.
Children aged 6 months and adolescents:
The doctor will decide the dose.
• the usual dose for a child is up to 4mg twice daily.
• This may be given up to 5 days.
To prevention nausea and vomiting after an operation
The usual adult dose is 16mg before an operation or:
• 8mg before the operation, then
• 8mg after the operation, then
• 8mg after a further eight hours.
Children ages 1 month and adolescents.
It is recommended that ondansetron be given as an injection.
Patients with moderate to severe liver disease:
The total dose should not be more than 8 mg per day.
If you are sick (vomit) within one hour of taking a dose
• Take the same dose again,
• Otherwise, do not any more Ondansetron.
If you forget to take Ondansetron Tablet:
If you miss a dose, do not worry. Take a dose as soon as possible if you feel sick or vomit, or just take the next dose as normal.
Do not take a double dose to make-up for a forgotten dose.
If you take too many Ondansetron Tablets:
It is important to take these tablets as directed - taking more than prescribed can make you ill. If you do take more than you should, tell your doctor or go to the nearest hospital casualty department AS SOON AS POSSIBLE. If you go to the hospital/doctor remember to take this leaflet and any remaining tablets with you so the doctor knows what you have taken.
If you stop taking Ondansetron Tablets:
This medication has been prescribed by your doctor; you should not stop taking Ondansetron Tablets without discussing this with your doctor first.
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.
Allergic reactions:
If you have an allergic reaction, stop taking Ondansetron Tablets and go see your doctor straight away. The signs of an allergic reaction may include:
■ swelling of the face, eyelids or lips,
■ sudden chest tightness or difficulty in breathing,
■ skin rash - red spots or hives (lumps),
■ collapse.
Other side effects include:
Very common (may affect more than 1 in 10 people)
■ headache
Common (may affect up to 1to 10 people)
■ sensation of warmth or flushing
■ constipation
■ changes to liver function test results (if you are taking with a medicine called cisplatin, otherwise it’s effect is uncommon).
Uncommon (affects less than 1 in 10 people)
■ hiccups,
■ low blood pressure, which can make you feeling dizzy or faint,
■ uneven heartbeat,
■ chest pain,
■ fits,
■ unusual body movements or shaking.
Rare (affects less than 1 in 1,000 people)
■ feeling dizzy or light heated,
■ blurred vision,
■ disturbances in heart rhythm ( sometimes a sudden loss of consciousness).
Very rare (affects less than 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 medicines.
5 HOW TO STORE ONDANSETRON 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. The expiry date refers to the last day of the month.
Do not use this medicine if you notice any damage/ discoloration to the tablets.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer need, these measures will help protect the environment.
Store the tablets in the original package. Keep the blister in the outer carton.
6 CONTENTS OF THE PACK AND OTHER INFORMATION What Ondansetron Tablets contain:
The active substance is ondansetron (as ondansetron hydrochloride dihydrate).
The other ingredients include: lactose monohydrate, microcrystalline cellulose, maize starch, magnesium stearate, hypromellose, titanium dioxide (E171) and macrogol.
What Ondansetron Tablets look like and contents of the pack:
Ondansetron 4 mg Tablets are white, round film-coated tablets marked ‘OSN 4’ on one side and ‘NEO’ on the other.
Ondansetron 8 mg Tablets are white, round film-coated tablets marked ‘OSN 8’ and ‘NEO’ with a breakline on one side and plain on the other.
The tablets are available in packs containing 30 x 4 mg tablets or 10 x 8 mg tablets.
Marketing Authorisation Holder: Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN8 6GT, UK.
Manufacturer responsible for batch release: Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN8 6GT, UK.
This leaflet was prepared in September 2013