Ondansetron 4mg 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, please 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.
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
The name of your medicine is Ondansetron 4 mg Film-Coated Tablets and 8 mg Film-Coated Tablets (also referred to as Ondansetron Tablets throughout this leaflet).
1. WHAT ONDANSETRON TABLETS ARE AND WHAT THEY ARE USED FOR
Ondansetron Tablets contains the active substance Ondansetron (as Ondansetron hydrochloride dihydrate).
Ondansetron belongs to the group of medicines known as antiemetics.
Ondansetron is used to treat nausea and vomiting caused by cancer chemotherapy and radiotherapy (in adults and children). It is also used to prevent and treat sickness that can sometimes occur after an operation (adults only).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ONDANSETRON TABLETS
Do not take Ondansetron Tablets if and of
the following apply to you.
• you are allergic (hypersensitive) to ondansetron or any of the other ingredients of Ondansetron Tablets (please refer to Section 6 for full list of ingredients). An allergic reaction may include rash, itching, swelling of face, lips, tongue or hands/feet, or breathing difficulties
• you are taking apomorphine (used to treat Parkinson's disease).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Ondansetron Tablets:
• if you have symptoms of subacute intestinal obstruction (blockage in the bowel) such as stomach ache, nausea, vomiting or difficulty in passing wind
• if you have undergone tonsil surgery. Prevention of nausea and vomiting with ondansetron may mask hidden bleeding. Therefore, such patients should be monitored carefully after taking Ondansetron
• if you are having cancer chemotherapy, especially if you are a child, you will be monitored more closely
• if you have an abnormal heart rhythm, suffer from palpitations, take drugs to control your heart rhythm, take beta-blocking drugs or
if you have significant abnormalities of the electrolytes (sodium and potassium salts) in your blood
Please consult your doctor, even if these statements were applicable to you at any time in the past.
Other medicines and Ondansetron
Please inform your doctor or pharmacist if you are taking or have recently taken, any other medicines, even those not prescribed but bought/ obtained without a prescription. In particular you should tell your doctor if you are taking any of the following:
• phenytoin, used in treatment of epilepsy
• carbamazepine, used to treat epilepsy and bipolar disorder
• rifampicin, an antibiotic used to treat bacterial infections
Ondansetron may reduce the effects of tramadol.
The use of ondansetron with medicines that affect the heart (e.g. anthracyclines such as doxorubicin and indarubicin) may increase the risk of arrhythmias (changes in your heart beat).
In patients receiving cancer chemotherapy with medicines such as doxorubicin, the rhythm of the heart may be affected.
Caution should be taken in patients who are being treated with medication that suppresses abnormal rhythms of the heart, such as beta blockers (e.g. atenolol) or antiarrhythmics (e.g. amiodarone).
Pregnancy and Breast-feeding
If you are pregnant or breast-feeding you should talk to your doctor or pharmacist before taking any medicine.
Driving and using machines
Ondansetron does not affect your ability to drive or operate machines.
Important information about some of the ingredients in Ondansetron Tablets
This medicinal product contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, check with your doctor before taking Ondansetron Tablets.
3. HOW TO TAKE ONDANSETRON TABLETS
Adults over 18 years of age
For oral use.
Always take Ondansetron Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Unless told otherwise, take the tablets with water.
To obtain a tablet press on the tablet from the blister (or bubble) side, pushing it through the foil. Do not remove the tablet from the blister until you are ready to take it.
For most patients receiving chemotherapy or radiotherapy that causes nausea and vomiting:
The recommended dose is 8 mg, given by injection, two hours before chemotherapy, followed by 8 mg, given orally, after 12 hours.
For patients receiving chemotherapy that causes severe nausea and vomiting:
Any of the following dose schedules are recommended:
• 8 mg by injection, immediately before chemotherapy
• 8 mg by injection, immediately before chemotherapy followed by two further doses of 8 mg, given by injection 2 to 4 hours apart
You may be told to take Ondansetron Tablets every l2 hours for up to 5 days to prevent any further nausea and vomiting.
Children over 6 months and adolescents
The doctor will decide the dose. Look at the label for more information.
• The usual dose for a child is up to 8mg given by injection, immediately before chemotherapy.
• This can be followed by further oral doses up to 4mg every 12 hours given for up to five days. The total daily dose must not exceed 32mg
To prevent nausea and vomiting after an operation:
the usual adult dose is a single dose of 4mg, given by injection before the operation.
If you take more Ondansetron Tablets than you should
If you or your child or anybody else takes too many tablets, you should contact your doctor or go to a hospital immediately. Take this leaflet and any tablets you have left with you.
If you forget to take Ondansetron Tablets
If you forget to take a dose and are feeling sick or being sick, take the dose as soon as possible.
If you miss a dose but are not feeling sick or being sick, just take the next dose when it is due. Never double the next dose to make up for the one missed.
If you stop taking Ondansetron Tablets
Do not stop taking the medicine without talking to your doctor first.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ondansetron can have side effects, although not everybody gets them.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
A few people can be allergic to some medicines; if any of the following rare side effects come on soon after taking your tablets tell your doctor immediately:
• sudden chest tightness or wheezing
• swelling of eyelids, face or lips
• skin rashes - red spots or hives (skin lumps)
• collapse
The following side effects are uncommon or very rare but if you have them you should let your doctor know immediately:
• upward rolling of the eyes
• abnormal muscular stiffness, body movements or shaking
• fits
• blurring of vision
• temporary blindness
• yellowing of the skin or whites of the eyes caused by liver problems
• low blood pressure (symptoms may include dizziness, fainting and nausea)
• slow or irregular heartbeat
• chest pain
Other possible side effects are:
• headache
• feeling of warmth in the head or stomach
• flushes of the face
• hiccups
• upset bowels - constipation
If you have any blood tests to check how your liver is working, this medicine may affect the results. If you feel unwell or have any other unusual discomfort you do not understand, tell your doctor as soon as possible.
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 affects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ONDANSETRON TABLETS
Keep this medicine out the sight and reach of children.
Do not store above 25°C.
Do not use Ondansetron Tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not take Ondansetron Tablets if you notice they are discoloured (they should be pale yellow).
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Ondansetron Tablets contain
• The active substance is Ondansetron
(as Ondansetron hydrochloride dihydrate)
• Each tablet contains either 4mg or 8mg Ondansetron (as Ondansetron hydrochloride dihydrate)
• The other ingredients are lactose monohydrate, microcrystalline cellulose (E460(i)), pregelatinised starch, magnesium stearate, hyprolose, propylene glycol (E1520), sorbitan oleate (E494), sorbic acid (E200), vanillin and quinolone yellow (E104).
What Ondansetron Tablets look like and contents of the pack
Ondansetron 4mg Film-Coated Tablets are pale yellow, round, biconvex, film-coated tables with '41' embossed on one side. Ondansetron 8mg Film-Coated Tablets are pale yellow, round, biconvex, film-coated with '42' embossed on one side.
Ondansetron 4mg tablets are available in blister packs of 30 tablets and Ondansetron 8mg tablets are available in blister packs of 10 tablets.
Marketing Authorisation Holder
Wockhardt UK Limited, Ash Road North, Wrexham, LL13 9UF, UK
Manufacturer
CP Pharmaceuticals Limited, Ash Road North, Wrexham, LL13 9UF, UK
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
|
Product name |
Reference number |
|
Ondansetron 4 mg Tablets |
PL 29831/0155 |
|
Ondansetron 8 mg Tablets |
PL 29831/0156 |
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in 09/2016
103229/7 ^WOCKHARDT