PACKAGE LEAFLET: INFORMATION FOR THE USER …

1 Read all of this leaflet carefully before youstart taking this medicine because it containsimportant INFORMATION for you. Keep this leaflet. You may need to read it again. If you have any further questions, please askyour doctor or pharmacist. This medicine has been prescribed for you not pass it on to others. It may harm them,even if their signs of illness are the same asyours. If you get any side effects, talk to your doctoror pharmacist. This includes any possible sideeffects not listed in this leaflet. See section this LEAFLET: 1. what Ondansetron Tablets are and what they areused for2. what you need to know before you takeOndansetron Tablets3. How to take Ondansetron Tablets4. Possible side effects5. How to store Ondansetron Tablets6. Contents of the pack and other informationThe name of your medicine is Ondansetron4 mg Film-Coated Tablets and 8 mg Film-CoatedTablets (also referred to as Ondansetron Tabletsthroughout this leaflet).

2 1. what ONDANSETRON TABLETS ARE ANDWHAT THEY ARE USED FORO ndansetron tablets contain a medicine calledondansetron. This belongs to a group of medicinescalled tablets are used for: preventing nausea and vomiting caused bychemotherapy (in adults and children) orradiotherapy for cancer (adults only) preventing nausea and vomiting after surgery(adults only).Ask your doctor, nurse or pharmacist if you wouldlike any further explanation about these what YOU NEED TO know BEFORE YOUTAKE ONDANSETRON TABLETSDo not take Ondansetron Tablets If you are taking apomorphine (used to treatParkinson s disease). If you are allergic (hypersensitive) to ondansetronor any of the other ingredients in Ondansetrontablets (listed in Section 6).If you are not sure, talk to your doctor, nurse orpharmacist before taking Ondansetron and precautionsTalk to your doctor, nurse or pharmacist beforetaking Ondansetron Tablets.

3 If you have ever had heart problems( congestive heart failure which causesshortness of breath and swollen ankles) If you have an uneven heart beat (arrhythmias) If you are allergic to medicines similarto ondansetron, such as granisetron orpalonosetron If you have liver problems If you have a blockage in your gut If you have problems with the levels of saltsin your blood, such as potassium, sodium you are not sure if any of the above apply to you,talk to your doctor, nurse or pharmacist beforetaking ondansetron medicines and OndansetronPlease tell your doctor, nurse or pharmacist if youare taking or have recently taken or might takeother medicines. This includes medicines that youbuy without a prescription and herbal is because Ondansetron can affect the waysome medicines work. Also some other medicinescan affect the way Ondansetron particular, tell your doctor, nurse or pharmacist ifyou are taking any of the following medicines: carbamazepine or phenytoin used to treatepilepsy rifampicin used to treat infections such astuberculosis ( TB) antibiotics such as erythromycin or ketoconazole anti-arrhythmic medicines used to treat anuneven heart beat beta-blocker medicines used to treat certainheart or eye problems, anxiety or preventmigraines tramadol, a pain killer medicines that affect the heart (such ashaloperidol or methadone) cancer medicines (especially anthracyclines andtrastuzumab).

4 SSRIs (selective serotonin reuptake inhibitors)used to treat depression and/or anxiety includingfluoxetine, paroxetine, sertraline, fluvoxamine,citalopram, escitalopram SNRIs (serotonin noradrenaline reuptakeinhibitors) used to treat depression and/oranxiety including venlafaxine, you are not sure if any of the above applies toyou, talk to your doctor, nurse or pharmacist beforehaving Ondansetron and Breast-feedingOnly use Ondansetron Tablets during the firsttrimester of pregnancy after discussion with yourdoctor of the potential benefits and risks to youand your unborn baby of the different treatmentoptions. This is because Ondansetron Tablets canslightly increase the risk of a baby being born withcleft lip and/or cleft palate (openings or splits inthe upper lip and/or the roof of the mouth). If youare already pregnant, think you might be pregnantor are planning to have a baby, ask your doctor orpharmacist for advice before taking OndansetronTablets.

5 If you are a woman of childbearingpotential you may be advised to use not breast-feed if you are taking Ondansetrontablets. This is because small amounts pass intothe mother s milk. Ask your doctor or midwife Tablets contain lactosemonohydrateThis medicinal product contains lactosemonohydrate. If you have been told by your doctorthat you have an intolerance to some sugars, checkwith your doctor before taking medicinal HOW TO TAKE ONDANSETRON TABLETSA lways take Ondansetron Tablets exactly as yourdoctor has told you. You should check with yourdoctor, nurse or pharmacist if you are not dose that you have been prescribed willdepend on the treatment you are prevent nausea and vomiting fromchemotherapy or radiotherapyOn the day of chemotherapy or radiotherapy the usual adult dose is 8 mg taken one to twohours before treatment and another 8 mgtwelve hours the following days the usual adult dose is 8 mg twice a day this may be given for up to 5 aged over 6 months and adolescentsThe doctor will decide the dose depending on thechild s size (body surface area) or weight.

6 Look atthe label for more LEAFLET: INFORMATION FOR THE USERONDANSETRON 4 mg and 8 mg FILM-COATED TABLETS(Ondansetron)CustomerDescriptionI tem SizeActual Min Point SizeMarketLanguagePharmacodeBarcodeProof ByProof Text Fonts:Body Text UsedWarning!We cannot accept responsibility for any errors in this proof afterapproval. Whilst we take extreme care at all times to ensure accuracy toour client s brief, the final responsibility must be taken by our YOU SIGN THIS PROOF YOU ARE SIGNIFYINGFULL APPROVAL OF DESIGN AND UK Limited103229/11 Keyline (Non-Printing)BlackCirrus_Info_BoxOndans etron common leafletn/a160 x 300mm9pt (Leaflet)EnglishUKN/AMyriadRPA26/11/2020 29 pt the usual dose for a child is up to 4 mg twice aday this can be given for up to 5 prevent nausea and vomiting after anoperationThe usual adult dose is 16 mg before youroperationChildren aged over 1 month and adolescents.

7 It is recommended that Ondansetron is given as with moderate or severe liver problemsThe total daily dose should not be more than 8 tablets should start to work withinone or two hours of taking a you are sick (vomit) within one hour of takinga dose take the same dose again otherwise, do not take more Ondansetron tabletsthan the label you continue to feel sick, tell your doctor or you take more Ondansetron tablets than youshouldIf you or your child take more Ondansetron thanyou should, talk to a doctor or go to a hospitalstraight away. Take the medicine pack with you forget to take Ondansetron tabletsIf you miss a dose and feel sick or vomit: take Ondansetron tablets as soon as possible,then take your next tablet at the usual time (as shownon the label) do not take a double dose to make up for aforgotten you miss a dose but do not feel sick take the next dose as shown on the label do not take a double dose to make up for aforgotten POSSIBLE SIDE EFFECTSLike all medicines, Ondansetron can cause sideeffects, although not everybody gets reactionsIf you have an allergic reaction, stop taking it andsee a doctor straight away.

8 The signs may include: sudden wheezing and chest pain or chesttightness swelling of your eyelids, face, lips, mouth ortongue skin rash - red spots or lumps under your skin(hives) anywhere on your body side effects include:Very common (may affect more than 1 in10 people) (may affect up to 1 in 10 people) a feeling of warmth or flushing constipation changes to liver function test results (if you takeOndansetron tablets with a medicine calledcisplatin, otherwise this side effect is uncommon).Uncommon (may affect up to 1 in 100 people) hiccups low blood pressure, which can make you feelfaint or dizzy uneven heart beat chest pain fits unusual body movements or (may affect up to 1 in 1,000 people) feeling dizzy or light headed blurred vision disturbance in heart rhythm (sometimes causinga sudden loss of consciousness)Very rare (may affect up to 1 in 10,000 people) poor vision or temporary loss of eyesight, whichusually comes back within 20 of side effectsIf you get any side effects, talk to your doctor,pharmacist or nurse.

9 This includes any possible sideeffects not listed in this leaflet. You can also reportside effects directly via Yellow Card Scheme or search for MHRAY ellow Card in the Google Play or Apple App reporting side effects you can help providemore INFORMATION on the safety of this HOW TO STORE ONDANSETRON TABLETSKeep this medicine out the sight and reach not store above 25 not use this medicine after the expiry datewhich is stated on the carton. The expiry date refersto the last day of that not take Ondansetron Tablets if you notice theyare discoloured (they should be pale yellow).Do not throw away any medicines via wastewateror household waste. Ask your pharmacist how todispose of medicines no longer required. Thesemeasures will help to protect the CONTENTS OF THE PACK AND OTHERINFORMATIONWhat Ondansetron Tablets contain The active substance is Ondansetron(as Ondansetron hydrochloride dihydrate) Each tablet contains either 4mg or 8mgOndansetron (as Ondansetron hydrochloridedihydrate) The other ingredients are lactose monohydrate,microcrystalline cellulose (E460(i)), pregelatinisedstarch, magnesium stearate, hyprolose, propyleneglycol (E1520), sorbitan oleate (E494), sorbic acid(E200), vanillin and quinolone yellow (E104).

10 what Ondansetron Tablets look like andcontents of the packOndansetron 4mg Film-Coated Tablets are paleyellow, 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 4mg tablets are available in blisterpacks of 7, 14, 15, 28, 30 or 100 8mg tablets are available in blisterpacks of 7, 10, 14, 28, 30 or 100 all pack sizes may be Authorisation HolderWockhardt UK Limited, Ash Road North, Wrexham,LL13 9UF, UKManufacturerCP Pharmaceuticals Ltd, Ash Road North, Wrexham,LL13 9UF, UKOther 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 Please be ready to give the following INFORMATION :Product nameReference numberOndansetron 4 mgFilm-coated TabletsPL 29831/0155 Ondansetron 8 mgFilm-coated TabletsPL 29831/0156 This is a service provided by the Royal NationalInstitute of Blind leaflet was last revised in 11 SizeActual Min Point SizeMarketLanguagePharmacodeBarcodeProof ByProof Text Fonts:Body Text UsedWarning!