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Package Leaflet: Information for the User
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Zofran® melt 4 mg and 8 mg
ondansetron
GSK-ContractMfg-Eur-Deu-Germany-Aspen-Bad Oldesloe
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
United Kingdom-GBR
• Keepthisleaflet.Youmayneedtoreaditagain.
• Ifyouhaveanyfurtherquestionsaboutyourillnessoryourmedicine,askyourdoctor,nurseor
pharmacist.
• Thismedicinehasbeenprescribedforyou.Donotpassitontoothers.Itmayharmthem,eveniftheir
symptomsarethesameasyours.
• Ifanyofthesideeffectsgetserious,orifyounoticeanysideeffectsnotlistedinthisleaflet,pleasetell
yourdoctor,nurseorpharmacist.(seesection4).
Zofran
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What is in this leaflet:
1
2
3
4
5
6
WhatZofranmeltisandwhatitisusedfor
WhatyouneedtoknowbeforeyoutakeZofranmelt
HowtotakeZofranmelt
Possiblesideeffects
HowtostoreZofranmelt
Contentsofthepackandotherinformation
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1 What Zofran melt is and what it is used for
Zofranmeltcontainsamedicinecalledondansetron.Thisbelongstoagroupofmedicinescalled
anti-emetics.ZofranmeltisaspecialtypeofZofrantabletthatdissolvesveryquicklywhenputontopofthe
tongue.
Zofranmeltisusedfor:
• preventingnauseaandvomitingcausedbychemotherapy(inadultsandchildren)orradiotherapyfor
cancer(adultsonly)
• preventingnauseaandvomitingaftersurgery(adultsonly).
Askyourdoctor,nurseorpharmacistifyouwouldlikeanyfurtherexplanationabouttheseuses.
2 What you need to know before you take Zofran melt
Do not take Zofran melt if:
• youaretakingapomorphine(usedtotreatParkinson’sdisease)
• youareallergic(hypersensitive)toondansetronoranyoftheotheringredientsinZofranmelt(listedin
Section6).
Ifyouarenotsure,talktoyourdoctor,nurseorpharmacistbeforetakingZofranmelt.
Warnings and precautions
CheckwithyourdoctororpharmacistbeforetakingZofranmeltif:
• youhaveeverhadheartproblems(e.g.congestiveheartfailurewhichcausesshortnessofbreathand
swollenankles)
• youhaveanunevenheartbeat(arrhythmias)
• youareallergictomedicinessimilartoondansetron,suchasgranisetron
• youhaveliverproblems
• youhaveablockageinyourgut
• youhaveproblemswiththelevelsofsaltsinyourblood,suchaspotassium,sodiumandmagnesium.
Ifyouarenotsureifanyoftheaboveapplytoyou,talktoyourdoctor,nurseorpharmacistbeforetaking
Zofranmelt.
Other medicines and Zofran
Pleasetellyourdoctor,nurseorpharmacistifyouaretakingorhaverecentlytakenormighttakeother
medicines.Thisincludesmedicinesthatyoubuywithoutaprescriptionandherbalmedicines.Thisisbecause
Zofrancanaffectthewaysomemedicineswork.AlsosomeothermedicinescanaffectthewayZofranworks.
Inparticular,tellyourdoctor,nurseorpharmacistifyouaretakinganyofthefollowingmedicines:
• carbamazepineorphenytoinusedtotreatepilepsy
• rifampicinusedtotreatinfectionssuchastuberculosis(TB)
• antibioticssuchaserythromycinorketoconazole
• anti-arrhythmicmedicinesusedtotreatanunevenheartbeat
• beta-blockermedicinesusedtotreatcertainheartoreyeproblems,anxietyorpreventmigraines
• tramadol,apainkiller.
• medicinesthataffecttheheart(suchashaloperidolormethadone)
• cancermedicines(especiallyanthracyclinesandtrastuzumab).
• SSRIs(selectiveserotoninreuptakeinhibitors)usedtotreatdepressionand/oranxietyincludingfluoxetine,
paroxetine,sertraline,fluvoxamine,citalopram,escitalopram
• SNRIs(serotoninnoradrenalinereuptakeinhibitors)usedtotreatdepressionand/oranxietyincluding
venlafaxine,duloxetine.
Ifyouarenotsureifanyoftheaboveappliestoyou,talktoyourdoctor,nurseorpharmacistbeforehaving
Zofranmelt.
Aspen Bad Oldesloe
Additional Information Panel
Replacement: 12000000101181
Pregnancy and breast-feeding
ItisnotknownifZofranissafeduringpregnancy.Ifyouarepregnant,thinkyouarepregnantorare
planningtohaveababy,askyourdoctororpharmacistforadvicebeforetakingZofranmelt.
Donotbreast-feedifyouaretakingZofran.Thisisbecausesmallamountspassintothemother’smilk.Ask
yourdoctorormidwifeforadvice.
Important information about some of the ingredients of Zofran melt
TYPE SIZE: 10/11
HORIZONTAL SCALE: 100%
• Thismedicinecontainsaspartame(whichisasourceofphenylalanine).Ifyouhaveaninheritedillness
calledphenylketonuriaspeaktoyourdoctorbeforetakingthismedicine.
• Thismedicinecontainssodiummethylparahydroxybenzoateandsodiumpropylparahydroxybenzoate.This
maycauseallergicreactions(whichcouldbedelayed).
3 How to take Zofran melt
AlwaystakeZofranmeltexactlyasyourdoctorhastoldyou.Youshouldcheckwithyourdoctor,nurseor
pharmacistifyouarenotsure.Thedoseyouhavebeenprescribedwilldependonthetreatmentyouarehaving.
To prevent nausea and vomiting from chemotherapy or radiotherapy
Onthedayofchemotherapyorradiotherapy
• theusualadultdoseis8mgtakenoneortwohoursbeforetreatmentandanother8mgtwelvehoursafter.
Onthefollowingdays
• theusualadultdoseis8mgtwiceaday
• thismaybegivenforupto5days.
Childrenagedover6monthsandadolescents
Thedoctorwilldecidethedosedependingonthechild’ssize(bodysurfacearea)orweight.Lookatthelabel
formoreinformation.
• theusualdoseforachildisupto4mgtwiceaday
• thiscanbegivenforupto5days.
To prevent nausea and vomiting after an operation
Theusualadultdoseis16mgbeforeyouroperation
Childrenagedover1monthandadolescents
ItisrecommendedthatZofranisgivenasaninjection.
Patients with moderate or severe liver problems
Thetotaldailydoseshouldnotbemorethan8mg.
How to remove Zofran melt from the blister and take the medicine
• DonottakeaZofranmelttabletoutfromitsblisteruntilyouarereadytotakeit.
• BeforeyoutaketheZofranmeltmakesurethefoilpackaginghasnotbeenpierced.
• Important: DonottrytopushZofranmeltthroughthefoiltoplikeausualtablet.ThisisbecauseZofran
meltisfragileandwillbreak.
1
Tear off one
Zofran melt in its
blister.
2
Peel back the
foil, as shown by
the arrow.
3
Gently push out
the Zofran melt
tablet.
4
Place the Zofran
melt on top of the
tongue. It will dissolve
very quickly. Then
you can swallow as
normal.
Zofranmeltshouldstarttoworkwithinoneortwohoursoftakingadose.
If you are sick (vomit) within one hour of taking a dose
• takethesamedoseagain
• otherwise,donottakemoreZofranmeltthanthelabelsays.
Ifyoucontinuetofeelsick,tellyourdoctorornurse.
If you take more Zofran melt than you should
IfyoutakemoreZofranthanyoushould,talktoadoctororgotoahospitalstraightaway.Takethe
medicinepackwithyou.
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If you forget to take Zofran melt
Ifyoumissadoseandfeelsickorvomit:
• takeaZofranmeltassoonaspossible,then
• takeyournexttabletattheusualtime(asshownonthelabel)
• donottakeadoubledosetomakeupforaforgottendose.
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Ifyoumissadosebutdonotfeelsick
• takethenextdoseasshownonthelabel
• donottakeadoubledosetomakeupforaforgottendose.
GSK-ContractMfg-Eur-Deu-Germany-Aspen-Bad Oldesloe
4 Possible side effects
United Kingdom-GBR
Likeallmedicines,Zofranmeltcancausesideeffects,althoughnoteverybodygetsthem.
Zofran
Allergic reactions
Ifyouhaveanallergicreaction,stoptakingitandseeadoctorstraightaway.Thesignsmayinclude:
• suddenwheezingandchestpainorchesttightness
• swellingofyoureyelids,face,lips,mouthortongue
• skinrash-redspotsorlumpsunderyourskin(hives)anywhereonyourbody
• collapse.
Other side effects include:
Very common (affects more than 1 in 10 people)
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• headache.
Common (affects less than 1 in 10 people)
• afeelingofwarmthorflushing
• constipation
• changestoliverfunctiontestresults(ifyoutakeZofranmeltwithamedicinecalledcisplatin,otherwise
thissideeffectisuncommon).
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Uncommon (affects less than 1 in 100 people)
•
•
•
•
•
•
hiccups
lowbloodpressure,whichcanmakeyoufeelfaintordizzy
unevenheartbeat
chestpain
fits
unusualbodymovementsorshaking.
Rare (affects less than 1 in 1,000 people)
• feelingdizzyorlightheaded
• blurredvision
• disturbanceinheartrhythm(sometimescausingasuddenlossofconsciousness).
Very rare (affects less than 1 in 10,000 people)
• poorvisionortemporarylossofeyesight,whichusuallycomesbackwithin20minutes.
Reporting of side effects
Ifyougetanysideeffects,talktoyourdoctor,pharmacistornurse.Thisincludesanypossiblesideeffectsnot
listedinthisleaflet.YoucanalsoreportsideeffectsdirectlyviatheYellowCardSchemeat:
www.mhra.gov.uk/yellowcard.
Byreportingsideeffectsyoucanhelpprovidemoreinformationonthesafetyofthismedicine.
5 How to store Zofran melt
• Keepoutofthesightandreachofchildren.
• DonotuseZofranmeltaftertheexpirydatewhichisstatedonthepackafter‘Exp’.Theexpirydaterefers
tothelastdayofthatmonth.
• StoreZofranmeltbelow30°C
• Zofranmeltshouldonlybetakenoutoftheblisterimmediatelybeforetakingit.
• Donotthrowawayanymedicinesviawastewaterorhouseholdwaste.Askyourpharmacisthowtothrow
awaymedicinesyounolongeruse.Thesemeasureswillhelpprotecttheenvironment.
6 Contents of the pack and other information
What Zofran melt contains
• Theactiveingredientisondansetron.EachZofranmeltcontainsondansetron4mgor8mg.
• Theotheringredientsaregelatin,mannitol,aspartame,sodiummethylhydroxybenzoate,sodium
propylhydroxybenzoate,strawberryflavour.
What Zofran melt looks like and contents of the pack
Zofranmeltisawhiteroundorallyophilisate.Eachpackcontains10Zofranmeltunits.
Marketing Authorisation Holder and Manufacturer
MarketingAuthorisationholder:
GlaxoWellcomeUKLtd,StockleyParkWest,Uxbridge,MiddlesexUB111BT
Manufacturer:
AspenBadOldesloeGmbH,23843BadOldesloe,Germany
Aspen Bad Oldesloe
Additional Information Panel
Other formats:
TolistentoorrequestacopyofthisleafletinBraille,largeprintoraudiopleasecall,freeofcharge:
Replacement: 12000000101181
08001985000(UKonly).
Pleasebereadytogivethefollowinginformation:
Product name
Referencenumber
Zofran melt
10949/0263/0264
TYPE SIZE: 10/11
HORIZONTAL SCALE: 100%
ThisisaserviceprovidedbytheRoyalNationalInstituteofBlindPeople.
ThisleafletwaslastrevisedinJuly2013
ZofranisaregisteredtrademarkoftheGlaxoSmithKlinegroupofcompanies
©2013GlaxoSmithKlinegroupofcompanies.Allrightsreserved
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