BUTRANS 5
Active substance: BUPRENORPHINE
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Package leaflet: Information for the user BuTrans 5 micrograms/hour transdermal patches BuTrans 10 micrograms/hour transdermal patches BuTrans 20 micrograms/hour transdermal patches Buprenorphine
Read all of this leaflet carefully before you start using this medicine. Keepthisleaflet.Youmayneedto readitagain. Ifyouhaveanyfurtherquestions, askyourdoctororpharmacist. Thismedicinehasbeenprescribed foryou.Donotpassitonto others.Itmayharmthem,even iftheirsymptomsarethesameas yours. Ifanyofthesideeffectsbecome serious,orifyounoticeany sideeffectsnotlistedinthis leaflet,pleasetellyourdoctoror pharmacist. In this leaflet: 1.WhatBuTranspatchesareand whattheyareusedfor 2.BeforeyouuseBuTranspatches 3.HowtouseBuTranspatches 4.Possiblesideeffects 5.HowtostoreBuTranspatches 6.Furtherinformation 1. what BuTrans patches are and what they are used for BuTranspatchescontainthe activeingredientbuprenorphine whichbelongstoagroupof medicinescalledstronganalgesics orpainkillers.Theyhavebeen prescribedforyoubyyourdoctor torelievemoderate,long-lasting painthatrequirestheuseofastrong painkiller. BuTranspatchesshouldnotbeused torelieveacutepain. BuTranspatchesactthrough theskin.Afterapplication, buprenorphinepassesthroughthe skinintotheblood.Eachpatchlasts forsevendays.
2. Before you use BuTrans patches Do not use BuTrans patches: ifyouareallergic(hypersensitive) tobuprenorphineoranyofthe otheringredientsofBuTrans patches; ifyouhavebreathingproblems; ifyouareaddictedtodrugs; ifyouaretakingatypeof medicineknownasamonoamine oxidaseinhibitor(examples includetranylcypromide, phenelzine,isocarboxazid, moclobamideandlinezolid), oryouhavetakenthistypeof medicineinthelasttwoweeks; ifyousufferfrommyasthenia gravis(aconditioninwhichthe musclesbecomeweak); ifyouhavepreviouslysuffered fromwithdrawalsymptomssuch asagitation,anxiety,shakingor sweatinguponstoppingtaking alcohol. BuTranspatchesmustnotbeusedto treatsymptomsassociatedwithdrug withdrawal.
Take special care with BuTrans patches BeforetreatmentwithBuTrans patchestellyourdoctororpharmacist: ifyousufferfromseizures,fitsor convulsions; ifyouhaveasevereheadacheor feelsickduetoaheadinjuryor increasedpressureinyourskull(for instanceduetobraindisease).This isbecausethepatchesmaymake symptomsworseorhidetheextent ofaheadinjury; ifyouarefeelinglight-headedor faint; ifyouhavesevereliverproblems; ifyouhaveeverbeenaddictedto drugs; ifyouhaveahightemperature,as thismayleadtolargerquantitiesof theactiveingredientbeingabsorbed intothebloodthannormal. Ifyouhaverecentlyhadanoperation, pleasespeaktoyourdoctorbefore usingthesepatches. Taking other medicines Pleasetellyourdoctororpharmacist ifyouaretakingorhaverecently takenanyothermedicines,including medicinesobtainedwithouta prescription.IfyouuseBuTrans patcheswithsomeothermedicines,the
effectofBuTranspatchesortheother medicinemaybechanged. BuTranspatchesmustnotbeused togetherwithatypeofmedicine knownasamonoamineoxidase inhibitor(examplesinclude tranylcypromide,phenelzine, isocarboxazid,moclobamideand linezolid),orifyouhavetakenthis typeofmedicineinthelasttwo weeks. Ifyoutakesomemedicinessuch asphenobarbitalorphenytoin (medicinescommonlyusedto treatseizures,fitsorconvulsions), carbamazepine(amedicineto treatseizures,fitsorconvulsions andcertainpainconditions),or rifampicin(amedicinetotreat tuberculosis)theeffectsofBuTrans patchesmaybereduced. BuTranspatchesmaymakesome peoplefeeldrowsy,sickorfaintor makethembreathemoreslowly orweakly.Thesesideeffectsmay bemadeworseifothermedicines thatproducethesameeffectsare takenatthesametime.These includecertainmedicinestotreat depression,anxiety,psychiatric ormentaldisorders,medicines tohelpyousleep,medicinesto treathighbloodpressuresuchas
clonidine,otheropioids(whichmay befoundinpainkillersorcertain coughmixturese.g.morphine, dextropropoxyphene,codeine, dextromethorphan,noscapine), antihistamineswhichmakeyou drowsy,oranaestheticssuchas halothane. BuTranspatchesmustnotbeused togetherwithbenzodiazepines (medicinesusedtotreatanxiety ortohelpyousleep).This combinationmaycauseserious breathingproblemswhichmaybe fatal. Using BuTrans patches with alcohol Alcoholmaymakesomeoftheside effectsworseandyoumayfeelunwell ifyoudrinkalcoholwhilstwearing BuTranspatches.Drinkingalcohol whilstusingBuTranspatchesmay alsoaffectyourreactiontime. Pregnancy and breastfeeding YoushouldnotuseBuTranspatches ifyouarepregnant,likelytobecome pregnantorarebreastfeeding. Askyourdoctororpharmacistfor advicebeforetakinganymedicines.
Driving and using machines BuTranspatchesmayaffectyour reactionstosuchanextentthatyou maynotreactadequatelyorquickly enoughintheeventofunexpected orsuddenoccurrences.Thisapplies particularly: atthebeginningoftreatment; ifyouaretakingmedicinestotreat anxietyorhelpyousleep; ifyourdoseisincreased. Ifyouareaffectedyoushouldnot driveoroperatemachinerywhilst usingBuTranspatches,orfor24 hoursafterremovingthepatch. 3. How to use BuTrans patches ThreedifferentstrengthsofBuTrans patchesareavailable.Yourdoctorwill decidewhichstrengthofBuTrans patchwillsuityoubest.During treatment,yourdoctormaychangethe patchyouusetoasmallerorlarger oneifnecessary.You should not apply more than two patches at the same time, regardless of the patch strength. AlwaysusetheBuTranspatch exactlyasyourdoctorhastoldyou. Youshouldcheckwithyourdoctoror pharmacistifyouarenotsure.
Adults and elderly patients Unlessyourdoctorhastoldyou differently,attachoneBuTrans patch(asdescribedindetailbelow) andchangeiteveryseventhday, preferablyatthesametimeofday. Yourdoctormaywishtoadjustthe doseafter3-7daysuntilthecorrect levelofpaincontrolhasbeenfound. Ifyourdoctorhasadvisedyouto takeotherpainkillersinadditionto thepatch,strictlyfollowthedoctors instructions,otherwiseyouwillnot fullybenefitfromtreatmentwiththe BuTranspatch.Thepatchshouldbe wornfor3fulldaysbeforeincreasing thedose,thisiswhenthemaximum effectofagivendoseisestablished. Patients under 18 years of age BuTranspatchesshouldnotbeused inpatientsbelowtheageof18years. Patients with kidney disease/dialysis patients Inpatientswithkidneydisease,no changeindoseisnecessary. Patients with liver disease Inpatientswithliverdisease,the effectsandperiodofactionofthe BuTranspatchmaybeaffectedand yourdoctorwillthereforecheckon youmoreclosely.
Before applying the BuTrans patch Chooseanareaofnon-irritated, intactskinonyourupperarm, outerarm,upperchest,upper backorsideofthechest.(See illustrationsbelow).Askfor assistanceifyoucannotapplythe patchyourself.
TheBuTranspatchshouldbe appliedtoarelativelyhairless ornearlyhairlessskinsite.Ifno suitablehairfreesitesareavailable thehairsshouldbecutoffwitha pairofscissors.Donotshavethem off. Avoidskinwhichisred,irritated orhasanyotherblemishes,for instancelargescars. Theareaofskinyouchoosemust bedryandclean.Ifnecessary, washitwithcoldorlukewarm water.Donotusesoap,alcohol, oil,lotionsorotherdetergents. Afterahotbathorshower,wait untilyourskiniscompletelydry andcool.Donotapplylotion, creamorointmenttothechosen area.Thismightpreventyour patchfromstickingproperly.
Applying the patch Step1:Eachpatchissealed inapouch.Justbeforeuse, openthepouchbytearing whereindicated.Takeout thepatch.Donotusethe patchifthepouchsealisbroken. Step2:Thestickysideofthepatchis coveredwithasilveryprotectivefoil. Carefullypeeloffhalfthefoil.Trynotto touchthestickypartofthepatch. Step3:Stickthepatchontotheareaof skinyouhavechosenand removetheremainingfoil. Step4:Pressthepatch againstyourskinwiththe palmofyourhandandcountslowlyto 30.Makesurethatthewholepatchisin contactwithyourskin,especiallyatthe edges. wearing the patch You shouldwearthepatchforseven days.Providedthatyouhaveapplied thepatchcorrectly,thereislittleriskof itcomingoff.Iftheedgesofthepatch begintopeeloff,theymaybetaped downwithasuitableskintape.You may shower,batheorswimwhilstwearingit. Donotexposethepatchtoextremeheat (e.g.heatingpads,electricblanket,heat lamps,sauna,hottubs,heatedwater
beds,hotwaterbottle,etc)asthismay leadtolargerquantitiesoftheactive ingredientbeingabsorbedintotheblood thannormal.Externalheatmayalso preventthepatchfromstickingproperly. Ifyouhaveahightemperaturethismay altertheeffectsofBuTranspatches(see Takespecialcaresectionabove). Intheunlikelyeventthatyourpatchfalls offbeforeitneedschanging,donotuse thesamepatchagain.Stickanewoneon straightaway(seeChangingthepatch below). Changing the patch Taketheoldpatchoff. Folditinhalfwiththestickyside inwards. Openandtakeoutanewpatch.Use theemptypouchtodisposeoftheold patch.Nowdiscardthepouchsafely. Evenusedpatchescontainsome activeingredientthatmayharm childrenoranimals,somakesureyour usedpatchesarealwayskeptoutof thereachandsightofthem. Stickanewpatchonadifferent appropriateskinsite(asdescribed above).You shouldnotapplyanew patchtothesamesitefor3-4weeks. Remembertochangeyourpatchatthe sametimeofday.Itisimportantthat youmakeanoteofthetimeofday. 6507181
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Duration of treatment Yourdoctorwilltellyouhowlongyou shouldbetreatedwiththeBuTrans patch.Donotstoptreatmentwithout consultingadoctor,becauseyourpain mayreturnandyoumayfeelunwell (seealsoIfyoustopusingBuTrans patchesbelow). Ifyoufeelthattheeffectofthe BuTranspatchistooweakor toostrong,talktoyourdoctoror pharmacist. If you use more BuTrans patches than you should Assoonasyoudiscoverthatyou haveusedmorepatchesthanyou should,removeallpatchesandcall yourdoctororhospitalstraightaway. Peoplewhohavetakenanoverdose mayfeelverysleepyandsick.They mayalsohavebreathingdifficulties orloseconsciousnessandmayneed emergencytreatmentinhospital.When seekingmedicalattentionmakesurethat youtakethisleafletandanyremaining patcheswithyoutoshowtothedoctor. If you forget to apply the BuTrans patch Stickanewpatchonassoonasyou remember.Alsomakeanoteofthe date,asyourusualdayofchanging
maynowbedifferent.Ifyouarevery latechangingyourpatch,yourpainmay return.Inthiscase,pleasecontactyour doctor. Donotapplyadditionalpatchestomake upfortheforgottenapplication. If you stop using BuTrans patches IfyoustopusingBuTranspatchestoo soonoryouinterruptyourtreatment yourpainmayreturn.Ifyouwishtostop treatmentpleaseconsultyourdoctor. Theywilltellyouwhatcanbedoneand whetheryoucanbetreatedwithother medicines. Somepeoplemayhavesideeffects whentheyhaveusedstrongpainkillers foralongtimeandstopusingthem. Theriskofhavingeffectsafterstopping BuTranspatchesisverylow.However, ifyoufeelagitated,anxious,nervous orshaky,ifyouareoveractive,have difficultysleepingordigestiveproblems, tellyourdoctor. ThepainrelievingeffectofBuTrans patchismaintainedforsometimeafter removalofthepatch.Youshouldnot startanotheropioidanalgesic(strong painkiller)within24hoursafterremoval ofthepatch. Ifyouhaveanyfurtherquestionsonthe useofthisproduct,askyourdoctoror pharmacist.
4. Possible side effects LikeallmedicinesBuTranspatches canhavesideeffects,althoughnot everybodygetsthem. Serioussideeffectsthatmaybe associatedwithBuTranspatchesare similartothoseseenwithotherstrong painkillersandincludedifficultyin breathingandlowbloodpressure. Thismedicinecancauseallergic reactions,althoughseriousallergic reactionsarerare.Removethepatch andtellyourdoctorimmediately ifyougetanysuddenwheeziness, difficultiesinbreathing,swelling oftheeyelids,faceorlips,rashor itchingespeciallythosecoveringyour wholebody. Aswithallstrongpainkillers,thereis ariskthatyoumaybecomeaddicted orreliantonBuTranspatches. InpatientstreatedwithBuTrans patches,thefollowingotherside effectshavebeenreported: Very common (probablyoccurringin morethan1in10people) Headache,dizziness,drowsiness. Constipation,drymouth,feelingor actuallybeingsick. Itching,redness,itchingat applicationsite.
Common (probablyoccurringin between1and10outofevery100 people) Lossofappetite. Confusion,depression,difficultyin sleeping,nervousness. Tinglingornumbness. Flushingoftheskin. Shortnessofbreath. Abdominalpainordiscomfort, diarrhoea,indigestion. Sweating,rash,skineruptions. Tiredness,afeelingofunusual weakness,muscleweakness,pain, chestpain,swellingofhands, anklesorfeet,rednessorrashatthe applicationsite. Uncommon (probablyoccurringin between1and10outofevery1,000 people) Dehydration. Moodswings,restlessness, agitation,anxiety,feelingdetached fromoneself,afeelingofextreme happiness,hallucinations, nightmares. Changesintaste,difficultyin speaking,reducedsensitivityto painortouch,lossofmemory, migraine,fainting,shaking, problemswithconcentrationorcoordination. Dryeyes,blurredvision.
Aringingorbuzzingsoundin theears,afeelingofdizzinessor spinning. Highorlowbloodpressure,angina (severechestpainassociatedwith heartdisease),fastorirregularheart beat. Worseningofbreathingproblems associatedwithasthma,cough, hiccups,overbreathing,reduced oxygenintheblood,runnynose, wheezing. Wind. Weightloss. Dryskin,swellingoftheface. Musclecramps,spasms,achesand pains. Difficultyinpassingurine. Aflulikeillness,hightemperature, shivering,generallyfeelingunwell. Anincreaseinaccidentalinjuries (e.g.falls). Withdrawalsymptomssuchas agitation,anxiousness,sweating orshakinguponstoppingusing BuTranspatches. Ifyouneedtohavebloodtests remindyourdoctorthatyouareusing BuTranspatches.Thisisimportant becauseBuTranspatchesmaychange thewayyourliverworksandthis couldaffecttheresultsofsomeblood tests.
Rare (probablyoccurringinbetween 1and10outofevery10,000people) Decreasedsexualdrive,mental disorder. Difficultieswithbalance. Swellingoftheeyelids,areductionin sizeofthepupilsintheeye. Difficultyinbreathing. Diverticulitis(inflammationofthe intestine),difficultyinswallowing. Localallergicreactionwithmarked signsofswelling(insuchcases treatmentshouldbestopped). Decreasederection,sexual dysfunction. Very rare (probablyoccurringinfewer than1outofevery10,000people) Muscletwitching. Earpain. Blisters. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. How to store BuTrans patches Keepoutofthereachandsightof children. DonotuseBuTranspatchesafterthe expirydatewhichisstatedonthecarton andonthepouch.Theexpirydaterefers tothelastdayofthatmonth.Afterthe
expirydate,takeanyunusedpatches toapharmacy. DonotstoreBuTranspatchesabove 25C. Donotusethepatchifthepouchseal isbroken. Usedpatchesmustbefoldedoveron themselveswiththeadhesivelayer inwards,anddiscardedsafelyoutof sightandreachofchildren. 6. Further information what BuTrans patches contain Theactiveingredientis buprenorphine. BuTrans5microgram/hour transdermalpatch Eachtransdermalpatchcontains 5mgofbuprenorphineinapatch sizeof6.25cm2andreleasesabout 5microgramsofbuprenorphineper hour(overaperiodof7days). BuTrans 10microgram/hour transdermalpatch Eachtransdermalpatchcontains 10mgofbuprenorphineinapatch sizeof12.5cm2andreleasesabout 10microgramsofbuprenorphineper hour(overaperiodof7days).
BuTrans 20microgram/hour transdermalpatch Eachtransdermalpatchcontains 20mgofbuprenorphineinapatch sizeof25cm2andreleasesabout 20microgramsofbuprenorphineper hour(overaperiodof7days). Theotheringredientsare: Polyacrylate(Durotak387-2051 &387-2054) Levulinicacid Oleyloleate Povidone Polyethyleneterephthalate what BuTrans patches look like and contents of the pack Transdermalpatch Threesizesareavailable. 5micrograms/hour:square,beige colouredpatchwithroundedcorners markedBuTrans5g/h 10micrograms/hour:rectangular, beigecolouredpatchwithrounded cornersmarkedBuTrans10g/h 20micrograms/hour:square,beige colouredpatchwithroundedcorners markedBuTrans20g/h BuTranspatchesareavailablein cartonscontaining4poucheseach containingasinglepatch.
Marketing Authorisation Holder: NappPharmaceuticalsLimited, CambridgeSciencePark, MiltonRoad, CambridgeCB40GW, UK. Manufacturers: BardPharmaceuticalsLimited, CambridgeSciencePark, MiltonRoad, CambridgeCB40GW, UK MundipharmaDCB.V., DeWel20, 3871MVHoevelaken, TheNetherlands. This medicinal product is authorised in the Member States of the EEA under the following names: Austria Norspan Belgium Norspan CzechRepublic Norspan Denmark Norspan Estonia Norspan Finland Norspan Germany Norspan Hungary Norspan Iceland Norspan Latvia Norspan Lithuania Norspan
Luxembourg Netherlands Norway Poland Portugal
Norspan BuTrans Norspan Norspan Norspan
RepublicofIreland BuTrans SlovakRepublic Norspan Sweden Norspan UnitedKingdom BuTrans
Thisleafletisalsoavailableinlargeprint,Brailleoras anaudioCD.Torequestacopy,pleasecalltheRNIB MedicineInformationline(freeofcharge)on: You willneedtogivedetailsoftheproductnameand referencenumber. Theseareasfollows: Productname:BuTranspatches Referencenumber:16950/0136
This leaflet was last revised in May 2012 BuTranstransdermalpatchesareprotectedbyEuropeanPatent(UK)Nos. 0430019and0964677. BuTransandtheNAPPdevice(logo)areRegisteredTradeMarks 2007-2012NappPharmaceuticalsLtd You canalsogetsupportandinformationaboutarthritisfromArthritisCare: Phonefree:0808800405012pmto4pmMondaytoFriday(or02073806555 10amto4pmstandardcallchargesapply). Orwriteto:Helplines,ArthritisCare,18StephensonWay, London,NW12HD. Oremailhelplines@arthritiscare.org.uk 6507181
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Read all of this leaflet carefully before you start using this medicine. Keepthisleaflet.Youmayneedto readitagain. Ifyouhaveanyfurtherquestions, askyourdoctororpharmacist. Thismedicinehasbeenprescribed foryou.Donotpassitonto others.Itmayharmthem,even iftheirsymptomsarethesameas yours. Ifanyofthesideeffectsbecome serious,orifyounoticeany sideeffectsnotlistedinthis leaflet,pleasetellyourdoctoror pharmacist. In this leaflet: 1.WhatBuTranspatchesareand whattheyareusedfor 2.BeforeyouuseBuTranspatches 3.HowtouseBuTranspatches 4.Possiblesideeffects 5.HowtostoreBuTranspatches 6.Furtherinformation 1. what BuTrans patches are and what they are used for BuTranspatchescontainthe activeingredientbuprenorphine whichbelongstoagroupof medicinescalledstronganalgesics orpainkillers.Theyhavebeen prescribedforyoubyyourdoctor torelievemoderate,long-lasting painthatrequirestheuseofastrong painkiller. BuTranspatchesshouldnotbeused torelieveacutepain. BuTranspatchesactthrough theskin.Afterapplication, buprenorphinepassesthroughthe skinintotheblood.Eachpatchlasts forsevendays.
2. Before you use BuTrans patches Do not use BuTrans patches: ifyouareallergic(hypersensitive) tobuprenorphineoranyofthe otheringredientsofBuTrans patches; ifyouhavebreathingproblems; ifyouareaddictedtodrugs; ifyouaretakingatypeof medicineknownasamonoamine oxidaseinhibitor(examples includetranylcypromide, phenelzine,isocarboxazid, moclobamideandlinezolid), oryouhavetakenthistypeof medicineinthelasttwoweeks; ifyousufferfrommyasthenia gravis(aconditioninwhichthe musclesbecomeweak); ifyouhavepreviouslysuffered fromwithdrawalsymptomssuch asagitation,anxiety,shakingor sweatinguponstoppingtaking alcohol. BuTranspatchesmustnotbeusedto treatsymptomsassociatedwithdrug withdrawal.
Take special care with BuTrans patches BeforetreatmentwithBuTrans patchestellyourdoctororpharmacist: ifyousufferfromseizures,fitsor convulsions; ifyouhaveasevereheadacheor feelsickduetoaheadinjuryor increasedpressureinyourskull(for instanceduetobraindisease).This isbecausethepatchesmaymake symptomsworseorhidetheextent ofaheadinjury; ifyouarefeelinglight-headedor faint; ifyouhavesevereliverproblems; ifyouhaveeverbeenaddictedto drugs; ifyouhaveahightemperature,as thismayleadtolargerquantitiesof theactiveingredientbeingabsorbed intothebloodthannormal. Ifyouhaverecentlyhadanoperation, pleasespeaktoyourdoctorbefore usingthesepatches. Taking other medicines Pleasetellyourdoctororpharmacist ifyouaretakingorhaverecently takenanyothermedicines,including medicinesobtainedwithouta prescription.IfyouuseBuTrans patcheswithsomeothermedicines,the
effectofBuTranspatchesortheother medicinemaybechanged. BuTranspatchesmustnotbeused togetherwithatypeofmedicine knownasamonoamineoxidase inhibitor(examplesinclude tranylcypromide,phenelzine, isocarboxazid,moclobamideand linezolid),orifyouhavetakenthis typeofmedicineinthelasttwo weeks. Ifyoutakesomemedicinessuch asphenobarbitalorphenytoin (medicinescommonlyusedto treatseizures,fitsorconvulsions), carbamazepine(amedicineto treatseizures,fitsorconvulsions andcertainpainconditions),or rifampicin(amedicinetotreat tuberculosis)theeffectsofBuTrans patchesmaybereduced. BuTranspatchesmaymakesome peoplefeeldrowsy,sickorfaintor makethembreathemoreslowly orweakly.Thesesideeffectsmay bemadeworseifothermedicines thatproducethesameeffectsare takenatthesametime.These includecertainmedicinestotreat depression,anxiety,psychiatric ormentaldisorders,medicines tohelpyousleep,medicinesto treathighbloodpressuresuchas
clonidine,otheropioids(whichmay befoundinpainkillersorcertain coughmixturese.g.morphine, dextropropoxyphene,codeine, dextromethorphan,noscapine), antihistamineswhichmakeyou drowsy,oranaestheticssuchas halothane. BuTranspatchesmustnotbeused togetherwithbenzodiazepines (medicinesusedtotreatanxiety ortohelpyousleep).This combinationmaycauseserious breathingproblemswhichmaybe fatal. Using BuTrans patches with alcohol Alcoholmaymakesomeoftheside effectsworseandyoumayfeelunwell ifyoudrinkalcoholwhilstwearing BuTranspatches.Drinkingalcohol whilstusingBuTranspatchesmay alsoaffectyourreactiontime. Pregnancy and breastfeeding YoushouldnotuseBuTranspatches ifyouarepregnant,likelytobecome pregnantorarebreastfeeding. Askyourdoctororpharmacistfor advicebeforetakinganymedicines.
Driving and using machines BuTranspatchesmayaffectyour reactionstosuchanextentthatyou maynotreactadequatelyorquickly enoughintheeventofunexpected orsuddenoccurrences.Thisapplies particularly: atthebeginningoftreatment; ifyouaretakingmedicinestotreat anxietyorhelpyousleep; ifyourdoseisincreased. Ifyouareaffectedyoushouldnot driveoroperatemachinerywhilst usingBuTranspatches,orfor24 hoursafterremovingthepatch. 3. How to use BuTrans patches ThreedifferentstrengthsofBuTrans patchesareavailable.Yourdoctorwill decidewhichstrengthofBuTrans patchwillsuityoubest.During treatment,yourdoctormaychangethe patchyouusetoasmallerorlarger oneifnecessary.You should not apply more than two patches at the same time, regardless of the patch strength. AlwaysusetheBuTranspatch exactlyasyourdoctorhastoldyou. Youshouldcheckwithyourdoctoror pharmacistifyouarenotsure.
Adults and elderly patients Unlessyourdoctorhastoldyou differently,attachoneBuTrans patch(asdescribedindetailbelow) andchangeiteveryseventhday, preferablyatthesametimeofday. Yourdoctormaywishtoadjustthe doseafter3-7daysuntilthecorrect levelofpaincontrolhasbeenfound. Ifyourdoctorhasadvisedyouto takeotherpainkillersinadditionto thepatch,strictlyfollowthedoctors instructions,otherwiseyouwillnot fullybenefitfromtreatmentwiththe BuTranspatch.Thepatchshouldbe wornfor3fulldaysbeforeincreasing thedose,thisiswhenthemaximum effectofagivendoseisestablished. Patients under 18 years of age BuTranspatchesshouldnotbeused inpatientsbelowtheageof18years. Patients with kidney disease/dialysis patients Inpatientswithkidneydisease,no changeindoseisnecessary. Patients with liver disease Inpatientswithliverdisease,the effectsandperiodofactionofthe BuTranspatchmaybeaffectedand yourdoctorwillthereforecheckon youmoreclosely.
Before applying the BuTrans patch Chooseanareaofnon-irritated, intactskinonyourupperarm, outerarm,upperchest,upper backorsideofthechest.(See illustrationsbelow).Askfor assistanceifyoucannotapplythe patchyourself.
TheBuTranspatchshouldbe appliedtoarelativelyhairless ornearlyhairlessskinsite.Ifno suitablehairfreesitesareavailable thehairsshouldbecutoffwitha pairofscissors.Donotshavethem off. Avoidskinwhichisred,irritated orhasanyotherblemishes,for instancelargescars. Theareaofskinyouchoosemust bedryandclean.Ifnecessary, washitwithcoldorlukewarm water.Donotusesoap,alcohol, oil,lotionsorotherdetergents. Afterahotbathorshower,wait untilyourskiniscompletelydry andcool.Donotapplylotion, creamorointmenttothechosen area.Thismightpreventyour patchfromstickingproperly.
Applying the patch Step1:Eachpatchissealed inapouch.Justbeforeuse, openthepouchbytearing whereindicated.Takeout thepatch.Donotusethe patchifthepouchsealisbroken. Step2:Thestickysideofthepatchis coveredwithasilveryprotectivefoil. Carefullypeeloffhalfthefoil.Trynotto touchthestickypartofthepatch. Step3:Stickthepatchontotheareaof skinyouhavechosenand removetheremainingfoil. Step4:Pressthepatch againstyourskinwiththe palmofyourhandandcountslowlyto 30.Makesurethatthewholepatchisin contactwithyourskin,especiallyatthe edges. wearing the patch You shouldwearthepatchforseven days.Providedthatyouhaveapplied thepatchcorrectly,thereislittleriskof itcomingoff.Iftheedgesofthepatch begintopeeloff,theymaybetaped downwithasuitableskintape.You may shower,batheorswimwhilstwearingit. Donotexposethepatchtoextremeheat (e.g.heatingpads,electricblanket,heat lamps,sauna,hottubs,heatedwater
beds,hotwaterbottle,etc)asthismay leadtolargerquantitiesoftheactive ingredientbeingabsorbedintotheblood thannormal.Externalheatmayalso preventthepatchfromstickingproperly. Ifyouhaveahightemperaturethismay altertheeffectsofBuTranspatches(see Takespecialcaresectionabove). Intheunlikelyeventthatyourpatchfalls offbeforeitneedschanging,donotuse thesamepatchagain.Stickanewoneon straightaway(seeChangingthepatch below). Changing the patch Taketheoldpatchoff. Folditinhalfwiththestickyside inwards. Openandtakeoutanewpatch.Use theemptypouchtodisposeoftheold patch.Nowdiscardthepouchsafely. Evenusedpatchescontainsome activeingredientthatmayharm childrenoranimals,somakesureyour usedpatchesarealwayskeptoutof thereachandsightofthem. Stickanewpatchonadifferent appropriateskinsite(asdescribed above).You shouldnotapplyanew patchtothesamesitefor3-4weeks. Remembertochangeyourpatchatthe sametimeofday.Itisimportantthat youmakeanoteofthetimeofday. 6507181
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Duration of treatment Yourdoctorwilltellyouhowlongyou shouldbetreatedwiththeBuTrans patch.Donotstoptreatmentwithout consultingadoctor,becauseyourpain mayreturnandyoumayfeelunwell (seealsoIfyoustopusingBuTrans patchesbelow). Ifyoufeelthattheeffectofthe BuTranspatchistooweakor toostrong,talktoyourdoctoror pharmacist. If you use more BuTrans patches than you should Assoonasyoudiscoverthatyou haveusedmorepatchesthanyou should,removeallpatchesandcall yourdoctororhospitalstraightaway. Peoplewhohavetakenanoverdose mayfeelverysleepyandsick.They mayalsohavebreathingdifficulties orloseconsciousnessandmayneed emergencytreatmentinhospital.When seekingmedicalattentionmakesurethat youtakethisleafletandanyremaining patcheswithyoutoshowtothedoctor. If you forget to apply the BuTrans patch Stickanewpatchonassoonasyou remember.Alsomakeanoteofthe date,asyourusualdayofchanging
maynowbedifferent.Ifyouarevery latechangingyourpatch,yourpainmay return.Inthiscase,pleasecontactyour doctor. Donotapplyadditionalpatchestomake upfortheforgottenapplication. If you stop using BuTrans patches IfyoustopusingBuTranspatchestoo soonoryouinterruptyourtreatment yourpainmayreturn.Ifyouwishtostop treatmentpleaseconsultyourdoctor. Theywilltellyouwhatcanbedoneand whetheryoucanbetreatedwithother medicines. Somepeoplemayhavesideeffects whentheyhaveusedstrongpainkillers foralongtimeandstopusingthem. Theriskofhavingeffectsafterstopping BuTranspatchesisverylow.However, ifyoufeelagitated,anxious,nervous orshaky,ifyouareoveractive,have difficultysleepingordigestiveproblems, tellyourdoctor. ThepainrelievingeffectofBuTrans patchismaintainedforsometimeafter removalofthepatch.Youshouldnot startanotheropioidanalgesic(strong painkiller)within24hoursafterremoval ofthepatch. Ifyouhaveanyfurtherquestionsonthe useofthisproduct,askyourdoctoror pharmacist.
4. Possible side effects LikeallmedicinesBuTranspatches canhavesideeffects,althoughnot everybodygetsthem. Serioussideeffectsthatmaybe associatedwithBuTranspatchesare similartothoseseenwithotherstrong painkillersandincludedifficultyin breathingandlowbloodpressure. Thismedicinecancauseallergic reactions,althoughseriousallergic reactionsarerare.Removethepatch andtellyourdoctorimmediately ifyougetanysuddenwheeziness, difficultiesinbreathing,swelling oftheeyelids,faceorlips,rashor itchingespeciallythosecoveringyour wholebody. Aswithallstrongpainkillers,thereis ariskthatyoumaybecomeaddicted orreliantonBuTranspatches. InpatientstreatedwithBuTrans patches,thefollowingotherside effectshavebeenreported: Very common (probablyoccurringin morethan1in10people) Headache,dizziness,drowsiness. Constipation,drymouth,feelingor actuallybeingsick. Itching,redness,itchingat applicationsite.
Common (probablyoccurringin between1and10outofevery100 people) Lossofappetite. Confusion,depression,difficultyin sleeping,nervousness. Tinglingornumbness. Flushingoftheskin. Shortnessofbreath. Abdominalpainordiscomfort, diarrhoea,indigestion. Sweating,rash,skineruptions. Tiredness,afeelingofunusual weakness,muscleweakness,pain, chestpain,swellingofhands, anklesorfeet,rednessorrashatthe applicationsite. Uncommon (probablyoccurringin between1and10outofevery1,000 people) Dehydration. Moodswings,restlessness, agitation,anxiety,feelingdetached fromoneself,afeelingofextreme happiness,hallucinations, nightmares. Changesintaste,difficultyin speaking,reducedsensitivityto painortouch,lossofmemory, migraine,fainting,shaking, problemswithconcentrationorcoordination. Dryeyes,blurredvision.
Aringingorbuzzingsoundin theears,afeelingofdizzinessor spinning. Highorlowbloodpressure,angina (severechestpainassociatedwith heartdisease),fastorirregularheart beat. Worseningofbreathingproblems associatedwithasthma,cough, hiccups,overbreathing,reduced oxygenintheblood,runnynose, wheezing. Wind. Weightloss. Dryskin,swellingoftheface. Musclecramps,spasms,achesand pains. Difficultyinpassingurine. Aflulikeillness,hightemperature, shivering,generallyfeelingunwell. Anincreaseinaccidentalinjuries (e.g.falls). Withdrawalsymptomssuchas agitation,anxiousness,sweating orshakinguponstoppingusing BuTranspatches. Ifyouneedtohavebloodtests remindyourdoctorthatyouareusing BuTranspatches.Thisisimportant becauseBuTranspatchesmaychange thewayyourliverworksandthis couldaffecttheresultsofsomeblood tests.
Rare (probablyoccurringinbetween 1and10outofevery10,000people) Decreasedsexualdrive,mental disorder. Difficultieswithbalance. Swellingoftheeyelids,areductionin sizeofthepupilsintheeye. Difficultyinbreathing. Diverticulitis(inflammationofthe intestine),difficultyinswallowing. Localallergicreactionwithmarked signsofswelling(insuchcases treatmentshouldbestopped). Decreasederection,sexual dysfunction. Very rare (probablyoccurringinfewer than1outofevery10,000people) Muscletwitching. Earpain. Blisters. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. How to store BuTrans patches Keepoutofthereachandsightof children. DonotuseBuTranspatchesafterthe expirydatewhichisstatedonthecarton andonthepouch.Theexpirydaterefers tothelastdayofthatmonth.Afterthe
expirydate,takeanyunusedpatches toapharmacy. DonotstoreBuTranspatchesabove 25C. Donotusethepatchifthepouchseal isbroken. Usedpatchesmustbefoldedoveron themselveswiththeadhesivelayer inwards,anddiscardedsafelyoutof sightandreachofchildren. 6. Further information what BuTrans patches contain Theactiveingredientis buprenorphine. BuTrans5microgram/hour transdermalpatch Eachtransdermalpatchcontains 5mgofbuprenorphineinapatch sizeof6.25cm2andreleasesabout 5microgramsofbuprenorphineper hour(overaperiodof7days). BuTrans 10microgram/hour transdermalpatch Eachtransdermalpatchcontains 10mgofbuprenorphineinapatch sizeof12.5cm2andreleasesabout 10microgramsofbuprenorphineper hour(overaperiodof7days).
BuTrans 20microgram/hour transdermalpatch Eachtransdermalpatchcontains 20mgofbuprenorphineinapatch sizeof25cm2andreleasesabout 20microgramsofbuprenorphineper hour(overaperiodof7days). Theotheringredientsare: Polyacrylate(Durotak387-2051 &387-2054) Levulinicacid Oleyloleate Povidone Polyethyleneterephthalate what BuTrans patches look like and contents of the pack Transdermalpatch Threesizesareavailable. 5micrograms/hour:square,beige colouredpatchwithroundedcorners markedBuTrans5g/h 10micrograms/hour:rectangular, beigecolouredpatchwithrounded cornersmarkedBuTrans10g/h 20micrograms/hour:square,beige colouredpatchwithroundedcorners markedBuTrans20g/h BuTranspatchesareavailablein cartonscontaining4poucheseach containingasinglepatch.
Marketing Authorisation Holder: NappPharmaceuticalsLimited, CambridgeSciencePark, MiltonRoad, CambridgeCB40GW, UK. Manufacturers: BardPharmaceuticalsLimited, CambridgeSciencePark, MiltonRoad, CambridgeCB40GW, UK MundipharmaDCB.V., DeWel20, 3871MVHoevelaken, TheNetherlands. This medicinal product is authorised in the Member States of the EEA under the following names: Austria Norspan Belgium Norspan CzechRepublic Norspan Denmark Norspan Estonia Norspan Finland Norspan Germany Norspan Hungary Norspan Iceland Norspan Latvia Norspan Lithuania Norspan
Luxembourg Netherlands Norway Poland Portugal
Norspan BuTrans Norspan Norspan Norspan
RepublicofIreland BuTrans SlovakRepublic Norspan Sweden Norspan UnitedKingdom BuTrans
Thisleafletisalsoavailableinlargeprint,Brailleoras anaudioCD.Torequestacopy,pleasecalltheRNIB MedicineInformationline(freeofcharge)on: You willneedtogivedetailsoftheproductnameand referencenumber. Theseareasfollows: Productname:BuTranspatches Referencenumber:16950/0136
This leaflet was last revised in May 2012 BuTranstransdermalpatchesareprotectedbyEuropeanPatent(UK)Nos. 0430019and0964677. BuTransandtheNAPPdevice(logo)areRegisteredTradeMarks 2007-2012NappPharmaceuticalsLtd You canalsogetsupportandinformationaboutarthritisfromArthritisCare: Phonefree:0808800405012pmto4pmMondaytoFriday(or02073806555 10amto4pmstandardcallchargesapply). Orwriteto:Helplines,ArthritisCare,18StephensonWay, London,NW12HD. Oremailhelplines@arthritiscare.org.uk 6507181
0800 198 5000
BUTRANS PIL UK 6507181 V2.indd 3
27/04/2012 18:53
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
