ABSTRAL

Main information

  • Trade name:
  • ABSTRAL Tablet Sublingual 50 Microgram
  • Dosage:
  • 50 Microgram
  • Pharmaceutical form:
  • Tablet Sublingual
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ABSTRAL Tablet Sublingual 50 Microgram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1049/006/001
  • Authorization date:
  • 22-05-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA1049/006/001

CaseNo:2059445

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

ProStrakanLimited

GalabankBusinessPark,Galashiels,TD11QH,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Abstral50microgramsublingualtablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom29/09/2009until21/05/2014.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Abstral50microgramsublingualtablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachsublingualtabletcontains:

50microgramsfentanyl(ascitrate)

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Sublingualtablet

50microgramsublingualtabletisawhitepentagon-shapedtablet

4CLINICALPARTICULARS

4.1TherapeuticIndications

Managementofbreakthroughpaininadultpatientsusingopioidtherapyforchroniccancerpain.Breakthroughpainis

atransientexacerbationofotherwisecontrolledchronicbackgroundpain.

4.2Posologyandmethodofadministration

Abstralshouldonlybeadministeredtopatientswhoareconsideredtoleranttotheiropioidtherapyforpersistentcancer

pain.Patientscanbeconsideredopioidtolerantiftheytakeatleast60mgoralmorphineperday,25micrograms

transdermalfentanylperhour,oranequianalgesicdoseofanotheropioidforaweekorlonger.

Abstralsublingualtabletsshouldbeadministereddirectlyunderthetongueatthedeepestpart.Abstralsublingual

tabletsshouldnotbeswallowed,butallowedtocompletelydissolveinthesublingualcavitywithoutchewingor

sucking.Patientsshouldbeadvisednottoeatordrinkanythinguntilthesublingualtabletiscompletelydissolved.

InpatientswhohaveadrymouthwatermaybeusedtomoistenthebuccalmucosabeforetakingAbstral.

Dosetitration:

Theobjectofdosetitrationistoidentifyanoptimalmaintenancedoseforongoingtreatmentofbreakthroughpain

episodes.Thisoptimaldoseshouldprovideadequateanalgesiawithanacceptablelevelofadversereactions.

TheoptimaldoseofAbstralwillbedeterminedbyupwardtitration,onanindividualpatientbasis. Severaldosesare

availableforuseduringthedosetitrationphase.TheinitialdoseofAbstralusedshouldbe100micrograms,titrating

upwardsasnecessarythroughtherangeofavailabledosagestrengths.

Patientsshouldbecarefullymonitoreduntilanoptimaldoseisreached.

SwitchingfromotherfentanylcontainingproductstoAbstralmustnotoccurata1:1ratiobecauseof

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withAbstralisrequired.

Thefollowingdoseregimenisrecommendedfortitration,althoughinallcasesthephysicianshouldtakeintoaccount

theclinicalneedofthepatient,ageandconcomitantillness.

Allpatientsmuststarttherapywithasingle100microgramsublingualtablet.Ifadequateanalgesiaisnotobtained

within15-30minutesofadministrationofasinglesublingualtablet,asupplemental(second)100microgram

sublingualtabletmaybeadministered.Ifadequateanalgesiaisnotobtainedwithin15-30minutesofthefirstdosean

increaseindosetothenexthighesttabletstrengthshouldbeconsideredforthenextepisodeofbreakthroughpain

(Refertofigurebelow).Doseescalationshouldcontinueinastepwisemanneruntiladequateanalgesiaisachieved.

Thedosestrengthforthesupplemental(second)sublingualtabletshouldbeincreasedfrom100to200microgramsat

dosesof400microgramsandhigher.Thisisillustratedintheschedulebelow.Nomorethantwo(2)sublingualtablets

shouldbeadministeredforasingleepisodeofbreakthroughpainduringthistitrationphase.

Ifadequateanalgesiaisachievedatthehigherdose,butundesirableeffectsareconsideredunacceptable,an

intermediatedose(usingthe100microgramsublingualtabletwhereappropriate)maybeadministered.

Strength(micrograms)offirstsublingualtablet

perepisodeofbreakthroughpain Strength(micrograms)ofsupplemental(second)sublingualtabletto

betaken15-30minutesafterfirsttablet,ifrequired

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Inordertominimisetheriskofopioid–relatedadversereactionsandtoidentifytheappropriatedose,itisimperative

thatpatientsbemonitoredcloselybyhealthprofessionalsduringthetitrationprocess.

Maintenancetherapy:

Onceanappropriatedosehasbeenestablished,whichmaybemorethanonetablet,patientsshouldbemaintainedon

thisdoseandshouldlimitconsumptiontoamaximumoffourAbstraldosesperday.

Dosere-adjustment:

Iftheresponse(analgesiaoradversereactions)tothetitratedAbstraldosemarkedlychanges,anadjustmentofdose

maybenecessarytoensurethatanoptimaldoseismaintained.

Ifmorethanfourepisodesofbreakthroughpainareexperiencedperdayoveraperiodofmorethanfourconsecutive

days,thenthedoseofthelongactingopioidusedforpersistentpainshouldbere-evaluated.Ifthelongactingopioid

ordoseoflongactingopioidischangedtheAbstraldoseshouldbere-evaluatedandre-titratedasnecessarytoensure

thepatientisonanoptimaldose.

Itisimperativethatanydosere-titrationofanyanalgesicismonitoredbyahealthprofessional.

Discontinuationoftherapy:

Forpatientsnolongerrequiringanyopioidtherapy,theAbstraldoseshouldbetakenintoconsiderationbeforea

gradualdownwardtitrationofopioidstominimisepossiblewithdrawaleffects.

Inpatientswhocontinuetotaketheirchronicopioidtherapyforpersistentpainbutnolongerrequiretreatmentfor

breakthroughpain,Abstraltherapymayusuallybediscontinuedimmediately.

Useinchildrenandadolescents:

Abstralmustnotbeusedinpatientslessthan18yearsofageduetoalackofdataonsafetyandefficacy.

Useinelderlypatients

Dosetitrationneedstobeapproachedwithparticularcareandpatientsobservedcarefullyforsignsoffentanyltoxicity

(seesection4.4).

Useinpatientswithrenalandhepaticimpairment

PatientswithkidneyorliverdysfunctionshouldbecarefullyobservedforsignsoffentanyltoxicityduringtheAbstral

titrationphase(seesection4.4).

4.3Contraindications

Hypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Opioid-naïvepatientsbecauseoftheriskoflife-threateningrespiratorydepression.

Severerespiratorydepressionorsevereobstructivelungconditions.

4.4Specialwarningsandprecautionsforuse

PatientsandtheircarersmustbeinstructedthatAbstralcontainsanactivesubstanceinanamountthatcanbefataltoa

child,andthereforetokeepalltabletsoutofthereachandsightofchildren.

DuetothepotentiallyseriousundesirableeffectsthatcanoccurwhentakinganopioidtherapysuchasAbstral,patients

andtheircarersshouldbemadefullyawareoftheimportanceoftakingAbstralcorrectlyandwhatactiontotake

shouldsymptomsofoverdoseoccur.

BeforeAbstraltherapyisinitiated,itisimportantthatthepatient’slong-actingopioidtreatmentusedtocontroltheir

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Uponrepeatedadministrationofopioidssuchasfentanyl,toleranceandphysicaland/orpsychologicaldependencemay

develop.Iatrogenicaddictionfollowingtherapeuticuseofopioidsisrare.

Incommonwithallopioids,thereisariskofclinicallysignificantrespiratorydepressionassociatedwiththeuseof

Abstral.ParticularcautionshouldbeexercisedduringdosetitrationwithAbstralinpatientswithchronicobstructive

pulmonarydiseaseorothermedicalconditionspredisposingthemtorespiratorydepression(e.g.myastheniagravis)

becauseoftheriskoffurtherrespiratorydepression,whichcouldleadtorespiratoryfailure.

Abstralshouldonlybeadministeredwithextremecautioninpatientswhomaybeparticularlysusceptibletothe

intracranialeffectsofhyperkapnia,suchasthoseshowingevidenceofraisedintracranialpressure,reduced

consciousness,comaorbraintumours.Inpatientswithheadinjuries,theclinicalcoursemaybemaskedbytheuseof

opioids.Insuchacase,opioidsshouldbeusedonlyifabsolutelynecessary.

Intravenousfentanylhasbeenshowntocausebradycardia.Abstralshouldbeusedwithcautioninpatientswith

bradyarrhythmias.

Datafromintravenousstudieswithfentanylsuggestthatelderlypatientsmayhavereducedclearance,aprolongedhalf-

lifeandtheymaybemoresensitivetotheactivesubstancethanyoungerpatients.Elderly,cachectic,ordebilitated

patientsshouldbeobservedcarefullyforsignsoffentanyltoxicityandthedosereducedifnecessary.

Abstralshouldbeadministeredwithcautiontopatientswithliverorkidneydysfunction,especiallyduringthetitration

phase.TheuseofAbstralinpatientswithhepaticorrenalimpairmentmayincreasethebioavailabilityoffentanyland

decreaseitssystemicclearance,whichcouldleadtoaccumulationandincreasedandprolongedopioideffects.

Careshouldbetakenintreatingpatientswithhypovolaemiaandhypotension.

Abstralhasnotbeenstudiedinpatientswithmouthwoundsormucositis.Theremaybeariskofincreasedsystemic

drugexposureinsuchpatientsandthereforeextracautionisrecommendedduringdosetitration.

ThereshouldbenonoticeableeffectsoncessationoftreatmentwithAbstral,butpossiblesymptomsof

withdrawalareanxiety,tremor,sweating,paleness,nauseaandvomiting.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

FentanylismetabolisedbyCYP3A4.ActivesubstancesthatinhibitCYP3A4activitysuchasmacrolideantibiotics

(e.g.erythromycin),azoleantifungalagents(e.g.ketoconazole,itraconazole)orcertainproteaseinhibitors(e.g.

ritonavir)mayincreasethebioavailabilityoffentanylbydecreasingitssystemicclearance,potentiallyenhancingor

prolongingopioideffects.GrapefruitjuiceisalsoknowntoinhibitCYP3A4.Fentanylshouldthereforebegivento

patientswithcautionifadministeredconcomitantlywithCYP3A4inhibitors.

ConcomitantuseofotherCNSdepressants,suchasothermorphinederivatives(analgesicsandantitussives),general

anaesthetics,skeletalmusclerelaxants,sedativeantidepressants,sedativeH1antihistamines,barbiturates,anxiolytics

(iebenzodiazepines),hypnotics,antipsychotics,clonidineandrelatedsubstancesmayproduceincreasedCNS

depressanteffects.Respiratorydepression,hypotensionandprofoundsedationmayoccur.

Alcoholpotentiatesthesedativeeffectsofmorphine-basedanalgesics,thereforeconcomitantadministrationof

alcoholicbeveragesormedicinalproductscontainingalcoholwithAbstralisnotrecommended.

Abstralisnotrecommendedforuseinpatientswhohavereceivedmonoamineoxidase(MAO)inhibitorswithin14

daysbecausesevereandunpredictablepotentiationbyMAOinhibitorshasbeenreportedwithopioidanalgesics.

Theconcomitantuseofpartialopioidagonists/antagonists(e.g.buprenorphine,nalbuphine,pentazocine)isnot

recommended.Theyhavehighaffinitytoopioidreceptorswithrelativelylowintrinsicactivityandthereforepartially

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4.6Pregnancyandlactation

Thesafetyoffentanylinpregnancyhasnotbeenestablished.Studiesinanimalshaveshownreproductivetoxicity(see

section5.3).Thepotentialriskforhumansisunknown.Fentanylshouldonlybeusedduringpregnancywhenclearly

necessary.

Long-termtreatmentduringpregnancymaycausewithdrawalsymptomsinthenew-borninfant.

Fentanylshouldnotbeusedduringlabouranddelivery(includingcaesareansection)sincefentanylcrossesthe

placentaandmaycauserespiratorydepressioninthefoetusorinthenew-borninfant.

Fentanylisexcretedintobreastmilkandmaycausesedationandrespiratorydepressioninthebreast-fedchild.

Fentanylshouldonlybeusedbybreast-feedingwomenifthebenefitsclearlyoutweighthepotentialrisksforboth

motherandchild.

4.7Effectsonabilitytodriveandusemachines

Nostudiesontheeffectsontheabilitytodriveandusemachineshavebeenperformed.

However,fentanylmayimpairthementalorphysicalabilitytoperformpotentiallyhazardoustaskssuchasdrivingor

operatingmachinery.Patientsshouldbeadvisednottodriveoroperatemachineryiftheybecomedizzyordrowsyor

experienceblurredordoublevisionwhiletakingAbstral.

4.8Undesirableeffects

UndesirableeffectstypicalofopioidsaretobeexpectedwithAbstral;theytendtodecreaseinintensitywithcontinued

use.Themostseriouspotentialadversereactionsassociatedwithopioidusearerespiratorydepression(whichcould

leadtorespiratoryarrest),hypotensionandshock.Otherverycommonlyreportedadversereactionsinclude:nausea,

vomiting,constipation,headache,somnolence/fatigueanddizziness.

AdversereactionsfromclinicalstudieswithAbstralinpatientsandvolunteers,withasuspectedrelationshipto

treatment,arelistedbelowbysystemorganclassandfrequency(verycommon 1/10;common 1/100to<1/10).

Withineachfrequencygrouping,undesirableeffectsarepresentedinorderofdecreasingseriousness.

Nervoussystemdisorders

Verycommon:Dizziness,somnolence,headache

Common:Vasovagalreaction,hypoaesthesia,paraesthesia,hyperacusis

Eyedisorders

Common:Visionabnormal

Respiratory,thoracicandmediastinaldisorders

Common:Respiratorydepression,rhinitis,pharyngitis

Gastrointestinaldisorders

Verycommon:Nausea

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Skinandsubcutaneoustissuedisorders

Common:Rash,pruritus

Vasculardisorders

Common:Orthostatichypotension,flushing,hotflush

Generaldisordersandadministrationsiteconditions

Verycommon:Fatigue

Common:Asthenia,applicationsiteirritation

Psychiatricdisorders

Common:Depression,anorexia,concentrationimpaired,euphoria

AlltheaboveadversereactionswerereportedinopioidnaïvevolunteersadministeredwithAbstral.Patients(n=23)

treatedwithAbstralonlyexperienceddizziness,nauseaandvomiting.

Thefollowingadversereactionsassociatedwithothermedicinalproductscontainingfentanylhavealsobeenreported

(verycommon 1/10;common 1/100to<1/10;uncommon 1/1000to<1/100;rare 1/10,000to<1/1000;very

rare<1/10,000;notknown(cannotbeestimatedfromavailabledata)):

Cardiacdisorders

Uncommon:Bradycardia,tachycardia,hypertension

Veryrare:Arrhythmias

Nervoussystemdisorders

Common:Myoclonus,insomnia,tastedisorders

Uncommon:Abnormalgait/coordination,vertigo,amnesia,speechdisorders,tremor

Respiratorythoracicandmediastinaldisorders

Uncommon:Hypoventilation,asthma,dyspnoea,

Veryrare:Apnoea,haemoptysis

Gastrointestinaldisorders

Common:Gastro-intestinalocclusion,dysphagia,mouthulcers/stomatitis,tonguedisorder

Uncommon:Enlargedabdomen,flatulence,thirst

Rare:Hiccups

Renalandurinarydisorders

Uncommon:Urinaryretention,changeinurinaryfrequency

Veryrare:bladderspasm,oliguria

Skinandsubcutaneoustissuedisorders

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Injury,poisoningandproceduralcomplications

Common:Accidentalinjuries

Vasculardisorders

Common:Vasodilation

Generaldisordersandadministrationsiteconditions

Uncommon:Malaise

Psychiatricdisorders

Common:Hallucinations,confusion,anxiety,nervousness,abnormalthinking,abnormaldreams

Uncommon:Agitation,depersonalisation,emotionallability

4.9Overdose

Thesymptomsoffentanyloverdoseareanextensionofitspharmacologicalactions,themostseriouseffectbeing

respiratorydepression,whichmayleadtorespiratoryarrest.

ManagementofopioidoverdoseintheimmediatetermincludesremovalofanyremainingAbstralsublingualtablets

fromthemouth,physicalandverbalstimulationofthepatientandanassessmentofthelevelofconsciousness.A

patentairwayshouldbeestablishedandmaintained.Ifnecessaryanoropharyngealairwayorendotrachealtubeshould

beinserted,oxygenadministeredandmechanicalventilationinitiated,asappropriate.Adequatebodytemperatureand

parenteralfluidintakeshouldbemaintained.

Forthetreatmentofaccidentaloverdoseinopioid-naïveindividuals,naloxoneorotheropioidantagonistsshouldbe

usedasclinicallyindicatedandinaccordancewiththeirSummaryofProductCharacteristics.Repeatedadministration

oftheopioidantagonistmaybenecessaryifthedurationofrespiratorydepressionisprolonged.

Careshouldbetakenwhenusingnaloxoneorotheropioidantagoniststotreatoverdoseinopioid-maintainedpatients,

duetotheriskofprecipitatinganacutewithdrawalsyndrome.

Ifsevereorpersistenthypotensionoccurs,hypovolaemiashouldbeconsidered,andtheconditionshouldbemanaged

withappropriateparenteralfluidtherapy.

Musclerigidityinterferingwithrespirationhasbeenreportedwithfentanylandotheropioids.Inthissituation,

endotrachealintubation,assistedventilationandadministrationofopioidantagonistsaswellasmusclerelaxantsmay

berequested.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Phenylpiperidinederivatives.

ATCcode:N02AB03

Fentanylisapotentµ-opioidanalgesicwithrapidonsetofanalgesiaandshortdurationofaction.Fentanylis

approximately100-foldmorepotentthanmorphineasananalgesic.Secondaryeffectsoffentanyloncentralnervous

system(CNS),respiratoryandgastro-intestinalfunctionaretypicalofopioidanalgesicsandareconsideredtobeclass

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Theanalgesiceffectsoffentanylarerelatedtothebloodleveloftheactivesubstance;inopioid-naïvepatients,

minimumeffectiveanalgesicserumconcentrationsoffentanylrangefrom0.3-1.2ng/ml,whilebloodlevelsof10-20

ng/mlproducesurgicalanaesthesiaandprofoundrespiratorydepression.

Inpatientswithchroniccancerpainonstablemaintenancedosesofopioids,Abstralhasbeenshowntoinduce

significantlysuperiorreliefofbreakthroughpaincomparedtoplacebofrom15minutesafteradministrationonwards,

withasignificantlylowerneedforrescueanalgesictherapy.ThesafetyandefficacyofAbstralhavebeenevaluatedin

patientstakingthedrugattheonsetofthebreakthroughpainepisode.PreemptiveuseofAbstralforpredictablepain

episodeswasnotinvestigatedintheclinicaltrials.

Fentanyl,incommonwithallµ-opioidreceptoragonists,producesdosedependentrespiratorydepression.Thisriskis

higherinopioid-naïvesubjectsthaninpatientsexperiencingseverepainorreceivingchronicopioidtherapy.Long-

termtreatmentwithopioidstypicallyleadstodevelopmentoftolerancetotheirsecondaryeffects.

Whileopioidsgenerallyincreasethetoneofurinarytractsmoothmuscle,theneteffecttendstobevariable,insome

casesproducingurinaryurgency,inothers,difficultyinurination.

Opioidsincreasethetoneanddecreasethepropulsivecontractionsofthesmoothmuscleofthegastrointestinaltract

leadingtoaprolongationingastrointestinaltransittime,whichmayberesponsiblefortheconstipatingeffectof

fentanyl.

5.2Pharmacokineticproperties

Fentanylisahighlylipophilicdrugabsorbedveryrapidlythroughtheoralmucosaandmoreslowlythroughthe

gastrointestinaltract.Orallyadministeredfentanylundergoespronouncedhepaticandintestinalfirstpasseffects.

Abstralisaquickdissolvingsublingualtabletformulation.Rapidabsorptionoffentanyloccursoverabout30minutes

followingadministrationofAbstral.ThebioavailabilityofAbstralhasnotbeenstudiedbutisestimatedtobeabout

70%.Meanmaximalplasmaconcentrationsoffentanylrangefrom0.2to1.3ng/ml(afteradministrationof100to800

µgAbstral)andarereachedwithin22.5to240minutes.

About80-85%offentanylisboundbyplasmaproteins,mainly1-glycoproteinandtoalesserextentalbuminand

lipoprotein.Thevolumeofdistributionoffentanylatsteadystateisabout3-6l/kg.

FentanylismetabolisedprimarilyviaCYP3A4toanumberofpharmacologicallyinactivemetabolites,including

norfentanyl.Within72hoursofintravenousfentanyladministrationaround75%ofthedoseisexcretedintotheurine,

mostlyasmetabolites,withlessthan10%asunchangeddrug.About9%ofthedoseisrecoveredinthefaeces,

primarilyasmetabolites.Totalplasmaclearanceoffentanylisabout0.5l/h/kg.AfterAbstraladministration,themain

eliminationhalf-lifeoffentanylisabout7hours(range3-12.5hours)andtheterminalhalf-lifeisabout20hours(range

11.5-25hours).

ThepharmacokineticsofAbstralhavebeenshowntobedoseproportionaloverthedoserangeof100to800µg.

Renal/hepaticimpairment

Impairedhepaticorrenalfunctioncouldcauseincreasedserumconcentrations.Elderly,cachecticorgenerally

impairedpatientsmayhavealowerfentanylclearance,whichcouldcausealongerterminalhalf-lifeforthecompound

(seesections4.2and4.4).

5.3Preclinicalsafetydata

Safetypharmacologyandrepeateddosetoxicitydatarevealnospecialhazardforhumansthatisnotalreadycoveredby

othersectionsofthisSPC.Animalstudieshaveshownreducedfertilityandincreasedmortalityinratfoetuses.

Teratogeniceffectshave,however,notbeendemonstrated.

Mutagenicitytestinginbacteriaandinrodentsyieldednegativeresults.Likeotheropioidsfentanylshowedmutagenic

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onlyatveryhighconcentrations.

Long-termcarcinogenicitystudieshavenotbeenperformed.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Mannitol(E421)

Silicifiedmicrocrystallinecellulose

Croscarmellosesodium

Magnesiumstearate

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Storeintheoriginalblisterpackageinordertoprotectfrommoisture.

6.5Natureandcontentsofcontainer

AbstralsublingualtabletsarepackagedinOPA/PVC/aluminium/aluminiumblisterscontainedinacardboardouter

carton.Thepackagingiscolour-codedforeachAbstralsublingualtabletstrength.

Packsize:Packsof10or30sublingualtablets.Notallpacksizesmaybemarketed

6.6Specialprecautionsfordisposal

Wastematerialshouldbedisposedofsafely.Patients/carersshouldbeencouragedtoreturnanyunusedproducttothe

Pharmacy,whereitshouldbedisposedofinaccordancewithnationalandlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

ProStrakanLtd

GalabankBusinessPark

GalashielsTD11QH

8MARKETINGAUTHORISATIONNUMBER

PA1049/6/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

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10DATEOFREVISIONOFTHETEXT

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