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

Other information

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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5-11-2018

November 5, 2018: Nurse Sentenced for Taking Fentanyl for Personal Use

November 5, 2018: Nurse Sentenced for Taking Fentanyl for Personal Use

November 5, 2018: Nurse Sentenced for Taking Fentanyl for Personal Use

FDA - U.S. Food and Drug Administration

22-10-2018

October 18, 2018: Grand Jury Returns Superseding Indictment In Shamo Case; Adds Distribution Of Fentanyl Count Resulting In Death

October 18, 2018: Grand Jury Returns Superseding Indictment In Shamo Case; Adds Distribution Of Fentanyl Count Resulting In Death

October 18, 2018: Grand Jury Returns Superseding Indictment In Shamo Case; Adds Distribution Of Fentanyl Count Resulting In Death

FDA - U.S. Food and Drug Administration

19-9-2018

September 18, 2018: "The Drug Llama" Faces Federal Indictment and Mandatory Minimum Sentence for Distributing Fentanyl on Dark Web

September 18, 2018: "The Drug Llama" Faces Federal Indictment and Mandatory Minimum Sentence for Distributing Fentanyl on Dark Web

September 18, 2018: "The Drug Llama" Faces Federal Indictment and Mandatory Minimum Sentence for Distributing Fentanyl on Dark Web

FDA - U.S. Food and Drug Administration

1-8-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s continued, careful oversight of the REMS associated with transmucosal immediate-release fentanyl products

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s continued, careful oversight of the REMS associated with transmucosal immediate-release fentanyl products

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s continued, careful oversight of the REMS associated with transmucosal immediate-release fentanyl products

FDA - U.S. Food and Drug Administration

24-7-2018

July 23, 2018: Springfield EMT/Paramedic Pleads Guilty to Stealing Fentanyl, Morphine

July 23, 2018: Springfield EMT/Paramedic Pleads Guilty to Stealing Fentanyl, Morphine

July 23, 2018: Springfield EMT/Paramedic Pleads Guilty to Stealing Fentanyl, Morphine

FDA - U.S. Food and Drug Administration

11-7-2018

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

FDA - U.S. Food and Drug Administration

11-7-2018

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

FDA - U.S. Food and Drug Administration

9-7-2018

July 6, 2018: Vero Beach Orthopedic Surgeon Sentenced to Life in Prison Following Conviction for Fentanyl Analog Drug Conspiracy Resulting in Death

July 6, 2018: Vero Beach Orthopedic Surgeon Sentenced to Life in Prison Following Conviction for Fentanyl Analog Drug Conspiracy Resulting in Death

July 6, 2018: Vero Beach Orthopedic Surgeon Sentenced to Life in Prison Following Conviction for Fentanyl Analog Drug Conspiracy Resulting in Death

FDA - U.S. Food and Drug Administration

5-7-2018

July 3, 2018: Canton Man Indicted on Fentanyl and Firearms Charges

July 3, 2018: Canton Man Indicted on Fentanyl and Firearms Charges

July 3, 2018: Canton Man Indicted on Fentanyl and Firearms Charges

FDA - U.S. Food and Drug Administration

22-6-2018

Health Canada reminds Canadians of the limitations of fentanyl test strips being used to check street drugs before consumption

Health Canada reminds Canadians of the limitations of fentanyl test strips being used to check street drugs before consumption

OTTAWA – With the growing availability of fentanyl test strips on store shelves and online, Health Canada would like to remind Canadians of the potential limitations when using fentanyl test strips to detect fentanyl or other deadly substances in street drugs before consuming them.

Health Canada

2-5-2018

May 1, 2018: Vero Beach Orthopedic Surgeon Convicted at Trial of Fentanyl Analog Drug Conspiracy Resulting in Death

May 1, 2018: Vero Beach Orthopedic Surgeon Convicted at Trial of Fentanyl Analog Drug Conspiracy Resulting in Death

May 1, 2018: Vero Beach Orthopedic Surgeon Convicted at Trial of Fentanyl Analog Drug Conspiracy Resulting in Death

FDA - U.S. Food and Drug Administration

19-4-2018

March 30, 2018: KC Paramedic Indicted for Stealing Fentanyl, Morphine from Ambulances

March 30, 2018: KC Paramedic Indicted for Stealing Fentanyl, Morphine from Ambulances

March 30, 2018: KC Paramedic Indicted for Stealing Fentanyl, Morphine from Ambulances

FDA - U.S. Food and Drug Administration

17-4-2018

March 27, 2018: Federal Jury Finds Three Guilty in Fentanyl Distribution Conspiracy

March 27, 2018: Federal Jury Finds Three Guilty in Fentanyl Distribution Conspiracy

March 27, 2018: Federal Jury Finds Three Guilty in Fentanyl Distribution Conspiracy

FDA - U.S. Food and Drug Administration

1-10-2018

IONSYS (Incline Therapeutics Europe Ltd)

IONSYS (Incline Therapeutics Europe Ltd)

IONSYS (Active substance: fentanyl) - Centralised - Withdrawal - Commission Decision (2018)6412 of Mon, 01 Oct 2018

Europe -DG Health and Food Safety

23-7-2018

PecFent (Kyowa Kirin Holdings B.V.)

PecFent (Kyowa Kirin Holdings B.V.)

PecFent (Active substance: Fentanyl ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4890 of Mon, 23 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1164/T/46

Europe -DG Health and Food Safety

1-6-2018

#DYK #Opioids are a type of drug that includes the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OxyContin®) #FDAInnovationChallenge (1 of 2 messages)

#DYK #Opioids are a type of drug that includes the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OxyContin®) #FDAInnovationChallenge (1 of 2 messages)

#DYK #Opioids are a type of drug that includes the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OxyContin®) #FDAInnovationChallenge (1 of 2 messages)

FDA - U.S. Food and Drug Administration

15-5-2018

Instanyl (Takeda Pharma A/S)

Instanyl (Takeda Pharma A/S)

Instanyl (Active substance: Fentanyl ) - PSUSA - Modification - Commission Decision (2018)3006 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/959/PSUSA/1369/201704

Europe -DG Health and Food Safety

15-5-2018

Effentora (Teva B.V.)

Effentora (Teva B.V.)

Effentora (Active substance: fentanyl citrate) - PSUSA - Modification - Commission Decision (2018)3013 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/1369/201704

Europe -DG Health and Food Safety

15-5-2018

PecFent (Kyowa Kirin Services Ltd)

PecFent (Kyowa Kirin Services Ltd)

PecFent (Active substance: Fentanyl ) - PSUSA - Modification - Commission Decision (2018)3007 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1164/PSUSA/1369-201704

Europe -DG Health and Food Safety