ALACARE 8 Milligram Medicated Plaster

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
5-AMINOLEVULINIC ACID HYDROCHLORIDE
Available from:
Galderma (UK) Ltd
ATC code:
L01XD04
INN (International Name):
5-AMINOLEVULINIC ACID HYDROCHLORIDE
Dosage:
8 Milligram
Pharmaceutical form:
Medicated Plaster
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Sensitizers used in photodynamic/radiation therapy
Authorization status:
Transfer Pending
Authorization number:
PA0590/029/001
Authorization date:
2014-05-16

Packageleaflet:Informationforthe user

Alacare 8mg medicated plaster

5-aminolevulinic acid

Readallofthisleafletcarefullybeforeyoustartusingthismedicine becauseitcontains

importantinformationfor you.

- Keep thisleaflet. You mayneedto readitagain.

- Ifyou have anyfurtherquestions,askyourdoctor.

- Thismedicinehasbeenprescribedforyouonly.Donotpassitontoothers.Itmayharmthem,

even iftheirsigns ofillnessarethesame as yours.

- Ifyougetanysideeffects,talktoyourdoctor.Thisincludesanypossiblesideeffectsnot

listedinthis leaflet. See section4.

Whatisin thisleaflet

1. WhatAlacare is and whatitis usedfor

2. Whatyou needto knowbefore you useAlacare

3. Howto useAlacare

4. Possibleside effects

5. Howto store Alacare

6. Contents ofthe packand otherinformation

1. WhatAlacare is andisandwhatitis usedfor

Alacareisusedforthetreatmentofmildskinabnormalitiesontheheadorfacecalledsolarkeratosis.

Thesearesmall,rough,spotswhichdevelopontheskin.Theyarecausedbyalotofexposuretothe

sun overmanyyears.Theyare also called actinic keratosis.

TreatmentwithAlacareisatwo-stepprocedureandiscalled‚photodynamictherapy’.Itconsistsof

Alacareplasterapplicationtothespotsfor4hours.Thisisfollowedbyilluminationwithredlightfor

acoupleofminutes.Illuminationwithred lightinducesachemicalreactioninthecellsofthechanged

skin, whichleadsto theirdestruction.Thereactionis called ‚phototoxicreaction’.

2. What you needto knowbefore you use Alacare

Alacareshouldbeappliedbyaphysician,anurseorotherhealthcareprofessionalsinonesingle

session.

Do not useAlacare:

- ifyouareallergicto5-aminolevulinicacidoranyoftheotheringredientsofthismedicine

(listed in section 6).

- ifyousufferfroma certaindiseaseofblood metabolismknownasporphyria.

- ifyouwereundergoingsimilartherapywith5-aminolevulinicacid-containingpreparations

and itwasunsuccessful.

- ifyou have otherskin conditions causedbyormadeworsebyexposureto light.

Thesuccessandassessmentoftreatmentmaybeimpairedifthetreatedareaoftheskinisfurther

affected by:

- inflammation,infection, psoriasis, eczemaorcancer

- tattoos

Warnings andprecautionsTalkto yourdoctorbeforeusingAlacare:

- ifyouhavedarkbrownorblackskinorifyouhaveverythicklesionssincethereisno

experiencewith Alacaretreatments in thosecases.

- ifyoumightbe pregnantsincetreatmentwith Alacareis notrecommended then.

- ifyouare receivingUV-therapy, itshould bestoppedbefore treatmentwith Alacare.

YourdoctorornursewillmakesurethattheAlacareplasterdoesnotgetintocontactwithyoureyes.

Asageneralprecaution,treatedandsurroundingskinshouldnotbeexposedtosunlightforabout48

hoursfollowingtreatment.

OthermedicinesandAlacare

Informyourdoctorifyouusemedicinesthatincreaseallergicorotherharmfulreactionsafterlight

exposure,suchas:

- St.John’s wortorits preparations:medicinesto treatdepression.

- griseofulvin:a medicinetotreatfungalinfections.

- medicinestoincreasewateroutputthroughyourkidneyswithactivesubstancenamesmostly

endingin“thiazide”or“tizide”.

- certain medicinesto treatdiabetes, such as glibenclamide, glimepiride.

- medicinestotreatmentaldisorders,nauseaorvomitingwithactivesubstancenamesmostly

endingin“azine”.

- medicinestotreatbacterialinfectionwithactivesubstancenamesbeginningwith“sulfa”or

endingin“oxacin” or“cycline”.

Tellyourdoctorifyou aretaking,have recentlytakenormighttakeanyothermedicines.

Pregnancyandbreast-feeding

Possibleharmfuleffectsandrisksforapregnancyandfortheunbornchildcannotbecompletely

excludedatthis time.

Alacareshouldnotbeusedduringpregnancyunlessclearlynecessary.Breast-feedingshouldbe

stoppedfor48hoursafterapplicationofAlacare.Alwaysaskyourdoctorforadvicebefore takingany

medicines.

Driving andusingmachines

Alacare hasno known effectonthe abilityto drive andusemachines.

3. Howto useAlacare

Itisimportantthatyoudonotapplyanycreamtoyourscalporfaceonthedayoftreatment

before arrivingfor therapy atyour doctor.

Adults(including the elderly)

Alacareplasterswillbeappliedtoyouractinickeratoses(changedskin)for4hoursinonesingle

session.Afterwards theseareaswillbe exposed tored lightforafewminutes(photodynamictherapy).

To protectyoureyesfromthe intenselight, you willbegiven goggles to wearduringlightexposure.

Aftertreatmentwithplasterandilluminationyoushouldprotecttheskinfromsunlightfor48hours.

Lesions shouldbe checkedbyyourdoctorafterthreemonths.

Useinchildren andadolescents

UseofAlacareisnotrecommended,asthereisnoexperienceintreatmentofchildrenandadolescents

below18 years ofage.

Ifyoustop using Alacare

Theeffectivenessofthetreatmentmightbe reduced,if

- plasterapplicationisstopped prematurelyor

- lighttherapyis stoppedtooearly.

4. Possiblesideeffects

Like allmedicines,this medicinecan causeside effects, although noteverybodygetsthem.

Side effects involvingthetreatmentsite (localsideeffects)

Almostallpatients(99%)experiencesideeffectslocalisedtothetreatmentsite(localsideeffects).

ThesecanoccurduringapplicationoftheAlacareplaster,duringilluminationofthetreatmentsite

and/orthereafter.Symptomsareusuallyofmildormoderateintensity.Theyrarelyrequireearly

terminationofillumination.Forrelief,thetreatedareacanbecooledbyafanorsimilarduring

illumination. Aftertherapy, localsideeffects persistfor1 to2 weeks oroccasionallylonger.

Verycommon (more than1outof10 patients):

flaking

irritation

itching

pain

redness

scab

Common (more than 1outof100 patients, butless than 1 outof10patients):

areas ofpalenessordarkeningoftheskin

bleeding

blister

discomfort

erosion

oedema (fluidaccumulatedin the tissue)

peeling

pustules (pimples)

skin reaction

secretion

swelling

Uncommon (more than 1 outof1000 patients, butlessthan 1outof100 patients):

burn

staining

infection

inflammation

ulcer

superficialskin defects

Side effects notinvolvingthe treatmentsite:

Common

headache

Uncommon

anxiety

increasedlevels ofthe enzyme alanineaminotransferase

nosebleed

pustule(pimplelike)rash

stainingofthe skin

Reporting ofside effects

Ifyougetanysideeffects,talktoyourdoctor.Thisincludesanypossiblesideeffectsnotlistedinthis

leaflet.Youcanalsoreportsideeffectsdirectly(seedetailsbelow).Byreportingsideeffects,youcan

helpprovide moreinformation onthesafetyofthis medicine.

UnitedKingdom

YellowCard Scheme

www.mhra.gov.uk/yellowcard

Ireland

FREEPOST:HPRAPharmacovigilance, EarlsfortTerrace, IRL-Dublin 2;

Tel:+353 16764971;Fax:+353 1 6762517.

Website: www.hpra.ie ;E-mail: medsafety@hpra.ie .

5. HowtostoreAlacare

Keepthis medicineoutofthesightandreachofchildren.

Donotusethismedicineaftertheexpirydatewhichisstatedonthecartonandsachetafter‘EXP’.

Theexpirydate referstothe lastdayofthatmonth.

Usewithin 3months afterfirstopening.

Afteropeningstoreplasterinthesachetinordertoprotectfromlight.Afterremoval,theusedplaster

shouldbefoldedinhalf,adhesivesideinwardssothattheadhesiveisnotexposed,andthendiscarded

safely.Donotthrowawayanymedicinesviawastewaterorhouseholdwaste.Askyourpharmacist

howtothrowawaymedicinesyounolongeruse.Thesemeasureswillhelp protectthe environment.

6. Contents ofthe pack andotherinformation

What Alacare contains

- Theactivesubstanceis5-aminolevulinicacidhydrochloride.Eachmedicatedplasterof4cm 2

contains8 mg5-aminolevulinic acid(as hydrochloride), 2 mgpercm 2 .

- Theotheringredientsareacrylicpressuresensitiveadhesive,backingfilm,consisting

ofpigmentedpolyethyleneandaluminiumvapourcoatedpolyester,releaselinerconsistingof

polyethyleneterephthalatefilm(to be removed before application).

What Alacare lookslikeandcontents ofthe pack

Eachmedicatedplasterhasasizeof4cm²,issquarewithroundedcornersandconsistsofaskintone

backingfoilandaself-adhesivematrix,coveredbyareleaselinerwhichisremovedpriortouse.4

plasters aresealedin aprotective sachet.

Alacareis availablein packsizesof4 or8 plasters (1 or2 protective sachet(s))ina cardboard box.

MarketingAuthorisationHolderandManufacturer

MarketingAuthorisation Holder: Galdema (UK)Ltd

Meridien House

69-71 Clarendon Road

Watford

Herts

WD17 1DS

UK

Manufacturer:

medac Gesellschaft

fürklinischeSpezialpraeparate mbH

Theaterstrasse 6

D-22880 Wedel

Germany

ThismedicinalproductisauthorisedintheMemberStatesoftheEEAunderthefollowing

names:

Austria Alacare

Denmark Alacare

Finland Alacare

France Effala

Germany Alacare

Ireland Alacare

Italy Alacare

Norway Alacare

Poland Alacare

Portugal Alacare

Spain Effala

Sweden Alacare

UK Alacare

Thisleafletwaslastapproved inSeptember 2015

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Alacare8mgmedicatedplaster

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmedicatedplasterof4cm²contains8mg5-aminolevulinicacid,2mgpercm 2

Forthefulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Medicatedplaster.

Eachplasterhasasizeof4cm²,issquarewithroundedcornersandconsistsofaskintonebackingfoilandaself-

adhesivematrix,coveredbyareleaselinerwhichisremovedpriortouse.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Singleusetreatmentofmildactinickeratoseswithamaximumdiameterof1.8cmonthefaceandscalp(hairless

areas).

4.2Posologyandmethodofadministration

Adults(includingtheelderly)

ForthetreatmentofAKwithonesessionphotodynamictherapy(PDT),applyuptoamaximumofsixAlacarepatches

usedonsixdifferentlesionstothepatientonasingletreatmentsession.IftheAlacareplasterdoesnotsticktothe

lesionsproperly,itcanbefixedwithanadhesivestrip.

Afterfourhours,removetheAlacareplaster(s)andexposethelesion(s)toredlightwithanarrowbandredlightsource

withaspectrumof630 ±

3nmandatotallightdoseof37J/cm²atthelesionsurface.OnlyCEmarkedlampsshouldbe

used,equippedwithnecessaryfiltersand/orreflectingmirrorstominimizeexposuretoheat,bluelightandUV

radiation.Itisimportanttoensurethatthecorrectlightdoseisadministered.Thelightdoseisdeterminedbyfactors

suchasthesizeofthelightfield,thedistancebetweenlampandskinsurfaceandilluminationtime.Thesefactorsvary

withlamptype,andthelampshouldbeusedaccordingtotheusermanual.Patientandoperatorshouldadheretosafety

instructionsprovidedwiththelightsource.Duringilluminationpatientandoperatorshouldwearprotectivegoggles

whichcorrespondtothelamplightspectrum.

Untreatedskinsurroundingthelesiondoesnotneedtobeprotectedduringillumination.

Lesionresponsesshouldbeassessedafterthreemonths.IftheareatreatedwithAlacareisnotlesionfreeat3months

followingsingleusepleaseusealternativetherapiesforremovalofactinickeratosislesions.

Paediatricpopulation

Thereisnoexperienceoftreatingpatientsbelowtheageof18years.

4.3Contraindications

Hypersensitivitytotheactivesubstanceortoanyoftheexcipientslistedinsection6.1.

NoresponsetopreviousPDTwith5aminolevulinicacid-containingpreparations.

Porphyria.

Knownphotodermatosesofvaryingpathologyandfrequency,e.g.metabolicdisorderssuchasaminoaciduria,

idiopathicorimmunologicaldisorderssuchaspolymorphiclightreaction,geneticdisorderssuchasxeroderma

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pemphiguserythematosus.

4.4Specialwarningsandprecautionsforuse

Alacareisnotrecommendedforthetreatmentofpregnantwomenunlessclearlynecessary(see4.6).

Verythick,red,scalyinduratedAKlesionsshouldnotbetreatedwithAlacare.

ThereisnoexperienceoftreatingAKlesionsinpatientswithdarkbrownorblackskin(skinsunsensitivitytypeVor

VIaccordingtoFitzpatrick).

NodataregardingefficacyandsafetyareavailableforrepeatedtreatmentofAKlesionswithAlacare.

AnyUV-therapyshouldbediscontinuedbeforetreatment.Asageneralprecaution,sunexposureofthetreatedlesion

sitesandsurroundingskinshouldbeavoidedforapproximately48hoursfollowingtreatment.

DirecteyecontactwithAlacareshouldbeavoided.

Alacareshouldonlybeadministeredbyanurseorotherhealthcareprofessionaltrainedwiththeuseofphotodynamic

therapiesunderthesupervisionofaphysician.

Thesuccessandassessmentoftreatmentmaybeimpairedifthetreatedareaisaffectedbythepresenceofskindiseases

(skininflammation,locatedinfection,psoriasis,eczema,andbenignormalignantskincancers)aswellastattoos.No

experienceexistswiththesesituations.

ConcomitantuseofmedicinalproductswithknownphototoxicorphotoallergicpotentialsuchasSt.John’swort,

griseofulvin,thiazidediuretics,sulfonylureas,phenothiazines,sulphonamides,quinolonesandtetracyclinesmay

enhancethephototoxicreactiontophotodynamictherapy.Concomitantusewithothertopicalmedicinalproducts

shouldbeavoided.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

AshypericincanincreasephototoxicreactionsinducedbyPDT,treatmentwithhypericin-containingproducts(St

John'sWort,Hypericumperforatum)shouldbediscontinuedtwoweeksbeforePDTwithAlacare.

4.6Fertility,pregnancyandlactation

Pregnancy

Therearenoadequatedatafromtheuseof5-aminolevulinicacidinpregnantwomen.Animalstudiesareinsufficient

withrespecttoeffectsonpregnancy,embryonalandfetaldevelopment,parturitionandpostnataldevelopment(see

section5.3).Thepotentialriskforhumansisunknown.Alacareshouldnotbeusedduringpregnancyunlessclearly

necessary.

Breastfeeding

Itisunknownwhether5-aminolevulinicacidisexcretedinhumanbreastmilk.Theexcretionof5-aminolevulinicacid

hasnotbeenstudiedinanimals.Breast-feedingshouldbediscontinuedfor48hafterapplicationofAlacare.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

a)Almostallpatients(99%)experienceadversereactionslocalisedatthetreatmentsite(localreactions)thatare

attributabletotoxiceffectsofthephotodynamictherapy(phototoxicity).DuringapplicationofAlacareandpriorto

illuminationofthetreatmentsite,33%ofpatientsshowlocalreactions,mostfrequentlypruritus,burninganderythema.

Duringillumination,erythema,burningandpainarethelocalreactionsreportedmostoften.Thesymptomsareusually

ofmildormoderateseverityandrequireearlyterminationofilluminationin1%ofthepatients.Coolingofthetreated

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localreactionswhicharelikewisemainlymildtomoderateandpersistfor1to2weeksoroccasionallylonger.

Acommon(<10%)adversereactionnotinvolvingthetreatmentsiteisheadache.

b)TheincidenceofadversereactionsinpatientsreceivingAlacareplusillumination,isshowninthetablebelow.

Reportingofsuspectedadversereactions

Reportingofsuspectedadversereactionsafterauthorisationofthemedicinalproductisimportant.Itallowscontinued

monitoringofthebenefit/riskbalanceofthemedicinalproduct.Healthcareprofessionalsareaskedtoreportany

suspectedadversereactionsviaHPRAPharmacovigilance,EarlsfortTerrace,IRL-Dublin2,Tel:+35316764971,Fax:

+35316762517.Website:www.hpra.ie,E-mail: medsafety@hpra.ie .

4.9Overdose

Nocaseofoverdosehasbeenreported.Nevertheless,reactionsatthetreatmentsitemaybemorepronouncedifthe

Alacareplastersareappliedformuchmorethan4hoursorifamuchhigherlightdosethantherecommended37J/cm²

ischosen.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:

SensitisersusedinPhotodynamic/Radiationtherapy,ATCCode:L01XD04

Mechanismofaction

Aftertopicalapplicationof5-aminolevulinicacid,protoporphyrinIX(PPIX)accumulatesintracellularlyinthetreated

AKlesions.TheintracellularPPIXisaphotoactive,fluorescingcompoundand,uponlightactivationinthepresenceof

oxygen,singletoxygenisformedwhichcausesdamagetocellularcompartmentsofthelight-exposedtargetcells,in

Adversereactionsinvolvingthetreatmentsite(localreactions)

Generaldisordersand

applicationsiteconditions Verycommon

1/10 Erythema,exfoliation,irritation,

pain,pruritus,scab

Common

1/100,<1/10 Bleeding,desquamation,discharge,

discomfort,erosion,

hyper/hypopigmentation,oedema,

reaction,swelling,vesicles

Uncommon

1/1000,<1/100 Burn,discolouration,excoriation,

inflammation,ulcer

Infectionsandinfestations Common

1/100,<1/10 Pustules

Uncommon

1/1000,<1/100 Infection

Adversereactionsnotinvolvingthetreatmentsite

Nervoussystemdisorders Common

1/100,<1/10 Headache

InfectionsandInfestations Uncommon

1/1000,<1/100 Pyoderma

Psychiatricdisorders Uncommon

1/1000,<1/100 Emotionaldistress

Respiratory,thoracicand

mediastinaldisorders Uncommon

1/1000,<1/100 Epistaxis

Skinandsubcutaneoustissue

disorders Uncommon

1/1000,<1/100 Skindiscolouration

Investigations Uncommon

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Clinicalefficacyandsafety

Withregardtoclinicalsafetyandefficacy,Alacarewascomparedwithplacebotreatment,inarandomisedobserver

blindedclinicaltrialwhichenrolled107patientswithafollow-updurationof6,9and12months.Allpatientshada

minimumof3mildtomoderateAKlesionsontheheadand/orface.AlacarewasappliedtoAKlesionsfor4hours

withoutpreparationofthelesion,afterwhichtheywereilluminatedwithredlightat 630 ±

3nm(37J/cm²).

12weeksaftertreatment,completeclinicalclearanceonlesionandonpatientbasisofaonce-onlyphotodynamic

therapywithAlacarewasstatisticallysignificantlymoreeffectivethanphotodynamictherapywithplacebo.Thiswas

sustainedduringfollow-up,inwhichpatientswereseenevery3months(after6,9and12months).Inanopen

randomisedtrial,whichenrolled349patients,AlacarePDTinthesameregimeasdescribedabove,wascomparedwith

cryosurgeryandplacebo-PDT.Inthistrial,Alacare-PDTprovednon-inferiortocryosurgery.After12weeksintheFull

AnalysisSet87%oflesionstreatedwithAlacare-PDTwerecleared,comparedto77%aftercryosurgery(OddsRatio

1.86;95%CI[1.18,2.93])and32%afterplacebo-PDT.Differencesweresustainedduringthecompletefollow-up

period(after6,9and12months).Recurrenceratesofclearedlesions12monthsaftertherapywere12%forAlacare-

PDTand18%forcryosurgery(OddsRatio0.627;95%CI[0.461,0.854]).

5.2Pharmacokineticproperties

Pharmacokineticdatafromaclinicaltrialinpatientswithmildtomoderateactinickeratosesontheheadand/orface,

whohad8Alacareplastersappliedfor4h,showedabaselinecorrectedCmaxof16.4µg/LandanAUC

0-24 of101.4

µg*h/Lofsystemicexogenous5-aminolevulinicacid.Tmaxwasat4hoursTheexcretionof5 -ALAinurineduringthe

first12hoursafterapplicationwaslow.Themaximumexcretionwas2.06%ofthetotaldose,themedianwas1.39%

PPIXwasnotdetectedinanyoftheplasmasamples.

Inanotherclinicaltrialin12AKpatientswithmildtomoderateAKlesionsontheheadand/orface,itcouldbeshown

thatAlacare-inducedPPIXspecificfluorescenceishigherinAKlesionsthaninnormalskinandincreaseswith

durationoftheAlacareexposure.However,extendingapplicationintervalbeyond4hdidnotresultinhigherPPIX

fluorescence.

5.3Preclinicalsafetydata

Preclinicalstudiesongeneraltoxicityandgenotoxicitystudiesinthepresenceorabsenceofphotoactivation,donot

indicatepotentialrisksforman.Conventionalcarcinogenicitystudieshavenotbeenperformedwith5-aminolevulinic

acid.Studiesreportedintheliteraturedonotindicateacarcinogenicpotential.Studiesonthereproductivefunction

havenotbeenperformed.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Plasters: Acrylicpressuresensitiveadhesive

(Poly[(2-ethylhexyl)acrylate-co-methylacrylate-co-acrylicacid-co-glycidylmethacrylate])

Backingfilm: PigmentedpolyethyleneAluminiumvaporcoatedpolyester

Releaseliner(polyethyleneterephthalatefilm)whichisremovedpriortoapplication.

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years.

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6.4Specialprecautionsforstorage

Afteropeningstoreplasterinthesachetinordertoprotectfromlight.

6.5Natureandcontentsofcontainer

4medicatedplasterssealedinprotectivesachetsconsistingof4layers:paper(outerlayer),polyethyleneLDPE,

aluminium,ethylenecopolymer(innerlayer).

Packsizesof4or8medicatedplasters(1or2protectivesachet(s)).

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposal

Afterremoval,theusedpatchshouldbefoldedinhalf,adhesivesideinwardssothattheadhesiveisnotexposed,and

thendiscardedsafely.

7MARKETINGAUTHORISATIONHOLDER

Galderma(UK)Limited

MeridienHouse

69-71ClarendonRoad

Watford

HertsWD171DS

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA0590/029/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:28thAugust2009

10DATEOFREVISIONOFTHETEXT

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