CALCIL 50 MICROGRAM/G CREAM

Main information

  • Trade name:
  • CALCIL 50 MICROGRAM/G CREAM
  • Dosage:
  • 0.05 mg/g
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CALCIL 50 MICROGRAM/G CREAM
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0711/104/001
  • Authorization date:
  • 27-07-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0711/104/001

CaseNo:2041764

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

RowexLtd

Bantry,Co.Cork,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Calcil50micrograms/gCream

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom21/08/2008until26/07/2012.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 29/09/2008 CRN 2041764 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Calcil50micrograms/gCream

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Onegramofcreamcontains0.05mg(isequalto50micrograms)ofcalcipotriol.

Excipient:Cetostearylalcohol60mg/g

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cream

Whitecream.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Calcipotriolcreamisindicatedforthetopicaltreatmentofmildtomoderatelyseverepsoriasis(psoriasisvulgaris).

4.2Posologyandmethodofadministration

Adults:

Asmonotherapy

Thecalcipotriolcreamshouldbeappliedtotheaffectedskinonlimbsortrunkonceortwicedaily.Atthebeginningof

treatment,twicedaily(morningandevening)applicationisrecommended.Formaintenancetherapy,thefrequencyof

applicationmaybedecreasedtooncedaily,dependingontheresponse.

Creamhastobeappliedasathinlayertoaffectedskinwithgentlerubbingtocovertheaffectedareauntilmostofthe

creamdisappears.

Themaximumamountofcreamappliedshouldnotexceed100gramsperweek.Ifitisusedtogetherwithointmentor

solutioncontainingcalcipotriol,thetotalweeklydoseofcalcipotriolshouldnotexceed5mg(forexample30mlof

scalpsolutionplus60gofcreamorointment).

Thedurationoftherapydependsontheclinicalappearance.Apronouncedtherapeuticeffectisgenerallyseenaftera

maximumof4-8weeks.Therapycanberepeated.

Ascombinationtherapy

Oncedailyapplicationofcalcipotriolcreamincombinationwithtopicalcorticosteroids(e.g.administrationof

calcipotriolcreaminthemorningandsteroidintheevening)iseffectiveandwelltolerated.

Renal/hepaticimpairment

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Childrenandadolescents(<18years):

Thereislimitedexperiencewiththeuseofcalcipotriolcreaminchildrenandadolescents.Theefficacyandlong-term

safetyofabovementioneddosage(underadults)hasnotbeenestablishedinchildrenandadolescents.Thereforeitsuse

inthispopulationcannotberecommended.

4.3Contraindications

Hypersensitivitytotheactivesubstanceortoanyoftheexcipients

Knowndisordersofcalciummetabolism

Hypercalcaemia

4.4Specialwarningsandprecautionsforuse

Calcipotriolcreamshouldnotbeusedontheface.

Patientsshouldbeadvisedtowashtheirhandsafterapplyingthecreaminordertopreventtheinadvertenttransferto

otherareas,especiallytheface.

Theefficacyandlong-termsafetyofcalcipotriolcreaminchildrenandadolescentshasnotbeenestablished.Therefore

itsuseinthispopulationcannotberecommended.

Hypercalcaemiadoesnotoccurwiththeusualdosage(upto100gofcreamaweek).Excessiveuse(50-100gofcream

perday)maycauseelevationsinserumcalciumlevelswhichreverserapidlyondiscontinuationoftreatment.Studies

onadultsoveraperiodofoneyearhavenotyieldedanyevidenceofariskofhypercalcaemia.However,theserum

calciumlevelshouldbemonitoredonlong-termusewithapplicationtoextensiveareasofskin.

Inviewofapossibleeffectoncalciummetabolism,patientsshouldbeadvisedtousenomorethantherecommended

dose(seesection4.2.)andtheadditionofpenetration-promotingsubstances(suchassalicylicacid)tothecreamisnot

permitted.Occlusionisundesirableforthesamereason.

Theclinicalsymptomsofhypercalcaemiamayresemblethoseofcholecalciferoloverdose,i.e.thehypercalcaemia

syndromeorcalciumintoxication(seesection4.9),dependingontheintensityanddurationofthehypercalcaemia.

Persistenthypercalcaemiamayresultinectopicdepositsofcalciuminthebloodvesselwalls,jointcapsules,gastric

mucosa,corneaandrenalparenchyma.

TherearedataindicatingthatthecombinationofcalcipotriolwithUVlightmaycausedarkareasof

hyperpigmentation;thesearereversible.IftreatmentwithcalcipotriolcreamisstartedduringacourseofUV-B

therapy,photosensitiveeczemamayoccur.

Patientswithknownrenalorliverimpairmentshouldnotbetreatedwiththismedicinalproductduetolimited

experience.

Thismedicinalproductcontainscetostearylalcohol.Itmaycauselocalskinreactions(e.g.contactdermatitis).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Althoughstudiesto-datehaveshownthatthecombinationofcalcipotriolcreamwithUV-Atherapy,ciclosporinor

acitretiniseffectiveandwell-tolerated,thereisnotenoughdatathatthecombinationismoreeffectiveorthatthe

dosageoftheothermedicinalproductscanbereduced.

ThecreamwillnotincreasetheoveralleffectivenessofUV-Btreatment.However,ithasalight-savingeffectwhen

usedincombinationwithUV-BinadultsandresponseisachievedatalowerdoseofUV-B.Calcipotriolcreamshould

beappliedatleast2hoursbeforeUV-Btherapy.CombinationofcalcipotriolwithUV-Blightmaycausedarkareasof

hyperpigmentation(seesection4.4.).Creamshouldnotbeinitiatedwherepatientsmayalreadybereceivingan

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Concomitantadministrationofcalcipotriolandsalicylicacidexternalsmaycauseaninactivationofcalcipotriol.

Thereisnoexperienceofconcomitanttherapywithotherantipsoriaticproductsappliedtothesameareaofskinatthe

sametime.

4.6Pregnancyandlactation

Pregnancy:

Forcalcipotriolnodataonpregnantpatientsareavailable.Alimitedabsorptionisexpectedafterlocalapplicationof

calcipotriolcreamatsmallareas.Ifusedasindicatednodisturbanceofthecalciumhomeostasisistobeexpected.

Animalstudiesdonotindicatedirectorindirectharmfuleffectswithrespecttoreproductivetoxicity.Asa

precautionarymeasureitispreferabletoavoidtheuseofcalcipotriolinpregnancy.

Lactation:

Itisunknownwhethercalcipotriolisexcretedinhumanbreastmilk.Theexcretionofcalcipotriolinmilkhasnotbeen

studiedinanimals.

Asaprecautionarymeasureitispreferabletoavoidtheuseofcalcipotriolinlactation.

4.7Effectsonabilitytodriveandusemachines

Inviewofthenatureoftheproductandtheindicationsforitsuse,noeffectontheabilitytodriveandusemachinesis

tobeexpected.

4.8Undesirableeffects

Basedontheclinicaldataundesirableeffectsoccurredinapproximately25%ofthepatients.

Themostfrequentlyreportedundesirableeffectsarevarioustransientskinreactionsandinparticularapplicationsite

reactions,whichseldomrequiresdiscontinuationoftreatment.

Pruritus,skinirritation,burningandstingingsensation,dryskin,erythemaandrasharecommon.

TheundesirableeffectsarelistedbyMedDraSOCandtheindividualundesirableeffectsarelistedstartingwiththe

mostfrequentlyreported.

Skinandsubcutaneousdisorders

*varioustypesofrashreactionsuchasscaly,erythematous,maculo-papularandpustularhavebeenreported.

Metabolismandnutritiondisorders

Thefollowingundesirableeffectshavebeenreportedforcalcipotriolcream,ointmentandscalpsolutionduringpost-

marketingexperience:transientchangesinskinpigmentation,transientphotosensitivityreactionandhypersensitivity

reactionincludingurticaria,angioedema,periorbitalorfacialoedema(veryrarely).Perioraldermatitismayoccur

rarely.Basedonpost-marketingdatathetotal‘reportingrate’ofundesirableeffectsisveryrarebeingapproximately

Common(>1/100and<1/10) Pruritus,skinburningsensation,skinstinging

sensation,skinirritation,skindry,erythema,

rash*

Uncommon(>1/1,000and<1/100) Eczema,contactdermatitis,aggravated,

psoriasis

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4.9Overdose

Thepossibleoccurrenceofhypercalcaemiaattherecommendeddosagecannotbeexcluded.Excessiveuse(morethan

50-100gramsperday)mayresultinanelevatedserumcalciumlevel,whichdisappearsrapidlyaftercessationof

treatment,andhypercalcaemiahasbeenreportedatlowerdosesinpatientswithgeneralisedpustularorerythrodermic

exfoliativepsoriasis.Theclinicalsignsofhypercalcaemiaincludeanorexia,nausea,vomiting,constipation,hypotonia,

depression,lethargyandcoma.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Otherantipsoriaticsfortopicaluse,ATCcode:D05AX02

CalcipotriolisavitaminDderivative.Invitrodatashowthatcalcipotriolinducesdifferentiationandsuppresses

proliferationofkeratinocytes.Theeffectofcalcipotriolinpsoriasisisascribedmainlytothis.

Aneffect,firstofallonthedesquamation,thenontheinfiltrationandfinallyontheerythema,isseenaftertwotofour

weeksoftreatment.Themaximumeffectisusuallyachievedaftersixweeks.

5.2Pharmacokineticproperties

Datafromasinglestudycontaining5evaluablepatientswithpsoriasistreatedwith0.3–1.7gofa50micrograms/g

tritiumlabelledcalcipotriolointmentsuggestedthatlessthan1%ofthedosewasabsorbed.However,totalrecoveryof

thetritiumlabelovera96hourperiodrangedfrom6.7to32.6%,figuresmaximisedbyuncorrected

chemiluminescence.Therewerenodataontissuedistributionfromthelungs.

5.3Preclinicalsafetydata

Studiesinratshaveshownthattheeffectofcalcipotrioloncalciummetabolismisapproximately100timeslessthan

thatofactivevitaminD3(1,25(OH)

,calcitriol).Therearenootherpreclinicaldataconsideredrelevanttoclinical

safetybeyonddataincludedinothersectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Disodiumedetate

Disodiumphosphatedihydrate

Sodiumdihydrogenphosphatedihydrate

Chloroallylmethenaminechloride

Glycerol

Macrogolcetostearylether

Cetostearylalcohol

Paraffin,lightliquid

Paraffin,whitesoft

Water,purified

6.2Incompatibilities

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6.3ShelfLife

2years

Afterfirstopening:3months

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Donotfreeze.

6.5Natureandcontentsofcontainer

Membraneclosedaluminiumtubewithpolyethyleneneckandscrewcap.

Packsize:30gram

Membraneclosedaluminiumtubewithpolyethyleneneckandscrewcap.

Packsizes:30gram,60gram,100gramand120gram.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

RowexLtd.

Bantry

Co.Cork

8MARKETINGAUTHORISATIONNUMBER

PA711/104/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:27 th

July2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 29/09/2008 CRN 2041764 page number: 6