CALCIL

Main information

  • Trade name:
  • CALCIL Ointment 0.05 mg/g
  • Dosage:
  • 0.05 mg/g
  • Pharmaceutical form:
  • Ointment
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CALCIL Ointment 0.05 mg/g
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0711/093/001
  • Authorization date:
  • 13-07-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0711/093/001

CaseNo:2042715

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

RowexLtd

Bantry,Co.Cork,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Calcil50micrograms/gOintment

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom21/08/2008until12/07/2012.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/09/2008 CRN 2042715 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Calcil50micrograms/gOintment

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Onegramofointmentcontains0.05mg(isequalto50micrograms)ofcalcipotriol.

Excipient:Propyleneglycol10mg/g

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Ointment

Whitetooff-whiteointment.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Calcilisindicatedforthetopicaltreatmentofmildtomoderatelyseverepsoriasis(psoriasisvulgaris).

4.2Posologyandmethodofadministration

Adults:

Asmonotherapy

Calcilshouldbeappliedtotheaffectedskinonceortwicedaily.Atthebeginningoftreatment,twicedailyapplication

isrecommended.Formaintenancetherapy,thefrequencyofapplicationmaybedecreasedtooncedaily,dependingon

theresponse.

Themaximumamountofointmentappliedshouldnotexceed100gramsperweek.IfCalcilisusedtogetherwith

creamorsolutioncontainingcalcipotriol,thetotalweeklydoseofcalcipotriolshouldnotexceed5mg.

Ascombinationtherapy

TwicedailyapplicationofCalcilincombinationwithphototherapy,acitretin,ciclosporinandoncedailyapplicationin

combinationwithtopicalcorticosteroids(e.g.administrationofCalcilinthemorningandsteroidintheevening)is

effectiveandwelltolerated.

Thedurationoftherapydependsontheclinicalappearance.Apronouncedtherapeuticeffectisgenerallyseenaftera

maximumof4-8weeks.Therapycanberepeated.

Renal/hepaticimpairment

Patientswithknownsevererenalorliverimpairmentshouldnotbetreatedwithcalcipotriol.

Childrenandadolescents(under18yearsofage)

ThereislimitedexperiencewiththeuseofCalcilinchildrenandadolescentsunder18yearsofage.Theefficacyand

longtermsafetyofabovementioneddosage(underadults)hasnotbeenestablishedinchildrenandadolescents.

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4.3Contraindications

Hypersensitivitytotheactivesubstancecalcipotriolortoanyoftheexcipients

Knowndisordersofcalciummetabolism

Hypercalcaemia

4.4Specialwarningsandprecautionsforuse

Calcilshouldnotbeusedontheface.

Patientsshouldbeadvisedtowashtheirhandsafterapplyingtheointmentinordertopreventtheinadvertenttransferto

otherareas,especiallytheface.

Theefficacyandlong-termsafetyofthisointmentinchildrenhasnotbeenestablished.

Hypercalcaemiadoesnotoccurwiththeusualdosage(upto100gperweek).Excessiveuse(50-100gofointmentper

day)maycauseelevationsinserumcalciumlevelswhichreverserapidlyondiscontinuationoftreatment.Studieson

adultsoveraperiodofoneyearhavenotyieldedanyevidenceofariskofhypercalcaemia.However,theserum

calciumlevelshouldbemonitoredonlong-termusewithapplicationtoextensiveareasofskin.

Inviewofapossibleeffectoncalciummetabolism,patientsshouldbeadvisedtousenomorethantherecommended

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

notpermitted.Occlusionisundesirableforthesamereason.

Theclinicalsymptomsofhypercalcaemiamayresemblethoseofcholecalciferoloverdose,i.e.thehypercalcaemia

syndromeorcalciumintoxication(seesection4.9),dependingontheintensityanddurationofthehypercalcaemia.

Persistenthypercalcaemiamayresultinectopicdepositsofcalciuminthebloodvesselwalls,jointcapsules,gastric

mucosa,corneaandrenalparenchyma.

TherearedataindicatingthatthecombinationofcalcipotriolwithUV-lightmaycausedarkareasof

hyperpigmentation;thisisreversible.IfcalcipotriolisstartedduringacourseofUV-Btherapy,photosensitiveeczema

mayoccur.

PatientswithknownsevererenalorliverimpairmentshouldnotbetreatedwithCalcilduetolimitedexperience.

Calcilcontainspropyleneglycol.Maycauseskinirritations.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Althoughstudiesto-datehaveshownthatthecombinationofCalcilwithUV-Atherapy,ciclosporinoracitretinis

effectiveandwell-tolerated,thereisnotenoughdatathatthecombinationismoreeffectiveorthatthedosageofthe

othermedicinalproductscanbereduced.

OintmentwillnotincreasetheoveralleffectivenessofUV-Btreatment.However,ithasalight-savingeffectwhenused

incombinationwithUV-BinadultsandresponseisachievedatalowerdoseofUV-B.Calcilshouldbeappliedatleast

2hoursbeforeUV-Btherapy.CombinationofcalcipotriolwithUV-Blightmaycausedarkareasofhyperpigmentation

andphotosensitiveeczema(seesection4.4.).Ointmentshouldnotbeinitiatedwherepatientsmayalreadybereceiving

anerythemogenicorsub-erythmogenicdoseofUV-B.

Concomitantadministrationofcalcipotriolandsalicylicacidexternalsmaycauseaninactivationofcalcipotriol.There

isnoexperienceofconcomitanttherapywithotherantipsoriaticproductsappliedtothesameareaofskinatthesame

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4.6Pregnancyandlactation

Pregnancy:

Forcalcipotriolnodataonpregnantpatientsareavailable.Alimitedabsorptionisexpectedafterlocalapplicationof

Calcilatsmallareas.Ifusedasindicatednodisturbanceofthecalciumhomeostasisistobeexpected.Animalstudies

donotindicatedirectorindirectharmfuleffectswithrespecttoreproductivetoxicity.Asaprecautionarymeasure,itis

preferabletoavoidtheuseofcalcipotriolinpregnancy.

Lactation:

Itunknownwhethercalcipotriolisexcretedinbreastmilk.Theexcretionofcalcipotriolinmilkhasnotbeenstudiedin

animals.Asaprecautionarymeasure,itispreferabletoavoidtheuseofcalcipotriolinlactation.

4.7Effectsonabilitytodriveandusemachines

Inviewofthenatureoftheproductandtheindicationsforitsuse,noeffectontheabilitytodriveandusemachinesis

tobeexpected.

4.8Undesirableeffects

Basedontheclinicaldataundesirableeffectsoccurredinapproximately15%ofthepatients.

Themostfrequentlyreportedundesirableeffectsarevarioustransientskinreactionsandinparticularapplicationsite

reactions,whichseldomrequiresdiscontinuationoftreatment.

TheundesirableeffectsarelistedbyMedDraSOCandtheindividualundesirableeffectsarelistedstartingwiththe

mostfrequentlyreported.

Skinandsubcutaneousdisorders

Common(>1/100and<1/10)

Pruritus,skinburningsensation,skinstingingsensation,skinirritation,skindry,erythema,rash*

Uncommon(>1/1,000and<1/100)

Eczema,contactdermatitis,aggravated,psoriasis

*varioustypesofrashreactionsuchasscaly,erythematous,maculo-papularandpustularhavebeenreported.

Metabolismandnutritiondisorders

Veryrare(<1/10,000)

Hypercalcaemia,hypercalciuria

Thefollowingundesirableeffectshavebeenreportedforcalcipotriolcream,ointmentandscalpsolutionduringpost-

marketingexperience:transientchangesinskinpigmentation,transientphotosensitivityreactionandhypersensitivity

reactionincludingurticaria,angioedema,periorbitalorfacialoedema(veryrarely).Perioraldermatitismayoccur

rarely.Basedonpost-marketingdatathetotal‘reportingrate’ofundesirableeffectsisveryrarebeingapproximately

1:10,000treatmentcourses.

4.9Overdose

Uptonow,hypercalcaemiahasnotbeenreportedinpatientswithpsoriasisvulgarisattheusualdosageofupto100

gramsofointmentperweek,althoughthepossibleoccurrenceofhypercalcaemiaatthisdosagecannotbecompletely

excluded.Excessiveuse(50-100gramsperday)mayresultinanelevatedserumcalciumlevel,whichdisappears

rapidlyaftercessationoftreatment,andhypercalcaemiahasbeenreportedatlowerdosesinpatientswithgeneralised

pustularorerythrodermicexfoliativepsoriasis.Theclinicalsignsofhypercalcaemiaincludeanorexia,nausea,

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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,totalrecoveryofthetritiumlabelovera96hourperiodrangedfrom6.7to32.6%,figuresmaximisedby

uncorrectedchemiluminescence.Therewerenodataontissuedistributionorexcretionfromthelungs.

5.3Preclinicalsafetydata

TherearenopreclinicaldataconsideredrelevanttoclinicalsafetybeyonddataincludedinothersectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Macrogolstearylether

Disodiumedetate

Disodiumphosphatedihydrate

-Tocopherylacetate

Propyleneglycol(E490)

Paraffin,lightliquid

Water,purified

Paraffin,whitesoft

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years

Afterfirstopening:3months

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Donotrefrigerateorfreeze.

Irish Medicines Board

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6.5Natureandcontentsofcontainer

Membraneclosedaluminiumtubewithpolypropylenescrewcap.

Packsize:30gram.

Membraneclosedalmuninumtubewithpolyethyleneneckandscrewcap.

Packsizes:30,60,90and120gram

Notallpacksizesmaybemarketed

6.6Specialprecautionsfordisposalandotherhandling

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

RowexLtd

Bantry

Co.Cork

8MARKETINGAUTHORISATIONNUMBER

PA711/93/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:13 th

July2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 29/09/2008 CRN 2042715 page number: 6