CALCIL 50 MICROGRAMS/ML CUTANEOUS SOLUTION

Main information

  • Trade name:
  • CALCIL 50 MICROGRAMS/ML CUTANEOUS SOLUTION
  • Dosage:
  • 50 Microgram/ML
  • Pharmaceutical form:
  • Cutaneous Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CALCIL 50 MICROGRAMS/ML CUTANEOUS SOLUTION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0711/149/001
  • Authorization date:
  • 08-04-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0711/149/001

CaseNo:2066595

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

RowexLtd

Bantry,Co.Cork,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Calcil50micrograms/mlCutaneousSolution

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom07/09/2009until07/04/2014.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 07/09/2009 CRN 2066595 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Calcil50micrograms/mlCutaneousSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Onemlofcalcipotriolcutaneoussolutioncontains50microgramscalcipotriol.

Excipient:Propyleneglycol30mg/ml.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cutaneoussolution

Clear,colourlesssolutionwithanodourofmenthol.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Calcil50micrograms/mlCutaneousSolutionisindicatedforthetopicaltreatmentofmildtomoderatescalppsoriasis.

4.2Posologyandmethodofadministration

Adults

Calcil50micrograms/mlCutaneousSolutionshouldbeappliedtotheaffectedareastwicedaily(morningand

evening).

Themaximumweeklydoseshouldnotexceed60ml.

Ifthissolutionisusedtogetherwithcreamorointmentcontainingcalcipotriol,thetotalweeklydoseofcalcipotriol

shouldnotexceed5mg(forexample60mlofCalcil50micrograms/mlCutaneousSolutionplus30gofcreamor

ointment,or30mlofCalcil50micrograms/mlCutaneousSolutionplus60gofcreamorointment.

Durationoftreatmentshouldbedecidedbythephysician,butshouldnormallynotbeforlongerthan22weeks.

Renal/hepaticimpairment

Patientswithknownsevererenalorliverimpairmentshouldnotbetreatedwithcalcipotriol.

Childrenandadolescents(under18yearsofage)

Calcil50micrograms/mlCutaneousSolutionisnotrecommendedforuseinchildrenandadolescentsbelow18years

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4.3Contraindications

Hypersensitivitytotheactivesubstancecalcipotriolortoanyoftheexcipients

Patientswithsevererenalorliverimpairment

Knowndisordersofcalciummetabolismortreatmentwithothermedicinalproductswhichincreaseserum

calciumlevel

Hypercalcaemia

4.4Specialwarningsandprecautionsforuse

ApplicationofCalcil50micrograms/mlCutaneousSolutiontothefacemaycauselocalirritation.Calcil50

micrograms/mlCutaneousSolutionshouldthereforenotbeapplieddirectlytotheface.Patientsshouldbeadvisedto

washtheirhandsafterapplyingthesolutioninordertopreventinadvertenttransfertotheface.

Theefficacyandlong-termsafetyofthissolutioninchildrenhasnotbeenestablished.Thereforeitsuseinthis

populationcannotberecommended.

Patientsshouldbeadvisedtousenomorethanthemaximumweeklydosesincehypercalcaemia,whichrapidly

reversesoncessationoftreatment,mayoccur.

Duringcalcipotrioltreatmentphysiciansarerecommendedtoadvisepatientstolimitoravoidexcessiveexposureto

eithernaturalorartificialsunlight.TopicalcalcipotriolshouldbeusedwithUVradiationonlyifthephysicianand

patientconsiderthatthepotentialbenefitsoutweighthepotentialrisks(seesection5.3).

Calcil50micrograms/mlCutaneousSolutioncontainspropyleneglycol.Itmaycauseskinirritation.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nointeractionstudieshavebeenperformed.

Thereisnoexperienceofconcomitanttherapywithotherantipsoriaticproductsappliedtothesamearea.

4.6Pregnancyandlactation

Pregnancy:

Forcalcipotriolnodataonpregnantpatientsareavailable.Alimitedabsorptionisexpectedafterlocalapplication

ofCalcil50micrograms/mlCutaneousSolutiononsmallareas.Ifusedasindicatednodisturbanceofthecalcium

homeostasisistobeexpected.Animalstudiesdonotindicatedirectorindirectharmfuleffectswithrespectto

reproductivetoxicity.Asaprecautionarymeasure,itispreferabletoavoidtheuseofcalcipotriolduringpregnancy.

Lactation:

Itisunknownwhethercalcipotriolisexcretedinbreastmilk.Theexcretionofcalcipotriolinmilkhasnotbeenstudied

inanimals.Asaprecautionarymeasure,itispreferabletoavoidtheuseofcalcipotriolduringlactation.

4.7Effectsonabilitytodriveandusemachines

Nostudiesontheeffectsontheabilitytodriveandusemachineshavebeenperformed.

Inviewofthenatureoftheproductandtheindicationsforitsuse,noeffectontheabilitytodriveandusemachinesis

tobeexpected.

4.8Undesirableeffects

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Themostfrequentlyreportedundesirableeffectsarevarioustransientskinreactionsandinparticularapplicationsite

reactions.

TheundesirableeffectsarelistedbyMedDraSOCandtheindividualundesirableeffectsarelistedstartingwiththe

mostfrequentlyreported.Thefollowingconventionhasbeenusedfortheclassificationoffrequencyofundesirable

effects:

Verycommon1/10

Common1/100and<1/10

Uncommon1/1,000and<1/100

Rare1/10,000and<1/1,000

Veryrare<1/10,000,notknown(cannotbeestimatedfromtheavailabledata)

Skinandsubcutaneousdisorders

*varioustypesofrashreactionsuchasscaly,erythematous,maculo-papularandpustularhavebeenreported.

Metabolismandnutritiondisorders

Thefollowingundesirableeffectshavebeenreportedonotherproductscontainingcalcipotriol(cream,ointment,scalp

solution)duringpost-marketingexperience:

Transientchangesinskinpigmentation,transientphotosensitivityreactionsandhypersensitivityreactionsincluding

urticaria,angioedema,periorbitalorfacialoedema(veryrarely),perioraldermatitis(rarely).

Basedonpost-marketingdatathetotal‘reportingrate’ofundesirableeffectsisveryrarebeingapproximately1:10,000

treatmentcourses.

4.9Overdose

Useabovetherecommendeddose(seesection4.2)maycauseelevatedserumcalciumwhichdisappearsrapidlyafter

cessationoftreatment.

Theclinicalsignsofhypercalcaemiaincludeanorexia,nausea,vomiting,constipation,hypotonia,cognitive

dysfunction,depression,lethargy,comaandrenaldysfunction.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Otherantipsoriaticsfortopicaluse,ATCcode:D05AX02

CalcipotriolisavitaminDderivative.Invitrodatashowthatcalcipotriolinducesdifferentiationandsuppresses

proliferationofkeratinocytes.Theeffectofcalcipotriolinpsoriasisisascribedmainlytothis.

5.2Pharmacokineticproperties

Verycommon Skinburningsensationand

skinstingingsensation

Common Pruritus,skinirritation,dry

skin,erythema,rash*

Uncommon Eczema,contactdermatitis,

aggravationofpsoriasis

Rare Perioraldermatitis

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Datafromasinglestudycontaining5evaluablepatientswithpsoriasistreatedwith0.3–1.7gofa50micrograms/g

tritiumlabelledcalcipotriolointmentsuggestedthatlessthan1%ofthedosewasabsorbed.However,totalrecoveryof

thetritiumlabelovera96hourperiodrangedfrom6.7to32.6%,figuresmaximisedbyuncorrected

chemiluminescence.Therewerenodataon 3

Htissuedistributionorexcretionfromthelungs.

5.3Preclinicalsafetydata

Theeffectoncalciummetabolismisapproximately100timeslessthanthatofthehormonallyactiveformofvitamin

Adermalcarcinogenicitystudyinmicerevealednospecialhazardsforhumans.

Inanotherstudywherealbinohairlessmicewererepeatedlyexposedtobothultraviolet(UV)radiationandtopically

appliedcalcipotriolfor40weeksatdoseswhichcorrespondto9,30and90µg/m2/day(equivalentto0.25,0.84and

2.5timesthemaximumrecommendeddailydosefora60kgadult,respectively),areductioninthetimerequiredfor

UVradiationtoinducetheformationofskintumourswasobserved(statisticallysignificantinmalesonly),suggesting

thatcalcipotriolmayenhancetheeffectofUVradiationtoinduceskintumours.Theclinicalrelevanceofthese

findingsisunknown.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumcitrate

Hypromellose

Propyleneglycol

Isopropylalcohol

Levomenthol

Water,purified

6.2Incompatibilities

Notapplicable

6.3ShelfLife

Beforeopening: 2years

Afterfirstopening: 3months

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Keepthebottleintheoutercartoninordertoprotectfromlight.

Donotrefrigerateorfreeze.

Keepthecutaneoussolutionawayfromfireorflames(thealcoholbaseisinflammable).

6.5Natureandcontentsofcontainer

Polyethenebottlefittedwithpolyethenenozzleandclosedwithpolypropylenescrewcap.

Packsizes:30and60ml.

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6.6Specialprecautionsfordisposalandotherhandling

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

RowexLtd

Bantry

Co.Cork

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA711/149/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:8April2009

Irish Medicines Board

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Date Printed 07/09/2009 CRN 2066595 page number: 6