DOVONEX

Main information

  • Trade name:
  • DOVONEX Ointment 50 Micrograms/ g
  • Dosage:
  • 50 Micrograms/ g
  • Pharmaceutical form:
  • Ointment
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DOVONEX Ointment 50 Micrograms/g
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1328/023/001
  • Authorization date:
  • 01-09-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995

MEDICINALPRODUCTS(LICENSINGANDSALE)REGULATIONS,1998

(S.I.No.142of1998)

PPA1328/023/001

CaseNo:2034068

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrants

B&SHealthcare

Unit4,BradfieldRoad,Ruislip,Middlesex,HA40NU,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Dovonex50Micrograms/gOintment

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjectto

thegeneralconditionsasmaybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom26/03/2007until31/08/2011.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 12/04/2007 CRN 2034068 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dovonex50micrograms/gOintment

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgramofointmentcontains50microgramsofcalcipotriol.

Excipientsincludepropyleneglycol

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Ointment.

ProductimportedfromFrance:

Afainttranslucentwhitetoyellowishointment.

4CLINICALPARTICULARS

4.1TherapeuticIndications

DovonexOintmentisindicatedforthetopicaltreatmentofplaquepsoriasis(psoriasisvulgaris).Dovonexointment

mayalsobeusedincombinationwithphototherapy,acitretin,cyclosporinortopicalcorticosteroids.

4.2Posologyandmethodofadministration

Adults:

Theointmentshouldbeappliedtotheaffectedareaoncetotwicedaily.Twicedailyapplicationofthe

ointmentisoftenpreferredinitially.Applicationoftheointmentcanbereducedtooncedailywhen

appropriate.Maximumweeklydoseshouldnotexceed100g.

TwicedailyapplicationofDovonexincombinationwithphototherapy,cyclosporinoracitretinand

oncedailyapplicationofDovonexincombinationwithcorticosteroids(e.g.administrationof

Dovonexinthemorningandsteroidintheevening)iseffectiveandwelltolerated.

TheadditionofDovonextwicedailywillenhancetheefficacyandreducethedosageofcyclosporin,

acitretinandphototherapy.

Children:

Over12years:DovonexOintmentshouldbeappliedtotheaffectedareatwicedaily.Maximum

weeklydoseshouldnotexceed75g.

Aged6to12years:DovonexOintmentshouldbeappliedtotheaffectedareatwicedaily.Maximum

weeklydoseshouldnotexceed50g.

Under6years:ThereislimitedexperienceoftheuseofDovonexOintmentinthisagegroup.Amaximumsafedose

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4.3Contraindications

Knownhypersensitivitytoanyoftheingredients.

DuetothecontentofcalcipotriolDovonexiscontraindicatedinpatientswithknowndisordersofcalciummetabolism.

4.4Specialwarningsandprecautionsforuse

DovonexOintmentshouldnotbeusedontheface.Thepatientmustbeinstructedincorrectuseofthe

producttoavoidapplicationandaccidentaltransfertotheface.Handsmustbewashedaftereach

application.

UseofDovonex ®

shouldbeavoidedinpatientswithsevererenalfailureorseverehepaticdisorders.

Theriskofhypercalcaemiaisminimalwhenthedosagerecommendationsarefollowed.

Hypercalcaemiamayoccurifthemaximumweeklydose(100g)isexceeded.However,serum

calciumisquicklynormalisedwhentreatmentisdiscontinued.

Propyleneglycolmaycauseskinirritation.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ThereisnointeractionbetweencalcipotriolandsunlightorUVlight.

4.6Pregnancyandlactation

Safetyforuseduringhumanpregnancyhasnotyetbeenestablished,althoughstudiesinexperimentalanimalshavenot

shownteratogeniceffects.Avoiduseinpregnancyunlessthereisnosaferalternative.Itisnotknownwhether

calcipotriolisexcretedinbreastmilk.

4.7Effectsonabilitytodriveandusemachines

Doesnotapply.

4.8Undesirableeffects

Verycommon>1/10

Common>1/100and<1/10

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

Rare>1/10,000and<1/1,000

Veryrare<1/10,000

Themostfrequentlyreportedundesirableeffectsarevariousskinreactionsandinparticular

applicationsitereactions.Hypercalcaemiaandallergicreactionshavebeenreportedveryrarely.

BasedonclinicaldataforDovonexOintmentundesirableeffectsoccurredinapproximately15%of

thepatients.

Pruritus,skinirritation,burningandstingingsensation,dryskin,erythemaandrasharecommon.

Contactdermatitis,eczemaandaggravatedpsoriasisareuncommon.

Systemiceffectsaftertopicalusemayappearveryrarelycausinghypercalcaemiaorhypercalciuria,cf.

section4.4.

Post-marketdataonDovonex ®

cream,ointmentandscalpsolution

Transientchangesinskinpigmentation,transientphotosensitivityreactionsandhypersensitivity

reactionsincludingurticaria,angioedema,periorbitalorfacialoedemahavebeenreportedveryrarely.

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Basedonpost-marketingdatathetotal'reportingrate'ofundesirableeffectisveryrarebeing

approximately1:10,000treatmentcourses.

TheundesirableeffectsarelistedbyMedDRASOCandtheindividualundesirableeffectsarelisted

startingwiththemostfrequentlyreported.

Skinandsubcutaneoustissuedisorders:

Pruritus

Skinburningsensation

Skinstingingsensation

Skinirritation

Skindry

Erythema

Rash*

Eczema

ContactDermatitis

AggravatedPsoriasis

Skinhyperpigmentation

Skindepigmentation

Photosensitivityreaction

Urticaria

Facialoedema

Periorbitaloedema

Angioedema

*Varioustypesofrashreactionssuchasscaly,erythematous,maculo-papularandpustularhavebeen

reported.

Metabolismandnutritiondisorders:

Hypercalcaemia

Hypercalciuria

4.9Overdose

Hypercalcaemiamayoccurinpatientswithplaquepsoriasiswhousemorethan100gofDovonexOintmentweeklyand

hasbeenreportedatlowerdosesinpatientswithgeneralisedpustularorerythrodermicexfoliativepsoriasis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

CalcipotriolisavitaminDderivative.Invitrodatasuggestthatcalcipotriolinducesdifferentiationandsuppresses

proliferationofkeratinocytesbutwithlesseffectoncalciummetabolism.Thisistheproposedbasisforitseffectin

psoriasis.

5.2Pharmacokineticproperties

Absorptionthroughskinappearstobelowbutthatwhichreachesthesystemiccirculationisrapidlymetabolisedto

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5.3Preclinicalsafetydata

Theeffectoncalciummetabolismisapproximately100timeslessthanthatofthehormonallyactiveformofvitamin

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

disodiumedetate

disodiumphosphatedihydrate

D,L-alpha-tocopherol

liquidparaffin

macrogol-(2)-stearylether

propyleneglycol

whitesoftparaffin

purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelf-lifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Lacqueredaluminiumtubewithpolyethylenescrewcap.Packsizes:30g

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerials

derivedfromsuchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7ParallelProductAuthorisationHolder

B&SHealthcare

Unit4

BradfieldRoad

Ruislip

Middlesex

HA40NU

Irish Medicines Board

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Date Printed 12/04/2007 CRN 2034068 page number: 5

8ParallelProductAuthorisationNumber

PPA1328/23/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:1stSeptember2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 12/04/2007 CRN 2034068 page number: 6