ANTHRANOL 0.4

Main information

  • Trade name:
  • ANTHRANOL 0.4
  • Dosage:
  • 0.4 %w/w
  • Pharmaceutical form:
  • Ointment
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ANTHRANOL 0.4
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0144/017/004
  • Authorization date:
  • 01-10-1984
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Anthranol0.4%

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Dithranol0.40%w/w.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Ointment

Waxy,yellowhomogeneousointmentfreefromparticles.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Anthranol0.4%isindicatedforthetopicaltreatmentofsub-acuteandchronicpsoriasis,includingpsoriasisofthe

scalp.

4.2Posologyandmethodofadministration

Anthranol0.4%isoneofarangeofdithranolproductswhichinclude1.0,and2.0ointments.

TreatmentshouldbeginwithAnthranol0.4%.Clinicalresponseandtolerancewilldeterminethenecessityfor

progressiontoAnthranol1.0OintmentandsubsequentlyAnthranol2.0Ointment.

Applytheointmentoncedaily,sparinglytothepsoriaticplaque.Surroundingnormalskinshouldbeprotectedwith

whitesoftparaffin.Leavetheointmentonfortherequiredtimethenremoveexcessointmentwithapapertissueand

washofftheremainderthoroughly.

IfAnthranol0.4%hasbeenappliedtothescalp,theointmentshouldberemovedbyshampooing.

Theinitialdailytreatmenttimewitheachstrengthshouldnotexceed10minutes.Thetimemaybeincreasedgradually

overaperiodof7daystoamaximumof30minutes.Thedailytreatmenttimeshouldnotnormallyexceed30minutes.

Intheeventofundueirritation,stoptreatmentfor2daysandresumeonalternatedays.

Treatmentshouldbecontinuedattheoptimumtoleratedstrengthandleave-ontime,dependingonpatientresponse.

Anthranol0.4%canalsobeusedfortreatmentofscalppsoriasisbytheovernightmethod.

4.3Contraindications

Anthranol0.4%iscontra-indicatedinpustularpsoriasisandisnotsuitableforthetreatmentofacutepsoriasis.Itshould

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/12/2006 CRN 2030824 page number: 1

4.4Specialwarningsandprecautionsforuse

Anthranol0.4%shouldnotbeappliedtotheface,theinsideofthethighs,thegenitalregionorskinfoldareas.

Dithranolisastrongirritant,thehandsshouldalwaysbewashedafteruseandtheproductkeptawayfromtheeyes.

Shouldcontactwiththeeyesoccur,batheimmediatelywithwaterandseekmedicaladvice.

Theproductwillcausestaininganddiscolourationoftheskin.Itwillalsostainordiscolourclothingandmaystain

bathroomware.Stainsonclothingshouldbeassumedtobepermanent;stainsonbathroomwaremayberemovedby

bleach.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

None.

4.6Pregnancyandlactation

AlthoughthereisnoevidencetosupportthesafetyofAnthranol0.4%inpregnancyandlactation,noadverseeffects

havebeenreported.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Dithranolpreparationscancauseirritation;ifthisdevelops,orrednessisobservedonadjacentnormalskin,the

frequencyofapplicationshouldbereduced.

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Theuseofdithranolinthetreatmentofpsoriasisiswellestablished.Ithasbeensuggestedthatthemodeofaction

involvescombinationwithdeoxyribonucleicacidandothernucleicacids,inhibitingthesynthesisofnucleicprotein

andthusdecreasingthecellularproliferationwhichisincreasedinthepsoriaticepidermis.

5.2Pharmacokineticproperties

Theproductisatopicalpreparationwhichactslocallyatthesiteofapplication.Pharmacokineticdataarenot

applicable.

5.3Preclinicalsafetydata

Notapplicable.Dithranolhasbeeninwide-spreaduseformanyyears.Therelevantinformationisgiveninsection4of

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/12/2006 CRN 2030824 page number: 2

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Whitesoftparaffin

Cetylalcohol

Sodiumlaurilsulfate

Salicylicacid

Lightliquidparaffin

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Storebelow25°C.

6.5Natureandcontentsofcontainer

Internallylacqueredaluminiumtubesof50g.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

StiefelLaboratories(UK)Ltd

HoltspurLane

WooburnGreen

HighWycombe

Buckinghamshire

HP100AU

8MARKETINGAUTHORISATIONNUMBER

PA144/17/4

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01October1984

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/12/2006 CRN 2030824 page number: 3

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/12/2006 CRN 2030824 page number: 4