ANTHRANOL 2.0

Main information

  • Trade name:
  • ANTHRANOL 2.0
  • Dosage:
  • 2.0 %w/ w
  • Pharmaceutical form:
  • Ointment
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ANTHRANOL 2.0
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0144/017/002
  • Authorization date:
  • 23-03-1990
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Anthranol2.0%

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Dithranol2.0%w/w.

3PHARMACEUTICALFORM

Ointment

Awaxyyellowointment.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Anthranol2.0Ointmentisindicatedforthetopicaltreatmentofpsoriasis.

4.2Posologyandmethodofadministration

Anthranol2.0Ointmentisoneofarangeofdithranolproductswhichinclude0.4and1.0ointments.

TreatmentshouldbeginwithAnthranol0.4.Clinicalresponseandtolerancewilldeterminethenecessityfor

progressiontoAnthranol1.0andsubsequentlyAnthranol2.0.

Applytheointmentoncedaily,sparinglytothepsoriaticplaque.Surroundingnormalskinshouldbeprotectedwith

whitesoftparaffin.Leavetheointmentonfortherequiredtimethenremoveexcessointmentwithapapertissueand

washofftheremainderthoroughly.

IfAnthranolhasbeenappliedtothescalp,theointmentshouldberemovedbyshampooing.

Theinitialdailytreatmenttimewitheachstrengthshouldnotexceed10minutes.Thetimemaybeincreasedgradually

overaperiodof7daystoamaximumof30minutes.Thedailytreatmenttimeshouldnotnormallyexceed30minutes.

Intheeventofundueirritation,stoptreatmentfor2daysandresumeonalternatedays.

Treatmentshouldbecontinuedattheoptimumtoleratedstrengthandleave-ontime,dependingonpatientresponse.

4.3Contraindications

Anthranol2.0Ointmentiscontra-indicatedinpustularpsoriasisandisnotsuitableforthetreatmentofacutepsoriasis.

Itshouldnotbeusedbypatientswithknownhypersensitivitytotheingredients.

Anthranol2.0Ointmentshouldnotbeappliedtotheface,theinsideofthethighs,thegenitalregionorskinfoldareas.

4.4Specialwarningsandprecautionsforuse

Dithranolisastrongirritant,thehandsshouldalwaysbewashedafteruseandtheproductkeptawayfromtheeyes.

Irish Medicines Board

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Date Printed 06/12/2006 CRN 2030819 page number: 1

Theproductwillcausestaininganddiscolourationoftheskin.Itwillalsostainordiscolourclothingandmaystain

bathroomware.Stainsonclothingshouldbeassumedtobepermanent;stainsonbathroomwaremayberemovedby

bleach.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

None.

4.6Pregnancyandlactation

AlthoughthereisnoevidencetosupportthesafetyofAnthranolinpregnancyandlactation,noadverseeffectshave

beenreported.

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

theSummaryofProductCharacteristics.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Whitesoftparaffin

Cetylalcohol

SodiumLaurilsulfate

Salicylicacid

Irish Medicines Board

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Date Printed 06/12/2006 CRN 2030819 page number: 2

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

6.5Natureandcontentsofcontainer

Internallylacqueredaluminiumtubesof50g.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

StiefelLaboratories(UK)Ltd.

HoltspurLane

WooburnGreen

HighWycombe

Buckinghamshire

HP100AU

England

8MARKETINGAUTHORISATIONNUMBER

PA144/17/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:23March1990

Dateoflastrenewal:23March2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 06/12/2006 CRN 2030819 page number: 3