ANTHRANOL 1.0 1.0 %w/w Ointment

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
DITHRANOL
Available from:
Stiefel Laboratories (U.K.) Ltd.
INN (International Name):
DITHRANOL
Dosage:
1.0 %w/w
Pharmaceutical form:
Ointment
Authorization status:
Withdrawn
Authorization number:
PA0144/017/001
Authorization date:
2009-05-08

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Anthranol1.0%

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Dithranol1.0%w/w.

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Ointment

Awaxyyellowointment.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Anthranol1.0Ointmentisindicatedforthetopicaltreatmentofpsoriasis.

4.2Posologyandmethodofadministration

Anthranol1.0Ointmentisoneofarangeofdithranolproducts,whichinclude0.4and2.0ointments.

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

Anthranol1.0Ointmentiscontra-indicatedinpustularpsoriasisandisnotsuitableforthetreatmentofacutepsoriasis.

Itshouldnotbeusedbypatientswithknownhypersensitivitytotheingredients.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/12/2006 CRN 2030816 page number: 1

4.4Specialwarningsandprecautionsforuse

Dithranolisastrongirritant,thehandsshouldalwaysbewashedafteruseandtheproductkeptawayfromtheeyes.

Shouldcontactwiththeeyesoccur,batheimmediatelywithwaterandseekmedicaladvice.

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

andthusdecreasingthecellularproliferation,whichisincreasedinthepsoriaticepidermis.

5.2Pharmacokineticproperties

Theproductisatopicalpreparation,whichactslocallyatthesiteofapplication.Pharmacokineticdataarenot

applicable.

5.3Preclinicalsafetydata

Notapplicable.Dithranolhasbeeninwide-spreaduseformanyyears.Therelevantinformationisgiveninsection4of

Irish Medicines Board

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Date Printed 06/12/2006 CRN 2030816 page number: 2

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Whitesoftparaffin

Cetylalcohol

Sodiumlaurilsulfate

Salicylicacid

Lightliquidparaffin

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

PA144/17/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:23March1990

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/12/2006 CRN 2030816 page number: 3

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/12/2006 CRN 2030816 page number: 4

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