DENOREX

Main information

  • Trade name:
  • DENOREX Shampoo
  • Pharmaceutical form:
  • Shampoo
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DENOREX Shampoo
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0172/023/001
  • Authorization date:
  • 23-03-1990
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DenorexShampoo

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Shampoo

Anamber/brownliquidshampoowiththecharacteristicodourofcoaltar.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthereliefofthesymptomsofandinthemanagementofdandruff,seborrhoeicdermatitisandpsoriasisofthescalp.

4.2Posologyandmethodofadministration

Usetopicallyasshampoo.

Shampooeveryotherdayforthefirsttendays,then2-3timesweeklythereafter.

4.3Contraindications

Noneknown.

4.4Specialwarningsandprecautionsforuse

1.Discontinueuseifirritationoccurs.

2.Donotuseonhighlyinflamedorbrokenskin.

3.Ifnoimprovementisseenconsultadoctor.

4.Keepoutofeyes.

5.Keepoutofreachofchildren.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Pregnancyandlactation

CoalTarSolution 7.5 %w/w

Irish Medicines Board

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Date Printed 18/08/2006 CRN 2026961 page number: 1

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Occasionalirritation.

Althoughcarcinogenicityofcoaltarhasbeendemonstratedinanimalstudies,nostudiesdemonstratinganincreased

riskofskincancerwithnormaltherapeuticuseinhumanshavebeenreported.Thereisnounequivocalevidencetolink

theuseoftopicallyappliedcoaltarproductswithskincancer.(SeealsoSection5.3).

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

CoalTaractslocallytoslowdownproductionandsheddingofskincells.

Mentholhelpstorelievetheinflammationofitching.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Tarpreparationshavebeeninwideuseformanyyears.Althoughcoaltarpreparationscontainingpolycyclicaromatic

hydrocarbons(PAHs)havebeendemonstratedtobecarcinogenicintheskinofexperimentalanimals,present

evidence,baseduponepidemiologystudiesinhumansandfollow-uptrials,revealsnoevidenceofincreasedriskof

skinorinternalcancer,particularlywhentheproductisusedasdirected.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Trolaminelaurilsulfate

Hypromellose

Lauryldiethanolamide

Stearicacid

Chloroxylenol

Perfumecompound64.404NY/D

Purifiedwater

Ethanol(96%)

6.2Incompatibilities

Irish Medicines Board

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Date Printed 18/08/2006 CRN 2026961 page number: 2

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Nospecialprecautionsnecessary.

6.5Natureandcontentsofcontainer

Theproductissuppliedinscrewcappedpolypropylenebottles,fittedwithureaformaldehydewaddedcapsfilledwith

125mlofshampoo.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Avoidcontactwiththeeyes.

7MARKETINGAUTHORISATIONHOLDER

WhitehallLaboratoriesLimited

TradingasWyethConsumerHealthcare

HuntercombeLaneSouth

Taplow

Maidenhead

BerksSL60PH

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA172/23/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:23March1990

Dateoflastrenewal:23March2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 18/08/2006 CRN 2026961 page number: 3