GELCOTAR

Main information

  • Trade name:
  • GELCOTAR Shampoo 1.25/ 0.5 %w/ w
  • Dosage:
  • 1.25/ 0.5 %w/ w
  • Pharmaceutical form:
  • Shampoo
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GELCOTAR Shampoo 1.25/0.5 %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0308/012/001
  • Authorization date:
  • 18-04-1988
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

GelcotarShampoo

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Forexcipientssee6.1.

3PHARMACEUTICALFORM

Shampoo

GelcotarShampooisaclear,viscousshampoo,deepredtobrownincolour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Psoriasisofthescalp,seborrhoeicdermatitisanddandruff.

4.2Posologyandmethodofadministration

Routeofadministration

Fortopicaluseonly.

Adults,childrenandtheelderly

Wetthescalpandhairwithwarmwater.SufficientGelcotarShampooshouldbeappliedtoproduceagenerouslather.

Massagethescalpandsurroundingareawiththefingertips.Rinseandrepeat.Finallyrinsethehairandscalp

thoroughly.

UsetwiceweeklyorasdirectedbytheMedicalPractitioner.

4.3Contraindications

PatientswithknownsensitivityorintolerancetostrongcoaltarorcadeoilshouldnotuseGelcotarShampoo.

4.4Specialwarningsandprecautionsforuse

Contactwitheyesandothermucosalsurfacesshouldbeavoided.Allmedicinesshouldbekeptoutofthereachof

children.GelcotarShampoocanbeeasilyremovedbywarmwater.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

StrongCoalTarSolution1.25%w/w

Irish Medicines Board

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Date Printed 21/07/2006 CRN 2025837 page number: 1

4.6Pregnancyandlactation

GelcotarShampooisnotcontra-indicatedinpregnancyorlactation.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Althoughcarcinogenicityofcoaltarhasbeendemonstratedinanimalstudies,nostudiesdemonstratinganincreased

riskofskincancerwithnormaltherapeuticuseinhumanshavebeenreported.Thereisnounequivocalevidencetolink

theuseoftopicallyappliedcoaltarproductswithskincancer.(SeealsoSection5.3).

4.9Overdose

Notapplicable.GelcotarShampooisfortopicaluseonly.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Thecombinationofstrongcoaltarsolutionandcadeoilprovidesapreparationwithantisepticandkeratolytic

propertiestobeusedamedicatedscalpcleanser.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Tarpreparationshavebeeninwideuseformanyyears.Althoughcoaltarpreparationscontainingpolycyclicaromatic

hydrocarbons(PAHs)havebeendemonstratedtobecarcinogenicintheskinofexperimentalanimals,present

evidence,baseduponepidemiologystudiesinhumansandfollow-uptrials,revealsnoevidenceofincreasedriskof

skinorinternalcancer,particularlywhentheproductisusedasdirected.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Polyethylene-glycol-200hydrogenatedglycerylpalmate

Disodiumfattyacidmonoethanolamidesulphosuccinate

Ricinoleicpropylamidotrimethylammoniummethosulphate

Coconutdiethanolamide

Triethanolaminelaurylsulphate

Chlorocresol

Lecithin

PurifiedWater

6.2Incompatibilities

Irish Medicines Board

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Date Printed 21/07/2006 CRN 2025837 page number: 2

6.3ShelfLife

Twoyears.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

6.5Natureandcontentsofcontainer

GelcotarShampooispackedinprintedpolythenebottlesof150mland350ml.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

QuinodermLimited

ManchesterRoad

Hollinwood

Oldham

OL84PB

Lancashire

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA308/12/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:18April1988

Dateoflastrenewal:18April2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 21/07/2006 CRN 2025837 page number: 3