DRAPOLENE CREAM, BENZALKONIUM CHLORIDE 0.01% W/W ,

Main information

  • Trade name:
  • DRAPOLENE CREAM, BENZALKONIUM CHLORIDE 0.01% W/W ,
  • Dosage:
  • 0.01/0.2 %w/w
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DRAPOLENE CREAM, BENZALKONIUM CHLORIDE 0.01% W/W ,
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1186/002/001
  • Authorization date:
  • 14-01-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DrapoleneCream

Benzalkoniumchloride0.01%w/w

Cetrimide0.2%w/w

2QUALITATIVEANDQUANTITATIVECOMPOSITION

DRAPOLENECreamcontainsbenzalkoniumchloride0.01%w/w(asbenzalkoniumchloridesolution0.02%w/w)and

Cetrimide0.2%w/w.

Forafulllistofexcipient,seesection6.1

3PHARMACEUTICALFORM

Cream

Asmoothhomogenouspinkwatermisciblecream.

4CLINICALPARTICULARS

4.1TherapeuticIndications

DRAPOLENECreamisindicatedforthepreventionandtreatmentofurinaryammoniadermatitis,particularlynappy

rash,andinthetreatmentofminorburnsandwounds.

4.2Posologyandmethodofadministration

Children:Nappyrash.Fortopicalapplication.Tobeappliedevenlyateachnappychange,particularattentionbeing

paidtothefoldsoftheskin.

Adults:UrinaryDermatitis.Regularroutineapplicationisadvised.

UseintheElderly:Nospecialcomment.

Minorburnsandwounds:Applyasrequired.

BeforeapplyingDrapoleneCream,theaffectedareashouldbedryandfreefromalltracesofsoap.

4.3Contraindications

DRAPOLENECreamiscontraindicatedinpatientswithahypersensitivitytotheactivesubstanceortoanyofthe

Excipient(s)

WoolFat(purifiedlanolin) 2.0 % w/w

CetylAlcohol 5.0 % w/w

Cetostearylalcohol 4.0 % w/w

Chlorocresol 0.1 % w/w

Irish Medicines Board

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Date Printed 18/11/2011 CRN 2107998 page number: 1

4.4Specialwarningsandprecautionsforuse

DRAPOLENECreamisforexternaluseonly.

DrapoleneCreamcontainswoolfat(purifiedlanolin),cetylalcoholandcetostearylalcoholwhichmaycauselocalskin

reactions(e.g.contactdermatitis)insomepeople.

DrapoleneCreamalsocontainschlorocresolwhichmaycauseallergicreactionsinsomepeople.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Fertility,pregnancyandlactation

Whenusedinaccordancewiththespecifiedindications,systematicabsorptionofthespecifiedcomponentsisnot

envisagedandsotherearenospecialprecautions/warningsappropriatetopregnancyandlactation.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Frequencyofadverseeventscannotbeestimatedfromavailabledata.

Iftheconditionisaggravated,applicationshouldbediscontinuedandthedoctorconsulted

Hypersensitivity,contactdermatitisandprurituswithcetrimidemayoccur.

4.9Overdose

TherearenoreportsofadverseeventsresultingfromexcessiveapplicationoraccidentalingestionofDrapoleneCream.

Incasesofaccidentalingestion,symptomatictreatmentisappropriate.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ACTCodesD08AJ01andD08AJ04.

Benzalkoniumchlorideandcetrimidearebothquaternaryammoniumdisinfectantswithpropertiestypicalofcationic

surfactants.Thispreparationisusefulinthepreventionandtreatmentofnappyrash,actingtosuppressthe

developmentofammoniaproducingorganismsusuallyassociatedwiththiscondition.

5.2Pharmacokineticproperties

NodataisavailableonthepharmacokineticsoftheactiveingredientsofDrapoleneCream,whenusedforthespecified

indications.Systemicabsorptionoftheactiveingredientsisnotenvisaged.

5.3Preclinicalsafetydata

Irish Medicines Board

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Date Printed 18/11/2011 CRN 2107998 page number: 2

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Whitesoftparaffin

Woolfat(purifiedlanolin)

Cetylalcohol

Emulsifyingwax

Chlorocresol

Amaranth(E123)

Water

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years.

6.4Specialprecautionsforstorage

Storebelow25°C.

6.5Natureandcontentsofcontainer

25g,75g,150g,200g,350g,inwhitepolypropylenecontainerswithwhiteLDPEorLDPE/HDPEsnap-fitcaps.

500ginpolypropylenepotswithPVDCfacedwadandpolypropylenescrewcaps.

100ginpolyolefin/foil/polyolefinlaminatetubewithpolypropylenecaps.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ChefaroIrelandLimited,

FirstFloor,BlockA,

TheCrescentBuilding,

NorthwoodOfficePark,

Dublin9

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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Date Printed 18/11/2011 CRN 2107998 page number: 3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1983

Dateoflastrenewal:01April2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 18/11/2011 CRN 2107998 page number: 4