DETTOL MED

Main information

  • Trade name:
  • DETTOL MED
  • Dosage:
  • 4.8 %w/w
  • Pharmaceutical form:
  • Cutaneous Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DETTOL MED
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0979/004/003
  • Authorization date:
  • 16-10-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DettolMed4.8%w/wConcentrateforCutaneousSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Chloroxylenol4.8mgin100mgconcentrateforCutaneoussolution

Forafulllistofexcipientsseesection6.1

3PHARMACEUTICALFORM

Concentrateforcutaneoussolution

Clear,amberliquid

4CLINICALPARTICULARS

4.1TherapeuticIndications

Antisepticcleansingofcuts,bites,abrasionsandinsectbitesandstings.

4.2Posologyandmethodofadministration

Forcutaneoususe

Dettolmedshouldnotbeusedundiluted

Cuts,bites,abrasionsandinsectstings-washtheareawith50mlDettolMeddilutedtoonelitre(5%,1:20)withwater

andcoverwithdrygauzeorlint.

Oncedilutedtheliquidbecomesamilkywhite,opaquesolutionwithpineodour.

Dettolmedshouldnotbeusedundiluted

PaediatricPatients

Nottobeusedonchildrenunder12months.

4.3Contraindications

Knownhypersensitivitytotheactivesubstanceoranyoftheexcipients

Eczematousconditions.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 15/03/2012 CRN 2093353 page number: 1

4.4Specialwarningsandprecautionsforuse

Forexternaluseonly.

Thisproductisonlysuitableforwoundcleansingasafirstaidmeasureandisnotsuitableforsurgicalantisepsisoruse

inahospitalsetting.

Followingaccidentalingestionitisadvisedtoconsiderdilutionwithmilkorwaterifvomitinghasnotoccured.Ifskin

oreyecontaminationhasoccured,copiousirrigationshouldbeperformed.Thisshouldbefollowedbyacarefuleye

examinationforcornealburns.Ifcornealburnsarenoted,opthalmologicconsultationshouldbeobtained.

Donotuseinoraroundtheeyes,ears,noseormouth.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nospecificdruginteractionstudieshavebeenundertaken;thereforetheuseofDettolMedwithanyothertopical

productsisnotrecommended.

4.6Fertility,pregnancyandlactation

DettolMedCutaneousSolution4.8%w/wcanbeusedduringpregnancyundermedicalsupervision.

ItisnotadvisedtoapplyDettolMedCutaneousSolution4.8%w/wtotheskinofthebreastduringlactation.

4.7Effectsonabilitytodriveandusemachines

DettolMedhasnoinfluenceontheabilitytodriveandusemachines.

4.8Undesirableeffects

Adversedrugreactionsareveryrare(<1/10,000)followingthetopicaluseofDettolMed.

ThefollowingoutlinestheskinandsubcutaneoustissuedisorderslinkedwiththeuseofDettolMed.

4.9Overdose

OverdoseisunlikelywhenusedasdirectedsincetheDettolMedwillrunofftheskinsurfaceifanexcessiveamountis

applied.

Chloroxylenolhasalowsystemictoxicity,whenusedasinstructed.

Therehavebeenisolatedreportsofpoisoning.Symptomsreportedafteroralingestionincludecorrosionoftheoral

mucosa,larynx,andthegastrointestinaltract,bradycardia,hypotension,andrenalfailure.Largeamountsmaycause

CNSdepression.Pulmonaryaspirationofchloroxylenol-baseddisinfectantsmayresultinpneumonia,acuterespiratory

SkinandSubcutaneous

TissueDisorders Veryrare Skindystrophy,applicationsitefissure,

acrodermatitis,eczema,contactdermatitis,

skinirritation,skinburningsensation,

alopecia,popularrash,pruritus,erythema,

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 15/03/2012 CRN 2093353 page number: 2

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Antiseptic.

ATCcode:D08AE05

Chloroxylenolisasubstitutedphenolwhichhasbeenwidelyusedformanyyearsasaningredientof

antiseptic/disinfectantproductsintendedforexternaluse.Itisknowntobebacteriocidalinlowconcentrationtoawide

rangeofGram-positiveandGram-negativebacteria.

5.2Pharmacokineticproperties

PCMXiswellabsorbedafteroraldosingandalmosttotallyexcretedintheurinewithin24hours.PCMXhasat

~30to60minutesandahalflife~50to60minutes.TheclearanceofPCMXis~6hourswithnoPCMXbeingdetected

intissueafter24hours.PCMXismetabolisedintheliverandexcretedinaconjugatedformasamixtureof

glucuronideandsulfateconjugatesinaratioof6:1withverylowlevelsoffreePCMX.

5.3Preclinicalsafetydata

PreclinicalstudieswithChloroxylenol,althoughlimited,donotindicateariskofgenotoxicity,carcinogenicityor

teratogenicity.EffectsobserveduponoraladministrationofasingledoseofanundilutedformulationsimilartoDettol

Medincludedsedation,salivationandrespiratorydepression.OralLD

valuesvariedbetween9.7and17.4ml/kg.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Pineoil,

Isopropylalcohol,

Castoroilsoap,

Caramel(E150(c)),

Purifiedwater

6.2Incompatibilities

Thisproductshouldnotbemixedwithanyothermedicinalproduct.

6.3Shelflife

Twoyears

Oncedilutedthesolutionshouldbeusedimmediately

6.4Specialprecautionsforstorage

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 15/03/2012 CRN 2093353 page number: 3

6.5Natureandcontentsofcontainer

Whitehighdensitypolythyleneorunpigmentedpolypropylenebottleswithpolypropylenescrewcap.

Packsizes:125,250,500,750,1000&1250ml

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposal

Nospecialrequirements

7MARKETINGAUTHORISATIONHOLDER

ReckittBenckiserHealthcareIrelandLimited

7Riverwalk

CitywestBusinessCampus

Dublin24

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA979/4/3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:16October2009

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 15/03/2012 CRN 2093353 page number: 4