AUDAX

Main information

  • Trade name:
  • AUDAX Ear Drops Solution 20/12.6 %w/v
  • Dosage:
  • 20/12.6 %w/v
  • Pharmaceutical form:
  • Ear Drops Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AUDAX Ear Drops Solution 20/12.6 %w/v
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1138/029/001
  • Authorization date:
  • 12-05-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AudaxEarDropsSolution

CholineSalicylate20%w/v

Glycerol12.6%w/v

2QUALITATIVEANDQUANTITATIVECOMPOSITION

CholineSalicylate20.0%w/v.

Glycerol12.6%w/v.

Excipients:alsocontains1.25%w/vethyleneoxidepolyoxypropyleneglycolandupto66.6%w/vpropyleneglycol.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Eardropssolution

Clear,faintlytansolution,withacharacteristicodour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forreliefofpaininotitisexternaandmedia,furunclesandotherlocalinflammation,softeningofearwaxandaidto

earwaxremoval.

4.2Posologyandmethodofadministration

Topicalintoear.

Placetheheadononesidewiththeaffectedearuppermost.Completelyfilltheexternalauditorycanalwithdrops.The

earshouldbepluggedwithcottonwoolsoakedwiththeeardropsorawickmaybeinsertedifpreferred.AudaxEar

Dropsshouldbeinstilledevery3to4hoursuntilpermanentreliefofsymptomsisobtained.

4.3Contraindications

1.Useinpatientshypersensitivetosalicylates.

2.Perforatedeardrum.

4.4Specialwarningsandprecautionsforuse

Ifsymptomspersist,thedoctorshouldbeconsulted.

Ifthepatientisunderthedoctor’scareorisonanymedication,thedoctorshouldbeconsultedbeforeusing.

Containspropyleneglycolandesterswhichmaycauseskinirritation.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Irish Medicines Board

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4.6Fertility,pregnancyandlactation

Irish Medicines Board

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4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Nonestated.

4.9Overdose

EachbottleofAudaxEarDropscontains1.6gofcholinesalicylateequivalentto1.2gofaspirin.Accidentalor

deliberateingestionofthecontentsofabottleofAudaxEarDropsisthereforeonlyofconcerninsmallinfants.

Insuchcases,signsofintoxificationmayincludedizziness,tinnitus,sweating,vomiting,confusionand

hyperventilation.Grossoverdosagemayleadtocentralnervoussystemdepression.

Managementshouldinclude,asappropriate,inducedvomiting,correctionoffluidandelectrolytebalanceand

measurementofplasmasalicylatelevels.Atconcentrationsinexcessof300mg/litremeasuressuchasforcedalkaline

diuresisandhaemodialysistoenhanceclearancemaybeappropriate.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Cholinesalicylatehasactionssimilartothoseofaspirin,i.e.,analgesic,anti-inflammatory,andanti-pyreticactions

consideredtobeduetoinhibitionofthebiosynthesisofprostaglandins.Glycerolsoftensearwaxduetoitswater-

retainingandemollientproperties.

5.2Pharmacokineticproperties

NotapplicableasAudaxEarDropsareappliedtopically.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Ethyleneoxidepolyoxypropyleneglycol

Chlorobutanolhemihydrate

Hydrochloricacid(forpHadjustment)

Propyleneglycol

6.2Incompatibilities

Irish Medicines Board

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Date Printed 06/02/2012 CRN 2105686 page number: 3

6.3Shelflife

Irish Medicines Board

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6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Amberglassbottle(Ph.Eur.TypeIII),withapolypropylenepipette,containing8mlor10mlofproduct.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

SSLInternationalplc

Venus

1OldParkLane

TraffordPark

Manchester

M417HA

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA1138/29/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1983

Dateoflastrenewal:01April2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 06/02/2012 CRN 2105686 page number: 5