EAREX

Main information

  • Trade name:
  • EAREX Ear Drops Solution
  • Pharmaceutical form:
  • Ear Drops Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EAREX Ear Drops Solution
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0547/001/001
  • Authorization date:
  • 19-08-1992
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

EarexEarDrops

2QUALITATIVEANDQUANTITATIVECOMPOSITION

3PHARMACEUTICALFORM

Eardrops,solution

Clear,yellowoilyliquid.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Fortheeasyremovalofearwax.

4.2Posologyandmethodofadministration

Adults,childrenandtheelderly:

Routeofadministration:Installationintotheear.

4.3Contraindications

Useinthepresenceofinflammationorinfectionoftheearornasopharynx.

Useinthepresenceofaperforatedeardrum.

4.4Specialwarningsandprecautionsforuse

Neveruseforceorinstrumentsintheear.Violentnoseblowingshouldalwaysbeavoided.Wisdomoranydecayed

teethshouldbeexaminedinallcasesofeartrouble.

Iftherearenoimprovementsconsultthedoctor.

EarexEarDropscontainArachisoil(peanutoil)andshouldnotbeappliedbypatientsknowntobeallergictopeanut.

AsthereisapossiblerelationshipbetweenallergytopeanutandallergytoSoya,patientswithSoyaallergyshouldalso

AlmondOil 33.33 %v/v

ArachisOil(peanutoil) 33.33 %v/v

RectifiedCamphorOil 33.33 %v/v

1.Inclinetheheadtooneside.

2.Insertfourdropswiththeapplicatorsupplied.

3.Insertapieceofcottonwool.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 02/08/2006 CRN 2026299 page number: 1

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Pregnancyandlactation

Nospecialprecautions.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Nonestated.

4.9Overdose

Unlikelywiththisdosageform.Gastriclavagemaybeusedincasesofaccidentalingestion.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Notapplicable.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

None.

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

5years.

6.4Specialprecautionsforstorage

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 02/08/2006 CRN 2026299 page number: 2

6.5Natureandcontentsofcontainer

Cartoncontaininganamberglassbottle,withadropperapplicatorconsistingofapolypropyleneorureaformaldehyde

closureandasodaglassdropperwithabutylornitrilerubberteat.

Contents:10mlofeardrops.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

PharmalabLtd

TubitonHouse

Oldham

OL13HS

England

8MARKETINGAUTHORISATIONNUMBER

PA547/1/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:19August1992

Dateoflastrenewal:19August2002

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 02/08/2006 CRN 2026299 page number: 3