ANTHISAN PLUS STING RELIEF (SPRAY)

Main information

  • Trade name:
  • ANTHISAN PLUS STING RELIEF (SPRAY)
  • Dosage:
  • 2/2 %w/w %w/w
  • Pharmaceutical form:
  • Cutaneous Spray Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ANTHISAN PLUS STING RELIEF (SPRAY)
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0540/013/001
  • Authorization date:
  • 07-01-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AnthisanPlusStingReliefSpray

2QUALITATIVEANDQUANTITATIVECOMPOSITION

MepyramineMaleate2%w/w.

Benzocaine2%w/w.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Cutaneousspray,solution

Aclear,colourlesstoslightlyyellowsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Symptomaticreliefininsectbitesandstings,andnettlestings.

4.2Posologyandmethodofadministration

Eachmetereddosedelivers2mgmepyraminemaleateand2mgbenzocaine.

Adults,elderlyandchildrenover12years:

Pressingthenozzleheadoncedeliversasinglemetereddose.

Twotothreemetereddosestobesprayedontothesiteofthebiteorstingtwoorthreetimesadayforuptothreedays.

Earlyapplicationisessentialtoobtainoptimumresponse.

4.3Contraindications

Hypersensitivitytoanyoftheingredients.

AnthisanPlusStingReliefSprayshouldnotbeusedineczematousconditionsoronextensivelybrokenskinsurfaces.

Donotuseonlargeareasofskinoronareasofsunburntskin.

Donotuseneartheeyesormouth.

4.4Specialwarningsandprecautionsforuse

RepeatedapplicationsofAnthisanPlusStingReliefSprayforlongerthanafewdaysarenotrecommendedand

treatmentshouldbediscontinuedimmediatelyifskinsensitisationoccurs.Thesprayshouldnotbeappliednearanaked

Irish Medicines Board

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Date Printed 22/12/2006 CRN 2031448 page number: 1

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noclinicallysignificantinteractionsfollowingtopicaluseareknown.

4.6Pregnancyandlactation

ThereisinadequateevidenceforthesafetyofAnthisanPlusStingReliefSprayinpregnancyorlactation.Anthisan

PlusStingReliefSprayshouldnotbeusedinpregnancyorlactationunlessconsideredessentialbyaphysician.

4.7Effectsonabilitytodriveandusemachines

Nonewhenusedasrecommended.Howeverfollowinginappropriateusewithapplicationtolargeareasabsorptionmay

theoreticallyoccurwhichcouldresultinsomnolenceormilddisorientation.

4.8Undesirableeffects

Hypersensitivityreactions.

4.9Overdose

Unlikelyfollowingtopicaladministration.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Mepyraminemaleateisanantihistaminewithanti-pruriticpropertiesandlocalanalgesicactions.

Benzocaineissurfaceanaestheticoftheestertypewithlowsystemictoxicity,whichprovideseffectivereliefofpain.

5.2Pharmacokineticproperties

Nodataavailable.

5.3Preclinicalsafetydata

NoanimaldataisavailablerelatingtoAnthisanPlusStingReliefSpray.Theactiveagentsmepyraminemaleateand

benzocainehavebeenusedinhumanmedicineforover40years.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Ethanol

PropyleneGlycol

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Irish Medicines Board

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Date Printed 22/12/2006 CRN 2031448 page number: 2

6.4Specialprecautionsforstorage

Storebelow25 o

C.Keepawayfromnakedflames.

6.5Natureandcontentsofcontainer

Aluminiuminternallylacqueredcanwith100microlitrepump/actuatorandcontainingeither60or180metereddoses.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Sanofi-AventisIrelandLtd.

CitywestBusinessCampus

Dublin24

8MARKETINGAUTHORISATIONNUMBER

PA540/13/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:07January2000

Dateoflastrenewal:07January2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 22/12/2006 CRN 2031448 page number: 3