AULIN

Main information

  • Trade name:
  • AULIN Gel 3 %w/w
  • Dosage:
  • 3 %w/w
  • Pharmaceutical form:
  • Gel
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AULIN Gel 3 %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0294/018/003
  • Authorization date:
  • 10-12-1999
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Aulin3%w/wGel.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Aulin3%w/wgelcontains3%w/wnimesulide(1gofgelcontains30mgofnimesulide).

Excipients:

Methylparahydroxybenzoate0.80%w/w

Propylparahydroxybenzoate0.02%w/w

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Gel.

Opalescent,paleyellowgel.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Symptomaticreliefofpainassociatedwithsprainsandacutetraumatictendinitis.

4.2Posologyandmethodofadministration

Adults:

Nimesulide3%w/wgel(usually3g,correspondingtoaline6-7cmlong)shouldbeappliedinathinlayertothe

affectedarea2-3timesdailyandmassageduntilitiscompletelyabsorbed.

Durationoftreatment:7–15days.

Childrenunder12years:

Nimesulide3%w/wgelhasnotbeenstudiedinchildren.Therefore,safetyandefficacyhavenotbeenestablishedand

theproductshouldnotbeusedinchildren(seesection4.3).

4.3Contraindications

Knownhypersensitivitytonimesulideortoanyotherexcipientsinthegel.

Useinpatientsinwhomaspirin,orothermedicinalproductsinhibitingprostaglandinsynthesis,inducedallergic

reactionssuchasrhinitis,urticariaorbronchospasm.Useonbrokenordenudedskinorinthepresenceoflocal

infection.Simultaneoususewithothertopicalcreams.Useinchildrenunder12years.

4.4Specialwarningsandprecautionsforuse

Nimesulide3%w/wgelshouldnotbeappliedtoskinwoundsoropeninjuries.

Nimesulide3%w/wgelshouldnotbeallowedtocomeintocontactwiththeeyesormucousmembranes;incaseof

accidentalcontact,washimmediatelywithwater.

Theproductshouldneverbetakenbymouth.Handsshouldbewashedafterapplyingtheproduct.

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Nimesulide3%w/wgelisnotrecommendedforuseinchildrenunder12years(seesection4.3).

Undesirableeffectsmaybereducedbyusingtheminimumeffectivedosefortheshortestpossibleduration.

Patientswithgastro-intestinalbleeding,activeorsuspectedpepticulcer,severerenalorhepaticdysfunction,severe

coagulationdisordersorsevere/noncontrolledheartfailureshouldbetreatedwithcaution.

SinceNimesulide3%w/wgelhasnotbeenstudiedinhypersensitivesubjects,particularcautionshouldbeusedwhen

treatingpatientswithknownhypersensitivitytootherNSAIDs.Thepossibilityofdevelopinghypersensitivityinthe

courseoftherapycannotbeexcluded.

SincewithothertopicalNSAIDsburningsensationandexceptionallyphotodermatitiscanoccur,careshouldbetaken

duringtreatmentwithNimesulide3%w/wgel.

Toreducetheriskofphotosensitivity,patientsshouldbewarnedagainstexposuretodirectandsolariumsunlight.

Ifsymptomspersistortheconditionisaggravatedmedicaladviceshouldbesought.

Thisproductcontainsparahydroxybenzoates.Thesesubstancesmaycauseallergicreactions(possiblydelayed).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

NointeractionsofNimesulide3%w/wgelwithothermedicinalproductsareknownortobeexpectedviathetopical

route.

4.6Fertility,pregnancyandlactation

TherearenodatarelevanttothetopicaluseofNimesulide3%w/wgelinpregnantwomenorduringbreastfeeding.

Therefore,Nimesulide3%w/wgelshouldnotbeusedduringpregnancyorlactationunlessclearlynecessary.

4.7Effectsonabilitytodriveandusemachines

NostudiesontheeffectofNimesulide3%w/wgelontheabilitytodriveandusemachineshavebeenperformed.

4.8Undesirableeffects

Thefollowingsideeffectslistingisbasedonreportsfromclinicalstudies,inalimitednumberofpatients,wheremild

localreactionshavebeenreported.Thereportingratesareclassifiedas:verycommon(>1/10);common(>1/100,

<1/10),uncommon(>1/1,000,<1/100);rare(>1/10,000,<1/1,000);veryrare(<1/10,000),includingisolatedcases.

4.9Overdose

IntoxicationwithnimesulideasaresultoftopicalapplicationofNimesulide3%w/wgelisnottobeexpectedsincethe

highestplasmalevelsofnimesulidefollowingapplicationofNimesulidegelarefarbelowthosefoundfollowing

systemicadministration.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:ATCcode:M02AA.

Skinandsubcutaneoustissuedisorders(seealso

section4.4) Common Itching

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Nimesulideisaninhibitoroftheprostaglandinsynthesisenzymecyclo-oxygenase.

Cyclo-oxygenaseproducesprostaglandins,someofthembeingimplicatedinthedevelopmentandmaintenanceof

inflammation.

5.2Pharmacokineticproperties

WhenNimesulide3%w/wgelisappliedtopically,plasmaconcentrationsofnimesulideareverylowincomparison

withthoseachievedfollowingoralintake.Afterasingleapplicationof200mgofnimesulide,inthegelform,the

highestplasmalevelof9.77ng/mlwasnotedafter24hours.Notraceofthemainmetabolite4-hydroxy-nimesulide,

wasdetected.Atsteady-state(day8)peakplasmaconcentrationswerehigher(37.25 ±

13.25ng/ml)butalmost100

timeslowerthanthosemeasuredfollowingrepeatedoraladministration.

5.3Preclinicalsafetydata

ThelocaltoleranceandtheirritationandsensitisationpotentialofNimesulide3%w/wgelhavebeentestedinseveral

recognisedanimalmodels.TheresultsofthesestudiesindicatethatNimesulide3%w/wgeliswelltolerated.

Preclinicaldataforsystemicallyadministerednimesuliderevealnospecialhazardsforhumansbasedonconventional

studiesofsafetypharmacology,repeateddosetoxicity,genotoxicityandcarcinogenicpotential.Inrepeateddose

toxicitystudies,nimesulideshowedgastrointestinal,renalandhepatictoxicity.Inreproductivetoxicitystudies,

embryotoxicandteratogeniceffects(skeletalmalformations,dilatationofcerebralventricles)wereobservedinrabbits,

butnotinrats,atmaternallynon-toxicdoselevels.Inrats,increasedmortalityofoffspringwasobservedintheearly

postnatalperiodandnimesulideshowedadverseeffectsonfertility.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

PurifiedWater

Diethyleneglycolmonoethylether

Caprylcaproylmacrogolglycerides

Carbomers

Disodiumedetate

Triethanolamine

Methylparahydroxybenzoate(E218)

Propylparahydroxybenzoate(E216)

6.2Incompatibilities

Notapplicable.

6.3Shelflife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove30 °

6.5Natureandcontentsofcontainer

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polypropylenecap.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Washhandsafteruse.

7MARKETINGAUTHORISATIONHOLDER

HelsinnBirexPharm.Limited

Damastown

Mulhuddart

Dublin15

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA0294/018/003

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:10December1999

Dateoflastrenewal:10December2009

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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