EASOFEN MAX STRENGTH

Main information

  • Trade name:
  • EASOFEN MAX STRENGTH
  • Dosage:
  • 400 Milligram
  • Pharmaceutical form:
  • Film Coated Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EASOFEN MAX STRENGTH
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0126/232/001
  • Authorization date:
  • 09-09-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

EasofenMaxStrength400mgFilm-coatedTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachfilm-coatedtabletcontains400mgibuprofen.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablet.

Round,white,biconvexfilm-coatedtablets,12mmindiameter.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Fortheshorttermmanagementofmuscularpain,backache,dentalpainanddysmenorrhoea.

4.2Posologyandmethodofadministration

Adultsandchildrenovertheageof12years:

Theusualdoseis400mgandsubsequentlyifnecessary400mgeveryfourtosixhourswithamaximumof1200mgin

atwenty-fourhourperiod.

Notrecommendedinchildrenundertheageof12years.

Elderly

NSAIDsshouldbeusedwithparticularcautioninelderlypatientswhoaremorepronetoadverseevents.Thelowest

dosecompatiblewithadequatesafeclinicalcontrolshouldbeemployed(seealsosection4.4).

Treatmentshouldbereviewedatregularintervalsanddiscontinuedifnobenefitisseenorintoleranceoccurs.

Undesirableeffectsmaybeminimisedbyusingthelowesteffectivedosefortheshortestdurationnecessarytocontrol

symptoms(seesection4.4).

Routeofadministration

Oral.

4.3Contraindications

Historyofgastrointestinalbleedingorperforation,relatedtopreviousNSAIDstherapy.Active,orhistoryofrecurrent

pepticulcer/haemorrhage(twoormoredistinctepisodesofprovenulcerationorbleedingorothergastrointestinal

disorder).

Patientswithaknownhistoryofhypersensitivityreactions(e.g.,bronchospasm,rhinitisorurticaria)inresponseto

ibuprofen(theactivesubstanceoranyoftheexcipientsinEasofenMaxStrength,aspirinorothernon-steroidalanti-

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Useinchildrenunder12yearsofage.

Patientswithseverehepaticfailure,severerenalfailureorsevereheartfailure.

Duringthelasttrimesterofpregnancy.

4.4Specialwarningsandprecautionsforuse

TheuseofIbuprofenwithconcomitantNSAIDsincludingcyclooxygenase-2selectiveinhibitorsshouldbeavoided.

Undesirableeffectsmaybeminimisedbyusingtheminimumeffectivedosefortheshortestpossibledurationtocontrol

symptoms(seesection4.2,andGIandcardiovascularrisksbelow).PatientstreatedwithNSAIDslong-termshould

undergoregularmedicalsupervisiontomonitorforadverseevents.Inpatientswithrenal,cardiacorhepatic

impairment,cautionisrequiredsincetheuseofNSAIDsmayresultindeteriorationofrenalfunction.Assessmentof

renalfunctionshouldoccurpriortotheinitiationoftherapyandregularlythereafter.

Cardiovascularandcerebrovasculareffects

Appropriatemonitoringandadvicearerequiredforpatientswithahistoryofhypertensionand/ormildtomoderate

congestiveheartfailureasfluidretentionandoedemahavebeenreportedinassociationwithNSAIDtherapy.

Clinicaltrialandepidemiologicaldatasuggestthatuseofibuprofen,particularlyatahighdose(2400mgdaily)andin

longtermtreatmentmaybeassociatedwithasmallincreasedriskofarterialthromboticevents(forexample

myocardialinfarctionorstroke).Overall,epidemiologicalstudiesdonotsuggestthatlowdoseibuprofen(e.g. 1200

mgdaily)isassociatedwithanincreasedriskofmyocardialinfarction.

Patientswithuncontrolledhypertension,congestiveheartfailure,establishedischaemicheartdisease,peripheralarterial

diseaseand/orcerebrovasculardiseaseshouldonlybetreatedwithibuprofenaftercarefulconsideration.Similar

considerationshouldbemadebeforeinitiatinglonger-termtreatmentofpatientswithriskfactorsforcardiovascular

events(e.g.hypertension,hyperlipidaemia,diabetesmellitus,smoking).

Elderly:TheelderlyhaveanincreasedfrequencyofadversereactionstoNSAIDsespeciallygastrointestinalbleeding

andperforationwhichmaybefatal(seesection4.2).ProlongeduseofNSAIDsintheelderlyisnotrecommended.

Whereprolongedtherapyisrequired,patientsshouldbereviewedregularly.

Gastrointestinalbleeding,ulcerationandperforation:GIbleeding,ulcerationorperforationwhichcanbefatal,hasbeen

reportedwithallNSAIDsatanytimeduringtreatment,withorwithoutwarningsymptomsoraprevioushistoryof

seriousGIevents.TheriskofGIbleeding,ulcerationorperforationishigherwithincreasingNSAIDdoses,inpatients

withahistoryofulcer,particularlyifcomplicatedwithhaemorrhageorperforation(seesection4.3),andintheelderly.

Thesepatientsshouldcommencetreatmentonthelowestdoseavailable.Combinationtherapywithprotectiveagents

(e.g.misoprostolorprotonpumpinhibitors)shouldbeconsideredforthesepatients,andalsoforpatientsrequiring

concomitantlowdoseaspirin,orotherdrugslikelytoincreasegastrointestinalrisk(seebelowandsection4.5).

PatientswithahistoryofGItoxicity,particularlywhenelderly,shouldreportanyunusualabdominalsymptoms

(especiallyGIbleeding)particularlyintheinitialstagesoftreatment.

Cautionshouldbeadvisedinpatientsreceivingconcomitantmedicationswhichcouldincreasetheriskofulcerationor

bleeding,suchasoralcorticosteroids,anticoagulantssuchaswarfarin,selectiveserotonin-reuptakeinhibitorsoranti-

plateletagentssuchasaspirin(seesection4.5).WhenGIbleedingorulcerationoccursinpatientsreceivingIbuprofen,

thetreatmentshouldbewithdrawn.

NSAIDsshouldbegivenwithcaretopatientswithahistoryofgastrointestinaldisease(ulcerativecolitis,Crohn’s

disease)astheirconditionmaybeexacerbated(seesection4.8).

AsNSAIDscaninterferewithplateletfunction,theyshouldbeusedwithcautioninpatientswithintracranial

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Ibuprofenshouldbeusedwithcautioninpatientswithasthmaorahistoryofbronchospasm.

TheuseofIbuprofenmayimpairfemalefertilityandisnotrecommendedinwomenattemptingtoconceive.Inwomen

whohavedifficultiesconceivingorwhoareundergoinginvestigationofinfertility,withdrawalofIbuprofenshouldbe

considered.

Cautionisrequiredinpatientswithahistoryofhypertensionand/orheartfailureasfluidretentionandoedemahave

beenreportedinassociationwithNSAIDtherapy.

Seriousskinreactions,someofthemfatal,includingexfoliativedermatitis,Stevens-Johnsonsyndrome,andtoxic

epidermalnecrolysis,havebeenreportedveryrarelyinassociationwithuseofNSAIDs(seesection4.8).Patients

appeartobeathighestriskofthesereactionsearlyinthecourseoftherapy,theonsetofthereactionoccurringinthe

majorityofcaseswithinthefirstmonthoftreatment.Ibuprofenshouldbediscontinuedatthefirstappearanceofskin

rash,mucosallesions,oranyothersignsofhypersensitivity.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ItisconsideredunsafetotakeNSAIDsincombinationwithwarfarinorheparinunlessunderdirectmedical

supervision.

Careshouldbetakeninpatientstreatedwithanyofthefollowingdrugsasinteractionshavebeenreported:

Anti-hypertensives: Reducedanti-hypertensiveeffect.

Aspirin: Experimentaldatasuggestthatibuprofenmayinhibit

theeffectoflowdoseaspirinonplateletaggregation

whentheyaredosedconcomitantly.However,the

limitationsofthesedataandtheuncertainties

regardingextrapolationofexvivodatatotheclinical

situationimplythatnofirmconclusionscanbemade

forregularibuprofenuse,andnoclinicallyrelevant

effectisconsideredtobelikelyforoccasional

ibuprofenuse(seesection5.1).

Diuretics: Reduceddiureticeffects.Diureticscanincreasethe

riskofnephrotoxicityofNSAIDs.

Cardiacglycosides: NSAIDsmayexacerbatecardiacfailure,reduceGFR

andincreaseplasmacardiacglycosidelevels.

Lithium: Decreasedeliminationoflithium.

Methotrexate: Decreasedeliminationofmethotrexate.

Ciclosporin: IncreasedriskofnephrotoxicitywithNSAIDs.

OtherNSAIDs: AvoidconcomitantuseoftwoormoreNSAIDs.

Corticosteroids: Increasedriskofgastrointestinalulcerationor

bleeding(seesection4.4).

Anticoagulants: Enhancedanticoagulanteffect.

Quinoloneantibiotics: AnimaldataindicatethatNSAIDscanincreasethe

riskofconvulsionsassociatedwithquinolone

antibiotics.PatientstakingNSAIDsandquinolones

mayhaveincreasedriskofdevelopingconvulsions.

Aminoglycosides: Reductioninrenalfunctioninsusceptibleindividuals,

decreasedeliminationofaminoglycosideand

increasedplasmaconcentrations.

Probenecid: ReductioninmetabolismandeliminationofNSAIDs

andmetabolites.

Oralhypoglycaemic

agents: Inhibitionofmetabolismofsulfonylureadrugs,

prolongedhalf-lifeandincreasedriskof

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4.6Fertility,pregnancyandlactation

Whilenoteratogeniceffectshavebeendemonstratedinanimaltoxicitystudies,theuseofibuprofenduringpregnancy

should,ifpossible,beavoided.Congenitalabnormalitieshavebeenreportedinassociationwithibuprofen

administrationinman;howeverthesearelowinfrequencyanddonotappeartofollowanydiscerniblepattern.Inview

oftheknowneffectsofNSAIDsonthefoetalcardiovascularsystem(closureofductusarteriosus),useinthethird

trimesterofpregnancyiscontraindicated.

Inthelimitedstudiessofaravailable,ibuprofenappearsinthebreastmilkinverylowconcentrationsandisunlikelyto

adverselyaffectthebreast-fedinfant.

4.7Effectsonabilitytodriveandusemachines

Nofurtherinformationprovided.

4.8Undesirableeffects

ThelistofthefollowingadverseeffectsrelatestothoseexperiencedwithibuprofenatOTCdoses,forshort-termuse.

Anti-plateletagentsand

selectiveserotonin

reuptakeinhibitors

(SSRIs): Increasedriskofgastrointestinalbleeding(seesection

4.4).

GastrointestinalDisorders Uncommon: Abdominalpain,dyspepsiaandnausea.

Rare: Diarrhoea,flatulence,constipationandvomiting.

Veryrare: Pepticulcer,perforationorgastrointestinalhaemorrhage,

sometimesfatal,particularlyintheelderly(seeSection

4.4).

Melaena,haematemesis,ulcerativestomatitis,

exacerbationofulcerativecolitisandCrohn'sdisease(see

Section4.4).

Lessfrequently,gastritishasbeenobserved.

NervousSystem Uncommon: Headache,dizziness,hearingdisturbance.

Renal Veryrare: Decreaseofureaexcretionandoedemacanoccur.Also,

acuterenalfailure.Papillarynecrosis,especiallyinlong-

termuse,andincreasedserumureaconcentrationshave

beenreported.

HepatobiliaryDisorders Veryrare: Liverdisorders,especiallyinlong-termtreatment.

BloodandLymphaticsystem

Disorders Veryrare: Haematopoieticdisorders(anaemia,leucopenia,

thrombocytopenia,pancytopenia,agranulocytosis).First

signsare:fever,sorethroat,superficialmouthulcers,flu-

likesymptoms,severeexhaustion,noseandskin

bleeding.

SkinandSubcutaneous

Disorders Veryrare: Severeformsofskinreactionssuchaserythema,

erythemamultiforme,epidermalnecrolysis,bullous

reactions,Stevens-JohnsonSyndrome,maculopapular

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Clinicaltrialandepidemiologicaldatasuggestthattheuseofibuprofen(particularlyathighdoses2400mgdaily)and

inlongtermtreatmentmaybeassociatedwithasmallincreasedriskofarterialthromboticevents(forexample

myocardialinfarctionorstroke)(seeSection4.4).

4.9Overdose

Symptomsincludenausea,vomiting,dizzinessandrarelylossofconsciousness.Largeoverdosesaregenerallywell

toleratedwhennootherdrugsareinvolved.

Treatmentofoverdosage:Gastriclavageandifnecessary,correctionofserumelectrolytes.Thereisnospecificantidote

toibuprofen.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:M01AE01

PharmacotherapeuticGroup:AntiinflammatoryandAntirheumaticProducts.NonSteroids.

Ibuprofen,aderivativeofpropionicacid,hasusefulanti-inflammatory,analgesicandantipyreticactivity.Similarto

otherpropionicacidderivativessuchasnaproxenandfenoprofenitcancausegastrointestinalerosions(gastric,

duodenalandintestinal)inexperimentalanimals.

Allproducegastrointestinalsideeffectsinmanbuttheyareusuallylessseverethanwithaspirin.Thepropionicacid

derivativesarealleffectiveinhibitorsofthecyclooxygeneaseresponsibleforthebiosynthesisofprostaglandins.Allof

theseagentsalterplateletfunctionandprolongbleedingtime.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.Inonestudy,whenasingledoseofibuprofen400mgwastakenwithin8hbeforeorwithin

30minafterimmediatereleaseaspirindosing(81mg),adecreasedeffectofASAontheformationofthromboxaneor

plateletaggregationoccurred.However,thelimitationsofthesedataandtheuncertaintiesregardingextrapolationofex

vivodatatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofenuse,andno

clinicallyrelevanteffectisconsideredtobelikelyforoccasionalibuprofenuse.

5.2Pharmacokineticproperties

Ibuprofenisrapidlyabsorbedfollowingoraladministrationtoman,andpeakconcentrationsinplasmaareobserved

after1to2hours.Thehalf-lifeinplasmaisabout2hours.Ibuprofenisextensively(99%)andfirmlyboundtoplasma

ImmuneSystem Veryrare: Inpatientswithexistingauto-immunedisorders(suchas

systemiclupuserythematosus,mixedconnectivetissue

disease)duringtreatmentwithibuprofen,singlecasesof

symptomsofasepticmeningitis,suchasstiffneck,

headache,nausea,vomiting,feverordisorientationhave

beenobserved(seeSection4.4).

HypersensitivityReactions Uncommon: Hypersensitivityreactionswithurticariaandpruritus.

Veryrare: Severehypersensitivityreactions.Symptomscouldbe:

facial,tongueandlarynxswelling,dyspnoea,tachycardia,

hypotension,(anaphylaxis,angioedemaorsevereshock).

Exacerbationofasthmaandbronchospasm.

CardiacDisorders Veryrare: Oedema,hypertensionandcardiacfailurehavebeen

reportedinassociationwithNSAIDtreatmentathigh

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Ibuprofenpassesslowlyintothesynovialspacesandmayremainthereinhigherconcentrationsastheconcentrationsin

plasmadecline.Inexperimentalanimals,ibuprofenanditsmetabolitespasseasilyacrosstheplacenta.Theexcretionof

ibuprofenisrapidandcomplete.Greaterthan90%ofaningesteddoseisexcretedintheurineasmetabolitesortheir

conjugates,andnoibuprofenperseisfoundintheurine.Themajormetabolitesareahydroxylatedandacarboxylated

compound.

5.3Preclinicalsafetydata

Nofurtherinformationprovided.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Tabletcore

Maizestarch

SodiumstarchglycolateTypeA

Magnesiumstearate

Film-coating

Hypromellose

Macrogol400

Macrogol6000

6.2Incompatibilities

Notapplicable.

6.3Shelflife

5years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Storeintheoriginalpackageinordertoprotectfromlight.

6.5Natureandcontentsofcontainer

Blisterstripsconsistingof9µmaluminiumfoilwith50g/m 2

sulphatepaperand250µmwhiteopaquePVC.

Packsize:

10,12,18,20and24tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

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7MARKETINGAUTHORISATIONHOLDER

ClonmelHealthcareLtd

WaterfordRoad

Clonmel

CountyTipperary

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA126/232/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:9thSeptember2011.

10DATEOFREVISIONOFTHETEXT

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