BRUFEN

Main information

  • Trade name:
  • BRUFEN Film Coated Tablet 600 Milligram
  • Dosage:
  • 600 Milligram
  • Pharmaceutical form:
  • Film Coated Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BRUFEN Film Coated Tablet 600 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0038/080/003
  • Authorization date:
  • 19-10-2004
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Brufen600mgfilm-coatedtablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains600mgofibuprofen.

Excipients:eachtabletcontains40.0mgoflactosemonohydrate.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablet(tablet).

Awhite,pillow-shaped,film-coatedtablet.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Brufenisindicatedinthesymptomaticmanagementofvariousarthrosessuchasrheumatoidarthritis(including

juvenilerheumatoidarthritisorStill’sdisease)andosteoarthritis,fibrositis,ankylosingspondylitisandothermuscular

syndromes,suchaslowbackpain,softtissuetraumaandvariousinflammationsoftendon,jointcapsulesand

ligaments.

Brufenisalsousedasananalgesicinthereliefofmildtomoderatepain.

4.2Posologyandmethodofadministration

Fororaladministration.

Undesirableeffectsmaybeminimisedbyusingthelowesteffectivedosefortheshortestdurationnecessarytocontrol

symptoms(seesection4.4).

Adults:TherecommendeddosageofBrufenis1200-1800mgdailyindivideddoses.Somepatientscanbemaintained

on600-1200mgdaily.Thetotaldailydoseshouldnotexceed2400mg.

Children:TherecommendeddoseofBrufenis20mg/kgbodyweightdailyindivideddosesbutinjuvenilerheumatoid

arthritis,thedailydosagemaybeincreasedto40mg/kgbodyweightinseverecases.

Inchildrenweighinglessthan30kg,thetotaldailydoseofBrufenshouldnotexceed500mg(theliquidformulation

shouldbeused).

Elderly:Nospecificdosagemodificationsarerequiredforelderlypatients,unlessrenalorhepaticfunctionisimpaired,

inwhichcase,dosageshouldbeassessedindividually.

NSAIDsshouldbeusedwithparticularcautioninelderlypatientswhoaremorepronetoadverseevents.Thelowest

dosecompatiblewithadequatesafeclinicalcontrolshouldbeemployed.SeealsoSection4.4.

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4.3Contraindications

Brufeniscontraindicatedinpatientswithknownhypersensitivitytotheactivesubstanceortoanyoftheinactive

ingredients.

Brufeniscontraindicatedinpatientswithahistoryofgastrointestinalbleedingorperforation,relatedtoprevious

NSAIDstherapy.Active,orhistoryofrecurrentpepticulcer/haemorrhage(twoormoredistinctepisodesofproven

ulcerationorbleeding).

Brufeniscontraindicatedinpatientswithsevereheartfailure.

Brufenshouldnotbeusedinpatientswithknownhypersensitivityorwhohaveexperiencedasthma,urticaria,or

allergic-typereactionsaftertakingBrufen,aspirinorotherNSAIDs.

4.4Specialwarningsandprecautionsforuse

GeneralPrecautions

Undesirableeffectsmaybeminimisedbyusingthelowesteffectivedosefortheshortestdurationnecessarytocontrol

symptoms(seesection4.2,andGIandcardiovascularrisksbelow).PatientstreatedwithNSAIDslongtermshould

undergoregularmedicalsupervisiontomonitorforadverseevents.

CautionisrequiredifBrufenisadministeredtopatientssufferingfrom,orwithaprevioushistoryof,bronchialasthma

sinceibuprofenhasbeenreportedtocausebronchospasminsuchpatients.

Cautionisrequiredinpatientswithrenal,hepaticorcardiacimpairmentsincetheuseofNSAIDsmayresultin

deteriorationofrenalfunction.Thedoseshouldbekeptaslowaspossibleandassessmentofrenalfunctionshould

occurpriortotheinitiationoftherapyandregularlythereafter.

Cautionisrequiredinpatientswithahistoryofheartfailureand/orhypertensionasfluidretentionandoedemahas

beenreportedinassociationwithNSAIDtherapy.

Theuseofibuprofenmayimpairfertilityandisnotrecommendedinwomenattemptingtoconceive.Inwomenwho

havedifficultiesconceivingorwhoareundergoinginvestigationofinfertility,withdrawalofibuprofenshouldbe

considered.

Elderly:theelderlyhaveanincreasedfrequencyofadversereactionstoNSAIDsespeciallygastrointestinalbleeding

andperforationwhichmaybefatal(seesection4.2).

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyofglucose-galactose

malabsorptionshouldnottakethismedication.

AswithotherNSAIDs,ibuprofenmaymaskthesignsofinfection.

TheuseofBrufenwithconcomitantNSAIDsincludingcyclooxygenase-2selectiveinhibitorsshouldbeavoideddueto

thepotentialforadditiveeffects.

Gastrointestinalbleeding,ulcerationandperforation:

GIbleeding,ulcerationorperforation,whichcanbefatal,hasbeenreportedwithallNSAIDsatanytimeduring

treatment,withorwithoutwarningsymptomsoraprevioushistoryofseriousGIevents.

TheriskofGIbleeding,ulcerationorperforationishigherwithincreasingNSAIDdoses,inpatientswithahistoryof

ulcer,particularlyifcomplicatedwithhaemorrhageorperforation(Seesection4.3),andintheelderly.Thesepatients

shouldcommencetreatmentonthelowestdoseavailable.Combinationtherapywithprotectiveagents(e.g.misoprostol

orprotonpumpinhibitors)shouldbeconsideredforthesepatients,andalsoforpatientsrequiringconcomitantlowdose

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PatientswithahistoryofGIdisease,particularlywhenelderly,shouldreportanyunusualabdominalsymptoms

(especiallyGIbleeding)particularlyintheinitialstagesoftreatment.

Cautionshouldbeadvisedinpatientsreceivingconcomitantmedicationswhichcouldincreasetheriskofulcerationor

bleeding,suchasoralcorticosteroids,anticoagulantssuchaswarfarin,selectiveserotonin-reuptakeinhibitorsoranti-

plateletagentsauchasaspirin(Seesection4.5).

WhenGIbleedingorulcerationoccursinpatientsreceivingBrufen,thetreatmentshouldbewithdrawn.

NSAIDsshouldbegivenwithcaretopatientswithahistoryofgastrointestinaldisease(ulcerativecolitis,Crohn’s

disease)astheirconditionmaybeexacerbated(Seesection4.8).

Cardiovascularandcerebrovasculareffects

Appropriatemonitoringandadvicearerequiredforpatientswithahistoryofhypertensionand/ormildtomoderate

congestiveheartfailureasfluidretentionandoedemahavebeenreportedinassociationwithNSAIDtherapy.

Clinicaltrialdatasuggeststhatuseofibuprofen,particularlyatahighdose(2400mg/daily)andinlongtermtreatment

maybeassociatedwithasmallincreasedriskofarterialthromboticevents(forexamplemyocardialinfarctionor

stroke).Overall,epidemiologicalstudiesdonotsuggestthatlowdoseibuprofen(e.g. 1200mgdaily)isassociated

withanincreasedriskofmyocardialinfarction.

Patientswithuncontrolledhypertension,congestiveheartfailure,establishedischaemicheartdisease,peripheralarterial

disease,and/orcerebrovasculardiseaseshouldonlybetreatedwithibuprofenaftercarefulconsideration.Similar

considerationshouldbemadebeforeinitiatinglonger-termtreatmentofpatient’swithriskfactorsforcardiovascular

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

RenalEffects

CautionshouldbeusedwheninitiatingtreatmentwithBrufeninpatientswithconsiderabledehydration.

AswithotherNSAIDs,long-termadministrationofBrufenhasresultedinrenalpapillarynecrosisandotherrenal

pathologicalchanges.Renaltoxicityhasalsobeenseeninpatientsinwhomrenalprostaglandinshaveacompensatory

roleinmaintenanceofrenalperfusion.Inthesepatients,administrationofanNSAIDmaycauseadose-dependant

reductioninprostaglandinsformationand,secondarily,inrenalbloodflow,whichmayprecipitateovertrenal

decompensation,patientsatgreatestriskofthisreactionarethosewithimpairedrenalfunction,heartfailure,liver

dysfunction,thosewhoaretakingdiureticsandACEinhibitorsandtheelderly.DiscontinuationofNSAIDtherapyis

usuallyfollowedbyrecoverytothepre-treatmentstate.

HaematologicalEffects

AsNSAIDscaninterferewithplateletfunctionandmayprolongbleedingtime,Brufenshouldbeusedwithcautionin

patientswithintercranialhaemorrhageandbleedingdiathesis.

DermatologicalEffects

Seriousskinreactions,someofthemfatal,includingexfoliativedermatitis,Stevens-Johnsonsyndrome,andtoxic

epidermalnecrolysis,havebeenreportedveryrarelyinassociationwiththeuseofNSAIDs(seesection4.8).Patients

appeartobeatthehighestriskofthesereactionsearlyinthecourseoftherapy,theonsetofthereactionoccurringin

themajorityofcaseswithinthefirstmonthoftreatment.Brufenshouldbediscontinuedatthefirstappearanceofskin

rash,mucosallesions,oranyothersignofhypersensitivity.

AsepticMeningitis

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Althoughitisprobablymoreunlikelytooccurinpatientswithsystematiclupuserythematosusandrelatedconnective

tissuediseases,ithasbeenreportedinpatientswhodonothaveanunderlyingchronicdisease.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ItisconsideredunsafetotakeNSAIDsincombinationwithwarfarinorheparinunlessunderdirectmedical

supervision.

Careshouldbetakeninpatientstreatedwithanyofthefollowingdrugsasinteractionshavebeenreported:

Antihypertensives:NSAIDsmayreducetheeffectofantihypertensives,suchasACEinhibitors.

Diuretics:NSAIDsmayreducethediureticeffect.DiureticscanalsoincreasetheriskofnephrotoxicityofNSAIDs.

Cardiacglycosides:NSAIDsmayexacerbatecardiacfailure,reduceGFRandincreaseplasmacardiacglycoside

levels.

Lithium:NSAIDsmaydecreaseeliminationoflithium.

Methotrexate:NSAIDsmaydecreaseeliminationofmethotrexate.

Cyclosporin:increasedriskofnephrotoxicitywithNSAIDs.

Otheranalgesicsincludingcyclooxygenase-2selectiveinhibitors:avoidconcomitantuseoftwoormoreNSAIDs,

(includingaspirin)asthismayincreasetheriskofadverseeffects(seesection4.4).

Corticosteroids:increasedriskofgastrointestinalulcerationorbleedingwithNSAIDs(seesection4.4,special

warningsandspecialprecautionsforuse)

Anticoagulants:NSAIDsmayenhancetheeffectsofanticoagulantssuchaswarfarin(seesection4.4,Special

warningsandprecautionsforuse).

Aspirin:AswithotherproductscontainingNSAIDs,concomitantadministrationofibuprofenandaspirinisnot

generallyrecommendedbecauseofthepotentialofincreasedadverseeffects.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.However,thelimitationsofthesedataandtheuncertaintiesregardingextrapolationofexvivo

datatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofenuse,andnoclinically

relevanteffectisconsideredtobelikelyforoccasionaluse(seesection5.1).

Anti-plateletagentsandselectiveserotoninreuptakeinhibitors(SSRIs):increasedriskofgastrointestinalbleeding

withNSAIDs(seesection4.4,Specialwarningsandprecautionsforuse).

Aminoglycosides:NSAIDsmaydecreasetheexcretionofaminoglycosides

Quinoloneantibiotics:animaldataindicatethatNSAIDscanincreasetheriskofconvulsionsassociatedwith

quinoloneantibiotics.PatientstakingNSAIDsandquinolonesmayhaveincreasedriskofdevelopingconvulsions.

Probenecid:therehavebeennoreportsofinteractionsbetweenprobenacidandibuprofen.However,probenacid

producesareductioninmetabolismandeliminationofsomeNSAIDsandmetabolites.

Oralhypoglycaemicagents:inhibitionofmetabolismofsulfonylureadrugs,prolongedhalf-lifeandincreasedriskof

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Mifepristone:NSAIDsshouldnotbeusedfor8-12daysaftermifepristoneadministrationasNSAIDscanreducethe

effectofmifepristone.

Tacrolimus:PossibleincreasedriskofnephrotoxicitywhenNSAIDsaregivenwithtacrolimus.

Zidovudine:IncreasedriskofhaematologicaltoxicitywhenNSAIDsaregivenwithzidovudine.Thereisevidenceof

anincreasedriskofhaemarthrosesandhaematomainHIV(+)haemophiliacsreceivingconcurrenttreatmentwith

zidovudineandibuprofen.

GinkgobilobamaypotentiatetheriskofbleedingwithNSAIDs.

4.6Fertility,pregnancyandlactation

Whilstnoteratogeniceffectshavebeendemonstratedinanimaltoxicologystudies,theuseofibuprofenduring

pregnancyshould,beavoidedexceptundercompellingcircumstances.Congenitalabnormalitieshavebeenreportedin

associationwithibuprofenadministrationinman;however,thesearelowinfrequencyanddonotappeartofollowany

discerniblepattern.InviewoftheknowneffectsofNSAIDsonthefoetalcardiovascularsystem(closureofductus

arteriosus),ibuprofenshouldnotbeusedinthethirdtrimesterofpregnancy.

Labouranddelivery:Administrationofibuprofenisnotrecommendedduringlabouranddelivery.Theonsetoflabour

maybedelayedandthedurationincreasedwithagreaterbleedingtendencyinbothmotherandchild

Inthelimitedstudiestodate,ibuprofenappearsinbreastmilkinverylowconcentrations,brufenisnotrecommended

foruseinnursingmothers.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Immunesystemdisorders:

Hypersensitivityreactionshavebeenreportedfollowingtreatmentwithibuprofen.Thesemayconsistof(a)non-

specificallergicreactionandanaphylaxis,(b)respiratorytractreactivitycomprisingasthma,aggravatedasthma,

bronchospasmordyspnoea,or(c)assortedskindisorders,includingrashesofvarioustypes,pruritus,urticaria,purpura,

angioedemaand,veryrarely,bullousdermatoses(includingStevens-Johnsonsyndrome,toxicepidermalnecrolysisand

erythemamultiforme).

Gastrointestinaldisorders:

Themostcommonlyobservedadverseeventsaregastrointestinalinnature.Pepticulcers,perforationorGIbleeding,

sometimesfatal,particularlyintheelderly,mayoccur(Seesection4.4,Specialwarningsandprecautionsforuse).

Nausea,vomitingdiarrhoea,flatulence,constipation,dyspepsia,abdominalpain,melaena,haematemesis,ulcerative

stomatitis,exacerbationofcolitisandCrohn’sdisease(Seesection4.4,Specialwarningsandprecautionsforuse)have

beenreportedfollowingadministration.Lessfrequently,gastritishasbeenobserved.Pancreatitishasbeenreported

veryrarely.

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Cardiovascular:

Oedema,hypertensionandcardiacfailurehavebeenreportedinassociationwithNSAIDtreatment.Clinicaltrialand

epidemiologicaldatasuggeststhatuseofibuprofen,particularlyatahighdose(2400mg/daily)andinlongterm

treatmentmaybeassociatedwithasmallincreasedriskofarterialthromboticevents(forexamplemyocardial

infarctionorstroke)(seesection4.4,Specialwarningsandprecautionsforuse).

Bloodandlymphaticsystemdisorders:thrombocytopenia,neutropenia,agranulocytosis,aplasticanemiaand

haemolyticanaemia.

Psychiatricdisorders:depression,confusion,hallucinations

Nervoussystemdisorders:headaches,paraesthesia,dizziness,drowsiness

Eyedisorders:disturbancesofvisionofvision,opticneuritis

Earandlabyrinthdisorders:vertigo,tinnitus

Hepatobiliarydisorders:abnormalliverfunction,hepaticfailure,hepatitis,jaundice

Skinandsubcutaneoustissuedisorders:photosensitivity,bullousreactionsincludingSteven’sJohnsonsyndrome

andtoxicepidermalnecrolysis(veryrare).

Generaldisordersandadministrationsiteconditions:malaise,fatigue.

Renalandurinarydisorders:impairedrenalfunction,renalnephrotoxicityinvariousforms,includinginterstitial

nephritis,nephriticsyndromeandrenalfailure.

4.9Overdose

Symptomsincludenausea,vomiting,dizziness,convulsion,lossofconsciousnessanddepressionoftheCNSand

respiratorysystem.Largeoverdosesaregenerallywelltoleratedwhennootherdrugsareinvolved.

Treatmentconsistsofgastriclavageand,ifnecessary,correctionofserumelectrolytesandappropriatesupportive

measures.

Thereisnospecificantidotetoibuprofen.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Ibuprofenisaphenylpropionicacidderivativewithanalgesic,anti-inflammatoryandantipyreticactivity.Thedrug's

therapeuticeffectsasaNSAIDarethoughttoresultfromitsinhibitoryeffectontheenzymecyclo-oxygenase,which

resultsinamarkedreductioninprostaglandinsynthesis.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.Inonestudy,whenasingledoseofibuprofen400mgwastakenwithin8hoursbeforeor

within30minutesafterimmediatereleaseaspirindosing(81mg),adecreasedeffectofASAontheformationof

thromboxaneorplateletaggregationoccurred.However,thelimitationsofthesedataandtheuncertaintiesregarding

extrapolationofexvivodatatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofen

use,andnoclinicallyrelevanteffectisconsideredtobelikelyforoccasionalibuprofenuse.

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Ibuprofenisrapidlyabsorbedafteroraladministration,isstronglyplasmaproteinbound,andisexcretedmainlyinthe

urineasmetabolites.Thedrughasaplasmahalf-lifeof2hours.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Microcrystallinecellulose

CroscarmelloseSodium

LactoseMonohydrate

ColloidalAnhydrousSilica

SodiumLaurilsulfate

MagnesiumStearate

Opadrywhite(containinghypromellose,titaniumdioxideandtalc)

or

Hypromellose

Plus

Talc

Plus

OpaspraywhiteM-1-7111B(contains:TitaniumDioxide(E171)andHypromellose)

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

C.Storeintheoriginalpackinordertoprotectfrommoisture.

6.5Natureandcontentsofcontainer

Blisterpackcomprisingoftransparentpolyvinylchloride(PVC)orpolyvinylchloride/polyvinylidene(PVC/PVDC)

filmwithaluminiumfoilbacking.

Packsize:60tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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7MARKETINGAUTHORISATIONHOLDER

AbbottLaboratoriesIrelandLtd,

4051KingswoodDrive,

CitywestBusinessCampus,

Dublin24

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA0038/080/003

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01June1982

Dateoflastrenewal:01June2007

10DATEOFREVISIONOFTHETEXT

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