BRUFEN PAEDIATRIC

Main information

  • Trade name:
  • BRUFEN PAEDIATRIC
  • Dosage:
  • 100 MG/ 5ml
  • Pharmaceutical form:
  • Oral Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BRUFEN PAEDIATRIC
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0038/080/006
  • Authorization date:
  • 02-03-2001
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BrufenPaediatric100mg/5mlOralSuspension.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each5mlcontains100mgibuprofen

Excipients:Each5mlalsocontains:

5mgmethylparahydroxybenzoate(E218)

2.5mgpropylparahydroxybenzoate(E216)

500mgsorbitolsolutionnon-crystallising(E420)

3.3gsucrose

0.5mgsunsetyellowFCedicol(E110)

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Oralsuspension.

Orange-colouredandflavouredsyrup-likesuspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

BrufenPaediatricOralSuspensionisindicatedinthemanagementofvariousarthrosessuchasrheumatoidarthritis

(includingjuvenilerheumatoidarthritisorStill’sDisease)andosteoarthritis,fibrositis,ankylosingandothermuscular

syndromessuchaslowbackpain,softtissuetraumaandvariousinflammationsoftendon,jointcapsulesandligaments.

Asananalgesicinthereliefofmildtomoderatepain.

Forthetreatmentofpyrexiainchildren.

4.2Posologyandmethodofadministration

Fororaladministration.

Undesirableeffectsmaybeminimisedbyusingthelowesteffectivedosefortheshortestdurationnecessarytocontrol

symptoms(seesection4.4,Specialwarningsandprecautionsforuse).

Adults:TherecommendeddosageofBrufenis1200-1800mgdailyindivideddoses.Somepatientscanbemaintained

on600-1200mgdaily.Totaldailydoseshouldnotexceed2400mg.

Children:TherecommendeddoseofBrufenis20mgperkgofbodyweightdailyindivideddoses.Thiscanbe

achievedasfollows:

1-2years:2.5ml(50mg)threetofourtimesaday.

3-7years:one5mlspoonful(100mg)threetofourtimesaday.

8-12years:two5mlspoonfuls(200mg)threetofourtimesaday.

Injuvenilerheumatoidarthritis,thedailydosagemaybeincreasedto40mg/kgbodyweightdailyinseverecases.In

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Elderly:nospecialdosagemodificationsarerequired,unlessrenalorhepaticfunctionisimpaired,inwhichcase

dosageshouldbeassessedindividually.

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,Posologyandmethodofadministration,andGIandcardiovascularrisksbelow).Patients

treatedwithNSAIDslongtermshouldundergoregularmedicalsupervisiontomonitorforadverseevents.

CautionisrequiredifBrufenPaediatricOralSuspensionisadministeredtopatientssufferingfrom,orwithaprevious

historyof,bronchialasthmasinceibuprofenhasbeenreportedtocausebronchospasminsuchpatients.

Cautionisrequiredinpatientswithrenal,hepaticorcardiacimpairmentsincetheuseofNSAIDsmayresultin

deteriorationofrenalfunction.Thedoseshouldbekeptaslowaspossibleandassessmentofrenalfunctionshouldbe

monitoredpriortotheinitiationoftherapyandregularlythereafter.

Cautionisrequiredinpatientswithahistoryofheartfailureand/orhypertensionasfluidretentionandoedemahas

beenreportedinassociationwithNSAIDtherapy.

Theuseofibuprofenmayimpairfertilityandisnotrecommendedinwomenattemptingtoconceive.Inwomenwho

havedifficultiesconceivingorwhoareundergoinginvestigationofinfertility,withdrawalofibuprofenshouldbe

considered.

Elderly:theelderlyhaveanincreasedfrequencyofadversereactionstoNSAIDsespeciallygastrointestinalbleeding

andperforationwhichmaybefatal(seesection4.2,Posologyandmethodofadministration)

AswithotherNSAIDs,ibuprofenmaymaskthesignsofinfection.

Patientswithrarehereditaryproblemsoffructoseintolerance,glucose-galactosemalabsorptionorsucrase-isomaltase

insufficiencyshouldnottakethismedicine.

Brufencontains3.3gsucroseper5mldose.Thisshouldbetakenintoaccountinpatientswithdiabetesmellitus.May

beharmfultotheteeth.

Theexcipientsmethylparahydroxybenzoate(E218),propylparahydroxybenzoate(E216)andsunsetyellowFCedicol

(E110)maycauseallergicreactions(possiblydelayed).

TheuseofBrufenwithconcomitantNSAIDsincludingcyclooxygenase-2selectiveinhibitorsshouldbeavoideddueto

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Gastrointestinalbleeding,ulcerationandperforation:

GIbleeding,ulcerationorperforation,whichcanbefatal,hasbeenreportedwithallNSAIDsatanytimeduring

treatment,withorwithoutwarningsymptomsoraprevioushistoryofseriousGIevents.

TheriskofGIbleeding,ulcerationorperforationishigherwithincreasingNSAIDdoses,inpatientswithahistoryof

ulcer,particularlyifcomplicatedwithhaemorrhageorperforation(Seesection4.3,Contraindications),andinthe

elderly.Thesepatientsshouldcommencetreatmentonthelowestdoseavailable.Combinationtherapywithprotective

agents(e.g.misoprostolorprotonpumpinhibitors)shouldbeconsideredforthesepatients,andalsoforpatients

requiringconcomitantlowdoseaspirin,orotherdrugslikelytoincreasegastrointestinalrisk(Seebelowand4.5,

Interactionwithothermedicinalproductsandotherformsofinteractions).

PatientswithahistoryofGIdisease,particularlywhenelderly,shouldreportanyunusualabdominalsymptoms

(especiallyGIbleeding)particularlyintheinitialstagesoftreatment.

Cautionshouldbeadvisedinpatientsreceivingconcomitantmedicationswhichcouldincreasetheriskofulcerationor

bleeding,suchasoralcorticosteroids,anticoagulantssuchaswarfarin,selectiveserotoninreuptakeinhibitorsoranti-

plateletagentssuchasaspirin(Seesection4.5,Interactionwithothermedicinalproductsandotherformsof

interactions).

WhenGIbleedingorulcerationoccursinpatientsreceivingBrufen,thetreatmentshouldbewithdrawn.

NSAIDsshouldbegivenwithcaretopatientswithahistoryofgastrointestinaldisease(ulcerativecolitis,Crohn’s

disease)astheirconditionmaybeexacerbated(Seesection4.8,Undesirableeffects).

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,andsmoking).

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

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DermatologicalEffects

Seriousskinreactions,someofthemfatal,includingexfoliativedermatitis,Stevens-Johnsonsyndrome,andtoxic

epidermalnecrolysis,havebeenreportedveryrarelyinassociationwiththeuseofNSAIDs(seesection4.8,

Undesirableeffects).Patientsappeartobeatthehighestriskofthesereactionsearlyinthecourseoftherapy,theonset

ofthereactionoccurringinthemajorityofcaseswithinthefirstmonthoftreatment.Brufenshouldbediscontinuedat

thefirstappearanceofskinrash,mucosallesions,oranyothersignofhypersensitivity.

AsepticMeningitis

AsepticmeningitishasbeenobservedonrareoccasionsinpatientswithBrufentherapy.Althoughitisprobablymore

likelytooccurinpatientswithsystematiclupuserythematosusandrelatedconnectivetissuediseases,ithasbeen

reportedinpatientswhodonothaveanunderlyingchronicdisease.

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

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Aminoglycosides:NSAIDsmaydecreasetheexcretionofaminoglycosides

Quinoloneantibiotics:animaldataindicatethatNSAIDscanincreasetheriskofconvulsionsassociatedwith

quinoloneantibiotics.PatientstakingNSAIDsandquinolonesmayhaveincreasedriskofdevelopingconvulsions.

Probenecid:therehavebeennoreportsofinteractionsbetweenprobenacidandibuprofen.However,probenacid

producesareductioninmetabolismandeliminationofsomeNSAIDsandmetabolites.

Oralhypoglycaemicagents:inhibitionofmetabolismofsulfonylureadrugs,prolongedhalf-lifeandincreasedriskof

hypoglycaemia.

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

Noadverseeffectsknown.

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

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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.

Otheradverseeventsreportedinclude

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.

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Ibuprofenisapropionicacidderivative,havinganalgesic,anti-inflammatoryandanti-pyreticactivity.Thedrug’s

therapeuticeffectasanonsteroidalanti-inflammatorydrugisthoughttoresultfromitsinhibitoryactivityonthe

enzymecyclo-oxygenase,whichresultsinamarkedreductioninprostaglandinsynthesis.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.Inonestudy,whenasingledoseofibuprofen400mgwastakenwithin8hoursbeforeor

within30minutesafterimmediatereleaseaspirindosing(81mg),adecreasedeffectofASAontheformationof

thromboxaneorplateletaggregationoccurred.However,thelimitationsofthesedataandtheuncertaintiesregarding

extrapolationofexvivodatatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofen

use,andnoclinicallyrelevanteffectisconsideredtobelikelyforoccasionalibuprofenuse.

5.2Pharmacokineticproperties

Ibuprofenisrapidlyabsorbedfromthegastrointestinaltract,peakserumconcentrationsoccurring1-2hoursafter

administration.Theeliminationhalf-lifeisapproximately2hours.

Ibuprofenismetabolisedinthelivertotwoinactivemetabolitesandthese,togetherwithunchangedibuprofen,are

excretedbythekidneyeitherassuchorasconjugates.Excretionbythekidneyisbothrapidandcomplete.

Ibuprofenisextensivelyboundtoplasmaproteins.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Methylparahydroxybenzoate(E218)

Propylparahydroxybenzoate(E216)

Sucrose

CitricAcidMonohydrate

SodiumBenzoate(E211)

AgarBPC’54Pdr

Glycerol(E422)

SorbitolSolutionNon-Crystallising(E420)

IrradiatedLightKaolin

Polysorbate80

SunsetYellowFCEdicol(E110)

OrangeFlavourD717

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6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years.

Onceopenedthecontentsofthebottleshouldbeusedwithin12months.

6.4Specialprecautionsforstorage

Nospecialstorageconditions.

6.5Natureandcontentsofcontainer

A200mlamber-colouredpolyethyleneterepthalate(PET)bottlewithapilfer-proofneckfinish,fittedwithan

aluminiumcapfittedwithaLDPEliner.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

AbbottLaboratoriesIrelandLtd.

4051KingswoodDrive

CitywestBusinessCampus

Dublin24

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA0038/080/006

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:02March1981

Dateoflastrenewal:02March2011

10DATEOFREVISIONOFTHETEXT

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