FROBEN

Main information

  • Trade name:
  • FROBEN Tablets 25 Milligram
  • Dosage:
  • 25 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FROBEN Tablets 25 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0038/083/004
  • Authorization date:
  • 11-11-1976
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FrobenTablets25mg.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains25mgflurbiprofen.

Forexcipients,see6.1

3PHARMACEUTICALFORM

Coatedtablets.

Yellow,circular,sugar-coatedtablets,imprintedinblackwithanidentifyingmotif(F25).

4CLINICALPARTICULARS

4.1TherapeuticIndications

Frobenisindicatedforthemanagementofvariousarthrosessuchasrheumatoidarthritisandosteoarthritis,fibrositis,

ankylosingspondylitisandothermuscularsyndromessuchaslowbackpain.Frobenisalsousedforthereliefofacute

andchronicpain.

4.2Posologyandmethodofadministration

Fororaladministration.

Adults:Theusualtotaldailydosageis150to200mgindivideddoses.Duringtheacutephase,thedailydosemaybe

increasedto300mg.

Elderly:NSAIDsshouldbeusedwithparticularcautioninelderlypatients.Dosageshouldbeatthelowestlevelofthe

range.Prolongeduseshouldbeavoided.ThosepatientswithimpairedrenalfunctionmayeliminateNSAIDsmore

slowlythannormal.Inthesecases,Frobenshouldbeusedwithcautionanddosageshouldbeassessedindividually.

Treatmentshouldbereviewedatregularintervalsanddiscontinuedifnobenefitisseenorintoleranceoccurs.

4.3Contraindications

Frobeniscontra-indicatedinchildrenandduringlactation.Itisalsocontra-indicatedinpatientswithactivepeptic

ulceration,gastrointestinalhaemorrhageorulcerativecolitis.

Frobenshouldnotbeusedinpatientswithahistoryofasthmaorinpatientswhohaveexperiencedbronchospasm,

anaphylacticreactions,angioedemaorotherhypersensitivity-typereactionsfromtheuseofaspirinorotherNSAIDs.

4.4Specialwarningsandprecautionsforuse

Undesirableeffectsmaybereducedbyusingtheminimumeffectivedosefortheshortestpossibleduration.Patients

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/09/2008 CRN 2055769 page number: 1

Frobenshouldbeusedwithcautioninpatientswithahistoryofpepticorintestinalulcerationorbleeding.

NSAIDshavebeenreportedtocausenephrotoxicityinvariousforms,includinginterstitialnephritis,nephrotic

syndromeandrenalfailure.Inpatientswithrenal,cardiacorhepaticimpairment,cautionisrequiredsincetheuseof

NSAIDsmayresultindeteriorationofrenalfunction.Thedoseshouldbekeptaslowaspossibleandrenalfunction

shouldbemonitoredinthesepatientspriortotheinitiationoftreatmentandregularlythereafter.

ElderlypatientsareparticularlysusceptibletotheadverseeffectsofNSAIDs.ProlongeduseofNSAIDsintheelderly

isnotrecommended.Whereprolongedtherapyisrequired,patientsshouldbereviewedregularly.

CautionisnecessaryifFrobenisgiventopatientswithahistoryofheartfailure,hypertensionornon-allergic

asthma.Asithasbeenshownthatflurbiprofenmaybeusedwithcautioninpatientswithapotentialforabnormal

bleedingorintracranialhaemorrhage.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ItisconsideredunsafetotakeNSAIDsincombinationwithwarfarinorheparinunlessunderdirectmedical

supervision.

Careshouldbetakeninpatientstreatedwithanyofthefollowingdrugsasinteractionshavebeenreported:

Antihypertensives:reducedanti-hypertensiveeffect

Diuretics:reduceddiureticeffect.DiureticscanincreasetheriskofnephrotoxicityofNSAIDs.

Cardiacglycosides:NSAIDSmayexacerbatecardiacfailure,reduceGFRandincreaseplasmacardiacglycoside

levels.

Lithium:decreasedeliminationoflithium.

Methotrexate:decreasedeliminationofmethotrexate.

Cyclosporin:increasedriskofnephrotoxicitywithNSAIDs.

OtherNSAIDs:avoidconcomitantuseoftwoormoreNSAIDs.

Corticosteroids:increasedriskofgastrointestinalbleeding.

Aminoglycosides:reductioninrenalfunctioninsusceptibleindividuals,decreasedeliminationofaminoglycosideand

increasedplasmaconcentrations.

Probenacid:reductioninmetabolismandeliminationofNSAIDandmetabolites.

Oralhypoglycaemicagents:inhibitionofmetabolismofsulphonylureadrugs,prolongedhalflifeandincreasedriskof

hypoglycaemia.

4.6Pregnancyandlactation

Preclinicalstudieshavenotrevealedanyteratogeniceffects.However,Frobenshouldnotbeprescribedduring

pregnancyunlessthebenefitsoutweighthepossiblerisks.IfFrobenisusedduringearlypregnancy,thelowest

effectivedosageshouldbeemployed.Duringthethirdtrimesterofpregnancy,regularuseofNSAIDshasbeen

associatedwithdelayedandprolongedparturitionandprematureclosureofthefoetalductusarteriosusinuteroand

possiblypersistentpulmonaryhypertensionofthenewborn.

Theamountofflurbiprofensecretedintothebreastmilkduringlactationisconsideredtoosmalltobeharmful.Forthis

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/09/2008 CRN 2055769 page number: 2

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Dyspepsia,nausea,vomiting,gastrointestinalhaemorrhage,diarrhoea,mouthulcers,fluidretentionandoedema,as

wellaspepticulcerationandperforation,havebeenreported.

Urticaria,angioedemaandrashesofvaryingdescriptionmayoccur.Veryrarely,cholestaticjaundiceand

thrombocytopeniahavebeenreported:theseareusuallyreversibleonwithdrawalofthedrug.

Veryrarely,aplasticanaemiaandagranulocytosishavebeenassociatedwiththeuseofflurbiprofenbutcausalityhas

notbeenestablished.

4.9Overdose

Symptomsofoverdosagemayincludenausea,vomitingandgastrointestinalirritation.Treatmentshouldconsistof

gastriclavageandifnecessary,correctionofserumelectrolytes.Thereisnospecificantidotetoflurbiprofen.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Flurbiprofenisaphenylpropionicacid-derivedNSAIDwhichhasanalgesic,anti-inflammatoryandantipyretic

properties.Thesearethoughttoresultfromthedrug’sabilitytoinhibitprostaglandinsynthesis.

5.2Pharmacokineticproperties

Flurbiprofeniswellabsorbed,reachingpeaklevelsintheplasma2-3hourspost-administration.Peaklevelsinthe

synovialfluidoccur6hourspost-administration.Thedrugishighlyprotein-boundandisslowlymetabolisedto

inactivesubstances.Thehalf-lifeis4hourswitheliminationmainlythroughthekidney.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sucrose,lactose,talc,maizestarch,titaniumdioxide,povidone,liquidglucose,magnesiumstearate,stearicacid,

colloidalsilicondioxide,sandaractabletvarnish,carnaubawax,OpaluxyellowAS-F-2230andOpacodeS-1-8152

blackprintingink.

ThecolouringOpaluxyellowAS-F-2230,containssucrose,QuinolineYellowAluminiumLake(E104),titanium

dioxide,FD&CYellowNo.6AluminiumLake(sunsetyellowE110),povidoneandsodiumbenzoate.

Theprintingink,OpacodeS-1-8152Blackcontainsshellac,blackironoxide(E172),soyalecithin(E322)and

dimeticone.

6.2Incompatibilities

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/09/2008 CRN 2055769 page number: 3

6.3ShelfLife

36months.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

C.Storeinadryplace.

6.5Natureandcontentsofcontainer

PVC/Aluminiumblisterpackcontaining10tablets.Therequirednumberofblisterpacksareenclosedinprinted

cartons.Packsizes:100tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

None.

7MARKETINGAUTHORISATIONHOLDER

AbbottLaboratoriesIrelandLimited

4051KingswoodDrive

CitywestBusinessCampus

Dublin24

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA0038/083/004

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateiffirstauthorisation:10November1976

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/09/2008 CRN 2055769 page number: 4