CATAFLAM 25 Milligram Coated Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
DICLOFENAC POTASSIUM
Available from:
Novartis Pharmaceuticals UK Ltd
INN (International Name):
DICLOFENAC POTASSIUM
Dosage:
25 Milligram
Pharmaceutical form:
Coated Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization number:
PA0013/088/001
Authorization date:
0000-00-00

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Cataflam25mgCoatedTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains25mgdiclofenacpotassium.

Eachtabletalsocontains45mgsucrose.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

CoatedTablet(Tablet).

Circular,biconvex,paleredsugarcoatedtabletapproximately7.7mmdiameterimprinted“CG”ononesideand“DD”

ontheother.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Short-termtreatmentofallgradesofpainandinflammationinthefollowingacuteconditions:

Posttraumaticpain,inflammationandswelling,e.g.duetosprains.

Acutemusculo-skeletaldisorderssuchasperiarthritis(forexamplefrozenshoulder),tendonitis,tenosynovitis,

bursitis.

Post-operativepain,inflammationandswelling,e.g.followingdentalororthopaedicsurgery.

Painfuland/orinflammatoryconditionsingynaecology,e.g.primarydysmenorrhoeaoradnexitisandassociated

menorrhagia.

Migraineattacks.

Acutegout.

Painfulsyndromesofthevertebralcolumn.

Non-articularrheumatism.

Asanadjuvantinseverepainfulinflammatoryinfectionsoftheear,noseorthroat,e.g.pharyngotonsillitis,otitis.

Inkeepingwithgeneraltherapeuticprinciples,theunderlyingdiseaseshouldbetreatedwithbasictherapy,as

appropriate.Feveraloneisnotanindication.

4.2Posologyandmethodofadministration

Undesirableeffectsmaybeminimisedbyusingthelowesteffectivedosefortheshortestdurationnecessarytocontrol

symptoms(seesection4.4).

Thetabletsshouldbeswallowedwholewithliquid,preferablybeforemeals,andmustnotbedividedorchewed.

Adults

Thetotaldailydoseshouldgenerallybedividedin2to3doses.

Inprimarydysmenorrhoea,thedailydoseshouldbeindividuallyadjustedandisgenerally50to150mg.Adoseof50

to100mgshouldbegiveninitiallyand,ifnecessary,increasedoverthecourseofseveralmenstrualcyclesuptoa

maximumof200mg/day.Treatmentshouldbestartedonappearanceofthefirstsymptomsand,dependingonthe

symptomatology,continuedforafewdays.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/05/2014 CRN 2146516 page number: 1

within2hoursafterthefirstdoseisnotsufficient,afurtherdoseof50mgmaybetaken.Ifneeded,furtherdosesof50

mgmaybetakenatintervalsof4to6hours,notexceedingatotaldoseof200mgperday.

Childrenandadolescents:

Cataflamtabletsarenotrecommendedforuseinchildrenandadolescentsbelow14yearsofage;otherformsof

diclofenacsuchasoraldropsorsuppositoriescouldbeusedinthesepatients.Foradolescentsaged14yearsandover,a

dailydoseof75to100mgisusuallysufficient.Thetotaldailydoseshouldgenerallybedividedin2to3doses.

Themaximumdailydoseof150mgshouldnotbeexceeded.

TheuseofCataflam(allforms)inmigraineattackshasnotbeenestablishedinchildrenandadolescents.

Olderpeople(Patientsaged65orabove)

AlthoughthepharmacokineticsofCataflamarenotimpairedtoanyclinicallyrelevantextentinelderlypatients,non-

steroidalanti-inflammatorydrugsshouldbeusedwithparticularcautioninolderpatientswhogenerallyaremoreprone

toadversereactions.Inparticular,itisrecommendedthatthelowesteffectivedosagebeusedinfrailelderlypatients

orthosewithalowbodyweight(seealsoprecautions).Treatmentshouldbereviewedatregularintervalsand

discontinuedifnobenefitisseenorifintoleranceoccurs.

Renalimpairment

Diclofenaciscontraindicatedinpatientswithsevererenalimpairment(seesection4.3).

Nospecificstudieshavebeencarriedoutinpatientswithrenalimpairment,therefore,nospecificdoseadjustment

recommendationscanbemade.

Cautionisadvisedwhenadministeringdiclofenactopatientswithmildtomoderaterenalimpairment(seesection4.3

and4.4).

Hepaticimpairment

Diclofenaciscontraindicatedinpatientswithseverehepaticimpairment(seesection4.3).

Nospecificstudieshavebeencarriedoutinpatientswithhepaticimpairment,therefore,nospecificdoseadjustment

recommendationscanbemade.

Cautionisadvisedwhenadministeringdiclofenactopatientswithmildtomoderatehepaticimpairment(seesection4.3

and4.4).

4.3Contraindications

Knownhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Activegastricorintestinalulcer,bleedingorperforation

Historyofgastrointestinalbleedingorperforation,relatedtopreviousNSAIDstherapy.Activeorhistoryof

recurrentpepticulcer/haemorrhage(twoormoredistinctepisodesofprovenulcerationorbleeding).

Lasttrimesterofpregnancy(seesection4.6Pregnancyandlactation).

Hepaticfailure

ChronicKidneyDiseaseGrade5(GFR<15)

Establishedcongestiveheartfailure(NYHAII-IV),ischemicheartdisease,peripheralarterialdiseaseand/or

cerebrovasculardisease.

Likeothernon-steroidalanti-inflammatorydrugs(NSAIDs),Cataflamisalsocontraindicatedinpatientsinwhom

attacksofasthma,urticaria,oracuterhinitisareprecipitatedbyacetylsalicylicacidorotherNSAIDs

4.4Specialwarningsandprecautionsforuse

General

Undesirableeffectsmaybeminimisedbyusingthelowesteffectivedosefortheshortestpossibledurationnecessaryto

controlsymptoms(seesection4.2PosologyandGIandcardiovascularrisksbelow).

TheuseofCataflamwithconcomitantNSAIDsincludingcyclooxygenase-2selectiveinhibitors,shouldbeavoideddue

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/05/2014 CRN 2146516 page number: 2

Cautionisindicatedintheelderlyonbasicmedicalgrounds.Inparticularitisrecommendedthatthelowesteffective

dosebeusedinfrailelderlypatientsorthosewithalowbodyweight.

LikeotherNSAIDs,Cataflammaymaskthesignsandsymptomsofinfectionduetoitspharmacodynamicproperties.

Theuseofdiclofenacpotassiummayimpairfemalefertilityandisnotrecommendedinwomenattemptingtoconceive.

Inwomenwhohavedifficultiesconceivingorwhoareundergoinginvestigationofinfertility,withdrawalofdiclofenac

potassiumshouldbeconsidered.

Cataflamtabletscontainsucroseandthereforearenotrecommendedforpatientswithrarehereditaryproblemsof

fructoseintolerance,glucose-galactosemalabsorptionorsucrase-isomaltaseinsufficiency.

Gastrointestinaleffects

Gastrointestinalbleeding,orulcerationorperforation,whichcanbefatal,havebeenreportedwithallNSAIDs,

includingdiclofenac,andmayoccuratanytimeduringtreatment,withorwithoutwarningsymptomsoraprevious

historyofseriousgastrointestinaleventsTheelderlyhaveanincreasedfrequencyofadversereactionstoNSAIDs

especiallygastrointestinalbleedingandperforationwhichmaybefatal(seesection4.2Posologyandmethodof

administration).WhengastrointestinalbleedingorulcerationoccurinpatientsreceivingCataflam,themedicinal

productshouldbewithdrawn

AswithallNSAIDs,includingdiclofenac,closemedicalsurveillanceisimperativeandparticularcautionshouldbe

exercisedwhenprescribingCataflaminpatientswithsymptomsindicativeofgastrointestinal(GI)disordersorwitha

historysuggestiveofgastricorintestinalulceration,bleedingorperforation(seesection4.8Undesirableeffects).The

riskofGIbleeding,ulcerationorperforationishigherwithincreasingNSAIDdoses,inpatientswithahistoryof

ulcer,particularlyifcomplicatedwithhaemorrhageorperforation(seesection4.3Contra-indications)Theelderlyhave

anincreasedfrequencyofadversereactionstoNSAIDsespeciallygastrointestinalbleedingandperforationwhichmay

befatal.

ToreducetheriskofGItoxicityinpatientswithahistoryofulcer,particularlyifcomplicatedwithhaemorrhageor

perforationandintheelderly,thetreatmentshouldbeinitiatedandmaintainedatthelowesteffectivedose.

Combinationtherapywithprotectiveagents(e.g.protonpumpinhibitorsormisoprostol)shouldbeconsidered

forthesepatients,andalsoforpatientsrequiringconcomitantuseofmedicinalproductscontaininglow-dose

acetylsalicylicacid(ASA)/aspirinorothermedicinalproductslikelytoincreasegastrointestinalrisk(seebelow

andsection4.5Interactionswithothermedicinalproductsandotherformsofinteraction).

PatientswithahistoryofGItoxicity,particularlytheelderly,shouldreportanyunusualabdominalsymptoms

(especiallyGIbleeding)particularlyintheearlystagesoftreatment.Cautionisrecommendedinpatientsreceiving

concomitantmedicationswhichcouldincreasetheriskofulcerationorbleeding,suchasoralcorticosteroids,

anticoagulantssuchaswarfarin,anti-plateletagentssuchasaspirinorselectiveserotonin-reuptakeinhibitors(see

section4.5Interactionwithothermedicinalproductsandotherformsofinteraction).

Closemedicalsurveillanceandcautionshouldalsobeexercisedinpatientswithahistoryofgastrointestinaldisease

(ulcerativecolitisorCrohn’sdisease,astheirconditionmaybeexacerbated(seesection4.8Undesirableeffects).

Hepaticeffects

ClosemedicalsurveillanceisrequiredwhenprescribingCataflamtopatientswithimpairedhepaticfunction,astheir

conditionmaybeexacerbated.

AswithotherNSAIDs,includingdiclofenac,valuesofoneormoreliverenzymesmayincrease.Duringprolonged

treatmentwithdiclofenac,regularmonitoringofhepaticfunctionisindicatedasaprecautionarymeasure.Ifabnormal

liverfunctiontestspersistorworsen,ifclinicalsignsorsymptomsconsistentwithliverdiseasedevelop,orifother

manifestationsoccur(e.g.eosinophilia,rash,etc),diclofenacshouldbediscontinued.Hepatitismayoccurwithuseof

diclofenacwithoutprodromalsymptoms.

Cautioniscalledforwhenusingdiclofenacinpatientswithhepaticporphyria,sinceitmaytriggeranattack.

Renaleffects

AsfluidretentionandoedemahavebeenreportedinassociationwithNSAIDtherapy,includingdiclofenac,particular

cautioniscalledforinpatientswithimpairedcardiacorrenalfunction,historyofhypertension.theelderly,patients

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/05/2014 CRN 2146516 page number: 3

inthosepatientswithsubstantialextracellularvolumedepletionfromanycause,e.g.beforeoraftermajorsurgery(see

section4.3Contraindications).Monitoringofrenalfunctionisrecommendedasaprecautionarymeasurewhenusing

Cataflaminsuchcases.Discontinuationoftherapyisnormallyfollowedbyrecoverytothepre-treatmentstate.

SkinEffects

Seriousskinreactions,someofthemfatal,includingexfoliativedermatitis,Stevens-Johnsonsyndromeandtoxic

epidermalnecrolysis,havebeenreportedveryrarelyinassociationwiththeuseofNSAIDs,includingCataflam(see

section4.8Undesirableeffects).Patientsappeartobeathighestriskofthesereactionsearlyinthecourseoftherapy,

theonsetofthereactionoccurringinthemajorityofcaseswithinthefirstmonthoftreatment.Cataflamshouldbe

discontinuedatthefirstappearanceofskinrash,mucosallesionsoranyothersignofhypersensitivity.Aswithother

NSAIDs,allergicreactions,includinganaphylactic/anaphylactoidreactions,canalsooccurinrarecaseswithdiclofenac

withoutearlierexposuretothedrug.

Cardiovascularandcerebrovasculareffects

Appropriatemonitoringandadvicearerequiredforpatientswithahistoryofhypertensionand/orcongestiveheart

failure(NYHA-1)asfluidretentionandoedemahavebeenreportedinassociationwithNSAIDtherapy.

Clinicaltrialandepidemiologicaldatasuggestthattheuseofdiclofenac,particularlyathighdoses(150mgdaily)and

inlongtermtreatmentmaybeassociatedwithasmallincreasedriskofarterialthromboticevents(forexample

myocardialinfarctionorstroke).

Patientswithcongestiveheartfailure(NYHA-1)andpatientswithsignificantriskfactorsforcardiovascularevents

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

consideration.Asthecardiovascularrisksofdiclofenacmayincreasewithdoseanddurationofexposure,theshortest

durationpossibleandthelowesteffectivedailydoseshouldbeused.Thepatient'sneedforsymptomaticreliefand

responsetotherapyshouldbere-evaluatedperiodically.

Patientsshouldremainalertforthesignsandsymptomsofseriousarteriothromboticevents(e.g.chestpain,shortness

ofbreath,weakness,slurringofspeech),whichcanoccurwithoutwarnings.Patientsshouldbeinstructedtoseea

physicianimmediatelyincaseofsuchanevent.

Haematologicaleffects

UseofCataflamisrecommendedonlyforshort-termtreatment.If,however,Cataflamisusedforaprolongedperiod,

monitoringofthebloodcountisrecommended,aswithotherNSAIDs.

LikeotherNSAIDs,Cataflammaytemporarilyinhibitplateletaggregation.Patientswithdefectsofhaemostasisshould

becarefullymonitored.

Pre-existingasthma

Inpatientswithasthma,seasonalallergicrhinitis,swellingofthenasalmucosa(i.e.nasalpolyps),chronicobstructive

pulmonarydiseasesorchronicinfectionsoftherespiratorytract(especiallyiflinkedtoallergicrhinitis-likesymptoms),

reactionsonNSAIDslikeasthmaexacerbations(so-calledintolerancetoanalgesics/analgesics-asthma),Quincke’s

oedemaorurticariaaremorefrequentthaninotherpatients.Therefore,specialprecautionisrecommendedinsuch

patients(readinessforemergency).Thisisapplicableaswellforpatientswhoareallergictoothersubstances,e.g.with

skinreactions,pruritusorurticaria.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ThefollowinginteractionsincludethoseobservedwithCataflamsugar-coatedtabletsand/orotherpharmaceutical

formsofdiclofenac.

ObservedInteractionstobeconsidered

PotentCYP2C9inhibitors:Cautionisrecommendedwhenco-prescribingdiclofenacwithpotentCYP2C9inhibitors

(suchasvoriconazole),whichcouldresultinasignificantincreaseinpeakplasmaconcentrationsandexposureto

diclofenacduetoinhibitionofdiclofenacmetabolism

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/05/2014 CRN 2146516 page number: 4

lithiumlevelisrecommended

Digoxin:Ifusedconcomitantly,diclofenacmayraiseplasmaconcentrationsofdigoxin.Monitoringoftheserum

digoxinlevelisrecommended.

Diureticsandantihypertensiveagents:LikeotherNSAIDs,concomitantuseofdiclofenacwithdiureticsor

antihypertensiveagents(e.g.beta-blockers,angiotensinconvertingenzyme(ACE)inhibitors)maycauseadecreasein

theirantihypertensiveeffect.Therefore,thecombinationshouldbeadministeredwithcautionandpatients,especially

theelderly,shouldhavetheirbloodpressureperiodicallymonitored.Patientsshouldbeadequatelyhydratedand

considerationshouldbegiventomonitoringofrenalfunctionafterinitiationofconcomitanttherapyandperiodically

thereafter,particularlyfordiureticsandACEinhibitorsduetotheincreasedriskofnephrotoxicity.(seesection4.4

Specialwarningsandprecautionsforuse).

Ciclosporin:Diclofenac,likeotherNSAIDs,mayincreasethenephrotoxicityofciclosporinduetotheeffectonrenal

prostaglandins.Therefore,itshouldbegivenatdoseslowerthanthosethatwouldbeusedinpatientsnotreceiving

ciclosporin.

Drugsknowntocausehyperkalemia:Concomitanttreatmentwithpotassium-sparingdiuretics,ciclosporin,tacrolimus

ortrimethoprimmaybeassociatedwithincreasedserumpotassiumlevels,whichshouldthereforebemonitored

frequently(seesection4.4Specialwarningsandprecautionsforuse).

Quinoloneantibacterials:Therehavebeenisolatedreportsofconvulsionswhichmayhavebeenduetoconcomitant

useofquinolonesandNSAIDs.

AnticipatedInteractionstobeconsidered

OtherNSAIDsandcorticosteroids:ConcomitantadministrationofdiclofenacandothersystemicNSAIDsor

corticosteroidsmayincreasetheriskofgastrointestinalulcerationorbleeding(seesection4.4Specialwarningsand

precautionsforuse)

Anticoagulantsandanti-plateletagents:Cautionisrecommendedsinceconcomitantadministrationcouldincreasethe

riskofgastrointestinalbleeding(seesection4.4Specialwarningsandprecautionsforuse).Althoughclinical

investigationsdonotappeartoindicatethatdiclofenacaffectstheactionofanticoagulants,NSAIDsmayenhancethe

effectsofanti-coagulants,suchaswarfarin(seesection4.4.)Therearealsoisolatedreportsofanincreasedriskof

haemorrhageinpatientsreceivingdiclofenacandanticoagulantsconcomitantly.Closemonitoringofsuchpatientsis

thereforerecommended.

Selectiveserotoninreuptakeinhibitors(SSRIs):ConcomitantadministrationofsystemicNSAIDs,including

diclofenac,andSSRIsmayincreasetheriskofgastrointestinalbleeding(seesection4.4Specialwarningsand

precautionsforuse)

Antidiabetics:Clinicalstudieshaveshownthatdiclofenaccanbegiventogetherwithoralantidiabeticagentswithout

influencingtheirclinicaleffect.However,therehavebeenisolatedreportsofbothhypoglycaemicandhyperglycaemic

effectsnecessitatingchangesinthedosageoftheantidiabeticagentsduringtreatmentwithdiclofenac.Forthisreason,

monitoringofthebloodglucoselevelisrecommendedasaprecautionarymeasureduringconcomitanttherapy.

Methotrexate:Diclofenaccaninhibitthetubularrenalclearanceofmethotrexateherebyincreasingmethotrexatelevels.

CautionisrecommendedwhenNSAIDs,includingdiclofenac,areadministeredlessthan24hoursbeforeorafter

treatmentwithmethotrexate,sincebloodconcentrationsofmethotrexatemayriseandthetoxicityofthissubstancebe

increased

Colestipolandcholestyramine:Theseagentscaninduceadelayordecreaseinabsorptionofdiclofenac.Therefore,it

isrecommendedtoadministerdiclofenacatleastonehourbeforeor4to6hoursafteradministrationofcolestipol/

cholestyramine

Phenytoin:Whenusingphenytoinconcomitantlywithdiclofenac,monitoringofphenytoinplasmaconcentrationsis

recommendedduetoanexpectedincreaseinexposuretophenytoin

4.6Fertility,pregnancyandlactation

Pregnancy

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/05/2014 CRN 2146516 page number: 5

fromepidemiologicalstudiessuggestanincreasedriskofmiscarriageandofcardiacmalformationandgastroschisis

afteruseofaprostaglandinsynthesisinhibitorinearlypregnancy.Theabsoluteriskforcardiovascularmalformation

wasincreasedfromlessthan1%,uptoapproximately1.5%.

Theriskisbelievedtoincreasewithdoseanddurationoftherapy.Inanimals,administrationofaprostaglandin

synthesisinhibitorhasbeenshowntoresultinincreasedpre-andpost-implantationlossandembryo-foetallethality.

Inaddition,increasedincidencesofvariousmalformations,includingcardiovascular,havebeenreportedinanimals

givenaprostaglandinsynthesisinhibitorduringtheorganogeneticperiod.Duringthefirstandsecondtrimesterof

pregnancy,diclofenacshouldnotbegivenunlessclearlynecessary.Ifdiclofenacisusedbyawomanattemptingto

conceive,orduringthefirstandsecondtrimesterofpregnancy,thedoseshouldbekeptaslowanddurationof

treatmentasshortaspossible.

Duringthethirdtrimesterofpregnancy,allprostaglandinsynthesisinhibitorsmayexpose

thefoetusto:

cardiopulmonarytoxicity(withprematureclosureoftheductusarteriosusandpulmonaryhypertension);

renaldysfunction,whichmayprogresstorenalfailurewitholigo-hydroamniosis;themotherandtheneonate,at

theendofpregnancy,to:

possibleprolongationofbleedingtime,ananti-aggregatingeffectwhichmayoccurevenatverylowdoses.

inhibitionofuterinecontractionsresultingindelayedorprolongedlabour.

Consequently,diclofenaciscontraindicatedduringthethirdtrimesterofpregnancy.

Lactation

LikeotherNSAIDs,diclofenacpassesintothebreastmilkinsmallamounts.Therefore,Cataflamshouldnotbe

administeredduringbreastfeedinginordertoavoidundesirableeffectsintheinfant.

Fertility

AswithotherNSAIDs,theuseofCataflammayimpairfemalefertilityandisnotrecommendedinwomenattempting

toconceive.Inwomenwhohavedifficultiesconceivingorwhoareundergoinginvestigationofinfertility,withdrawal

ofCataflamshouldbeconsidered.

4.7Effectsonabilitytodriveandusemachines

Patientswhoexperiencedizziness,vertigo,somnolenceorothercentralnervoussystemdisturbances,includingvisual

disturbances,whiletakingNSAIDsshouldrefrainfromdrivingorusingmachinery.

4.8Undesirableeffects

Adversedrugreactionsfromclinicaltrialsand/orspontaneousorliteraturecases(Table1)arelistedbyMedRAsystem

orderclass.Withineachsystemorganclass,theadversedrugreactionsarerankedbyfrequency,withthemostfrequent

reactionsfirst.Withineachfrequencygrouping,adversedrugreactionsarepresentedinorderofdecreasing

seriousness.Inaddition,thecorrespondingfrequencycategoryforeachadversedrugreactionisbasedonthefollowing

convention(CIOMSIII):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).

Themostcommonlyobservedadverseeventsaregastrointestinalinnature.Pepticulcers,perforationorGIbleeding,

sometimesfatal,particularlyintheelderly,mayoccur(seesection4.4Specialwarningsandprecautionsforuse).

Nausea,vomiting,diarrhoea,flatulence,constipation,dyspepsia,abdominalpain,melaena,haematemesis,ulcerative

stomatitis,exacerbationofcoilitisandCrohn’sdisease(seesection4.4Specialwarningsandprecautionsforuse)have

beenreportedfollowingadministration.Lessfrequently,gastritishasbeenobserved.

ThefollowingtableofundesirableeffectsincludethosereportedwithCataflamsugarcoatedtabletsand/orother

pharmaceuticalformsofdiclofenac,witheithershort-termorlong-termuse.

Table1

Bloodandlymphaticsystemdisorders

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/05/2014 CRN 2146516 page number: 6

hemolyticanemiaandaplasticanemia),agranulocytosis

Immunesystemdisorders

Rare: Hypersensitivity,anaphylacticandanaphylactoid

reactions(includinghypotensionandshock)

Veryrare: Angioedema(includingfaceedema).

Psychiatricdisorders

Veryrare: Disorientation,depression,insomnia,nightmare,

irritability,psychoticdisorder.

Nervoussystemdisorders

Common: Headache,dizziness

Rare: Somnolence

Veryrare: Paresthesia,memoryimpairment,convulsion,anxiety,

tremor,meningitisaseptic,dysgeusia,cerebrovascular

accident.

Eyedisorders

Veryrare: Visualimpairment,visionblurred,diplopia

Earandlabyrinthdisorders

Common: Vertigo

Veryrare: Tinnitus,hearingimpaired

Cardiacdisorders

Uncommon*: Myocardialinfarction,cardiacfailure,palpitations,chest

pain

Vasculardisorders

Veryrare: Hypertension,vasculitis.

Respiratory,thoracicandmediastinaldisorders

Rare: Asthma/bronchospasm(includingdyspnea).

Veryrare: Pneumonitis.

Gastrointestinaldisorders

Common: Nausea,vomiting,diarrhea,dyspepsia,abdominalpain,

flatulence,decreasedappetite

Rare: Gastritis,gastrointestinalhemorrhage,Hematemesis,

diarrheahemorrhagic,melena,gastrointestinalulcer

(withorwithoutbleedingorperforation)

Veryrare: Colitis(includinghaemorrhagiccolitisandexacerbation

ofulcerativecolitisorCrohn’sdisease),constipation,

stomatitis(includingulcerativestomatitis)glossitis,

oesophagealdisorder,diaphragm-likeintestinal

strictures,pancreatitis

Hepatobiliarydisorders

Common: Transaminasesincreased.

Rare: Hepatitis,jaundiceliverdisorder

Veryrare: Hepatitisfulminant,hepaticnecrosis,hepaticfailure

Skinandsubcutaneoustissuedisorders

Common: Rash

Rare: Urticaria.

Veryrare: Dermititisbullous,eczema,erythema,erythema

multiforme,Stevens-Johnsonsyndrome,toxicepidermal

necrolysis(Lyell'ssyndrome),dermatitisexfoliative,

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/05/2014 CRN 2146516 page number: 7

*Thefrequencyreflectsdatafromlong-termtreatmentwithahighdose(150mg/day).

Clinicaltrialandepidemiologicaldataconsistentlypointtowardsanincreasedriskofarterialthromboticevents(for

examplemyocardialinfarctionorstroke)associatedwiththeuseofdiclofenac,particularlyathighdoses(150mg

daily)andinlongtermtreatment(seesection4.3and4.4forContraindicationsandSpecialwarningsandspecial

precautionsforuse).

Oedema,hypertensionandcardiacfailurehavebeenreportedinassociationwithNSAIDtreatment.

Reportingofsuspectedadversereactions

Reportingsuspectedadversereactionsafterauthorisationofthemedicinalproductisimportant.Itallowscontinued

monitoringofthebenefit/riskbalanceofthemedicinalproduct.Healthcareprofessionalsareaskedtoreportany

suspectedadversereactionsviatheonlinereportingoption(preferredmethod)accessiblefromtheIMBhomepage

(www.imb.ie).AdownloadablereportformisalsoaccessiblefromtheIMBwebsite,whichmaybecompleted

manuallyandsubmittedtotheIMBvia‘freepost’(seedetailsbelow).Alternatively,thetraditionalpost-paid‘yellow

card’optionmayalsobeused.

FREEPOST

PharmacovigilanceSection

IrishMedicinesBoard

KevinO’MalleyHouse

EarlsfortCentre

EarlsfortTerrace

Dublin2

Tel:+35316764971

Fax:+35316762517

Website:www.imb.ie

e-mail:imbpharmacovigilance@imb.ie

4.9Overdose

Symptoms

Thereisnotypicalclinicalpictureresultingfromdiclofenacoverdosage.Overdosagecancausesymptomssuchas

vomiting,gastrointestinalhaemorrhage,diarrhoea,dizziness,tinnitusorconvulsions.Intheeventofsignificant

poisoning,acuterenalfailureandliverdamagearepossible.

Therapeuticmeasures

ManagementofacutepoisoningwithNSAIDs,includingdiclofenac,essentiallyconsistsofsupportivemeasuresand

symptomatictreatment.Supportivemeasuresandsymptomatictreatmentshouldbegivenforcomplicationssuchas

hypotension,renalfailure,convulsions,gastrointestinaldisorder,andrespiratorydepression.

Specialmeasuressuchasforceddiuresis,dialysisorhaemoperfusionareprobablyunlikelytobehelpfulinaccelerating

theeliminationofNSAIDs,includingdiclofenac,duetothehighproteinbindingandextensivemetabolism.

Activatedcharcoalmaybeconsideredafteringestionofapotentiallytoxicoverdose,andgastricdecontamination(e.g.

Schonleinpurpura,pruritus

Renalandurinarydisorders

Veryrare: Renalfailureacute,hematuria,proteinuria,nephritic

syndrome,tubulointerstitialnephritis,renalpapillary

necrosis

Generaldisordersandadministrationsiteconditions

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/05/2014 CRN 2146516 page number: 8

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Anti-inflammatoryandantirheumaticproducts,non-steroids,aceticacidderivativesand

relatedsubstances(NSAID)(ATCcode:M01AB05).

Mechanismofaction

Cataflamcontainsthepotassiumsaltofdiclofenac,anon-steroidalcompoundwithpronouncedanalgesic,anti-

inflammatoryandantipyreticproperties.Inhibitionofprostaglandinbiosynthesis,whichhasbeendemonstratedin

experiments,isconsideredtobefundamentaltoitsmechanismofaction.Prostaglandinsplayamajorroleincausing

inflammation,painandfever.

Cataflamtabletshavearapidonsetofactionwhichmakesthemparticularlysuitableforthetreatmentofacutepainful

andinflammatoryconditions .

Diclofenacpotassiuminvitrodoesnotsuppressproteoglycanbiosynthesisincartilageatconcentrationsequivalentto

thoseconcentrationsreachedinhumans.

Pharmacodynamiceffects

Cataflamhasbeenfoundtoexertapronouncedanalgesiceffectinmoderateandseverepain.Inthepresenceof

inflammation,e.g.duetotraumaorfollowingsurgicalinterventions,itrapidlyrelievesbothspontaneouspainandpain

onmovementanddiminishesinflammatoryswellingandwoundoedema

Clinicalstudieshavealsorevealedthatinprimarydysmenorrhoeatheactivesubstanceiscapableofrelievingthepain

andreducingtheextentofbleeding

InmigraineattacksCataflamhasbeenshowntobeeffectiveinrelievingtheheadacheandinimprovingthe

accompanyingsymptomsofnauseaandvomiting

ThereislimitedclinicaltrialexperienceoftheuseofdiclofenacinJuvenileRheumatoidArthritis(JRA)/Juvenile

IdiopathicArthritis(JIA)paediatricpatients.Inarandomized,double-blind,2-week,parallelgroupstudyinchildren

aged3-15yearswithJRA/JIA,theefficacyandsafetyofdaily2-3mg/kgBWdiclofenacwascomparedwith

acetylsalicylicacid(ASS,50-100mg/kgBW/d)andplacebo–15patientsineachgroup.Intheglobalevaluation,11of

15diclofenacpatients,6of12aspirinand4of15placebopatientsshowedimprovementwiththedifferencebeing

statisticallysignificant(p<0.05).ThenumberoftenderjointsdecreasedwithdiclofenacandASSbutincreasedwith

placebo.Inasecondrandomized,double-blind,6-week,parallelgroupstudyinchildrenaged4-15yearswithJRA/JIA,

theefficacyofdiclofenac(dailydose2-3mg/kgBW,n=22)wascomparablewiththatofindomethacin(dailydose2-

3mg/kgBW,n=23).

5.2Pharmacokineticproperties

Absorption:

Diclofenacisrapidlyandcompletelyabsorbedfromdiclofenacpotassiumtablets.Theabsorptionsetsinimmediately

afteradministrationandthesameamountisabsorbedasfrom

anequivalentdoseofdiclofenacsodiumgastro-resistanttablets.

Meanpeakplasmaconcentrationsof3.8micromol/Lareattainedafter20-60minutesafteringestionofonetabletof

50mg.Ingestiontogetherwithfoodhasnoinfluenceontheamountofdiclofenacabsorbedalthoughonsetandrateof

absorptionmaybeslightlydelayed.Sinceabouthalfofdiclofenacismetabolizedduringitsfirstpassagethroughthe

liver("firstpass"effect),theareaundertheconcentrationcurve(AUC)isabouthalfaslargefollowingoralorrectal

administrationasitisfollowingaparenteraldoseofequalsize.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/05/2014 CRN 2146516 page number: 9

Pharmacokineticbehaviourdoesnotchangeafterrepeatedadministration.Noaccumulationoccursprovidedthe

recommendeddosageintervalsareobserved.

Distribution:

Theactivesubstanceis99.7%proteinbound,mainlytoalbumin(99.4%).

Diclofenacentersthesynovialfluid,wheremaximumconcentrationsaremeasured2-4hoursafterpeakplasmavalues

havebeenattained.Theapparenthalf-lifeforeliminationfromthesynovialfluidis3-6hours.Twohoursafter

reachingthepeakplasmavalues,concentrationsoftheactivesubstancearealreadyhigherinthesynovialfluidthan

theyareintheplasma,andremainhigherforupto12hours.

Diclofenacwasdetectedinalowconcentration(100ng/mL)inbreastmilkinonenursingmother.Theestimated

amountingestedbyaninfantconsumingbreastmilkisequivalenttoa0.03mg/kg/daydose.

Biotransformation/Metabolism:

Biotransformationofdiclofenactakesplacepartlybyglucuronidationoftheintactmolecule,butmainlybysingleand

multiplehydroxylationandmethoxylation,resultinginseveralphenolicmetabolites,mostofwhichareconvertedto

glucuronideconjugates.Twophenolicmetabolitesarebiologicallyactive,buttoamuchlesserextentthandiclofenac.

Elimination:

Totalsystemicclearanceofdiclofenacinplasmais263±56mL/min(meanvalueSD).Theterminalhalf-lifeinplasma

is1-2hours.Fourofthemetabolites,includingthetwoactiveones,alsohaveshortplasmahalf-livesof1-3hours.

About60%oftheadministereddoseisexcretedintheurineastheglucuronideconjugateoftheintactmoleculeandas

metabolites,mostofwhicharealsoconvertedtoglucuronideconjugates.Lessthan1%isexcretedasunchanged

substance.Therestofthedoseiseliminatedasmetabolitesthroughthebileinthefaeces.

SpecialPopulations:

Norelevantage-dependentdifferencesinthedrug’sabsorption,metabolism,orexcretionhavebeenobserved.

Patientswithrenalimpairment:Inpatientssufferingfromrenalimpairment,noaccumulationoftheunchangedactive

substancecanbeinferredfromthesingle-dosekineticswhenapplyingtheusualdosageschedule.Atacreatinine

clearanceof<10mL/min,thecalculatedsteady-stateplasmalevelsofthehydroxymetabolitesareabout4timeshigher

thaninnormalsubjects.However,themetabolitesareultimatelyclearedthroughthebile.

Patientswithhepaticdisease:Inpatientswithchronichepatitisornon-decompensatedcirrhosis,thekineticsand

metabolismofdiclofenacarethesameasinpatientswithoutliverdisease.

5.3Preclinicalsafetydata

Preclinicaldatafromacuteandrepeateddosetoxicitystudies,aswellasfromgenotoxicity,mutagenicity,and

carcinogenicitystudieswithdiclofenacrevealednospecifichazardforhumansattheintendedtherapeuticdoses.In

standardpreclinicalanimalstudies,therewasnoevidencethatdiclofenachadateratogenicpotentialinmice,ratsor

rabbits.

Diclofenachadnoinfluenceonthefertilityofparentanimalsinrats.Exceptforminimalfetaleffectsatmaternally

toxicdosestheprenatal,perinatal,andpostnataldevelopmentoftheoffspringwasnotaffected.

AdministrationofNSAIDs(includingdiclofenac)inhibitedovulationintherabbitandimplantationandplacentationin

therat,andledtoprematureclosureoftheductusarteriosusinthepregnantrat.Maternallytoxicdosesofdiclofenac

wereassociatedwithdystocia,prolongedgestation,decreasedfetalsurvival,andintrauterinegrowthretardationinrats.

Theslighteffectsofdiclofenaconreproductionparametersanddeliveryaswellasconstrictionoftheductusarteriosus

inuteroarepharmacologicconsequencesofthisclassofprostaglandinsynthesisinhibitors(seesections4.3

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/05/2014 CRN 2146516 page number: 10

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

TabletCore:

Colloidalanhydroussilica

Calciumphosphate

Magnesiumstearate

Maizestarch

PovidoneK30

Sodiumstarchglycolate(TypeA)

CoatingandPolish:

Microcrystallinecellulose

Dispersedred(redironoxide(E172)andtitaniumdioxide(E171)

Macrogol8000

Sucrose

Povidone

Talc

6.2Incompatibilities

Notapplicable.

6.3Shelflife

30months

6.4Specialprecautionsforstorage

Donotstoreabove30 °

C.Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

PVC/PE/PVDCfilmonaluminiumfoilblisterstrips,10tablets/strip.

Packsizes:20or30tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

NovartisPharmaceuticalsUKLimited,

FrimleyBusinessPark,

Frimley,

Camberley,

SurreyGU167SR,

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/05/2014 CRN 2146516 page number: 11

8MARKETINGAUTHORISATIONNUMBER

PA0013/088/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:13March1995

Dateoflastrenewal:25July2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/05/2014 CRN 2146516 page number: 12

Similar products

Search alerts related to this product

View documents history

Share this information