DICLAC 150 MG PROLONGED-RELEASE TABLETS

Main information

  • Trade name:
  • DICLAC 150 MG PROLONGED-RELEASE TABLETS
  • Dosage:
  • 150 Milligram
  • Pharmaceutical form:
  • Tablet Prolonged Release
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DICLAC 150 MG PROLONGED-RELEASE TABLETS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0711/009/004
  • Authorization date:
  • 20-03-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995

MEDICINALPRODUCTS(LICENSINGANDSALE)REGULATIONS,1998

(S.I.No.142of1998)

PA0711/009/004

CaseNo:2025679

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

RowexLtd

Bantry,Co.Cork,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Diclac150mgProlonged-releaseTablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom04/10/2006until26/05/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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Date Printed 05/10/2006 CRN 2025679 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Diclac150mgProlonged-releaseTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains150mgDiclofenacSodium.

Forexcipients,see6.1

3PHARMACEUTICALFORM

Prolonged-releasetablet

Round,flat,two-layeredpinkandwhitecoloured,prolongedreleasetablets.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthesymptomatictreatmentofosteoarthritis

Reliefofallgradesofpainandinflammationinawiderangeofconditions,including:

arthriticconditions:rheumatoidarthritis,osteoarthritis,ankylosingspondylitis,acutegout,psoriaticarthropathy;

(ii) acutemusculo-skeletaldisorderssuchasperiarthritis(forexamplefrozenshoulder),tendinitis,tenosynovitis,

bursitis;

(iii) otherpainfulconditionsresultingfromtrauma,includingfracture,lowbackpain,sprains,strains,dislocations,

orthopaedic,dentalandotherminorsurgery;

(iv) inthemanagementofdysmenorrhoeaandassociatedmenorrhagia.

4.2Posologyandmethodofadministration

Asageneralrecommendation,thedoseshouldbeindividually

adjustedandthelowesteffectivedosegivenfortheshortest

possibleduration.

RouteofAdministration:

Oral.

RecommendedDosageSchedule:

Adults:DiclacProlongedReleasetablet150mg:Onetabletdaily,swallowwholewithliquid,donotchew.

Elderly:AlthoughthepharmacokineticsofDiclacarenotimpairedtoanyclinicallyrelevantextentinelderlypatients,

nonsteroidalanti-inflammatorydrugsshouldbeusedwithparticularcautioninsuchpatientswhogenerallyaremore

pronetoadversereactions.Inparticularitisrecommendedthatthelowesteffectivedosagebeusedinfrailelderly

patientsorthosewithalowbodyweight.

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Children:Notrecommended.

Treatmentshouldbereviewedatregularintervalsanddiscontinuedifnobenefitisseenorintoleranceoccurs.

4.3Contraindications

Knownhypersensitivitytotheactivesubstanceortoanyoftheexcipients

HistoryofgastrointestinalbleedingorperforationrelatedtopreviousNSAID'stherapy

Activeorhistoryofrecurrentgastricorintestinalulcer,bleedingorperforation

Lasttrimesterofpregnancy(seesection4.6PregnancyandLactation)

Severehepatic,renalorcardiacfailure(seesection4.4Specialwarningsand specialprecautionsforuse

Likeothernon-steroidalanti-inflammatorydrugs(NSAID’s),diclofenacisalsocontra-indicatedinpatientsin

whomattacksofasthma,urticaria,oracuterhinitisareprecipitatedbyacetylsalicylicacidorotherNSAID’s.

4.4Specialwarningsandprecautionsforuse

Warnings

Gastrointestinalbleeding,ulcerationorperforation,whichcanbefatal,havebeenreportedwithallNSAIDsandmayoc

atanytimeduringtreatment,withorwithoutwarningsymptomsoraprevioushistoryofseriousgastrointestinalevents.

Theygenerallyhavemoreseriousconsequencesintheelderly.Ifgastrointestinalbleedingorulcerationoccursinpatient

receivingdiclofenac,themedicinalproductshouldbewithdrawn.

Seriousskinreactions,someofthemfatal,includingexfoliativedermatitis,Stevens-Johnsonsyndromeandtoxic

epidermalnecrolysis,havebeenreportedveryrarelyinassociationwiththeuseofNSAIDs,includingdiclofenac(see

section4.8Undesirableeffects).

Patientsappeartobeathighestriskofthesereactionsearlyinthecourseoftherapy,theonsetofthereactionoccurring

themajorityofcaseswithinthefirstmonthoftreatment.Diclofenacshouldbediscontinuedatthefirstappearanceofs

rash,musosallesionsoranyothersignofhypersensitivity.

AswithotherNSAIDs,allergicreactions,includinganaphylactic/anaphylactoidreactions,canalsooccurinrareca

withoutearlierexposuretothedrug.

LikeotherNSAIDs,diclofenacmaymaskthesignsandsymptomsofinfectionduetoitspharmacodynamicproperties.

Precautions

General

TheconcomitantuseofdiclofenacwithsystemicNSAIDsincludingcyclooxygenase-2selectiveinhibitors,shouldbe

avoidedduetotheabsenceofanyevidencedemonstratingsynergisticbenefitsandthepotentialforadditiveundesirable

effects.

Cautionisindicatedintheelderlyonbasicmedicalgrounds.Inparticular,itisrecommendedthatthelowesteffect

dosebeusedinfrailelderlypatientsorthosewithalowbodyweight.

Pre-existingasthma

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

pulmonarydiseasesorchronicinfectionsoftherespiratorytract(especiallyiflinkedtoallergicrhinitis-likesymptoms),

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

orurticariaaremorefrequentthaninotherpatients.Therefore,specialprecautionisrecommendedinsuchpatients

(readinessforemergency).Thisisapplicableaswellforpatientswhoareallergictoothersubstances,e.g.withskin

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Gastrointestinaleffects

AswithallNSAIDs,closemedicalsurveillanceisimperativeandparticularcautionshouldbeexcerisedwhenprescribin

diclofenacinpatientswithsymptomsindicativeofgastrointestinal(GI)disordersorwithahistorysuggestiveofgastric

intestinalulceration,bleedingorperforation(seesection4.8Undesirableeffects).TheriskofGIbleedingishigherwith

increasingNSAIDdosesandinpatientswithahistoryofulcer,particularlyifcomplicatedwithhaemorrhageor

perforationandintheelderly.

ToreducetheriskofGItoxicityinpatientswithahistoryofulcer,particularlyifcomplicatedwithhaemorrhageor

perforation,andintheelderly,thetreatmentshouldbeinitiatedandmaintainedatthelowesteffectivedose.

Combinationtherapywithprotectiveagents(e.g.protonpumpinhibitorsormisoprostol)shouldbeconsideredforthese

patients,andalsoforpatientsrequiringconcomitantuseofmedicinalproductscontaininglow-doseacetylsalicylicacid

(ASA)/aspirinorothermedicinalproductslikelytoincreasegastrointestinalrisk.

PatientswithahistoryofGItoxicity,particularlytheelderly,shouldreportanyunusualabdominalsymptoms(especiall

GIbleeding).Cautionisrecommendedinpatientsreceivingconcomitantmedicationswhichcouldincreasetheriskof

ulcerationorbleeding,suchassystemiccorticosteroids,anticoagulants,anti-plateletagentsorselectiveserotonin-reupta

inhibitors(seesection4.5Interactionwithothermedicinalproductsandotherformsofinteraction).

ClosemedicalsurveillanceandcautionshouldalsobeexercisedinpatientswithulcerativecolitisorCrohn’sdisease,as

theirconditionmaybeexacerbated(seesection4.8Undesirableeffects).

Hepaticeffects

Closemedicalsurveillanceisrequiredwhenprescribingdiclofenactopatientswithimpairedhepaticfunction,astheir

conditionmaybeexacerbated.

AswithotherNSAIDs,valuesofoneormoreliverenzymesmayincrease.Duringprolongedtreatmentwithdiclofenac

regularmonitoringofhepaticfunctionisindicatedasaprecautionarymeasure.Ifabnormalliverfunctiontestspersisto

worsen,ifclinicalsignsorsymptomsconsistentwithliverdiseasedevelop,ofifothermanifestationsoccur(e.g.

eosinophilia,rash),diclofenacshouldbediscontinued.Hepatitismayoccurwithoutprodromalsymptoms.

Cautioniscalledforwhenusingdiclofenacinpatientswithhepaticporphyria,sinceitmaytriggeranattack.

Renaleffects

AsfluidretentionandoedemahavebeenreportedinassociationwithNSAIDtherapy,particularcautioniscalledforin

patientswithimpairedcardiacorrenalfunction,historyofhypertension,theelderly,patientsreceivingconcomitant

treatmentwithdiureticsormedicinalproductsthatcansignificantlyimpactrenalfunction,andinthosepatientswith

substantialextracellularvolumedepletionfromanycause,e.g.beforeoraftermajorsurgery(seesection4.3

Contraindications).

Monitoringofrenalfunctionisrecommendedasaprecautionarymeasurewhenusingdiclofenacinsuchcases.

Discontinuationoftherapyisusuallyfollowedbyrecoverytothepre-treatmentstate.

Cautionisrequiredinpatientswithahistoryofhypertensionand/orheartfailureasfluidretentionandoedemahave

beenreportedinassociationwithNSAIDtherapy.

Haematologicaleffects

Duringprolongedtreatmentwithdiclofenac,aswithotherNSAIDs,monitoringofthebloodcountisrecommended.

LikeotherNSAIDs,diclofenacmaytemporarilyinhibitplateletaggregation.Patientswithdefectsorhaemostatisshould

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Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactose

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thefollowinginteractionsincludethoseobservedwithdiclofenacgastro-resistanttabletsand/orotherpharmaceutical

formsofdiclofenac.

Lithium:Ifusedconcomitantly,diclofenacmayraiseplasmaconcentrationsoflithium.Monitoringoftheserum

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,particularlyfordiureticsandACEinhibitorsduetheincreasedriskofnephrotoxicity.Concomitant

treatmentwithpotassium-sparingdrugsmaybeassociatedwithincreasedserumpotassiumlevels,whichshould

thereforebemonitoredfrequently(seesection4.4Specialwarningsandspecialprecautionsforuse).

OtherNSAIDsandcorticosteroids:ConcomitantadministrationofdiclofenacandothersystemicNSAIDsor

corticosteroidsmayincreasethefrequencyofgastrointestinalundesirableeffects(seesection4.4Specialwarningand

specialprecautionsforuse).

Anticoagulantsandanti-plateletagents:Cautionisrecommendedsinceconcomitantadministrationcouldincreasethe

riskofbleeding(seesection4.4Specialwarningsandspecialprecautionsforuse).Althoughclinicalinvestigationsdo

notappeartoindicatethatdiclofenacaffectstheactionofanticoagulants,thereareisolatedreportsofanincreasedrisk

ofhaemorrhageinpatientsreceivingdiclofenacandanticoagulantsconcomitantly.Closemonitoringofsuchpatientsis

thereforerecommended.

Selectiveserotoninreuptakeinhibitors(SSRIs):ConcomitantadministrationofsystemicNSAIDandSSRIsmay

increasetheriskofgastrointestinalbleeding(seesection4.4Specialwarningsandspecialprecautionsforuse).

Antidiabetic:Clinicalstudieshaveshownthatdiclofenaccanbegiventogetherwithoralantidiabeticagentswithout

influencingtheirclinicaleffect.However,therehavebeenisolatedreportsofbothhypoglycaemicandhyperglycaemic

effectsnecessitatingchangesinthedosageoftheantidiabeticagentsduringtreatmentwithdiclofenac.Forthisreason,

monitoringofthebloodglucoselevelisrecommendedasaprecautionarymeasureduringconcomitanttherapy.

Methotrexate:CautionisrecommendedwhenNSAIDsareadministeredlessthan24hoursbeforeoraftertreatment

withmethotrexate,sincebloodconcentrationsofmethotrexatemayriseandthetoxicityofthissubstancebeincreased.

Ciclosporin:Diclofenac,likeotherNSAIDs,mayincreasethenephrotoxicityofciclosporinduetoeffectonrenal

prostaglandins.Therefore,itshouldbegivenatdoseslowerthanthosethatwouldbeusedinpatientsnotreceiving

ciclosporin.

Quinoloneantimicrobials:Therehavebeenisolatedreportsofconvulsionswhichmayhavebeenduetoconcomitant

useofquinolonesandNSAIDs.

Cardiacglycosides:NSAIDSmayexacerbatecardiacfailure,reduceGFRandincreaseplasmacardiacglycosidelevels.

Aminoglycosides:reductioninrenalfunctioninsusceptibleindividuals,decreasedeliminationofaminoglycosideand

increasedplasmaconcentrations.

Probenecid:reductioninmetabolismandeliminationofNSAIDandmetabolites.

4.6Pregnancyandlactation

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Theuseofdiclofenacinpregnantwomenhasnotbeenstudied.Therefore,diclofenacshouldnotbeusedduringthe

firsttwotrimestersofpregnancyunlessthepotentialbenefittothemotheroutweighstherisktothefoetus.Aswith

otherNSAIDs,useduringthethirdtrimesterofpregnancyiscontraindicatedowingtothepossibilityofuterineinertia

and/orprematureclosureoftheductusarteriosus(seesection4.3Contraindications).Animalstudieshavenotshown

anydirectlyorindirectlyharmfuleffectsonpregnancy,embryonal/fetaldevelopment,parturitionorpostnatal

development(seesection5.3Preclinicalsafetydata).

Lactation

LikeanyotherNSAIDs,diclofenacpassesintothebreastmilkinsmallamounts.Therefore,diclofenacshouldnotbe

administeredduringbreastfeedinginordertoavoidundesirableeffectsintheinfant.

Fertility

AswithotherNSAIDs,theuseofdiclofenacmayimpairfemalefertilityandisnotrecommendedinwomenattempting

toconceive.Inwomenwhohavedifficultiesconceivingorwhoareundergoinginvestigationofinfertility,withdrawal

ofdiclofenacshouldbeconsidered.

4.7Effectsonabilitytodriveandusemachines

Patientsexperiencingvisualdisturbances,dizziness,vertigo,somnolenceorothercentralnervoussystemdisturbances

whiletakingdiclofenac,shouldrefrainfromdrivingorusingmachines.

4.8Undesirableeffects

Adversereactionsarerankedunderheadingoffrequency,themostfrequentfirst,usingthefollowingconvention:

common( 1/100,<1/10);uncommon( 1/1,000,<1/100);rare( 1/10,000,<1/1,000);veryrare(<1/10,000),

includingisolatedreports.

Thefollowingundesirableeffectsincludethosereportedwithdiclofenacgastro-resistanttabletsand/orother

pharmaceuticalformsofdiclofenac,witheithershort-termorlong-termuse.

Bloodandlymphaticdisorders

Veryrare: Thrombocytopenia,leukopenia,anaemia(including

haemolyticandaplasticanaemia),agranulocytosis

Immunesystemdisorders

Rare: Hypersensitivity,anaphylacticandanaphylactoidreactions(includinghypotensionandshock)

Veryrare: Angioneuroticoedema(includingfaceoedema)

Psychiatricdisorders

Veryrare: Disorientation,depression,insomnia,nightmare,irritability,psychoticdisorder

Nervoussystemdisorders

Common: Headache,dizziness

Rare: Somnolence

Veryrare: Paraesthesia,memoryimpairment,convulsion,anxiety,tremor,asepticmeningitis,tastedisturbances,

cerebrovascularaccident

Eyedisorders

Veryrare: Visualdisturbance,visionblurred,diplopia

Earandlabyrinthdisorders

Common: Vertigo

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Cardiacdisorders

Veryrare: Palpitations,chestpain,cardiacfailure,myocardial

infarction

Vasculardisorders

Veryrare: Hypertension,vasculitis

Respiratory,thoracicandmediastinaldisorders

Rare: Asthma(includingdyspnoea)

Veryrare: Pneumonitis

Gastrointestinaldisorders

Common: Nausea,vomiting,diarrhoea,dyspepsia,abdominalpain,flatulence,anorexia

Rare: Gastritis,gastrointestinalhaemorrhage,haematemesis,diarrhoeahaemorrhagic,melaena,gastrointestinal

ulcer(withorwithoutbleedingorpeforation)

Veryrare: Colitis(includinghaemorrhagiccolitisandexacerbationofulcerativecolitisorCrohn’sdisease),

constipation,stomatitis,glossitis,oesophagealdisorder,diaphragm-likeintestinalstrictures,pancreatitis

Hepatobiliarydisorders

Common: Transaminasesincreased

Rare: Hepatitis,jaundice,liverdisorder

Veryrare: Fulminanthepatitis

Skinandsubcutaneoustissuedisorders

Common: Rash

Rare: Urticaria

Veryrare: Bullouseruptions,eczema,erythema,erythemamultiforme,Stephens-Johnsonsyndrome,toxicepiderm

necrolysis(Lyell’ssyndrome),dermatitisexfoliative,lossofhair,photosensitivityreaction,purpura,

allergicpurpura,pruritus

Renalandurinarydisorders

Veryrare: Acuterenalfailure,haematuria,proteinuria,nephroticsyndrome,interstitialnephritis,renalpapillary

necrosis

Generaldisordersandadministrationsiteconditions

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4.9Overdose

Symptoms

Thereisnotypicalclinicalpictureresultingfromdiclofenacoverdosage.Overdosagecancausesymptomssuchas

vomiting,gastrointestinalhaemorrhage,diarrhoea,dizziness,tinnitusorconvulsions.Intheeventofsignificantpoisonin

acuterenalfailureandliverdamagearepossible.

Therapeuticmeasures

ManagementofacutepoisoningwithNSAIDsessentiallyconsistsofsupportivemeasuresandsymptomatictreatment.

Supportivemeasuresandsymptomatictreatmentshouldbegivenforcomplicationssuchashypotension,renalfailure,

convulsions,gastrointestinaldisorder,andrespiratorydepression.

Specialmeasuressuchasforceddiuresis,dialysisorhaemoperfusionareprobablyofnohelpineliminatingNSAIDsdue

tothehighproteinbindingandextensivemetabolism.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCcode: Musculo-skeletalsystem.

Anti-inflammatoryandanti-rheumaticproducts.

MO1AB05: Aceticacidderivativesandrelatedsubstances

Diclacisanon-steroidalagentwithmarkedanalgesic/anti-inflammatoryproperties.Itisaninhibitorofprostaglandin

synthetase(cyclo-oxygenase).

Diclofenacsodiuminvitrodoesnotsuppressproteoglycanbiosynthesisincartilageatconcentrationsequivalenttothe

concentrationsreachedinhumans.

5.2Pharmacokineticproperties

Diclofenacsodiumisrapidlyabsorbedfromthegutandissubjecttofirst-passmetabolism.Tabletsgivepeakplasma

concentrationsafter1-4hours,suppositorieswithin1hourandampouleswithinhalfandhour.Theactivesubstanceis

99.7%proteinboundandplasmahalf-lifefortheterminaleliminationphaseis1-2hours.Approximately60%ofthe

administereddoseisexcretedviathekidneysintheformofmetabolitesandlessthan1%intheunchangedform.The

remainderofthedoseisexcretedviathebileinmetabolisedform.Inpatientswithimpairedrenalfunction,no

accumulationofDiclachasbeenreported.

5.3Preclinicalsafetydata

Preclinicaldatafromacuteandrepeateddosetoxicitystudies,aswellasfromgenotoxicity,mutagenicity,and

carcinogenicitystudieswithdiclofenacrevealednospecifichazardforhumansattheintendedtherapeuticdoses.There

wasnoevidencethatdiclofenachadateratogenicpotentialinmice,ratsorrabbits.

Diclofenachadnoinfluenceonthefertilityofparentanimalsinrats.Theprenatal,perinatalandpostnatal

developmentoftheoffspringwasnotaffected.

6PHARMACEUTICALPARTICULARS

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Lactosemonohydrate

Hypromellose

Microcrystallinecellulose

Calciumhydrogenphosphatedihydrate

Maizestarch

Sodiumstarchglycolate

Colloidalanhydroussilica

Magnesiumstearate

Redferricoxide(E172)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3yearsinPVC/Alupackaging.

2yearsinPP/Alupackaging.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Storeintheoriginalcontainer.

6.5Natureandcontentsofcontainer

Diclac150mgProlongedReleasetabletsareeachpackedinblistersofbothpolypropyleneandpolyvinylchlorideand

aluminiumfoil.DiclacProlongedRelease150mgTabletsareavailableinpacksof30tabletsandsamplepacksof10

tabletsarealsoavailable.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

RowexLtd.,

Bantry,

Co.Cork.

8MARKETINGAUTHORISATIONNUMBER

PA711/9/4

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:20 th

March2000

Dateoflastrenewal:27 th

May2004

10DATEOFREVISIONOFTHETEXT

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