DICLO (ENTERIC-COATED)

Main information

  • Trade name:
  • DICLO (ENTERIC-COATED)
  • Dosage:
  • 50 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DICLO (ENTERIC-COATED)
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0281/085/002
  • Authorization date:
  • 22-03-1999
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Diclo50mgGastro-resistantTablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains50mgofdiclofenacsodium.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Gastro-resistanttablet.

Tan,circular,biconvex,enteric-coatedtablets,engraved‘50’over‘0519’ononesideandplainonthereverse.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Diclofenacisindicatedinthesymptomaticmanagementofrheumatoidarthritis(includingjuvenilechronicarthritis),

osteoarthrosis,ankylosingspondylitis,psoriaticarthropathyandlowbackpain;alsoforacutemusculo-skeletal

disordersincludingperiarthritis,tendinitis,tenosynovitis,bursitis,sprains,strainsanddislocations,andforthereliefof

paininfracturesandacutegout.

Diclofenacisalsoindicatedinthemanagementofpostoperativepainandinflammationinorthopaedic,dentaland

otherminorsurgery.

4.2Posologyandmethodofadministration

Fororaladministration.

Adults: 75-150mgdailyin2-3divideddoses.Thetabletsshouldbeswallowedwholewithliquid,preferably

beforemealtimes.

Children:1-3mg/kgperdayindivideddoses.

Elderly Althoughthepharmacokineticsofdiclofenacarenotimpairedtoanyclinicallyrelevantextentinelderly

patients,non-steroidalanti-inflammatorydrugsshouldbeusedwithparticularcautioninsuchpatientswho

generallyaremorepronetoadversereactions.Inparticular,itisrecommendedthatthelowesteffective

dosagebeusedinfrailelderlypatientsorthosewithalowbodyweight(seesection4.4,Specialwarnings

andprecautionsforuse).Ifprolongeduseisessential,theelderlymustbekeptunderclosesurveillance.

Treatmentshouldbereviewedatregularintervalsanddiscontinuedifnobenefitisseenorintoleranceoccurs.

Undesirableeffectsmaybeminimisedbyusingthelowesteffectivedosefortheshortestdurationnecessarytocontrol

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4.3Contraindications

Knownhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Historyofgastro-intestinalbleedingorperforationrelatedtopreviousNSAID’stherapy.

Activegastricorintestinalulcer,bleedingorperforation.

Lasttrimesterofpregnancy(Seesection4.6,Pregnancyandlactation).

Severehepatic,renalorcardiacfailure(seesection4.4,Specialwarningsandprecautionsforuse).

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

whomattacksofasthma,urticaria,oracuterhinitisareprecipitatedbyacetylsalicylicacidorotherNSAID’s.

Active,orhistoryofrecurrentpepticulcer/haemorrhage(twoormoredistinctepisodesofprovenulceration).

4.4Specialwarningsandprecautionsforuse

Warnings

Theuseofdclofenacmayimpairfemalefertilityandisnotrecommendedinwomenattemptingtoconceive.Inwomen

whohavedifficultyconceivingorwhoareundergoinginvestigationofinfertility,withdrawalofdiclofenacshouldbe

considered.

TheuseofdiclofenacwithconcomitantNSAIDsincludingcyclooxygenase-2selectiveinhibitors,shouldbeavoided

duetotheabsenceofanyevidencedemonstratingsynergisticbenefitsandthepotentialforadditiveundesirableeffects.

Gastrointestinalbleeding,ulcerationorperforation:GIbleeding,ulcerationorperforation,whichcanbefatal,hasbeen

reportedwithallNSAIDsatanytimeduringtreatment,withorwithoutwarningsymptomsoraprevioushistoryof

seriousgastrointestinalevents.

WhenGIbleedingorulcerationoccursinpatientsreceivingdiclofenac,thetreatmentshouldbewithdrawn.

Seriousskinreactions,someofthemfatal,includingexfoliativedermatitis,Stevens-Johnsonsyndromeandtoxic

epidermalnecrolysis,havebeenreportedveryrarelyinassociationwiththeuseofNSAIDs,(Seesection4.8,

Undesirableeffects).

Patientsappeartobeathighestriskofthesereactionsearlyinthecourseoftherapy,theonsetofthereactionoccurring

inthemajorityofcaseswithinthefirstmonthoftreatment.Dicloshouldbediscontinuedatthefirstappearanceof

skinrash,mucosallesionsoranyothersignofhypersensitivity.

AswithotherNSAIDs,allergicreactions,includinganaphylactic/anaphylactoidreactions,canalsooccurinrarecases

withoutearlierexposuretothedrug.

LikeotherNSAIDs,diclofenacmaymaskthesignsandsymptomsofinfectionduetoitspharmacodynamicproperties.

Precautions

General

Undesirableeffectsmaybeminimisedbyusingtheminimumeffectivedosefortheshortestdurationnecessaryto

controlthesymptoms.

Elderly:TheelderlyhaveanincreasedfrequencyofadversereactionstoNSAID’sespeciallygastrointestinalbleeding

andperforationwhichmaybefatal(seesection4.2,Posologyandmethodofadministration).

Cautionisindicatedintheelderlyonbasicmedicalgrounds.Inparticular,itisrecommendedthatthelowesteffective

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Pre-existingasthma

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

pulmonarydiseasesorchronicinfectionsoftherespiratorytract(especiallyiflinkedtoallergicrhinitis-like

symptoms),reactionsonNSAIDslikeasthmaexacerbations(so-calledintolerancetoanalgesics/analgesics-asthma),

Quincke’soedemaorurticariaaremorefrequentthaninotherpatients.Therefore,specialprecautionisrecommended

insuchpatients(readinessforemergency).Thisisapplicableaswellforpatientswhoareallergictoothersubstances,

e.g.withskinreactions,pruritusorurticaria.

Cardiovascularandcerebrovasculareffects

Appropriatemonitoringandadvicearerequiredforpatientswithahistoryofhypertensionand/prmildtomoderate

congestiveheartfailureasfluidretentionandoedemahavebeenreportedinassociationwithNSAIDtherapy.

Clinicaltrialandepidemiologydatasuggestthatuseofdiclofenac,particularlyathighdose(150mgdaily)andinlong

termtreatmentmaybeassociatedwithasmallincreasedriskofarterialthromboticevents(forexamplemyocardial

infarctionorstroke).

Patientswithuncontrolledhypertension,congestiveheartfailure,establishedischaemicheartdisease,peripheral

arterialdisease,and/orcerebrovasculardiseaseshouldonlybetreatedwithdiclofenacaftercarefulconsideration.

Similarconsiderationshouldbemadebeforeinitiatinglonger-termtreatmentofpatientswithriskoffactorsfor

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

Gastrointestinaleffects

AswithallNSAIDs,closemedicalsurveillanceisimperativeandparticularcautionshouldbeexercisedwhen

prescribingdiclofenacinpatientswithsymptomsindicativeofgastrointestinal(GI)disordersorwithahistory

suggestiveofgastricorintestinalulceration,bleedingorperforation(seesection4.8,Undesirableeffects).

TheriskofGIbleeding,ulcerationorperforationishigherwithincreasingNSAIDdosesinpatientswithahistoryof

ulcer,particularlyifcomplicatedwithhaemorrhageorperforation(Seesection4.3,Contraindications)andinthe

elderly.

Thesepatientsshouldcommencetreatmentonthelowestdoseavailable.Combinationtherapywithprotectiveagents

(e.g.protonpumpinhibitorsormisoprostol)shouldbeconsideredforthesepatients,andalsoforpatientsrequiring

concomitantlow-doseacetylsalicylicacid(ASA)/aspirinorothermedicinalproductslikelytoincreasegastrointestinal

risk(seebelowandsection4.5,Interactionwithothermedicinalproductsandotherformsofinteractions).

PatientswithahistoryofGItoxicity,particularlywhenelderly,shouldreportanyunusualabdominalsymptoms

(especiallyGIbleeding)particularlyintheinitialstagesoftreatment.Cautionshouldbeadvisedinpatientsreceiving

concomitantmedicationswhichcouldincreasetheriskofulcerationorbleeding,suchasoralcorticosteroids,

anticoagulantssuchaswarfarin,anti-plateletagentssuchasaspirinorselectiveserotonin-reuptakeinhibitors(See

section4.5,Interactionwithothermedicinalproductsandotherformsofinteractions).

NSAIDsshouldbegivenwithcaretopatientswithahistoryofgastrointestinaldisease(ulcerativecolitisorCrohn’s

disease),astheirconditionmaybeexacerbated(seesection4.8,Undesirableeffects).

Hepaticeffects

Closemedicalsurveillanceisrequiredwhenprescribingdiclofenactopatientswithimpairedhepaticfunction,astheir

conditionmaybeexacerbated.

AswithotherNSAIDs,valuesofoneormoreliverenzymesmayincrease.Duringprolongedtreatmentwith

diclofenac,regularmonitoringofhepaticfunctionisindicatedasaprecautionarymeasure.Ifabnormalliverfunction

testspersistorworsen,ifclinicalsignsorsymptomsconsistentwithliverdiseasedevelop,ofifothermanifestations

occur(e.g.eosinophilia,rash),diclofenacshouldbediscontinued.Hepatitismayoccurwithoutprodromalsymptoms.

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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.Patientswithdefectsorhaemostatis

shouldbecarefullymonitored.

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactose

malabsorptionshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thefollowinginteractionsincludethoseobservedwithdiclofenacprolongedreleasetabletsand/orother

pharmaceuticalformsofdiclofenac.

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.

Concomitanttreatmentwithpotassium-sparingdrugsmaybeassociatedwithincreasedserumpotassiumlevels,which

shouldthereforebemonitoredfrequently(seesection4.4,Specialwarningsandprecautionsforuse).

OtherNSAIDsandcorticosteroids:

ConcomitantadministrationofdiclofenacandothersystemicNSAIDsorcorticosteroidsmayincreasetheriskof

gastrointestinalulcerationorbleeding(seesection4.4,Specialwarningsandprecautionsforuse).

Anticoagulants:NSAIDsmayenhancetheeffectsofanti-coagulants,suchaswarfarin(seesection4.4,Special

warningsandprecautionsforuse).Althoughclinicalinvestigationsdonotappeartoindicatethatdiclofenacaffectsthe

actionofanticoagulants,thereareisolatedreportsofanincreasedriskofhaemorrhageinpatientsreceivingdiclofenac

andanticoagulantsconcomitantly.Closemonitoringofsuchpatientsisthereforerecommended.

Anti-plateletagents:Cautionisrecommendedsinceconcomitantadministrationcouldincreasetheriskof

gastroinestinalbleeding(seesection4.4,Specialwarningsandprecautionsforuse).

Selectiveserotoninreuptakeinhibitors(SSRIs):ConcomitantadministrationofsystemicNSAIDandSSRIsmay

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Antidiabetic:Clinicalstudieshaveshownthatdiclofenaccanbegiventogetherwithoral

antidiabeticagentswithoutinfluencingtheirclinicaleffect.

However,therehavebeenisolatedreportsofbothhypoglycaemicandhyperglycaemiceffectsnecessitatingchangesin

thedosageoftheantidiabeticagentsduringtreatmentwithdiclofenac.Forthisreason,monitoringofthebloodglucose

levelisrecommendedasaprecautionarymeasureduringconcomitanttherapy.

Methotrexate:CautionisrecommendedwhenNSAIDsareadministeredlessthan24hours

beforeoraftertreatmentwithmethotrexate,sincebloodconcentrationsofmethotrexatemayriseandthetoxicityofthis

substancebeincreased.

Ciclosporin:Diclofenac,likeotherNSAIDs,mayincreasethenephrotoxicityofciclosporinduetoeffectonrenal

prostaglandins.Therefore,itshouldbegivenatdoseslowerthanthosethatwouldbeusedinpatientsnotreceiving

ciclosporin.

Quinoloneantimicrobials:Therehavebeenisolatedreportsofconvulsionswhichmayhavebeenduetoconcomitant

useofquinolonesandNSAIDs.

Cardiacglycosides:NSAIDsmayexacerbatecardiacfailure,reduceGFRandincreaseplasmacardiacglycoside

levels.

Aminoglycosides:reductioninrenalfunctioninsusceptibleindividuals,decreasedeliminationofaminoglycosideand

increasedplasmaconcentrations.

Probenecid:reductioninmetabolismandeliminationofNSAIDandmetabolites.

4.6Pregnancyandlactation

Pregnancy

Theuseofdiclofenacinpregnantwomenhasnotbeenstudied.Therefore,diclofenacshouldnotbeusedduringthe

firsttwotrimestersofpregnancyunlessthepotentialbenefittothemotheroutweighstherisktothefoetus.Aswith

otherNSAIDs,useduringthethirdtrimesterofpregnancyiscontraindicatedowingtothepossibilityofuterineinertia

and/orprematureclosureoftheductusarteriosus(Seesection4.3,Contraindications).Animalstudieshavenotshown

anydirectlyorindirectlyharmfuleffectsonpregnancy,embryonal/fetaldevelopment,parturitionorpostnatal

development(seesection5.3,Preclinicalsafetydata).

Lactation

LikeanyotherNSAIDs,diclofenacpassesintothebreastmilkinsmallamounts.Therefore,diclofenacshouldnotbe

administeredduringbreastfeedinginordertoavoidundesirableeffectsintheinfant.

Fertility

AswithotherNSAIDs,theuseofdiclofenacmayimpairfemalefertilityandisnotrecommendedinwomenattempting

toconceive.Inwomenwhohavedifficultiesconceivingorwhoareundergoinginvestigationofinfertility,withdrawal

ofdiclofenacshouldbeconsidered.

4.7Effectsonabilitytodriveandusemachines

Patientsexperiencingvisualdisturbances,dizziness,vertigo,somnolenceorothercentralnervoussystemdisturbances

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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(includinghaemolyticandaplasticanaemia),agranulocytosis

Immunesystemdisorders

Rare: Hypersensitivity,anaphylacticandanaphylactoidreactions(includinghypotensionand

shock)

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[224]

Eyedisorders

Veryrare: Visualdisturbance,visionblurred,diplopia

Earandlabyrinthdisorders

Common: Vertigo

Veryrare: Tinnitus,hearingimpaired

Cardiacdisorders

Oedema,hypertensionandcardiacfailurehavebeenreportedinassociationwithNSAIDtreatment.Clinicaltrailand

epidemiologicaldatesuggestthatuseofdiclofenacparticularlyathighdoses(150mgdaily)andinlongtermtreatment

maybeassociatedwithasmallincreasedriskofarterialthromboticevents(forexamplemyocardialinfarctionor

stroke)(seesection4.4,Specialwarningsandprecautionsforuse)

Vasculardisorders

Veryrare: Hypertension,vasculitis

Respiratory,thoracicandmediastinaldisorders

Rare: Asthma(includingdyspnoea)

Veryrare: Pneumonitis

Gastrointestinaldisorders

Themostcommonlyobservedadverseeventsaregastrointestinalinnature.

Pepticulcers,perforationofGIbleeding,sometimesfatal,particularlyintheelderly,mayoccur(seesection4.4,

Specialwarningsandprecautionsforuse).Nausea,vomiting,diarrhea,flatulence,constipation,dyspepsia,abdominal

pain,melaena,haematemesis,ulcerativestomatitis,exacerbationofcolitisandCrohn’sdisease(seesection4.4,Special

warningsandprecautionsforuse)havebeenreportedfollowingadministration.

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Hepatobiliarydisorders

Common: Transaminasesincreased

Rare: Hepatitis,jaundice,liverdisorder

Veryrare: Fulminanthepatitis

Skinandsubcutaneoustissuedisorders

Common: Rash

Rare: Urticaria

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

Johnsonsyndrome,toxicepidermalnecrolysis(Lyell’ssyndrome),dermatitisexfoliative,lossofhair,

photosensitivityreaction,purpura,allergicpurpura,pruritus

Renalandurinarydisorders

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

necrosis

Generaldisordersandadministrationsiteconditions

Rare: Oedema

4.9Overdose

Symptoms:

Thereisnotypicalclinicalpictureresultingfromdiclofenacoverdosage.Overdosagecancausesymptomssuchas

vomiting,gastrointestinalhaemorrhage,diarrhoea,dizziness,tinnitusorconvulsions.Intheeventofsignificant

poisoning,acuterenalfailureandliverdamagearepossible.

Therapeuticmeasures:

ManagementofacutepoisoningwithNSAIDsessentiallyconsistsofsupportivemeasuresandsymptomatictreatment.

Supportivemeasuresandsymptomatictreatmentshouldbegivenforcomplicationssuchashypotension,renalfailure,

convulsions,gastrointestinaldisorder,andrespiratorydepression.

Specialmeasuressuchasforceddiuresis,dialysisorhaemoperfusionareprobablyofnohelpineliminatingNSAIDs

duetothehighproteinbindingandextensivemetabolism.

Activatedcharcoalmaybeconsideredafteringestionofapotentiallytoxicoverdose,andgastricdecontamination(e.g.

vomiting,gastriclavage)afteringestionofapotentiallylife-threateningoverdose.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup(ATCcode):

Anti-inflammatoryandanti-rheumaticproduct,non-steroid(M01AB05)

Diclofenacisanon-steroidalanti-inflammatoryanalgesicagent.Itisaninhibitorofprostaglandinsynthetase(cyclo-

oxygenase).Diclofenacinvitrodoesnotsuppressproteoglycanbiosynthesisincartilageatconcentrationsequivalentto

theconcentrationreachedinhumans.

5.2Pharmacokineticproperties

Diclofenacisrapidlyabsorbedfromthegutandissubjecttofirst-passmetabolism.Peakplasmaconcentrationsoccur

1-4hoursafteringestionoftablets.Theactivesubstanceis99.7%proteinboundandplasmahalf-lifefortheterminal

eliminationphaseis1-2hours.Approximately60%oftheadministereddoseisexcretedviathekidneysintheform

ofmetabolitesandlessthan1%inunchangedform.Theremainderofthedoseisexcretedviathebileinmetabolised

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5.3Preclinicalsafetydata

Preclinicaldatafromacuteandrepeateddosetoxicitystudies,aswellasfromgenotoxicity,mutagenicity,and

carcinogenicitystudieswithdiclofenacrevealednospecifichazardforhumansattheintendedtherapeuticdoses.

Therewasnoevidencethatdiclofenachadateratogenicpotentialinmice,ratsorrabbits.

Diclofenachadnoinfluenceonthefertilityofparentanimalsinrats.Theprenatal,perinatalandpostnatal

developmentoftheoffspringwasnotaffected.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Core:

LactoseMonohydrate

MaizeStarch

Povidone

SodiumStarchGlycollate(TypeA)

ColloidalAnhydrousSilica

MagnesiumStearate

Coating:

Hypromellose

CitricAcidMonohydrate

Methacrylicacidcopolymer

PurifiedTalc

Macrogol6000

Colours:

SunsetYellow(E110)

Titaniumdioxide(E171)

Ironoxideredandyellow(E172)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

6.5Natureandcontentsofcontainer

PVCcoatedPVCfilmwithhardtemperaluminiumfoilblisterstripsof10,20,28,30,56,60or100tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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7MARKETINGAUTHORISATIONHOLDER

PinewoodLaboratoriesLimited

Tradingas:

PinewoodHealthcare

Ballymacarbry

Clonmel

Co.Tipperary

8MARKETINGAUTHORISATIONNUMBER

PA0281/085/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 28November1991

Dateoflastrenewal: 22March2004

10DATEOFREVISIONOFTHETEXT

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