CAPRIN 300 MG TABLETS

Main information

  • Trade name:
  • CAPRIN 300 MG TABLETS
  • Dosage:
  • 300 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CAPRIN 300 MG TABLETS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0281/130/002
  • Authorization date:
  • 12-05-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0281/130/002

CaseNo:2035464

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

PinewoodLaboratoriesLtd

Ballymacarbry,Clonmel,Co.Tipperary,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Caprin300mgTablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom20/01/2009until22/06/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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Date Printed 20/01/2009 CRN 2035464 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Caprin300mgTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains300mgofAcetylsalicylicAcid(Aspirin)Ph.Eur.

3PHARMACEUTICALFORM

Gastro-resistanttablets

4CLINICALPARTICULARS

4.1TherapeuticIndications

Caprin300mgisanantipyretic,anti-inflammatoryandanalgesicagentdesignedtoreducethegastricside-effectsof

aspirininrheumatoidarthritisandinconditionsrequiringcontinuedmanagementwithaspirin.

Caprin300mgmayalsobeusedtoreducetheriskofmyocardialinfarctioninpatientswithunstableanginaorin

patientswithaprevioushistoryofmyocardialinfarction.

4.2Posologyandmethodofadministration

ANALGESIC,ANTI-INFLAMMATORY,ANTIPYRETIC,

Adults(includingtheelderly)andchildrenover16years:

3tablets(900mg)3-4timesdailyasrequired.

Childrenandadolescentsunder16years

Donotgivetochildrenandadolescentsunder16years,exceptonmedicaladvice,wherethebenefitoutweighstherisk.

ANTITHROMBOTICEFFECT

Toreducetheriskofmyocardialinfarction.

Onetabletdaily.

Elderly:Non-steroidalanti-inflammatorydrugsshouldbeusedwith

particularcautioninelderlypatientswhoaremorepronetoadverseevents.

Thelowestdosecompatiblewithadequatesafeclinicalcontrolshouldbe

employed,SeealsoSection4.4..

Routeofadministration-oral.

Caprin300mgtabletsmustnotbechewedorcrushed.

Thetabletsarebesttakenbeforemeals.

Undesirableeffectsmaybeminimisedbyusingthelowesteffectivedosefortheshortestdurationnecessarytocontrol

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4.3Contraindications

Historyofgastrointestinalbleedingorperforation,relatedtopreviousNSAIDstherapy.Active,orhistoryofrecurrent

pepticulcer/haemorrhage(twoormoredistinctepisodesofprovenulcerationorbleeding).

Severeheartfailure

Hypersensitivity(e.g.bronchospasm,rhinitis,urticaria)toaspirinortoothernon-steroidalanti-inflammatorydrugs.

Coagulationdeficiencydisorders.

4.4Specialwarningsandprecautionsforuse

TheuseofCaprinwithconcomitantNSAIDsincludingcyclooxygenase-2selectiveinhibitorsshouldbeavoided.

Elderly:TheelderlyhaveanincreasedfrequencyofadversereactionstoNSAIDsespeciallygastrointestinalbleeding

andperforationwhichmaybefatal(Seesection4.2).

Gastrointestinalbleeding,ulcerationandperforation:GIbleeding,ulcerationorperforation,whichcanbefatal,has

beenreportedwithallNSAIDsatanytimeduringtreatment,withorwithoutwarningsymptomsoraprevioushistoryof

seriousGIevents.

TheriskofGIbleeding,ulcerationorperforationishigherwithincreasingNSAIDdoses,inpatientswithahistoryof

ulcer,particularlyifcomplicatedwithhaemorrhageorperforation(Seesection4.3),andintheelderly.Thesepatients

shouldcommencetreatmentonthelowestdoseavailable.Combinationtherapywithprotectiveagents(e.g.misoprostol

orprotonpumpinhibitors)shouldbeconsideredforthesepatients,andalsoforpatientsrequiringconcomitantlowdose

aspirin,orotherdrugslikelytoincreasegastrointestinalrisk(Seebelowand4.5).

PatientswithahistoryofGItoxicity,particularlywhenelderly,shouldreportanyunusualabdominalsymptoms

(especiallyGIbleeding)particularlyintheinitialstagesoftreatment.

Cautionshouldbeadvisedinpatientsreceivingconcomitantmedicationswhichcouldincreasetheriskofulcerationor

bleeding,suchasoralcorticosteroids,anticoagulantssuchaswarfarin,selectiveserotonin-reuptakeinhibitorsoranti-

plateletagents(Seesection4.5).

WhenGIbleedingorulcerationoccursinpatientsreceivingCaprin,thetreatmentshouldbewithdrawn.

NSAIDsshouldbegivenwithcaretopatientswithahistoryofgastrointestinaldisease(ulcerativecolitis,Crohn’s

disease)astheirconditionmaybeexacerbated(Seesection4.8–undesirableeffects).

Seriousskinreactions,someofthemfatal,includingexfoliativedermatitis,Stevens-Johnsonsyndrome,andtoxic

epidermalnecrolysis,havebeenreportedveryrarelyinassociationwiththeuseofNSAIDSs(see4.8).Patientsappear

tobeathighestriskofthesereactionsearlyinthecourseoftherapy,theonsetofthereactionoccurringinthemajority

ofcaseswithinthefirstmonthoftreatment.Caprinshouldbediscontinuedatthefirstappearanceofskinrash,mucosal

lesions,oranyothersignofhypersensitivity.

Undesirableeffectsmaybeminimisedbyusingthelowesteffectivedosefortheshortestdurationnecessarytocontrol

symptoms(seesection4.2,andGIandcardiovascularrisksbelow).

Cardiovascularandcerebrovasulareffects

Appropriatemonitoringandadvicearerequiredforpatientswithahistoryofhypertensionand/ormildtomoderate

congestiveheartfailureasfluidretentionandoedemahavebeenreportedinassociationwithNSAIDtherapy.

ClinicaltrialandepidemiologydatasuggestthatuseofsomeNSAIDs(particularlyathighdosesandinlongterm

treatment)maybeassociatedwithasmallincreasedriskofarterialthromboticevents(forexamplemyocardial

infarctionorstroke).Thereareinsufficientdatatoexcludesuchariskforaspirin.

Patientswithuncontrolledhypertension,congestiveheartfailure,establishedischaemicheartdisease,peripheral

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considerationshouldbemadebeforeinitiatinglonger-termtreatmentofpatientswithriskfactorsforcardiovascular

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

ThereisapossibleassociationbetweenaspirinandReye’ssyndromewhengiventochildren.Reye’ssyndromeisa

veryraredisease,whichaffectsthebrainandliverandcanbefatal.Forthisreasonaspirinshouldnotbegivento

childrenandadolescentsagedunder16yearsunlessspecificallyindicated.

Thisproductshouldbetakenonlywhennecessary.Prolongeduseexceptonmedicaladvicecanbeharmful.

Thedoctorshouldbeconsultedifthereisnoimprovementin24hours.

Ifthepatientisonanymedicationconsultthedoctororpharmacistbeforeusing.

Ifthepatientsuffersfromasthma,hasrenalorhepaticimpairment,orinflammatoryboweldiseasethenadoctorshould

beconsultedbeforetakingtheproduct.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Corticosteroids:increasedriskofgastrointestinalulcerationorbleeding(Seesection4.4)

Anti-coagulants:NSAIDsmayenhancetheeffectsofanti-coagulants,suchaswarfarin(Seesection4.4).

Anti-plateletagentsandselectiveserotoninreuptakeinhibitors(SSRIs):increasedriskofgastrointestinalbleeding(See

section4.4).

Careshouldbetakeninpatientstreatedwithanyofthefollowingdrugsasinteractionshavebeenreported:

Antihypertensives:reducedantihypertensiveeffect.

Diuretics:reduceddiureticeffect.DiureticscanincreasetheriskofnephrotoxicityofNSAIDs.

Cardiacglycosides:NSAIDsmayexacerbatecardiacfailure,reduceGFRandincreaseplasmacardiacglycosidelevels.

Lithium:decreasedeliminationoflithium.

Methotrexate:decreasedeliminationofmethotrexate.

Cyclosporin:increasedriskofnephrotoxicitywithNSAIDs.

OtherNSAIDs:avoidconcomitantuseoftwoormoreNSAIDs.

Aminoglycosides:reductioninrenalfunctioninsusceptibleindividuals,decreasedeliminationofaminoglycosideand

increasedplasmaconcentrations.

Probenecid:reductioninmetabolismandeliminationofNSAIDandmetabolites.Oralhypoglycaemicagents:

inhibitionofmetabolismofsulphonylureadrugs,prolongedhalf-lifeandincreasedriskofhypoglycaemia.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.However,thelimitationsofthesedataandtheuncertaintiesregardingextrapolationofexvivo

datatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofenuse,andnoclinically

relevanteffectisconsideredtobelikelyforoccasionalibuprofenuse(seesection5.1).

4.6Pregnancyandlactation

Cautionshouldbeusedinprescribingaspirinforuseduringpregnancyandlactationandisbestavoidedatterm.

Aspirinmayprolonglabourandcontributetomaternalandneonatalbleeding.Thedrugisexcretedintobreastmilk.

4.7Effectsonabilitytodriveandusemachines

Aspirindoesnotusuallyaffecttheabilitytodriveoroperatemachinery.

4.8Undesirableeffects

Gastrointestinal:Themostcommonlyobservedadverseeventsaregastrointestinalinnature.Pepticulcers,perforation

orGIbleeding,sometimesfatal,particularlyintheelderly,mayoccur(Seesection4.4).Nausea,vomiting,diarrhoea,

flatulence,constipation,dyspepsia,abdominalpain,melaena,haematemesis,ulcerativestomatitis,exacerbationof

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administration.Lessfrequently,gastritishasbeenobserved.

Oedema,hypertensionandcardiacfailurehavebeenreportedinassociationwithNSAIDtreatment.

BullousreactionsincludingStevens-Johnsonsyndromeandtoxicepidermalnecrolysis(veryrare).

ClinicaltrialandepidemiologicaldatasuggestthatuseofsomeNSAIDs(particularlyathighdosesandinlongterm

treatment)maybeassociatedwithasmallincreasedriskofarterialthromboticevents(forexamplemyocardial

infarctionorstroke)(seesection4.4).

Aspirinmayprecipitatebronchospasm,andinduceattacksofasthmainsusceptiblesubjects.

4.9Overdose

Overdosageproducesdizziness,tinnitus,sweating,nauseaandvomiting,confusionandhyperventilation.Gross

overdosagemayleadtoCNSdepressionwithcoma,cardiovascularcollapseandrespiratorydepression.

Overdosageshouldbetreatedinitiallybyaspirationandlavageandasalinepurgativesuchassodiumsulphate,30gin

250mlofwatershouldbegiventopromoteperistalsis.Otherwisetreatasforaspirinpoisoning,andobserveforatleast

72hourstoallowforpossibledelayedreleasefromtheenteric-coatedsystem.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Aspirinisananalgesicandantipyreticwithanti-inflammatoryproperties.

Aspirininhibitsprostaglandinsynthetase.

Aspirininhibitsplateletaggregation.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.Inonestudy,whenasingledoseofibuprofen400mgwastakenwithin8hbeforeorwithin

30minafterimmediatereleaseaspirindosing(81mg),adecreasedeffectofASAontheformationofthromboxaneor

plateletaggregationoccurred.However,thelimitationsofthesedataandtheuncertaintiesregardingextrapolationofex

vivodatatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofenuse,andno

clinicallyrelevanteffectisconsideredtobelikelyforoccasionalibuprofenuse.

5.2Pharmacokineticproperties

Aspirinisreadilyabsorbedfromthegutandrapidlydistributedtoallbodytissues.Aspirinisexcretedintobreastmilk

andcrossestheplacenta.Proteinbindingisextensive.TherateofexcretionvarieswithurinarypH,increasingas

urinarypHrises.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

PregelatinisedMaizeStarch

ColloidalAnhydrousSilica

ZincStearate

MicrocrystallineCellulose

TitaniumDioxide

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MethacrylicAcidCopolymerTypeC

TriethylCitrate

PurifiedTalc

Macrogol6000

ColorconBlackInkS-1-27794consistingof:

ShellacGlaze

BlackIronOxide(E172)

n-ButylAlcohol

IsopropylAlcohol

PropyleneGlycol

IndustrialMethylatedSpirit

6.2Incompatibilities

Noneknown.

6.3ShelfLife

24months.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

C.Keepthecontainertightlyclosed.

6.5Natureandcontentsofcontainer

35x82mmwhitepolypropylenesecuritainerandcap,100pack.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialinstructions.

7MARKETINGAUTHORISATIONHOLDER

PinewoodLaboratoriesLimited

Ballymacarbry

Clonmel

Co.Tipperary

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA281/130/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:03February1987

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10DATEOFREVISIONOFTHETEXT

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