CAMPRAL EC

Main information

  • Trade name:
  • CAMPRAL EC
  • Dosage:
  • 333 Milligram
  • Pharmaceutical form:
  • Tablets Gastro-Resistant
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CAMPRAL EC
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1328/073/001
  • Authorization date:
  • 30-03-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995

MEDICINALPRODUCTS(LICENSINGANDSALE)REGULATIONS,1998

(S.I.No.142of1998)

PPA1328/073/001

CaseNo:2029776

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrants

B&SHealthcare

Unit4,BradfieldRoad,Ruislip,Middlesex,HA40NU,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

CampralEC333mgGastro-ResistantTablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjectto

thegeneralconditionsasmaybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom30/03/2007until29/03/2012.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 12/04/2007 CRN 2029776 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CampralEC333mgGastro-resistanttablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgastro-resistanttabletcontains333.0mgacamprosatecalcium.

Forafulllistofexcipientsseesection6.1.

3PHARMACEUTICALFORM

Gastro-resistanttablet

ProductimportedfromTheNetherlandsandPortugal:

Whitecoatedgastro-resistanttabletmarkedwith‘333’ononeside

4CLINICALPARTICULARS

4.1TherapeuticIndications

CampralECisindicatedastherapytomaintainabstinenceinalcoholdependentpatients.Itshouldbecombinedwith

counselling.

4.2Posologyandmethodofadministration

Adults:

Withintheagerange18-65years:

§Subjectsweighing60kgormore:

2tabletsthreetimesdailywithmeals(2tabletsmorning,noonandnight).

§Subjectsweighinglessthan60kg:

4tabletsdividedintothreedailydoseswithmeals(2tabletsinthemorning,1atnoon,1atnight).

ChildrenandtheElderly:

CampralECshouldnotbeadministeredtochildrenandtheelderly.

Therecommendedtreatmentperiodisoneyear.TreatmentwithCampralECshouldbeinitiatedassoonaspossible

afterthewithdrawalperiodandshouldbemaintainedifthepatientrelapses.

4.3Contraindications

−inpatientswithaknownhypersensitivitytothedrug

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−incasesofrenalinsufficiency(serumcreatinine>120micromol/L)

−incaseswithseverehepaticfailure(Childs-PughClassificationC)

4.4Specialwarningsandprecautionsforuse

CampralECdoesnotconstitutetreatmentforthewithdrawalperiod.

Theprescriptionoftheproductshouldbeinitiatedunderthedirectsupervisionofaconsultantoraclinician

experiencedinthefield,workinginahospitalbasedclinicoranalcoholtreatmentunit.Generalpractitionerswithan

interestintreatingalcoholdependentpatientsareallowedtoinitiateand/orpursueCampraltreatment.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

TheconcomitantintakeofalcoholandCampralECdoesnotaffectthepharmacokineticsofeitheralcoholor

acamprosate.AdministeringCampralECwithfooddiminishesthebioavailabilityofthedrugcomparedwithits

administrationinthefastingstate.Pharmacokineticstudieshavebeencompletedandshownointeractionbetween

acamprosateanddiazepam,disulfiramorimipramine.Thereisnoinformationavailableontheconcomitant

administrationofCampralECwithdiuretics.

4.6Pregnancyandlactation

Althoughanimalstudieshavenotshownanyevidenceoffoetotoxicityorteratogenicity,thesafetyofacamprosatehas

notbeenestablishedinpregnantwomen.Acamprosateisexcretedinthemilkoflactatinganimalsandsafeusehasnot

beendemonstratedinlactatingwomen.CampralECthereforeshouldnotbeadministeredtopregnantortobreast

feedingwomen.

4.7Effectsonabilitytodriveandusemachines

CampralECshouldnotimpairthepatient'sabilitytodriveoroperatemachinery.

4.8Undesirableeffects

AdverseeventsassociatedwithCampralECtendtobemildandtransientinnature.Theyare

predominantlygastrointestinalordermatological.Diarrhoea,andlessfrequentlynausea,vomitingand

abdominalpainarethegastrointestinaladverseevents.Pruritusisthepredominantdermatological

adverseevent.Anoccasionalmaculopapularrashandrarecasesofbullousskinreactionshavebeen

reported.FluctuationinlibidohasbeenreportedbypatientsreceivingCampralECaswellasby

patientsreceivingtheplacebo.

Asthisproductrepresentsanovelchemicalentity,anysuspectedadverseevents/reactionsshouldbereportedtothe

companyandtheIrishMedicinesBoardintheusualway.

4.9Overdose

Fivecasesofoverdoseassociatedwithacamprosatetherapyhavebeenreportedinhumans,includingonepatientwho

ingested43g.Aftergastriclavageallpatientshadanuneventfulrecovery.Diarrhoeawasobservedintwocases.No

caseofhypercalaemiawasreportedinthecourseoftheseoverdoses.However,shouldthisoccur,thepatientsshouldbe

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Acamprosatecalcium(calciumacetylhomotaurinate)hasachemicalstructuresimilartothatofamino

acidneurotransmitters,suchastaurineorgamma-amino-butyricacid(GABA),includingan

acetylationtopermitpassageacrossthebloodbrainbarrier.Acamprosatemayactbystimulating

GABAergicinhibitoryneurotransmissionandantagonisingexcitatoryamino-acids,particularly

glutamicacid.

Animalexperimentalstudieshavedemonstratedthatacamprosateaffectsalcoholdependenceinrats,decreasingthe

voluntaryintakeofalcoholwithoutaffectingfoodandtotalfluidintake.

5.2Pharmacokineticproperties

Acamprosateabsorptionacrossthegastrointestinaltractismoderate,slowandsustainedandvaries

substantiallyfrompersontoperson.

Oralabsorptionshowsconsiderablevariabilityandisusuallylessthan10%oftheingesteddruginthe

first24hours.Foodreducestheoralabsorptionofacamprosate.Steadystatelevelsofacamprosateare

achievedbytheseventhdayofdosing.Acamprosateisnotproteinbound.

Thedrugisexcretedintheurineandisnotsignificantlymetabolised.Thereisalinearrelationshipbetweencreatinine

clearancevaluesandtotalapparentplasmaclearance,renalclearanceandplasmahalf-lifeofacamprosate.The

pharmacokineticsofacamprosatearenotalteredbyhepaticdysfunction.

5.3Preclinicalsafetydata

Inpreclinicalstudies,signsoftoxicityarerelatedtotheexcessiveintakeofcalciumandnot

acetylhomotaurine.Disordersofphosphorus/calciummetabolismhavebeenobservedincluding

diarrhoea,softtissuecalcification,renalandcardiaclesions.

Therewerenomutagenicorcarcinogeniceffects,noranyteratogenicoradverseaffectsonthemaleor

femalereproductivesystemsofanimals.

Detailedinvitroandinvivoresearchonacamprosatetodetectgeneticandchromosomalmutationshasnotproduced

anyevidenceofpotentialgenetictoxicity.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Crospovidone

Microcrystallinecellulose

Magnesiumsilicate

Sodiumstarchglycolate

Anhydrouscolloidalsilica

Magnesiumstearate

Anioniccopolymermethacrylicacidandacrylicacidethylester

Talc

Propyleneglycol

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Notapplicable

6.3ShelfLife

Theshelf-lifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

PVC/PVDCaluminiumsheetsofblisterscontaining12tablets.Sheetsofblistersarepresentedincartonsof60or84

tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerials

derivedfromsuchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7ParallelProductAuthorisationHolder

B&SHealthcare

Unit4

BradfieldRoad

Ruislip

MiddlesexHA40NU

UnitedKingdom

8ParallelProductAuthorisationNumber

PPA1328/73/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation30 th

March2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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