CAPOTEN 25 Milligram Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
CAPTOPRIL
Available from:
B & S Healthcare
INN (International Name):
CAPTOPRIL
Dosage:
25 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization number:
PPA1328/056/002
Authorization date:
0000-00-00

PackageLeaflet:Informationfortheuser

CAPOTEN ® 25mgTABLETS

(captopril)

Pleasereadthisleafletcarefullybeforeyoustart

takingyourmedicine.

Thisleafletprovidesasummaryoftheinformation

availableonyourmedicine.

Thismedicinehasbeenprescribedforyou.Donot

passitonto others.Itmayharmthem, eveniftheir

symptomsarethesameasyours.

Ifyouwantto knowmoreorarenotsure,askyour

doctororpharmacist.

ThenameofyourmedicineisCapoten25mgTabletsbutwill

bereferredtoasCapotenthroughoutthisleaflet.

Inthisleaflet:

1.WhatCapotenisandwhatitisusedfor

2.BeforeyoutakeCapoten

3.Takingyourmedicine

4.Possiblesideeffects

5.Howtostoreyourmedicine

6.Furtherinformation

1.WhatCapotenisandwhatitisusedfor

ThenameofthismedicineisCapoten.Eachtabletcontains

captopril(25mg)astheactiveingredient.

CapotenbelongstothegroupofmedicinescalledAngiotensin

ConvertingEnzyme(ACE)Inhibitors.ACEinhibitorsworkby

helpingtowidenyourbloodvessels,whichthenmakeit

easierforyourhearttopumpbloodthroughthem.

Capotenisusedtotreathighbloodpressureandcertain

heartconditions.Ifhighbloodpressureisleftuncontrolledit

canincreasetheriskofheartdiseaseorstroke.Capoten

worksbyloweringyourbloodpressurewhichreducesthis

risk.

Capotencanalsohelppeoplewhoseheartnolongerpumps

bloodaswellasitoncedid.Thisconditionisknownasheart

failure.

Capotenmayalsobeusedtotreatpatientswhorecently

sufferedaheartattack.Aheartattackhappensonceoneof

themajorbloodvesselssupplyingbloodtotheheartmuscle

becomesblocked.Thismeansthattheheartdoesnotreceive

theoxygenitneedsandtheheartmusclebecomesdamaged.

Inaddition,Capotencanbeusedforthetreatmentofkidney

diseaseinpatientswithdiabetes.

2.BeforeyoutakeCapoten

DonottakeCapotenifyou:

Aremorethan3monthspregnant.(Itisalsobettertoavoid

Capoteninearlypregnancy–seepregnancysection.),

Haveeverhadanallergicreactiontoanyingredientsof

Capotenortoanyothermedicines,includingotherACE

inhibitors,

Haveeverhadareactionwhichincludedswellingofthe

hands,lips,faceortonguewherethecausewasunknown,

Sufferfromanyauto-immunedisease(e.g.rheumatoid

arthritis,systemiclupuserythematosusorscleroderma).

Ifanyoftheaboveaffectsyou,oryouareunsureiftheydo,

tellyourdoctorwhowillbeabletoadviseyou.

TakespecialcarewithCapoten

Youmusttellyourdoctorifyou:

Thinkyouare(ormightbecome)pregnant.Capotenisnot

recommendedinearlypregnancy,andmustnotbetakenif

youaremorethan3monthspregnant,asitmaycause

seriousharmtoyourbabyifusedatthatstage(see

pregnancysection).

Sufferfromkidneydisease,

Sufferfromliverdisease,

Areundergoingdialysis,

Sufferfromheartdisease,inparticularproblemswiththe

valvesoftheheart,

Havediabetes,

Haverecentlysufferedfromexcessivevomitingor

diarrhoea,

Arereceivingimmuno-suppressanttherapy.

Ifyouaretohavedesensitisationtreatmentforwasporbee

stingsyoushouldtellthedoctorwhoistreatingyouthatyou

Ifyouareabouttohavetreatmentfortheremovalof

cholesterolfromyourbloodbyamachine,(calledLDL

apheresis)youshouldtellyourdoctoryouaretaking

Capoten.

TellyourdoctoryouaretakingCapotentabletsbeforeyou

haveanybloodorurinetestsasCapotentabletsmay

interferewiththeresultsofsometests.

SomeAfro-Caribbeanpatientsmayrequirehigherdosesof

Capotentoobtainanadequatereductioninbloodpressure.

TakingCapotenwithothermedicines

Pleasetellyourdoctororpharmacistifyouaretakingorhave

recentlytakenanyothermedicines,includingmedicines

obtainedwithoutaprescription.Itisespeciallyimportantto

tellyourdoctorifyouaretakinganyofthefollowing:

Nonsteroidalanti-inflammatorypainkillersNSAIDs(e.g.

indometacin,ibuprofen),

Immunosuppressants(e.g.azathioprineand

cyclophosphamide),

Potassiumsupplements,saltsubstitutescontaining

potassiumoranyothermedicineswhichcanincrease

potassiuminyourbody,e.g.(amiloride,spironolactone),

Watertablets(diuretics),

Medicinesforgout(e.g.allopurinol),

Medicinesfordiabetes(astheamountyouneedtouse

mayhavetobechangedwhiletakingCapoten),

Medicinesthatcausedilationofthebloodvessels(e.g.

minoxidil,clonidine),

Medicinestotreatmental healthproblemsincluding

depression(suchaslithiumoramitriptyline),

Anyothermedicinestotreathighbloodpressure(e.g.

beta-blockerssuchaspropanolol,atenololorcalcium

channelblockerssuchasamlodipine,nifedipine),

Anymedicinethatmaybeusedduringandafteraheart

attack.

Pregnancyandbreast-feeding

Pregnancy

Youmusttellyourdoctorifyouthinkyouare(ormight

become)pregnant.Yourdoctorwillnormallyadviseyouto

stoptakingCapotenbeforeyoubecomepregnantorassoon

asyouknowyouarepregnantandwilladviseyoutotake

anothermedicineinsteadofCapoten.Capotenisnot

recommendedinearlypregnancy,andmustnotbetaken

whenmorethan3monthspregnant,asitmaycauseserious

harmtoyourbabyifusedafterthethirdmonthofpregnancy.

Breast-feeding

Tellyourdoctorifyouarebreast-feedingorabouttostart

breast-feeding.Breast-feedingnewbornbabies(firstfew

weeksafterbirth),andespeciallyprematurebabies,isnot

recommendedwhilsttakingCapoten.

Inthecaseofanolderbabyyourdoctorshouldadviseyouon

thebenefitsandrisksoftakingCapotenwhilstbreast-

feeding,comparedwithothertreatments.

Ifyouareduetohavesurgery

Beforesurgeryandanaesthesia(evenatthedentist)you

shouldtellyourdoctorordentistthatyouaretakingCapoten

astheremaybeasuddenfallinyourbloodpressure.

TakingwithFoodorDrink

Capotencanbetakenwithorwithoutfood.

ModerateamountsofalcoholwillnotaffectCapoten,

however,youshouldcheckwithyourdoctorfirsttoseeif

drinkingisadvisableforyou.

Drivingoroperatingmachinery

Capotencanaffectyourabilitytodrive,usuallywhenyoufirst

starttakingyourmedicineorifyourdoctorchangesyour

dose.Ifyoudofeellight-headedordizzywhentaking

Capoten,youshouldnotdriveorusemachinery.

Important informationabout someofthe

ingredientsinCapoten

Capotencontains25mglactosewhichisatypeofsugar.If

youhavebeentoldbyyourdoctorthatyouhavean

intolerancetosomesugars,contactyourdoctorbeforetaking

thismedicinalproduct.

3.Takingyourmedicine

TakeCapotenasinstructed.Yourpharmacistmayalsohelpif

youarenotsure.

Theusualdosesare:

Forthetreatmentofhighbloodpressure

Theusualstartingdoseis12.5-25mgtwiceaday.Your

doctormaygraduallyincreasethisdoseto100-150mga

day.Youmayalsoneedtobegivenothermedicinestolower

yourbloodpressure.

Olderpatientsandthosewithkidneyproblemsmaybegiven

alowerstartingdose.

Inheartfailure

Theusualstartingdoseis6.25–12.5mgtwoorthreetimesa

day.Yourdoctormaygraduallyincreasethisdosetoa

maximumof150mgaday.

Afteraheartattack

Theusualstartingdoseis6.25mg,whichwillthenbe

increasedbyyourdoctortoamaximumof150mgaday.

Forthetreatmentofdiabeticpatientswithkidneydisease

Theusualdoseis75-100mgaday.

Forchildren

Thestartingdoseis0.3mg/kgbodyweight,whichmaybe

increasedgraduallybythedoctor.

Forchildrenwithkidneyproblems,prematurebabiesand

newbornbabiesandinfants

Thestartingdoseshouldbe0.15mg/kgbodyweight.

Doctorssometimesprescribedifferentdosestotheaboveand

ifthisappliestoyou,youshoulddiscussitwithyourdoctor.

Sometimespatientsmayfeeldizzyaftertakingthefirstone

ortwodosesofCapoten.Ifthishappenstoyou,liedown

untilthesesymptomsdisappear

YoushouldtrytotakeCapotenataboutthesametimeeach

morning.Itcanbetakenbefore,duringoraftermeals.

EvenifyoufeelwellcontinuetotakeCapotenuntilyour

doctortellsyouotherwise.

IfyoutakemoreCapotenthanyoushould

Ifyouoranyoneelsetakestoomanytabletsyoushouldgo

toyournearesthospitalemergencydepartmentortellyour

doctorimmediately.Takethecartonandanyremaining

tabletsyouhavewithyou.

IfyouforgettotakeCapoten

Ifyoumissadosedonotworry.Justcarryontakingyour

normaldosewhenthenextoneisdue.

Donottakeadoubledosetomakeupfortheoneyou

missed.

Ifyouhaveanyfurtherquestionsontheuseofthisproduct,

askyourdoctororpharmacist.

4.Possiblesideeffects

Likeallmedicines,Capotenmaycausesomeunwantedside

effectsalthoughnoteverybodygetsthem.

Ifyouexperienceanyofthefollowingreactionsstoptaking

Capotenandcontactyourdoctorimmediately:

Swellingofthehands,face,lipsortongue

Difficultyinbreathing,

Asudden,unexpectedrashorburning,redorpeeling

skin,

Sorethroatorfever,

Severedizzinessorfainting,

Severestomachpain,

Unusuallyfastorirregularheartbeat,

Yellowingoftheskinand/oreyes(jaundice).

Commonsideeffects(affectingbetween1in10and1in

100people)

Dizziness,

Drymouth,

Itching,

Sleepproblems,

Rashes,

Diarrhoeaorconstipation,

Hairloss,

Dry,irritatingcough,

Changesinthewaythingstaste,

Upsetstomach,sickness,abdominalpain,

Shortnessofbreath.

Uncommonsideeffects(affectingbetween1in100and1

in1000people)

Fast,irregular,louderheartbeat,

Tiredness,

Chestpain,

Generallyfeelingunwell,

Lowbloodpressure,

Lookingpale,

Reducedbloodflowtothehandsandfeet(e.g.Raynaud

syndrome),

Swellingoftheeyesandlips(angiodema),

Flushing.

Raresideeffects(affectingbetween1in1000and1in

10,000people)

Lossofappetite,

Mouthulcers,

Drowsiness,

Kidneydisordersorfailure,

Headache,

Changesinfrequencyofpassingurine,

Pinsandneedles,numbnessortingling.

Veryraresideeffects(affectinglessthan1in10,000

people)

Impairedliverfunctionandraisedliverenzymes,

Liverdamage,inflammationoftheliverorjaundice,

Confusion,depression,fainting,

Stomachulcers,

Mini-stroke,

Musclepain,

Blurredvision,

Jointpain,

Heartproblemsincludingheartattackandchest

infections,

Wheezingordifficultybreathing,

Inflammationofthepancreas,

Rashesorskinreactions,

Runnynose,

Swellingofbreasttissueinmen,

Swollentongue,

Fever,

Impotence,

Sensitivityoftheskintolight,

Stevens-Johnsonsyndrome(aseriousillnesswith

blisteringoftheskin,inthebloodorlymphaticsystems

mouth,eyesandgenitals),

Changesinlevelsofchemicalsinthebloodorlymphatic

systems(e.g.potassium,sugars).

Ifanyofthesideeffectsbecomeserious,orifyounoticeany

sideeffectsnotlistedinthisleaflet,pleasetellyourdoctoror

pharmacistimmediately.Itwillhelpifyoumakeanoteof

whatyouexperienced,whenitstartedandhowlongitlasted.

5.Howtostoreyourmedicine

Donotstoreabove25°C.

Storeintheoriginalpackandmakesurethetabletsdonot

gettoohotordamp;sodonotleaveyourtabletsneara

radiator,onawindowsillorinthebathroom.

Checktheexpirydateoftheproduct,shownontheouter

packaging.Donotusethetabletsafterthisdate.

Keepoutofthereachandsightofchildren.

Ifyourdoctordecidestostopthetablets,askyour

pharmacisttotellyouwhattodowithanyyouhaveleft.

6.Furtherinformation

WhatCapotencontains

Eachtabletcontains25mgcaptopril.Inaddition,Capoten

containslactose,maizestarch,microcrystallinecelluloseand

stearicacid.

WhatCapotenlookslikeandthecontentsofthe

pack

Capoten25mgtabletsarewhitebiconvextablet,squarewith

roundedcornersengravedwith‘25’ononesideandwith

quadriscentbarsontheother.

Thetabletsareavailableinblisterpackof60tablets.

Manufacturedby:Bristol-MyersSquibbS.r.l.,Contrada

FontanadelCeraso,03012Anagni,Italy.

ProcuredfromwithintheEUandrepackagedbyPPA

holder:B&SHealthcare,Unit4,BradfieldRoad,Ruislip,

Middlesex,HA40NU,UK.

Capoten ® 25mgTablets,PPA: 1328/56/2

Leafletdate:04.03.2013

CapotenisaregisteredtrademarkofBristol-MeyersSquibb

companies. POM

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Capoten25mgtablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains25mgcaptopril.

Excipients:lactose

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablet

ProductimportedfromSpain:

Whitebiconvextablet,squarewithroundedcornersengravedwith‘25’ononesideandwithquadriscentbarsonthe

other.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Hypertension:

Capotenisindicatedforthetreatmentofhypertension.

HeartFailure:

Capotenisindicatedforthetreatmentofchronicheartfailurewithreductionofsystolicventricularfunction,in

combinationwithdiureticsandwhenappropriate,digitalisandbeta-blockers.

MyocardialInfarction:

Short-term(4weeks)treatment:Capotenisindicatedinanyclinicallystablepatientswithinthefirst24hoursof

aninfarction.

Longtermpreventionofsymptomaticheartfailure:Capotenisindicatedinclinicallystablepatientswith

asymptomaticleftventriculardysfunction(ejectionfraction 40%).

TypeIDiabeticNephropathy:

CapotenisindicatedforthetreatmentofmacroproteinuricdiabeticnephropathyinpatientswithtypeIdiabetes.(See

Section5.1,Pharmacodynamicproperties).

4.2Posologyandmethodofadministration

Doseshouldbeindividualisedaccordingtopatient’sprofile(see4.4,specialwarningsandprecautionsforuse)and

bloodpressureresponse.Therecommendedmaximumdailydoseis150mg.

Capotenmaybetakenbefore,duringandaftermeals.

Hypertension:

Therecommendedstartingdoseis25-50mgdailyintwodivideddoses.Thedosemaybeincreasedincrementally,

withintervalsofatleast2weeks,to100-150mg/dayintwodivideddosesasneededtoreachtargetbloodpressure.

Captoprilmaybeusedaloneorwithotherantihypertensiveagents,especiallythiazidediuretics.Aonce-dailydosing

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Inpatientswithastronglyactiverenin-angiotensin-aldosteronesystem(hyovolaemia,renovascularhypertension,

cardiacdecompensation)itispreferabletocommencewithasingledoseof6.25mgor12.5mg.Theinaugurationof

thistreatmentshouldpreferablytakeplaceunderclosemedicalsupervision.Thesedoseswillthenbeadministeredata

rateoftwoperday.Thedosagecanbegraduallyincreasedto50mgperdayinoneortwodosesandifnecessaryto

100mgperdayinoneortwodoses.

HeartFailure:

Treatmentwithcaptoprilforheartfailureshouldbeinitiatedunderclosemedicalsupervision.Theusualstartingdose

is6.25mg-12.5mgBIDorTID.Titrationtothemaintenancedose(75-150mgperday)shouldbecarriedoutbased

onpatient’sresponse,clinicalstatusandtolerability,uptoamaximumof150mgperdayindivideddoses.Thedose

shouldbeincreasedincrementally,withintervalsofatleast2weekstoevaluatepatientsresponse.

MyocardialInfarction:

-Short-termtreatment:Capotentreatmentshouldbegininhospitalassoonaspossiblefollowingtheappearanceofthe

signsand/orsymptomsinpatientswithstablehaemodynamics.A6.25mgtestdoseshouldbeadministered,witha

12.5mgdosebeingadministered2hoursafterwardsanda25mgdose12hourslater.Fromthefollowingday,

captoprilshouldbeadministeredina100mg/daydose,intwodailyadministrations,for4weeks,ifwarrantedbythe

absenceofadversehaemodynamicreactions.Attheendofthe4weeksoftreatment,thepatient’sstateshouldbe

reassessedbeforeadecisionistakenconcerningtreatmentforthepost-myocardialinfarctionstage.

-chronictreatment: Ifcaptopriltreatmenthasnotbegunduringthefirst24hoursoftheacutemyocardialinfarction

stage,itissuggestedthattreatmentbeinstigatedbetweenthe3rdand16thdaypost-infarctiononcethenecessary

treatmentconditionshavebeenattained(stablehaemodynamicsandmanagementofanyresidualischaemia).Treatment

shouldbestartedinhospitalunderstrictsurveillance(particularlyofbloodpressure)untilthe75mgdoseisreached.

Theinitialdosemustbelow(seesection4.4,Specialwarningsandprecautionsforuse),particularlyifthepatient

exhibitsnormalorlowbloodpressureattheinitiationoftherapy.Treatmentshouldbeinitiatedwithadoseof6.25mg

followedby12.5mg3timesdailyfor2daysandthen25mg3timesdailyifwarrantedbytheabsenceofadverse

haemodynamicreactions.Therecommendeddoseforeffectivecardioprotectionduringlong-termtreatmentis75to

150mgdailyintwoorthreedoses.

Incasesofsymptomatichypotension,asinheartfailure,thedosageofdiureticsand/orotherconcomitantvasodilators

maybereducedinordertoattainthesteadystatedoseofcaptopril.Wherenecessary,thedoseofcaptoprilshouldbe

adjustedinaccordancewiththepatient’sclinicalreactions.Captoprilmaybeusedincombinationwithother

treatmentsformyocardialinfarctionsuchasthrombolyticagents,beta-blockersandacetylsalicylicacid.

TypeIDiabeticnephropathy:

InpatientswithtypeIdiabeticnephropathy,therecommendeddailydoseofcaptoprilis75-100mgindivideddoses.If

additionalloweringofbloodpressureisdesired,additionalantihypertensivemedicationsmaybeadded.

Renalimpairment:

Sincecaptoprilisexcretedprimarilyviathekidneys,dosageshouldbereducedorthedosageintervalshouldbe

increasedinpatientswithimpairedrenalfunction.Whenconcomitantdiuretictherapyisrequired,aloopdiuretic(e.g.

furosemide),ratherthanathiazidediuretic,ispreferredinpatientswithsevererenalimpairment.

Inpatientswithimpairedrenalfunction,thefollowingdailydosemayberecommendedtoavoidaccumulationof

captopril.

Creatinineclearance DailyStartingdose Dailymaximumdose

(ml/min/1.73m 2

(mg) (mg)

>40 25-50 150

21-40 25 100

10-20 12.5 75

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Elderlypatients:

Aswithotherantihypertensiveagents,considerationshouldbegiventoinitiatingtherapywithalowerstartingdose

(6.25mgBID)inelderlypatientswhomayhavereducedrenalfunctionandotherorgandysfunctions(seeaboveand

section4.4,specialwarningsandprecautionsforuse).

Dosageshouldbetitratedagainstthebloodpressureresponseandkeptaslowaspossibletoachieveadequatecontrol.

Childrenandadolescents:

Theefficacyandsafetyofcaptoprilhavenotbeenfullyestablished.Theuseofcaptoprilinchildrenandadolescents

shouldbeinitiatedunderclosemedicalsupervision.Theinitialdoseofcaptoprilisabout0.3mg/kgbodyweight.For

patientsrequiringspecialprecautions(childrenwithrenaldysfunction,prematureinfants,new-bornsandinfants,

becausetheirrenalfunctionisnotthesamewitholderchildrenandadults)thestartingdoseshouldonlybe0.15mg

captopril/kgweight.Generally,captoprilisadministeredtochildren3timesaday,butdoseandintervalofdoseshould

beadaptedindividuallyaccordingtopatient’sresponse.

4.3Contraindications

Ahistoryofprevioushypersensitivitytoanyingredientsoftheproduct.

Useinpatientswithaorticstenosisoroutflowtractobstruction.Useinpatientswithbilateralrenalarterystenosisina

singlefunctioningkidney.

UseinpatientswithahistoryofangioneuroticoedemarelatingtoprevioustreatmentwithanACEinhibitor.

Pregnancy:

Capoteniscontraindicatedinthesecondandthirdtrimestersofpregnancy(seesections4.4and4.6).

Capotenhasbeenshowntobelethaltorabbitandsheepfoetuses.Therewerenofoetotoxiceffectstohamsterorrat

foetuses.

Capotenshouldnotbeusedinwomenofchildbearingpotentialunlessprotectedbyeffectivecontraception.

4.4Specialwarningsandprecautionsforuse

Hypotension:

Rarelyhypotensionisobservedinuncomplicatedhypertensivepatients.Symptomatichypotensionismorelikelyto

occurinhypertensivepatientswhoarevolumeand/orsodiumdepletedbyvigorousdiuretictherapy,dietarysalt

restriction,diarrhoea,vomitingorhaemodialysis.Volumeand/orsodiumdepletionshouldbecorrectedbeforethe

administrationofanACEinhibitorandalowerstartingdoseshouldbeconsidered.

Patientswithheartfailureareatahighriskofhypotensionandalowerstartingdoseisrecommendedwheninitiating

therapywithanACEinhibitor.Cautionshouldbeusedwheneverthedoseofcaptoprilordiureticisincreasedin

patientswithheartfailure.

Aswithanyantihypertensiveagent,excessivebloodpressureloweringinpatientswithischaemiccardiovascularor

cerebrovasculardiseasemayincreasetheriskofmyocardialinfarctionorstroke.Ifhypotensiondevelops,thepatient

shouldbeplacedinasupineposition.Volumerepletionwithintravenousnormalsalinemayberequired.

Renovascularhypertension:

Thereisanincreasedriskofhypotensionandrenalinsufficiencywhenpatientswithbilateralrenalarterystenosisor

stenosisofthearterytoasinglefunctioningkidneyaretreatedwithACEinhibitors.Lossofrenalfunctionmayoccur

withonlymildchangesinserumcreatinine.Inthesepatients,therapyshouldbeinitiatedunderclosemedical

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Renalimpairment:

Incasesofrenalimpairment(creatinineclearance<40ml/min),theinitialdosageofcaptoprilmustbeadjusted

accordingtothepatient’screatinineclearance(see4.2),andthenasafunctionofthepatient’sresponsetotreatment.

Routinemonitoringofpotassiumandcreatininearepartofnormalmedicalpracticeforthesepatients.

Angioedema:

Angioedemaoftheextremities,face,lips,mucousmembranes,tongue,glottisorlarynxmayoccurinpatientstreated

withACEinhibitorsparticularlyduringthefirstweeksoftreatment.However,inrarecases,severeangioedemamay

developafterlong-termtreatmentwithanACEinhibitor.Treatmentshouldbediscontinuedpromptly.Angioedema

involvingthetongue,glottisorlarynxmaybefatal.Emergencytherapyshouldbeinstituted.

Thepatientshouldbehospitalisedandobservedforatleast12to24hoursandshouldnotbedischargeduntilcomplete

resolutionofsymptomshasoccurred.

IntestinalangioedemahasalsobeenreportedveryrarelyinpatientstreatedwithACEinhibitorsandshouldbeincluded

inthedifferentialdiagnosisofpatientsonACEinhibitorspresentingwithabdominalpain.

Cough:

CoughhasbeenreportedwiththeuseofACEinhibitors.Characteristically,thecoughisnon-productive,persistentand

resolvesafterdiscontinuationoftherapy.

Hepaticfailure:

Rarely,ACEinhibitorshavebeenassociatedwithasyndromethatstartswithcholestaticjaundiceandprogressesto

fulminanthepaticnecrosisand(sometimes)death.Themechanismofthissyndromeisnotunderstood.Patients

receivingACEinhibitorswhodevelopjaundiceormarkedelevationsofhepaticenzymesshoulddiscontinuetheACE

inhibitorandreceiveappropriatemedicalfollowup.

Hyperkalaemia:

ElevationsinserumpotassiumhavebeenobservedinsomepatientstreatedwithACEinhibitors,includingcaptopril.

Patientsatriskforthedevelopmentofhyperkalaemiaincludethosewithrenalinsufficiency,diabetesmellitus,orthose

usingconcomitantpotassium-sparingdiuretics,potassiumsupplementsorpotassium-containingsaltsubstitutes;or

thosepatientstakingotherdrugsassociatedwithincreasesinserumpotassium(e.g.heparin).Ifconcomitantuseofthe

abovementionedagentsisdeemedappropriate,regularmonitoringofserumpotassiumisrecommended.

Lithium:

Thecombinationoflithiumandcaptoprilisnotrecommended(seesection4.5,Interactionwithothermedicinal

productsandotherformsofinteraction).

Aorticandmitralvalvestenos/Obstructivehypertropiccardiomyopathy:

ACEinhibitorsshouldbeusedwithcautioninpatientswithleftventricularvalvularandoutflowtractobstructionand

avoidedincasesofcardiogenicshockandhaemodynamicallysignificantobstruction.

Neutropenia/Agranulocytosis:

Neutropenia/agranulocytosis,thrombocytopeniaandanaemiahavebeenreportedinpatientsreceivingACEinhibitors,

includingcaptopril.Inpatientswithnormalrenalfunctionandnoothercomplicatingfactors,neutropeniaoccurs

rarely.Captoprilshouldbeusedwithextremecautioninpatientswithcollagenvasculardisease,immunosuppressant

therapy,treatmentwithallopurinolorprocainamide,oracombinationofthesecomplicatingfactors,especiallyifthere

isapre-existingimpairedrenalfunction.Someofthesepatientsdevelopedseriousinfectionswhichinafewinstances

didnotrespondtointensiveantibiotictherapy.

Ifcaptoprilisusedinsuchpatients,itisadvisedthatwhitebloodcellcountanddifferentialcountsshouldbeperformed

priortotherapy,every2weeksduringthefirst3monthsofcaptopriltherapy,andperiodicallythereafter.During

treatmentallpatientsshouldbeinstructedtoreportanysignofinfection(e.g.sorethroat,fever)whenadifferential

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Captoprilandotherconcomitantmedication(see4.5)shouldbewithdrawnifneutropenia(neutrophilslessthan

1000/mm 3

)isdetectedorsuspected.

Inmostpatientsneutrophilcountsrapidlyreturntonormalupondiscontinuingcaptopril.

Proteinuria:

Proteinuriamayoccurparticularlyinpatientswithexistingrenalfunctionimpairmentoronrelativelyhighdosesof

ACEinhibitors.

Totalurinaryproteinsgreaterthan1gperdaywereseeninabout0.7%ofpatientsreceivingcaptopril.Themajorityof

patientshadevidenceofpriorrenaldiseaseorhadreceivedrelativelyhighdosesofcaptopril(inexcessof150mg/day),

orboth.Nephroticsyndromeoccurredinaboutone-fifthofproteinuricpatients.Inmostcases,proteinuriasubsidedor

clearedwithinsixmonthswhetherornotcaptoprilwascontinued.Parametersofrenalfunction,suchasBUNand

creatinine,wereseldomalteredinthepatientswithproteinuria.Patientswithpriorrenaldiseaseshouldhaveurinary

proteinestimations(dip-stickonfirstmorningurine)priortotreatment,andperiodicallythereafter.

Anaphylactoidreactionsduringdesensitisation:

Sustainedlife-threateninganaphylactoidreactionshavebeenrarelyreportedforpatientsundergoingdesensitising

treatmentwithhymenopteravenomwhilereceivinganotherACEinhibitor.Inthesamepatients,thesereactionswere

avoidedwhentheACEinhibitorwastemporarilywithheld,buttheyreappeareduponinadvertentrechallenge.

Therefore,cautionshouldbeusedinpatientstreatedwithACEinhibitorsundergoingsuchdesensitisationprocedures.

Anaphylactoidreactionsduringhigh-fluxdialysis/lipoproteinapheresismembraneexposure:

Anaphylactoidreactionshavebeenreportedinpatientshaemodialysedwithhigh-fluxdialysismembranesor

undergoinglow-densitylipoproteinapheresiswithdextransulphateabsorption.Inthesepatients,considerationshould

begiventousingadifferenttypeofdialysis;membraneoradifferentclassofmedication.

Surgery/Anesthesia:

Hypotensionmayoccurinpatientsundergoingmajorsurgeryorduringtreatmentwithanaestheticagentsthatare

knowntolowerbloodpressure.Ifhypotensionoccurs,itmaybecorrectedbyvolumeexpansion.

Diabeticpatients:

Theglycaemialevelsshouldbecloselymonitoredindiabeticpatientspreviouslytreatedwithoralantidiabeticdrugsor

insulin,namelyduringthefirstmonthoftreatmentwithanACEinhibitor.

Lactose:

Capotencontainslactose,thereforeitshouldnotbeusedincasesofcongenitalgalactosaemia,glucoseandgalactose

malabsorptionorlactasedeficiencysyndromes(raremetabolicdiseases).

Ethnicdifferences:

Aswithotherangiotensinconvertingenzymeinhibitors,captoprilisapparentlylesseffectiveinloweringblood

pressureinblackpeoplethaninnon-blacks,possiblybecauseofahigherprevalenceoflow-reninstatesintheblack

hypertensivepopulation.

Pregnancy:

ACEinhibitorsshouldnotbeinitiatedduringpregnancy.UnlesscontinuedACEinhibitortherapyisconsidered

essential,patientsplanningpregnancyshouldbechangedtoalternativeantihypertensivetreatmentswhichhavean

establishedsafetyprofileforuseinpregnancy.Whenpregnancyisdiagnosed,treatmentwithACEinhibitorsshouldbe

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Potassiumsparingdiureticsorpotassiumsupplements:

ACEinhibitorsattenuatediureticinducedpotassiumloss.Potassiumsparingdiuretics(e.g.spironolactone,triamterene

oramiloride),potassiumsupplements,orpotassium-containingsaltsubstitutesmayleadtosignificantincreasesin

serumpotassium.Ifconcomitantuseisindicatedbecauseofdemonstratedhypokalaemiatheyshouldbeusedwith

cautionandwithfrequentmonitoringofserumpotassium(seesection4.4,Specialwarningsandprecautionsforuse).

Diuretics(ThiazideorloopDiuretics)

Priortreatmentwithhighdosediureticsmayresultinvolumedepletionandariskofhypotensionwheninitiating

therapywithcaptopril(seesection4.4,Specialwarningsandprecautionsforuse)Thehypotensiveeffectscanbe

reducedbydiscontinuationofthediuretic,byincreasingvolumeorsaltintakeorbyinitiatingtherapywithalowdose

ofcaptopril.However,noclinicallysignificantdruginteractionshavebeenfoundinspecificstudieswith

hydrochlorothiazideorfurosemide.

Otherantihypertensiveagents:

Captoprilhasbeensafelyco-administeredwithothercommonlyusedanti-hypertensiveagents(e.g.beta-blockersand

long-actingcalciumchannelblockers).Concomitantuseoftheseagentsmayincreasethehypotensiveeffectsof

captopril.Treatmentwithnitroglycerineandothernitrates,orothervasodilators,shouldbeusedwithcaution.

Treatmentsofacutemyocardialinfarction:

Captoprilmaybeusedconcomitantlywithacetylsalicylicacid(atcardiologicdoses),thrombolytics,beta-blockers

and/ornitratesinpatientswithmyocardialinfarction.

Lithium:

Reversibleincreasesinserumlithiumconcentrationsandtoxicityhavebeenreportedduringconcomitant

administrationoflithiumwithACEinhibitors.Concomitantuseofthiazidediureticsmayincreasetheriskoflithium

toxicityandenhancethealreadyincreasedriskoflithiumtoxicitywithACEinhibitors.Useofcaptoprilwithlithiumis

notrecommended,butifthecombinationprovesnecessary,carefulmonitoringofserumlithiumlevelsshouldbe

performed(seesection4.4,Specialwarningsandprecautionsforuse).

Tricyclicantidepressants/Antipsychotics:

ACEinhibitorsmayenhancethehypotensiveeffectsofcertaintricyclicantidepressantsandantipsyschotics(seesection

4.4,Specialwarningsandprecautionsforuse)Posturalhypotensionmayoccur.

Allopurinol,procainamide,cytostaticorimmuno-suppressiveagents:

ConcomitantadministrationwithACEinhibitorsmayleadtoanincreasedriskforleucopeniaespeciallywhenthelatter

areusedatahigherthancurrentlyrecommendeddoses.

Non-steroidalanti-inflammatorymedicinalproducts:

Ithasbeendescribedthatnon-steroidalanti-inflammatorymedicinalproducts(NSAIDs)andACEinhibitorsexertan

additiveeffectontheincreaseinserumpotassiumwhereasrenalfunctionmaydecrease.Theseeffectsareinprinciple,

reversible.Rarely,acuterenalfailuremayoccur,particularlyinpatientswithcompromisedrenalfunctionsuchasthe

elderlyordehydrated.ChronicadministrationofNSAIDsmayreducetheantihypertensiveeffectofanACEinhibitor.

Sympathomimetics:

MayreducetheantihypertensiveeffectsofACEinhibitors;patientsshouldbecarefullymonitored.

Antidiabetics:

PharmacologicalstudieshaveshownthatACEinhibitors,includingcaptopril,canpotentiatethebloodglucose-

reducingeffectsofinsulinandoralantidiabeticssuchassulphonylureaindiabetics.Shouldthisveryrareinteraction

occur,itmaybenecessarytoreducethedoseofantidiabeticduringsimultaneoustreatmentwithACEinhibitors.

ClinicalChemistry:

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4.6Fertility,pregnancyandlactation

Pregnancy:

TheuseofACEinhibitorsisnotrecommendedduringthefirsttrimesterofpregnancy(seesection4.4).Theuseof

ACEinhibitorsiscontraindicatedduringthesecondandthirdtrimestersofpregnancy(seesections4.3and4.4).

ControlledstudieswithACEinhibitorshavenotbeendoneinhumans,butlimitednumbersofcasesoffirsttrimester

exposureshavenotshownmalformations.

EpidemiologicalevidenceregardingtheriskofteratogenicityfollowingexposuretoACEinhibitorsduringthefirst

trimesterofpregnancyhasnotbeenconclusive;howeverasmallincreaseinriskcannotbeexcluded.Unlesscontinued

ACEinhibitortherapyisconsideredessential,patientsplanningpregnancyshouldbechangedtoalternative

antihypertensivetreatmentswhichhaveanestablishedsafetyprofileforuseinpregnancy.

Whenpregnancyisdiagnosed,treatmentwithACEinhibitorsshouldbestoppedimmediately,and,ifappropriate,

alternativetherapyshouldbestarted.

ExposuretoACEinhibitortherapyduringthesecondandthirdtrimestersisknowntoinducehumanfoetotoxicity

(decreasedrenalfunction,oligohydramnios,skullossificationretardation)andinneonataltoxicity(renalfailure,

hypotension,hyperkalaemia)(Seesection5.3).ShouldexposuretoACEinhibitorshaveoccurredfromthesecond

trimesterofpregnancy,ultrasoundcheckofrenalfunctionandskullisrecommended.Infantswhosemothershave

takenACEinhibitorsshouldbecloselyobservedforhypotension(seesections4.3and4.4).

Lactation:

Limitedpharmacokineticdatademonstrateverylowconcentrationsinbreastmilk(seesection5.2).Althoughthese

concentrationsseemtobeclinicallyirrelevant,theuseofCapoteninbreastfeedingisnotrecommendedforpreterm

infantsandforthefirstfewweeksafterdelivery,becauseofthehypotheticalriskofcardiovascularandrenaleffects

andbecausethereisnotenoughclinicalexperience.

Inthecaseofanolderinfant,theuseofCapoteninabreast-feedingmothermaybeconsideredifthistreatmentis

necessaryforthemotherandthechildisobservedforanyadverseeffect.

4.7Effectsonabilitytodriveandusemachines

Aswithotherantihpertensives,theabilitytodriveandusemachinesmaybereduced,namelyatthestartofthe

treatment,orwhenposologyismodified,andalsowhenusedincombinationwithalcohol,buttheseseffectsdependon

theindividual’ssusceptibility.

4.8Undesirableeffects

Undesirableeffectsreportedforcaptopriland/orACEinhibitorinclude:

Bloodandlymphaticdisorders:

VeryRare: neutropenia/agranulocytosis(seesection4.4,Specialwarningsandprecautionsforuse),pancytopenia

particularlyinpatientswithrenaldysfunction(seesection4.4,Specialwarningsandprecautionsfor

use),anaemia(includingaplasticandhaemolytic),thrombocytopenia,lymphadenopathy,

eosinophilia,auto-immunediseasesand/orpositiveANA-titres.

Metabolismandnutritiondisorders:

Rare: Anorexia

VeryRare: Hyperkalaemia,hypoglycaemia(seesection4.4,Specialwarningsandprecautionsforuse)

Psychiatricdisorders:

Common: Sleepdisorders.

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Nervoussystemdisorders:

Common: Tasteimpairment,dizziness.

Rare: Drowsiness,headacheandparaesthesia.

VeryRare: Cerebrovascularincidents,includingstroke,andsyncope.

Eyedisorders:

VeryRare: Blurredvision.

Cardiacdisorders:

Uncommon: Tachycardiaortachyarrhythmia,anginapectoris,palpitations.

VeryRare: Cardiacarrest,cardiogenicshock.

Vasculardisorders:

Uncommon: Hypotension(seesection4.4,Specialwarningsandprecautionsforuse),Raynaudsyndrome,flush,

pallor.

Respiratory,thoracicandmediastinaldisorders:

Common: Dry,irritating(nonproductive)cough(seesection4.4,Specialwarningsandprecautionsforuse)and

dyspnoea.

VeryRare: Bronchospasm,rhinitis,allergicalveolitis/eosinophilicpneumonia.

Gastrointestinaldisorders:

Common: Nausea,vomiting,gastricirritations,abdominalpain,diarrhoea,constipation,drymouth.

Rare: Stomatitis/aphthousulcerations.

VeryRare: Glossitis,pepticulcer,pancreatitis.

Hepato-biliarydisorders:

VeryRare: Impairedhepaticfunctionandcholestasis.(includingjaundice),hepatitisincludingnecrosis,elevated

liverenzymesandbilirubin.

Skinandsubcutaneoustissuedisorders:

Common: Prurituswithorwithoutarash,rashandalopecia.

Uncommon: Angioedema(seesection4.4,Specialwarningsandprecautionsforuse)

VeryRare: Urticaria,StevensJohnsonsyndrome,erythemamultiforme,photosensitivity,erythroderma,pemphigoid

reactionsandexfoliativedermatitis.

Musculoskeletal,connectivetissueandbonedisorders:

Veryrare: Myalgia,arthralgia.

Renalandurinarydisorders:

Rare: Renalfunctiondisordersincludingrenalfailure,polyuria,oliguria,increasedurinefrequency.

VeryRare: Nephroticsyndrome.

Reproductivesystemandbreastdisorders:

VeryRare: Impotence,gynaecomastia.

Generaldisorders:

Uncommon: Chestpain,fatigue,malaise.

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Investigations:

VeryRare: Proteinuria,eosinophilia,increaseofserumpotassium,decreaseofserumsodium,elevationofBUN,

serumcreatinineandserumbilirubin,decreasesinhaemoglobin,haematocrit,leucocytes,thrombocytes,

positiveANA-titre,elevatedESR.

IntestinalangioedemahasalsobeenreportedveryrarelyinpatientswithACEinhibitorsandshouldbeincludedinthe

differentialdiagnosisofpatientsonACEinhibitorspresentingwithabdominalpain.

4.9Overdose

Symptomsofoverdosageareseverehypotension,shock,stupor,bradycardia,

electrolytedisturbancesandrenalfailure.

Measurestopreventabsorption(e.g.gastriclavage,administrationofabsorbentsand

sodiumsulphatewithin30minutesafterintake)andhasteneliminationshouldbeappliedifingestionisrecent.If

hypotensionoccurs,thepatientshouldbeplacedintheshockpositionandsaltandvolumesupplementsshouldbegiven

rapidly.Treatmentwithangiotension-IIshouldbeconsidered.Bradycardiaorextensivevagalreactionsshouldbe

treatedbyadministeringatropine.Theuseofapacemakermaybeconsidered.

Captoprilmayberemovedfromcirculationbyhaemodialysis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:ACEinhibitors,plain,ATCcode:C09AA01.

Captoprilisahighlyspecific,competitiveinhibitorofangiotensin-Iconvertingenzyme(ACEinhibitors).

ThebeneficialeffectsofACEinhibitorsappeartoresultprimarilyfromthesuppressionoftheplasmarenin-

angiotensin-aldosteronesystem.Reninisanendogenousenzymesynthesisedbythekidneysandreleasedintothe

circulationwhereitconvertsangiotensinogentoangiotensin-Iarelativelyinactivedecapeptide.Angiotensin-Iisthen

convertedbyangiotensinconvertingenzyme,apeptidyldipeptidase,toangiotensin-II.Angiotensin-IIisapotent

vasoconstrictorresponsibleforarterialvasoconstrictionandincreasedbloodpressure,aswellasforstimulationofthe

adrenalglandtosecretealdosterone.InhibitionofACEresultsindecreasedplasmaangiotension-IIwhichleadsto

decreasedvasopressoractivityandtoreducedaldosteronesecretion.Althoughthelatterdecreaseissmall,small

increasesinserumpotassiumconcentrationsmayoccur,alongwithsodiumandfluidloss.Thecessationofthe

negativefeedbackofangiotensin-IIonthereninsecretionresultsinanincreaseoftheplasmareninactivity.

Anotherfunctionoftheconvertingenzymeistodegradethepotentvasodepressivekininpeptidebradykinintoinactive

metabolites.Therefore,inhibitionofACEresultsinanincreasedactivityofcirculatingandlocalkallikrein-kinin-

systemwhichcontributestoperipheralvasodilationbyactivatingtheprostaglandinsystem;itispossiblethatthis

mechanismisinvolvedinthehypotensiveeffectofACEinhibitorsandisresponsibleforcertainadversereactions.

Reductionsofbloodpressureareusuallymaximal60to90minutesafteroraladministrationofanindividualdoseof

captopril.Thedurationofeffectisdoserelated.Thereductioninbloodpressuremaybeprogressive,sotoachieve

maximaltherapeuticeffects,severalweeksoftherapymayberequired.Thebloodpressureloweringeffectsof

captoprilandthiazide-typediureticsareadditive.

Inpatientswithhypertension,captoprilcausesareductioninsupineanderectbloodpressure,withoutinducingany

compensatoryincreaseinheartrate,norwaterandsodiumretention.

Inhaemodynamicinvestigations,captoprilcausedamarkedreductioninperipheralarterialresistance.Ingeneralthere

werenoclinicallyrelevantchangesinrenalplasmafloworglomerularfiltrationrate.Inmostpatients,the

antihypertensiveeffectbeganabout15to30minutesafteroraladministrationofcaptopril;thepeakeffectwasachieved

after60to90minutes.Themaximumreductioninbloodpressureofadefinedcaptoprildosewasgenerallyvisible

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Intherecommendeddailydose,theantihypertensiveeffectpersistsevenduringlong-termtreatment.Temporary

withdrawalofcaptoprildoesnotcauseanyrapid,excessiveincreaseinbloodpressure(rebound).Thetreatmentof

hypertensionwithcaptoprilleadsalsotoadecreaseinleftventricularhypertrophy.

Haemodynamicinvestigationsinpatientswithheartfailure,showedthatcaptoprilcausedareductioninperipheral

systemicresistanceandariseinvenouscapacity.Thisresultedinareductioninpre-loadandafterloadoftheheart

(reductioninventricularfilingpressure).Inaddition,risesincardiacoutput,workindexandexercisecapacityhave

beenobservedduringtreatmentwithcaptopril.Inalarge,placebo-controlledstudyinpatientswithleftventricular

dysfunction(LVEF 40%)followingmyocardialinfarction,itwasshownthatcaptopril(initiatedbetweenthe3 rd

the16 th

dayafterinfarction)prolongedthesurvivaltimeandreducedcardiovascularmortality.Thelatterwas

manifestedasadelayinthedevelopmentofsymptomaticheartfailureandareductioninthenecessityfor

hospitalisationduetoheartfailurecomparedtoplacebo.Therewasalsoareductioninre-infarctionandincardiac

revascularisationproceduresand/orintheneedforadditionalmedicationwithdiureticsand/oranincreaseintheir

dosagecomparedtoplacebo.

Aretrospectiveanalysisshowedthatcaptoprilreducedrecurrentinfarctsandcardiacrevascularisationprocedures

(neitherweretargetcriteriaofthestudy).

Anotherlarge,placebo-controlledstudyinpatientswithmyocardialinfarctionshowedthatcaptopril(givenwithin24

hoursoftheeventandforadurationofonemonth)significantlyreducedoverallmortalityafter5weekscomparedto

placebo.Thefavourableeffectofcaptoprilontotalmortalitywasstilldetectableevenafteroneyear.Noindicationof

anegativeeffectinrelationtoearlymortalityonthefirstdayoftreatmentwasfound.

Captoprilcardioprotectioneffectsareobservedregardlessofthepatient’sageorgender,locationoftheinfarctionand

concomitanttreatmentswithprovenefficacyduringthepost-infarctionperiod(thrombolyticagents,beta-blockersand

acetylsalicylicacid).

TypeIdiabeticnephropathy

Inaplacebo-controlled,multicentredoubleblindclinicaltrialininsulin-dependent(TypeI)diabeteswithproteinuria,

withorwithouthypertension(simultaneousadministrationofotherantihypertensivestocontrolbloodpressurewas

allowed),captoprilsignificantlyreduced(by51%)thetimetodoublingofthebaselinecreatinineconcentration

comparedtoplacebo;theincidenceofterminalrenalfailure(dialysis,transplantation)ordeathwasalsosignificantly

lesscommonundercaptoprilthanunderplacebo(51%).Inpatientswithdiabetesandmicroalbuminuria,treatment

withcaptoprilreducedalbuminexcretionwithintwoyears.

Theeffectsoftreatmentwithcaptoprilonthepreservationofrenalfunctionareinadditiontoanybenefitthatmayhave

beenderivedfromthereductioninbloodpressure.

5.2Pharmacokineticproperties

Captoprilisanorallyactiveagentthatdoesnotrequirebiotransformationforactivity.Theaverageminimalabsorption

isapproximately75%.Peakplasmaconcentrationsarereachedwithin60-90minutes.Thepresenceoffoodinthe

gastrointestinaltractreducesabsorptionbyabout30-40%.Approximately25-30%ofthecirculatingdrugisboundto

plasmaproteins.

Theapparenteliminationhalf-lifeofunchangedcaptoprilinbloodisabout2hours.Greaterthan95%oftheabsorbed

doseiseliminatedintheurinewithin24hours;40-50%isunchangeddrugandtheremainderareinactivedisulphide

metabolites(captoprildisulphideandcaptoprilcysteinedisulphide).Impairedrenalfunctioncouldresultindrug

accumulation.Therefore,inpatientswithimpairedrenalfunctionthedoseshouldbereducedand/ordosageinterval

prolonged(seesection4.2,Posologyandmethodofadministration).

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Lactation:

Inthereportoftwelvewomentakingoralcaptopril100mg3timesdaily,theaveragepeakmilklevelwas4.7µg/Land

occurred3.8hoursafterthedose.Basedonthesedata,themaximumdailydosagethatanursinginfantwouldreceiveis

lessthan0.002%ofthematernaldailydosage.

5.3Preclinicalsafetydata

Animalstudiesperformedduringorganogenesiswithcaptoprilhavenotshownanyteratogeniceffectbutcaptoprilhas

producedfoetaltoxicityinseveralspecies,includingfoetalmortalityduringlatepregnancy,growthretardationand

postnatalmortalityintherat.Preclinicaldatarevealnootherspecifichazardforhumansbasedonconventionalstudiesof

safetypharmacology,repeateddosetoxicology,genotoxicityandcarcinogenicity.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactose

Maizestarch

Microcrystallinecellulose

Stearicacid.

6.2Incompatibilities

Notapplicable

6.3Shelflife

Theshelf-lifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

6.4Specialprecautionsforstorage

Storebelow25°C.

Storeintheoriginalpackagetoprotectfrommoisture.

6.5Natureandcontentsofcontainer

Thetabletsarepackagedinblistersinoverlabelledcartonsof60tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7PARALLELPRODUCTAUTHORISATIONHOLDER

B&SHealthcare

Unit4

BradfieldRoad

Ruislip

Middlesex

HA40NU

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8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1328/56/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:10thNovember2006

DateofLastRenewal:10thNovember2011

10DATEOFREVISIONOFTHETEXT

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