CARDURA XL 4 Milligram Tablet Prolonged Release

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
DOXAZOSIN
Available from:
B & S Healthcare
INN (International Name):
DOXAZOSIN
Dosage:
4 Milligram
Pharmaceutical form:
Tablet Prolonged Release
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization number:
PPA1328/079/001
Authorization date:
0000-00-00

PACKAGELEAFLET:INFORMATIONFORTHEUSER

CARDURA™XL4mgProlonged-releaseTablets

CARDURA™XL8mgProlonged-releaseTablets

(doxazosin(asmesilate))

ThenameofyourmedicineisCARDURAXLProlonged-

releaseTabletsbutwillbereferredtoasCARDURAXL

throughoutthisleaflet.

Inthisleaflet:

1.WhatCARDURAXLisandwhatitisusedfor

2.BeforeyoutakeCARDURAXL

3.HowtotakeCARDURAXL

4.Possiblesideeffects

5.HowtostoreCARDURAXL

6.Furtherinformation

1.WHATCARDURAXLISANDWHATITISUSED

FOR

CARDURAXLisoneofagroupofmedicinescalledalpha-

blockers.Itisusedtotreathighbloodpressure.

CARDURAXLcanbeusedtotreathighbloodpressure

(hypertension),byrelaxingbloodvesselssothatblood

passesthroughthemmoreeasily.Thishelpstolower

bloodpressure.

2.BEFOREYOUTAKECARDURAXL

DonottakeCARDURAXL:

Ifyouhavehadanallergicreactioninthepastto

CARDURAXL,theactiveingredientdoxazosin,other

typesofquinazolines(suchasprazosinorterazosin)or

anyoftheotheringredientslistedinsection6.This

mayhavebeenitching,reddeningoftheskinor

difficultyinbreathing.

Ifyouarebreast-feeding

Ifyouhaveanyformofobstructionofthedigestive

tract

Ifyouareunder12yearsofage

Ifyouhaveahistoryofaconditionknownas

‘orthostatichypotension’whichisaformoflowblood

pressurethatcausesyoutofeeldizzyorlight-headed

whenyoustandupfromsittingorlyingdown

Ifyouhaveanenlargedprostateglandwithoneofthe

following:anykindofcongestionorblockageinyour

urinarytract;alongstandinginfectionoftheurinary

tract;oryouhavebladderstones.

Ifyouhaveanenlargedprostateglandandhave

overflowincontinence(youdonotfeeltheurgeto

urinate),oranuria(yourbodyisnotproducingany

urine)withorwithoutkidneyproblems.

TakespecialcarewithCARDURAXL:

ThefollowingarereasonswhyCARDURAXLmaynotbe

suitableforyou:

Ifyouarepregnantortryingtobecomepregnant

Ifyouhaveliver,kidneyorheartdisease

Ifyouarealsotakingothermedicines

Ifyouareundergoingeyesurgerybecauseofcataract

(cloudinessofthelens)pleaseinformyoureyespecialist

beforetheoperationthatyouareusingorhavepreviously

usedCARDURAXL.Thisisbecausethismedicinemay

causecomplicationsduringthesurgerywhichcanbe

managedifyourspecialistispreparedinadvance.

WhenyoustarttotakeCARDURAXLyoumayexperience

faintnessordizzinesscausedbylowbloodpressure,when

gettingupfromsittingorlyingdown.Ifyoufeelfaintor

dizzy,youshouldsitorliedownuntilyoufeelbetterand

avoidsituationswhereyoumightfallorhurtyourself.

Takingothermedicines:

Therearesomemedicinesthatmayinteractwith

CARDURAXL:

Medicinesforerectiledysfunction(impotence)suchas

sildenafil,tadalafilorvardenafil.Somepatientswho

takealpha-blockertherapyforthetreatmentofhigh

bloodpressureorprostateenlargementmayexperience

dizzinessorlight-headedness,whichmaybecausedby

lowbloodpressureuponsittingorstandingupquickly.

Certainpatientshaveexperiencedthesesymptoms

whentakingdrugsforerectiledysfunction(impotence)

withalpha-blockers.Inordertoreducethelikelihood

thatthesesymptomsoccur,youshouldbeonaregular

dailydoseofyouralpha-blockerbeforeyoustartdrugs

forerectiledysfunction.

CARDURAXLmayalsoincreasetheeffectsofdrugs

usedtotreathighbloodpressure(hypertension)

Youshouldalwaystellyourdoctorifyouaretakingor

haverecentlytakenanyothermedicine,eventhosenot

prescribed,becausetheymightinteractwithCARDURA

XL.

TakingCARDURAXLwithfoodanddrink:

CARDURAXLcanbetakenwithorwithoutfood.

PregnancyandBreast-feeding:

ThesafetyofusingCARDURAXLduringpregnancyhas

notbeenestablished.Ifyouarepregnantortryingto

becomepregnantspeaktoyourdoctorwhowilldecideif

thismedicineissuitableforyou.DonottakeCARDURAXL

ifyouarebreast-feeding.

Drivingandusingmachinery:

Takecareifyoudriveoroperatemachinery.Yourtablets

mayaffectyourabilitytodriveoroperatemachinery

safely,particularlywhenyoufirststarttotakethem.They

maycausedrowsinessandcouldmakeyoufeelweakor

dizzy.Ifyouareaffected,donotdriveoroperate

machineryandcontactyourdoctorimmediately.

3.HOWTOTAKECARDURAXL

CARDURAXLisamodifiedreleasetablet.Themedicineis

containedwithinanon-absorbableshellthathasbeen

speciallydesignedtoslowlyreleasethemedicine.Once

swallowed,themedicine(doxazosin)isslowlyreleased

intothebodyfromthetablet,untilthetabletisempty.

Sincetheemptytabletiseliminatedfromthebodyin

bowelmovements,youmayoccasionallyobserveinthe

stools,somethingthatlookslikeatablet.Thisistobe

expectedandyoushouldnotbeconcerned.

Howtotakeyourmedicine

TheusualdoseofCARDURAXLisone4mgmodified

releasetablettakenonceaday.Yourdoctormaywish

toincreaseyourdoseto8mg.Thisisthemaximum

doseofthismedicine.

Swallowyourmedicinewholewithwater.Donot

chew,divideorcrushthetablets.

Takeyourtabletsasyourdoctortoldyou.

Itisimportanttokeeptakingyourtablets.Theyhelpto

controlyourbloodpressure.

Don'tchangethedoseorstoptakingthetabletswithout

firstcheckingwithyourdoctor.

Don'twaituntilyourtabletsarefinishedbeforeseeing

yourdoctor.

Ifyouarestillnotsurehowtotakeyourtablets,ask

yourdoctororpharmacist.

IfyoutakemoreCARDURAXLthanyoushould:

Takingtoomanytabletsatoncemaymakeyouunwell.If

severaltabletsaretakenitmaybedangerous.Tellyour

doctorimmediatelyorgotoyournearesthospitalcasualty

departmentimmediately.

IfyoumissadoseofCARDURAXL:

Donotworry.Ifyouforgettotakeatablet,leavethat

doseoutcompletely.Thengoonasbefore.

4.POSSIBLESIDEEFFECTS

Likeallmedicines,CARDURAXLcancausesideeffects

althoughnoteverybodygetsthem.

STOPtakingCARDURAXLandcallanambulance

immediatelyifyouexperienceanyofthefollowing:

Heartattack.

Increased,decreasedorirregularheartbeat.

Weaknessofarms,legsorproblemsspeakingwhich

maybesymptomsofastroke

Allergicreactions(hypersensitivity).Symptomsinclude

suddenwheeziness,tightnessinchest,difficultyin

breathing,swellingoftheface,tongueorthroat,rash

oritching(especiallyaffectingthewholebody).

Tellyourdoctorimmediatelyifyouexperienceanyof

thefollowingsymptomsaftertakingCARDURAXL:

Chestpain(angina),wheezing,shortnessofbreath,

difficultybreathing.

Feelingyourheartbeat(palpitations).

Fainting.

Yellowingoftheskinortheeyes(jaundice).

Lownumbersofwhitebloodcellsorbloodplatelets,

ImportantthingsthatyouSHOULDknowabout

yourmedicine:

CARDURAXLisatreatmentforhighbloodpressure

Thismedicinehasbeenprescribedforyou.Donot

passitontoothers.Itmayharmthen,eveniftheir

symptomsarethesameasyours.

YoushouldtakeCARDURAXLregularlytogetthe

maximumbenefit,evenifyouarefeelingwell.

Mostpeopledonothaveseriousproblemswhen

takingCARDURAXLbutsideeffectscanoccur–see

Section4fordetails.Ifyouexperienceswellingof

theface,tongueorwindpipe,seeyourdoctor

immediately.Ifanyofthesideeffectsgetsserious,

orifyounoticeanysideeffectsnotlistedinthis

leaflet,pleasetellyourdoctororpharmacist.

Takingothermedicinesmaysometimescause

problems.Checkwithyourdoctororpharmacist

beforetakingthiswithanyothermedicines.

Ifyouare,oraretryingtobecome,pregnant,donot

takeCARDURAXLandtellyourdoctor.

Pleasereadtherestofthisleaflet.Itincludesother

importantinformationonthesafeandeffectiveuseof

thismedicinethatmightbeespeciallyimportantto

you.Ifyouhaveanyfurtherquestions,askyour

doctororpharmacist.

Thefollowingeventshavebeenreportedinpatientsbeing

treatedwithCARDURAXL.Ifanyofthesesideeffectsget

serious,orifyounoticeanysideeffectsnotlistedinthis

leaflet,pleasetellyourdoctor.

Commonsideeffects

Thesecanaffectbetween1in10and1in100patients:

dizziness,feelingofspinningorrotationofsurroundings

(vertigo),headache

lowbloodpressure

swellingoffeet,anklesorfingers

bronchitis,coughing,respiratorytract(nose,throat,

lungs)infection

nasalstuffiness,sneezingand/orrunnynosecausedby

inflammationoftheliningofthenose(rhinitis)

stomach/abdominalpains,feeling/beingsick

urinarytractinfection,cystitis,urinaryincontinence

(inabilitytocontrolpassingurine)

sleepiness,generalweakness

indigestion,drymouth

itching

backpain,painfulmuscles

flu-likesymptoms

Uncommonsideeffects:

Thesecanaffectbetween1in100and1in1,000

patients:

constipation,wind,inflammationofthestomachand

intestines(gastroenteritis)whichcancausediarrhoea

andvomiting

painordiscomfortonpassingurine,increased

frequencyinpassingurine,bloodinurine

inflammationofthejoints(gout),painfuljoints,general

pain

sleeplessness,anxiety,depression

reducedoralteredsenseoftouchorsensationofthe

handsandfeet

increasedappetiteorlossofappetite,weightgain

nosebleeds

skinrash

ringingornoiseintheears,tremor

failure/inabilitytoachievepenileerection

liverenzymeincreaseswhichmayhaveaneffecton

somemedicaltests

Veryraresideeffects

Thesecanaffectlessthan1in10,000patients:

faintnessordizzinesscausedbylowbloodpressure

whengettingupfromasittingorlyingposition

agitationornervousness

hepatitis(liverinflammation)orbiledisorder

hives,hairloss,redorpurplepatchesontheskin,

bleedingundertheskin

tinglingornumbnessofthehandsandfeet

tiredness,generallyfeelingunwell

blurredvision

hotflushes

musclecramps,muscleweakness

disorderinpassingurine,needingtopassurineat

night,increasednumberoftimesofpassingurine,

increasedvolumeofurinepassed

discomfortorenlargementofthebreastsinmen

painfulpersistenterectionofthepenis

Othersideeffects

Thefrequencyofthesesideeffectsisunknown:

littleornosemenejaculatedatsexualclimax,cloudy

urinefollowingsexualclimax

eyeproblemsmayoccurduringeyesurgeryforcataract

(cloudinessofthelensoftheeye).Seesection“Take

specialcarewithCARDURAXL”.

Ifanyofthesideeffectsgetsserious,orifyounoticeany

sideeffectsnotlistedinthisleaflet,pleasetellyourdoctor.

5.HOWTOSTORECARDURAXL

Keepoutofthereachandsightofchildren.

DonotuseCARDURAXLaftertheexpirydatewhichis

statedoncartonandblisterafter‘Exp’.Theexpirydate

referstothelastdayofthatmonth.

Donotstoreabove30°C.

Storeintheoriginalpackinordertoprotectfrom

moisture.

Medicinesshouldnotbedisposedofviawastewateror

householdwaste.Askyourpharmacisthowtodisposeof

medicinesnolongerrequired.Thesemeasureswillhelpto

protecttheenvironment.

6.FURTHERINFORMATION

WhatCARDURAXLcontainsanditspackage:

Theactivesubstanceisdoxazosin(asdoxazosin

mesilate)

Theotheringredientsare:

polyethyleneoxide,sodiumchloride,

hydroxypropylmethylcellulose,redferricoxide(E172)

andmagnesiumstearate,celluloseacetate,polyethylene

glycol(Macrogol)3350,hydroxypropylmethylcellulose,

titaniumdioxide(E171),printingink(shellac,blackiron

oxide(E172),n-butylalcohol,isopropylalcohol,

ammoniumhydroxideandpropyleneglycol).

CARDURAXLprolonged-releasetabletscomeintwo

strengths,4mgand8mg.

Eachprolonged-releasetabletcontainsdoxazosinmesilate

equivalentto4mgor8mgdoxazosin,withinashellthat

hasbeenspeciallydesignedtoslowlyreleasethedrug.

The4mgprolonged-releasetabletsarewhite,round

biconvex-shapedwithaholeinoneside,marked‘CXL4’.

The8mgprolonged-releasetabletsarewhite,round

biconvex-shapedwithaholeinoneside,marked‘CXL8’.

CARDURAXLprolonged-releasetabletsareavailablein

calendarpacksof28.

Translationsofthedaysoftheweekontheblisterareas

follows:

Lu MaMi Ju Vi SaDo

Mon Tue Wed Thu Fri Sat Sun

Manufacturedby:

4mg:PfizerManufacturingDeutschlandGmbH,Heinrich-

Mack-Strasse35,89257Illertissen,Germany.

8mg:FARMASIERRAMANUFACTURING,S.L.Ctra.N-I

km.26.200,28700-SanSebastiándelosReyes,Madrid,

Spain

ProcuredfromwithintheEUandrepackagedbyPPA

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

Middlesex,HA40NU,UK.

CARDURA™XL4mgProlonged-releaseTablets

PPANo:1328/79/1

CARDURA™XL8mgProlonged-releaseTablets

PPANo:1328/79/2

Leafletdate:26.07.2012

CARDURAisaregisteredtrademarkofPfizer

POM POM

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CarduraXL4mgProlonged-releaseTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains4mgdoxazosin(asmesilate).

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Prolonged-releaseTablet.

ProductimportedfromtheUK,PolandandSpain:

White,round,biconvexshapedtabletswithanorificeononesidemarked‘CXL4’andplainontheother.

4CLINICALPARTICULARS

4.1TherapeuticIndications

CarduraXLisindicatedforthetreatmentofhypertensionandcanbeusedasasoleagenttocontrolbloodpressurein

hypertensivepatients.

Inpatientsinadequatelycontrolledonsingleantihypertensivetherapy,CarduraXLmaybeusedincombinationwitha

thiazidediuretic,beta-adrenoceptorblockingagent,calciumantagonistoranangiotensin-convertingenzymeinhibitor.

4.2Posologyandmethodofadministration

TheinitialdoseofCarduraXLis4mgoncedaily.Asignificantnumberofpatientswillbecontrolledonthisdose.If

necessary,thedosagemaybeincreasedto8mgoncedailyaccordingtopatientresponse.

Themaximumrecommendeddoseis8mgoncedaily.

CarduraXLcanbetakenwithorwithoutfood.

Thetabletsshouldbeswallowedwholewithasufficientamountofliquid.Theyshouldnotbecutorchewed.

Elderly:Incommonwithotherdrugsofthisclass,thedosageshouldbekeptaslowaspossibleandincrementsmade

underclosesupervision.

Useinrenallyimpairedpatients:Sincethepharmacokineticsofdoxazosinareunchangedinpatientswithrenal

insufficiency,andthereisnoevidencethatdoxazosinaggravatesexistingrenaldysfunction,theusualdosagesmaybe

usedinthesepatients.CarduraXLisnotdialysable.

Useinhepaticallyimpairedpatients:Thereareonlylimiteddatainpatientswithliverimpairmentandontheeffectsof

drugsknowntoinfluencehepaticmetabolism(e.g.cimetidine).Aswithanydrugmetabolisedwhollybytheliver,

CarduraXLshouldbeusedwithcareinpatientswithsignificantexistinghepaticdysfunction.(seesection4.4Special

warningsandprecautionsforuse,andsection5.2Pharmacokineticproperties).

Useinchildren:ThereisinsufficientexperiencetorecommendtheuseofCarduraXLinchildrenunder12yearsof

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/11/2011 CRN 2100695 page number: 1

4.3Contraindications

CarduraXLiscontraindicatedin:

1)Patientswithaknownhypersensitivitytoquinazolines(e.g.doxazosin,prazosin,terazosin),oranyofthe

excipients.

2)Patientswithahistoryoforthostatichypotension

3)Patientswithbenignprostatichyperplasiaandconcomitantcongestionoftheupperurinarytract,chronicurinary

tractinfectionorbladderstones.

4)Patientswithahistoryofgastro-intestinalobstruction,oesophagealobstruction,oranydegreeofdecreasedlumen

diameterofthegastro-intestinaltract.

5)Duringlactation(pleaseseesection4.6)

Doxazosiniscontraindicatedinhypertensivepatientswithconcomitantbenignprostatichyperplasiawitheither

overflowbladderoranuriawithorwithoutprogressiverenalinsufficiency.

4.4Specialwarningsandprecautionsforuse

Informationtobegiventothepatient:PatientsshouldbeinformedthatCarduraXLtabletsshouldbeswallowedwhole.

Patientsshouldnotchew,divideorcrushthetablets.

InCarduraXL,theactivecompoundissurroundedbyaninert,non-absorbableshellthathasbeenspeciallydesignedto

controlthereleaseofthedrugoveraprolongedperiod.

Aftertransitthroughthegastrointestinaltract,whenthisprocessiscompletedtheemptytabletshelliseliminatedfrom

thebody.Patientsshouldbeadvisedthattheyshouldnotbeconcernediftheyoccasionallyobserveremainsintheir

stoolsthatlooklikeatablet.

Abnormallyshorttransittimesthroughthegastrointestinaltract(e.g.followingsurgicalresection)couldresultin

incompleteabsorption.Inviewofthelonghalflifeofdoxazosintheclinicalsignificanceofthisisunclear.

PosturalHypotension/Syncope:

Initiationoftherapy-Aswithallalpha-blockers,averysmallpercentageofpatientshaveexperiencedpostural

hypotensionevidencedbydizzinessandweakness,orrarelylossofconsciousness(syncope),particularlywiththe

commencementoftherapy.Therefore,itisprudentmedicalpracticetomonitorbloodpressureoninitiationoftherapy

tominimisethepotentialforposturaleffects.

Wheninstitutingtherapywithanyeffectivealpha-blocker,thepatientshouldbeadvisedhowtoavoidsymptoms

resultingfromposturalhypotensionandwhatmeasurestotakeshouldtheydevelop.Thepatientshouldbecautionedto

avoidsituationswhereinjurycouldresultshoulddizzinessorweaknessoccurduringtheinitiationofCarduraXL

therapy,suchasdrivingoroperatingmachinery.

UseinpatientswithAcuteCardiacConditions:

Aswithanyothervasodilatoryanti-hypertensiveagentitisprudentmedicalpracticetoadvisecautionwhen

administeringdoxazosintopatientswiththefollowingacutecardiacconditions:

-pulmonaryoedemaduetoaorticormitralstenosis

-heartfailureathighoutput

-right-sidedheartfailureduetopulmonaryembolismorpericardialeffusion

-leftventricularheartfailurewithlowfillingpressure.

UseinHepaticallyImpairedPatients:Aswithanydrugwhollymetabolisedbytheliver,CarduraXLshouldbe

administeredwithparticularcautiontopatientswithevidenceofimpairedhepaticfunction(seesection5.2

Pharmacokineticproperties).Sincethereisnoclinicalexperienceinpatientswithseverehepaticimpairmentusein

thesepatientsisnotrecommended.

UseinpatientswithImpairedRenalFunction:ThereisnoevidencethatCarduraXLaggravatesrenaldysfunction.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/11/2011 CRN 2100695 page number: 2

UsewithPDE-5Inhibitors:Concomitantadministrationofdoxazosinwithphosphodiesterase-5-inhibitors(eg

sildenafil,tadalafil,andvardenafil)shouldbeusedwithcautionasbothdrugshavevasodilatingeffectsandmayleadto

symptomatichypotensioninsomepatients.Toreducetheriskoforthostatichypotensionitisrecommendedtoinitiate

thetreatmentwithphosphodiesterase-5-inhibitorsonlyifthepatientishemodynamicallystabilizedonalpha-blocker

therapy.Furthermore,itisrecommendedtoinitiatephosphodiesterase-5-inhibitortreatmentwiththelowestpossible

doseandtorespecta6-hourtimeintervalfromintakeofdoxazosin.Nostudieshavebeenconductedwithdoxazosin

prolongedreleaseformulations.

UseinpatientsundergoingCataractSurgery:The'IntraoperativeFloppyIrisSyndrome'(IFIS,avariantofsmallpupil

syndrome)hasbeenobservedduringcataractsurgeryinsomepatientsonorpreviouslytreatedwithtamsulosin.

Isolatedreportshavealsobeenreceivedwithotheralpha-1blockersandthepossibilityofaclasseffectcannotbe

excluded.AsIFISmayleadtoincreasedproceduralcomplicationsduringthecataractoperationcurrentorpastuseof

alpha-1blockersshouldbemadeknowntotheophthalmicsurgeoninadvanceofsurgery.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ConcomitantadministrationofanalphablockerwithaPDE-5inhibitormayleadtosymptomatichypotensioninsome

patients(seesection4.4SpecialWarningsandSpecialPrecautionsforUse).Nostudieshavebeenconductedwith

CarduraXL.

Doxazosinishighlyboundtoplasmaproteins(98%).Invitrodatainhumanplasmaindicatesthatdoxazosinhasno

effectonproteinbindingofthedrugstested(digoxin,phenytoin,warfarinorindometacin).However,thetheoretical

potentialforinteractionwithotherproteinbounddrugsshouldbeborneinmind.

Conventionaldoxazosinhasbeenadministeredwithoutanyadversedruginteractionsinclinicalexperiencewith

thiazidediuretics,furosemide,beta-blockingagents,non-steroidalanti-inflammatorydrugs,antibiotics,oral

hypoglycaemicdrugs,uricosuricagents,oranticoagulants.However,datafromformaldrug/druginteractionstudiesare

notpresent.

Doxazosincanpotentiatethebloodpressureloweringactivityofotheralpha-blockersandotherantihypertensives.

Inanopen-label,randomized,placebo-controlledtrialin22healthymalevolunteers,theadministrationofasingle1

mgdoseofdoxazosinonday1ofafour-dayregimenoforalcimetidine(400mgtwicedaily)resultedina10%

increaseinmeanAUCofdoxazosin,andnostatisticallysignificantchangesinmeanCmaxandmeanhalf-lifeof

doxazosin.The10%increaseinthemeanAUCfordoxazosinwithcimetidineiswithinintersubjectvariation(27%)of

themeanAUCfordoxazosinwithplacebo.

4.6Fertility,pregnancyandlactation

Forthehypertensionindication:

Useduringpregnancy:Astherearenoadequateandwell-controlledstudiesinpregnantwomen,thesafetyofCardura

XLduringpregnancyhasnotyetbeenestablished.Accordingly,CarduraXLshouldbeusedonlywhen,intheopinion

ofthephysician,thepotentialbenefitoutweighsthepotentialrisk.

Doxazosincrossestheplacenta.Althoughnoteratogeniceffectswereseeninanimaltesting,reducedfoetalsurvival

wasobservedinanimalsatextremelyhighdoses(seeSection5.3:PreclinicalSafetyData).Thesedoseswere

approximately300timesthemaximumrecommendedhumandose.

Useduringlactation:Doxazosiniscontraindicatedduringlactationasanimalstudieshaveshownthatdoxazosin

accumulatesinmilkoflactatingrats,andthereisnoinformationabouttheexcretionofthedrugintothemilkof

lactatingwomen.TheclinicalsafetyofCarduraduringlactationhasnotbeenestablished;consequentlyCardurais

contra-indicatedinnursingmothers.

Alternatively,mothersshouldstopbreast-feedingwhentreatmentwithdoxazosinisnecessary(Pleaseseesection5.3:

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/11/2011 CRN 2100695 page number: 3

4.7Effectsonabilitytodriveandusemachines

Theabilitytoengageinactivitiessuchasoperatingmachineryoroperatingamotorvehiclemaybeimpaired,

especiallywheninitiatingtherapy.Thedrugmayalsoinducedrowsiness.Patientsshouldnotdriveoroperate

machineryunlessithasbeenshownnottoaffecttheiralertnessordexterity.

4.8Undesirableeffects

Inclinicaltrials,themostcommonreactionsassociatedwithCarduraXLwereofaposturaltype(rarelyassociatedwith

fainting)ornon-specific.

Frequenciesusedareasfollows:Verycommon1/10,Common1/100and<1/10,Uncommon1/1,000and<1/100,

Rare1/10,000and<1/1,000,Veryrare<1/10,000

MedDRA

SystemOrganClass Frequency UndesirableEffects

Infectionsandinfestations Common Respiratorytractinfection,urinarytractinfection

Bloodandlymphaticsystemdisorders VeryRare Leukopenia,thrombocytopenia

ImmuneSystemDisorders Uncommon Allergicdrugreaction

MetabolismandNutritionDisorders Uncommon Anorexia,gout,increasedappetite

PsychiatricDisorders Uncommon Anxiety,depression,insomnia

VeryRare Agitation,nervousness

NervousSystemDisorders Common Dizziness,headache,somnolence

Uncommon Cerebrovascularaccident,hypoesthesia,syncope,tremor

VeryRare Dizzinesspostural,paresthesia

EyeDisorders VeryRare Blurredvision

Unknown Introperativefloppyirissyndrome(seeSection4.4)

EarandLabyrinthDisorders Common Vertigo

Uncommon Tinnitus

CardiacDisorders Common Palpitation,tachycardia

Uncommon Anginapectoris,myocardialinfarction

VeryRare Bradycardia,cardiacarrhythmias

VascularDisorders Common Hypotension,posturalhypotension

VeryRare HotFlush

Respiratory,ThoracicandMediastinal

Disorders Common Bronchitis,cough,dyspnea,rhinitis

Uncommon Epistaxis

VeryRare AggravatedBronchospasm

GastrointestinalDisorders Common Abdominalpain,dyspepsia,drymouth,nausea

Uncommon Constipation,diarrhoea,flatulence,vomiting,gastroenteritis

HepatobiliaryDisorders Uncommon Abnormalliverfunctiontests

VeryRare Cholestasis,hepatitis,jaundice

SkinandSubcutaneousTissueDisorders Common Pruritus

Uncommon Skinrash

VeryRare Alopecia,purpura,urticaria

MusculoskeletalandConnectiveTissue

Disorders Common Backpain,myalgia

Uncommon Arthralgia

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/11/2011 CRN 2100695 page number: 4

TheundesirableeffectsforCarduraXLaresimilartothosewithimmediatereleaseCarduratablets.

4.9Overdose

Shouldoverdosageleadtohypotension,thepatientshouldbeimmediatelyplacedinasupine,headdownposition.

Othersupportivemeasuresmaybeappropriateinindividualcases.Sincedoxazosinishighlyproteinbound,dialysisis

notindicated.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Doxazosinisapotentandselectivepost-junctionalalpha1-adrenoceptorantagonist.

AdministrationofCarduraXLtohypertensivepatientscausesaclinicallysignificantreductioninbloodpressureasa

resultofareductioninsystemicvascularresistance.Thiseffectisthoughttoresultfromselectiveblockadeofthe

alpha-1-adrenoreceptorslocatedinthevasculature.

Withoncedailydosing,clinicallysignificantreductionsinbloodpressurearepresentthroughoutthedayandat24

hourspostdose.Themajorityofpatientsarecontrolledontheinitialdose.Inpatientswithhypertension,blood

pressureduringtreatmentwithCarduraXLwassimilarinboththesupineandstandingposition.

Responderdatafromthe2primaryhypertensionefficacystudies(includingatotalof630doxazosintreatedpatients)

indicatethatthosepatientscontrolledon1mg,2mgor4mgdoxazosinimmediatereleasetabletswouldbeequallywell

controlledon4mgCarduraXL.

Doxazosinhasbeenshowntobefreeofadversemetaboliceffectsandissuitableforuseinpatientswithcoexistent

diabetesmellitus,goutandinsulinresistance.

Doxazosinissuitableforuseinpatientswithcoexistentasthma,leftventricularhypertrophyandinelderlypatients.

Treatmentwithdoxazosinhasbeenshowntoresultinregressionofleftventricularhypertrophy,inhibitionofplatelet

aggregationandenhancedactivityoftissueplasminogenactivator.Additionally,doxazosinimprovesinsulinsensitivity

inpatientswithimpairment.

Doxazosinproducesfavourableeffectsonbloodlipids,withasignificantincreaseintheHDL/totalcholesterolratio

andtrendstoafavourablereductionintotaltriglycerides.Itthereforeconfersanadvantageoverdiureticsandbeta

RenalandUrinaryDisorders Common Cystitis,urinaryincontinence

Uncommon Dysuria,hematuria,micturitionfrequency

VeryRare Micturitiondisorder,nocturia,polyuria,increaseddiuresis

ReproductiveSystemandBreast

Disorders Uncommon Impotence

VeryRare Gynecomastia,priapism

Unknown Retrogradeejaculation

GeneralDisordersandAdministration

SiteConditions Common Asthenia,chestpain,influenza-likesymptoms,peripheral

oedema

Uncommon Pain,facialoedema

VeryRare Fatigue,malaise,

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/11/2011 CRN 2100695 page number: 5

Basedontheestablishedassociationofhypertensionandbloodlipidswithcoronaryheartdisease,thefavourable

effectsofdoxazosintherapyonbothbloodpressureandlipidsindicateareductioninriskofdevelopingcoronaryheart

disease.

5.2Pharmacokineticproperties

Absorption:Afteroraladministrationoftherapeuticdoses,CarduraXLiswellabsorbedwithpeakbloodlevels

graduallyreachedat8to9hoursafterdosing.Peakplasmalevelsareapproximatelyonethirdofthoseofthesamedose

ofimmediatereleaseCarduratablets.Troughlevelsat24hoursare,however,similar.

ThepharmacokineticcharacteristicsofCarduraXLwillleadtoasmootherplasmaprofile.

Peak/troughratioofCarduraXLislessthanhalfthatofimmediatereleaseCarduratablets.

Atsteady-state,therelativebioavailabilityofdoxazosinfromCarduraXLcomparedtotheimmediatereleaseformwas

54%atthe4mgdoseand59%atthe8mgdose.

PharmacokineticstudieswithCarduraXLintheelderlyhaveshownnosignificantalterationscomparedtoyounger

patients.

Biotransformation/Elimination:Theplasmaeliminationisbiphasicwiththeterminaleliminationhalf-lifebeing22

hoursandhencethisprovidesthebasisforoncedailydosing.Doxazosinisextensivelymetabolisedwith<5%excreted

asunchangeddrug.

PharmacokineticstudieswithimmediatereleaseCardurainpatientswithrenalimpairmentalsoshowednosignificant

alterationscomparedtopatientswithnormalrenalfunction.

Thereareonlylimiteddatainpatientswithliverimpairmentandontheeffectsofdrugsknowntoinfluencehepatic

metabolism(e.g.cimetidine).Inaclinicalstudyin12patientswithmoderatehepaticimpairment,singledose

administrationofdoxazosinresultedinanincreaseinAUCof43%andadecreaseinapparentoralclearanceof30%.

(Seealso4.4Specialwarningsandspecialprecautionsforuse).

Approximately98%ofdoxazosinisprotein-boundinplasma.

DoxazosinisprimarilymetabolisedbyO-demethylationandhydroxylation.

5.3Preclinicalsafetydata

Preclinicaldatarevealnospecialhazardforhumansbasedonconventionalanimalstudiesinsafetypharmacology,

repeateddosetoxicity,genotoxicityandcarcinogenicity.Forfurtherinformationseesection4.6Pregnancyand

lactation.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Polyethyleneoxide

Sodiumchloride

Hypromellose

Redferricoxide(E172)

Titaniumdioxide(E171)

Magnesiumstearate

Celluloseacetate

Macrogol3350

Shellac

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/11/2011 CRN 2100695 page number: 6

Blackironoxide(E172)

AmmoniumHydroxide(E527)

PropyleneGlycol

n-butylalcohol

Isopropylalcohol

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Theshelf-lifeexpirydateofthisproductisthedateshownontheblisterandouterpackageoftheproductonthemarket

inthecountryoforigin.

6.4Specialprecautionsforstorage

UKproduct

Donotstoreabove30°C.

Storeintheoriginalpackage.

Polishproduct

Donotstoreabove30°C.

Storeintheoriginalpackageinordertoprotectfrommoisture.

6.5Natureandcontentsofcontainer

UKproduct

Overlabelledblisterpackscontaining28tablets.

Polishproduct

Overlabelledblisterpackscontaining30tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements

7PARALLELPRODUCTAUTHORISATIONHOLDER

B&SHealthcare

Unit4

BradfieldRoad

Ruislip

MiddlesexHA40NU

UnitedKingdom

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1328/79/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/11/2011 CRN 2100695 page number: 7

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/11/2011 CRN 2100695 page number: 8

Similar products

Search alerts related to this product

View documents history

Share this information