CARDURA XL 8 Milligram Tablet Prolonged Release

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
DOXAZOSIN MESILATE
Available from:
PCO Manufacturing
ATC code:
C02CA04
INN (International Name):
DOXAZOSIN MESILATE
Dosage:
8 Milligram
Pharmaceutical form:
Tablet Prolonged Release
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Alpha-adrenoreceptor antagonists
Authorization status:
Authorised
Authorization number:
PPA0465/095/002
Authorization date:
2003-10-17

PACKAGELEAFLET:INFORMATION FOR THEUSER

Cardura

XL4mg

Cardura

XL8mg

Prolonged-releaseTablets

doxazosin (asmesilate)

Importantthingsthatyou SHOULDknowaboutyourmedicine:

Cardura XL isa treatmentforhigh blood pressure

Thismedicinehasbeen prescribed foryou.Donotpassitonto others.It

mayharmthem,even iftheirsymptomsarethesame asyours.

YoushouldtakeCardura XL regularlyto getthemaximumbenefit,even if

you are feeling well.

Mostpeopledo nothaveseriousproblemswhen taking Cardura XLbut

sideeffectscanoccur–seeSection 4 fordetails.Ifyou experience

swelling ofthe face,tongue orwindpipe,seeyourdoctorimmediately.If

anyofthesideeffectsgetsserious,orifyounoticeanysideeffectsnot

listedinthisleaflet,pleasetellyourdoctororpharmacist.

Taking othermedicinesmaysometimescause problems.Checkwith

yourdoctororpharmacistbefore takingthisoranyothermedicines.

Ifyou are,orare tryingto become,pregnant,do nottakeCardura XL and

tellyourdoctor.

Pleaseread therestofthisleaflet.Itincludesotherimportantinformation

on thesafeand effective use ofthismedicinethatmightbeespecially

importantto you.Ifyou have anyfurtherquestions,askyourdoctor or

pharmacist.

Inthis leaflet:

1.WhatCardura XL isand whatitisusedfor

2.Before you take Cardura XL

3.Howtotake Cardura XL

4.Possiblesideeffects

5.HowtoStore Cardura XL

6.Furtherinformation

1. WHATCARDURAXLISANDWHATITISUSEDFOR

CarduraXL isone ofa group ofmedicinescalled alpha-blockers.Itisused

to treathigh bloodpressure.

CarduraXL can be usedtotreathigh blood pressure(hypertension),by

relaxing blood vesselssothatbloodpassesthrough themmore easily.This

helpsto lowerblood pressure.

2. BEFOREYOU TAKECARDURAXL

Donottake CarduraXL:

Ifyou have hadan allergicreaction in thepastto Cardura XL,the

active ingredientdoxazosin,othertypesofquinazolines(such as

prazosin orterazosin)oranyofthe otheringredientslistedinsection6.

Thismayhave been itching,reddening oftheskin ordifficultyin

breathing,

Ifyouarebreast-feeding,

Ifyouhave anyformofobstructionofthe digestivetract,

Ifyouareunder12 yearsofage,

Ifyouhave ahistoryofaconditionknown as‘orthostatichypotension’

which isaformoflowblood pressure thatcausesyou tofeeldizzyor

light-headed when you stand upfromsitting orlying down,

Ifyouhave anenlarged prostate gland with one ofthefollowing:any

kind ofcongestion orblockage in yoururinarytract;alongstanding

infection oftheurinarytractoryou havebladderstones,

Ifyouhave anenlarged prostate gland and haveoverflowincontinence

(youdo notfeeltheurge tourinate),oranuria (yourbodyisnot

producing anyurine)withorwithoutkidneyproblems.

Take specialcarewithCarduraXL:

The followingare reasonswhyCarduraXL maynotbesuitableforyou:

Ifyouarepregnantortryingto becomepregnant

Ifyouhave liver,kidneyorheartdisease

Ifyou arealsotaking othermedicines

Ifyouhave problemswithyourheart

Ifyouareundergoing eyesurgerybecause ofcataract(cloudinessofthe

lens)please informyoureyespecialistbeforethe operationthatyouare

using orhavepreviouslyusedCardura XL.Thisisbecausethismedicine

maycausecomplicationsduring the surgerywhich canbemanagedifyour

specialistisprepared in advance.

When youstarttotake Cardura XL youmayexperiencefaintnessor

dizzinesscausedbylowblood pressure,whengetting upfromsittingor

lyingdown.Ifyoufeelfaintordizzy,youshouldsitorlie down untilyoufeel

Takingothermedicines:

There are somemedicinesthatmayinteractwith CarduraXL:

Medicinesforerectiledysfunction(impotence)suchassildenafil,

tadalafilorvardenafil.Some patientswho take alpha-blockertherapy

forthetreatmentofhighblood pressure orprostate enlargementmay

experience dizzinessorlight-headedness,whichmaybe caused bylow

blood pressure uponsitting orstanding upquickly.Certain patients

have experienced thesesymptomswhen takingdrugsforerectile

dysfunction(impotence)with alpha-blockers.Inorderto reducethe

likelihood thatthese symptomsoccur,youshould beon a regulardaily

dose ofyouralpha blockerbeforeyou startdrugsforerectile

dysfunction,

CarduraXL mayalso increasetheeffectsofdrugsusedto treathigh

blood pressure (hypertension),

Youshouldalwaystellyourdoctorifyouaretaking orhaverecently

takenanyothermedicine,even those notprescribed,becausethey

mightinteractwith Cardura XL.

Taking CarduraXLwithfood anddrink:

CarduraXL canbe taken with orwithoutfood.

PregnancyandBreast-feeding:

The safetyofusing Cardura XL duringpregnancyhasnotbeen

established.Ifyou are pregnantortrying tobecome pregnantspeakto your

doctorwho willdecide ifthismedicine issuitableforyou.Do nottake

CarduraXL ifyouare breast-feeding.

Drivingandusingmachinery:

Takecare ifyou drive oroperatemachinery.Yourtabletsmayaffectyour

abilitytodrive oroperatemachinerysafely,particularlywhen you firststart

to takethem.Theymaycausedrowsinessandcouldalsomake youfeel

weakordizzy.Ifyou are affected,do notdrive oroperatemachineryand

contactyourdoctorimmediately.

3. HOWTOTAKECARDURAXL

CarduraXL isaprolongedreleasetablet.The medicineiscontained within

a non-absorbableshellthathasbeen speciallydesigned toslowlyrelease

themedicine.Onceswallowed,themedicine (doxazosin)isslowlyreleased

into thebodyfromthetablet,untilthe tabletisempty.

Sincetheemptytabletiseliminatedfromthebodyinbowelmovements,

you mayoccasionallyobserve inthe stools,something thatlookslike a

tablet.Thisistobe expected andyoushould notbeconcerned.

Howtotakeyourmedicine:

The usualdoseofCardura XL isone 4mgprolongedreleasetablet

takenonce aday.Yourdoctormaywish toincreaseyourdoseto 8mg.

Thisisthemaximumdose ofthismedicine.

Swallowyourmedicine wholewith water.Do notchew,divideor

crushthetablets.

Take yourtabletsasyourdoctortold you.

Itisimportanttokeeptakingyourtablets.Theyhelptocontrolyour

blood pressure.

Don'tchangethedose orstop taking thetabletswithoutfirstchecking

with yourdoctor.

Don'twaituntilyourtabletsare finished beforeseeing yourdoctor.

Ifyou arestillnotsure howtotakeyourtablets,askyourdoctoror

pharmacist.

Ifyoutake more CarduraXLthanyou should:

Takingtoomanytabletsatoncemaymakeyou unwell.Ifseveraltablets

are takenitmaybe dangerous.Tellyourdoctorimmediatelyorgotoyour

nearesthospitalcasualtydepartmentimmediately.

Ifyou missadoseofCarduraXL:

Donotworry.Ifyou forgetto takeatablet,leave thatdoseoutcompletely.

Thengo on asbefore.

4. POSSIBLE SIDE EFFECTS

Like allmedicines,CarduraXLcan causeside effectsalthough not

everybodygetsthem.

STOPtakingCardura XLandcallanambulanceimmediatelyifyou

experience anyofthefollowing:

Heartattack.

Increased,decreasedorirregularheartbeat.

Weaknessofarms,legsorproblemsspeaking whichmaybe

symptomsofastroke

Allergicreactions(hypersensitivity).Symptomsincludesudden

wheeziness,tightnessinchest,difficultyinbreathing,swelling ofthe

face,tongue orthroat,rash oritching (especiallyaffectingthe whole

body).

Tellyourdoctorimmediatelyifyou experience anyofthefollowing

symptomsaftertaking Cardura XL:

Chestpain(angina),wheezing,shortnessofbreath,difficultybreathing.

Feeling yourheartbeat(palpitations).

Fainting.

Yellowing oftheskinortheeyes(jaundice).

Lownumbersofwhite bloodcellsorblood platelets,whichmayresultin

bruising oreasybleeding.

The following eventshave been reportedinpatientsbeingtreatedwith

CarduraXL.Ifanyoftheseside effectsgetserious,orifyou notice any

side effectsnotlisted inthisleaflet,pleasetellyourdoctor.

Commonside effects

Thesecan affectbetween1 in 10and 1 in 100 patients:

dizziness,feelingofspinningorrotationofsurroundings(vertigo),

headache

lowblood pressure

swelling offeet,anklesorfingers

bronchitis,coughing,respiratorytract(nose,throat,lungs)infection

nasalstuffiness,sneezing and/orrunnynose caused byinflammation of

theliningofthe nose (rhinitis)

stomach/abdominalpains,feeling/being sick

urinarytractinfection,cystitis,urinaryincontinence (inabilitytocontrol

passingurine)

sleepiness,generalweakness

indigestion,drymouth

itching

backpain,painfulmuscles

flu-like symptoms

Uncommonsideeffects:

Thesecan affectbetween 1 in 100and 1 in1,000 patients:

constipation,wind,inflammation ofthestomachandintestines

(gastroenteritis)which can causediarrhoea and vomiting

pain ordiscomforton passingurine,increasedfrequencyinpassing

urine,blood inurine

inflammationofthe joints(gout),painfuljoints,generalpain

sleeplessness,anxiety,depression

reduced oralteredsense oftouchorsensationofthehandsand feet

increased appetiteorlossofappetite,weightgain

nose bleeds

skin rash

ringing ornoiseintheears,tremor

failure/inabilityto achieve penileerection

liverenzyme increaseswhichmayhave an effectonsomemedical

tests

VeryRareside effects

Thesecan affectlessthan 1in 10,000 patients:

faintnessordizzinesscausedbylowblood pressurewhen getting up

fromasitting orlying position

agitation ornervousness

hepatitis(liverinflammation)orbile disorder

hives,hairloss,red orpurple patchesontheskin,bleedingunderthe

skin.

tingling ornumbnessofthe handsand feet

tiredness,generallyfeeling unwell

blurred vision

hotflushes

muscle cramps,muscleweakness

disorderin passing urine,needingto passurine atnight,increased

numberoftimesofpassing urine,increasedvolumeofurine passed

discomfortorenlargementofthebreastsinmen

painfulpersistenterectionofthepenis

Othersideeffects

The frequencyofthesesideeffectsisunknown:

little ornosemenejaculated atsexualclimax,cloudyurinefollowing

sexualclimax

Eye problemsmayoccurduringeye surgeryforcataract(cloudinessof

thelensoftheeye).Seesection “Takespecialcare withCardura XL”.

Ifanyoftheside effectsgetsserious,orifyou notice anysideeffects

notlistedinthisleaflet,please tellyourdoctor.

Reporting ofside effects

Ifyougetanyside effects,talktoyourdoctor,pharmacistornurse. This

includesanypossibleside effectsnotlistedinthisleaflet.You canalso

reportsideeffectsdirectlyviaHPRAPharmacovigilance,EarlsfortTerrace,

IRL-Dublin 2;Tel:+353 1 6764971;Fax:+353 1 6762517.Website:

www.hpra.ie ; E-mail: medsafety@hpra.ie .Byreportingside effectsyou can

help providemore information onthe safetyofthismedicine.

5. HOWTOSTORECARDURAXL

Keepyourtabletsoutofthe reachand sightofchildren.

Donotstore above 30ºC.

Store inthe originalpackagein orderto protectfrommoisture

Donotuse Cardura XLafterthe expirydatewhich isstatedonthe

carton,labelandblister.The expirydate referstothelastdayofthe

month.

The tabletsshouldbe whole to workeffectively,ifyou notice any

defects(suchasbrokentablets)consultyourpharmacistimmediately.

6. FURTHER INFORMATION

WhatCarduraXLcontains andits package:

CarduraXL 4mgProlonged Release Tabletscontain4mg ofthe active

substancedoxazosin (asdoxazosinmesilate).

CarduraXL 8mgProlonged ReleaseTabletscontain8mg ofthe active

ingredientdoxazosin (asdoxazosinmesilate).

Theyalsocontainthefollowing inactiveingredients:

ammoniumhydroxide(E527),propylene glycol,polyethylene oxide,sodium

chloride,hypromellose,red iron oxide(E172),titaniumdioxide (E171),

magnesiumstearate,celluloseacetate,macrogol3350,pharmaceutical

glaze,blackiron oxide (E172).

The productsimportedfromSpainalsoincludesthefollowing inactive

ingredients:shellac,N-butylalcohol,Isopropylalcohol

Pharmaceuticalform:Prolonged-release Tablets

Cardura XL4mgProlongedRelease Tabletsare white,round,biconvex

tabletswithan orifice in oneside,marked ‘CLX4’ononeside,plainonthe

other.

Cardura XL8mgProlongedRelease Tabletsare white,round,biconvex

tabletswithan orifice in oneside,marked ‘CLX8’ononeside,plainonthe

other.

Pack size:Cardura XL comesin packsof28or30tablets.

Manufacturer:

PfizerManufacturing DeutschlandGmbH,Heinrich-Mack-Strasse35,

89257Illertissen,GermanyorFARMASIERRAMANUFACTURING,S.L.,

Carretera N-I,Km.26,200,28700San Sebastiende losReyes(Madrid),

Spain

Productprocuredwithin theEU,repackagedand distributedbythe

ParallelProductAuthorisation Holder:

PCOManufacturing,Unit10,Ashbourne BusinessPark,Rath,Ashbourne,

Co.Meath.

ParallelProductAuthorisation Numbers:

CarduraXL4mg Prolonged-release Tablets-PPA465/95/1

CarduraXL 8mgProlonged-releaseTablets-PPA465/95/2

Cardura isa registeredtrademarkofPfizerLimited

Date ofLeafletPreparationbyPCOManufacturing:August2014

Asthe daysoftheweekare notlisted ontheblisterfoilinEnglish,please

use thefollowingtable shouldyourequirea translation:

English Spanish

Mon (Monday) Lu (Lunes)

Tue (Tuesday) Ma(Martes)

Wed (Wednesday) Mi(Miércoles)

Thu (Thursday) Ju (Jueves)

Fri (Friday) Vi(Viernes)

Sat(Saturday) Sa (Sábado)

Sun (Sunday) Do(Domingo)

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CarduraXL8mgProlonged-releasetablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains8mgdoxazosin(asmesilate).

Forafulllistofexcipientsseesection6.1

3PHARMACEUTICALFORM

Prolonged-releasetablet

ProductimportedfromtheNetherlands,UKandSpain:

White,round,biconvexshapedtabletswithanorificeinoneside,marked‘CXL8’ononeside,plainontheother.

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.

Useinrenally-impairedPatients:Sincethepharmacokineticsofdoxazosinareunchangedinpatientswithrenal

insufficiency,andthereisnoevidencethatdoxazosinaggravatesexistingrenaldysfunction,theusualdosagesmaybe

usedinthesepatients.CarduraXLisnotdialysable.

Useinhepaticallyimpairedpatients:

Thereareonlylimiteddatainpatientswithliverimpairmentandontheeffectsofdrugsknowntoinfluencehepatic

metabolism(e.g.cimetidine).Aswithanydrugmetabolisedwhollybytheliver,CarduraXLshouldbeusedwithcare

inpatientswithsignificantexistinghepaticdysfunction.(seesection4.4Specialwarningsandprecautionsforuse,and

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Useinchildren:

ThereisinsufficientexperiencetorecommendtheuseofCarduraXLinchildrenunder12yearsofage.

4.3Contraindications

CarduraXLiscontraindicatedin:

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

excipientslistedinsection6.1.

2)Patientswithahistoryoforthostatichypotension

3)Patientswithbenignprostatichyperplasiaandconcomitantcongestionoftheupperurinarytract,chronic

urinarytractinfectionorbladderstones.

4)Patientswithahistoryofgastro-intestinalobstruction,oesophagealobstruction,oranydegreeofdecreased

lumendiameterofthegastro-intestinaltract.

5)Duringlactation(pleaseseesection4.6)

Doxazosiniscontraindicatedasmonotherapyinpatientswitheitheroverflowbladderoranuriawithorwithout

progressiverenalinsufficiency.

4.4Specialwarningsandprecautionsforuse

Informationtobegiventothepatient:PatientsshouldbeinformedthatCarduraXLtabletsshouldbeswallowed

whole.Patientsshouldnotchew,divideorcrushthetablets.

InCarduraXL,theactivecompoundissurroundedbyaninert,non-absorbableshellthathasbeenspeciallydesignedto

controlthereleaseofthedrugoveraprolongedperiod.Aftertransitthroughthegastrointestinaltract,whenthisprocess

iscompletedtheemptytabletshelliseliminatedfromthebody.Patientsshouldbeadvisedthattheyshouldnotbe

concernediftheyoccasionallyobserveremainsintheirstoolsthatlooklikeatablet.

Abnormallyshorttransittimesthroughthegastrointestinaltract(e.g.followingsurgicalresection)couldresultin

incompleteabsorption.Inviewofthelonghalflifeofdoxazosintheclinicalsignificanceofthisisunclear.

PosturalHypotension/Syncope:

Initiationoftherapy–Inrelationwiththealpha-blockingpropertiesofdoxazosin,patientsmayexperiencepostural

hypotensionevidencedbydizzinessandweakness,orrarelylossofconsciousness(syncope),particularlywiththe

commencementoftherapy.Therefore,itisprudentmedicalpracticetomonitorbloodpressureoninitiationoftherapy

tominimisethepotentialforposturaleffects.

Wheninstitutingtherapywithanyeffectivealpha-blocker,thepatientshouldbeadvisedhowtoavoidsymptoms

resultingfromposturalhypotensionandwhatmeasurestotakeshouldtheydevelop.Thepatientshouldbecautionedto

avoidsituationswhereinjurycouldresultshoulddizzinessorweaknessoccurduringtheinitiationofCarduraXL

therapy,suchasdrivingoroperatingmachinery.

UseinpatientswithAcuteCardiacConditions:

Aswithanyothervasodilatoryanti-hypertensiveagentitisprudentmedicalpracticetoadvisecautionwhen

administeringdoxazosintopatientswiththefollowingacutecardiacconditions:

-pulmonaryoedemaduetoaorticormitralstenosis

-heartfailureathighoutput

-right-sidedheartfailureduetopulmonaryembolismorpericardialeffusion

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UseinHepaticallyImpairedPatients:Aswithanydrugwhollymetabolisedbytheliver,CarduraXLshouldbe

administeredwithparticularcautiontopatientswithevidenceofimpairedhepaticfunction(seesection5.2

Pharmacokineticproperties).Sincethereisnoclinicalexperienceinpatientswithseverehepaticimpairmentusein

thesepatientsisnotrecommended.

UseinpatientswithImpairedrenalfunction:ThereisnoevidencethatCarduraXLaggravatesrenaldysfunction.

However,CarduraXLdosageintroductionandadjustmentsshouldbecarriedoutwithgreatcare.

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

Phosphodiesterase-5-inhibitors(eg.Sildenafil,tadalafil,vardenafil)

ConcomitantadministrationofanalphablockerwithaPDE-5inhibitormayleadtosymptomatichypotensioninsome

patients(seesection4.4).NostudieshavebeenconductedwithCarduraXL.

Doxazosinishighlyboundtoplasmaproteins(98%).Invitrodatainhumanplasmaindicatesthatdoxazosinhasnoeffect

onproteinbindingofthedrugstested(digoxin,phenytoin,warfarinorindomethacin).However,thetheoreticalpotential

forinteractionwithotherproteinbounddrugsshouldbeborneinmind.

Conventionaldoxazosinhasbeenadministeredwithoutanyadversedruginteractionsinclinicalexperiencewiththiazide

diuretics,furosemide,beta-blockingagents,non-steroidalanti-inflammatorydrugs,antibiotics,oralhypoglycaemicdrugs,

uricosuricagents,oranticoagulants.However,datafromformaldrug/druginteractionstudiesarenotpresent.

Doxazosinpotentiatesthebloodpressureloweringactivityofotheralpha-blockersandotherantihypertensives.

Inanopen-label,randomized,placebo-controlledtrialin22healthymalevolunteers,theadministrationofasingle1mg

doseofdoxazosinonday1ofafour-dayregimenoforalcimetidine(400mgtwicedaily)resultedina10%increasein

meanAUCofdoxazosin,andnostatisticallysignificantchangesinmeanCmaxandmeanhalf-lifeofdoxazosin.The

10%increaseinthemeanAUCfordoxazosinwithcimetidineiswithinintersubjectvariation(27%)ofthemeanAUCfor

doxazosinwithplacebo.

4.6Fertility,pregnancyandlactation

Forthehypertensionindication:

Useduringpregnancy:Astherearenoadequateandwell-controlledstudiesinpregnantwomen,thesafetyofCardura

XLduringpregnancyhasnotyetbeenestablished.Accordingly,CarduraXLshouldbeusedonlywhen,intheopinion

ofthephysician,thepotentialbenefitoutweighsthepotentialrisk.

Doxazosincrossestheplacenta.Althoughnoteratogeniceffectswereseeninanimaltesting,reducedfoetalsurvival

wasobservedinanimalsatextremelyhighdoses(seeSection5.3:PreclinicalSafetyData).Thesedoseswere

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Useduringlactation:Doxazosiniscontraindicatedduringlactationasanimalstudieshaveshownthatdoxazosin

accumulatesinmilkoflactatingrats,andthereisnoinformationabouttheexcretionofthedrugintothemilkof

lactatingwomen.TheclinicalsafetyofCarduraduringlactationhasnotbeenestablished,consequentlyCardurais

contra-indicatedinnursingmothers.

Useduringbreast-feeding:Alternatively,mothersshouldstopbreast-feedingwhentreatmentwithdoxazosinis

necessary(Pleaseseesection5.3:PreclinicalSafetyData).

4.7Effectsonabilitytodriveandusemachines

Theabilitytoengageinactivitiessuchasoperatingmachineryoroperatingamotorvehiclemaybeimpaired,especially

wheninitiatingtherapy.Thedrugmayalsoinducedrowsiness.Patientsshouldnotdriveoroperatemachineryunlessit

hasbeenshownnottoaffecttheiralertnessordexterity.

4.8Undesirableeffects

Inclinicaltrials,themostcommonreactionsassociatedwithCarduraXLwereofaposturaltype(rarelyassociatedwith

fainting)ornon-specific.

TheundesiableeffectsforCarduraXLaresimilartothosewithimmediatereleaseCarduratablets.

ThefollowingundesirableeffectshavebeenobservedandreportedduringtreatmentwithCarduraXLwiththe

followingfrequencies:Verycommon(1/10),Common(1/100to<1/10),Uncommon(1/1,000to<1/100),Rare

(1/10,000to<1/1,000),Veryrare(<1/10,000).

SystemOrgan

Class Very

Common

(1/10) Common

(1/1,100to

<1/10) Uncommon

(1/1,000to

<1/100) Rare

(1/10,000

to

<1/1,000) VeryRare

(<1/10,000) Unknown

Infectionsand

infestations Respiratory

tract

infection,

urinarytract

infection

Bloodandthe

lymphatic

system

disorders Leukopenia,

thrombocytopenia

Immune

System

disorders Allergicdrug

reaction

Metabolism

andnutrition

disorders Anorexia,gout,

increased

appetite

Psychiatric

disorders Anxiety,

depression,

insomnia Agitation,

nervousness

Nervous

system

disorders Dizziness,

headache,

somnolence Cerebrovascular

accident,

hypoesthesia,

syncope,

tremor Dizziness,

postural

paraesthesia

Eyedisorders Blurredvision Intraoperative

floppyiris

syndrome(see

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Reportingofsuspectedadversereactions

Reportingsuspectedadversereactionsafterauthorisationofthemedicinalproductisimportant.Itallowscontinued

monitoringofthebenefit/riskbalanceofthemedicinalproduct.Healthcareprofessionalsareaskedtoreportany

suspectedadversereactionsviaHPRAPharmacovigilance,EarlsfortTerrace,IRL-Dublin2;Tel:+35316764971;

Earand

labyrinth

disorders Vertigo Tinnitus

Cardiac

disorders Palpitation,

tachycardia Angina

pectoris,

myocardial

infarction Bradycardia,

cardiac

arrhythmias

Vascular

disorders Hypotension,

postural

hypotension Hotflush

Respiratory,

thoracicand

mediastinal

disorders Bronchitis,

cough,

dyspnea,

rhinitis epistaxis Bronchospasm

Gastrointestinal

disorders Abdominal

pain,

dyspepsia,

drymouth,

nausea Constipation,

diarrhoea,

flatulence,

vomiting,

gastroenteritis

Hepato-biliary

disorders Abnormalliver

functiontests Cholestasis,

hepatitis,

jaundice

Skinand

subcutaneous

tissue

disorders pruritis Skinrash Alopecia,

purpura,urticaria

Musculoskeletal,

connective

tissueandbone

disorders Backpain,

myalgia arthralgia Musclecramps,

muscleweakness

Renaland

urinary

disorders Cystitis,

urinary

incontinence Dysuria,

hematuria,

micturition

frequency Micturition

disorder,

Nocturia,

polyuria,

increased

diuresis

Reproductive

systemand

breast

disorders Impotence Gynaecomastia,

priapism Retrograde

ejaculation

General

disordersand

administration

siteconditions Asthenia,

chestpain,

influenza-

like

symptoms,

peripheral

oedema Pain,facial

oedema Fatigue,malaise

Investigations Weight

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4.9Overdose

Shouldoverdosageleadtohypotension,thepatientshouldbeimmediatelyplacedinasupine,headdownposition.

Othersupportivemeasuresmaybeappropriateinindividualcases.Sincedoxazosinishighlyproteinbound,dialysisis

notindicated.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Doxazosinisapotentandselectivepost-junctionalalpha1-adrenoreceptorantagonist.

AdministrationofCarduraXLtohypertensivepatientscausesaclinicallysignificantreductioninbloodpressureasa

resultofareductioninsystemicvascularresistance.Thiseffectisthoughttoresultfromselectiveblockadeofthealpha-

1-adrenoreceptorslocatedinthevasculature.Withoncedailydosing,clinicallysignificantreductionsinbloodpressure

arepresentthroughoutthedayandat24hourspostdose.Themajorityofpatientsarecontrolledontheinitialdose.In

patientswithhypertension,bloodpressureduringtreatmentwithCarduraXLwassimilarinboththesupineandstanding

position.

Responderdatafromthe2primaryhypertensionefficacystudies(includingatotalof630doxazosintreatedpatients)

indicatethatthosepatientscontrolledon1mg,2mgor4mgdoxazosinimmediatereleasetabletswouldbeequallywell

controlledon4mgCarduraXL.

Doxazosinhasbeenshowntobefreeofadversemetaboliceffectsandissuitableforuseinpatientswithcoexistent

diabetesmellitus,goutandinsulinresistance.

Doxazosinissuitableforuseinpatientswithco-existentasthma,leftventricularhypertrophyandinelderlypatients.

Treatmentwithdoxazosinhasbeenshowntoresultinregressionofleftventricularhypertrophy,inhibitionofplatelet

aggregationandenhancedactivityoftissueplasminogenactivator.Additionally,doxazosinimprovesinsulinsensitivityin

patientswithimpairment.

Doxazosinproducesfavourableeffectsonbloodlipids,withasignificantincreaseintheHDL/totalcholesterolratioand

trendstoafavourablereductionintotaltriglycerides.Itthereforeconfersanadvantageoverdiureticsandbeta

adrenoreceptorblockingagentswhichadverselyaffecttheseparameters.Basedontheestablishedassociationof

hypertensionandbloodlipidswithcoronaryheartdisease,thefavourableeffectsofdoxazosintherapyonbothblood

pressureandlipidsindicateareductioninriskofdevelopingcoronaryheartdisease.

5.2Pharmacokineticproperties

Absorption

Afteroraladministrationoftherapeuticdoses,CarduraXLiswellabsorbedwithpeakbloodlevelsgraduallyreachedat

8to9hoursafterdosing.Peakplasmalevelsareapproximatelyonethirdofthoseofthesamedoseofimmediate

releaseCarduratablets.Troughlevelsat24hoursare,however,similar.

ThepharmacokineticcharacteristicsofCarduraXLwillleadtoasmootherplasmaprofile.

Peak/troughratioofCarduraXLislessthanhalfthatofimmediatereleaseCarduratablets.

Atsteadystate,therelativebioavailabilityofdoxazosinfromCarduraXLcomparedtotheimmediatereleaseformwas

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PharmacokineticstudieswithCarduraXLintheelderlyhaveshownnosignificantalterationscomparedtoyounger

patients.

Biotransformation/Elimination

Theplasmaeliminationisbiphasicwiththeterminaleliminationhalf-lifebeing22hoursandhencethisprovidesthe

basisforoncedailydosing.Doxazosinisextensivelymetabolisedwith<5%excretedasunchangeddrug.

PharmacokineticstudieswithimmediatereleaseCardurainpatientswithrenalimpairmentalsoshowednosignificant

alterationscomparedtopatientswithnormalrenalfunction.

Thereareonlylimiteddatainpatientswithliverimpairmentandontheeffectsofdrugsknowntoinfluencehepatic

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

administrationofdoxazosinresultedinanincreaseinAUCof43%andadecreaseinapparentoralclearanceof30%.

(Seealso4.4SpecialWarningsandPrecautionsforUse).

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

Macrogol

Pharmaceuticalglaze

Propyleneglycol

Blackironoxide(E172)

Ammoniumhydroxide

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove30 o

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6.5Natureandcontentsofcontainer

CarduraXL8mgProlongedReleaseTabletsareavailableascalendarpacksof28tablets.

Aluminiumfoil/aluminiumfoilblisterstripsinacarton.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7PARALLELPRODUCTAUTHORISATIONHOLDER

PCOManufacturing

Unit10,AshbourneBusinessPark

Rath

Ashbourne

Co.Meath

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA0465/095/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:29October1999

Dateoflastrenewal:29October2009

10DATEOFREVISIONOFTHETEXT

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