CARDURA XL 4 Milligram Tablet Prolonged Release

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
DOXAZOSIN
Available from:
IMED Healthcare Ltd.
INN (International Name):
DOXAZOSIN
Dosage:
4 Milligram
Pharmaceutical form:
Tablet Prolonged Release
Authorization status:
Authorised
Authorization number:
PPA1463/005/001
Authorization date:
0000-00-00

PACKAGELEAFLET:INFORMATION FOR THEUSER

CARDURA™ XL 4mg

CARDURA™ XL 8mg

Prolonged –releaseTablets

doxazosin (asmesilate)

ImportantthingsthatyouSHOULDknowaboutyourmedicine:

CarduraXLisatreatmentforhighbloodpressure

Thismedicinehasbeenprescribedforyou.Donotpassitontoothers.It

mayharmthem,eveniftheirsymptomsarethesameasyours.

YoushouldtakeCarduraXLregularlytogetthemaximumbenefit,evenif

youarefeelingwell.

MostpeopledonothaveseriousproblemswhentakingCarduraXLbut

sideeffectscanoccur –seeSection4fordetails.Ifyouexperience

swellingoftheface,tongueorwindpipe,seeyourdoctorimmediately.If

anyofthesideeffectsgetsserious,orifyounoticeanysideeffectsnot

listedinthisleaflet,pleasetellyourdoctororpharmacist.

Takingothermedicinesmaysometimescauseproblems.Checkwithyour

doctororpharmacistbeforetakingthisoranyothermedicines.

Ifyouare,oraretryingtobecome,pregnant,donottakeCarduraXLand

tellyourdoctor.

Pleasereadtherestofthisleaflet.Itincludesotherimportantinformationon

thesafeandeffectiveuseofthismedicinethatmightbeespecially

importanttoyou.Ifyouhaveanyfurtherquestions,askyourdoctoror

pharmacist.

Inthisleaflet:

1.WhatCarduraXLisandwhatitisusedfor

2.BeforeyoutakeCarduraXL

3.HowtotakeCarduraXL

4.Possiblesideeffects

5.HowtoStoreCarduraXL

6.Furtherinformation

1.WhatCarduraXLisandwhatitisusedfor

CarduraXLisoneofagroupofmedicinescalledalpha-blockers.Itisused

totreathighbloodpressure.

CarduraXLcanbeusedtotreathighbloodpressure(hypertension),by

relaxingbloodvesselssothatbloodpassesthroughthemmoreeasily.This

helpstolowerbloodpressure.

2.BeforeYouTakeCarduraXL

Donot takeCarduraXL:

IfyouhavehadanallergicreactioninthepasttoCarduraXL,theactive

ingredientdoxazosin,othertypesofquinazolines(suchasprazosinor

terazosin)oranyoftheotheringredientslistedinsection6.Thismay

havebeenitching,reddeningoftheskinordifficultyinbreathing.

Ifyouarebreast-feeding

Ifyouhaveanyformofobstructionofthedigestivetract

Ifyouareunder12yearsofage

Ifyouhaveahistoryofaconditionknownas„orthostatichypotension‟

whichisaformoflowbloodpressurethatcausesyoutofeeldizzyor

light-headedwhenyoustandupfromsittingorlyingdown

Ifyouhaveanenlargedprostateglandwithoneofthefollowing:any

kindofcongestionorblockageinyoururinarytract;alongstanding

infectionoftheurinarytract;oryouhavebladderstones.

Ifyouhaveanenlargedprostateglandandhaveoverflowincontinence

(youdonotfeeltheurgetourinate),oranuria(yourbodyisnot

producinganyurine)withorwithoutkidneyproblems.

TakespecialcarewithCarduraXL:

ThefollowingarereasonswhyCarduraXLmaynotbesuitableforyou:

Ifyouarepregnantortryingtobecomepregnant

Ifyouhaveliver,kidneyorheartdisease

Ifyouarealsotakingothermedicines

Ifyouhaveproblemswithyourheart

Ifyouareundergoingeyesurgerybecauseofcataract(cloudinessofthe

lens)pleaseinformyoureyespecialistbeforetheoperationthatyouare

usingorhavepreviouslyusedCarduraXL.Thisisbecausethismedicine

maycausecomplicationsduringthesurgerywhichcanbemanagedifyour

specialistispreparedinadvance.

WhenyoustarttotakeCarduraXLyoumayexperiencefaintnessor

lyingdown.Ifyoufeelfaintordizzy,youshouldsitorliedownuntilyoufeel

betterandavoidsituationswhereyoumightfallorhurtyourself.

Takingothermedicines:

TherearesomemedicinesthatmayinteractwithCarduraXL:

Medicinesforerectiledysfunction(impotence)suchassildenafil,

tadalafilorvardenafil.Somepatientswhotakealpha-blockertherapyfor

thetreatmentofhighbloodpressureorprostateenlargementmay

experiencedizzinessorlight-headedness,whichmaybecausedbylow

bloodpressureuponsittingorstandingupquickly.Certainpatients

haveexperiencedthesesymptomswhentakingdrugsforerectile

dysfunction(impotence)withalpha-blockers.Inordertoreducethe

likelihoodthatthesesymptomsoccur,youshouldbeonaregulardaily

doseofyouralphablockerbeforeyoustartdrugsforerectile

dysfunction.

CarduraXLmayalsoincreasetheeffectsofdrugsusedtotreathigh

bloodpressure(hypertension)

Youshouldalwaystellyourdoctorifyouaretakingorhaverecentlytaken

anyothermedicine,eventhosenotprescribed,becausetheymightinteract

withCarduraXL.

TakingCarduraXLwithfoodanddrink:

CarduraXLcanbetakenwithorwithoutfood.

PregnancyandBreast-feeding:

ThesafetyofusingCarduraXLduringpregnancyhasnotbeenestablished.

Ifyouarepregnantortryingtobecomepregnantspeaktoyourdoctorwho

willdecideifthismedicineissuitableforyou.DonottakeCarduraXLifyou

arebreast-feeding.

Drivingandusingmachinery:

Takecareifyoudriveoroperatemachinery.Yourtabletsmayaffectyour

abilitytodriveoroperatemachinerysafely,particularlywhenyoufirststart

totakethem.Theymaycausedrowsinessandcouldalsomakeyoufeel

weakordizzy.Ifyouareaffected,donotdriveoroperatemachineryand

contactyourdoctorimmediately.

3.HowtoTakeCarduraXL

CarduraXLisamodifiedreleasetablet.Themedicineiscontainedwithina

non-absorbableshellthathasbeenspeciallydesignedtoslowlyreleasethe

medicine.Onceswallowed,themedicine(doxazosin)isslowlyreleasedinto

thebodyfromthetablet,untilthetabletisempty.

Sincetheemptytabletiseliminatedfromthebodyinbowelmovements,

youmayoccasionallyobserveinthestools,somethingthatlookslikea

tablet.Thisistobeexpectedandyoushouldnotbeconcerned.

Howtotakeyourmedicine:

TheusualdoseofCarduraXLisone4mgmodifiedreleasetablettaken

onceaday.Yourdoctormaywishtoincreaseyourdoseto8mg.Thisis

themaximumdoseofthismedicine.

Swallowyourmedicinewholewithwater.Donotchew,divideor

crushthetablets.

Takeyourtabletsasyourdoctortoldyou.

Itisimportanttokeeptakingyourtablets.Theyhelptocontrolyour

bloodpressure.

Don'tchangethedoseorstoptakingthetabletswithoutfirstchecking

withyourdoctor.

Don'twaituntilyourtabletsarefinishedbeforeseeingyourdoctor.

Ifyouarestillnotsurehowtotakeyourtablets,askyourdoctoror

pharmacist.

IfyoutakemoreCarduraXLthanyoushould:

Takingtoomanytabletsatoncemaymakeyouunwell.Ifseveraltabletsare

takenitmaybedangerous.Tellyourdoctorimmediatelyorgotoyour

nearesthospitalcasualtydepartmentimmediately.

IfyoumissadoseofCarduraXL:

Donotworry.Ifyouforgettotakeatablet,leavethatdoseoutcompletely.

Thengoonasbefore.

4.Possibleside effects

Likeallmedicines,CarduraXLcancausesideeffectsalthoughnot

everybodygetsthem.

STOPtakingCarduraXLandcallanambulanceimmediatelyifyou

experienceanyofthefollowing:

Heartattack.

Increased,decreasedorirregularheartbeat.

Weaknessofarms,legsorproblemsspeakingwhichmaybesymptoms

ofastroke

Allergicreactions(hypersensitivity).Symptomsincludesudden

wheeziness,tightnessinchest,difficultyinbreathing,swellingofthe

face,tongueorthroat,rashoritching(especiallyaffectingthewhole

body).

Tellyourdoctorimmediatelyifyouexperienceanyofthefollowing

symptomsaftertakingCarduraXL:

Chestpain(angina),wheezing,shortnessofbreath,difficultybreathing.

Feelingyourheartbeat(palpitations).

Fainting.

Yellowingoftheskinortheeyes(jaundice).

Lownumbersofwhitebloodcellsorbloodplatelets,whichmayresultin

bruisingoreasybleeding.

Thefollowingeventshavebeenreportedinpatientsbeingtreatedwith

CarduraXL.Ifanyofthesesideeffectsgetserious,orifyounoticeanyside

effectsnotlistedinthisleaflet,pleasetellyourdoctor.

Commonsideeffects

Thesecanaffectbetween1in10and1in100patients:

dizziness,feelingofspinningorrotationofsurroundings(vertigo),

headache

lowbloodpressure

swellingoffeet,anklesorfingers

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

nasalstuffiness,sneezingand/orrunnynosecausedbyinflammationof

theliningofthenose(rhinitis)

stomach/abdominalpains,feeling/beingsick

urinarytractinfection,cystitis,urinaryincontinence(inabilitytocontrol

passingurine)

sleepiness,generalweakness

indigestion,drymouth

itching

backpain,painfulmuscles

flu-likesymptoms

Uncommonsideeffects:

Thesecanaffectbetween1in100and1in1,000patients:

constipation,wind,inflammationofthestomachandintestines

(gastroenteritis)whichcancausediarrhoeaandvomiting

painordiscomfortonpassingurine,increasedfrequencyinpassing

urine,bloodinurine

inflammationofthejoints(gout),painfuljoints,generalpain

sleeplessness,anxiety,depression

reducedoralteredsenseoftouchorsensationofthehandsandfeet

increasedappetiteorlossofappetite,weightgain

nosebleeds

skinrash

ringingornoiseintheears,tremor

failure/inabilitytoachievepenileerection

liverenzymeincreaseswhichmayhaveaneffectonsomemedical

tests

VeryRareside effects

Thesecanaffectlessthan1in10,000patients:

faintnessordizzinesscausedbylowbloodpressurewhengettingup

fromasittingorlyingposition

agitationornervousness

hepatitis(liverinflammation)orbiledisorder

hives,hairloss,redorpurplepatchesontheskin,bleedingunderthe

skin

tinglingornumbnessofthehandsandfeet

tiredness,generallyfeelingunwell

blurredvision

hotflushes

musclecramps,muscleweakness

disorderinpassingurine,needingtopassurineatnight,increased

numberoftimesofpassingurine,increasedvolumeofurinepassed

discomfortorenlargementofthebreastsinmen

painfulpersistenterectionofthepenis

Othersideeffects

Thefrequencyofthesesideeffectsisunknown:

littleornosemenejaculatedatsexualclimax,cloudyurinefollowing

sexualclimax

eyeproblemsmayoccurduringeyesurgeryforcataract(cloudinessof

thelensoftheeye).Sees ection“TakespecialcarewithCarduraXL”.

Ifanyofthesideeffectsgetsserious,orifyounoticeanysideeffectsnot

listedinthisleaflet,pleasetellyourdoctor.

5.HowtoStoreCarduraXL

Keepyourtabletsoutofthereachandsightofchildren.

DonotuseCarduraXLaftertheexpirydatewhichisstatedonthecarton

andtabletblisterafterExp.Theexpirydatereferstothelastdayofthat

month.

Donotstoreabove30ºC.

Keepyourtabletsintheoriginalpackaging.Thismedicineissensitiveto

moisture.

Thetabletsshouldbewholetoworkeffectively;ifyounoticeanydefects

(suchasbrokentablets)consultyourpharmacistimmediately.

6.FurtherInformation

WhatCarduraXLcontains anditspackage:

Theactivesubstanceisdoxazosin(asdoxazosinmesilate)

Theotheringredientsarepolyethyleneoxide,sodiumchloride,

hypromellose,redferricoxide(E172),titaniumdioxide(E171),

magnesiumstearate,celluloseacetate,Macrogol,pharmaceutical

glaze,blackironoxide(E172),ammoniumhydroxideandpropylene

glycol

CarduraXLtabletscomeintwostrengths,4mgand8mg.

Eachtabletcontainsdoxazosinmesilateequivalentto4mgor8mgof

doxazosin,withinashellthathasbeenspeciallydesignedtoslowlyrelease

thedrug.

The4mgtabletsarewhite,roundbiconvexshapedwithaholeinoneside,

markedCXL4.

The8mgtabletsarewhite,roundbiconvexshapedwithaholeinoneside,

markedCXL8.

CarduraXLtabletsareavailableinpacksof28tablets.

ProductprocuredfromwithintheEUbythe ParallelProduct

AuthorisationHolder:

IMEDHealthcareLtd

Unit625KilshaneAvenue

NorthwestBusinessPark

Ballycoolin

Dublin15

Ireland.

Manufacturer:

PfizerManufacturingDeutschlandGmbH

Heinrich-Mack-Strasse35

89257Illertissen

Germany

Repackagedby:

CastHealthcareLtd

UnitB6TheBusinessCentre

5-7TobermoreRoad

Draperstown

NorthernIreland

BT457AG

Dateoflastrevision:November2013

PACKAGELEAFLET:INFORMATION FOR THEUSER

CARDURA™ XL 4mg

CARDURA™ XL 8mg

Prolonged –releaseTablets

doxazosin (asmesilate)

ImportantthingsthatyouSHOULDknowaboutyourmedicine:

CarduraXLisatreatmentforhighbloodpressure

Thismedicinehasbeenprescribedforyou.Donotpassitontoothers.It

mayharmthem,eveniftheirsymptomsarethesameasyours.

YoushouldtakeCarduraXLregularlytogetthemaximumbenefit,evenif

youarefeelingwell.

MostpeopledonothaveseriousproblemswhentakingCarduraXLbut

sideeffectscanoccur –seeSection4fordetails.Ifyouexperience

swellingoftheface,tongueorwindpipe,seeyourdoctorimmediately.If

anyofthesideeffectsgetsserious,orifyounoticeanysideeffectsnot

listedinthisleaflet,pleasetellyourdoctororpharmacist.

Takingothermedicinesmaysometimescauseproblems.Checkwithyour

doctororpharmacistbeforetakingthisoranyothermedicines.

Ifyouare,oraretryingtobecome,pregnant,donottakeCarduraXLand

tellyourdoctor.

Pleasereadtherestofthisleaflet.Itincludesotherimportantinformationon

thesafeandeffectiveuseofthismedicinethatmightbeespecially

importanttoyou.Ifyouhaveanyfurtherquestions,askyourdoctoror

pharmacist.

Inthisleaflet:

1.WhatCarduraXLisandwhatitisusedfor

2.BeforeyoutakeCarduraXL

3.HowtotakeCarduraXL

4.Possiblesideeffects

5.HowtoStoreCarduraXL

6.Furtherinformation

1.WhatCarduraXLisandwhatitisusedfor

CarduraXLisoneofagroupofmedicinescalledalpha-blockers.Itisused

totreathighbloodpressure.

CarduraXLcanbeusedtotreathighbloodpressure(hypertension),by

relaxingbloodvesselssothatbloodpassesthroughthemmoreeasily.This

helpstolowerbloodpressure.

2.BeforeYouTakeCarduraXL

Donot takeCarduraXL:

IfyouhavehadanallergicreactioninthepasttoCarduraXL,theactive

ingredientdoxazosin,othertypesofquinazolines(suchasprazosinor

terazosin)oranyoftheotheringredientslistedinsection6.Thismay

havebeenitching,reddeningoftheskinordifficultyinbreathing.

Ifyouarebreast-feeding

Ifyouhaveanyformofobstructionofthedigestivetract

Ifyouareunder12yearsofage

Ifyouhaveahistoryofaconditionknownas„orthostatichypotension‟

whichisaformoflowbloodpressurethatcausesyoutofeeldizzyor

light-headedwhenyoustandupfromsittingorlyingdown

Ifyouhaveanenlargedprostateglandwithoneofthefollowing:any

kindofcongestionorblockageinyoururinarytract;alongstanding

infectionoftheurinarytract;oryouhavebladderstones.

Ifyouhaveanenlargedprostateglandandhaveoverflowincontinence

(youdonotfeeltheurgetourinate),oranuria(yourbodyisnot

producinganyurine)withorwithoutkidneyproblems.

TakespecialcarewithCarduraXL:

ThefollowingarereasonswhyCarduraXLmaynotbesuitableforyou:

Ifyouarepregnantortryingtobecomepregnant

Ifyouhaveliver,kidneyorheartdisease

Ifyouarealsotakingothermedicines

Ifyouhaveproblemswithyourheart

Ifyouareundergoingeyesurgerybecauseofcataract(cloudinessofthe

lens)pleaseinformyoureyespecialistbeforetheoperationthatyouare

usingorhavepreviouslyusedCarduraXL.Thisisbecausethismedicine

maycausecomplicationsduringthesurgerywhichcanbemanagedifyour

specialistispreparedinadvance.

WhenyoustarttotakeCarduraXLyoumayexperiencefaintnessor

lyingdown.Ifyoufeelfaintordizzy,youshouldsitorliedownuntilyoufeel

betterandavoidsituationswhereyoumightfallorhurtyourself.

Takingothermedicines:

TherearesomemedicinesthatmayinteractwithCarduraXL:

Medicinesforerectiledysfunction(impotence)suchassildenafil,

tadalafilorvardenafil.Somepatientswhotakealpha-blockertherapyfor

thetreatmentofhighbloodpressureorprostateenlargementmay

experiencedizzinessorlight-headedness,whichmaybecausedbylow

bloodpressureuponsittingorstandingupquickly.Certainpatients

haveexperiencedthesesymptomswhentakingdrugsforerectile

dysfunction(impotence)withalpha-blockers.Inordertoreducethe

likelihoodthatthesesymptomsoccur,youshouldbeonaregulardaily

doseofyouralphablockerbeforeyoustartdrugsforerectile

dysfunction.

CarduraXLmayalsoincreasetheeffectsofdrugsusedtotreathigh

bloodpressure(hypertension)

Youshouldalwaystellyourdoctorifyouaretakingorhaverecentlytaken

anyothermedicine,eventhosenotprescribed,becausetheymightinteract

withCarduraXL.

TakingCarduraXLwithfoodanddrink:

CarduraXLcanbetakenwithorwithoutfood.

PregnancyandBreast-feeding:

ThesafetyofusingCarduraXLduringpregnancyhasnotbeenestablished.

Ifyouarepregnantortryingtobecomepregnantspeaktoyourdoctorwho

willdecideifthismedicineissuitableforyou.DonottakeCarduraXLifyou

arebreast-feeding.

Drivingandusingmachinery:

Takecareifyoudriveoroperatemachinery.Yourtabletsmayaffectyour

abilitytodriveoroperatemachinerysafely,particularlywhenyoufirststart

totakethem.Theymaycausedrowsinessandcouldalsomakeyoufeel

weakordizzy.Ifyouareaffected,donotdriveoroperatemachineryand

contactyourdoctorimmediately.

3.HowtoTakeCarduraXL

CarduraXLisamodifiedreleasetablet.Themedicineiscontainedwithina

non-absorbableshellthathasbeenspeciallydesignedtoslowlyreleasethe

medicine.Onceswallowed,themedicine(doxazosin)isslowlyreleasedinto

thebodyfromthetablet,untilthetabletisempty.

Sincetheemptytabletiseliminatedfromthebodyinbowelmovements,

youmayoccasionallyobserveinthestools,somethingthatlookslikea

tablet.Thisistobeexpectedandyoushouldnotbeconcerned.

Howtotakeyourmedicine:

TheusualdoseofCarduraXLisone4mgmodifiedreleasetablettaken

onceaday.Yourdoctormaywishtoincreaseyourdoseto8mg.Thisis

themaximumdoseofthismedicine.

Swallowyourmedicinewholewithwater.Donotchew,divideor

crushthetablets.

Takeyourtabletsasyourdoctortoldyou.

Itisimportanttokeeptakingyourtablets.Theyhelptocontrolyour

bloodpressure.

Don'tchangethedoseorstoptakingthetabletswithoutfirstchecking

withyourdoctor.

Don'twaituntilyourtabletsarefinishedbeforeseeingyourdoctor.

Ifyouarestillnotsurehowtotakeyourtablets,askyourdoctoror

pharmacist.

IfyoutakemoreCarduraXLthanyoushould:

Takingtoomanytabletsatoncemaymakeyouunwell.Ifseveraltabletsare

takenitmaybedangerous.Tellyourdoctorimmediatelyorgotoyour

nearesthospitalcasualtydepartmentimmediately.

IfyoumissadoseofCarduraXL:

Donotworry.Ifyouforgettotakeatablet,leavethatdoseoutcompletely.

Thengoonasbefore.

4.Possibleside effects

Likeallmedicines,CarduraXLcancausesideeffectsalthoughnot

everybodygetsthem.

STOPtakingCarduraXLandcallanambulanceimmediatelyifyou

experienceanyofthefollowing:

Heartattack.

Increased,decreasedorirregularheartbeat.

Weaknessofarms,legsorproblemsspeakingwhichmaybesymptoms

ofastroke

Allergicreactions(hypersensitivity).Symptomsincludesudden

wheeziness,tightnessinchest,difficultyinbreathing,swellingofthe

face,tongueorthroat,rashoritching(especiallyaffectingthewhole

body).

Tellyourdoctorimmediatelyifyouexperienceanyofthefollowing

symptomsaftertakingCarduraXL:

Chestpain(angina),wheezing,shortnessofbreath,difficultybreathing.

Feelingyourheartbeat(palpitations).

Fainting.

Yellowingoftheskinortheeyes(jaundice).

Lownumbersofwhitebloodcellsorbloodplatelets,whichmayresultin

bruisingoreasybleeding.

Thefollowingeventshavebeenreportedinpatientsbeingtreatedwith

CarduraXL.Ifanyofthesesideeffectsgetserious,orifyounoticeanyside

effectsnotlistedinthisleaflet,pleasetellyourdoctor.

Commonsideeffects

Thesecanaffectbetween1in10and1in100patients:

dizziness,feelingofspinningorrotationofsurroundings(vertigo),

headache

lowbloodpressure

swellingoffeet,anklesorfingers

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

nasalstuffiness,sneezingand/orrunnynosecausedbyinflammationof

theliningofthenose(rhinitis)

stomach/abdominalpains,feeling/beingsick

urinarytractinfection,cystitis,urinaryincontinence(inabilitytocontrol

passingurine)

sleepiness,generalweakness

indigestion,drymouth

itching

backpain,painfulmuscles

flu-likesymptoms

Uncommonsideeffects:

Thesecanaffectbetween1in100and1in1,000patients:

constipation,wind,inflammationofthestomachandintestines

(gastroenteritis)whichcancausediarrhoeaandvomiting

painordiscomfortonpassingurine,increasedfrequencyinpassing

urine,bloodinurine

inflammationofthejoints(gout),painfuljoints,generalpain

sleeplessness,anxiety,depression

reducedoralteredsenseoftouchorsensationofthehandsandfeet

increasedappetiteorlossofappetite,weightgain

nosebleeds

skinrash

ringingornoiseintheears,tremor

failure/inabilitytoachievepenileerection

liverenzymeincreaseswhichmayhaveaneffectonsomemedical

tests

VeryRareside effects

Thesecanaffectlessthan1in10,000patients:

faintnessordizzinesscausedbylowbloodpressurewhengettingup

fromasittingorlyingposition

agitationornervousness

hepatitis(liverinflammation)orbiledisorder

hives,hairloss,redorpurplepatchesontheskin,bleedingunderthe

skin

tinglingornumbnessofthehandsandfeet

tiredness,generallyfeelingunwell

blurredvision

hotflushes

musclecramps,muscleweakness

disorderinpassingurine,needingtopassurineatnight,increased

numberoftimesofpassingurine,increasedvolumeofurinepassed

discomfortorenlargementofthebreastsinmen

painfulpersistenterectionofthepenis

Othersideeffects

Thefrequencyofthesesideeffectsisunknown:

littleornosemenejaculatedatsexualclimax,cloudyurinefollowing

sexualclimax

eyeproblemsmayoccurduringeyesurgeryforcataract(cloudinessof

thelensoftheeye).Sees ection“TakespecialcarewithCarduraXL”.

Ifanyofthesideeffectsgetsserious,orifyounoticeanysideeffectsnot

listedinthisleaflet,pleasetellyourdoctor.

5.HowtoStoreCarduraXL

Keepyourtabletsoutofthereachandsightofchildren.

DonotuseCarduraXLaftertheexpirydatewhichisstatedonthecarton

andtabletblisterafterExp.Theexpirydatereferstothelastdayofthat

month.

Donotstoreabove30ºC.

Keepyourtabletsintheoriginalpackaging.Thismedicineissensitiveto

moisture.

Thetabletsshouldbewholetoworkeffectively;ifyounoticeanydefects

(suchasbrokentablets)consultyourpharmacistimmediately.

6.FurtherInformation

WhatCarduraXLcontains anditspackage:

Theactivesubstanceisdoxazosin(asdoxazosinmesilate)

Theotheringredientsarepolyethyleneoxide,sodiumchloride,

hypromellose,redferricoxide(E172),titaniumdioxide(E171),

magnesiumstearate,celluloseacetate,Macrogol,pharmaceutical

glaze,blackironoxide(E172),ammoniumhydroxideandpropylene

glycol

CarduraXLtabletscomeintwostrengths,4mgand8mg.

Eachtabletcontainsdoxazosinmesilateequivalentto4mgor8mgof

doxazosin,withinashellthathasbeenspeciallydesignedtoslowlyrelease

thedrug.

The4mgtabletsarewhite,roundbiconvexshapedwithaholeinoneside,

markedCXL4.

The8mgtabletsarewhite,roundbiconvexshapedwithaholeinoneside,

markedCXL8.

CarduraXLtabletsareavailableinpacksof28tablets.

ProductprocuredfromwithintheEUbythe ParallelProduct

AuthorisationHolder:

IMEDHealthcareLtd

Unit625KilshaneAvenue

NorthwestBusinessPark

Ballycoolin

Dublin15

Ireland.

Manufacturer:

PfizerManufacturingDeutschlandGmbH

Heinrich-Mack-Strasse35

89257Illertissen

Germany

Repackagedby:

CrossHealthcareLtd

Unit2ABandeathIndustrialEstate

Throsk

Stirlingshire

FK77NP

UK

Dateoflastrevision:November2013

PACKAGELEAFLET:INFORMATION FOR THEUSER

CARDURA™ XL 4mg

CARDURA™ XL 8mg

Prolonged –releaseTablets

doxazosin (asmesilate)

ImportantthingsthatyouSHOULDknowaboutyourmedicine:

CarduraXLisatreatmentforhighbloodpressure

Thismedicinehasbeenprescribedforyou.Donotpassitontoothers.It

mayharmthem,eveniftheirsymptomsarethesameasyours.

YoushouldtakeCarduraXLregularlytogetthemaximumbenefit,evenif

youarefeelingwell.

MostpeopledonothaveseriousproblemswhentakingCarduraXLbut

sideeffectscanoccur –seeSection4fordetails.Ifyouexperience

swellingoftheface,tongueorwindpipe,seeyourdoctorimmediately.If

anyofthesideeffectsgetsserious,orifyounoticeanysideeffectsnot

listedinthisleaflet,pleasetellyourdoctororpharmacist.

Takingothermedicinesmaysometimescauseproblems.Checkwithyour

doctororpharmacistbeforetakingthisoranyothermedicines.

Ifyouare,oraretryingtobecome,pregnant,donottakeCarduraXLand

tellyourdoctor.

Pleasereadtherestofthisleaflet.Itincludesotherimportantinformationon

thesafeandeffectiveuseofthismedicinethatmightbeespecially

importanttoyou.Ifyouhaveanyfurtherquestions,askyourdoctoror

pharmacist.

Inthisleaflet:

1.WhatCarduraXLisandwhatitisusedfor

2.BeforeyoutakeCarduraXL

3.HowtotakeCarduraXL

4.Possiblesideeffects

5.HowtoStoreCarduraXL

6.Furtherinformation

1.WhatCarduraXLisandwhatitisusedfor

CarduraXLisoneofagroupofmedicinescalledalpha-blockers.Itisused

totreathighbloodpressure.

CarduraXLcanbeusedtotreathighbloodpressure(hypertension),by

relaxingbloodvesselssothatbloodpassesthroughthemmoreeasily.This

helpstolowerbloodpressure.

2.BeforeYouTakeCarduraXL

Donot takeCarduraXL:

IfyouhavehadanallergicreactioninthepasttoCarduraXL,theactive

ingredientdoxazosin,othertypesofquinazolines(suchasprazosinor

terazosin)oranyoftheotheringredientslistedinsection6.Thismay

havebeenitching,reddeningoftheskinordifficultyinbreathing.

Ifyouarebreast-feeding

Ifyouhaveanyformofobstructionofthedigestivetract

Ifyouareunder12yearsofage

Ifyouhaveahistoryofaconditionknownas„orthostatichypotension‟

whichisaformoflowbloodpressurethatcausesyoutofeeldizzyor

light-headedwhenyoustandupfromsittingorlyingdown

Ifyouhaveanenlargedprostateglandwithoneofthefollowing:any

kindofcongestionorblockageinyoururinarytract;alongstanding

infectionoftheurinarytract;oryouhavebladderstones.

Ifyouhaveanenlargedprostateglandandhaveoverflowincontinence

(youdonotfeeltheurgetourinate),oranuria(yourbodyisnot

producinganyurine)withorwithoutkidneyproblems.

TakespecialcarewithCarduraXL:

ThefollowingarereasonswhyCarduraXLmaynotbesuitableforyou:

Ifyouarepregnantortryingtobecomepregnant

Ifyouhaveliver,kidneyorheartdisease

Ifyouarealsotakingothermedicines

Ifyouhaveproblemswithyourheart

Ifyouareundergoingeyesurgerybecauseofcataract(cloudinessofthe

lens)pleaseinformyoureyespecialistbeforetheoperationthatyouare

usingorhavepreviouslyusedCarduraXL.Thisisbecausethismedicine

maycausecomplicationsduringthesurgerywhichcanbemanagedifyour

specialistispreparedinadvance.

WhenyoustarttotakeCarduraXLyoumayexperiencefaintnessor

lyingdown.Ifyoufeelfaintordizzy,youshouldsitorliedownuntilyoufeel

betterandavoidsituationswhereyoumightfallorhurtyourself.

Takingothermedicines:

TherearesomemedicinesthatmayinteractwithCarduraXL:

Medicinesforerectiledysfunction(impotence)suchassildenafil,

tadalafilorvardenafil.Somepatientswhotakealpha-blockertherapyfor

thetreatmentofhighbloodpressureorprostateenlargementmay

experiencedizzinessorlight-headedness,whichmaybecausedbylow

bloodpressureuponsittingorstandingupquickly.Certainpatients

haveexperiencedthesesymptomswhentakingdrugsforerectile

dysfunction(impotence)withalpha-blockers.Inordertoreducethe

likelihoodthatthesesymptomsoccur,youshouldbeonaregulardaily

doseofyouralphablockerbeforeyoustartdrugsforerectile

dysfunction.

CarduraXLmayalsoincreasetheeffectsofdrugsusedtotreathigh

bloodpressure(hypertension)

Youshouldalwaystellyourdoctorifyouaretakingorhaverecentlytaken

anyothermedicine,eventhosenotprescribed,becausetheymightinteract

withCarduraXL.

TakingCarduraXLwithfoodanddrink:

CarduraXLcanbetakenwithorwithoutfood.

PregnancyandBreast-feeding:

ThesafetyofusingCarduraXLduringpregnancyhasnotbeenestablished.

Ifyouarepregnantortryingtobecomepregnantspeaktoyourdoctorwho

willdecideifthismedicineissuitableforyou.DonottakeCarduraXLifyou

arebreast-feeding.

Drivingandusingmachinery:

Takecareifyoudriveoroperatemachinery.Yourtabletsmayaffectyour

abilitytodriveoroperatemachinerysafely,particularlywhenyoufirststart

totakethem.Theymaycausedrowsinessandcouldalsomakeyoufeel

weakordizzy.Ifyouareaffected,donotdriveoroperatemachineryand

contactyourdoctorimmediately.

3.HowtoTakeCarduraXL

CarduraXLisamodifiedreleasetablet.Themedicineiscontainedwithina

non-absorbableshellthathasbeenspeciallydesignedtoslowlyreleasethe

medicine.Onceswallowed,themedicine(doxazosin)isslowlyreleasedinto

thebodyfromthetablet,untilthetabletisempty.

Sincetheemptytabletiseliminatedfromthebodyinbowelmovements,

youmayoccasionallyobserveinthestools,somethingthatlookslikea

tablet.Thisistobeexpectedandyoushouldnotbeconcerned.

Howtotakeyourmedicine:

TheusualdoseofCarduraXLisone4mgmodifiedreleasetablettaken

onceaday.Yourdoctormaywishtoincreaseyourdoseto8mg.Thisis

themaximumdoseofthismedicine.

Swallowyourmedicinewholewithwater.Donotchew,divideor

crushthetablets.

Takeyourtabletsasyourdoctortoldyou.

Itisimportanttokeeptakingyourtablets.Theyhelptocontrolyour

bloodpressure.

Don'tchangethedoseorstoptakingthetabletswithoutfirstchecking

withyourdoctor.

Don'twaituntilyourtabletsarefinishedbeforeseeingyourdoctor.

Ifyouarestillnotsurehowtotakeyourtablets,askyourdoctoror

pharmacist.

IfyoutakemoreCarduraXLthanyoushould:

Takingtoomanytabletsatoncemaymakeyouunwell.Ifseveraltabletsare

takenitmaybedangerous.Tellyourdoctorimmediatelyorgotoyour

nearesthospitalcasualtydepartmentimmediately.

IfyoumissadoseofCarduraXL:

Donotworry.Ifyouforgettotakeatablet,leavethatdoseoutcompletely.

Thengoonasbefore.

4.Possibleside effects

Likeallmedicines,CarduraXLcancausesideeffectsalthoughnot

everybodygetsthem.

STOPtakingCarduraXLandcallanambulanceimmediatelyifyou

experienceanyofthefollowing:

Heartattack.

Increased,decreasedorirregularheartbeat.

Weaknessofarms,legsorproblemsspeakingwhichmaybesymptoms

ofastroke

Allergicreactions(hypersensitivity).Symptomsincludesudden

wheeziness,tightnessinchest,difficultyinbreathing,swellingofthe

face,tongueorthroat,rashoritching(especiallyaffectingthewhole

body).

Tellyourdoctorimmediatelyifyouexperienceanyofthefollowing

symptomsaftertakingCarduraXL:

Chestpain(angina),wheezing,shortnessofbreath,difficultybreathing.

Feelingyourheartbeat(palpitations).

Fainting.

Yellowingoftheskinortheeyes(jaundice).

Lownumbersofwhitebloodcellsorbloodplatelets,whichmayresultin

bruisingoreasybleeding.

Thefollowingeventshavebeenreportedinpatientsbeingtreatedwith

CarduraXL.Ifanyofthesesideeffectsgetserious,orifyounoticeanyside

effectsnotlistedinthisleaflet,pleasetellyourdoctor.

Commonsideeffects

Thesecanaffectbetween1in10and1in100patients:

dizziness,feelingofspinningorrotationofsurroundings(vertigo),

headache

lowbloodpressure

swellingoffeet,anklesorfingers

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

nasalstuffiness,sneezingand/orrunnynosecausedbyinflammationof

theliningofthenose(rhinitis)

stomach/abdominalpains,feeling/beingsick

urinarytractinfection,cystitis,urinaryincontinence(inabilitytocontrol

passingurine)

sleepiness,generalweakness

indigestion,drymouth

itching

backpain,painfulmuscles

flu-likesymptoms

Uncommonsideeffects:

Thesecanaffectbetween1in100and1in1,000patients:

constipation,wind,inflammationofthestomachandintestines

(gastroenteritis)whichcancausediarrhoeaandvomiting

painordiscomfortonpassingurine,increasedfrequencyinpassing

urine,bloodinurine

inflammationofthejoints(gout),painfuljoints,generalpain

sleeplessness,anxiety,depression

reducedoralteredsenseoftouchorsensationofthehandsandfeet

increasedappetiteorlossofappetite,weightgain

nosebleeds

skinrash

ringingornoiseintheears,tremor

failure/inabilitytoachievepenileerection

liverenzymeincreaseswhichmayhaveaneffectonsomemedical

tests

VeryRareside effects

Thesecanaffectlessthan1in10,000patients:

faintnessordizzinesscausedbylowbloodpressurewhengettingup

fromasittingorlyingposition

agitationornervousness

hepatitis(liverinflammation)orbiledisorder

hives,hairloss,redorpurplepatchesontheskin,bleedingunderthe

skin

tinglingornumbnessofthehandsandfeet

tiredness,generallyfeelingunwell

blurredvision

hotflushes

musclecramps,muscleweakness

disorderinpassingurine,needingtopassurineatnight,increased

numberoftimesofpassingurine,increasedvolumeofurinepassed

discomfortorenlargementofthebreastsinmen

painfulpersistenterectionofthepenis

Othersideeffects

Thefrequencyofthesesideeffectsisunknown:

littleornosemenejaculatedatsexualclimax,cloudyurinefollowing

sexualclimax

eyeproblemsmayoccurduringeyesurgeryforcataract(cloudinessof

thelensoftheeye).Sees ection“TakespecialcarewithCarduraXL”.

Ifanyofthesideeffectsgetsserious,orifyounoticeanysideeffectsnot

listedinthisleaflet,pleasetellyourdoctor.

5.HowtoStoreCarduraXL

Keepyourtabletsoutofthereachandsightofchildren.

DonotuseCarduraXLaftertheexpirydatewhichisstatedonthecarton

andtabletblisterafterExp.Theexpirydatereferstothelastdayofthat

month.

Donotstoreabove30ºC.

Keepyourtabletsintheoriginalpackaging.Thismedicineissensitiveto

moisture.

Thetabletsshouldbewholetoworkeffectively;ifyounoticeanydefects

(suchasbrokentablets)consultyourpharmacistimmediately.

6.FurtherInformation

WhatCarduraXLcontains anditspackage:

Theactivesubstanceisdoxazosin(asdoxazosinmesilate)

Theotheringredientsarepolyethyleneoxide,sodiumchloride,

hypromellose,redferricoxide(E172),titaniumdioxide(E171),

magnesiumstearate,celluloseacetate,Macrogol,pharmaceutical

glaze,blackironoxide(E172),ammoniumhydroxideandpropylene

glycol

CarduraXLtabletscomeintwostrengths,4mgand8mg.

Eachtabletcontainsdoxazosinmesilateequivalentto4mgor8mgof

doxazosin,withinashellthathasbeenspeciallydesignedtoslowlyrelease

thedrug.

The4mgtabletsarewhite,roundbiconvexshapedwithaholeinoneside,

markedCXL4.

The8mgtabletsarewhite,roundbiconvexshapedwithaholeinoneside,

markedCXL8.

CarduraXLtabletsareavailableinpacksof28tablets.

ProductprocuredfromwithintheEUbythe ParallelProduct

AuthorisationHolder:

IMEDHealthcareLtd

Unit625KilshaneAvenue

NorthwestBusinessPark

Ballycoolin

Dublin15

Ireland.

Manufacturer:

PfizerManufacturingDeutschlandGmbH

Heinrich-Mack-Strasse35

89257Illertissen

Germany

Repackagedby:

IMEDPharmaLtd

Unit625KilshaneAvenue

NorthwestBusinessPark

Ballycoolin

Dublin15

Ireland.

Dateoflastrevision:November2013

Document Outline

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CarduraXL4mgProlonged-releaseTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains4mgdoxazosin(asmesilate).

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

ProlongedReleaseTablet.

ProductimportedfromtheUK:

White,round,biconvexshapedtabletswithanorificeononesidemarked‘CXL4’.

4CLINICALPARTICULARS

4.1TherapeuticIndications

CarduraXLisindicatedforthetreatmentofhypertensionandcanbeusedasasoleagenttocontrolbloodpressure

inhypertensivepatients.

Inpatientsinadequatelycontrolledonsingleantihypertensivetherapy,CarduraXLmaybeusedincombinationwith

athiazidediuretic,beta-adrenoceptorblockingagent,calciumantagonistoranangiotensin-convertingenzymeinhibitor.

4.2Posologyandmethodofadministration

TheinitialdoseofCarduraXLis4mgoncedaily.Asignificantnumberofpatientswillbecontrolledonthisdose.

Ifnecessary,thedosagemaybeincreasedto8mgoncedailyaccordingtopatientresponse.

Themaximumrecommendeddoseis8mgoncedaily.CarduraXLcanbetakenwithorwithoutfood.Thetablets

shouldbeswallowedwholewithasufficientamountofliquid.Theyshouldnotbecutorchewed.

Elderly:Incommonwithotherdrugsofthisclass,thedosageshouldbekeptaslowaspossibleandincrementsmade

underclosesupervision.

Useinrenallyimpairedpatients:Sincethepharmacokineticsofdoxazosinareunchangedinpatientswithrenal

insufficiency,andthereisnoevidencethatdoxazosinaggravatesexistingrenaldysfunction,theusualdosagesmaybe

usedinthesepatients.CarduraXLisnotdialysable.

Useinhepaticallyimpairedpatients:Thereareonlylimiteddatainpatientswithliverimpairmentandontheeffects

ofdrugsknowntoinfluencehepaticmetabolism(e.g.cimetidine).Aswithanydrugmetabolisedwhollybytheliver,

CarduraXLshouldbeusedwithcareinpatientswithsignificantexistinghepaticdysfunction.(seesection4.4Special

warningsandprecautionsforuse,andsection5.2Pharmacokineticproperties).

Useinchildren:ThereisinsufficientexperiencetorecommendtheuseofCarduraXLinchildrenunder12yearsof

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4.3Contraindications

CarduraXLiscontraindicatedin:

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

listedinSection6.1.

2)Patientswithahistoryoforthostatichypotension

3)Patientswithbenignprostatichyperplasiaandconcomitantcongestionoftheupperurinarytract,chronicurinary

tractinfectionorbladderstones.

4)Patientswithahistoryofgastro-intestinalobstruction,oesophagealobstruction,oranydegreeofdecreasedlumen

diameterofthegastro-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

leftventricularheartfailurewithlowfillingpressure.

UseinHepaticallyImpairedPatients:Aswithanydrugwhollymetabolisedbytheliver,CarduraXLshouldbe

administeredwithparticularcautiontopatientswithevidenceofimpairedhepaticfunction(seesection5.2

Pharmacokineticproperties).Sincethereisnoclinicalexperienceinpatientswithseverehepaticimpairmentusein

thesepatientsisnotrecommended.

UseinpatientswithImpairedRenalFunction:ThereisnoevidencethatCarduraXLaggravatesrenaldysfunction.

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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,verdenafil)

ConcomitantadministrationofanalphablockerwithaPDE-5inhibitormayleadtosymptomatichypotensioninsome

patients(seesection4.4).NostudieshavebeenconductedwithCarduraXL.

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.

Doxazosinpotentiatesthebloodpressureloweringactivityofotheralpha-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

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Alternatively,mothersshouldstopbreast-feedingwhentreatmentwithdoxazosinisnecessary(Pleaseseesection5.3:

PreclinicalSafetyData).

4.7Effectsonabilitytodriveandusemachines

Theabilitytoengageinactivitiessuchasoperatingmachineryoroperatingamotorvehiclemaybeimpaired,

especiallywheninitiatingtherapy.Thedrugmayalsoinducedrowsiness.Patientsshouldnotdriveoroperate

machineryunlessithasbeenshownnottoaffecttheiralertnessordexterity.

4.8Undesirableeffects

Inclinicaltrials,themostcommonreactionsassociatedwithCarduraXLwereofaposturaltype(rarelyassociatedwith

fainting)ornon-specific.

TheundesirableeffectsforCarduraXLaresimilartothosewithimmediatereleaseCarduratablets.

ThefollowingundesirableeffectshavebeenobservedandreportedduringtreatmentwithCarduraXLwiththe

followingfrequencies:Verycommon>1/10,Common>1/100and<1/10,Uncommon>1/1,000and<1/100,Rare>

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

SystemOrganClass Very

Common

(>1/10) Common

(>1/100to

<1/10) Uncommon

(>1/1,000to

<1/100) Rare

(>1/10,000to

<1/1,000) VeryRare

(<1/10,000) Unknown

Infectionsand

infestations Respiratorytract

infection,

urinarytract

infection

Bloodandthe

lymphaticsystem

disorders Leukopenia

thrombocytopenia

Immunesystem

disorders Allergicdrug

reaction

Metabolismand

nutritiondisorders Anorexia,gout,

increasedappetite

Psychiatricdisorders Anxiety,

depression,

insomnia Agitation,

nervousness

Nervoussystem

disorders Dizziness,

headache,

somnolence Cerebrovascular

accident,

hypoesthesia,

syncope,tremor Dizzinesspostural,

paresthesia

Eyedisorders Blurredvision Intraoperative

floppyiris

syndrome(see

Section4.4)

Earandlabyrinth

disorders Vertigo Tinnitus

Cardiacdisorders Palpitation,

tachycardia Anginapectoris,

myocardial

infarction Bradycardia,cardiac

arrhythmias

Vasculardisorders Hypotension,

postural

hypotension Hotflush

Respiratory,thoracic

andmediastinal

disorders Bronchitis,

cough,dyspnea,

rhinitis Epistaxis Bronchospasm

Gastrointestinal

disorders Abdominalpain,

dyspepsia,dry

mouth,nausea Constipation,

diarrhoea,

flatulence,

vomiting,

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4.9Overdose

Shouldoverdosageleadtohypotension,thepatientshouldbeimmediatelyplacedinasupine,headdownposition.

Othersupportivemeasuresmaybeappropriateinindividualcases.Sincedoxazosinishighlyproteinbound,dialysisis

notindicated.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Doxazosinisapotentandselectivepost-junctionalalpha1-adrenoceptorantagonist.

AdministrationofCarduraXLtohypertensivepatientscausesaclinicallysignificantreductioninbloodpressureasa

resultofareductioninsystemicvascularresistance.Thiseffectisthoughttoresultfromselectiveblockadeofthe

alpha-1-adrenoreceptorslocatedinthevasculature.Withoncedailydosing,clinicallysignificantreductionsinblood

pressurearepresentthroughoutthedayandat24hourspostdose.Themajorityofpatientsarecontrolledontheinitial

dose.Inpatientswithhypertension,bloodpressureduringtreatmentwithCarduraXLwassimilarinboththesupine

andstandingposition.

Responderdatafromthe2primaryhypertensionefficacystudies(includingatotalof630doxazosintreatedpatients)

indicatethatthosepatientscontrolledon1mg,2mgor4mgdoxazosinimmediatereleasetabletswouldbeequallywell

controlledon4mgCarduraXL.

Doxazosinhasbeenshowntobefreeofadversemetaboliceffectsandissuitableforuseinpatientswithcoexistent

diabetesmellitus,goutandinsulinresistance.

Doxazosinissuitableforuseinpatientswithcoexistentasthma,leftventricularhypertrophyandinelderlypatients.

Treatmentwithdoxazosinhasbeenshowntoresultinregressionofleftventricularhypertrophy,inhibitionofplatelet

aggregationandenhancedactivityoftissueplasminogenactivator.Additionally,doxazosinimprovesinsulinsensitivity

inpatientswithimpairment.

Doxazosinproducesfavourableeffectsonbloodlipids,withasignificantincreaseintheHDL/totalcholesterolratio

andtrendstoafavourablereductionintotaltriglycerides.Itthereforeconfersanadvantageoverdiureticsandbeta

adrenoceptorblockingagentswhichadverselyaffecttheseparameters.Basedontheestablishedassociationof

hypertensionandbloodlipidswithcoronaryheartdisease,thefavourableeffectsofdoxazosintherapyonbothblood

Hepato-biliary

disorders Abnormalliver

functiontests Cholestasis,

hepatitis,jaundice

Skinand

subcutaneoustissue

disorders Oruritus Skinrash Alopecia,purpura,

urticaria

Musculoskeletal,

connectivetissueand

bonedisorders Backpain,

myalgia Arthralgia Musclecramps,

muscleweakness

Renalandurinary

disorders Cystitis,urinary

incontinence Dysuria,

hematuria,

micturition

frequency Micturitiondisorder,

nocturia,polyuria,

increaseddieresis

Reproductivesystem

andbreastdisorders Impotence Gynecomastia,

priapism Retrograde

ejaculation

Generaldisordersand

administrationsite

conditions Asthenia,chest

pain,influenza-

likesymptoms,

peripheral

oedema Pain,facial

oedema Fatigue,malaise

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5.2Pharmacokineticproperties

Absorption:Afteroraladministrationoftherapeuticdoses,CarduraXLiswellabsorbedwithpeakbloodlevels

graduallyreachedat8to9hoursafterdosing.Peakplasmalevelsareapproximatelyonethirdofthoseofthesamedose

ofimmediatereleaseCarduratablets.Troughlevelsat24hoursare,however,similar.

ThepharmacokineticcharacteristicsofCarduraXLwillleadtoasmootherplasmaprofile.

Peak/troughratioofCarduraXLislessthanhalfthatofimmediatereleaseCarduratablets.

Atsteady-state,therelativebioavailabilityofdoxazosinfromCarduraXLcomparedtotheimmediatereleaseform

was54%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

Macrogol

Pharmaceuticalglaze

Blackironoxide(E172)

AmmoniumHydroxide

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6.2Incompatibilities

Notapplicable

6.3Shelflife

Theshelf-lifeexpirydateofthisproductisthedateshownonthecontainerandouterpackageoftheproductonthe

marketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.

Storeintheoriginalpackageinordertoprotectfrommoisture.

6.5Natureandcontentsofcontainer

Aluminiumfoilblisterstripsinacardboardcarton.Calenderpacksof28tablets.

6.6Specialprecautionsfordisposalandotherhandling

Nospecialrequirements.

7PARALLELPRODUCTAUTHORISATIONHOLDER

IMEDHealthcareLtd

Unit625KilshaneAvenue

NorthwestBusinessPark

Ballycoolin

Dublin15

Ireland

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1463/5/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:20thJune2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 11/03/2014 CRN 2139741 page number: 7

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