CARDURA XL 4 Milligram Tablet Prolonged Release

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
DOXAZOSIN MESILATE
Available from:
Clear Pharmacy
ATC code:
C02CA04
INN (International Name):
DOXAZOSIN MESILATE
Dosage:
4 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:
PPA1596/024/001
Authorization date:
2010-11-05

PACKAGELEAFLET:INFORMATION FOR THEUSER

CARDURA™XL4mg

CARDURA™XL8mg

Prolonged–release Tablets

doxazosin(asmesilate)

Importantthingsthatyou SHOULDknowaboutyourmedicine:

CarduraXLisatreatmentforhigh bloodpressure.

Thismedicine hasbeen prescribedforyou.Do notpassiton to others.

Itmayharmthem,even iftheirsymptomsarethesameasyours.

Youshouldtake CarduraXLregularlytogetthe maximumbenefit,

evenifyouare feelingwell.

MostpeopledonothaveseriousproblemswhentakingCardura XL

butside effectscanoccur–see Section4fordetails.Ifyou

experienceswellingoftheface,tongueorwindpipe,seeyour

doctorimmediately.Ifanyofthe side effectsgetsserious,orifyou

notice anyside effectsnotlistedinthisleaflet,pleasetell your

doctororpharmacist.

Takingothermedicinesmaysometimescause problems.Checkwith

yourdoctororpharmacistbeforetakingthisoranyothermedicines.

Ifyouare,orare tryingtobecome,pregnant,donottake Cardura

XL and tellyourdoctor.

Please readthe restofthisleaflet.Itincludesotherimportant

information onthesafeand effectiveuseofthismedicinethatmightbe

especiallyimportantto you.Ifyou haveanyfurtherquestions,askyour

doctororpharmacist.

Inthisleaflet:

1.WhatCarduraXLisand whatitisused for

2.Before youtake Cardura XL

3.Howto takeCarduraXL

4.Possible side effects

5.HowtoStoreCarduraXL

6.Furtherinformation

1.WhatCarduraXLisandwhatitisused for

CarduraXLisoneofagroupofmedicinescalled alpha-blockers.It is

used totreathighblood pressure.

CarduraXLcan beused to treathigh blood pressure(hypertension),by

relaxingblood vesselsso thatbloodpassesthrough themmoreeasily.

Thishelpstolowerbloodpressure.

2.Before YouTake CarduraXL

Do nottakeCarduraXL:

Ifyouhave hadanallergic reactioninthe pasttoCarduraXL,the

activeingredientdoxazosin,othertypesofquinazolines(such as

prazosinorterazosin)oranyoftheotheringredientslistedin

section 6.Thismayhavebeen itching,reddeningoftheskinor

difficultyinbreathing.

Ifyouare breast-feeding

Ifyou haveanyformofobstructionofthedigestivetract

Ifyou areunder12 yearsofage

Ifyou haveahistoryofacondition known as‘orthostatic

hypotension’which isaformoflowblood pressurethatcausesyou

tofeel dizzyorlight-headedwhen you standupfromsittingor

lyingdown

Ifyou havean enlarged prostategland withoneofthefollowing:any

kind ofcongestionorblockagein yoururinarytract,alongstanding

infectionoftheurinarytractoryou havebladderstones.

Ifyou havean enlarged prostategland andhaveoverflow

incontinence(you donotfeeltheurgeto urinate),oranuria(your

bodyisnotproducinganyurine)with orwithoutkidneyproblems.

Take specialcare withCarduraXL:

ThefollowingarereasonswhyCarduraXLmaynotbesuitable

foryou:

Ifyou arepregnantortryingto becomepregnant

Ifyouhave liver,kidneyorheartdisease

Ifyou are alsotakingothermedicines

Ifyouare undergoingeye surgerybecause ofcataract(cloudinessofthe

lens)please informyoureye specialistbefore the operationthatyouare

usingorhavepreviouslyused CarduraXL.Thisisbecause this

medicine maycause complicationsduringthe surgerywhichcanbe

managedifyourspecialistispreparedinadvance.

Whenyou startto takeCarduraXLyoumayexperiencefaintnessor

dizzinesscaused bylowblood pressure,whengettingupfromsittingor

lyingdown.Ifyou feelfaintordizzy,you should sitorliedown untilyou

feelbetterand avoid situationswhereyoumightfallorhurtyourself.

Takingothermedicines:

There are somemedicinesthatmayinteractwithCardura XL

Medicinesforerectile dysfunction(impotence)suchassildenafil,

tadalafilorvardenafil.Somepatientswho takealpha-blocker

therapyforthetreatmentofhigh bloodpressureorprostate

enlargementmayexperience dizzinessorlight-headedness,which

may becaused bylowbloodpressureuponsittingorstandingup

quickly.Certainpatientshave experiencedthese symptomswhen

takingdrugsforerectiledysfunction (impotence)with alpha-

blockers.Inorderto reducethelikelihood thatthesesymptoms

occur,you should beonaregulardailydoseofyouralphablocker

beforeyou startdrugsforerectiledysfunction.

CarduraXLmayalsoincrease theeffectsofdrugsusedtotreathigh

blood pressure(hypertension)

You should alwaystellyourdoctorifyou aretakingorhave recently

takenanyothermedicine,eventhose notprescribed,because they

might interact withCarduraXL.

TakingCarduraXLwith foodand drink:

CarduraXLcan betaken with orwithoutfood.

PregnancyandBreast-feeding:

The safetyofusingCarduraXLduringpregnancyhasnotbeen

established.Ifyou arepregnantortryingto becomepregnantspeak to

yourdoctorwho willdecideifthismedicineissuitableforyou.Donot

take Cardura XLifyouare breast-feeding.

Drivingand usingmachinery:

Take care ifyoudrive oroperate machinery.Yourtabletsmayaffect

yourabilityto driveoroperatemachinerysafely,particularlywhen you

firststartto takethem.Theymaycausedrowsinessand could also

makeyoufeelweakordizzy.Ifyouare affected,donotdriveor

operate machineryandcontactyourdoctorimmediately.

3.Howto TakeCarduraXL

Cardura XLisaprolonged-releasetablet.Themedicine iscontained

within anon-absorbableshellthathasbeen speciallydesigned to slowly

release themedicine.Onceswallowed,themedicine (doxazosin)is

slowlyreleasedintothebodyfromthetablet,until thetablet isempty.

Sincetheemptytabletiseliminated fromthebodyin bowelmovements,

youmayoccasionallyobservein thestools,somethingthat lookslikea

tablet.Thisisto beexpected andyou should notbeconcerned.

Howtotake yourmedicine

TheusualdoseofCarduraXLisone4mgprolonged-release tablet

taken onceaday.Yourdoctormaywish to increaseyourdoseto

8mg.Thisisthemaximumdoseofthismedicine.

Swallowyourmedicine whole withwater.Donotchew,divide

orcrushthetablets.

Takeyourtabletsasyourdoctortold you.

Itisimportantto keep takingyourtablets.Theyhelp to controlyour

blood pressure.

Don'tchangethedoseorstoptakingthetabletswithout first

checkingwith yourdoctor.

Don'twaituntilyourtabletsarefinishedbeforeseeingyourdoctor.

Ifyou arestillnotsurehowto takeyourtablets,askyourdoctoror

pharmacist.

Ifyoutakemore CarduraXLthan you should:

Takingtoomanytabletsatonce maymakeyouunwell.Ifseveral

tabletsare takenitmaybe dangerous.Tellyourdoctorimmediatelyor

gotoyournearesthospitalcasualtydepartmentimmediately.

Ifyoumiss adoseofCarduraXL:

Do notworry.Ifyouforget totakeatablet,leavethat doseout completely.

Then go onasbefore.

4.Possible side effects

Like allmedicines,CarduraXLcancause side effectsalthoughnot

everybodygetsthem.

STOPtakingCarduraXLandcallanambulanceimmediatelyif

you experienceanyofthefollowing:

Heartattack

Increased,decreasedorirregularheartbeat

Weaknessofarms,legsorproblemsspeakingwhichmaybe

symptomsofastroke

Allergic reactions(hypersensitivity).Symptomsincludesudden

wheeziness,tightnessinchest,difficultyinbreathing,swellingof

theface,tongueorthroat,rash oritching(especiallyaffectingthe

wholebody)

Tellyourdoctorimmediatelyifyou experienceanyofthefollowing

symptomsaftertakingCarduraXL:

Chestpain(angina),wheezing,shortnessofbreath,difficulty

breathing

Feelingyourheartbeat(palpitations)

Fainting

Yellowingofthe skinorthe eyes(jaundice)

Lownumbersofwhiteblood cellsorbloodplatelets,which may

result inbruisingoreasybleeding

Thefollowingeventshavebeen reportedinpatientsbeingtreatedwith

CarduraXL.Ifanyofthesesideeffectsgetserious,orifyou noticeany

sideeffectsnot listedinthisleaflet,pleasetellyourdoctor.

Commonside effects

Thesecan affectbetween 1 in 10and 1in100patients:

dizziness,feelingofspinningorrotation ofsurroundings(vertigo),

headache

lowblood pressure

swellingoffeet,anklesorfingers

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

nasalstuffiness,sneezingand/orrunnynosecausedby

inflammation oftheliningofthenose(rhinitis)

stomach/abdominalpains,feeling/beingsick

urinarytract infection,cystitis,urinaryincontinence(inabilityto

controlpassingurine)

sleepiness,generalweakness

indigestion,drymouth

itching

backpain,painfulmuscles

flu-likesymptoms

Uncommonside effects

Thesecan affectbetween 1 in 100 and1in1,000 patients:

constipation,wind,inflammation ofthestomachand intestines

(gastroenteritis)whichcancause diarrhoea andvomiting

painordiscomfortonpassingurine,increased frequencyin passing

urine,blood inurine

inflammationofthejoints(gout),painful joints,general pain

sleeplessness,anxiety,depression

reduced oraltered senseoftouchorsensation ofthehandsand feet

increasedappetite orlossofappetite,weightgain

nosebleeds

skinrash

ringingornoisein theears,tremor

failure/ inabilitytoachievepenileerection

liverenzyme increaseswhichmayhaveaneffectonsomemedicaltests

VeryRare side effects

Thesecan affectlessthan 1in10,000patients:

faintnessordizzinesscaused bylowblood pressurewhen getting

upfromasittingorlyingposition

agitation ornervousness

hepatitis(liverinflammation)orbiledisorder

hives,hairloss,redorpurplepatchesontheskin,bleedingunder

theskin

tinglingornumbnessofthehandsand feet

tiredness,generallyfeelingunwell

hotflushes

musclecramps,muscle weakness

disorderinpassingurine,needingtopassurineatnight,increased

numberoftimesofpassingurine,increased volumeofurinepassed

discomfortorenlargementofthe breastsinmen

painfulpersistenterectionofthepenis

Other side effects

Thefrequencyofthesesideeffectsisunknown:

littleornosemenejaculatedat sexual climax,cloudyurine

followingsexual climax

eyeproblemsmayoccurduring eyesurgeryforcataract(cloudinessof

thelensoftheeye).Seesection“TakespecialcarewithCarduraXL”.

Ifanyofthe side effectsgetsserious,orifyounotice anyside effects

notlistedinthisleaflet,pleasetellyourdoctor.

5.Howto StoreCarduraXL

Keepyourtabletsoutofthereachand sightofchildren.

Donotuse CarduraXLafterthe expirydatewhichisstatedonthe

cartonandtabletblisterafterEXP.The expirydate referstothe lastday

ofthatmonth.

Do notstoreabove30ºC.

Storeintheoriginalpackagein order toprotectfrommoisture.

Thetabletsshouldbe whole toworkeffectively,ifyou noticeany

defects(suchasbrokentablets)consultyourpharmacistimmediately.

6.FurtherInformation

WhatCarduraXLcontainsand itspackage

The active substance isdoxazosin(asdoxazosinmesilate)

Theotheringredientsarepolyethyleneoxide,sodiumchloride,

hypromellose,red ferricoxide(E172),titaniumdioxide(E171),

magnesiumstearate,cellulose acetate,Macrogol,pharmaceutical

glaze,blackiron oxide(E172),ammoniumhydroxideand

propyleneglycol

CarduraXLtabletscomein two strengths,4mgand 8mg.

Each tabletcontainsdoxazosin mesilateequivalentto4mgor8mgof

doxazosin,within ashellthathasbeen speciallydesigned to slowly

release the drug.

The4mgtabletsarewhite,roundbiconvexshaped with aholeinone

side,marked CXL4.

The8mgtabletsarewhite,roundbiconvexshaped with aholeinone

side,marked CXL8.

CarduraXLtabletsare available inpacksof28tablets.

Procured fromwithin theEUbytheParallelProduct

Authorisation Holder:

ClearPharmacy,157-173RodenStreet,Belfast,BT12 5QA,UK.

Manufacturer

PfizerManufacturingDeutschlandGmbH,Heinrich-Mack-Strasse 35,

89257Illertissen,Germany.

Repackager

Pharmaram Limited,Unit F4TomBill Way,AshbyDeLaZouch,

Leicestershire,LE65 2UY,UK.

Company contactaddress:

Forfurtherinformation onyourmedicinecontactMedicalInformation

atthefollowingaddress:

PfizerHealthcare Ireland,9Riverwalk,NationalDigital Park,Citywest

BusinessCampus,Dublin 24,Ireland

Telephone:1800633 363

Thismedicinalproductisauthorised inUKasCardura XLModified

Release Tablets.

Leaflet date:APRIL2013

20130717

Thetrademarkfor Cardura®isheldbyPfizer Limited.

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CarduraXL4mgProlonged-releasetablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains4mgdoxazosin(asmesilate)

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Prolonged-releasetablet.

ProductimportedfromUK:

CarduraXL4mgprolonged-releasetabletsarewhite,round,biconvexshapedtabletswithanorificeononeside,

marked'CXL4'.

4CLINICALPARTICULARS

AsperPA0822/004/001

5PHARMACOLOGICALPROPERTIES

AsperPA0822/004/001

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Polyethyleneoxide

Sodiumchloride

Hypromellose

Redferricoxide(E172)

Titaniumdioxide(E171)

Magnesiumstearate

Celluloseacetate

Macrogol

Pharmaceuticalglaze

Blackironoxide(E172)

Ammoniumhydroxide

Propyleneglycol

6.2Incompatibilities

Notapplicable

6.3Shelflife

Theshelf-lifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackagingoftheproducton

Health Products Regulatory Authority

______________________________________________________________________________________________________________________

Date Printed 16/10/2014 CRN 2132369 page number: 1

6.4Specialprecautionsforstorage

Donotstoreabove30°C.Storeintheoriginalpackageinordertoprotectfrommoisture.

6.5Natureandcontentsofcontainer

Opaqueblistersinacardboardcarton.

Calendarpacksof28tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7PARALLELPRODUCTAUTHORISATIONHOLDER

ClearPharmacy

157-173RodenStreet

Belfast,UK

BTl25QA

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1596/024/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:5thNovember2010

10DATEOFREVISIONOFTHETEXT

Health Products Regulatory Authority

______________________________________________________________________________________________________________________

Date Printed 16/10/2014 CRN 2132369 page number: 2

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