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TERAZOSIN 5MG TABLETS

Active substance(s): TERAZOSIN HYDROCHLORIDE / TERAZOSIN HYDROCHLORIDE DIHYDRATE

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TEVA UK Ref:

Version:

231-30-85164-W LEA TERAZOSIN A/S TAB TUK

2

11 February 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

0!#+!'%,%!&,%4).&/2-!4)/.
&/24(%53%2
Read all of this leaflet carefully before you start
taking this medicine.
s +EEPTHISLEAFLET9OUMAYNEEDTOREADITAGAIN
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOUR
DOCTORORPHARMACIST
s 4HISMEDICINEHASBEENPRESCRIBEDFORYOU$O
NOTPASSITONTOOTHERS)TMAYHARMTHEM
EVENIFTHEIRSYMPTOMSARETHESAMEASYOURS
s )FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTOR
ORPHARMACIST4HISINCLUDESANYPOSSIBLESIDE
EFFECTSNOTLISTEDINTHISLEAFLET3EESECTION
).4()3,%!&,%4
1. What Terazosin is and what it is used for
2. Before you take Terazosin
3. How to take Terazosin
4. Possible side effects
5. How to store Terazosin
6. Further information

1

WHAT TERAZOSIN IS AND WHAT IT IS
USED FOR

0HARMACODE

4ERAZOSINBELONGSTOAGROUPOFMEDICINESCALLED
ALPHA BLOCKERS
4ERAZOSINISUSEDTOTREAT
s HIGHBLOODPRESSURE
s BLOCKEDURINEFLOWCAUSEDBYBENIGNPROSTATIC
HYPERPLASIA"0( WHICHISCOMMONINOLDERMEN
"0(ISCAUSEDBYTHEPROSTATEGLANDGROWING
TOOBIGANDOBSTRUCTINGTHEFLOWOFURINEFROM
THEBLADDER4HISLEADSTOSOMEUNPLEASANT
SYMPTOMSSUCHASWEAKORINTERRUPTEDURINE
FLOW ANEEDTOPASSWATERMOREFREQUENTLY
ANDORASUDDENNEEDTOPASSWATER4ERAZOSIN
CANRELAXTHEMUSCLEOFTHEPROSTATEGLANDAND
BLADDEREXITTOHELPRELIEVETHESESYMPTOMS

Important information about some of the
ingredients of Terazosin
s 0ATIENTSWHOAREINTOLERANTTOLACTOSESHOULD
NOTETHAT4ERAZOSINTABLETSCONTAINASMALL
AMOUNTOFLACTOSE)FYOURDOCTORHASTOLDYOU
THATYOUHAVEANINTOLERANCETOSOMESUGARS
CONTACTYOURDOCTORBEFORETAKINGTHISMEDICINE
Pregnancy and breast-feeding
s )FYOUAREPREGNANT PLANNINGTOBECOME
PREGNANTORAREBREAST FEEDING ASKYOUR
DOCTORFORADVICEBEFORETAKINGTHISMEDICINE
Driving and using machines
s 4ERAZOSINMAYCAUSELIGHT HEADEDNESS
DIZZINESS ORDROWSINESS PARTICULARLYWITHTHE
FIRSTDOSE ANINCREASEINYOURDOSE ORAFTER
MISSINGDOSESANDRESTARTINGTREATMENT$/
./4DRIVEOROPERATEMACHINERYFORHOURS
AFTERYOURFIRSTDOSE WHENYOURDOSEIS
INCREASED ORWHENRESTARTINGTREATMENT
s )FYOUAREAFFECTEDINANYWAYATANYOTHERTIME
WHILEYOUARETAKING4ERAZOSINTABLETS $/./4
DRIVEOROPERATEMACHINERY

3

HOW TO TAKE TERAZOSIN

!LWAYSTAKE4ERAZOSINEXACTLYASYOURDOCTORHAS
TOLDYOU9OUSHOULDCHECKWITHYOURDOCTOROR
PHARMACISTIFYOUARENOTSURE
9OURDOCTORWILLMONITORYOUREGULARLYDURING
YOURTREATMENT
(A) Read this section if you are taking Terazosin
for the first time or if you have not taken
Terazosin in the last week.
If you are continuing treatment without a break,
please read section (B).

It is important that you take the correct tablet at
the correct time.
s 4HETABLETSSHOULDBESWALLOWED PREFERABLY
WITHADRINKOFWATER
s 4HEFIRSTTIMEYOUTAKEANEWSTRENGTHOF
4ERAZOSIN4ABLET YOUSHOULDTAKEITINTHE
BEFORE YOU TAKE TERAZOSIN
EVENINGATBEDTIME
s &OLLOWINGDOSESOFTHESAMESTRENGTHMAYBE
DO NOT take Terazosin if you:
TAKENINTHEMORNING
s AREALLERGICHYPERSENSITIVE TOTERAZOSINORANY
s )FYOUAREATALLUNSUREABOUTWHENTOTAKE
OFTHEOTHERINGREDIENTSOFTHISMEDICINE
YOURTABLETS YOUSHOULDCONSULTYOURDOCTOR
s AREALLERGICHYPERSENSITIVE TOOTHERSIMILAR
FORADVICE
MEDICINESSUCHASPRAZOSINORDOXAZOSIN
s HAVEEVERFAINTEDWHENURINATING
Adults (including the elderly)
s HAVETHERAREHEREDITARYPROBLEMOFGALACTOSE s High Blood Pressure
INTOLERANCE ,APPLACTASEDEFICIENCY OR
/NDAYSTO TAKEONEMGTABLETEACHDAY
GLUCOSE GALACTOSEMALABSORPTION
4HEFIRSTTABLETSHOULDBETAKENATBEDTIME
&ROMDAYONWARDS TAKEONEMGTABLET
Take special care with Terazosin
YELLOWTABLET EACHDAYFORAWEEK UNTILYOU
Talk to your doctor before you start to take this
REACHDAY2EMEMBERYOUSHOULDTAKEYOUR
medicine if you:
FIRSTMGTABLETATBEDTIME
s HAVEANYLIVERPROBLEMS
7HENYOUHAVEFINISHEDTHISTWOWEEK
s HAVEANYHEARTPROBLEMS
TREATMENT YOURDOCTORWILLDECIDEHOWTO
CONTINUEYOURTREATMENT ANDMAYGIVEYOUA
Taking other medicines
PRESCRIPTIONFORMORETABLETS.OWREAD
Talk to your doctor if you are taking any of the
SECTION" 
following:
s !#%INHIBITORS USEDTOTREATHIGHBLOOD
s "ENIGNPROSTATICHYPERPLASIA
PRESSUREEGCAPTOPRILORLISINOPRIL
/NDAYSTO TAKEONEMGTABLETEACHDAY
s DIURETICShWATERTABLETSv USEDTOTREATHEART
4HEFIRSTTABLETSHOULDBETAKENATBEDTIME
FAILUREORHIGHBLOODPRESSUREEGFUROSEMIDE
&ROMDAYONWARDS STARTTAKINGONEMG
ORSPIRONOLACTONE
TABLETYELLOWTABLET EACHDAYFORDAYS
s ANYOTHERMEDICINEUSEDTOTREATHIGHBLOOD
2EMEMBERYOUSHOULDTAKEYOURFIRSTMG
PRESSUREEGATENOLOL VERAPAMILORAMLODIPINE
TABLETATBEDTIME
3OMEPATIENTSWHOTAKEALPHA BLOCKERTHERAPYFOR &ROMDAYONWARDS STARTTAKINGONEMG
TABLETTANTABLETS EACHDAYFORDAYS
THETREATMENTOFHIGHBLOODPRESSUREORPROSTATE
2EMEMBERYOUSHOULDTAKEYOURFIRSTMG
ENLARGEMENTMAYEXPERIENCEDIZZINESSORLIGHT
TABLETATBEDTIME
HEADEDNESS WHICHMAYBECAUSEDBYLOWBLOOD

7HENYOUHAVEFINISHEDTHISFOURWEEK
PRESSUREUPONSITTINGORSTANDINGUPQUICKLY#ERTAIN
TREATMENT YOURDOCTORWILLDECIDEHOWTO
PATIENTSHAVEEXPERIENCEDTHESESYMPTOMSWHEN
CONTINUEYOURTREATMENT ANDMAYGIVEYOUA
TAKINGDRUGSFORERECTILEDYSFUNCTIONIMPOTENCE
PRESCRIPTIONFORMORETABLETS.OWREAD
WITHALPHA BLOCKERS)NORDERTOREDUCETHE
SECTION" 
LIKELIHOODTHATTHESESYMPTOMSOCCUR YOUSHOULD
BEONAREGULARDAILYDOSEOFYOURALPHA BLOCKER
(B) Read this section if you have taken Terazosin
BEFOREYOUSTARTDRUGSFORERECTILEDYSFUNCTION
before and are continuing with your next pack.
s 7HENYOUHAVEFINISHEDYOURLASTPACK YOUR
0LEASETELLYOURDOCTORORPHARMACISTIFYOUARE
DOCTORMAYPRESCRIBEMORETABLETSTOCONTINUE
TAKINGORHAVERECENTLYTAKENANYOTHERMEDICINES
YOURTREATMENT9OURMAINTENANCEDOSEWILLBE
INCLUDINGMEDICINESOBTAINEDWITHOUTAPRESCRIPTION
ADJUSTEDACCORDINGTOHOWYOUHAVE
)FYOUAREUNDERGOINGEYESURGERYBECAUSEOF
RESPONDEDTOTREATMENT ANDISUSUALLY
CATARACTCLOUDINESSOFTHELENS PLEASEINFORM
BETWEENnMGDAILY9OURDOCTORWILL
YOUREYESPECIALISTBEFORETHEOPERATIONTHATYOU
DECIDEWHICHSTRENGTHOFTABLETYOUNEED9OU
AREUSINGORHAVEPREVIOUSLYUSED4ERAZOSIN4HIS
MAYBEGIVENANEWPACKOFTABLETSCONTAINING
ISBECAUSETERAZOSINMAYCAUSECOMPLICATIONS
EITHERMGYELLOWTABLETS MGTANTABLETS
DURINGTHESURGERYWHICHCANBEMANAGEDIFYOUR
ORMGBLUETABLETS OF4ERAZOSIN
SPECIALISTISPREPAREDINADVANCE
Take one tablet each day.

2

REG0068768

Version 1.3

Approved

Page 1 of 3

Top of page cut-off to middle of registration mark: 44 mm.

TERAZOSIN 2 mg, 5 mg
AND 10 mg TABLETS

TEVA UK Ref:

Version:

231-30-85164-W LEA TERAZOSIN A/S TAB TUK

2

11 February 2015

PAGE 2: REAR FACE (OUTSIDE OF REEL)

)NADDITION THEFOLLOWINGEFFECTSHAVEBEEN
REPORTED HOWEVERTHESEMAYNOTNECESSARILY
HAVEBEENCAUSEDBYTAKING4ERAZOSIN
s SWELLINGOFTHEFACE SWOLLENORSORETHROAT
If you take more Terazosin than you should
s CHESTPAIN STOMACHPAIN NECKANDSHOULDER
s )FYOUACCIDENTALLYTAKEMORETHANTABLETINA
PAIN
DAY YOUSHOULDCONTACTYOURDOCTOR
s SWEATING FEVER COLDANDFLUSYMPTOMS
IMMEDIATELY
s BRONCHITISANDINCREASEDCOUGH
s )FYOUORSOMEONEELSE SWALLOWALOTOFTHE
s NOSEBLEED RUNNYNOSE
TABLETSALLTOGETHER ORIFYOUTHINKACHILDHAS
s DRYMOUTH
SWALLOWEDANYOFTHETABLETS CONTACTYOUR
s INDIGESTION CONSTIPATION DIARRHOEA WIND
NEARESTHOSPITALCASUALTYDEPARTMENTORYOUR
BEINGSICK
DOCTORIMMEDIATELY
s JOINTPAINDISORDERS GOUT MUSCLEPAIN ARTHRITIS
!NOVERDOSEISLIKELYTOCAUSEVERYLOWBLOOD s TINNITUSRINGINGINTHEEARS
PRESSURERESULTINGINFAINTING DIZZINESS AND
s CONJUNCTIVITISEYEINFECTION CHANGESINVISION
DROWSINESS
s CHANGEINHEARTRATEBEAT
0LEASETAKETHISLEAFLET ANYREMAININGTABLETS s ITCHYSKIN REDSKIN RASHES
ANDTHECONTAINERWITHYOUTOTHEHOSPITALOR
s ANXIETY UNABLETOSLEEPINSOMNIA
DOCTORSOTHATTHEYKNOWWHICHTABLETSWERE
s CHANGEINTHEFREQUENCYOFPASSINGWATER
CONSUMED
s URINARYTRACTINFECTIONANDINCONTINENCEHAVE
BEENREPORTEDMAINLYBYWOMENWHOHAVE
If you forget to take Terazosin
GONETHROUGHTHEMENOPAUSE
s )FYOUHAVEFORGOTTENTOTAKEATABLETOFANEW
s
UNEXPLAINEDBRUISING SKINCUTSTAKINGLONGER
STRENGTHATBEDTIME ASKYOURDOCTOROR
TOHEAL
PHARMACISTFORADVICEBEFORECONTINUING
s
PAINFUL PROLONGEDERECTION
s )FYOUFORGETTOTAKEATABLETATTHENORMALTIME
s CHANGESINTHECHEMISTRYOFTHEBLOODIE
TAKEONEASSOONASYOUREMEMBER$/./4
BLOODCELLNUMBERSMAYREDUCE
TAKEADOUBLEDOSETOMAKEUPFORAFORGOTTEN
DOSE4AKETHEREMAININGDOSESATTHECORRECT
Reporting of side effects
TIME
)FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTOROR
s )FYOUHAVEFORGOTTENTOTAKEATABLETFOR
PHARMACIST4HISINCLUDESANYPOSSIBLESIDEEFFECTS
SEVERALDAYS $/./4CONTINUEUSINGTHESAME NOTLISTEDINTHISLEAFLET9OUCANALSOREPORTSIDE
TABLETSYou must contact your doctor for
EFFECTSDIRECTLYVIATHE9ELLOW#ARD3CHEMEAT
advice before you start taking Terazosin tablets WWWMHRAGOVUKYELLOWCARD
again as your treatment may have to be
"YREPORTINGSIDEEFFECTSYOUCANHELPPROVIDE
restarted as if you are taking it for the first time. MOREINFORMATIONONTHESAFETYOFTHISMEDICINE
Children
s 4ERAZOSINISNOTRECOMMENDEDFORUSEIN
CHILDREN

If you stop taking Terazosin
s 9OUSHOULDCONTINUETOTAKEYOURTABLETS
UNLESSYOURDOCTORTELLSYOUNOTTO$/./4
STOPJUSTBECAUSEYOUFEELBETTER
)FYOUHAVEANYFURTHERQUESTIONSONTHEUSEOF
THISPRODUCT ASKYOURDOCTORORPHARMACIST

4

POSSIBLE SIDE EFFECTS

,IKEALLMEDICINES 4ERAZOSINCANCAUSESIDE
EFFECTS ALTHOUGHNOTEVERYBODYGETSTHEM

5

HOW TO STORE TERAZOSIN

Keep out of the reach and sight of children.
$ONOTSTOREABOVEยช#3TOREINTHEORIGINAL
PACKAGE$ONOTUSE4ERAZOSINAFTERTHEEXPIRY
DATETHATISSTATEDONTHEOUTERPACKAGING4HE
EXPIRYDATEREFERSTOTHELASTDAYOFTHATMONTH
-EDICINESSHOULDNOTBEDISPOSEDOFVIA
WASTEWATERORHOUSEHOLDWASTE!SKYOUR
PHARMACISTHOWTODISPOSEOFMEDICINESNO
LONGERREQUIRED4HESEMEASURESWILLHELPTO
PROTECTTHEENVIRONMENT

)FTHEFOLLOWINGHAPPENS STOPTAKINGTHETABLETS
FURTHER INFORMATION
ANDTELLYOURDOCTORIMMEDIATELYORGOTOTHE
CASUALTYDEPARTMENTATYOURNEARESTHOSPITAL
s ANALLERGICREACTIONSWELLINGOFTHELIPS FACEOR What Terazosin tablets contain:
s 4HEACTIVEINGREDIENTISMG MGORMG
NECKLEADINGTOSEVEREDIFFICULTYINBREATHING
TERAZOSINASHYDROCHLORIDEDIHYDRATE 
SKINRASHORHIVES 
4HISISAVERYSERIOUSBUTRARESIDEEFFECT9OUMAY s 4HEOTHERINGREDIENTSARELACTOSEMONOHYDRATE
MAIZESTARCH POVIDONE CROSPOVIDONE TALCAND
NEEDURGENTMEDICALATTENTIONORHOSPITALISATION
MAGNESIUMSTEARATE% 
The most common side effects are:
s 4HEMGTABLETSALSOCONTAINQUINOLINEYELLOW
s DIZZINESS LIGHT HEADEDNESSORFAINTING
% 
4HESEEFFECTSMAYOCCURWHENYOUFIRSTSTART
s 4HEMGTABLETSALSOCONTAINYELLOWIRON
TAKINGTHETABLETSORWHENYOUSTARTTOTAKEA
OXIDE% ANDREDIRONOXIDE% 
HIGHERDOSE ESPECIALLYWHENSTANDINGUP
s 4HEMGTABLETSALSOCONTAININDIGOCARMINE
QUICKLYFROMALYINGORSITTINGPOSITION)FTHIS
% 
HAPPENSYOUSHOULDLIEDOWNUNTILYOUFEEL
What Terazosin tablets look like and contents of
BETTERTHENYOUSHOULDSITFORAFEWMINUTES
BEFORESTANDINGAGAINTOPREVENTTHESEEFFECTS the pack:
s 4HEMGTABLETSAREMOTTLEDYELLOW ROUND
FROMRETURNING
FLATTABLETWITHBEVELLEDEDGES%MBOSSEDWITH
4HESEEFFECTSUSUALLYGOAWAYANDSHOULDNOTRETURN
hvONONE SIDEANDhvONTHEOTHERSIDE
ONCEYOUHAVEBECOMEUSEDTOTAKINGYOURTABLETS
s 4HEMGTABLETSAREMOTTLEDTAN ROUND FLAT
Other common side effects are:
TABLETWITHBEVELLEDEDGES%MBOSSEDWITH
s WEAKNESS
hvONONE SIDEANDhvONTHEOTHERSIDE
s SLEEPINESS
s 4HEMGTABLETSAREMOTTLEDBLUE ROUND FLAT
s PALPITATIONS
TABLETWITHBEVELLEDEDGES%MBOSSEDWITH
s FEELINGSICK
hvONONE SIDEANDhvONTHEOTHERSIDE
s SWELLINGOFTHELEGSANDFEET
s 4HEMGAREAVAILABLEINPACKSOF  
s BLOCKEDORITCHYNOSE
  ANDTABLETS
s BLURREDVISION
s 4HEMGAREAVAILABLEINPACKSOF  
   ANDTABLETS
Other less frequent side effects are:
s 4HEMGAREAVAILABLEINPACKSOF  
s BACKPAIN
 ANDTABLETS
s PAININEXTREMITIESIEFINGERSANDTOES
s 4HEMGANDMGTABLETSALSOCOMEINSTARTER
s HEADACHE
PACKS
s WATERRETENTION
.OTALLPACKSIZESMAYBEMARKETED
s WEIGHTGAIN
s DECREASEDSEXDRIVE INABILITYTOGETORKEEPAN Marketing Authorisation Holder and Manufacturer
ERECTION
-ARKETING!UTHORISATIONHOLDERANDCOMPANY
s DEPRESSION NERVOUSNESS
RESPONSIBLEFORMANUFACTURE4%6!5+,IMITED
s PINS AND NEEDLES
%ASTBOURNE ".!'
s VERTIGO
This leaflet was last revised: *ANUARY
s SINUSITISINFLAMMATIONOFTHESINUSES
0, 
s FASTHEARTBEAT
s SHORTNESSOFBREATH

6

 7
X

REG0068768

Version 1.3

Approved

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THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2
mockup-pil-uk-pl-00289-0364-0365-0366-terazosin-2mg-5mg-10mg-tablets

APPROVALS
Signed by
Darryl Hill

REG0068768

Meaning of Signature
Regulatory Affairs Approval

Version 1.3

Approved

Server Date
16-Apr-2015 09:58:53 AM

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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