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HALOPERIDOL CAPSULES 500MCG

Active substance(s): HALOPERIDOL

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SERENACE 500 microgram CAPSULES
Haloperidol
PACKAGE LEAFLET: INFORMATION
FOR THE USER

Read all of this leaflet carefully before you start taking
this medicine.
s +EEPTHISLEAFLET9OUMAYNEEDTOREADITAGAIN
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOURDOCTOROR
pharmacist.
s 4HISMEDICINEHASBEENPRESCRIBEDFORYOU$ONOT
PASSITONTOOTHERS)TMAYHARMTHEM EVENIFTHEIR
SYMPTOMSARETHESAMEASYOURS
s )FANYOFTHESIDEEFFECTSGETSERIOUS ORIFYOUNOTICE
ANYSIDEEFFECTSNOTLISTEDINTHISLEAFLET PLEASETELL
YOURDOCTORORPHARMACIST
IN THIS LEAFLET:

25 March 2014

1. What Serenace is and what it is used for
2. Before you take Serenace
3. How to take Serenace
4. Possible side effects
5. How to store Serenace
6. Further information

1

Version:

2

3ERENACE#APSULESCONTAINHALOPERIDOL WHICHBELONGSTO
AGROUPOFDRUGSKNOWNASANTIPSYCHOTICS
Serenace Capsules are used to treat:
s SCHIZOPHRENIAANDOTHERSIMILARMENTALDISORDERS
SUCHASMANIAFEELINGELATEDOROVER EXCITED WHICH
CAUSESUNUSUALBEHAVIOUR ANDPARANOIA VIOLENTOR
DANGEROUSIMPULSIVEBEHAVIOUR
s AGGRESSION OVERACTIVITYANDSELF MUTILATIONIN
PATIENTSWHOAREMENTALLYILLANDARELIKELYTOBEHAVE
DANGEROUSLY
s 4OURETTESSYNDROME TICSREPEATEDANDLARGELY
INVOLUNTARYMOVEMENTS
s RESTLESSNESSANDAGITATIONINTHEELDERLY
s NAUSEAANDVOMITING
s WITHOTHERTHERAPY THESHORT TERMMANAGEMENTOF
ANXIETY
s BEHAVIOURALDISORDERSINCHILDREN ESPECIALLYTHOSE
ASSOCIATEDWITHHYPERACTIVITYANDAGGRESSION

231-30-01046-F LEA SERENACE (HALOPERIDOL) 500mcg CAP TUK
2

BEFORE YOU TAKE SERENACE

DO NOT take Serenace and talk to your doctor if you:
s AREALLERGICHYPERSENSITIVE TOHALOPERIDOLORANYOF
the other ingredients of this medicine
s AREBREAST FEEDING
s HAVEBEENTOLDBYYOURDOCTORTHATYOUHAVEA
CONDITIONTHATAFFECTSPARTOFYOURBRAINCALLEDTHE
“basal ganglia”
s SUFFERFROM0ARKINSONSDISEASE (UNTINGTONS#HOREA
ORARELATEDMOVEMENTDISORDER
s SUFFERFROMUNCORRECTEDHYPOKALAEMIALOWLEVELSOF
POTASSIUMINTHEBODY
s HAVESEVEREHEARTPROBLEMSEGRECENTHEARTATTACK
HEARTFAILURE IRREGULARHEARTBEATFORWHICHYOUNEED
TOTAKEMEDICINE
s HAVEAFAMILYHISTORYOFUNEXPLAINEDFAINTING
BLACKOUTSORHEARTATTACKS
s ARETAKINGCERTAINOTHERMEDICINESWHICHCANAFFECTTHE
HEARTSEE@4AKINGOTHERMEDICINES
s HAVEARAREHEREDITARYPROBLEMOFGALACTOSE
INTOLERANCE THE,APPLACTOSEDEFICIENCYOR
GLUCOSE GALACTOSEMALABSORPTION
s ARELESSAWAREOFTHINGSAROUNDYOUORYOURREACTIONS
become slower.
3ERENACESHOULDNOTBEGIVENTOPATIENTSIFTHEYAREINA
coma.
Warnings and precautions
Take special care with Serenace
Talk to your doctor before you start to take this medicine
if you:
s AREELDERLYASYOUMAYBEMORESENSITIVETOTHEEFFECTS
of Serenace
s AREATRISKOFBLOODCLOTINTHEVEINDEEPVEIN
THROMBOSIS
s HAVEORSOMEONEELSEINYOURFAMILYHASAHISTORYOF
BLOODCLOTS ASMEDICINESLIKETHESEHAVEBEEN
associated with formation of blood clots
s SUFFERFROMEPILEPSYORCONDITIONSTHATMIGHTCAUSE
EPILEPSYSUCHASALCOHOLWITHDRAWALORBRAINDAMAGE
s HAVEDISEASEDARTERIES
s SUFFERFROMDEMENTIA
s SUFFERFROMDEPRESSION
s HAVELOWBLOODPRESSURE CALCIUMORMAGNESIUM
LEVELSORHAVENOTEATENFORAPROLONGEDLENGTHOFTIME
s HAVEPROBLEMSWITHALCOHOLABUSEORALCOHOLISM
s HAVEEVERHADANYPROBLEMSWITHYOURLIVER KIDNEYS
ORHEART ORTHEREISAHISTORYINYOURFAMILYOFHEART
problems or sudden death
s HAVEEVERHADASTROKE TRANSIENTISCHAEMICATTACK
4)! ORHAVEAFAMILYHISTORYOFSTROKES
s HAVEEVERHADAGROWTHINYOURADRENALGLAND
PHAEOCHROMOCYTOMA ORTROUBLEWITHYOURTHYROID
GLAND WHICHCAUSESTOOMUCHTHYROIDHORMONETOBE
MADETHYROTOXICOSIS
s HAVEBEENFASTING
9OUMAYNEEDTOBEMORECLOSELYMONITORED ANDTHE
AMOUNTOF3ERENACE#APSULESYOUTAKEMAYHAVETOBE
ALTERED)FYOUARENOTSUREIFANYOFTHEABOVEAPPLYTOYOU
TALKTOYOURPHARMACISTBEFORETAKING3ERENACE#APSULES
-EDICALCHECKUPS
9OURDOCTORMAYWANTTOTAKEANELECTROCARDIOGRAM
%#' BEFOREORDURINGYOURTREATMENTWITH3ERENACE
#APSULES4HE%#'MEASURESTHEELECTRICALACTIVITYOF
YOURHEART
Blood tests
9OURDOCTORMAYWANTTOCHECKTHELEVELSOFMINERALS
ELECTROLYTES INYOURBLOOD

TEVA UK Ref:

REG0064534

WHAT SERENACE IS AND WHAT IT IS USED FOR

Version 3.2

Approved

!VAILABLESAFETYDATAINTHEPAEDIATRICPOPULATIONINDICATE
ARISKOFEXTRAPYRAMIDALSYMPTOMS INCLUDINGTARDIVE
DYSKINESIAINVOLUNTARY REPETITIVEBODYMOVEMENTS
ANDSEDATION.OLONG TERMSAFETYDATAAVAILABLE
Taking other medicines
3PECIALMONITORINGMAYBENEEDEDIFYOUARETAKING
lithium and Serenace Capsules at the same time. Tell
YOURDOCTORSTRAIGHTAWAYANDSTOPTAKINGBOTH
MEDICINESIFYOUGET
s CONFUSED DISORIENTED AHEADACHE BALANCEPROBLEMS
ANDFEELSLEEPY4HESEARESIGNSOFSERIOUSCONDITIONS
DO NOT take Serenace if you are taking:
s CERTAINOTHERMEDICINESWHICHCANAFFECTTHEHEARTEG
QUINIDINE BRETYLIUM DISOPYRAMIDE PROCAINAMIDE
AMIODARONE SOTALOL DOFETILIDE
Talk to your doctor if you are taking any of the following:
s ANYOTHERMEDICINESIMILARTO3ERENACEKNOWNASA
NEUROLEPTICEGPHENOTHIAZINES SERTINDOLE PIMOZIDE
PROMAZINE AMISULPRIDE
s CERTAINMEDICINESFORTHETREATMENTOFDEPRESSIONEG
FLUOXETINE AMITRIPTYLINE MAPROTILINE LITHIUM PAROXETINE
s SLEEPINGCAPSULES SEDATIVESORSTRONGPAINKILLERS
s MEDICINESFORCHANGESINYOURHEARTBEATORARETAKING
MEDICINESTHATAFFECTYOURHEARTBEAT
s MEDICINESWHICHCANAFFECTTHECHEMICALSINYOUR
BLOODSTREAMKNOWNASELECTROLYTES SUCHASDIURETICS
e.g. furosemide
s CERTAINANTIBIOTICSEGMOXIFLOXACIN SPARFLOXACIN
ERYTHROMYCIN
s LEVODOPA FOR0ARKINSONSDISEASE
s BUSPIRONE FORANXIETY
s QUININEANDMEFLOQUINE FORMALARIA
s INDOMETACIN FORRHEUMATOIDARTHRITIS
s METHYLDOPA TOLOWERYOURBLOODPRESSURE
s CARBAMAZEPINE FOREPILEPSY
s ANYANTIHISTAMINE FORANALLERGYORHAY FEVER
s SYMPATHOMIMETICAGENTSEGFOUNDINCOLDANDFLU
REMEDIESnPLEASECHECKWITHYOURPHARMACIST
s ADRENALINE USEDINEMERGENCYSITUATIONSEGTOTREAT
SEVEREALLERGICREACTIONS
s MEDICINESFORTHINNINGTHEBLOOD SUCHASPHENINDIONE
s MEDICINESFORAFUNGALINFECTION SUCHASKETOCONAZOLE
s LEVOTHYROXINE
0LEASETELLYOURDOCTORORPHARMACISTIFYOUARETAKINGOR
HAVERECENTLYTAKENANYOTHERMEDICINES INCLUDING
MEDICINESOBTAINEDWITHOUTAPRESCRIPTION)FYOUSUFFER
FROMADISORDERWITHRELATEDMEMORYLOSS YOUSHOULD
TALKFIRSTTOYOURDOCTOR WHOWILLDECIDEIFYOUCANBEGIVEN
3ERENACEANDWILLEXPLAINTHEPOSSIBLERISKSOFITSUSE
Important information about some of the ingredients of
Serenace
s 0ATIENTSWHOAREINTOLERANTTOlactose should note that
Serenace capsules contain a small amount of lactose.
)FYOURDOCTORHASTOLDYOUTHATYOUHAVEAN
INTOLERANCETOSOMESUGARS CONTACTYOURDOCTOR
BEFORETAKINGTHISMEDICINE
s 4HISMEDICINECONTAINStartrazine (E102) as a colouring
AGENT)TCANCAUSEALLERGICTYPEREACTIONSINCLUDING
ASTHMA)FYOUAREALLERGICTOASPIRIN YOUAREMORE
LIKELYTOSUFFERAREACTION
Taking Serenace with food and drink
s $/./4DRINKALCOHOLWHILSTTAKING3ERENACE
Pregnancy and breast-feeding
s 4HEFOLLOWINGSYMPTOMSMAYOCCURINNEWBORN
BABIES OFMOTHERSTHATHAVEUSED3ERENACEINTHELAST
TRIMESTERLASTTHREEMONTHSOFTHEIRPREGNANCY 
SHAKING MUSCLESTIFFNESSANDORWEAKNESS SLEEPINESS
AGITATION BREATHINGPROBLEMS ANDDIFFICULTYIN
FEEDING)FYOURBABYDEVELOPSANYOFTHESESYMPTOMS
YOUMAYNEEDTOCONTACTYOURDOCTOR
s $/./4TAKE3ERENACEIFYOUAREBREAST FEEDING4HIS
ISBECAUSESMALLAMOUNTSMAYPASSINTOMOTHERSMILK
s )FYOUAREPREGNANTORPLANNINGTOBECOMEPREGNANT
ASKYOURDOCTORFORADVICEBEFORETAKINGTHISMEDICINE
Driving and using machines
s 3ERENACEMAYCAUSEDROWSINESSORIMPAIRED
ALERTNESS ESPECIALLYATTHESTARTOFTREATMENT)FYOU
AREAFFECTED $/./4DRIVEOROPERATEMACHINERY
WITHOUTDISCUSSINGTHISWITHYOURDOCTORFIRST

3

HOW TO TAKE SERENACE

!LWAYSTAKE3ERENACEEXACTLYASYOURDOCTORHASTOLD
YOU9OUSHOULDCHECKWITHYOURDOCTORORPHARMACISTIF
YOUARENOTSURE
9OUMAYNOTFEELBETTERFORSEVERALWEEKSAFTERYOUSTART
TOTAKEYOURCAPSULES
4HECAPSULESSHOULDBESWALLOWEDWHOLEPREFERABLY
WITHADRINKOFWATER
)FYOUARETAKINGHIGHDOSESOF3ERENACE YOURDOCTORWILL
GIVEYOUAHIGHERSTRENGTHPRODUCTSOTHATYOUDONOT
NEEDTOTAKEALARGENUMBEROFCAPSULESEACHDAY4HE
usual dose is:
Adults
s Psychotic and behavioural conditions:
4HEUSUALSTARTINGDOSEISBETWEENMGCAPSULES
ANDMGCAPSULES ADAY TAKENEITHERASASINGLE
dose or two smaller doses.
9OURDOCTORMAYINCREASETHISDOSEUPTOAMAXIMUM
OFMGADAYCAPSULES INSOMECASES
7HENYOURDOCTORISHAPPYTHATYOUARERESPONDINGTO
YOURTREATMENT THEYMAYGRADUALLYREDUCETHEDOSE
4HISCOULDBEASLOWASMGCAPSULES TOMG
CAPSULES DAILY
s Tourette's Syndrome:
4HESTARTINGDOSEISUSUALLYMGCAPSULES ADAY
9OURDOCTORMAYINCREASETHISDOSETOBETWEEN
MGCAPSULES ANDMGCAPSULES ADAYIN
some cases.
7HENYOURSYMPTOMSARECONTROLLEDYOURDOCTORWILL
GRADUALLYREDUCEYOURDOSETOAROUNDMG
CAPSULES ADAY

Page 1 of 3

s

s


Version:

2

25 March 2014

Nausea and vomiting:
4HEUSUALDOSEISMGCAPSULES ADAY
Anxiety:
4HEUSUALDOSEISMICROGRAMSCAPSULE TWICEA
DAY
The Elderly
)FYOUAREELDERLY YOURDOCTORWILLPROBABLYGIVEYOUHALF
THEDOSESMENTIONEDABOVE
Children
9OURDOCTORWILLWORKOUTTHEDOSEDEPENDINGONYOUR
CHILDSWEIGHT4HEUSUALDOSEISTOMICROGRAMSFOR
EACHKILOGRAMKG OFBODYWEIGHTUPTOAMAXIMUMOF
MG4EENAGERSMAYBEGIVENUPTOMGADAY
If you take more Serenace than you should
)FYOUORSOMEONEELSE SWALLOWALOTOFTHECAPSULESALL
TOGETHER ORIFYOUTHINKACHILDHASSWALLOWEDANYOFTHE
CAPSULES CONTACTYOURNEARESTHOSPITALCASUALTY
DEPARTMENTORYOURDOCTORIMMEDIATELY
!NOVERDOSEISLIKELYTOCAUSEMUSCLEWEAKNESS MUSCLE
STIFFNESS SHAKING LOWBLOODPRESSURE DROWSINESS
0LEASETAKETHISLEAFLET ANYREMAININGCAPSULESANDTHE
CONTAINERWITHYOUTOTHEHOSPITALORDOCTORSOTHATTHEY
KNOWWHICHCAPSULESWERECONSUMED
If you forget to take Serenace Capsules
)FYOUFORGETTOTAKEACAPSULE TAKEONEASSOONASYOU
REMEMBER UNLESSITISNEARLYTIMETOTAKETHENEXTONE
$/./4TAKEADOUBLEDOSETOMAKEUPFORAFORGOTTEN
DOSE)FITISNEARLYTIMETOTAKETHENEXTDOSE WAITUNTIL
THENANDTHENCARRYONASBEFORE
If you stop taking Serenace
$/./4STOPTAKING3ERENACEWITHOUTTALKINGTOYOUR
DOCTORFIRSTEVENIFYOUFEELBETTER
7HENYOUSTOPTAKING3ERENACE YOURDOCTORWILLREDUCE
THEDOSEGRADUALLYTOAVOIDTHEPOSSIBILITYOFWITHDRAWAL
SYMPTOMS SUCHASFEELINGANDBEINGSICKANDBEING
UNABLETOSLEEP ORTHERECURRENCEOFYOURORIGINAL
condition.
)FYOUHAVEANYFURTHERQUESTIONSONTHEUSEOFTHIS
PRODUCT ASKYOURDOCTORORPHARMACIST

4
231-30-01046-F LEA SERENACE (HALOPERIDOL) 500mcg CAP TUK
,IKEALLMEDICINES 3ERENACECANCAUSESIDEEFFECTS
ALTHOUGHNOTEVERYBODYGETSTHEM
Stop taking the capsules and tell your doctor
immediatelyORGOTOTHECASUALTYDEPARTMENTATYOUR
nearest hospital if the following happens:
s ANALLERGICREACTIONCAUSINGSWELLINGOFTHELIPS FACE
ORNECKLEADINGTOSEVEREDIFFICULTYINBREATHING
SEVERESKINRASHORHIVES
4HISISAVERYSERIOUSBUTRARESIDEEFFECT9OUMAYNEED
urgent medical attention or hospitalisation.
See your doctor immediatelyIFYOUSUFFERFROMANYOFTHE
FOLLOWING ASYOURTREATMENTWILLNEEDTOBEREVIEWED
s UNCONTROLLEDMOVEMENTS ESPECIALLYINYOURLIMBSAND
FACE MOUTHANDJAW TREMORS TICSANDMUSCLESPASM
INYOURSHOULDERS NECK BODYANDARMS4HESEARE
VERYCOMMONSIDEEFFECTS(OWEVERRARELYTHISCANBE
SEVEREENOUGHTOCAUSEBREATHINGDIFFICULTIES4HEFIRST
SIGNSMAYBEUNCONTROLLEDMOVEMENTSOFYOURTONGUE
s YOURMUSCLESBEGINTOFEELRIGIDBODYADOPTSRIGID
POSTUREORAMASKLIKEFACE4HESEARECOMMONSIDE
effects.
s EXTREMERESTLESSNESS LOSSOFNORMALMUSCLECONTROL
DIFFICULTYINMOVING SHAKINESSANDLOSSOFMOVEMENT
s YOUFEELFEVERISHANDBECOMELESSALERTTHANUSUAL OR
YOUFEELHOT YOUSTARTSWEATINGANDYOURHEARTBEAT
speeds up
s BLOODCLOTSINTHEVEINSESPECIALLYINTHELEGS
SYMPTOMSINCLUDESWELLING PAINANDREDNESSINTHE
LEG WHICHMAYTRAVELTHROUGHBLOODVESSELSTOTHE
LUNGSCAUSINGCHESTPAINANDDIFFICULTYINBREATHING
s INELDERLYPEOPLEWITHDEMENTIA ASMALLINCREASEIN
the number of deaths has been reported for patients
TAKINGANTIPSYCHOTICSCOMPAREDWITHTHOSENOT
RECEIVINGANTIPSYCHOTICS
s ASERIOUSPROBLEMCALLEDhNEUROLEPTICMALIGNANT
SYNDROMEv 4HESIGNSMAYINCLUDE
s &ASTHEARTBEAT CHANGINGBLOODPRESSUREAND
SWEATINGFOLLOWEDBYFEVER
s &ASTERBREATHING MUSCLESTIFFNESS REDUCED
consciousness and coma
s 2AISEDLEVELSOFAPROTEININYOURBLOODANENZYME
CALLEDCREATINEPHOSPHOKINASE
s ANUNCONTROLLEDMUSCULARCONTRACTIONSPASM OFTHE
LARYNGEALCORDSASSOCIATEDWITHPURPLECOLORATIONOF
THESKIN TONGUE TIE DIFFICULTYINBREATHINGANDTOTHE
PSYCHOLOGICALEXPERIENCEASSOCIATEDWITHSUCH
DIFFICULTY DEFICIENTSUPPLYOFOXYGENTOTHEBODY
)FYOUNOTICEANYOFTHESESYMPTOMSSEEKMEDICALADVICE
IMMEDIATELY
9OUMAYALSOEXPERIENCEDIFFICULTIESWITHSEXSUCHAS
ERECTILEDYSFUNCTIONINABILITYTODEVELOPORMAINTAINAN
ERECTIONOFTHEPENIS DECREASEDSEXUALDESIRE AND
SOMEMENMAYEXPERIENCESWELLINGOFTHEBREASTSOR
painful and prolonged erection.
4HEFOLLOWINGSIDEEFFECTSHAVEBEENREPORTEDATTHE
APPROXIMATEFREQUENCIESSHOWN
Very common (affecting more than one person in 10):
s FEELINGAGITATEDORHAVINGDIFFICULTYSLEEPING
s HEADACHE
Common (affecting less than one person in 10 but more
than one person in 100):
s DEPRESSION MENTALPROBLEMS
s ROLLINGOFTHEEYES
s PROBLEMSWITHSIGHT
s AFALLINBLOODPRESSUREONSTANDINGUPWHICHCAUSES
DIZZINESS LIGHT HEADEDNESSORFAINTING
s CONSTIPATION DRYMOUTH EXCESSIVEMOUTHWATERING
FEELINGSICK BEINGSICK
s ABNORMALLIVERFUNCTIONWHICHMAYBEDETECTEDBY
BLOODTESTS

TEVA UK Ref:

REG0064534

POSSIBLE SIDE EFFECTS

Version 3.2

Approved

s RASH
s UNABLETOPASSURINE
s WEIGHTCHANGESINCREASEORDECREASE
s DIZZINESSORSLEEPINESS
Uncommon (affecting less than one person in 100 but
more than one person in 1,000):
s AFALLINTHENUMBEROFWHITEBLOODCELLSWHICHCAN
CAUSEFREQUENTINFECTIONS
s CONFUSIONALSTATE
s EPILEPTICFITSORSEIZURESCONVULSION
s BLURREDVISION
s RAPIDHEARTBEAT
s SHORTNESSOFBREATH
s INFLAMMATIONOFTHELIVER JAUNDICEYOURSKINANDTHE
WHITESOFYOUREYESMAYBECOMEYELLOW OR DUETOA
CHANGEINTHEWAYYOURLIVERWORKS
s ITCHING SWEATINGMORETHANUSUAL
s IFYOUAREAWOMAN YOUMAYUNEXPECTEDLYPRODUCE
MILK HAVINGPAINFULBREASTANDYOURPERIODSMAY
BECOMEINFREQUENTORSTOP
s SHUFFLING UNBALANCEDWALK NECKTILTEDTOONESIDE
s FEELINGTOOWARMHYPERTHERMIA
s FLUIDMAYBUILDUPINYOURBODYCAUSINGSWOLLENFEET
ORANKLES
Rare (affecting less than one person in 1000 but more
than one person in 10,000):
s IFYOUAREAWOMAN YOURBODYMAYMAKETOOMUCHOF
the hormone prolactin
s GETTINGEXCITED SYMPTOMSOFPSYCHOSISSUCHAS
ABNORMALTHOUGHTSORVISION ORHEARINGABNORMAL
sounds
s DIFFICULTYBREATHINGORWHEEZING
s DIFFICULTIESOPENINGTHEMOUTH4RISMUS
s MUSCLETWITCHING
s ABNORMALHEAVYANDPROLONGEDMENSTRUALPERIODSAT
REGULARINTERVALS
s ABNORMALHEARTRHYTHMS
Other side effects
s BLOODABNORMALITIES WHICHCANCAUSEFEVERORCHILLS
SORETHROATSANDULCERSINYOURMOUTHANDTHROAT
s FEELINGUNWELL CONFUSEDORWEAK FEELINGSICKNAUSEA
LOSSOFAPPETITE FEELINGIRRITABLE4HISCOULDBEAN
ILLNESSCALLED@SYNDROMEOFINAPPROPRIATEANTI DIURETIC
HORMONESECRETION3)!$( 
s LOWLEVELOFBLOODGLUCOSEHYPOGLYCAEMIA
s DROWSINESS
s VERTIGOASENSATIONTHATTHEWORLDISSPINNINGAROUND
YOU
s HEARTPROBLEMSCAUSINGSYMPTOMSSUCHAS
PALPITATIONS ABNORMALHEARTRHYTHMS FAINTING
BLACKOUTSORRARELYHEARTATTACKS
s SWELLINGOFTHEVOICEBOXORCONTRACTIONOFTHEMUSCLE
INTHEVOICEBOX
s LOSSOFAPPETITE
s INDIGESTION
s ACUTELIVERFAILURE
s INFLAMMATIONOFBLOODVESSELS
s FLAKINGORPEELINGOFTHESKIN
s INFLAMEDSKINRED HOTTOTHETOUCHANDTENDER
s SUDDENUNEXPLAINEDDEATHHASOCCURREDINRARECASES
BUTITISNOTKNOWNIFTHISWASDUETOTHEMEDICINE
s SWELLINGOFFACE
s FEELINGTOOCOLD
If you are concerned about any of these side effects, or if
you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5

HOW TO STORE SERENACE

Keep out of the reach and sight of children.
3TORETHECAPSULESINADRYPLACEBELOWª#+EEPTHEM
INTHEORIGINALPACKAGE DONOTPUTTHEMINTOANOTHER
container.
$ONOTUSE3ERENACEAFTERTHEEXPIRYDATETHATISSTATED
ONTHEOUTERPACKAGING4HEEXPIRYDATEREFERSTOTHELAST
DAYOFTHATMONTH
-EDICINESSHOULDNOTBEDISPOSEDOFVIAWASTEWATEROR
HOUSEHOLDWASTE!SKYOURPHARMACISTHOWTODISPOSEOF
MEDICINESNOLONGERREQUIRED4HESEMEASURESWILLHELP
TOPROTECTTHEENVIRONMENT

6

FURTHER INFORMATION

What Serenace Capsules contain:
s 4HEACTIVEINGREDIENTISHALOPERIDOLMICROGRAMS
s 4HEOTHERINGREDIENTSARELACTOSEANDCORNSTARCH4HE
CAPSULESHELLCONTAINS4ITANIUM$IOXIDE%
4ARTRAZINE% AND0ATENT"LUE6% 4HE
PRINTINGINKCONTAINSSHELLAC BLACKIRONOXIDE%
ANDPROPYLENEGLYCOL% 
What Serenace Capsules look like and contents of the
pack:
s 3ERENACE#APSULESAREHARDGELATINCAPSULES4WO TONE
GREENPRINTED@.ORTONONONEHALFAND3%2%.!#%
on the other.
s 4HECAPSULESAREAVAILABLEINPACKSOF    
         AND
s .OTALLPACKSIZESMAYBEMARKETED
Marketing Authorisation Holder and Manufacturer
4HECOMPANYRESPONSIBLEFORMANUFACTUREIS0IRAMAL
(EALTHCARE5+,IMITED 7HALTON2D -ORPETH
.ORTHUMBERLAND .%9!
4HE-ARKETING!UTHORISATIONHOLDERIS
4%6!5+,IMITED %ASTBOURNE ".!'
This leaflet was last revised: 03/2014
0,

 &
X

XXXXXXX

Page 2 of 3

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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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