Skip to Content

UK Edition. Click here for US version.

RISPERIDONE 6MG ORODISPERSIBLE TABLETS

Active substance(s): RISPERIDONE

View full screen / Print PDF » Download PDF ⇩
Transcript
TEVA UK Ref:

Version:

231-30-86518-X LEA RISPERIDONE OD TABS A/S TUK
3

02 June 2014

RISPERIDONE
2 mg, 3 mg, 4 mg and 6 mg
ORODISPERSIBLE TABLETS

RISPERIDONE
2 mg, 3 mg, 4 mg and 6 mg
ORODISPERSIBLE TABLETS

$UMMY0HARMA#ODESSHOWNNUMBER WILL
be replaced by the real ones prior to production.

RISPERIDONE
2 mg, 3 mg, 4 mg and 6 mg
ORODISPERSIBLE TABLETS

4HEFOLLOWINGMEDICINESMAYREDUCETHEEFFECTOFRISPERIDONE
s 2IFAMPICINAMEDICINEFORTREATINGSOMEINFECTIONS
s #ARBAMAZEPINE PHENYTOINMEDICINESFOREPILEPSY
s 0HENOBARBITAL

0!#+!'%,%!&,%4).&/2-!4)/.
&/24(%53%2

)FYOUSTARTORSTOPTAKINGSUCHMEDICINESYOUMAYNEEDA
different dose of risperidone.

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
s +EEPTHISLEAFLET9OUMAYNEEDTOREADITAGAIN
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOURDOCTOROR
pharmacist.
s 4HISMEDICINEHASBEENPRESCRIBEDFORYOUONLY$ONOTPASS
ITONTOOTHERS)TMAYHARMTHEM EVENIFTHEIRSIGNSOF
illness are the same as yours.
s )FYOUGETANYSIDEEFFECTSTALKTOYOURDOCTORORPHARMACIST

4HEFOLLOWINGMEDICINESMAYINCREASETHEEFFECTOF
risperidone.
s 1UINIDINEUSEDFORCERTAINTYPESOFHEARTDISEASE
s !NTIDEPRESSANTSSUCHASPAROXETINE FLUOXETINES TRICYCLIC
antidepressants
s -EDICINESKNOWNASBETABLOCKERSUSEDTOTREATHIGHBLOOD
PRESSURE
s 0HENOTHIAZINESEGUSEDTOTREATPSYCHOSISORTOCALM
DOWN

4HISINCLUDESANYPOSSIBLESIDEEFFECTSNOTLISTEDINTHIS
LEAFLET3EESECTION

7(!4)3).4()3,%!&,%4
1. What Risperidone is and what it is used for
2. What you need to know before you take Risperidone
3. How to take Risperidone
4. Possible side effects
5. How to store Risperidone
6. Contents of the pack and other information

1

)FYOUSTARTORSTOPTAKINGSUCHMEDICINESYOUMAYNEEDA
different dose of risperidone.
)FYOUARENOTSUREIFANYOFTHEABOVEAPPLIESTOYOU TALKTO
YOURDOCTORORPHARMACISTBEFOREUSING2ISPERIDONE
Risperidone with food and drink
YOUCANTAKETHISMEDICINEWITHORWITHOUTFOOD9OUSHOULD
AVOIDDRINKINGALCOHOLWHENTAKING2ISPERIDONE

WHAT RISPERIDONE IS AND WHAT IT IS USED FOR

2ISPERIDONEBELONGSTOAGROUPOFMEDICINESCALLED
@ANTI PSYCHOTICS
2ISPERIDONEISUSEDTOTREATTHEFOLLOWING
s 3CHIZOPHRENIA WHEREYOUMAYSEE HEARORFEELTHINGSTHAT
ARENOTTHERE believe things that are not true or feel
UNUSUALLYSUSPICIOUS ORCONFUSED
s -ANIA WHEREYOUMAYFEELVERYEXCITED ELATED AGITATED
enthusiastic or hyperactive. Mania occurs in an illness
CALLEDhBIPOLARDISORDERv
s 3HORT TERMTREATMENTUPTOWEEKS OFLONG TERM
AGGRESSIONINPEOPLEWITH!LZHEIMERSDEMENTIA WHOHARM
THEMSELVESOROTHERS!LTERNATIVENON DRUG TREATMENTS
should have been used previously.
s 3HORT TERMTREATMENTUPTOWEEKS OFLONG TERM
AGGRESSIONININTELLECTUALLYDISABLEDCHILDRENATLEAST
YEARSOFAGE ANDADOLESCENTSWITHCONDUCTDISORDER

2

s #IMETIDINE RANITIDINEBLOCKERSOFTHEACIDITYOFTHESTOMACH 

WHAT YOU NEED TO KNOW BEFORE YOU TAKE
RISPERIDONE

Do not take Risperidone:
s )FYOUAREALLERGICHYPERSENSITIVE TORISPERIDONEORANYOF
THEOTHERINGREDIENTSOFTHISMEDICINELISTEDINSECTION 
)FYOUARENOTSUREIFTHEABOVEAPPLIESTOYOU TALKTOYOUR
DOCTORORPHARMACISTBEFOREUSING2ISPERIDONE
Warnings and precautions
4ALKTOYOURDOCTORORPHARMACISTBEFORETAKING2ISPERIDONEIF
s 9OUHAVEAHEARTPROBLEM%XAMPLESINCLUDEANIRREGULAR
HEARTRHYTHMORIFYOUAREPRONETOLOWBLOODPRESSUREORIF
you are using medicines for your blood pressure.
2ISPERIDONEMAYCAUSELOWBLOODPRESSURE9OURDOSEMAY
need to be adjusted.
s 9OUKNOWOFANYFACTORSWHICHWOULDFAVOURYOUHAVINGA
STROKE SUCHASHIGHBLOODPRESSURE CARDIOVASCULAR
disorder or blood vessel problems in the brain
s 9OUHAVE0ARKINSONSDISEASEORDEMENTIA
s 9OUKNOWTHATYOUHAVEHADLOWLEVELSOFWHITEBLOODCELLS
INTHEPASTWHICHMAYORMAYNOTHAVEBEENCAUSEDBY
OTHERMEDICINES
s 9OUAREDIABETIC
s 9OUHAVEEPILEPSY
s 9OUAREAMANANDYOUHAVEEVERHADAPROLONGEDOR
PAINFULERECTION)FYOUEXPERIENCETHISWHILETAKING
2ISPERIDONE CONTACTYOURDOCTORSTRAIGHTAWAY
s 9OUHAVEPROBLEMSCONTROLLINGYOURBODYTEMPERATUREOR

Pregnancy and breast-feeding
s )FYOUAREPREGNANTORBREAST FEEDING THINKYOUMAYBE
PREGNANTORAREPLANNINGTOHAVEABABY ASKYOURDOCTOROR
pharmacist for advice before taking this medicine. Your
DOCTORWILLDECIDEIFYOUCANTAKEIT
s 4HEFOLLOWINGSYMPTOMSMAYOCCURINNEWBORNBABIES OF
MOTHERSTHATHAVEUSED2ISPERIDONEINTHELASTTRIMESTER
LASTTHREEMONTHSOFTHEIRPREGNANCY SHAKING MUSCLE
STIFFNESSANDORWEAKNESS SLEEPINESS AGITATION BREATHING
PROBLEMS ANDDIFFICULTYINFEEDING)FYOURBABYDEVELOPS
any of these symptoms you may need to contact your
doctor.
s 2ISPERIDONECANRAISEYOURLEVELSOFAHORMONECALLED
PROLACTINTHATMAYIMPACTFERTILITYSEE0OSSIBLESIDE
EFFECTS 
!SKYOURDOCTORORPHARMACISTFORADVICEBEFORETAKINGANY
medicine.
Driving and using machines
$IZZINESS TIREDNESS ANDVISIONPROBLEMSMAYOCCURDURING
TREATMENTWITH2ISPERIDONE$ONOTDRIVEORUSEANYTOOLSOR
MACHINESWITHOUTTALKINGTOYOURDOCTORFIRST
Risperidone 3 mg contains tartrazine
2ISPERIDONEMG/RODISPERSIBLE4ABLETSCONTAINSTARTRAZINE
and may cause allergic reactions.

3

HOW TO TAKE RISPERIDONE

!LWAYSTAKETHISMEDICINEEXACTLYASYOURDOCTORHASTOLDYOU
#HECKWITHYOURDOCTORORPHARMACISTIFYOUARENOTSURE
The recommended dose is as follows:
For the treatment of schizophrenia
Adults
s 4HEUSUALSTARTINGDOSEISMGPERDAY THISMAYBE
increased to 4 mg per day on the second day
s 9OURDOSEMAYTHENBEADJUSTEDBYYOURDOCTORDEPENDING
ONHOWYOURESPONDTOTHETREATMENT
s -OSTPEOPLEFEELBETTERWITHDAILYDOSESOFTOMG
s 4HISTOTALDAILYDOSECANBEDIVIDEDINTOEITHERONEORTWO
DOSESADAY9OURDOCTORWILLTELLYOUWHICHISTHEBESTFOR
you.
Elderly people

overheating
s 9OUHAVEKIDNEYPROBLEMS
s 9OUHAVELIVERPROBLEMS
s 9OUHAVEANABNORMALLYHIGHLEVELOFTHEHORMONE
PROLACTININYOURBLOODORIFYOUHAVEATUMOUR WHICHIS
possibly dependent on prolactin
s 9OUORSOMEONEELSEINYOURFAMILYHASAHISTORYOFBLOOD
CLOTS ASMEDICINESLIKETHESEHAVEBEENASSOCIATEDWITH
formation of blood clots.

9OURSTARTINGDOSEWILLNORMALLYBEMGTWICEADAY
s 9OURDOSEMAYTHENBEGRADUALLYINCREASEDBYYOURDOCTOR
TOMGTOMGTWICEADAY
s 9OURDOCTORWILLTELLYOUWHICHISTHEBESTFORYOU
Use in children and adolescents
s #HILDRENANDADOLESCENTSUNDERYEARSOLDSHOULDNOTBE
TREATEDWITH2ISPERIDONEFORSCHIZOPHRENIA
For the treatment of mania

Tell your doctor immediately if you experience
s INVOLUNTARYRHYTHMICMOVEMENTSOFTHETONGUE MOUTH and
FACE7ITHDRAWALOFRISPERIDONEMAYBENEEDED
s FEVER SEVEREMUSCLESTIFFNESS SWEATINGORALOWEREDLEVEL
OFCONSCIOUSNESSADISORDERCALLEDhNEUROLEPTICMALIGNANT
SYNDROMEv )MMEDIATEMEDICALTREATMENTMAYBENEEDED

Adults
s 9OURSTARTINGDOSEWILLUSUALLYBEMGONCEADAY
s 9OURDOSEMAYTHENBEGRADUALLYADJUSTEDBYYOURDOCTOR
DEPENDINGONHOWYOURESPONDTOTHETREATMENT
s -OSTPEOPLEFEELBETTERWITHDOSESOFTOMGONCEADAY

Elderly people
)FYOUARENOTSUREIFANYOFTHEABOVEAPPLIESTOYOU TALKTO
s 9OURSTARTINGDOSEWILLUSUALLYBEMGTWICEADAY
YOURDOCTORORPHARMACISTBEFOREUSING2ISPERIDONE
!SDANGEROUSLYLOWNUMBERSOFACERTAINTYPEOFWHITEBLOOD s 9OURDOSEMAYTHENBEGRADUALLYADJUSTEDBYYOURDOCTOR
TOMGTOMGTWICEADAYDEPENDINGONHOWMUCHYOU
cell needed to fight infection in your blood has been seen very
RARELYWITHPATIENTSTAKING2ISPERIDONE YOURDOCTORMAYCHECK respond to the treatment.
YOURWHITEBLOODCELLCOUNTS
Use in children and adolescents
2ISPERIDONEMAYCAUSEYOUTOGAINWEIGHT3IGNIFICANTWEIGHT s #HILDRENANDADOLESCENTSUNDERYEARSOLDSHOULDNOTBE
TREATEDWITH2ISPERIDONEFORBIPOLARMANIA
gain may adversely affect your health. Your doctor should
REGULARLYMEASUREYOURBODYWEIGHT
For the treatment of long-standing aggression in people with
Alzheimer’s dementia
!SDIABETESMELLITUSORWORSENINGOFPRE EXISTINGDIABETES
MELLITUSHAVEBEENSEENWITHPATIENTSTAKING2ISPERIDONE
Adults (including elderly people)
YOURDOCTORSHOULDCHECKFORSIGNSOFHIGHBLOODSUGAR)N
s 9OURSTARTINGDOSEWILLNORMALLYBEMGTWICEADAY
PATIENTSWITHPRE EXISTINGDIABETESMELLITUSBLOODGLUCOSE
s 9OURDOSEMAYTHENBEGRADUALLYADJUSTEDBYYOURDOCTOR
should be monitored regularly.
DEPENDINGONHOWYOURESPONDTOTHETREATMENT
s -OSTPEOPLEFEELBETTERWITHMGTWICEADAY3OME
During an operation on the eye for cloudiness of the lens
PATIENTSMAYNEEDMGTWICEADAY
CATARACT THEPUPILTHEBLACKCIRCLEINTHEMIDDLEOFYOUREYE
MAYNOTINCREASEINSIZEASNEEDED!LSO THEIRISTHECOLOURED s 4REATMENTDURATIONINPATIENTSWITH!LZHEIMERSDEMENTIA
SHOULDBENOTMORETHANWEEKS
PARTOFTHEEYE MAYBECOMEFLOPPYDURINGSURGERYANDTHAT
MAYLEADTOEYEDAMAGE)FYOUAREPLANNINGTOHAVEAN
For the treatment of conduct disorder in children and
OPERATIONONYOUREYE MAKESUREYOUTELLYOUREYEDOCTOR
adolescents
that you are taking this medicine.
4HEDOSEWILLDEPENDONYOURCHILDSWEIGHT
Elderly people with dementia
)NELDERLYPATIENTSWITHDEMENTIA THEREISANINCREASEDRISKOF &ORCHILDRENWHOWEIGHLESSTHANKG
stroke. You should not take risperidone if you have dementia s 4HESTARTINGDOSEWILLNORMALLYBEMGONCEADAY
s 4HEDOSEMAYBEINCREASEDEVERYOTHERDAYINSTEPSOF
caused by stroke.
MGPERDAY
$URINGTREATMENTWITHRISPERIDONEYOUSHOULDFREQUENTLYSEE
s 4HEUSUALMAINTENANCEDOSEISMGTOMGONCEA
your doctor.
day.
-EDICALTREATMENTSHOULDBESOUGHTSTRAIGHTAWAYIFYOUor
YOURCARE GIVERNOTICEASUDDENCHANGEINYOURMENTAL state or
&ORCHILDRENWHOWEIGHKGORMORE
SUDDENWEAKNESSORNUMBNESSOFYOURFACE ARMSORLEGS
s 4HESTARTINGDOSEWILLNORMALLYBEMGONCEADAY
ESPECIALLYONONESIDE ORSLURREDSPEECH EVENFORASHORT
s 4HEDOSEMAYBEINCREASEDEVERYOTHERDAYINSTEPSOF
PERIODOFTIME4HESEMAYBESIGNSOFASTROKE
MGPERDAY
s 4HEUSUALMAINTENANCEDOSEISMGTOMGONCEADAY
Children and adolescents
"EFORETREATMENTISSTARTEDINCONDUCTDISORDER OTHERCAUSES of
4REATMENTDURATIONINPATIENTSWITHCONDUCTDISORDERSHOULD
aggressive behaviour should have been ruled out.
BENOTMORETHANWEEKS
"EFORETREATMENTISSTARTEDYOUR ORYOURCHILDSBODYWEIGHT
#HILDRENUNDERYEARSOLDSHOULDNOTBETREATEDWITH
may be measured and it may be regularly monitored during

treatment.

2ISPERIDONEFORCONDUCTDISORDER

)FDURINGTREATMENTWITHRISPERIDONETIREDNESSOCCURS A
change in the time of administration might improve attention
difficulties.

People with kidney or liver problems
2EGARDLESSOFTHEDISEASETOBETREATED ALLSTARTINGDOSESAND
FOLLOWINGDOSESOFRISPERIDONESHOULDBEHALVED$OSE
INCREASESSHOULDBESLOWERINTHESEPATIENTS
2ISPERIDONESHOULDBEUSEDWITHCAUTIONINTHISPATIENTGROUP

Other medicines and Risperidone
4ELLYOURDOCTORORPHARMACISTIFYOUARETAKING HAVERECENTLY
Take the tablets as follows
taken or might take any other medicines.
/NLYREMOVEATABLETFROMTHEBLISTERWHENITISTIMETOTAKE
)TISESPECIALLYIMPORTANTTOTALKTOYOURDOCTORORPHARMACISTIF your medicine.
YOUARETAKINGANYOFTHEFOLLOWING
s -EDICINESTHATWORKONYOURBRAINSUCHASTOHELPYOUCALM s $ONOTPUSHTHETABLETOUTOFTHEPOCKET ASTHISWILLCRUSHIT
s %ACHSTRIPCONTAINSTABLETSSEPARATEDINPOCKETSBY
DOWNBENZODIAZEPINES ORSOMEMEDICINESFORPAIN
PERFORATIONS4EAROFFONETABLETPOCKETALONGTHEDOTTED
OPIATES MEDICINESFORALLERGYSOMEANTIHISTAMINES AS
LINES&IGURE 
risperidone may increase the sedative effect of all of these
s -EDICINESTHATMAYCHANGETHEELECTRICALACTIVITYOFYOUR
HEART SUCHASMEDICINESFORMALARIA HEARTRHYTHM
PROBLEMSSUCHASQUINIDINE ALLERGIESANTI HISTAMINES
some antidepressants or other medicines for mental
problems

s -EDICINESTHATCAUSEASLOWHEARTBEAT
s #AREFULLYPEELOFFTHELIDDINGFOIL STARTINGINTHECORNER
s -EDICINESTHATCAUSELOWBLOODPOTASSIUMEGCERTAIN
INDICATEDBYTHEARROW&IGURESAND 
DIURETICS
s -EDICINESTOTREATELEVATEDBLOODPRESSURE2ISPERIDONECAN
LOWERBLOODPRESSURE
s -EDICINESFOR0ARKINSONSDISEASESUCHASLEVODOPA
s 7ATERTABLETSDIURETICS USEDFORHEARTPROBLEMSORSWELLING
of parts of your body due to a build up of too much fluid


SUCHASFUROSEMIDEORCHLOROTHIAZIDE 2ISPERIDONETAKEN
BYITSELFORWITHFUROSEMIDE MAY have an increased risk of s +EEPYOURHANDSDRYANDTAKETHETABLETOUTOFTHESTRIP
s 4HETABLETSHOULDBEPLACEDONTOPOFTHETONGUE WHEREIT
STROKEORDEATHINELDERLYPEOPLEWITHDEMENTIA
WILLDISPERSEWITHINSECONDSANDCANTHENBESWALLOWED
WITHORWITHOUTWATER

TEVA UK Ref:

231-30-86518-X LEA RISPERIDONE OD TABS A/S TUK
Do not break or divide the tablets. Your mouth should be
empty before placing the tablet on the tongue.
If you take more Risperidone than you should
s 3EEADOCTORRIGHTAWAY4AKETHEMEDICINEPACKWITHYOU
s )NCASEOFOVERDOSEYOUMAYFEELSLEEPYORTIRED ORHAVE
ABNORMALBODYMOVEMENTS PROBLEMSSTANDINGAND
WALKING FEELDIZZYDUETOLOWBLOODPRESSURE ORHAVE
abnormal heart beats or fits.
If you forget to take Risperidone
s )FYOUFORGETTOTAKEADOSE TAKEITASSOONASYOUREMEMBER
IT(OWEVER IFITISALMOSTTIMEFORYOURNEXTDOSE SKIPTHE
MISSEDDOSEANDCONTINUEASUSUAL)FYOUMISSTWOOR
MOREDOSES CONTACTYOURDOCTOR
s $ONOTTAKEADOUBLEDOSETWODOSESATTHESAMETIME TO
make up for a forgotten dose.

Version:

3

02 June 2014

s !BNORMALPOSTURE JOINTSTIFFNESS JOINTSWELLING MUSCLE
WEAKNESS NECKPAIN
s &REQUENTPASSINGOFURINE INABILITYTOPASSURINE PAINWHEN
passing urine
s %RECTILEDYSFUNCTION EJACULATIONDISORDER
s ,OSSOFMENSTRUALPERIODS MISSEDMENSTRUALPERIODSOR
OTHERPROBLEMSWITHYOURCYCLEFEMALES
s $EVELOPMENTOFBREASTSINMEN LEAKAGEOFMILKFROMTHE
BREASTS SEXUALDYSFUNCTION BREASTPAIN BREASTDISCOMFORT
vaginal discharge
s 3WELLINGOFTHEFACE MOUTH EYES ORLIPS
s #HILLS ANINCREASEINBODYTEMPERATURE
s !CHANGEINTHEWAYYOUWALK
s &EELINGTHIRSTY FEELINGUNWELL CHESTDISCOMFORT FEELING
OUTOFSORTS DISCOMFORT
s )NCREASEDLIVERTRANSAMINASESINYOURBLOOD INCREASED''4
ALIVERENZYMECALLEDGAMMA GLUTAMYLTRANSFERASE INYOUR

If you stop taking Risperidone
You should not stop taking this medicine unless told to do so
BYYOURDOCTOR9OURSYMPTOMSMAYRETURN)FYOURDOCTOR
DECIDESTOSTOPTHISMEDICINE YOURDOSEMAYBEDECREASED
GRADUALLYOVERAFEWDAYS
)FYOUHAVEANYFURTHERQUESTIONSONTHEUSEOFTHISMEDICINE
ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

,IKEALLMEDICINES THISMEDICINECANCAUSESIDEEFFECTS
although not everybody gets them.
4ELLYOURDOCTORIMMEDIATELYIFYOU
s %XPERIENCEBLOODCLOTSINTHEVEINS ESPECIALLYINTHELEGS
SYMPTOMSINCLUDESWELLING PAIN ANDREDNESSINTHELEG
WHICHMAYTRAVELTHROUGHBLOODVESSELSTOTHELUNGS
CAUSINGCHESTPAINANDDIFFICULTYBREATHING)FYOUNOTICE
any if these symptoms seek medical advice immediately.
s (AVEDEMENTIAANDEXPERIENCEASUDDENCHANGEINYOUR
MENTALSTATEORSUDDENWEAKNESSORNUMBNESSOFYOUR
FACE ARMSORLEGS ESPECIALLYONONESIDE ORSLURRED
SPEECH EVENFORASHORTPERIODOFTIME4HESEMAYBESIGNS
of a stroke.
s %XPERIENCEFEVER MUSCLESTIFFNESS SWEATINGORALOWERED
LEVELOFCONSCIOUSNESSADISORDERCALLEDh.EUROLEPTIC
-ALIGNANT3YNDROMEv )MMEDIATEMEDICALTREATMENTMAY
be needed.
s !REAMANANDEXPERIENCEPROLONGEDORPAINFULERECTION
4HISISCALLEDPRIAPISM)MMEDIATEMEDICALTREATMENTMAY
be needed.
s %XPERIENCEINVOLUNTARYRHYTHMICMOVEMENTSOFTHETONGUE
MOUTHANDFACE7ITHDRAWALOFRISPERIDONEMAYBENEEDED
s %XPERIENCESEVEREALLERGICREACTIONCHARACTERIZEDBYFEVER
SWOLLENMOUTH FACE LIPORTONGUE SHORTNESSOFBREATH
ITCHING SKINRASHORDROPINBLOODPRESSURE
4HEFOLLOWINGSIDEEFFECTSMAYHAPPEN

BLOOD INCREASEDLIVERENZYMESINYOURBLOOD
s 0ROCEDURALPAIN
Rare (may affect up to 1 in 1,000 people):
s )NFECTION
s )NAPPROPRIATESECRETIONOFAHORMONETHATCONTROLSURINE
volume
s 3UGARINTHEURINE LOWBLOODSUGAR HIGHBLOOD
TRIGLYCERIDESAFAT
s ,ACKOFEMOTION INABILITYTOREACHORGASM
s .EUROLEPTICMALIGNANTSYNDROMECONFUSION REDUCEDOR
LOSSOFCONSCIOUSNESS HIGHFEVER ANDSEVEREMUSCLE
STIFFNESS
s "LOODVESSELPROBLEMSINTHEBRAIN
s #OMADUETOUNCONTROLLEDDIABETES
s 3HAKINGOFTHEHEAD
s 'LAUCOMAINCREASEDPRESSUREWITHINTHEEYEBALL
PROBLEMSWITHMOVEMENTOFYOUREYES EYEROLLING EYELID
margin crusting
s %YEPROBLEMSDURINGCATARACTSURGERY$URINGCATARACT
SURGERY ACONDITIONCALLEDINTRAOPERATIVEFLOPPYIRIS
SYNDROME)&)3 CANHAPPENIFYOUTAKEORHAVETAKEN
2ISPERIDONE)FYOUNEEDTOHAVECATARACTSURGERY BESURE
to tell your eye doctor if you take or have taken this
medicine.
s $ANGEROUSLYLOWNUMBERSOFACERTAINTYPEOFWHITEBLOOD
cell needed to fight infection in your blood
s 3EVEREALLERGICREACTIONCHARACTERISEDBYFEVER SWOLLEN
MOUTH FACE LIPORTONGUE SHORTNESSOFBREATH ITCHING SKIN
rash and sometimes drop in blood pressure
s $ANGEROUSLYEXCESSIVEINTAKEOFWATER
s )RREGULARHEARTBEAT
s "LOODCLOTINTHELEGS BLOODCLOTINTHELUNGS
s 4ROUBLEBREATHINGDURINGSLEEPSLEEPAPNEA FAST SHALLOW
breathing
s )NFLAMMATIONOFTHEPANCREAS ABLOCKAGEINTHEBOWELS
s 3WOLLENTONGUE CHAPPEDLIPS RASHONSKINRELATEDTODRUG
s $ANDRUFF
s "REAKDOWNOFMUSCLEFIBERSANDPAININMUSCLES
RHABDOMYOLYSIS
s !DELAYINMENSTRUALPERIODS ENLARGEMENTOFTHEGLANDSIN
YOURBREASTS BREASTENLARGEMENT DISCHARGEFROMTHE
breasts
s )NCREASEDINSULINAHORMONETHATCONTROLSBLOODSUGAR
LEVELS INYOURBLOOD
s 0RIAPISMAPROLONGEDPENILEERECTIONTHATMAYREQUIRE
SURGICALTREATMENT
s (ARDENINGOFTHESKIN
s $ECREASEDBODYTEMPERATURE ADECREASEINBODY
TEMPERATURE COLDNESSINARMSANDLEGS
s 3YMPTOMSOFDRUGWITHDRAWAL
s 9ELLOWINGOFTHESKINANDTHEEYESJAUNDICE 

Very Common (may affect more than 1 in 10 people):
s 0ARKINSONISM4HISISAMEDICALTERMTHATINCLUDESMANY
SYMPTOMS%ACHINDIVIDUALSYMPTOMMAYOCCURLESS
FREQUENTLYTHANININPEOPLE0ARKINSONISMINCLUDES
increase in saliva secretion ORWATERYMOUTH
MUSCULOSKELETALSTIFFNESS DROOLING JERKSWHENBENDINGTHE
LIMBS SLOW REDUCEDORIMPAIREDBODYMOVEMENTS NO
EXPRESSIONONTHEFACE MUSCLETIGHTNESS STIFFNECK MUSCLE
STIFFNESS SMALL SHUFFLING HURRIEDSTEPSANDLACKOFNORMAL
ARMMOVEMENTSWHENWALKING PERSISTENTBLINKINGIN
RESPONSETOTAPPINGOFTHEFOREHEADANABNORMALREFLEX 
s (EADACHE DIFFICULTYFALLINGORSTAYINGASLEEP FEELINGSLEEPY
Very rare (may affect up to 1 in 10,000 people):
or less alert.
s ,IFETHREATENINGCOMPLICATIONSOFUNCONTROLLEDDIABETES
s 3ERIOUSALLERGICREACTIONWITHSWELLINGTHATMAYINVOLVETHE
Common (may affect up to 1 in 10 people):
throat and lead to difficulty breathing
s 0NEUMONIA INFECTIONOFTHECHESTBRONCHITIS COMMONCOLD
s ,ACKOFBOWELMUSCLEMOVEMENTTHATCAUSESBLOCKAGE
SYMPTOMS SINUSINFECTION URINARYTRACTINFECTION EAR
INFECTION FEELINGLIKEYOUHAVETHEFLU
4HEFOLLOWINGSIDEEFFECTHASBEENSEENWITHTHEUSEOF
s 2ISPERIDONECANRAISEYOURLEVELSOFAHORMONECALLED

s
s
s

s
s
s
s
s
s
s
s
s
s
s
s

PROLACTINFOUNDONABLOODTESTWHICHMAYORMAYNOT
CAUSESYMPTOMS 7HENSYMPTOMSOFHIGHPROLACTINOCCUR
THEYMAYINCLUDEINMENBREASTSWELLING DIFFICULTYINGETTING
ORMAINTAININGERECTIONS OROTHERSEXUALDYSFUNCTION)N
WOMENTHEYMAYINCLUDEBREASTDISCOMFORT LEAKAGEOFMILK
FROMTHEBREASTS MISSEDMENSTRUALPERIODS OROTHER
PROBLEMSWITHYOURCYCLE
7EIGHTGAIN INCREASEDAPPETITE DECREASEDAPPETITE
3LEEPDISORDER IRRITABILITY DEPRESSION ANXIETY RESTLESSNESS
$YSTONIATHISISACONDITIONINVOLVINGSLOWORSUSTAINED
involuntary contraction of muscles. While it can involve any
PARTOFTHEBODYANDMAYRESULTINABNORMALPOSTURE
DYSTONIAOFTENINVOLVESMUSCLESOFTHEFACE INCLUDING
ABNORMALMOVEMENTSOFTHEEYES MOUTH TONGUEORJAW
$IZZINESS
$YSKINESIA4HISISACONDITIONINVOLVINGINVOLUNTARYMUSCLE
MOVEMENTS ANDCANINCLUDEREPETITIVE SPASTICORWRITHING
MOVEMENTS ORTWITCHING
4REMORSHAKING
"LURRYVISION EYEINFECTIONORPINKEYE
2APIDHEARTRATE HIGHBLOODPRESSURE SHORTNESSOFBREATH
3ORETHROAT COUGH NOSEBLEEDS STUFFYNOSE
!BDOMINALPAIN ABDOMINALDISCOMFORT VOMITING NAUSEA
CONSTIPATION DIARRHOEA INDIGESTION DRYMOUTH TOOTHACHE
2ASH SKINREDNESS
-USCLESPASMS BONEORMUSCLEACHE BACKPAIN JOINTPAIN
)NCONTINENCELACKOFCONTROL OFURINE
3WELLINGOFTHEBODY ARMSORLEGS FEVER CHESTPAIN
WEAKNESS FATIGUETIREDNESS PAIN
&ALL

Uncommon (may affect up to 1 in 100 people):
s )NFECTIONOFTHEBREATHINGPASSAGES BLADDERINFECTION EYE
INFECTION TONSILLITIS FUNGALINFECTIONOFTHENAILS INFECTIONOF
THESKIN ANINFECTIONCONFINEDTOASINGLEAREAOFSKINOR
PARTOFTHEBODY VIRALINFECTION SKININFLAMMATIONCAUSED
by mites
s $ECREASEINTHETYPEOFWHITEBLOODCELLSTHATHELPTO
PROTECTYOUAGAINSTINFECTION WHITEBLOODCELLCOUNT
DECREASED DECREASEINPLATELETSBLOODCELLSTHATHELPYOU
STOPBLEEDING ANAEMIA DECREASEINREDBLOODCELLS
INCREASEINEOSINOPHILSATYPEOFWHITEBLOODCELL INYOUR
blood
s !LLERGICREACTION
s $IABETESORWORSENINGOFDIABETES HIGHBLOODSUGAR
EXCESSIVEDRINKINGOFWATER
s 7EIGHTLOSS LOSSOFAPPETITERESULTINGINMALNUTRITIONAND
LOWBODYWEIGHT
s )NCREASEDCHOLESTEROLINYOURBLOOD
s %LATEDMOODMANIA CONFUSION DECREASEDSEXUALDRIVE
NERVOUSNESS NIGHTMARES
s 4ARDIVEDYSKINESIATWITCHINGORJERKINGMOVEMENTSTHAT
YOUCANNOTCONTROLINYOURFACE TONGUE OROTHERPARTSOF
YOURBODY 4ELLYOURDOCTORIMMEDIATELYIFYOUEXPERIENCE
INVOLUNTARYRHYTHMICMOVEMENTSOFTHETONGUE MOUTHAND
FACE7ITHDRAWALOF2ISPERIDONEMAYBENEEDED
s 3UDDENLOSSOFBLOODSUPPLYTOBRAINSTROKEORMINI
STROKE
s 5NRESPONSIVETOSTIMULI LOSSOFCONSCIOUSNESS LOWLEVELOF
consciousness

another medicine called paliperidone that is very similar to
2ISPERIDONE SOTHESECANALSOBEEXPECTEDWITH2ISPERIDONE
2APIDHEARTBEATUPONSTANDING
Additional side effects in children and adolescents
)NGENERAL SIDEEFFECTSINCHILDRENAREEXPECTEDTOBESIMILAR
to those in adults.
4HEFOLLOWINGSIDEEFFECTSWEREREPORTEDMOREOFTENIN
CHILDRENANDADOLESCENTSTOYEARS THANINADULTSFEELING
SLEEPY ORLESSALERT FATIGUETIREDNESS HEADACHE INCREASED
APPETITE VOMITING COMMONCOLDSYMPTOMS NASAL
CONGESTION ABDOMINALPAIN DIZZINESS COUGH FEVER TREMOR
SHAKING DIARRHOEA ANDINCONTINENCELACKOFCONTROL OF
urine.
Reporting of side effects
)FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTOR PHARMACISTOR
NURSE4HISINCLUDESANYPOSSIBLESIDEEFFECTSNOTLISTEDINTHIS
LEAFLET9OUCANALSOREPORTSIDEEFFECTSDIRECTLYVIATHE9ELLOW
#ARD3CHEMEATWWWMHRAGOVUKYELLOWCARD
"YREPORTINGSIDEEFFECTSYOUCANHELPPROVIDEMORE
information on the safety of this medicine.

5

HOW TO STORE RISPERIDONE

Keep this medicine out of the sight and reach of children.
$ONOTUSETHISMEDICINEAFTERTHEEXPIRYDATEWHICHISSTATED
ONTHEBLISTERANDCARTON4HEEXPIRYDATEREFERSTOTHELASTDAY
of the month.
4HISMEDICINEDOESNOTREQUIREANYSPECIALSTORAGE
conditions.
$ONOTTHROWAWAYANYMEDICINESVIAWASTEWATEROR
HOUSEHOLDWASTE!SKYOURPHARMACISTHOWTOTHROWAWAY
MEDICINESYOUNOLONGERUSE4HESEMEASURESWILLHELP
protect the environment.

6

CONTENTS OF THE PACK AND OTHER INFORMATION

What Risperidone contains
s 4HEACTIVESUBSTANCEISRISPERIDONE%ACHORODISPERSIBLE
TABLETCONTAINS  ORMGOFRISPERIDONE
s 4HEOTHERINGREDIENTSAREMANNITOL SODIUMSTARCHGLYCOLATE
TYPE! ANDPEPPERMINTFLAVOUR4HETABLETSALSOCONTAIN
THEFOLLOWINGCOLOURS
MGTARTRAZINE%
MGERYTHROSINE%
MGINDIGOCARMINE% 
What Risperidone looks like and the contents of the pack
s /RODISPERSIBLETABLET
s 2ISPERIDONEMG/RODISPERSIBLE4ABLETSAREWHITE FLAT
ROUNDTABLETS PLAINONBOTHSIDES ROUGHONBORDERSAND
face
s 2ISPERIDONEMG/RODISPERSIBLE4ABLETSARELIGHTYELLOW
FLAT ROUNDTABLETS PLAINONBOTHSIDES ROUGHONBORDERS
and face
s 2ISPERIDONEMG/RODISPERSIBLE4ABLETSAREMOTTLEDLIGHT

s #ONVULSIONFITS FAINTING
s !RESTLESSURGETOMOVEPARTSOFYOURBODY BALANCE
DISORDER ABNORMALCOORDINATION DIZZINESSUPONSTANDING
DISTURBANCEINATTENTION PROBLEMSWITHSPEECH LOSSOR
ABNORMALSENSEOFTASTE REDUCEDSENSATIONOFSKINTOPAIN
ANDTOUCH ASENSATIONOFTINGLING PRICKING ORNUMBNESSOF
skin
s /VERSENSITIVITYOFTHEEYESTOLIGHT DRYEYE INCREASEDTEARS
redness of the eyes
s 3ENSATIONOFSPINNINGVERTIGO RINGINGINTHEEARS EARPAIN
s !TRIALFIBRILLATIONANABNORMALHEARTRHYTHM AN
INTERRUPTIONINCONDUCTIONBETWEENTHEUPPERANDLOWER
PARTSOFTHEHEART ABNORMALELECTRICALCONDUCTIONOFTHE
HEART PROLONGATIONOFTHE14INTERVALFROMYOURHEART SLOW
HEARTRATE ABNORMALELECTRICALTRACINGOFTHEHEART
ELECTROCARDIOGRAMOR%#' AFLUTTERINGORPOUNDINGFEELING
INYOURCHESTPALPITATIONS
s ,OWBLOODPRESSURE LOWBLOODPRESSUREUPONSTANDING
CONSEQUENTLY SOMEPEOPLETAKING2ISPERIDONEMAYFEEL
FAINT DIZZY ORMAYPASSOUTWHENTHEYSTANDUPORSITUP
SUDDENLY FLUSHING
s 0NEUMONIACAUSEDBYINHALINGFOOD LUNGCONGESTION
CONGESTIONOFBREATHINGPASSAGES CRACKLYLUNGSOUNDS
WHEEZING VOICEDISORDER BREATHINGPASSAGEDISORDER
s 3TOMACHORINTESTINALINFECTION STOOLINCONTINENCE VERY
HARDSTOOL DIFFICULTYSWALLOWING EXCESSIVEPASSINGOFGAS
ORWIND
s (IVESORNETTLERASH ITCHING HAIRLOSS THICKENINGOFSKIN
ECZEMA DRYSKIN SKINDISCOLORATION ACNE FLAKY ITCHYSCALP
ORSKIN SKINDISORDER SKINLESION
s !NINCREASEOF#0+CREATINEPHOSPHOKINASE INYOURBLOOD
ANENZYMEWHICHISSOMETIMESRELEASEDWITHMUSCLE
BREAKDOWN

s
s
s
s
s

PINK FLAT ROUNDTABLETS PLAINONBOTHSIDES ROUGHON
borders and face
2ISPERIDONEMG/RODISPERSIBLE4ABLETSAREBLUE FLAT
ROUNDTABLETS PLAINONBOTHSIDES ROUGHONBORDERSAND
face
4HEMGTABLETSAREAVAILABLEINPACKSIZESOF   
     TABLETS HOSPITALPACK  
ORODISPERSIBLETABLETS
4HEMGTABLETSAREAVAILABLEINPACKSIZESOF   
     TABLETS HOSPITALPACK   
ORODISPERSIBLETABLETS
4HEMGTABLETSAREAVAILABLEINPACKSIZESOF   
     TABLETS HOSPITALPACK   
ORODISPERSIBLETABLETS
4HEMGTABLETSAREAVAILABLEINPACKSIZESOF   
    TABLETS HOSPITALPACK   
ORODISPERSIBLETABLETS

.OTALLPACKSIZESMAYBEMARKETED
Marketing Authorisation Holder:
4%6!5+,IMITED %ASTBOURNE ".!'
Manufacturer:
4EVA/PERATIONS0OLAND3PZOO 3IENKIEWICZA3TR 
+UTNO 0OLAND
This leaflet was last revised in 05/2014.
0, 

X
 8

Expand view ⇕

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.

Hide