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QUETIAPINE 25MG FILM-COATED TABLETS

Active substance(s): QUETIAPINE / QUETIAPINE FUMARATE

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PAGE 1: FRONT FACE (INSIDE OF REEL)

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0HARMACODE
&IRSTBARISMMFROMTOPEDGE

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

Other medicines and quetiapine
4ELLYOURDOCTORORPHARMACISTIFYOUARETAKING HAVERECENTLYTAKENORMIGHTTAKE
ANYOTHERMEDICINES
Do not take Quetiapine Film-coated Tablets if you are taking any of the following
medicines:
s 3OMEMEDICINESFOR()6
s !ZOLEMEDICINESFORFUNGALINFECTIONS
s %RYTHROMYCINORCLARITHROMYCINFORINFECTIONS
0!#+!'%,%!&,%4).&/2-!4)/.&/24(%53%2
s .EFAZODONEFORDEPRESSION 
Read all of this leaflet carefully before you start taking this medicine because it
Tell your doctor if you are taking any of the following medicines:
contains important information for you.
s %PILEPSYMEDICINESLIKEPHENYTOINORCARBAMAZEPINE
s Keep this leaflet. You may need to read it again.
s (IGHBLOODPRESSUREMEDICINES
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOURDOCTORORPHARMACIST
s "ARBITURATESFORDIFFICULTYSLEEPING
s 4HISMEDICINEHASBEENPRESCRIBEDFORYOUONLY$ONOTPASSITONTOOTHERS)TMAY
s 4HIORIDAZINEOR,ITHIUMOTHERANTI PSYCHOTICMEDICINES
HARMTHEM EVENIFTHEIRSIGNSOFILLNESSARETHESAMEASYOURS
s -EDICINESTHATHAVEANIMPACTONTHEWAYYOURHEARTBEATS FOREXAMPLE DRUGS
s )FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTORORPHARMACIST4HISINCLUDESANY
THATCANCAUSEANIMBALANCEINELECTROLYTESLOWLEVELSOFPOTASSIUMOR
POSSIBLESIDEEFFECTSNOTLISTEDINTHISLEAFLET3EESECTION
MAGNESIUM SUCHASDIURETICSWATERPILLS ORCERTAINANTIBIOTICSDRUGSTOTREAT
INFECTIONS
7(!4)3).4()3,%!&,%4
s -EDICINESTHATCANCAUSECONSTIPATION
1. What Quetiapine Film-coated Tablets is and what it is used for
"EFOREYOUSTOPTAKINGANYOFYOURMEDICINES PLEASETALKTOYOURDOCTORFIRST
2. What you need to know before you take Quetiapine Film-coated Tablets
Quetiapine Film-coated Tablets with food, drink and alcohol
3. How to take Quetiapine Film-coated Tablets
1UETIAPINE&ILM COATED4ABLETSCANBETAKENWITHORWITHOUTFOOD
4. Possible side effects
s "ECAREFULHOWMUCHALCOHOLYOUDRINK4HISISBECAUSETHECOMBINEDEFFECTOF
5. How to store Quetiapine Film-coated Tablets
1UETIAPINE&ILM COATED4ABLETSANDALCOHOLCANMAKEYOUSLEEPY
6. Contents of the pack and other information
s $ONOTDRINKGRAPEFRUITJUICEWHILEYOUARETAKING1UETIAPINE&ILM COATED4ABLETS
WHAT QUETIAPINE FILM-COATED TABLETS IS AND WHAT IT IS USED FOR )TCANAFFECTTHEWAYTHEMEDICINEWORKS
Pregnancy and breast-feeding
s 1UETIAPINECONTAINSASUBSTANCECALLEDQUETIAPINE4HISBELONGSTOAGROUPOFMEDICINES )FYOUAREPREGNANTORBREAST FEEDING THINKYOUMAYBEPREGNANTORAREPLANNINGTO
CALLEDANTIPSYCHOTICS
HAVEABABY ASKYOURDOCTORORPHARMACISTFORADVICEBEFORETAKINGTHISMEDICINE
1UETIAPINECANBEUSEDTOTREATSEVERALILLNESSES SUCHAS
9OUSHOULDNOTTAKE1UETIAPINE&ILM COATED4ABLETSDURINGPREGNANCYUNLESSTHIS
s "IPOLARDEPRESSIONWHEREYOUFEELSAD9OUMAYFINDTHATYOUFEELDEPRESSED FEELGUILTY HASBEENDISCUSSEDWITHYOURDOCTOR1UETIAPINE&ILM COATED4ABLETSSHOULDNOTBE
LACKENERGY LOSEYOURAPPETITEORCANTSLEEP
TAKENIFYOUAREBREAST FEEDING
s -ANIAWHEREYOUMAYFEELVERYEXCITED ELATED AGITATED ENTHUSIASTICORHYPERACTIVEOR 4HEFOLLOWINGSYMPTOMSWHICHCANREPRESENTWITHDRAWALMAYOCCURINNEWBORN
HAVEPOORJUDGMENTINCLUDINGBEINGAGGRESSIVEORDISRUPTIVE
BABIES OFMOTHERSTHATHAVEUSEDQUETIAPINEINTHELASTTRIMESTERLASTTHREEMONTHS
s 3CHIZOPHRENIAWHEREYOUMAYHEARORFEELTHINGSTHATARENOTTHERE BELIEVETHINGSTHAT
OFTHEIRPREGNANCY SHAKING MUSCLESTIFFNESSANDORWEAKNESS SLEEPINESS
ARENOTTRUEORFEELUNUSUALLYSUSPICIOUS ANXIOUS CONFUSED GUILTY TENSEORDEPRESSED
AGITATION BREATHINGPROBLEMS ANDDIFFICULTYINFEEDING)FYOURBABYDEVELOPSANYOF
9OURDOCTORMAYCONTINUETOPRESCRIBEQUETIAPINEEVENWHENYOUAREFEELINGBETTER THESESYMPTOMSYOUMAYNEEDTOCONTACTYOURDOCTOR
Driving and using machines
WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUETIAPINE
4HISMEDICINECANAFFECTYOURABILITYTODRIVEASITMAYMAKEYOUSLEEPYORDIZZY
FILM-COATED TABLETS
s $ONOTDRIVEWHILETAKINGTHISMEDICINEUNTILYOUKNOWHOWITAFFECTSYOU
Do not take Quetiapine Film-coated Tablets:
s )TISANOFFENCETODRIVEIFTHISMEDICINEAFFECTSYOURABILITYTODRIVE
s IFYOUAREALLERGICTOQUETIAPINEORANYOFTHEOTHERINGREDIENTSOFTHISMEDICINE
(OWEVER YOUWOULDNOTBECOMMITTINGANOFFENCEIF
LISTEDINSECTION
s 4HEMEDICINEHASBEENPRESCRIBEDTOTREATAMEDICALORDENTALPROBLEMAND
s IFYOUARETAKINGANYOFTHEFOLLOWINGMEDICINES
s 9OUHAVETAKENITACCORDINGTOTHEINSTRUCTIONSGIVENBYTHEPRESCRIBERORINTHE
s SOMEMEDICINESFOR()6
INFORMATIONPROVIDEDWITHTHEMEDICINEAND
s AZOLEMEDICINESFORFUNGALINFECTIONS
s )TWASNOTAFFECTINGYOURABILITYTODRIVESAFELY
s ERYTHROMYCINORCLARITHROMYCINFORINFECTIONS
4ALKTOYOURDOCTORORPHARMACISTIFYOUARENOTSUREWHETHERITISSAFEFORYOUTO
s NEFAZODONEFORDEPRESSION 
DRIVEWHILETAKINGTHISMEDICINE
$ONOTTAKE1UETIAPINE&ILM COATED4ABLETSIFTHEABOVEAPPLIESTOYOU)FYOUARENOT Quetiapine Film-coated Tablets contains lactose
SURE TALKTOYOURDOCTORORPHARMACISTBEFORETAKING1UETIAPINE&ILM COATED4ABLETS 1UETIAPINE&ILM COATED4ABLETSCONTAINLACTOSEWHICHISATYPEOFSUGAR)FYOUHAVE
Warnings and precautions
BEENTOLDBYYOURDOCTORTHATYOUHAVEANINTOLERANCETOSOMESUGARS TALKTOYOUR
4ALKTOYOURDOCTORORPHARMACISTBEFORETAKINGQUETIAPINEIF
DOCTORBEFORETAKINGTHISMEDICINE
s 9OU ORSOMEONEINYOURFAMILY HAVEORHAVEHADANYHEARTPROBLEMS FOR
Quetiapine Film-coated Tablets contains E110 (sunset yellow FCF aluminium lake)
EXAMPLEHEARTRHYTHMPROBLEMS WEAKENINGOFTHEHEARTMUSCLEORINFLAMMATION  MG4HISMEDICINALPRODUCTCONTAINSSUNSETYELLOW&#&ALUMINIUMLAKE%
OFTHEHEARTORIFYOUARETAKINGANYMEDICINESTHATMAYHAVEANIMPACTONTHE
ANDMAYCAUSEALLERGICREACTIONS
WAYYOURHEARTBEATS
Effect on Urine Drug Screens
s 9OUHAVELOWBLOODPRESSURE
)FYOUAREHAVINGAURINEDRUGSCREEN TAKING1UETIAPINE&ILM COATED4ABLETSMAY
s 9OUHAVEHADASTROKE ESPECIALLYIFYOUAREELDERLY
CAUSEPOSITIVERESULTSFORMETHADONEORCERTAINDRUGSFORDEPRESSIONCALLEDTRICYCLIC
s 9OUHAVEPROBLEMSWITHYOURLIVER
ANTIDEPRESSANTS4#!S WHENSOMETESTMETHODSAREUSED EVENTHOUGHYOUMAY
s 9OUHAVEEVERHADAFITSEIZURE
NOTBETAKINGMETHADONEOR4#!S)FTHISHAPPENS AMORESPECIFICTESTCANBE
s 9OUHAVEDIABETESORHAVEARISKOFGETTINGDIABETES)FYOUDO YOURDOCTORMAY
performed.
CHECKYOURBLOODSUGARLEVELSWHILEYOUARETAKINGQUETIAPINE
s 9OUKNOWTHATYOUHAVEHADLOWLEVELSOFWHITEBLOODCELLSINTHEPASTWHICH
HOW TO TAKE QUETIAPINE FILM-COATED TABLETS
MAYORMAYNOTHAVEBEENCAUSEDBYOTHERMEDICINES
s 9OUAREANELDERLYPERSONWITHDEMENTIALOSSOFBRAINFUNCTION )FYOUARE
!LWAYSTAKETHISMEDICINEEXACTLYASYOURDOCTORHASTOLDYOU#HECKWITHYOUR
1UETIAPINE&ILM COATED4ABLETSSHOULDNOTBETAKENBECAUSETHEGROUPOF
DOCTORORPHARMACISTIFYOUARENOTSURE
MEDICINESTHAT1UETIAPINE&ILM COATED4ABLETSBELONGSTOMAYINCREASETHERISK
9OURDOCTORWILLDECIDEONYOURSTARTINGDOSE4HEMAINTENANCEDOSEDAILYDOSE
OFSTROKE ORINSOMECASESTHERISKOFDEATH INELDERLYPEOPLEWITHDEMENTIA
WILLDEPENDONYOURILLNESSANDNEEDSBUTWILLUSUALLYBEBETWEENMGANDMG
s 9OUORSOMEONEELSEINYOURFAMILYHASAHISTORYOFBLOODCLOTS ASMEDICINESLIKE
s 9OUWILLTAKEYOURTABLETSONCEADAY ATBEDTIMEORTWICEADAY DEPENDINGON
THESEHAVEBEENASSOCIATEDWITHFORMATIONOFBLOODCLOTS
your illness
4ELLYOURDOCTORIMMEDIATELYIFYOUEXPERIENCEANYOFTHEFOLLOWINGAFTERTAKING
s 3WALLOWYOURTABLETSWHOLEWITHADRINKOFWATER
1UETIAPINE
s 9OUCANTAKEYOURTABLETSWITHORWITHOUTFOOD
s !COMBINATIONOFFEVER SEVEREMUSCLESTIFFNESS SWEATINGORALOWEREDLEVELOF
s $ONOTDRINKGRAPEFRUITJUICEWHILEYOUARETAKINGQUETIAPINE)TCANAFFECTTHE
CONSCIOUSNESSADISORDERCALLEDhNEUROLEPTICMALIGNANTSYNDROMEv )MMEDIATE
WAYTHEMEDICINEWORKS
MEDICALTREATMENTMAYBENEEDED
s $ONOTSTOPTAKINGYOURTABLETSEVENIFYOUFEELBETTER UNLESSYOURDOCTORTELLSYOU
s 5NCONTROLLABLEMOVEMENTS MAINLYOFYOURFACEORTONGUE
Liver problems
s $IZZINESSORASEVERESENSEOFFEELINGSLEEPY4HISCOULDINCREASETHERISKOF
)FYOUHAVELIVERPROBLEMSYOURDOCTORMAYCHANGEYOURDOSE
ACCIDENTALINJURYFALL INELDERLYPATIENTS
Elderly people
s &ITSSEIZURES
)FYOUAREELDERLYYOURDOCTORMAYCHANGEYOURDOSE
s !LONG LASTINGANDPAINFULERECTIONPRIAPISM 
Use in children and adolescents
4HESECONDITIONSCANBECAUSEDBYTHISTYPEOFMEDICINE
1UETIAPINESHOULDNOTBEUSEDBYCHILDRENORADOLESCENTSAGEDUNDERYEARS
4ELLYOURDOCTORASSOONASPOSSIBLEIFYOUHAVE
s !FEVER FLU LIKESYMPTOMS SORETHROAT ORANYOTHERINFECTION ASTHISCOULDBEA If you take more Quetiapine Film-coated Tablets than you should
RESULTOFAVERYLOWWHITEBLOODCELLCOUNT WHICHMAYREQUIRE1UETIAPINE
)FYOUTAKEMORE1UETIAPINE&ILM COATED4ABLETSTHANPRESCRIBEDBYYOURDOCTOR YOU
MAYFEELSLEEPY FEELDIZZYANDEXPERIENCEABNORMALHEARTBEATS#ONTACTYOUR
&ILM COATED4ABLETSTOBESTOPPEDANDORTREATMENTTOBEGIVEN
s #ONSTIPATIONALONGWITHPERSISTENTABDOMINALPAIN ORCONSTIPATIONWHICHHASNOT DOCTORORNEARESTHOSPITALSTRAIGHTAWAY+EEPTHE1UETIAPINE&ILM COATED4ABLETS
RESPONDEDTOTREATMENT ASTHISMAYLEADTOAMORESERIOUSBLOCKAGEOFTHEBOWEL WITHYOU
If you forget to take a dose of Quetiapine Film-coated Tablets
Thoughts of suicide and worsening of your depression
)FYOUFORGETTOTAKEADOSE TAKEITASSOONASYOUREMEMBER)FITISALMOSTTIMETO
)FYOUAREDEPRESSEDYOUMAYSOMETIMESHAVETHOUGHTSOFHARMINGORKILLING
TAKETHENEXTDOSE WAITUNTILTHEN$ONOTTAKEADOUBLEDOSETOMAKEUPFORA
YOURSELF4HESEMAYBEINCREASEDWHENFIRSTSTARTINGTREATMENT SINCETHESE
forgotten dose.
MEDICINESALLTAKETIMETOWORK USUALLYABOUTTWOWEEKSBUTSOMETIMESLONGER
4HESETHOUGHTSMAYALSOBEINCREASEDIFYOUSUDDENLYSTOPTAKINGYOURMEDICATION If you stop taking Quetiapine Film-coated Tablets
)FYOUSUDDENLYSTOPTAKINGQUETIAPINE YOUMAYBEUNABLETOSLEEPINSOMNIA OR
9OUMAYBEMORELIKELYTOTHINKLIKETHISIFYOUAREAYOUNGADULT
s )NFORMATIONFROMCLINICALTRIALSHASSHOWNANINCREASEDRISKOFSUICIDALTHOUGHTS YOUMAYFEELSICKNAUSEA ORYOUMAYEXPERIENCEHEADACHE DIARRHOEA BEINGSICK
ANDORSUICIDALBEHAVIOURINYOUNGADULTSAGEDLESSTHANYEARSWITHDEPRESSION. VOMITING DIZZINESSORIRRITABILITY9OURDOCTORMAYSUGGESTYOUREDUCETHEDOSE
GRADUALLYBEFORESTOPPINGTREATMENT
)FYOUHAVETHOUGHTSOFHARMINGORKILLINGYOURSELFATANYTIME CONTACTYOURDOCTOR
)FYOUHAVEANYFURTHERQUESTIONSONTHEUSEOFTHISMEDICINE ASKYOURDOCTOROR
ORGOTOAHOSPITALSTRAIGHTAWAY
PHARMACIST
9OUMAYFINDITHELPFULTOTELLARELATIVEORCLOSEFRIENDTHATYOUAREDEPRESSED AND
ASKTHEMTOREADTHISLEAFLET9OUMIGHTASKTHEMTOTELLYOUIFTHEYTHINKYOUR
POSSIBLE SIDE EFFECTS
DEPRESSIONISGETTINGWORSE ORIFTHEYAREWORRIEDABOUTCHANGESINYOURBEHAVIOUR
Weight gain
,IKEALLMEDICINES THISMEDICINECANCAUSESIDEEFFECTS ALTHOUGHNOTEVERYBODY
7EIGHTGAINHASBEENSEENINPATIENTSTAKING1UETIAPINE&ILM COATED4ABLETS9OU
gets them.
ANDYOURDOCTORSHOULDCHECKYOURWEIGHTREGULARLY
Very common side effectsMAYAFFECTMORETHANINPEOPLE 
Children and adolescents
s $IZZINESSMAYLEADTOFALLS HEADACHEDRYMOUTH
1UETIAPINEISNOTFORUSEINCHILDRENANDADOLESCENTSBELOWYEARSOFAGE
s &EELINGSLEEPYTHISMAYGOAWAYWITHTIME ASYOUKEEPTAKING1UETIAPINE

&ILM COATED4ABLETS MAYLEADTOFALLS

QUETIAPINE 25 mg FILM-COATED TABLETS
QUETIAPINE 100 mg FILM-COATED TABLETS
QUETIAPINE 150 mg FILM-COATED TABLETS
QUETIAPINE 200 mg FILM-COATED TABLETS
QUETIAPINE 300 mg FILM-COATED TABLETS

PAGE 2: REAR FACE (OUTSIDE OF REEL)

s $ISCONTINUATIONSYMPTOMSSYMPTOMSWHICHOCCURWHENYOUSTOPTAKING
1UETIAPINE&ILM COATED4ABLETS INCLUDENOTBEINGABLETOSLEEPINSOMNIA
FEELINGSICKNAUSEA HEADACHE DIARRHOEA BEINGSICKVOMITING DIZZINESSAND
IRRITABILITY'RADUALWITHDRAWALOVERAPERIODOFATLEASTTOWEEKSISADVISABLE
s 0UTTINGONWEIGHT
s !BNORMALMUSCLEMOVEMENTS4HESEINCLUDEDIFFICULTYSTARTINGMUSCLE
MOVEMENTS SHAKING FEELINGRESTLESSORMUSCLESTIFFNESSWITHOUTPAIN
s #HANGESINTHEAMOUNTOFCERTAINFATSTRIGLYCERIDESANDTOTALCHOLESTEROL 
Common side effectsMAYAFFECTUPTOINPEOPLE 
s 2APIDHEARTBEAT
s &EELINGLIKEYOURHEARTISPOUNDING RACINGORHASSKIPPEDBEATS
s INDIGESTION
s #ONSTIPATION UPSETSTOMACHINDIGESTION
s &EELINGWEAK
s 3WELLINGOFARMSORLEGS
s ,OWBLOODPRESSUREWHENSTANDINGUP4HISMAYMAKEYOUFEELDIZZYORFAINTMAY
LEADTOFALLS
s )NCREASEDLEVELSOFSUGARINTHEBLOOD
s "LURREDVISION
s !BNORMALDREAMSANDNIGHTMARES
s &EELINGMOREHUNGRY
s &EELINGIRRITATED
s $ISTURBANCEINSPEECHANDLANGUAGE
s 4HOUGHTSOFSUICIDEANDWORSENINGOFYOURDEPRESSION
s 3HORTNESSOFBREATH
s 6OMITINGMAINLYINTHEELDERLY
s &EVER
s #HANGESINTHEAMOUNTOFTHYROIDHORMONESINYOURBLOOD
s $ECREASESINTHENUMBEROFCERTAINTYPESOFBLOODCELLS
s )NCREASESINTHEAMOUNTOFLIVERENZYMESMEASUREDINTHEBLOOD
s )NCREASESINTHEAMOUNTOFTHEHORMONEPROLACTININTHEBLOOD)NCREASESINTHE
HORMONEPROLACTINCOULDINRARECASESLEADTOTHEFOLLOWING
s -ENANDWOMENTOHAVESWELLINGOFBREASTSANDUNEXPECTEDLYPRODUCEBREAST
MILK
s 7OMENTOHAVENOMONTHLYPERIODORIRREGULARPERIODS
Uncommon side effectsMAYAFFECTUPTOINPEOPLE 
s &ITSORSEIZURES
s !LLERGICREACTIONSTHATMAYINCLUDERAISEDLUMPSWEALS SWELLINGOFTHESKINAND
SWELLINGAROUNDTHEMOUTH
s 5NPLEASANTSENSATIONSINTHELEGSALSOCALLEDRESTLESSLEGSSYNDROME
s $IFFICULTYSWALLOWING
s 5NCONTROLLABLEMOVEMENTS MAINLYOFYOURFACEORTONGUE
s 3EXUALDYSFUNCTION
s $IABETES
s #HANGEINELECTRICALACTIVITYOFTHEHEARTSEENON%#'14PROLONGATION
s !SLOWERTHANNORMALHEARTRATEWHICHMAYOCCURWHENSTARTINGTREATMENTAND
WHICHMAYBEASSOCIATEDWITHLOWBLOODPRESSUREANDFAINTING
s $IFFICULTYINPASSINGURINE
s &AINTINGMAYLEADTOFALLS
s 3TUFFYNOSE
s $ECREASEINTHEAMOUNTOFREDBLOODCELLS
s $ECREASEINTHEAMOUNTOFSODIUMINTHEBLOOD
Rare side effectsMAYAFFECTUPTOINPEOPLE 
s !COMBINATIONOFHIGHTEMPERATUREFEVER SWEATING STIFFMUSCLES FEELINGVERY
DROWSYORFAINTADISORDERCALLED@NEUROLEPTICMALIGNANTSYNDROME
s 9ELLOWINGOFTHESKINANDEYESJAUNDICE
s )NFLAMMATIONOFTHELIVERHEPATITIS
s !LONG LASTINGANDPAINFULERECTIONPRIAPISM
s 3WELLINGOFBREASTSANDUNEXPECTEDPRODUCTIONOFBREASTMILKGALACTORRHOEA
s -ENSTRUALDISORDER
s "LOODCLOTSINTHEVEINSESPECIALLYINTHELEGSSYMPTOMSINCLUDESWELLING PAIN
ANDREDNESSINTHELEG WHICHMAYTRAVELTHROUGHBLOODVESSELSTOTHELUNGS
CAUSINGCHESTPAINANDDIFFICULTYINBREATHING)FYOUNOTICEANYOFTHESE

SYMPTOMSSEEKMEDICALADVICEIMMEDIATELY
s 7ALKING TALKING EATINGOROTHERACTIVITIESWHILEYOUAREASLEEP
s "ODYTEMPERATUREDECREASEDHYPOTHERMIA
s )NFLAMMATIONOFTHEPANCREAS
s !CONDITIONCALLED@METABOLICSYNDROME WHEREYOUMAYHAVEACOMBINATIONOF
ORMOREOFTHEFOLLOWINGANINCREASEINFATAROUNDYOURABDOMEN ADECREASEIN
@GOODCHOLESTEROL($, # ANINCREASEINATYPEOFFATINYOURBLOODCALLED

TRIGLYCERIDES HIGHBLOODPRESSUREANDANINCREASEINYOURBLOODSUGAR
s #OMBINATIONOFFEVER FLU LIKESYMPTOMS SORETHROAT ORANYOTHERINFECTIONWITH
VERYLOWWHITEBLOODCELLCOUNT ACONDITIONCALLEDAGRANULOCYTOSIS
s "OWELOBSTRUCTION
s )NCREASEDBLOODCREATINEPHOSPHOKINASEASUBSTANCEFROMTHEMUSCLES 
Very rare side effectsMAYAFFECTUPTOINPEOPLE 
s 3EVERERASH BLISTERS ORREDPATCHESONTHESKIN
s !SEVEREALLERGICREACTIONCALLEDANAPHYLAXIS WHICHMAYCAUSEDIFFICULTYIN
BREATHINGORSHOCK
s 2APIDSWELLINGOFTHESKIN USUALLYAROUNDTHEEYES LIPSANDTHROATANGIOEDEMA
s !SERIOUSBLISTERINGCONDITIONOFTHESKIN MOUTH EYESANDGENITALS

3TEVEN *OHNSONSYNDROME
s )NAPPROPRIATESECRETIONOFAHORMONETHATCONTROLSURINEVOLUME
s "REAKDOWNOFMUSCLEFIBERSANDPAININMUSCLESRHABDOMYOLYSIS
s 7ORSENINGOFPRE EXISTINGDIABETES
Not knownFREQUENCYCANNOTBEESTIMATEDFROMTHEAVAILABLEDATA 
3KINRASHWITHIRREGULARREDSPOTSERYTHEMAMULTIFORME
s 3ERIOUS SUDDENALLERGICREACTIONWITHSYMPTOMSSUCHASFEVERANDBLISTERSON
THESKINANDPEELINGOFTHESKINTOXICEPIDERMALNECROLYSIS
s 3YMPTOMSOFWITHDRAWALMAYOCCURINNEWBORNBABIESOFMOTHERSTHATHAVE
USED1UETIAPINE&ILM COATED4ABLETSDURINGTHEIRPREGNANCY
4HECLASSOFMEDICINESTOWHICH1UETIAPINE&ILM COATED4ABLETSBELONGSCANCAUSE
HEARTRHYTHMPROBLEMS WHICHCANBESERIOUSANDINSEVERECASESMAYBEFATAL
3OMESIDEEFFECTSAREONLYSEENWHENABLOODTESTISTAKEN4HESEINCLUDECHANGES
INTHEAMOUNTOFCERTAINFATSTRIGLYCERIDESANDTOTALCHOLESTEROL ORSUGARINTHE
BLOOD CHANGESINTHEAMOUNTOFTHYROIDHORMONESINYOURBLOOD INCREASEDLIVER
ENZYMES DECREASESINTHENUMBEROFCERTAINTYPESOFBLOODCELLS DECREASEINTHE
AMOUNTOFREDBLOODCELLS INCREASEDBLOODCREATINEPHOSPHOKINASEASUBSTANCEIN
THEMUSCLES DECREASEINTHEAMOUNTOFSODIUMINTHEBLOODANDINCREASESINTHE
AMOUNTOFTHEHORMONEPROLACTININTHEBLOOD
)NCREASESINTHEHORMONEPROLACTINCOULDINRARECASESLEADTOTHEFOLLOWING
s -ENANDWOMENTOHAVESWELLINGOFBREASTSANDUNEXPECTEDLYPRODUCEBREAST
MILK
s 7OMENTOHAVENOMONTHLYPERIODORIRREGULARPERIODS
9OURDOCTORMAYASKYOUTOHAVEBLOODTESTSFROMTIMETOTIME
Side effects in children and adolescents
4HESAMESIDEEFFECTSTHATMAYOCCURINADULTSMAYALSOOCCURINCHILDRENAND
ADOLESCENTS

4HEFOLLOWINGSIDEEFFECTSHAVEBEENSEENMOREOFTENINCHILDRENANDADOLESCENTS
ORHAVENOTBEENSEENINADULTS
Very common side effectsMAYAFFECTMORETHANINPEOPLE 
s )NCREASEINTHEAMOUNTOFAHORMONECALLEDPROLACTIN INTHEBLOOD)NCREASESIN
THEHORMONEPROLACTINCOULDINRARECASESLEADTOTHEFOLLOWING
s BOYSANDGIRLSTOHAVESWELLINGOFBREASTSANDUNEXPECTEDLYPRODUCEBREAST
MILK
s GIRLSTOHAVENOMONTHLYPERIODORIRREGULARPERIODS
s INCREASEDAPPETITE
s VOMITING
s !BNORMALMUSCLEMOVEMENTS4HESEINCLUDEDIFFICULTYSTARTINGMUSCLE
MOVEMENTS SHAKING FEELINGRESTLESSORMUSCLESTIFFNESSWITHOUTPAIN
s )NCREASEINBLOODPRESSURE
Common side effectsMAYAFFECTUPTOINPEOPLE 
s &EELINGWEAK FAINTINGMAYLEADTOFALLS
s 3TUFFYNOSE
s &EELINGIRRITATEd.
Reporting of side effects:
)FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTOR PHARMACISTORNURSE. 4HISINCLUDES
ANYPOSSIBLESIDEEFFECTSNOTLISTEDINTHISLEAFLET
9OUCANALSOREPORTSIDEEFFECTSDIRECTLYVIATHE9ELLOW#ARD3CHEMEAT
WWWMHRAGOVUKYELLOWCARD"YREPORTINGSIDEEFFECTSYOUCANHELPPROVIDEMORE
INFORMATIONONTHESAFETYOFTHISMEDICINE

5

HOW TO STORE QUETIAPINE FILM-COATED TABLETS
Keep this medicine out of the sight and reach of children.
$ONOTUSETHISMEDICINEAFTERTHEEXPIRYDATEWHICHISSTATEDONTHECARTONAND
BOTTLEORBLISTER4HEEXPIRYDATEREFERSTOTHELASTDAYOFTHATMONTH
4HISMEDICINALPRODUCTDOESNOTREQUIREANYSPECIALSTORAGECONDITIONS
$ONOTTHROWAWAYANYMEDICINESVIAWASTEWATERORHOUSEHOLDWASTE!SKYOUR
PHARMACISTHOWTOTHROWAWAYMEDICINESYOUNOLONGERUSE4HESEMEASURESWILL
HELPPROTECTTHEENVIRONMENT

6

CONTENTS OF THE PACK AND OTHER INFORMATION
What Quetiapine Film-coated Tablets contains
s 4HEACTIVESUBSTANCEISQUETIAPINE%ACHFILM COATEDTABLETCONTAINS  
 MGQUETIAPINEASQUETIAPINEFUMARATE 
s 4HEOTHERINGREDIENTSARECALCIUMHYDROGENPHOSPHATE DIHYDRATE LACTOSE
MONOHYDRATE POVIDONE+  CELLULOSEMICROCRYSTALLINE SODIUMSTARCHGLYCOLATE
TYPE! SILICA COLLOIDALANHYDROUS MAGNESIUMSTEARATE4HECOATINGCONTAINS
HYPROMELLOSE TITANIUMDIOXIDE% TRIACETIN    MGLACTOSE
MONOHYDRATE IRONOXIDEYELLOW%  MGSUNSETYELLOW&#&ALUMINIUM
LAKE% MGPOLYDEXTROSE MACROGOL
What Quetiapine Film-coated Tablets look like and contents of the pack
s 1UETIAPINEMG&ILM COATED4ABLETSARELIGHT ORANGE ROUND BICONVEX
FILM COATEDTABLETS ENGRAVEDhvONONESIDEANDPLAINONTHEOTHER
s 1UETIAPINEMG&ILM COATED4ABLETSARELIGHT ORANGE ROUND BICONVEX
FILM COATEDTABLETS ENGRAVEDhvONONESIDEANDPLAINONTHEOTHER
s 1UETIAPINEMG&ILM COATED4ABLETSAREPALEYELLOW ROUND BICONVEX
FILM COATEDTABLETS ENGRAVEDhvONONESIDEANDPLAINONTHEOTHER
s 1UETIAPINEMG&ILM COATED4ABLETSAREWHITETOOFF WHITE ROUND BICONVEX
FILM COATEDTABLETS ENGRAVEDhvONONESIDEANDPLAINONTHEOTHER
s 1UETIAPINEMG&ILM COATED4ABLETSAREPALEYELLOW CAPSULE SHAPED BICONVEX
FILM COATEDTABLETS ENGRAVEDhvONONESIDEANDPLAINONTHEOTHER
Quetiapine Film-coated Tablets are available in White opaque PVC/PE/Aclaraluminium or white opaque PVC/PVdC-aluminium Blister
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HDPE bottle with white child resistant, propylene caps, with desiccant.
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Marketing Authorisation Holder and Manufacturer:
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This leaflet was last revised in 10/2014
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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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