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ZEEBRAL XL 16 MG PROLONGED RELEASE CAPSULES

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PAGE 1: FRONT FACE (INSIDE OF REEL)

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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$ONOT
PASSITONTOOTHERS)TMAYHARMTHEM EVENIFTHEIRSIGNS
OFILLNESSARETHESAMEASYOURS
s )FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTOROR
PHARMACIST4HISINCLUDESANYPOSSIBLESIDEEFFECTSNOT
LISTEDINTHISLEAFLET3EESECTION
7(!4)3).4()3,%!&,%4

1.
2.
3.
4.
5.
6.

What Zeebral XL is and what it is used for
What you need to know before you take Zeebral XL
How to take Zeebral XL
Possible side effects
How to store Zeebral XL
Contents of the pack and other information

3OMEMEDICINESCANAFFECTTHEWAY:EEBRAL8,WORKS OR
ITSELFCANREDUCETHEEFFECTIVENESSOFOTHERMEDICINESTAKEN
ATTHESAMETIME4HESEINCLUDE
s PAROXETINEORFLUOXETINEANTIDEPRESSANTS
s QUINIDINEUSEDFORHEARTRHYTHMPROBLEMS
s KETOCONAZOLEANTIFUNGAL
s ERYTHROMYCINANTIBIOTIC
s RITONAVIRANTIVIRAL()6PROTEASEINHIBITOR 
9OURDOCTORMAYPRESCRIBEASMALLERDOSEOF:EEBRAL8,IF
YOUAREALSOTAKINGANYOFTHEMEDICINESLISTEDABOVE
3OMEMEDICINESCANINCREASETHENUMBEROFSIDEEFFECTS
CAUSEDBY:EEBRAL8, THESEINCLUDE
s NON STEROIDALANTI INFLAMMATORYPAINKILLERSEGIBUPROFEN
WHICHCANINCREASETHERISKOFULCERS
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EGDIGOXIN AMIODARONE ATROPINE BETA BLOCKERS OR
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)FYOUNEEDANOPERATIONWHICHREQUIRESAGENERALANAESTHETIC
YOUSHOULDINFORMTHEDOCTORTHATYOUARETAKING:EEBRAL8,
)FYOUHAVEANYQUESTIONS SPEAKTOYOURDOCTOROR
PHARMACISTFORADVICE

Pharma code 54

Zeebral XL with food and drink
:EEBRAL8,SHOULDBETAKENWITHFOODIFPOSSIBLE
1 WHAT ZEEBRAL XL IS AND WHAT IT IS USED FOR $RINKPLENTYOFLIQUIDSDURINGYOURTREATMENTWITH:EEBRAL8,
TOKEEPYOURSELFHYDRATED
:EEBRAL8,ISANANTI DEMENTIAMEDICINEUSEDTOTREATTHE 3EESECTIONOFTHISLEAFLETFORFULLDETAILSABOUTHOWTO
SYMPTOMSOFMILDTOMODERATELYSEVEREDEMENTIAOFTHE
TAKETHISMEDICINE
!LZHEIMERTYPE ADISEASETHATALTERSBRAINFUNCTION
Pregnancy and breast-feeding
4HESYMPTOMSOF!LZHEIMERSDISEASEINCLUDEINCREASING
!SKYOURDOCTORORPHARMACISTFORADVICEBEFORETAKINGANY
MEMORYLOSS CONFUSIONANDBEHAVIOURALCHANGES!SA
MEDICINE
RESULT ITBECOMESMOREANDMOREDIFFICULTTOCARRYOUT
)FYOUAREPREGNANTORBREAST FEEDING THINKYOUMAYBE
NORMALDAILYACTIVITIES
PREGNANTORYOUAREPLANNINGTOHAVEABABY ASKYOUR
4HESESYMPTOMSAREBELIEVEDTOBEDUETOALACKOF
DOCTOROFPHARMACISTFORADVICEBEFORETAKINGTHISMEDICINE
aCETYLCHOLINE ASUBSTANCERESPONSIBLEFORSENDINGMESSAGES 9OUSHOULDNOTBREAST FEEDWHILEYOUARETAKING:EEBRAL8,
BETWEENBRAINCELLS:EEBRAL8,INCREASESTHEAMOUNTOF
ACETYLCHOLINEINTHEBRAINANDSOCOULDIMPROVETHESYMPTOMS Driving and using machines
:EEBRAL8,MAYCAUSEDIZZINESSORDROWSINESS ESPECIALLY
OFTHEDISEASE
DURINGTHEFIRSTFEWWEEKSOFTREATMENT)FYOUEXPERIENCE
4HECAPSULESAREMADEINA@PROLONGEDRELEASEFORM4HIS THESESYMPTOMS DONOTDRIVEORUSEANYTOOLSORMACHINERY
MEANSTHATTHEYRELEASETHEMEDICINEMORESLOWLY
Zeebral XL contains sucrose
9OUMUSTTALKTOADOCTORIFYOUDONOTFEELBETTERORIFYOU 4HISMEDICINALPRODUCTCONTAINSsucrose)FYOUHAVEBEENTOLD
FEELWORSE
BYYOURDOCTORTHATYOUHAVEANINTOLERANCETOSOMESUGARS
CONTACTYOURDOCTORBEFORETAKINGTHISMEDICINALPRODUCT

2

WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ZEEBRAL XL

Do NOT take Zeebral XL
s )FYOUAREALLERGICHYPERSENSITIVE TOGALANTAMINEORTOANYOF
THEOTHERINGREDIENTSOFTHISMEDICINELISTEDINSECTION
s )FYOUHAVESEVERELIVERANDORSEVEREKIDNEYDISEASE
Warnings and precautions
4ALKTOYOURDOCTORORPHARMACISTBEFORETAKINGGALANTAMINE
:EEBRAL8,SHOULDBEUSEDIN!LZHEIMERSDISEASEANDNOT
OTHERFORMSOFMEMORYLOSSORCONFUSION
-EDICINESARENOTALWAYSSUITABLEFOREVERYONE9OURDOCTOR
NEEDSTOKNOWBEFOREYOUTAKE:EEBRAL8,IFYOUSUFFERFROMOR
HAVESUFFEREDINTHEPASTFROMANYOFTHEFOLLOWINGCONDITIONS
s LIVERORKIDNEYPROBLEMS
s AHEARTDISORDEREGANGINA HEARTATTACK HEARTFAILURE
SLOWORIRREGULARPULSE
s ELECTROLYTEDISTURBANCESEGDECREASEDINCREASEDBLOOD
POTASSIUMLEVELS
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s ACUTEABDOMINALPAIN
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YOUSHOULDINFORMTHEDOCTORTHATYOUARETAKING:EEBRAL8,
9OURDOCTORWILLTHENDECIDEWHETHERTREATMENTWITH:EEBRAL
8,ISSUITABLEFORYOUORIFTHEDOSENEEDSTOBECHANGED
Other medicines and galantamine
4ELLYOURDOCTORORPHARMACISTIFYOUARETAKING HAVE
RECENTLYTAKENORMIGHTTAKEANYOTHERMEDICINES
:EEBRAL8,SHOULDNOTBEUSEDWITHMEDICINESTHATWORK
INASIMILARWAY THESEINCLUDE
s DONEPEZILORRIVASTIGMINEFOR!LZHEIMERSDISEASE
s AMBENONIUM NEOSTIGMINEORPYRIDOSTIGMINEFORSEVERE
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s PILOCARPINEFORDRYMOUTHORDRYEYES IFTAKENBYMOUTH

3

HOW TO TAKE ZEEBRAL XL

!LWAYSTAKETHISMEDICINEEXACTLYASYOURDOCTOROR
PHARMACISTHASTOLDYOU#HECKWITHYOURDOCTOROR
PHARMACISTIFYOUARENOTSURE
)FYOUARECURRENTLYTAKINGGALANTAMINETABLETSORORAL
SOLUTIONANDHAVEBEENTOLDBYYOURDOCTORTOSWITCHTO
:EEBRAL8,PROLONGEDRELEASECAPSULES READTHEINSTRUCTIONS
ATTHEENDOFTHISSECTIONCAREFULLY
How to take Zeebral XL capsules
:EEBRAL8,CAPSULESSHOULDBESWALLOWEDWHOLE ./4
CHEWEDORCRUSHED4HEYSHOULDBETAKENINTHEMORNING
WITHWATEROROTHERLIQUIDS ANDPREFERABLYWITHFOOD
:EEBRAL8,PROLONGEDRELEASECAPSULESAREAVAILABLEIN
STRENGTHSMG MGANDMG:EEBRAL8,ISSTARTEDAT
ALOWDOSE9OURDOCTORMAYTHENTELLYOUTOSLOWLYINCREASE
THEDOSESTRENGTH OF:EEBRAL8,THATYOUTAKETOFINDTHE
MOSTSUITABLEDOSEFORYOU
 4HETREATMENTISSTARTEDWITHTHEMGCAPSULETAKENONCE
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 9OUWOULDTHENTAKETHEMGCAPSULEONCEDAILY!FTER
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 9OUWOULDTHENTAKETHEMGCAPSULEONCEDAILY
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9OURDOCTORWILLNEEDTOSEEYOUREGULARLYTOCHECKTHATTHIS
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WHILEYOUARETAKING:EEBRAL8,
Liver or kidney disease
s )FYOUHAVEMILDLIVERORKIDNEYDISEASE TREATMENTIS
STARTEDWITHTHEMGCAPSULEONCEDAILYINTHEMORNING
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YOUHAVEMODERATELIVERDISEASE

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

ZEEBRAL XL 8 mg, 16 mg AND 24 mg
PROLONGED RELEASE CAPSULES, hard
Galantamine

PAGE 2: REAR FACE (OUTSIDE OF REEL)

s )FYOUHAVESEVERELIVERANDORKIDNEYDISEASE DONOT
TAKE:EEBRAL8,
How do I switch from taking galantamine tablets or oral
solution to Zeebral XL prolonged release capsules?
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SOLUTION YOURDOCTORMAYDECIDETOSWITCHYOUTO:EEBRAL8,
PROLONGED RELEASECAPSULES
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GALANTAMINETABLETSORORALSOLUTION
Use in Children and adolescents
4HEREISNOUSEOF:EEBRAL8,INCHILDREN
If you take more Zeebral XL than you should
)FYOUTAKETOOMUCH:EEBRAL8, CONTACTADOCTORORHOSPITAL
STRAIGHTAWAY4AKEALONGANYREMAININGCAPSULESANDTHE
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INCLUDE AMONGOTHERS SEVERENAUSEA VOMITING MUSCLE
WEAKNESS SLOWHEARTBEAT SEIZURESANDLOSSOFCONSCIOUSNESS
If you forget to take Zeebral XL
)FYOUFORGETTOTAKEONEDOSE MISSOUTTHEFORGOTTENDOSE
COMPLETELYANDTAKETHENEXTDOSEATTHENORMALTIME$ONOT
TAKEADOUBLEDOSETOMAKEUPFORAFORGOTTENDOSE)FYOUFORGET
TOTAKEMORETHANONEDOSE YOUSHOULDCONTACTYOURDOCTOR
If you stop taking Zeebral XL
9OUSHOULDCONSULTYOURDOCTORBEFOREYOUSTOPTAKING
:EEBRAL8,)TISIMPORTANTTOCONTINUETAKINGTHISMEDICINE
TOTREATYOURCONDITION
)FYOUHAVEANYFURTHERQUESTIONSONTHEUSEOFTHISMEDICINE
ASKYOURDOCTORORPHARMACIST

4

POSSIBLE SIDE EFFECTS

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s 2EDDENINGOFTHEFACE
s 3EEINGORHEARINGTHINGSTHATARENOTREALVISUALOR

AUDITORYHALLUCINATIONS 
Rare side effectsMAYAFFECTUPTOIN PEOPLE 
s )NFLAMMATIONOFTHELIVERHEPATITIS 
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SIDEEFFECTSNOTLISTEDINTHISLEAFLET PLEASETELLYOURDOCTOR
ORPHARMACIST
Reporting of side effects
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4HISINCLUDESANYPOSSIBLESIDEEFFECTSNOTLISTEDINTHIS
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EFFECTSYOUCANHELPPROVIDEMOREINFORMATIONONTHESAFETY
OFTHISMEDICINE

5

HOW TO STORE ZEEBRAL XL

Keep this medicine out of the sight and reach of children.
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PROTECTTHEENVIRONMENT

6

CONTENTS OF THE PACK AND OTHER

,IKEALLMEDICINES THISMEDICINECANCAUSESIDEEFFECTS
INFORMATION
ALTHOUGHNOTEVERYBODYGETSTHEM3OMEOFTHESEEFFECTS
MAYBEDUETOTHEDISEASEITSELF
What Zeebral XL contains
Stop taking your medicine and see a doctor immediately IF s 4HEACTIVESUBSTANCEISGALANTAMINE%ACHPROLONGED
RELEASECAPSULECONTAINSEITHERMG MGORMGOF
YOUEXPERIENCE
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s 4HEOTHERINGREDIENTSARE
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s 0ALPITATIONSPOUNDINGHEART BEAT
MACROGOL ETHYLCELLULOSE TRIETHYLCITRATE
s #ONDITIONSLIKEBLACKOUT
#APSULESHELLTITANIUMDIOXIDE% GELATINMGALSO
s !NALLERGICREACTION4HESIGNSMAYINCLUDEARASH
SWALLOWINGORBREATHINGPROBLEMS SWELLINGOFYOURLIPS CONTAINS1UINOLINEYELLOW% ERYTHROSINE% MG
ALSOCONTAINSREDIRONOXIDE% YELLOWIRONOXIDE% 
FACE THROATORTONGUE
)NKSHELLACGLAZEANDIRONOXIDEBLACK% PROPYLENE
Side effects include:
GLYCOL
Very common side effectsMAYAFFECTMORETHANIN
What
Zeebral XL looks like and contents of the pack
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Common side effectsMAYAFFECTUPTOINPEOPLE 

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ANDX HOSPITALPACKANDBOTTLEPACKSIZESOF 
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