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SONDATE XL 50MG PROLONGED-RELEASE TABLET

Active substance(s): QUETIAPINE FUMARATE

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s 3YMPTOMSOFWITHDRAWALMAYOCCURIN
newborn babies of mothers that have
used Quetiapine Teva during their
pregnancy.

Very Common side effects (may affect more
than 1 in 10 people):
Increase in the amount of a hormone called
prolactin, in the blood. Increases in the
hormone prolactin could in rare cases lead
to the following:
s "OYSANDGIRLSTOHAVESWELLINGOF
breasts and unexpectedly produce
breast milk
s 'IRLSTOHAVENOMONTHLYPERIODOR
irregular periods
s )NCREASEDAPPETITE
s 6OMITING
s !BNORMALMUSCLEMOVEMENTS4HESE
include difficulty starting muscle
movements, shaking, feeling restless or
muscle stiffness without pain.
s )NCREASEINBLOODPRESSURE

Do not throw away any medicines via
WASTEWATERORHOUSEHOLDWASTE!SKYOUR
pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment.

6

Contents of the pack and other
information

What Sondate XL contains
s 4HEACTIVESUBSTANCEISQUETIAPINE
Sondate XL tablets contain 50 mg, 150 mg,
200 mg, 300 mg or 400 mg of quetiapine
ASQUETIAPINEFUMARATE 
s 4HEOTHERINGREDIENTSARE
Tablet core: hypromellose, cellulose
microcrystalline, sodium citrate anhydrous,
magnesium stearate.
4ABLETCOATINGTITANIUMDIOXIDE%
HYPROMELLOSE MACROGOL0%'
polysorbate 80. The 50 mg, 200 mg and
300 mg tablets contain Iron Oxide Yellow
% AND)RON/XIDE2ED% 4HEMG
and 300 mg tablets also contain Iron Oxide
"LACK% 
What Sondate XL looks like and contents of
the pack
!LLSTRENGTHSOF3ONDATE8,
0ROLONGED RELEASE4ABLETSARECAPSULE
shaped, film-coated tablets. 50 mg tablets
are brown coloured, debossed “Q 50” on
one side, plain on the other; 150 mg tablets
are white coloured, debossed “Q 150” on
one side, plain on the other; 200 mg tablets
are yellow coloured, debossed “Q 200” on
one side, plain on the other; 300 mg tablets
are light yellow coloured, debossed “Q 300”
on one side, plain on the other and 400 mg
tablets are white coloured, debossed “Q 400”
on one side, plain on the other.
0ACKSOF    XHOSPITALPACK
CALENDARPACK  ANDTABLETSARE
REGISTEREDFORALLSTRENGTHS.OTALLPACKSIZES
may be available.
Marketing Authorisation Holder and
Manufacturer
4EVA5+,IMITED %ASTBOURNE ".!'
5NITED+INGDOM
This leaflet was last revised in 11/2014.

Common side effects (may affect up to 1 in
10 people):
s &EELINGWEAK FAINTINGMAYLEADTOFALLS
s 3TUFFYNOSE
s &EELINGIRRITATED

0,   

Reporting of side effects:
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. You can also report side effects
DIRECTLYVIATHE9ELLOW#ARD3CHEMEAT
www.mhra.gov.uk/yellowcard
"YREPORTINGSIDEEFFECTSYOUCANHELP
provide more information on the safety of
this medicine.

5

Warnings and precautions
Talk to your doctor or pharmacist before
taking Sondate XL if:
s 9OU ORSOMEONEINYOURFAMILY HAVEOR
have had any heart problems, for
Read all of this leaflet carefully before you
example heart rhythm problems,
start taking this medicine because it
weakening of the heart muscle or
contains important information for you.
inflammation of the heart or if you are
s +EEPTHISLEAFLET9OUMAYNEEDTOREADIT
taking any medicines that may have an
again.
impact on the way your heart beats
s )FYOUHAVEANYFURTHERQUESTIONS ASK
s
9OUHAVELOWBLOODPRESSURE
your doctor or pharmacist.
s 9OUHAVEHADASTROKE ESPECIALLYIFYOU
s 4HISMEDICINEHASBEENPRESCRIBEDFOR
are elderly
you only. Do not pass it on to others. It
s 9OUHAVEPROBLEMSWITHYOURLIVER
may harm them, even if their signs of
s
9OUHAVEEVERHADAFITSEIZURE
illness are the same as yours.
s 9OUHAVEDIABETESORHAVEARISKOF
s )FYOUGETANYSIDEEFFECTSTALKTOYOUR
getting diabetes. If you do, your doctor
doctor or pharmacist. This includes any
may check your blood sugar levels while
possible side effects not listed in this
you are taking Sondate XL.
leaflet. See section 4.
s 9OUKNOWTHATYOUHAVEHADLOWLEVELSOF
What is in this leaflet:
WHITEBLOODCELLSINTHEPASTWHICHMAY
or may not have been caused by other
1. What Sondate XL is and what it is used
MEDICINES
for
2. What you need to know before you take s 9OUAREANELDERLYPERSONWITHDEMENTIA
LOSSOFBRAINFUNCTION )FYOUARE
Sondate XL
Sondate XL should not be taken because
3. How to take Sondate XL
the group of medicines that Sondate XL
4. Possible side effects
belongs to may increase the risk of
5. How to store Sondate XL
stroke, or in some cases the risk of death,
6. Contents of the pack and other
in elderly people with dementia.
information
s 9OUORSOMEONEELSEINYOURFAMILYHASA
history of blood clots, as medicines like
What
Sondate
XL
is
and
what
it
is
1 used for
these have been associated with
formation of blood clots.
Tell
your doctor immediately if you
Sondate XL contains a substance called
experience any of the following after taking
quetiapine. This belongs to a group of
Sondate
XL:
medicines called anti-psychotics. Sondate
s !COMBINATIONOFFEVER SEVEREMUSCLE
XL can be used to treat several illnesses,
stiffness,
sweating or a lowered level of
such as:
CONSCIOUSNESSADISORDERCALLED
s "IPOLARDEPRESSIONANDMAJORDEPRESSIVE
hNEUROLEPTICMALIGNANTSYNDROMEv 
EPISODESINMAJORDEPRESSIVEDISORDER
Immediate medical treatment may be
where you feel sad. You may find that you
needed.
feel depressed, feel guilty, lack energy,
s 5NCONTROLLABLEMOVEMENTS MAINLYOF
lose your appetite or can’t sleep.
your face or tongue
s -ANIAWHEREYOUMAYFEELVERYEXCITED
s $IZZINESSORASEVERESENSEOFFEELING
elated, agitated, enthusiastic or
sleepy. This could increase the risk of
HYPERACTIVEORHAVEPOORJUDGMENT
ACCIDENTALINJURYFALL INELDERLYPATIENTS
including being aggressive or disruptive
s
&ITSSEIZURES
s 3CHIZOPHRENIAWHEREYOUMAYHEAROR
s !LONG LASTINGANDPAINFULERECTION
feel things that are not there, believe
0RIAPISM 
things that are not true or feel unusually
These conditions can be caused by this type
suspicious, anxious, confused, guilty,
of
medicine.
tense or depressed.
When Sondate XL is being taken to treat
MAJORDEPRESSIVEEPISODESINMAJOR
depressive disorder, it will be taken in
addition to another drug being used to treat
this illness.

2

What you need to know before you
take Sondate XL

Do not take Sondate XL:
s )FYOUAREALLERGICTOQUETIAPINEORANYOF
the other ingredients of this medicine
LISTEDINSECTION 
s )FYOUARETAKINGANYOFTHEFOLLOWING
medicines:
s SOMEMEDICINESFOR()6
s AZOLEMEDICINESFORFUNGALINFECTIONS
s ERYTHROMYCINORCLARITHROMYCINFOR
INFECTIONS NEFAZODONEFOR
DEPRESSION 

How to store Sondate XL

Do not take Sondate XL if the above applies
to you. If you are not sure, talk to your doctor
or pharmacist before taking Sondate XL.

0ACKAGELEAFLET: Information
for the user

Your doctor may continue to prescribe
Sondate XL even when you feel better.

Keep this medicine out of the sight and
reach of children.
Do not use Sondate XL after the expiry date
WHICHISSTATEDONTHECONTAINERAFTER%80
The expiry date refers to the last day of that
month.

SONDATE XL
50 mg, 150 mg, 200 mg, 300 mg,
400 mg PROLONGED-RELEASE
TABLETS
quetiapine

Tell your doctor as soon as possible if you
have:
s !FEVER FLU LIKESYMPTOMS SORETHROAT OR
any other infection, as this could be a
result of a very low white blood cell
count, which may require Sondate XL to
be stopped and/or treatment to be given
s #ONSTIPATIONALONGWITHPERSISTENT
abdominal pain, or constipation which
has not responded to treatment, as this
may lead to a more serious blockage of
the bowel.
Thoughts of suicide and worsening of your
depression
If you are depressed you may sometimes
have thoughts of harming or killing yourself.
These may be increased when first starting
treatment, since these medicines all take
time to work, usually about two weeks but
sometimes longer. These thoughts may also
be increased if you suddenly stop taking
your medication.
You may be more likely to think like this if
you are a young adult. Information from

22211-D
320 x 323

0EEL(ERE4O/PEN

0HARMACODE%8!-0,%#/$%
&IRSTBARISMMFROMTOPEDGE

The class of medicines to which Sondate XL
belongs can cause heart rhythm problems,
which can be serious and in severe cases
may be fatal.
Some side effects are only seen when a
blood test is taken. These include changes in
THEAMOUNTOFCERTAINFATSTRIGLYCERIDESAND
TOTALCHOLESTEROL ORSUGARINTHEBLOOD
changes in the amount of thyroid hormones
in your blood, increased liver
ENZYMES DECREASESINTHENUMBEROFCERTAIN
types of blood cells, decrease in the amount
of red blood cells, increased blood creatine
PHOSPHOKINASEASUBSTANCEINTHE
MUSCLES DECREASEINTHEAMOUNTOFSODIUM
in the blood and increases in the amount of
the hormone prolactin in the blood.
Increases in the hormone prolactin could in
rare cases lead to the following:
s -ENANDWOMENTOHAVESWELLINGOF
breasts and unexpectedly produce breast
milk
s 7OMENTOHAVENOMONTHLYPERIODOR
irregular periods.
Your doctor may ask you to have blood tests
from time to time.
Side effects in children and adolescents
The same side effects that may occur in
adults may also occur in children and
adolescents.
The following side effects have been seen
more often in children and adolescents or
have not been seen in adults:

Sondate XL does not require any special
storage conditions.

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clinical trials has shown an increased risk of
suicidal thoughts and/or suicidal behaviour
in young adults aged less than 25 years with
depression.
If you have thoughts of harming or killing
yourself at any time, contact your doctor or
go to a hospital straight away. You may find
it helpful to tell a relative or close friend that
you are depressed, and ask them to read
this leaflet. You might ask them to tell you if
they think your depression is getting worse,
or if they are worried about changes in your
behaviour.

Driving and using machines
The medicine can affect your ability to drive
ASITMAYMAKEYOUSLEEPYORDIZZY
s $ONOTDRIVEWHILETAKINGTHISMEDICINE
until you know how it affects you
s )TISANOFFENCETODRIVEIFTHISMEDICINE
affects your ability to drive.
(OWEVER YOUWOULDNOTBECOMMITTINGAN
offence if:

s 4HEMEDICINEHASBEENPRESCRIBEDTO
treat a medical or dental problem and
Weight gain
s 9OUHAVETAKENITACCORDINGTOTHE
Weight gain has been seen in patients taking
instructions given by the prescriber or in
quetiapine. You and your doctor should
the information provided with the
check your weight regularly.
medicine and
s )TWASNOTAFFECTINGYOURABILITYTODRIVE
Children and Adolescents
safely.
Quetiapine Teva is not for use in children
and adolescents below 18 years of age.
Talk to your doctor or pharmacist if you are
not sure whether it is safe for you to drive
Other medicines and Sondate XL
while taking this medicine.
Tell your doctor if you are taking or have
recently taken or might take any other
Effect on Urine Drug Screens
medicines:
If you are having a urine drug screen, taking
Do not take Sondate XL if you are taking any
Sondate XL may cause positive results for
of the following medicines:
methadone or certain drugs for depression
s 3OMEMEDICINESFOR()6
CALLEDTRICYCLICANTIDEPRESSANTS4#!S WHEN
s !ZOLEMEDICINESFORFUNGALINFECTIONS 
some test methods are used. even though
s %RYTHROMYCINORCLARITHROMYCINFOR
YOUMAYNOTBETAKINGMETHADONEOR4#!S
INFECTIONS
If this happens, a more specific test can be
s .EFAZODONEFORDEPRESSION 
Tell your doctor if you are taking any of the performed.
following medicines:
s %PILEPSYMEDICINESLIKEPHENYTOINOR
CARBAMAZEPINE
s (IGHBLOODPRESSUREMEDICINES
s "ARBITURATESFORDIFFICULTYSLEEPING
s 4HIORIDAZINEOR,ITHIUMOTHER
ANTI PSYCHOTICMEDICINES
s -EDICINESTHATHAVEANIMPACTONTHE
way your heart beats, for example, drugs
that can cause an imbalance in electrolytes
LOWLEVELSOFPOTASSIUMORMAGNESIUM
SUCHASDIURETICSWATERPILLS ORCERTAIN
ANTIBIOTICSDRUGSTOTREATINFECTIONS
s -EDICINESTHATCANCAUSECONSTIPATION
"EFOREYOUSTOPTAKINGANYOFYOUR
medicines, please talk to your doctor first.
Sondate XL with food, drink and alcohol
s 3ONDATE8,CANBEAFFECTEDBYFOODAND
you should therefore take your tablets at
least one hour before a meal or prior to
bedtime
s "ECAREFULHOWMUCHALCOHOLYOUDRINK
This is because the combined effect of
Sondate XL and alcohol can make you
sleepy.
s $ONOTDRINKGRAPEFRUITJUICEWHILEYOU
are taking Sondate XL. It can affect the
way the medicine works.
Pregnancy and breast-feeding
If you are pregnant, or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor for advice
before taking this medicine. You should not
take Sondate XL during pregnancy unless
this has been discussed with your doctor.
Sondate XL should not be taken if you are
breast-feeding.

3

How to take Sondate XL

!LWAYSTAKETHISMEDICINEEXACTLYASYOUR
DOCTORHASTOLDYOU#HECKWITHYOURDOCTOR
or pharmacist if you are not sure. Your
doctor will decide on your starting dose. The
MAINTENANCEDOSEDAILYDOSE WILLDEPEND
on your illness and needs but will usually be
between 150 mg and 800 mg.
s 9OUWILLTAKEYOURTABLETSONCEADAY
s $ONOTSPLIT CHEWORCRUSHTHETABLETS
s 3WALLOWYOURTABLETSWHOLEWITHADRINK
of water
s 4AKEYOURTABLETSWITHOUTFOODATLEAST
one hour before a meal or at bedtime,
YOURDOCTORWILLTELLYOUWHEN
s $ONOTDRINKGRAPEFRUITJUICEWHILEYOU
are taking Sondate XL. It can affect the
way the medicine works.
s Do not stop taking your tablets even if you
feel better, unless your doctor tells you.
Liver problems
If you have liver problems your doctor may
change your dose.
Elderly people
If you are elderly your doctor may change
your dose.
Use in children and adolescents
Sondate XL should not be used by children
and adolescents aged under 18 years.

If you take more Sondate XL than you
should
If you take more Sondate XL than
prescribed by your doctor, you may feel
SLEEPY FEELDIZZYANDEXPERIENCEABNORMAL
HEARTBEATS#ONTACTYOURDOCTORORNEAREST
The following symptoms which can
hospital straight away.
represent withdrawal may occur in newborn
Keep the Sondate XL tablets with you.
babies, of mothers that have used
QUETIAPINEINTHELASTTRIMESTERLASTTHREE
If you forget to take a dose of Sondate XL
MONTHSOFTHEIRPREGNANCY SHAKING MUSCLE
If you forget to take a dose, take it as soon
stiffness and/or weakness, sleepiness,
agitation, breathing problems, and difficulty as you remember. If it is almost time to take
the next dose, wait until then. Do not take a
in feeding. If your baby develops any of
double dose to make up for a forgotten
these symptoms you may need to contact
tablet.
your doctor.

FOLD
LINE.

PAGE 3: RIGHT HAND INSIDE FACE AFTER FOLDING AND TACKING

s $IFFICULTYSWALLOWING
s 5NCONTROLLABLEMOVEMENTS MAINLYOF
your face or tongue
s 3EXUALDYSFUNCTION
s $IABETES
s #HANGEINELECTRICALACTIVITYOFTHEHEART
SEENON%#'14PROLONGATION
s !SLOWERTHANNORMALHEARTRATEWHICH
may occur when starting treatment and
If you have any further questions on the use of
which may be associated with low blood
this medicine, ask your doctor or pharmacist.
pressure and fainting
s $IFFICULTYINPASSINGURINE
s &AINTINGMAYLEADTOFALLS
4 Possible side effects
s 3TUFFYNOSE
Like all medicines, this medicine can cause s $ECREASEINTHEAMOUNTOFREDBLOODCELLS
side effects, although not everybody gets
s $ECREASEINTHEAMOUNTOFSODIUMINTHE
them.
blood.
Very common side effects (may affect more
than 1 in 10 people):
Rare side effects (may affect up to 1 in 1,000
s $IZZINESSMAYLEADTOFALLS HEADACHE
people):
dry mouth
s !COMBINATIONOFHIGHTEMPERATURE
s &EELINGSLEEPYTHISMAYGOAWAYWITH
FEVER SWEATING STIFFMUSCLES FEELING
TIME ASYOUKEEPTAKING3ONDATE8,
VERYDROWSYORFAINTADISORDERCALLED
MAYLEADTOFALLS
hNEUROLEPTICMALIGNANTSYNDROME
s $ISCONTINUATIONSYMPTOMSSYMPTOMS
s 9ELLOWINGOFTHESKINANDEYESJAUNDICE
which occur when you stop taking
s )NFLAMMATIONOFTHELIVERHEPATITIS
3ONDATE8, INCLUDENOTBEINGABLETO
s !LONG LASTINGANDPAINFULERECTION
SLEEPINSOMNIA FEELINGSICKNAUSEA
PRIAPISM
headache, diarrhoea, being sick
s 3WELLINGOFBREASTSANDUNEXPECTED
VOMITING DIZZINESS ANDIRRITABILITY
PRODUCTIONOFBREASTMILKGALACTORRHOEA
Gradual withdrawal over a period of at
s -ENSTRUALDISORDER
least 1 to 2 weeks is advisable.
s "LOODCLOTSINTHEVEINSESPECIALLYINTHE
s 0UTTINGONWEIGHT
LEGSSYMPTOMSINCLUDESWELLING PAIN
s !BNORMALMUSCLEMOVEMENTS4HESE
ANDREDNESSINTHELEG WHICHMAYTRAVEL
include difficulty starting muscle
through blood vessels to the lungs causing
movements, shaking, feeling restless or
chest pain and difficulty in breathing. If
muscle stiffness without pain.
you notice any of these symptoms seek
s #HANGESINTHEAMOUNTOFCERTAINFATS
medical advice immediately.
TRIGLYCERIDESANDTOTALCHOLESTEROL 
s 7ALKING TALKING EATINGOROTHERACTIVITIES
while you are asleep
Common side effects (may affect up to 1 in s "ODYTEMPERATUREDECREASEDHYPOTHERMIA
10 people):
s )NFLAMMATIONOFTHEPANCREAS
s 2APIDHEARTBEAT
s !CONDITIONCALLEDhMETABOLIC
s &EELINGLIKEYOURHEARTISPOUNDING
SYNDROMEv WHEREYOUMAYHAVEA
racing or has skipped beats
combination of 3 or more of the
s #ONSTIPATION UPSETSTOMACHINDIGESTION
following: an increase in fat around your
s &EELINGWEAK
abdomen, a decrease in “good
s 3WELLINGOFARMSORLEGS
CHOLESTEROLv($, # ANINCREASEINATYPE
s ,OWBLOODPRESSUREWHENSTANDINGUP
of fat in your blood called triglycerides,
4HISMAYMAKEYOUFEELDIZZYORFAINT
high blood pressure and an increase in
MAYLEADTOFALLS 
your blood sugar
s )NCREASEDLEVELSOFSUGARINTHEBLOOD
s #OMBINATIONOFFEVER FLU LIKESYMPTOMS
s "LURREDVISION
sore throat, or any other infection with
s !BNORMALDREAMSANDNIGHTMARES
very low white blood cell count, a
s &EELINGMOREHUNGRY
condition called agranulocytosis
s &EELINGIRRITATED
s "OWELOBSTRUCTION
s $ISTURBANCEINSPEECHANDLANGUAGE
s
)NCREASEDBLOODCREATINEPHOSPHOKINASE
s 4HOUGHTSOFSUICIDEANDWORSENINGOF
ASUBSTANCEFROMTHEMUSCLES 
your depression

If you stop taking Sondate XL
If you suddenly stop taking Sondate XL, you
MAYBEUNABLETOSLEEPINSOMNIA ORYOU
MAYFEELSICKNAUSEA ORYOUMAY
experience headache, diarrhoea, being sick
VOMITING DIZZINESSORIRRITABILITY9OUR
doctor may suggest you reduce the dose
gradually before stopping treatment.

s
s
s
s
s
s
s




3HORTNESSOFBREATH
6OMITINGMAINLYINTHEELDERLY
&EVER
#HANGESINTHEAMOUNTOFTHYROID
hormones in your blood
$ECREASESINTHENUMBEROFCERTAINTYPES
of blood cells
)NCREASESINTHEAMOUNTOFLIVERENZYMES
measured in the blood
)NCREASESINTHEAMOUNTOFTHEHORMONE
prolactin in the blood. Increases in the
hormone prolactin could in rare cases
lead to the following:
s -ENANDWOMENTOHAVESWELLINGOF
breasts and unexpectedly produce
breast milk
s 7OMENTOHAVENOMONTHLYPERIODOR
irregular periods.

Uncommon side effects (may affect up to 1
in 100 people):Fits or seizures.
s !LLERGICREACTIONSTHATMAYINCLUDERAISED
LUMPSWEALS SWELLINGOFTHESKINAND
swelling around the mouth
s 5NPLEASANTSENSATIONSINTHELEGSALSO
CALLEDRESTLESSLEGSSYNDROME

Very rare side effects (may affect up to 1 in
10,000 people):
s 3EVERERASH BLISTERS ORREDPATCHESON
the skin
s !SEVEREALLERGICREACTIONCALLED
ANAPHYLAXIS WHICHMAYCAUSEDIFFICULTY
in breathing or shock
s 2APIDSWELLINGOFTHESKIN USUALLYAROUND
THEEYES LIPSANDTHROATANGIOEDEMA
s !SERIOUSBLISTERINGCONDITIONOFTHESKIN
mouth, eyes and genitals
3TEVENS *OHNSONSYNDROME
s )NAPPROPRIATESECRETIONOFAHORMONETHAT
controls urine volume
s "REAKDOWNOFMUSCLEFIBERSANDPAININ
MUSCLESRHABDOMYOLYSIS
s 7ORSENINGOFPRE EXISTINGDIABETES
Not known (frequency cannot be estimated
from the available data)
s 3KINRASHWITHIRREGULARREDSPOTS
ERYTHEMAMULTIFORME
s 3ERIOUS SUDDENALLERGICREACTIONWITH
symptoms such as fever and blisters on
THESKINANDPEELINGOFTHESKINTOXIC
EPIDERMALNECROLYSIS

9OUMAYBEMORELIKELYTOTHINKLIKETHISIFYOUARE
AYOUNGADULT)NFORMATIONFROMCLINICALTRIALSHAS
SHOWNANINCREASEDRISKOFSUICIDALTHOUGHTSANDOR
SUICIDALBEHAVIOURINYOUNGADULTSAGEDLESSTHAN
YEARSWITHDEPRESSION
)FYOUHAVETHOUGHTSOFHARMINGORKILLINGYOURSELF
0ACKAGELEAFLET)NFORMATION
ATANYTIME CONTACTYOURDOCTORORGOTOAHOSPITAL
FORTHEUSER
STRAIGHTAWAY9OUMAYFINDITHELPFULTOTELLA
Read all of this leaflet carefully before you start
RELATIVEORCLOSEFRIENDTHATYOUAREDEPRESSED AND
taking this medicine because it contains important ASKTHEMTOREADTHISLEAFLET9OUMIGHTASKTHEMTO
information for you.
TELLYOUIFTHEYTHINKYOURDEPRESSIONISGETTING
s +EEPTHISLEAFLET9OUMAYNEEDTOREADITAGAIN WORSE ORIFTHEYAREWORRIEDABOUTCHANGESINYOUR
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOUR
BEHAVIOUR
DOCTORORPHARMACIST
s 4HISMEDICINEHASBEENPRESCRIBEDFORYOUONLY Weight gain
7EIGHTGAINHASBEENSEENINPATIENTSTAKING
$ONOTPASSITONTOOTHERS)TMAYHARMTHEM
EVENIFTHEIRSIGNSOFILLNESSARETHESAMEASYOURS QUETIAPINE9OUANDYOURDOCTORSHOULDCHECKYOUR
s )FYOUGETANYSIDEEFFECTSTALKTOYOURDOCTOROR WEIGHTREGULARLY
PHARMACIST4HISINCLUDESANYPOSSIBLESIDE
Children and Adolescents
EFFECTSNOTLISTEDINTHISLEAFLET3EESECTION
1UETIAPINE4EVAISNOTFORUSEINCHILDRENAND
ADOLESCENTSBELOWYEARSOFAGE
7HATISINTHISLEAFLET

Other medicines and Sondate XL
1. What Sondate XL is and what it is used for
4ELLYOURDOCTORIFYOUARETAKINGORHAVERECENTLY
2. What you need to know before you take
TAKENORMIGHTTAKEANYOTHERMEDICINES
Sondate XL
$ONOTTAKE3ONDATE8,IFYOUARETAKINGANYOFTHE
3. How to take Sondate XL
FOLLOWINGMEDICINES
4. Possible side effects
s 3OMEMEDICINESFOR()6
5. How to store Sondate XL
s !ZOLEMEDICINESFORFUNGALINFECTIONS 
6. Contents of the pack and other information
s %RYTHROMYCINORCLARITHROMYCINFORINFECTIONS
s .EFAZODONEFORDEPRESSION 
What Sondate XL is and what it is used for 4ELLYOURDOCTORIFYOUARETAKINGANYOFTHE

FOLLOWINGMEDICINES
3ONDATE8,CONTAINSASUBSTANCECALLEDQUETIAPINE s %PILEPSYMEDICINESLIKEPHENYTOINOR
4HISBELONGSTOAGROUPOFMEDICINESCALLED
CARBAMAZEPINE
ANTI PSYCHOTICS3ONDATE8,CANBEUSEDTOTREAT
s (IGHBLOODPRESSUREMEDICINES
SEVERALILLNESSES SUCHAS
s "ARBITURATESFORDIFFICULTYSLEEPING
s "IPOLARDEPRESSIONANDMAJORDEPRESSIVE
s 4HIORIDAZINEOR,ITHIUMOTHERANTI PSYCHOTIC
EPISODESINMAJORDEPRESSIVEDISORDERWHERE
MEDICINES
YOUFEELSAD9OUMAYFINDTHATYOUFEEL
s -EDICINESTHATHAVEANIMPACTONTHEWAYYOUR
DEPRESSED FEELGUILTY LACKENERGY LOSEYOUR
HEARTBEATS FOREXAMPLE DRUGSTHATCANCAUSE
APPETITEORCANTSLEEP
ANIMBALANCEINELECTROLYTESLOWLEVELSOF
s -ANIAWHEREYOUMAYFEELVERYEXCITED ELATED
POTASSIUMORMAGNESIUM SUCHASDIURETICS
AGITATED ENTHUSIASTICORHYPERACTIVEORHAVE
WATERPILLS ORCERTAINANTIBIOTICSDRUGSTOTREAT
POORJUDGMENTINCLUDINGBEINGAGGRESSIVEOR
INFECTIONS
DISRUPTIVE
s -EDICINESTHATCANCAUSECONSTIPATION
s 3CHIZOPHRENIAWHEREYOUMAYHEARORFEEL
THINGSTHATARENOTTHERE BELIEVETHINGSTHATARE "EFOREYOUSTOPTAKINGANYOFYOURMEDICINES
PLEASETALKTOYOURDOCTORFIRST
NOTTRUEORFEELUNUSUALLYSUSPICIOUS ANXIOUS
CONFUSED GUILTY TENSEORDEPRESSED
Sondate XL with food, drink and alcohol
s 3ONDATE8,CANBEAFFECTEDBYFOODANDYOU
7HEN3ONDATE8,ISBEINGTAKENTOTREATMAJOR
SHOULDTHEREFORETAKEYOURTABLETSATLEASTONE
DEPRESSIVEEPISODESINMAJORDEPRESSIVEDISORDER
HOURBEFOREAMEALORPRIORTOBEDTIME
ITWILLBETAKENINADDITIONTOANOTHERDRUGBEING
s "ECAREFULHOWMUCHALCOHOLYOUDRINK4HISIS
USEDTOTREATTHISILLNESS
BECAUSETHECOMBINEDEFFECTOF3ONDATE8,AND
9OURDOCTORMAYCONTINUETOPRESCRIBE3ONDATE8,
ALCOHOLCANMAKEYOUSLEEPY
EVENWHENYOUFEELBETTER
s $ONOTDRINKGRAPEFRUITJUICEWHILEYOUARE

TAKING3ONDATE8,)TCANAFFECTTHEWAYTHE
What you need to know before you take
MEDICINEWORKS
Sondate XL
Pregnancy and breast-feeding

)FYOUAREPREGNANT ORBREAST FEEDING THINKYOU
Do not take Sondate XL:
s )FYOUAREALLERGICTOQUETIAPINEORANYOFTHEOTHER MAYBEPREGNANTORAREPLANNINGTOHAVEABABY
INGREDIENTSOFTHISMEDICINELISTEDINSECTION  ASKYOURDOCTORFORADVICEBEFORETAKINGTHIS
MEDICINE9OUSHOULDNOTTAKE3ONDATE8,DURING
s )FYOUARETAKINGANYOFTHEFOLLOWING
PREGNANCYUNLESSTHISHASBEENDISCUSSEDWITH
MEDICINES
YOURDOCTOR3ONDATE8,SHOULDNOTBETAKENIFYOU
s SOMEMEDICINESFOR()6
AREBREAST FEEDING
s AZOLEMEDICINESFORFUNGALINFECTIONS
s ERYTHROMYCINORCLARITHROMYCINFOR
4HEFOLLOWINGSYMPTOMSWHICHCANREPRESENT
INFECTIONS NEFAZODONEFORDEPRESSION 
WITHDRAWALMAYOCCURINNEWBORNBABIES OF
$ONOTTAKE3ONDATE8,IFTHEABOVEAPPLIESTOYOU MOTHERSTHATHAVEUSEDQUETIAPINEINTHELAST
TRIMESTERLASTTHREEMONTHSOFTHEIRPREGNANCY 
)FYOUARENOTSURE TALKTOYOURDOCTOROR
SHAKING MUSCLESTIFFNESSANDORWEAKNESS
PHARMACISTBEFORETAKING3ONDATE8,
SLEEPINESS AGITATION BREATHINGPROBLEMS AND
Warnings and precautions
DIFFICULTYINFEEDING)FYOURBABYDEVELOPSANYOF
4ALKTOYOURDOCTORORPHARMACISTBEFORETAKING
THESESYMPTOMSYOUMAYNEEDTOCONTACTYOUR
3ONDATE8,IF
DOCTOR
s 9OU ORSOMEONEINYOURFAMILY HAVEORHAVE
Driving and using machines
HADANYHEARTPROBLEMS FOREXAMPLEHEART
4HEMEDICINECANAFFECTYOURABILITYTODRIVEASIT
RHYTHMPROBLEMS WEAKENINGOFTHEHEART
MAYMAKEYOUSLEEPYORDIZZY
MUSCLEORINFLAMMATIONOFTHEHEARTORIFYOU
ARETAKINGANYMEDICINESTHATMAYHAVEAN
s $ONOTDRIVEWHILETAKINGTHISMEDICINEUNTILYOU
IMPACTONTHEWAYYOURHEARTBEATS
KNOWHOWITAFFECTSYOU
s 9OUHAVELOWBLOODPRESSURE
s )TISANOFFENCETODRIVEIFTHISMEDICINEAFFECTS
s 9OUHAVEHADASTROKE ESPECIALLYIFYOUARE
YOURABILITYTODRIVE
ELDERLY
(OWEVER YOUWOULDNOTBECOMMITTINGANOFFENCE
s 9OUHAVEPROBLEMSWITHYOURLIVER
IF
s 9OUHAVEEVERHADAFITSEIZURE
s 4HEMEDICINEHASBEENPRESCRIBEDTOTREATA
s 9OUHAVEDIABETESORHAVEARISKOFGETTING
MEDICALORDENTALPROBLEMAND
DIABETES)FYOUDO YOURDOCTORMAYCHECKYOUR
BLOODSUGARLEVELSWHILEYOUARETAKING3ONDATE s 9OUHAVETAKENITACCORDINGTOTHEINSTRUCTIONS
GIVENBYTHEPRESCRIBERORINTHEINFORMATION
8,
PROVIDEDWITHTHEMEDICINEAND
s 9OUKNOWTHATYOUHAVEHADLOWLEVELSOFWHITE
s )TWASNOTAFFECTINGYOURABILITYTODRIVESAFELY
BLOODCELLSINTHEPASTWHICHMAYORMAYNOT
HAVEBEENCAUSEDBYOTHERMEDICINES
4ALKTOYOURDOCTORORPHARMACISTIFYOUARENOT
s 9OUAREANELDERLYPERSONWITHDEMENTIALOSSOF SUREWHETHERITISSAFEFORYOUTODRIVEWHILETAKING
BRAINFUNCTION )FYOUARE 3ONDATE8,SHOULD
THISMEDICINE
NOTBETAKENBECAUSETHEGROUPOFMEDICINES
Effect on Urine Drug Screens
THAT3ONDATE8,BELONGSTOMAYINCREASETHE
)FYOUAREHAVINGAURINEDRUGSCREEN TAKING
RISKOFSTROKE ORINSOMECASESTHERISKOFDEATH 3ONDATE8,MAYCAUSEPOSITIVERESULTSFOR
INELDERLYPEOPLEWITHDEMENTIA
METHADONEORCERTAINDRUGSFORDEPRESSIONCALLED
s 9OUORSOMEONEELSEINYOURFAMILYHASA
TRICYCLICANTIDEPRESSANTS4#!S WHENSOMETEST
HISTORYOFBLOODCLOTS ASMEDICINESLIKETHESE
METHODSAREUSEDEVENTHOUGHYOUMAYNOTBE
HAVEBEENASSOCIATEDWITHFORMATIONOFBLOOD
TAKINGMETHADONEOR4#!S)FTHISHAPPENS AMORE
CLOTS
SPECIFICTESTCANBEPERFORMED
4ELLYOURDOCTORIMMEDIATELYIFYOUEXPERIENCEANY
OFTHEFOLLOWINGAFTERTAKING3ONDATE8,
How to take Sondate XL
s !COMBINATIONOFFEVER SEVEREMUSCLESTIFFNESS
SWEATINGORALOWEREDLEVELOFCONSCIOUSNESSA !LWAYSTAKETHISMEDICINEEXACTLYASYOURDOCTOR
DISORDERCALLEDhNEUROLEPTICMALIGNANT
HASTOLDYOU#HECKWITHYOURDOCTORORPHARMACIST
SYNDROMEv )MMEDIATEMEDICALTREATMENTMAY IFYOUARENOTSURE9OURDOCTORWILLDECIDEONYOUR
BENEEDED
STARTINGDOSE4HEMAINTENANCEDOSEDAILYDOSE
s 5NCONTROLLABLEMOVEMENTS MAINLYOFYOURFACE WILLDEPENDONYOURILLNESSANDNEEDSBUTWILL
ORTONGUE
USUALLYBEBETWEENMGANDMG
s $IZZINESSORASEVERESENSEOFFEELINGSLEEPY
s 9OUWILLTAKEYOURTABLETSONCEADAY
4HISCOULDINCREASETHERISKOFACCIDENTALINJURY s $ONOTSPLIT CHEWORCRUSHTHETABLETS
FALL INELDERLYPATIENTS
s 3WALLOWYOURTABLETSWHOLEWITHADRINKOFWATER
s &ITSSEIZURES
s 4AKEYOURTABLETSWITHOUTFOODATLEASTONEHOUR
s !LONG LASTINGANDPAINFULERECTION0RIAPISM 
BEFOREAMEALORATBEDTIME YOURDOCTORWILLTELL
4HESECONDITIONSCANBECAUSEDBYTHISTYPEOF
YOUWHEN
MEDICINE
s $ONOTDRINKGRAPEFRUITJUICEWHILEYOUARE

SONDATE XL 50 mg, 150 mg,
200 mg, 300 mg, 400 mg
PROLONGED-RELEASE TABLETS
Quetiapine

1

2

3

4ELLYOURDOCTORASSOONASPOSSIBLEIFYOUHAVE
s !FEVER FLU LIKESYMPTOMS SORETHROAT ORANY
OTHERINFECTION ASTHISCOULDBEARESULTOFA
VERYLOWWHITEBLOODCELLCOUNT WHICHMAY
REQUIRE3ONDATE8,TOBESTOPPEDANDOR
TREATMENTTOBEGIVEN
s #ONSTIPATIONALONGWITHPERSISTENTABDOMINAL
PAIN ORCONSTIPATIONWHICHHASNOTRESPONDED
TOTREATMENT ASTHISMAYLEADTOAMORESERIOUS
BLOCKAGEOFTHEBOWEL
Thoughts of suicide and worsening of your
depression
)FYOUAREDEPRESSEDYOUMAYSOMETIMESHAVE
THOUGHTSOFHARMINGORKILLINGYOURSELF4HESEMAY
BEINCREASEDWHENFIRSTSTARTINGTREATMENT SINCE
THESEMEDICINESALLTAKETIMETOWORK USUALLY
ABOUTTWOWEEKSBUTSOMETIMESLONGER4HESE
THOUGHTSMAYALSOBEINCREASEDIFYOUSUDDENLY
STOPTAKINGYOURMEDICATION

TAKING3ONDATE8,)TCANAFFECTTHEWAYTHE
MEDICINEWORKS
s $ONOTSTOPTAKINGYOURTABLETSEVENIFYOUFEEL
BETTER UNLESSYOURDOCTORTELLSYOU
Liver problems
)FYOUHAVELIVERPROBLEMSYOURDOCTORMAYCHANGE
YOURDOSE
Elderly people
)FYOUAREELDERLYYOURDOCTORMAYCHANGEYOURDOSE
Use in children and adolescents
3ONDATE8,SHOULDNOTBEUSEDBYCHILDRENAND
ADOLESCENTSAGEDUNDERYEARS
If you take more Sondate XL than you should
)FYOUTAKEMORE3ONDATE8,THANPRESCRIBEDBY
YOURDOCTOR YOUMAYFEELSLEEPY FEELDIZZYAND
EXPERIENCEABNORMALHEARTBEATS#ONTACTYOUR
DOCTORORNEARESTHOSPITALSTRAIGHTAWAY
+EEPTHE3ONDATE8,TABLETSWITHYOU

If you forget to take a dose of Sondate XL
)FYOUFORGETTOTAKEADOSE TAKEITASSOONASYOU
REMEMBER)FITISALMOSTTIMETOTAKETHENEXTDOSE
WAITUNTILTHEN$ONOTTAKEADOUBLEDOSETOMAKE
UPFORAFORGOTTENTABLET
If you stop taking Sondate XL
)FYOUSUDDENLYSTOPTAKING3ONDATE8, YOUMAY
BEUNABLETOSLEEPINSOMNIA ORYOUMAYFEELSICK
NAUSEA ORYOUMAYEXPERIENCEHEADACHE
DIARRHOEA BEINGSICKVOMITING DIZZINESSOR
IRRITABILITY9OURDOCTORMAYSUGGESTYOUREDUCETHE
DOSEGRADUALLYBEFORESTOPPINGTREATMENT
)FYOUHAVEANYFURTHERQUESTIONSONTHEUSEOFTHIS
MEDICINE ASKYOURDOCTORORPHARMACIST


4

Possible side effects


,IKEALLMEDICINES THISMEDICINECANCAUSESIDE
EFFECTS ALTHOUGHNOTEVERYBODYGETSTHEM
Very common side effects (may affect more than 1
in 10 people):
s $IZZINESSMAYLEADTOFALLS HEADACHE DRYMOUTH
s &EELINGSLEEPYTHISMAYGOAWAYWITHTIME AS
YOUKEEPTAKING3ONDATE8, MAYLEADTOFALLS
s $ISCONTINUATIONSYMPTOMSSYMPTOMSWHICH
OCCURWHENYOUSTOPTAKING3ONDATE8, INCLUDE
NOTBEINGABLETOSLEEPINSOMNIA FEELINGSICK
NAUSEA HEADACHE DIARRHOEA BEINGSICK
VOMITING DIZZINESS ANDIRRITABILITY'RADUAL
WITHDRAWALOVERAPERIODOFATLEASTTOWEEKS
ISADVISABLE
s 0UTTINGONWEIGHT
s !BNORMALMUSCLEMOVEMENTS4HESEINCLUDE
DIFFICULTYSTARTINGMUSCLEMOVEMENTS SHAKING
FEELINGRESTLESSORMUSCLESTIFFNESSWITHOUTPAIN
s #HANGESINTHEAMOUNTOFCERTAINFATS
TRIGLYCERIDESANDTOTALCHOLESTEROL 
Common side effects (may affect up to 1 in 10
people):
s 2APIDHEARTBEAT
s &EELINGLIKEYOURHEARTISPOUNDING RACINGOR
HASSKIPPEDBEATS
s #ONSTIPATION UPSETSTOMACHINDIGESTION
s &EELINGWEAK
s 3WELLINGOFARMSORLEGS
s ,OWBLOODPRESSUREWHENSTANDINGUP4HISMAY
MAKEYOUFEELDIZZYORFAINTMAYLEADTOFALLS 
s )NCREASEDLEVELSOFSUGARINTHEBLOOD
s "LURREDVISION
s !BNORMALDREAMSANDNIGHTMARES
s &EELINGMOREHUNGRY
s &EELINGIRRITATED
s $ISTURBANCEINSPEECHANDLANGUAGE
s 4HOUGHTSOFSUICIDEANDWORSENINGOFYOUR
DEPRESSION
s 3HORTNESSOFBREATH
s 6OMITINGMAINLYINTHEELDERLY
s &EVER
s #HANGESINTHEAMOUNTOFTHYROIDHORMONESIN
YOURBLOOD
s $ECREASESINTHENUMBEROFCERTAINTYPESOF
BLOODCELLS
s )NCREASESINTHEAMOUNTOFLIVERENZYMES
MEASUREDINTHEBLOOD
s )NCREASESINTHEAMOUNTOFTHEHORMONE
PROLACTININTHEBLOOD)NCREASESINTHEHORMONE
PROLACTINCOULDINRARECASESLEADTOTHE
FOLLOWING
s -ENANDWOMENTOHAVESWELLINGOFBREASTS
ANDUNEXPECTEDLYPRODUCEBREASTMILK
s 7OMENTOHAVENOMONTHLYPERIODOR
IRREGULARPERIODS
Uncommon side effects (may affect up to 1 in 100
people): Fits or seizures.
s !LLERGICREACTIONSTHATMAYINCLUDERAISEDLUMPS
WEALS SWELLINGOFTHESKINANDSWELLING
AROUNDTHEMOUTH
s 5NPLEASANTSENSATIONSINTHELEGSALSOCALLED
RESTLESSLEGSSYNDROME
s $IFFICULTYSWALLOWING
s 5NCONTROLLABLEMOVEMENTS MAINLYOFYOURFACE
ORTONGUE
s 3EXUALDYSFUNCTION
s $IABETES
s #HANGEINELECTRICALACTIVITYOFTHEHEARTSEENON
%#'14PROLONGATION
s !SLOWERTHANNORMALHEARTRATEWHICHMAY
OCCURWHENSTARTINGTREATMENTANDWHICHMAY
BEASSOCIATEDWITHLOWBLOODPRESSUREAND
FAINTING
s $IFFICULTYINPASSINGURINE
s &AINTINGMAYLEADTOFALLS
s 3TUFFYNOSE
s $ECREASEINTHEAMOUNTOFREDBLOODCELLS
s $ECREASEINTHEAMOUNTOFSODIUMINTHEBLOOD

s 2APIDSWELLINGOFTHESKIN USUALLYAROUNDTHE
EYES LIPSANDTHROATANGIOEDEMA
s !SERIOUSBLISTERINGCONDITIONOFTHESKIN MOUTH
EYESANDGENITALS3TEVENS *OHNSONSYNDROME
s )NAPPROPRIATESECRETIONOFAHORMONETHAT
CONTROLSURINEVOLUME
s "REAKDOWNOFMUSCLEFIBERSANDPAININMUSCLES
RHABDOMYOLYSIS
s 7ORSENINGOFPRE EXISTINGDIABETES
Not known (frequency cannot be estimated from
the available data)
s 3KINRASHWITHIRREGULARREDSPOTSERYTHEMA
MULTIFORME
s 3ERIOUS SUDDENALLERGICREACTIONWITH
SYMPTOMSSUCHASFEVERANDBLISTERSONTHESKIN
ANDPEELINGOFTHESKINTOXICEPIDERMAL
NECROLYSIS
s 3YMPTOMSOFWITHDRAWALMAYOCCURINNEWBORN
BABIESOFMOTHERSTHATHAVEUSED1UETIAPINE
4EVADURINGTHEIRPREGNANCY
4HECLASSOFMEDICINESTOWHICH3ONDATE8,
BELONGSCANCAUSEHEARTRHYTHMPROBLEMS WHICH
CANBESERIOUSANDINSEVERECASESMAYBEFATAL
3OMESIDEEFFECTSAREONLYSEENWHENABLOODTEST
ISTAKEN4HESEINCLUDECHANGESINTHEAMOUNTOF
CERTAINFATSTRIGLYCERIDESANDTOTALCHOLESTEROL OR
SUGARINTHEBLOOD CHANGESINTHEAMOUNTOF
THYROIDHORMONESINYOURBLOOD INCREASEDLIVER
ENZYMES DECREASESINTHENUMBEROFCERTAINTYPES
OFBLOODCELLS DECREASEINTHEAMOUNTOFREDBLOOD
CELLS INCREASEDBLOODCREATINEPHOSPHOKINASEA
SUBSTANCEINTHEMUSCLES DECREASEINTHEAMOUNT
OFSODIUMINTHEBLOODANDINCREASESINTHEAMOUNT
OFTHEHORMONEPROLACTININTHEBLOOD
)NCREASESINTHEHORMONEPROLACTINCOULDINRARE
CASESLEADTOTHEFOLLOWING
s -ENANDWOMENTOHAVESWELLINGOFBREASTS
ANDUNEXPECTEDLYPRODUCEBREASTMILK
s 7OMENTOHAVENOMONTHLYPERIODORIRREGULAR
PERIODS
9OURDOCTORMAYASKYOUTOHAVEBLOODTESTSFROM
TIMETOTIME
Side effects in children and adolescents
4HESAMESIDEEFFECTSTHATMAYOCCURINADULTSMAY
ALSOOCCURINCHILDRENANDADOLESCENTS
4HEFOLLOWINGSIDEEFFECTSHAVEBEENSEENMORE
OFTENINCHILDRENANDADOLESCENTSORHAVENOTBEEN
SEENINADULTS
Very Common side effects (may affect more than 1
in 10 people):
)NCREASEINTHEAMOUNTOFAHORMONECALLED
PROLACTIN INTHEBLOOD)NCREASESINTHEHORMONE
PROLACTINCOULDINRARECASESLEADTOTHEFOLLOWING
s "OYSANDGIRLSTOHAVESWELLINGOFBREASTS
ANDUNEXPECTEDLYPRODUCEBREASTMILK
s 'IRLSTOHAVENOMONTHLYPERIODORIRREGULAR
PERIODS
s )NCREASEDAPPETITE
s 6OMITING
s !BNORMALMUSCLEMOVEMENTS4HESEINCLUDE
DIFFICULTYSTARTINGMUSCLEMOVEMENTS SHAKING
FEELINGRESTLESSORMUSCLESTIFFNESSWITHOUTPAIN
s )NCREASEINBLOODPRESSURE
Common side effects (may affect up to 1 in 10
people):
s &EELINGWEAK FAINTINGMAYLEADTOFALLS
s 3TUFFYNOSE
s &EELINGIRRITATED
Reporting of side effects:
)FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTOR
PHARMACISTORNURSE4HISINCLUDESANYPOSSIBLE
SIDEEFFECTSNOTLISTEDINTHISLEAFLET9OUCANALSO
REPORTSIDEEFFECTSDIRECTLYVIATHE9ELLOW#ARD
3CHEMEATWWWMHRAGOVUKYELLOWCARD
"YREPORTINGSIDEEFFECTSYOUCANHELPPROVIDE
MOREINFORMATIONONTHESAFETYOFTHISMEDICINE


5

How to store Sondate XL


Keep this medicine out of the sight and reach of
children.
$ONOTUSE3ONDATE8,AFTERTHEEXPIRYDATEWHICH
ISSTATEDONTHECONTAINERAFTER%804HEEXPIRYDATE
REFERSTOTHELASTDAYOFTHATMONTH
3ONDATE8,DOESNOTREQUIREANYSPECIALSTORAGE
CONDITIONS
$ONOTTHROWAWAYANYMEDICINESVIAWASTEWATER
ORHOUSEHOLDWASTE!SKYOURPHARMACISTHOWTO
THROWAWAYMEDICINESYOUNOLONGERUSE4HESE
MEASURESWILLHELPPROTECTTHEENVIRONMENT


6

Contents of the pack and other
information


What Sondate XL contains
Rare side effects (may affect up to 1 in 1,000
s 4HEACTIVESUBSTANCEISQUETIAPINE3ONDATE8,
people):
TABLETSCONTAINMG MG MG MG
s !COMBINATIONOFHIGHTEMPERATUREFEVER
ORMGOFQUETIAPINEASQUETIAPINEFUMARATE 
SWEATING STIFFMUSCLES FEELINGVERYDROWSYOR
s 4HEOTHERINGREDIENTSARE
FAINTADISORDERCALLEDhNEUROLEPTICMALIGNANT
4ABLETCOREHYPROMELLOSE CELLULOSE
SYNDROME
MICROCRYSTALLINE SODIUMCITRATEANHYDROUS
s 9ELLOWINGOFTHESKINANDEYESJAUNDICE
MAGNESIUMSTEARATE
s )NFLAMMATIONOFTHELIVERHEPATITIS
4ABLETCOATINGTITANIUMDIOXIDE%
s !LONG LASTINGANDPAINFULERECTIONPRIAPISM
s 3WELLINGOFBREASTSANDUNEXPECTEDPRODUCTION HYPROMELLOSE MACROGOL0%' POLYSORBATE
4HEMG MGANDMGTABLETSCONTAIN)RON
OFBREASTMILKGALACTORRHOEA
/XIDE9ELLOW% AND)RON/XIDE2ED% 4HE
s -ENSTRUALDISORDER
MGANDMGTABLETSALSOCONTAIN)RON/XIDE
s "LOODCLOTSINTHEVEINSESPECIALLYINTHELEGS
SYMPTOMSINCLUDESWELLING PAINANDREDNESS "LACK% 
INTHELEG WHICHMAYTRAVELTHROUGHBLOOD
What Sondate XL looks like and contents of the
VESSELSTOTHELUNGSCAUSINGCHESTPAINAND
pack
DIFFICULTYINBREATHING)FYOUNOTICEANYOFTHESE
!LLSTRENGTHSOF3ONDATE8,0ROLONGED RELEASE
SYMPTOMSSEEKMEDICALADVICEIMMEDIATELY
s 7ALKING TALKING EATINGOROTHERACTIVITIESWHILE 4ABLETSARECAPSULESHAPED FILM COATEDTABLETS
MGTABLETSAREBROWNCOLOURED DEBOSSEDh1
YOUAREASLEEP
vONONESIDE PLAINONTHEOTHERMGTABLETS
s "ODYTEMPERATUREDECREASEDHYPOTHERMIA
AREWHITECOLOURED DEBOSSEDh1vONONESIDE
s )NFLAMMATIONOFTHEPANCREAS
PLAINONTHEOTHERMGTABLETSAREYELLOW
s !CONDITIONCALLEDhMETABOLICSYNDROMEv
COLOURED DEBOSSEDh1vONONESIDE PLAINON
WHEREYOUMAYHAVEACOMBINATIONOFOR
MOREOFTHEFOLLOWINGANINCREASEINFATAROUND THEOTHERMGTABLETSARELIGHTYELLOWCOLOURED
YOURABDOMEN ADECREASEINhGOODCHOLESTEROLv DEBOSSEDh1vONONESIDE PLAINONTHEOTHER
ANDMGTABLETSAREWHITECOLOURED DEBOSSED
($, # ANINCREASEINATYPEOFFATINYOUR
BLOODCALLEDTRIGLYCERIDES HIGHBLOODPRESSURE h1vONONESIDE PLAINONTHEOTHER
0ACKSOF    XHOSPITALPACK 
ANDANINCREASEINYOURBLOODSUGAR
CALENDARPACK  ANDTABLETSARE
s #OMBINATIONOFFEVER FLU LIKESYMPTOMS SORE
REGISTEREDFORALLSTRENGTHS.OTALLPACKSIZESMAY
THROAT ORANYOTHERINFECTIONWITHVERYLOW
BEAVAILABLE
WHITEBLOODCELLCOUNT ACONDITIONCALLED
AGRANULOCYTOSIS
Marketing Authorisation Holder and Manufacturer
s "OWELOBSTRUCTION
4EVA5+,IMITED %ASTBOURNE ".!' 5NITED
s )NCREASEDBLOODCREATINEPHOSPHOKINASEA
+INGDOM
SUBSTANCEFROMTHEMUSCLES 
This leaflet was last revised in 11/2014.
Very rare side effects (may affect up to 1 in 10,000
0,   
people):
s 3EVERERASH BLISTERS ORREDPATCHESONTHESKIN
s !SEVEREALLERGICREACTIONCALLEDANAPHYLAXIS
WHICHMAYCAUSEDIFFICULTYINBREATHINGORSHOCK

 %

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.

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