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ESCITALOPRAM 15 MG FILM-COATED TABLETS

Active substance(s): ESCITALOPRAM / ESCITALOPRAM OXALATE

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231-30-86398-E LEA ESCITALOPRAM A/S FC TAB TUK
TEVA UK Ref:

PACKAGE LEAFLET: INFORMATION
FOR THE USER

ESCITALOPRAM
5 mg, 10 mg, 15 mg AND 20 mg
FILM-COATED TABLETS
Read all of this leaflet carefully
before you start taking this medicine
because it contains important
information for you.
s Keep this leaflet. You may need to
read it again.
s If you have any further questions,
ask your doctor or pharmacist.
s This medicine has been prescribed
for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same
as yours.
s If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
7HATISINTHISLEAFLET

1. What Escitalopram is and what it
is used for
2. What you need to know before you
take Escitalopram
3. How to take Escitalopram
4. Possible side effects
5. How to store Escitalopram
6. Contents of the pack and other
information

1

What Escitalopram is and
what it is used for

Escitalopram belongs to a group of
antidepressants called selective
serotonin reuptake inhibitors (SSRIs).
These medicines act on the
serotonin-system in the brain by
increasing the serotonin level.
Disturbances in the serotonin-system
are considered an important factor in
the development of depression and
related diseases.
Escitalopram Film-coated Tablets
contain escitalopram and are used to
treat depression (major depressive
episodes) and anxiety disorders
(such as panic disorder with or
without agoraphobia, social anxiety
disorder, generalised anxiety
disorder and obsessive-compulsive
disorder).

2

What you need to know
before you take Escitalopram

Do not take Escitalopram
s IFYOUAREALLERGICHYPERSENSITIVE
to escitalopram or any of the other
ingredients of this medicine (see
section 6 “Contents of the pack and
other information”)
s IFYOUTAKEOTHERMEDICINESTHAT
belong to a group called MAO
inhibitors, including selegiline
(used in the treatment of
Parkinson´s disease), moclobemide
(used in the treatment of
depression) and linezolid (an
antibiotic)
s IFYOUAREBORNWITHORHAVEHADAN
episode of abnormal heart rhythm
(seen at ECG; an examination to
evaluate how the heart is
functioning)
s IFYOUTAKEMEDICINESFORHEART
rhythm problems or that may affect
the heart’s rhythm (see section 2
“Other medicines and
Escitalopram”).
Warnings and precautions
Talk to your doctor or pharmacist
before taking Escitalopram:
s IFYOUHAVEEPILEPSY4REATMENTWITH
Escitalopram should be stopped if
seizures occur for the first time or if
there is an increase in the seizure
frequency (see also section 4
“Possible side effects")
s IFYOUSUFFERFROMIMPAIREDLIVEROR
kidney function. Your doctor may
need to adjust your dosage
s if you have diabetes. Treatment
with Escitalopram may alter
glycaemic control. Insulin and/or
oral hypoglycaemic dosage may
need to be adjusted
s IFYOUHAVEADECREASEDLEVELOF
sodium in the blood
s IFYOUHAVEATENDENCYTOEASILY
develop bleedings or bruises
s if you are receiving
electroconvulsive treatment
s IFYOUHAVECORONARYHEARTDISEASE
s IFYOUSUFFERORHAVESUFFEREDFROM
heart problems or have recently
had a heart attack
s if you have a low resting heart-rate
and/or you know that you may have
salt depletion as a result of
prolonged severe diarrhoea and
vomiting (being sick) or usage of
diuretics (water tablets)
s IFYOUEXPERIENCEAFASTORIRREGULAR
heartbeat, fainting, collapse or
dizziness on standing up, which
may indicate abnormal functioning
of the heart rate
s if you have or have previously had
eye problems, such as certain kinds
of glaucoma (increased pressure in
the eye).
Please note
Some patients with manic-depressive
illness may enter into a manic phase.
This is characterised by unusual and
rapidly changing ideas, inappropriate
happiness and excessive physical
activity. If you experience this,
contact your doctor.
Symptoms such as restlessness or
difficulty to sit or stand still can also
occur during the first weeks of the
treatment. Tell your doctor
immediately if you experience these
symptoms.
Thoughts of suicide and worsening
of your depression or anxiety
disorder
If you are depressed and/or have
anxiety disorders you can sometimes
have thoughts of harming or killing
yourself. These may be increased
when first starting antidepressants,
since these medicines all take time to
work, usually about two weeks but
sometimes longer.
You may be more likely to think like
this:
s IFYOUHAVEPREVIOUSLYHAD
thoughts about killing or harming
yourself
s IFYOUAREAyoung adult.
Information from clinical trials has
shown an increased risk of suicidal
behaviour in adults aged less than
25 years with psychiatric conditions
who were treated with an
antidepressant.
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 or have an anxiety
disorder and ask them to read this
leaflet. You might ask them to tell you
if they think your depression or
anxiety is getting worse, or if they are
worried about changes in your
behaviour.
Children and adolescents under 18
years of age
Escitalopram should normally not be
used for children and adolescents
under 18 years. Also, you should
know that patients under 18 have an
increased risk of side effects such as
suicide attempts, suicidal thoughts
and hostility (predominately
aggression, oppositional behaviour
and anger) when they take this class
of medicines. Despite this, your
doctor may prescribe Escitalopram
for patients under 18 because he/she
decides that this is in their best
interest. If your doctor has prescribed
Escitalopram for a patient under 18
and you want to discuss this, please
go back to your doctor. You should
inform your doctor if any symptoms
listed above develop or worsen when
patients under 18 are taking
Escitalopram. Also, the long term
safety effects concerning growth,
maturation and cognitive and
behavioural development of
Escitalopram in this age group have
not yet been demonstrated.
Other medicines and Escitalopram
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicine.

Version:

2

Tell your doctor if you are taking any
of the following medicines:
s hNON SELECTIVEMONOAMINEOXIDASE
inhibitors (MAOIs)”, containing
phenelzine, iproniazid,
isocarboxazid, nialamide and
tranylcypromine as active
ingredients. If you have taken any
of these medicines you will need to
wait 14 days before you start taking
Escitalopram. After stopping
Escitalopram you must allow 7
days before taking any of these
medicines
s hREVERSIBLE SELECTIVE-!/ !
inhibitors”, containing moclobemide
(used to treat depression)
s hIRREVERSIBLE-!/ "INHIBITORSv
containing selegiline (used to treat
Parkinson’s disease). These increase
the risk of side effects
s THEANTIBIOTICLINEZOLID
s LITHIUMUSEDINTHETREATMENTOF
manic-depressive disorder) and
tryptophan
s IMIPRAMINEANDDESIPRAMINEBOTH
used to treat depression)
s sumatriptan and similar medicines
(used to treat migraine) and
tramadol (used against severe
pain). These increase the risk of a
rare but potentially serious side
effect known as serotonin
syndrome
s CIMETIDINE OMEPRAZOLE
esomeprazole, lansoprazole (used
to treat stomach ulcers),
fluvoxamine (antidepressant) and
ticlopidine (used to reduce the risk
of stroke). These may cause
increased blood levels of
Escitalopram
s 3T*OHNS7ORThypericum
perforatum) – a herbal remedy used
for depression
s ACETYLSALICYLICACIDAND
non-steroidal anti-inflammatory
drugs (medicines used for pain relief
or to thin the blood, so called
anti-coagulants). These may
increase bleeding-tendency
s WARFARIN DIPYRIDAMOLE
acenocumarol and phenprocoumon
(medicines used to thin the blood,
so called anti-coagulants). Your
doctor will probably check the
coagulation time of your blood
when starting and discontinuing
Escitalopram in order to verify that
your dose of anti-coagulant is still
adequate
s mefloquin (used to treat malaria),
bupropion (used to treat depression)
and tramadol (used to treat severe
pain) due to a possible risk of a
lowered threshold for seizures
s NEUROLEPTICSANTIPSYCHOTICS
(medicines to treat schizophrenia,
psychosis) due to a possible risk of
a lowered threshold for seizures,
and antidepressants
s FLECAINIDE PROPAFENONEAND
metoprolol (used in cardiovascular
diseases) clomipramine and
nortriptyline (antidepressants) and
risperidone, thioridazine and
haloperidol (antipsychotics). The
dosage of Escitalopram may need
to be adjusted
s Medicines that decrease blood
levels of potassium or magnesium
as these conditions increase the
risk of life-threatening heart rhythm
disorder.
Do not take Escitalopram if you take
medicines for heart rhythm problems
or medicines that may affect the
heart’s rhythm, such as Class IA and
III antiarrhythmics, antipsychotics
(e.g. phenothiazine derivatives,
pimozide, haloperidol), tricyclic
antidepressants, certain antimicrobial
agents (e.g. sparfloxacin,
moxifloxacin, erythromycin IV,
pentamidine, anti-malarian treatment
particularly halofantrine), certain
antihistamines (astemizole,
mizolastine). If you have any further
questions about this you should
speak to your doctor.
Escitalopram with food, drink and
alcohol
Escitalopram can be taken with or
without food (see section 3 “How to
take Escitalopram”).
As with many medicines, combining
Escitalopram with alcohol is not
advisable, although Escitalopram is
not expected to interact with alcohol.
Pregnancy, breast-feeding and
fertility
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. Do not take Escitalopram if
you are pregnant or breast-feeding
unless you and your doctor have
discussed the risks and benefits
involved.
Citalopram, a medicine like
escitalopram, has been shown to
reduce the quality of sperm in animal
studies. Theoretically, this could affect
fertility, but impact on human fertility
has not been observed as yet.
If you take Escitalopram during the
last 3 months of your pregnancy you
should be aware that the following
effects may be seen in your newborn
baby: trouble with breathing, bluish
skin, fits, body temperature changes,
feeding difficulties, vomiting, low
blood sugar, stiff or floppy muscles,
vivid reflexes, tremor, jitteriness,
irritability, lethargy, constant crying,
sleepiness and sleeping difficulties. If
your newborn baby has any of these
symptoms, please contact your
doctor immediately.
Make sure your midwife and/or
doctor know you are on
%SCITALOPRAM7HENTAKENDURING
pregnancy, particularly in the last 3
months of pregnancy, medicines like
Escitalopram may increase the risk of
a serious condition in babies, called
persistent pulmonary hypertension of
the newborn (PPHN), making the
baby breathe faster and appear
bluish. These symptoms usually
begin during the first 24 hours after
the baby is born. If this happens to
your baby you should contact your
midwife and/or doctor immediately.
If used during pregnancy
Escitalopram should never be
stopped abruptly.
It is expected that Escitalopram will
be excreted into breast milk.
Ask your doctor or pharmacist for
advice before taking any medicine.
Driving and using machines
You are advised not to drive a car or
operate machinery until you know
how Escitalopram affects you.

3

How to take Escitalopram

Always take Escitalopram exactly as
your doctor has told you. You should
check with your doctor or pharmacist
if you are not sure.
Adults
Depression
The normally recommended dose of
Escitalopram is 10 mg taken as one
daily dose. The dose may be
increased by your doctor to a
maximum of 20 mg per day.
Panic disorder
The starting dose of Escitalopram is
5 mg as one daily dose for the first
week before increasing the dose to
10 mg per day. The dose may be
further increased by your doctor to a
maximum of 20 mg per day.
Social anxiety disorder
The normally recommended dose of
Escitalopram is 10 mg taken as one
daily dose. Your doctor can either
decrease your dose to 5 mg per day
or increase the dose to a maximum
of 20 mg per day, depending on how
you respond to the medicine.
Generalised anxiety disorder
The normally recommended dose of
Escitalopram is 10 mg taken as one
daily dose. The dose may be
increased by your doctor to a
maximum of 20 mg per day.

28 April 2014

TEVA UK Ref:

231-30-86398-E LEA ESCITALOPRAM A/S FC TAB TUK
Obsessive-compulsive disorder
The normally recommended dose of
Escitalopram is 10 mg taken as one
daily dose. The dose may be
increased by your doctor to a
maximum of 20 mg per day.
Older people (above 65 years of age)
The recommended starting dose of
Escitalopram is 5 mg taken as one
daily dose. The dose may be
increased by your doctor to 10 mg
per day.

Version:

2

28 April 2014

s SEXUALDISTURBANCESDELAYED
ejaculation, problems with erection,
decreased sexual drive and women
may experience difficulties
achieving orgasm)
s FATIGUE FEVER
s INCREASEDWEIGHT

Uncommon (may affect up to 1 in 100
people):
s NETTLERASHURTICARIA RASH ITCHING
(pruritus)
s GRINDINGONESTEETH AGITATION
nervousness, panic attack,
Use in children and adolescents
confusion state
(below 18 years of age)
s DISTURBEDSLEEP TASTEDISTURBANCE
Escitalopram should not normally be
fainting (syncope)
given to children and adolescents. For s ENLARGEDPUPILSMYDRIASIS VISUAL
further information please see section
disturbance, ringing in the ears
h7HATYOUNEEDTOKNOWBEFOREYOU
(tinnitus)
take Escitalopram”.
s LOSSOFHAIR
s VAGINALBLEEDINGATIRREGULAR
You can take Escitalopram with or
intervals, particularly between the
without food. Swallow the tablet with
expected menstrual periods or an
some water. Do not chew them, as
abnormally heavy and prolonged
the taste is bitter.
menstrual period at regular
intervals
Escitalopram 10 mg Film-coated
s DECREASEDWEIGHT
Tablets, Escitalopram 20 mg
s FASTHEARTBEAT
Film-coated Tablets
s SWELLINGOFTHEARMSORLEGS
If necessary, you can divide the
(oedema)
tablets by firstly placing the tablet on
s NOSEBLEEDS
a flat surface with the score facing
upwards. The tablets may then be
Rare (may affect up to 1 in 1,000
broken by pressing down on each
people):
end of the tablet, using both
s AGGRESSION DEPERSONALISATION
forefingers as shown in the drawing.
hallucination
s SLOWHEARTBEAT
Some patients have reported
(frequency can not be estimated from
the available data):
s THOUGHTSOFHARMINGYOURSELFOR
thoughts of killing yourself, see
also section “Take special care with
Escitalopram”
s DECREASEDLEVELSOFSODIUMINTHE
blood (the symptoms are feeling
sick and unwell with weak muscles
or confused)
Do not change the dose of your
s DIZZINESSWHENYOUSTANDUPDUETO
medicine without talking to your
low blood pressure (orthostatic
doctor first.
hypotension)
s ABNORMALLIVERFUNCTIONTEST
Continue to take Escitalopram for as
(increased amounts of liver
long as your doctor recommends. If
enzymes in the blood)
you stop your treatment too soon,
s MOVEMENTDISORDERSINVOLUNTARY
your symptoms may return. It is
movements of the muscles)
recommended that treatment should
s PAINFULERECTIONSPRIAPISM
be continued for at least 6 months
s BLEEDINGDISORDERSINCLUDINGSKIN
after you feel well again.
and mucous bleeding (ecchymosis)
and low level of blood platelets
If you take more Escitalopram than
(thrombocytopenia)
you should
If you take more than the prescribed s SUDDENSWELLINGOFSKINORMUCOSA
(angioedemas)
dose of Escitalopram, contact your
doctor or nearest hospital emergency s INCREASEINTHEAMOUNTOFURINE
excreted (inappropriate ADH
department immediately. Do this
secretion)
even if there are no signs of
s FLOWOFMILKINWOMENTHATARENOT
discomfort. Some of the signs of an
nursing
overdose could be dizziness, tremor,
s
MANIA
agitation, convulsion, coma, nausea,
s
ANINCREASEDRISKOFBONEFRACTURES
vomiting, change in heart rhythm,
has been observed in patients
decreased blood pressure and
taking this type of medicine
change in body fluid/salt balance.
s ALTERATIONOFTHEHEARTRHYTHM
Take the Escitalopram box/container
(called “prolongation of QT
with you when you go to the doctor
interval”, seen on ECG, electrical
or hospital.
activity of the heart).
If you forget to take Escitalopram
In
addition, a number of side effects
Do not take a double dose to make up
for forgotten doses. If you do forget to are known to occur with drugs that
take a dose and you remember before work in a similar way to escitalopram
(the active ingredient of Escitalopram
you go to bed, take it straight away.
Film-coated Tablets). These are:
Carry on as usual the next day. If you
only remember during the night, or the s MOTORRESTLESSNESSAKATHISIA
s ANOREXIA
next day, leave out the missed dose
and carry on as usual.
Reporting of side effects
If you get any side effects, talk to
If you stop taking Escitalopram
Do not stop taking Escitalopram until your doctor or pharmacist. This
YOURDOCTORTELLSYOUTODOSO7HEN includes any possible side effects not
listed in this leaflet.
you have completed your course of
treatment, it is generally advised that You can also report side effects
the dose of Escitalopram is gradually directly via the Yellow Card Scheme
at:
reduced over a number of weeks.
www.mhra.gov.uk/yellowcard
7HENYOUSTOPTAKING%SCITALOPRAM, "YREPORTINGSIDEEFFECTSYOUCANHELP
especially if it is abruptly, you may
provide more information on the
feel discontinuation symptoms. These safety of this medicine.
are common when treatment with
Escitalopram is stopped. The risk is
5 How to store Escitalopram
higher, when Escitalopram has been
used for a long time or in high doses Keep this medicine out of the sight
and reach of children.
or when the dose is reduced too
Store
below 30ºC. Store in the original
quickly. Most people find that the
symptoms are mild and go away on package (carton) in order to protect
from light and moisture.
their own within two weeks.
However, in some patients they may Do not use this medicine after the
be severe in intensity or they may be expiry date which is printed on the
blister and carton after the
prolonged (2-3 months or more). If
abbreviation EXP.
you get severe discontinuation
Do not throw away any medicines via
symptoms when you stop taking
wastewater or household waste. Ask
Escitalopram, please contact your
your pharmacist how to throw away
doctor. He or she may ask you to
medicines you no longer need. These
start taking your tablets again and
measures will help protect the
come off them more slowly.
environment.
Discontinuation symptoms include:
Feeling dizzy (unsteady or
6 Contents of the pack and
other information
off-balance), feelings like pins and
needles, burning sensations and (less
commonly) electric shock sensations, What Escitalopram contains
The
active substance is escitalopram.
including in the head, sleep
Each Escitalopram Film-coated Tablet
disturbances (vivid dreams,
contains 5 mg, 10 mg, 15 mg or
nightmares, inability to sleep),
20 mg escitalopram (as oxalate).
feeling anxious, headaches, feeling
s 4HEOTHERINGREDIENTSARE
sick (nausea), sweating (including
Core: microcrystalline cellulose,
night sweats), feeling restless or
agitated, tremor (shakiness), feeling colloidal silica anhydrous,
croscarmellose sodium, stearic acid
confused or disorientated, feeling
and magnesium stearate.
emotional or irritable, diarrhoea
Coating: hypromellose (E464),
(loose stools), visual disturbances,
macrogol 400, and titanium dioxide
fluttering or pounding heartbeat
(E171).
(palpitations).
Duration of treatment
It may take a couple of weeks before
you start to feel better. Continue to
take Escitalopram even if it takes
some time before you feel any
improvement in your condition.

If you have any further questions on
the use of this medicine, ask your
doctor or pharmacist.

4

Possible side effects

Like all medicines, this medicine can
cause side effects, although not
everybody gets them.

What Escitalopram looks like and
contents of the pack
Escitalopram 5 mg is a white,
film-coated tablet, marked “93” on
one side and “7414” on the other.
Escitalopram 10 mg is a white,
film-coated tablet, scored on one side
and marked “9” on one side and “3”
on the other. The other side of the
tablet is marked “7462”.The tablet can
be divided into equal halves.

The side effects usually disappear
after a few weeks of treatment.
Please be aware that many of the
Escitalopram 15 mg is a white,
effects may also be symptoms of
film-coated tablet, scored on one side
your illness and therefore will
and marked “S” on one side and “C”
improve when you start to get better.
on the other. The other side of the
tablet is marked “15”.
If you experience the following side
The score line is only to facilitate
effects you should contact your
doctor or go to the hospital straight breaking for ease of swallowing and
not to divide into equal doses.
away:
Uncommon (may affect up to 1 in 100 Escitalopram 20 mg is a white,
film-coated tablet, scored on one side
people):
and marked “9” on one side and “3”
s unusual bleeds, including
on the other. The other side of the
gastrointestinal bleeds.
tablet is marked “7463”.
Rare (may affect up to 1 in 1,000
The tablet can be divided into equal
people):
halves.
s IFYOUEXPERIENCESWELLINGOFSKIN
Escitalopram comes in blister packs
tongue, lips, or face, or have
difficulties breathing or swallowing of 7, 10, 14, 20, 28, 30, 49, 50, 56, 60,
90, 98, 100, 112, 120, 200 and 500
(allergic reaction), contact your
film-coated tablets and perforated
doctor or go to a hospital straight
unit dose blister 49x1, 50x1, 100x1
away
s IFYOUHAVEAHEADACHE INCREASED and 500x1 film-coated tablets.
PVC/PVdC–Aluminium blisters are in
heart rate, shivering, high fever,
the carton.
sweating, agitation, confusion,
nausea or diarrhoea, trembling and Not all pack sizes may be marketed.
abrupt contractions of muscles
Marketing Authorisation Holder and
these may be signs of a rare but
Manufacturer
potentially life-threatening
condition called serotonin
Marketing Authorisation Holder
syndrome. If you feel like this
4EVA5+,IMITED %ASTBOURNE ".
contact your doctor.
9AG, UK.
Some patients have reported
(frequency cannot be estimated from
the available data)
s FAST IRREGULARHEARTBEAT FAINTING
which could be symptoms of a
life-threatening condition known as
Torsades de Pointes
s DIFFICULTIESURINATING
s SEIZURESFITS SEEALSOSECTION
h7ARNINGSANDPRECAUTIONSv
s YELLOWINGOFTHESKINANDTHEWHITE
in the eyes are signs of liver
function impairment/hepatitis.

Manufacturer
Teva Operations Poland Sp. z.o.o., ul.
Mogilska 80, 31-546 Krakow,
POLAND.
This leaflet was last revised in
04/2014
PL 00289/1724
PL 00289/1725
PL 00289/1726
PL 00289/1727

In addition to above the following
side effects have been reported:
Very common (may affect more than 1
in 10 people):
s FEELINGSICKNAUSEA
s HEADACHE
Common (may affect up to 1 in 10
people):
s BLOCKEDORRUNNYNOSESINUSITIS
s DECREASEDORINCREASEDAPPETITE
s anxiety, restlessness, abnormal
dreams, difficulties falling asleep,
feeling sleepy, dizziness, yawning,
tremors, prickling of the skin
s DIARRHOEA CONSTIPATION VOMITING
dry mouth
s INCREASEDSWEATING
s PAININMUSCLEANDJOINTS
(arthralgia and myalgia)
86398-E

TEVA UK Ref:

231-30-91411-C LEA ESCITALOPRAM A/S TAB TUK

Version:

How to store Escitalopram

 #
X

PAGE 1: AFTER FOLDING FRONT FACE (INSIDE OF REEL AFTER FOLDING AND TACKING)

PACKAGE LEAFLET).&/2-!4)/.
&/24(%53%2

ESCITALOPRAM 5 mg, 10 mg, 15 mg
AND 20 mg FILM-COATED TABLETS
Read all of this leaflet carefully before you
start taking this medicine because it
contains important information for you.
s +EEPTHISLEAFLET9OUMAYNEEDTOREADIT
AGAIN
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOUR
DOCTORORPHARMACIST
s This medicine has been prescribed for you
ONLY$ONOTPASSITONTOOTHERS)TMAY
HARMTHEM EVENIFTHEIRSIGNSOFILLNESS
ARETHESAMEASYOURS
s If you get any side effects, talk to your
DOCTORORPHARMACIST4HISINCLUDESANY
possible side effects not listed in this
LEAFLET3EESECTION
7HATISINTHISLEAFLET

1. What Escitalopram is and what it is used
for
2. What you need to know before you take
Escitalopram
3. How to take Escitalopram
4. Possible side effects
5. How to store Escitalopram
6. Contents of the pack and other information

1

What Escitalopram is and what it is
used for

Escitalopram belongs to a group of
ANTIDEPRESSANTSCALLEDSELECTIVESEROTONIN
REUPTAKEINHIBITORS332)S 4HESEMEDICINES
ACTONTHESEROTONIN SYSTEMINTHEBRAINBY
INCREASINGTHESEROTONINLEVEL$ISTURBANCES
INTHESEROTONIN SYSTEMARECONSIDEREDAN
IMPORTANTFACTORINTHEDEVELOPMENTOF
DEPRESSIONANDRELATEDDISEASES
%SCITALOPRAM&ILM COATED4ABLETSCONTAIN
escitalopram and are used to treat
DEPRESSIONMAJORDEPRESSIVEEPISODES AND
ANXIETYDISORDERSSUCHASPANICDISORDER
WITHORWITHOUTAGORAPHOBIA SOCIALANXIETY
disorder, generalised ANXIETYDISORDERAND
OBSESSIVE COMPULSIVEDISORDER 

2

What you need to know before you
take Escitalopram

Do not take Escitalopram
s IFYOUAREALLERGICHYPERSENSITIVE TO
escitalopram or any of the other
ingredients of this medicine (see section 6
h#ONTENTSOFTHEPACKANDOTHER
information”)
s IFYOUTAKEOTHERMEDICINESTHATBELONGTO
a group called MAO inhibitors, including
selegiline (used in the treatment of
Parkinson´s disease), moclobemide (used
in the treatment of depression) and
linezolid (an antibiotic)
s IFYOUAREBORNWITHORHAVEHADAN
episode of abnormal heart rhythm (seen
AT%#'ANEXAMINATIONTOEVALUATEHOW
the heart is functioning)
s IFYOUTAKEMEDICINESFORHEARTRHYTHM
problems or that may affect the heart’s
RHYTHMSEESECTIONh/THERMEDICINES
AND%SCITALOPRAMv 
Warnings and precautions
Talk to your doctor or pharmacist before
taking Escitalopram:
s IFYOUHAVEEPILEPSY4REATMENTWITH
Escitalopram should be stopped if
seizures occur for the first time or if there
is an increase in the seizure frequency
SEEALSOSECTIONh0OSSIBLESIDEEFFECTS
s IFYOUSUFFERFROMIMPAIREDLIVERORKIDNEY
FUNCTION9OURDOCTORMAYNEEDTOADJUST
your dosage
s IFYOUHAVEDIABETES4REATMENTWITH
%SCITALOPRAMMAYALTERGLYCAEMICCONTROL
)NSULINANDORORALHYPOGLYCAEMICDOSAGE
may need to be adjusted
s IFYOUHAVEADECREASEDLEVELOFSODIUMIN
the blood

s IFYOUHAVEATENDENCYTOEASILYDEVELOP
bleedings or bruises
s IFYOUARERECEIVINGELECTROCONVULSIVE
treatment
s IFYOUHAVECORONARYHEARTDISEASE
s IFYOUSUFFERORHAVESUFFEREDFROMHEART
PROBLEMSORHAVERECENTLYHADAHEART
attack
s IFYOUHAVEALOWRESTINGHEART RATEANDOR
YOUKNOWTHATYOUMAYHAVESALT
DEPLETIONASARESULTOFPROLONGEDSEVERE
DIARRHOEAANDVOMITINGBEINGSICK OR
usage of diuretics (water tablets)
s IFYOUEXPERIENCEAFASTORIRREGULAR
heartbeat, fainting, collapse or dizziness
on standing up, which may indicate
abnormal functioning of the heart rate
s IFYOUHAVEORHAVEPREVIOUSLYHADEYE
problems, such as certain kinds of
GLAUCOMAINCREASEDPRESSUREINTHEEYE 
Please note
3OMEPATIENTSWITHMANIC DEPRESSIVEILLNESS
MAYENTERINTOAMANICPHASE4HISIS
characterised by unusual and rapidly
changing ideas, inappropriate happiness
ANDEXCESSIVEPHYSICALACTIVITY)FYOU
EXPERIENCETHIS CONTACTYOURDOCTOR
3YMPTOMSSUCHASRESTLESSNESSORDIFFICULTY
to sit or stand still can also occur during the
FIRSTWEEKSOFTHETREATMENT4ELLYOURDOCTOR
IMMEDIATELYIFYOUEXPERIENCETHESE
SYMPTOMS
Thoughts of suicide and worsening of your
depression or anxiety disorder
)FYOUAREDEPRESSEDANDORHAVEANXIETY
DISORDERSYOUCANSOMETIMESHAVETHOUGHTS
OFHARMINGORKILLINGYOURSELF4HESEMAYBE
increased when first starting
antidepressants, since these medicines all
take time to work, usually about two weeks
BUTSOMETIMESLONGER
You may be more likely to think like this:
s IFYOUHAVEPREVIOUSLYHADTHOUGHTSABOUT
killing or harming yourself
s IFYOUAREAyoung adult)NFORMATIONFROM
clinical trials has shown an increased risk
OFSUICIDALBEHAVIOURINADULTSAGEDLESS
than 25 years with psychiatric conditions
WHOWERETREATEDWITHANANTIDEPRESSANT
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 or have
ANANXIETYDISORDERANDASKTHEMTOREAD
THISLEAFLET9OUMIGHTASKTHEMTOTELLYOUIF
THEYTHINKYOURDEPRESSIONORANXIETYIS
getting worse, or if they are worried about
CHANGESINYOURBEHAVIOUR
Children and adolescents under 18 years of
age
Escitalopram should normally not be used
FORCHILDRENANDADOLESCENTSUNDERYEARS
Also, you should know that patients under
HAVEANINCREASEDRISKOFSIDEEFFECTS
such as suicide attempts, suicidal thoughts
and hostility (predominately aggression,
OPPOSITIONALBEHAVIOURANDANGER WHEN
THEYTAKETHISCLASSOFMEDICINES$ESPITE
this, your doctor may prescribe
Escitalopram for patients under 18 because
HESHEDECIDESTHATTHISISINTHEIRBEST
INTEREST)FYOURDOCTORHASPRESCRIBED
Escitalopram for a patient under 18 and you
want to discuss this, please go back to your
DOCTOR9OUSHOULDINFORMYOURDOCTORIFANY
SYMPTOMSLISTEDABOVEDEVELOPORWORSEN
when patients under 18 are taking
%SCITALOPRAM!LSO THELONGTERMSAFETY
effects concerning growth, maturation and
COGNITIVEANDBEHAVIOURALDEVELOPMENTOF
%SCITALOPRAMINTHISAGEGROUPHAVENOTYET
BEENDEMONSTRATED
Other medicines and Escitalopram
Tell your doctor or pharmacist if you are
TAKING HAVERECENTLYTAKENORMIGHTTAKE
ANYOTHERMEDICINE
0EEL(ERE4O/PEN

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

s SEXUALDISTURBANCESDELAYEDEJACULATION $ONOTTHROWAWAYANYMEDICINESVIA
PROBLEMSWITHERECTION DECREASEDSEXUAL WASTEWATERORHOUSEHOLDWASTE!SKYOUR
DRIVEANDWOMENMAYEXPERIENCE
pharmacist how to throw away medicines
DIFFICULTIESACHIEVINGORGASM
YOUNOLONGERNEED4HESEMEASURESWILL
s FATIGUE FEVER
HELPPROTECTTHEENVIRONMENT
s INCREASEDWEIGHT
Contents of the pack and other
Uncommon (may affect up to 1 in 100 people): 6 information
s NETTLERASHURTICARIA RASH ITCHING

What
Escitalopram contains
(pruritus)
s GRINDINGONESTEETH AGITATION
4HEACTIVESUBSTANCEISESCITALOPRAM%ACH
Escitalopram
FILM COATED4ABLET contains
NERVOUSNESS PANICATTACK CONFUSIONSTATE
s DISTURBEDSLEEP TASTEDISTURBANCE
5 mg, 10 mg, 15 mg or 20 mg escitalopram
ASOXALATE 
fainting (syncope)
s 4HEOTHERINGREDIENTSARE
s ENLARGEDPUPILSMYDRIASIS VISUAL
Core: microcrystalline cellulose, colloidal
disturbance, ringing in the ears (tinnitus)
silica anhydrous, croscarmellose sodium,
s LOSSOFHAIR
s VAGINALBLEEDINGATIRREGULARINTERVALS STEARICACIDANDMAGNESIUMSTEARATE
PARTICULARLYBETWEENTHEEXPECTED
Coating: hypromellose (E464), macrogol
MENSTRUALPERIODSORANABNORMALLYHEAVY  ANDTITANIUMDIOXIDE% 
What Escitalopram looks like and contents
and prolonged menstrual period at
of the pack
REGULARINTERVALS
%SCITALOPRAMMGISAWHITE FILM COATED
s DECREASEDWEIGHT
TABLET MARKEDhvONONESIDEANDhv
s FASTHEARTBEAT
ONTHEOTHER
s SWELLINGOFTHEARMSORLEGSOEDEMA
s NOSEBLEEDS
%SCITALOPRAMMGISAWHITE FILM COATED
TABLET SCOREDONONESIDEANDMARKEDhv
Rare (may affect up to 1 in 1,000 people):
s AGGRESSION DEPERSONALISATION
ONONESIDEANDhvONTHEOTHER4HEOTHER
SIDEOFTHETABLETISMARKEDhv4HETABLET
hallucination
CANBEDIVIDEDINTOEQUALHALVES
s SLOWHEARTBEAT
Some patients have reported (frequency can %SCITALOPRAMMGISAWHITE FILM COATED
TABLET SCOREDONONESIDEANDMARKEDh3v
NOTBEESTIMATEDFROMTHEAVAILABLEDATA 
s THOUGHTSOFHARMINGYOURSELFORTHOUGHTS ONONESIDEANDh#vONTHEOTHER4HEOTHER
OFKILLINGYOURSELF SEEALSOSECTIONh4AKE SIDEOFTHETABLETISMARKEDhv
The score line is only to facilitate breaking
special care with Escitalopram”
s DECREASEDLEVELSOFSODIUMINTHEBLOOD FOREASEOFSWALLOWINGANDNOTTODIVIDEINTO
(the symptoms are feeling sick and unwell EQUALDOSES
with weak muscles or confused)
%SCITALOPRAMMGISAWHITE FILM COATED
s DIZZINESSWHENYOUSTANDUPDUETOLOW TABLET SCOREDONONESIDEANDMARKEDhv
blood pressure (orthostatic hypotension)
ONONESIDEANDhvONTHEOTHER4HEOTHER
s ABNORMALLIVERFUNCTIONTESTINCREASED SIDEOFTHETABLETISMARKEDhv
AMOUNTSOFLIVERENZYMESINTHEBLOOD
4HETABLETCANBEDIVIDEDINTOEQUALHALVES
s MOVEMENTDISORDERSINVOLUNTARY

Escitalopram comes in blister packs of 7, 10,
MOVEMENTSOFTHEMUSCLES
14,           
s PAINFULERECTIONSPRIAPISM
 ANDFILM COATEDTABLETSAND
bleeding
disorders
including
skin
and
s
PERFORATEDUNITDOSEBLISTERX X
mucous bleeding (ecchymosis) and low
LEVELOFBLOODPLATELETSTHROMBOCYTOPENIA XANDXFILM COATEDTABLETS
s SUDDENSWELLINGOFSKINORMUCOSA
06#06D#n!LUMINIUMBLISTERSAREINTHE
CARTON
(angioedemas)
s INCREASEINTHEAMOUNTOFURINEEXCRETED .OTALLPACKSIZESMAYBEMARKETED
INAPPROPRIATE!$(SECRETION
Marketing Authorisation Holder and
s flow of milk in women that are not nursing Manufacturer
s MANIA
4EVA5+,IMITED %ASTBOURNE ".!'
s ANINCREASEDRISKOFBONEFRACTURESHAS
5+
BEENOBSERVEDINPATIENTSTAKINGTHISTYPE This leaflet was last revised in 04/2014
of medicine
0,
s ALTERATIONOFTHEHEARTRHYTHMCALLED
0,
hPROLONGATIONOF14INTERVALv SEENON
0,
%#' ELECTRICALACTIVITYOFTHEHEART 
0,
In addition, a number of side effects are
known to occur with drugs that work in a
similar way to escitalopram (the active
ingredient of Escitalopram Film-coated
Tablets). These are:
s MOTORRESTLESSNESSAKATHISIA
s ANOREXIA
Reporting of side effects
If you get any side effects, talk to your
DOCTORORPHARMACIST4HISINCLUDESANY
POSSIBLESIDEEFFECTSNOTLISTEDINTHISLEAFLET
9OUCANALSOREPORTSIDEEFFECTSDIRECTLYVIA
THE9ELLOW#ARD3CHEMEAT
WWWMHRAGOVUKYELLOWCARD
"YREPORTINGSIDEEFFECTSYOUCANHELP
PROVIDEMOREINFORMATIONONTHESAFETYOF
THISMEDICINE

5

28 April 2014

FOLD
LINE.

PAGE 4: AFTER FOLDING REAR FACE (OUTSIDE OF REEL AFTER FOLDING AND TACKING)

Keep this medicine out of the sight and
reach of children.
3TOREBELOWŽ#3TOREINTHEORIGINAL
package (carton) in order to protect from
LIGHTANDMOISTURE
$ONOTUSETHISMEDICINEAFTERTHEEXPIRY
date which is printed on the blister and
CARTONAFTERTHEABBREVIATION%80

2

TEVA UK Ref:

231-30-91411-C LEA ESCITALOPRAM A/S TAB TUK

Version:

PAGE 2: LEFT HAND INSIDE FACE AFTER FOLDING AND TACKING

Tell your doctor if you are taking any of the
following medicines:
s hNON SELECTIVEMONOAMINEOXIDASE
inhibitors (MAOIs)”, containing phenelzine,
IPRONIAZID ISOCARBOXAZID NIALAMIDEAND
TRANYLCYPROMINEASACTIVEINGREDIENTS)F
YOUHAVETAKENANYOFTHESEMEDICINES
you will need to wait 14 days before you
STARTTAKING%SCITALOPRAM!FTERSTOPPING
Escitalopram you must allow 7 days
before taking any of these medicines
s hREVERSIBLE SELECTIVE-!/ !INHIBITORSv
containing moclobemide (used to treat
depression)
s hIRREVERSIBLE-!/ "INHIBITORSv CONTAINING
SELEGILINEUSEDTOTREAT0ARKINSONSDISEASE 
These increase the risk of side effects
s THEANTIBIOTICLINEZOLID
s LITHIUMUSEDINTHETREATMENTOFMANIC
DEPRESSIVEDISORDER ANDTRYPTOPHAN
s IMIPRAMINEANDDESIPRAMINEBOTHUSED
to treat depression)
s sumatriptan and similar medicines (used
to treat migraine) and tramadol (used
AGAINSTSEVEREPAIN 4HESEINCREASETHE
risk of a rare but potentially serious side
effect known as serotonin syndrome
s CIMETIDINE OMEPRAZOLE ESOMEPRAZOLE
lansoprazole (used to treat stomach
ULCERS FLUVOXAMINEANTIDEPRESSANT AND
ticlopidine (used to reduce the risk of
STROKE 4HESEMAYCAUSEINCREASEDBLOOD
LEVELSOF%SCITALOPRAM
s 3T*OHNS7ORThypericum perforatum A
herbal remedy used for depression
s ACETYLSALICYLICACIDANDNON STEROIDAL
ANTI INFLAMMATORYDRUGSMEDICINESUSED
for pain relief or to thin the blood, so called
ANTI COAGULANTS  These may increase
BLEEDING TENDENCY
s WARFARIN DIPYRIDAMOLE ACENOCUMAROLAND
phenprocoumon (medicines used to thin
THEBLOOD SOCALLEDANTI COAGULANTS 9OUR
doctor will probably check the coagulation
time of your blood when starting and
discontinuing Escitalopram in order to
VERIFYTHATYOURDOSEOFANTI COAGULANTIS
still adequate
s MEFLOQUINUSEDTOTREATMALARIA
bupropion (used to treat depression) and
TRAMADOLUSEDTOTREATSEVEREPAIN DUE
to a possible risk of a lowered threshold
for seizures
s NEUROLEPTICSANTIPSYCHOTICSMEDICINESTO
treat schizophrenia, psychosis) due to a
possible risk of a lowered threshold for
seizures, and antidepressants
s flecainide, propafenone and metoprolol
USEDINCARDIOVASCULARDISEASES
clomipramine and nortriptyline
(antidepressants) and risperidone,
thioridazine and haloperidol
ANTIPSYCHOTICS 4HEDOSAGEOF
Escitalopram may need to be adjusted
s -EDICINESTHATDECREASEBLOODLEVELSOF
potassium or magnesium as these
conditions increase the risk of
LIFE THREATENINGHEARTRHYTHMDISORDER
Do not take Escitalopram if you take
medicines for heart rhythm problems or
medicines that may affect the heart’s
rhythm, such as Class IA and III
ANTIARRHYTHMICS ANTIPSYCHOTICSEG
PHENOTHIAZINEDERIVATIVES PIMOZIDE
haloperidol), tricyclic antidepressants,
CERTAINANTIMICROBIALAGENTSEG
SPARFLOXACIN MOXIFLOXACIN ERYTHROMYCINIV,
PENTAMIDINE ANTI MALARIANTREATMENT
particularly halofantrine), certain
ANTIHISTAMINESASTEMIZOLE MIZOLASTINE )F
YOUHAVEANYFURTHERQUESTIONSABOUTTHIS
YOUSHOULDSPEAKTOYOURDOCTOR
Escitalopram with food, drink and alcohol
Escitalopram can be taken with or without
FOODSEESECTIONh(OWTOTAKE
%SCITALOPRAMv 

As with many medicines, combining
%SCITALOPRAMWITHALCOHOLISNOTADVISABLE
ALTHOUGH%SCITALOPRAMISNOTEXPECTEDTO
INTERACTWITHALCOHOL
Pregnancy, breast-feeding and fertility
)FYOUAREPREGNANTORBREAST FEEDING THINK
YOUMAYBEPREGNANTORAREPLANNINGTOHAVE
ABABY ASKYOURDOCTORFORADVICEBEFORE
TAKINGTHISMEDICINE$ONOTTAKE
Escitalopram if you are pregnant or
BREAST FEEDINGUNLESSYOUANDYOURDOCTOR
HAVEDISCUSSEDTHERISKSANDBENEFITS
INVOLVED
Citalopram, a medicine like escitalopram,
has been shown to reduce the quality of
SPERMINANIMALSTUDIES4HEORETICALLY THIS
could affect fertility, but impact on human
FERTILITYHASNOTBEENOBSERVEDASYET
If you take Escitalopram during the last 3
months of your pregnancy you should be
aware that the following effects may be
seen in your newborn baby: trouble with
breathing, bluish skin, fits, body
temperature changes, feeding difficulties,
VOMITING LOWBLOODSUGAR STIFF or floppy
MUSCLES VIVIDREFLEXES TREMOR JITTERINESS
irritability, lethargy, constant crying,
SLEEPINESSANDSLEEPINGDIFFICULTIES)FYOUR
newborn baby has any of these symptoms,
PLEASECONTACTYOURDOCTORIMMEDIATELY
-AKESUREYOURMIDWIFEANDORDOCTORKNOW
YOUAREON%SCITALOPRAM7HENTAKENDURING
pregnancy, particularly in the last 3 months
of pregnancy, medicines like Escitalopram
may increase the risk of a serious condition
in babies, called persistent pulmonary
HYPERTENSIONOFTHENEWBORN00(. MAKING
THEBABYBREATHEFASTERANDAPPEARBLUISH
These symptoms usually begin during the
FIRSTHOURSAFTERTHEBABYISBORN)FTHIS
happens to your baby you should contact
YOURMIDWIFEANDORDOCTORIMMEDIATELY
If used during pregnancy Escitalopram
SHOULDNEVERBESTOPPEDABRUPTLY
)TISEXPECTEDTHAT%SCITALOPRAMWILLBE
EXCRETEDINTOBREASTMILK
!SKYOURDOCTORORPHARMACISTFORADVICE
BEFORETAKINGANYMEDICINE
Driving and using machines
9OUAREADVISEDNOTTODRIVEACAROROPERATE
machinery until you know how Escitalopram
AFFECTSYOU

3

How to take Escitalopram

!LWAYSTAKE%SCITALOPRAMEXACTLYASYOUR
DOCTORHASTOLDYOU9OUSHOULDCHECKWITH
your doctor or pharmacist if you are not
SURE
Adults
Depression
The normally recommended dose of
Escitalopram is 10 mg taken as one daily
DOSE4HEDOSEMAYBEINCREASEDBYYOUR
DOCTORTOAMAXIMUMOFMGPERDAY
Panic disorder
The starting dose of Escitalopram is 5 mg as
one daily dose for the first week before
INCREASINGTHEDOSETOMGPERDAY4HE
dose may be further increased by your
DOCTORTOAMAXIMUMOFMGPERDAY
Social anxiety disorder
The normally recommended dose of
Escitalopram is 10 mg taken as one daily
DOSE9OURDOCTORCANEITHERDECREASEYOUR
dose to 5 mg per day or increase the dose to
AMAXIMUMOFMGPERDAY DEPENDINGON
HOWYOURESPONDTOTHEMEDICINE
Generalised anxiety disorder
The normally recommended dose of
Escitalopram is 10 mg taken as one daily
DOSE4HEDOSEMAYBEINCREASEDBYYOUR
DOCTORTOAMAXIMUMOFMGPERDAY

2

28 April 2014

FOLD
LINE.

PAGE 3: RIGHT HAND INSIDE FACE AFTER FOLDING AND TACKING

Obsessive-compulsive disorder
The normally recommended dose of
Escitalopram is 10 mg taken as one daily
DOSE4HEDOSEMAYBEINCREASEDBYYOUR
DOCTORTOAMAXIMUMOFMGPERDAY
Older people (above 65 years of age)
The recommended starting dose of
Escitalopram is 5 mg taken as one daily
DOSE4HEDOSEMAYBEINCREASEDBYYOUR
DOCTORTOMGPERDAY
Use in children and adolescents (below
18 years of age)
%SCITALOPRAMSHOULDNOTNORMALLYBEGIVEN
TOCHILDRENANDADOLESCENTS&ORFURTHER
INFORMATIONPLEASESEESECTIONh7HATYOU
NEEDTOKNOWBEFOREYOUTAKE%SCITALOPRAMv
9OUCANTAKE%SCITALOPRAM with or without
FOOD3WALLOWTHETABLETWITHSOMEWATER
$ONOTCHEWTHEM ASTHETASTEISBITTER
Escitalopram 10 mg Film-coated Tablets,
Escitalopram 20 mg Film-coated Tablets
)FNECESSARY YOUCANDIVIDETHETABLETSBY
firstly placing the tablet on a flat surface
WITHTHESCOREFACINGUPWARDS4HETABLETS
may then be broken by pressing down on
each end of the tablet, using both
FOREFINGERSASSHOWNINTHEDRAWING

Duration of treatment
It may take a couple of weeks before you
STARTTOFEELBETTER#ONTINUETOTAKE
EscitalopramEVENIFITTAKESSOMETIME
beforeYOUFEELANYIMPROVEMENTINYOUR
CONDITION
$ONOTCHANGETHEDOSEOFYOURMEDICINE
WITHOUTTALKINGTOYOURDOCTORFIRST
Continue to take Escitalopram for as long as
YOURDOCTORRECOMMENDS)FYOUSTOPYOUR
treatment too soon, your symptoms may
RETURN)TISRECOMMENDEDTHATTREATMENT
should be continued for at least 6 months
AFTERYOUFEELWELLAGAIN
If you take more Escitalopram than you
should
If you take more than the prescribed dose of
Escitalopram, contact your doctor or nearest
hospital emergency department
IMMEDIATELY$OTHISEVENIFTHEREARENO
SIGNSOFDISCOMFORT3OMEOFTHESIGNSOFAN
OVERDOSECOULDBEDIZZINESS TREMOR
AGITATION CONVULSION COMA NAUSEA
VOMITING CHANGEINHEARTRHYTHM DECREASED
BLOODPRESSUREANDCHANGEINBODYFLUIDSALT
BALANCE4AKETHE%SCITALOPRAMBOXCONTAINER
with you when you go to the doctor or
hospital
If you forget to take Escitalopram
$ONOTTAKEADOUBLEDOSETOMAKEUPFOR
FORGOTTENDOSES)FYOUDOFORGETTOTAKEA
dose and you remember before you go to
bed, take it STRAIGHTAWAY#ARRYONASUSUAL
THENEXTDAY)FYOU only remember during
THENIGHT ORTHENEXTDAY LEAVEOUTTHE
MISSEDDOSEANDCARRYONASUSUAL
If you stop taking Escitalopram
$ONOTSTOPTAKING%SCITALOPRAMuntil your
DOCTORTELLSYOUTODOSO7HENYOUHAVE
completed your course of treatment, it is
GENERALLYADVISEDTHATTHEDOSEOF
EscitalopramISGRADUALLYREDUCEDOVERA
NUMBEROFWEEKS
7HENYOUSTOPTAKING%SCITALOPRAM,
especially if it is abruptly, you may feel
DISCONTINUATIONSYMPTOMS4HESEARE
common when treatment with Escitalopram
ISSTOPPED4HERISKISHIGHER WHEN
Escitalopram has been used for a long time
or in high doses or when the dose is
REDUCEDTOOQUICKLY-OSTPEOPLEFINDTHAT

the symptoms are mild and go away on
THEIROWNWITHINTWOWEEKS(OWEVER IN
SOMEPATIENTSTHEYMAYBESEVEREIN
intensity or they may be prolonged
 MONTHSORMORE )FYOUGETSEVERE
discontinuation symptoms when you stop
taking Escitalopram, please contact your
DOCTOR(EORSHEMAYASKYOUTOSTARTTAKING
your tablets again and come off them more
SLOWLY
$ISCONTINUATIONSYMPTOMSINCLUDE&EELING
DIZZYUNSTEADYOROFF BALANCE FEELINGSLIKE
pins and needles, burning sensations and
(less commonly) electric shock sensations,
including in the head, sleep disturbances
VIVIDDREAMS NIGHTMARES INABILITYTO
SLEEP FEELINGANXIOUS HEADACHES FEELING
sick (nausea), sweating (including night
sweats), feeling restless or agitated, tremor
(shakiness), feeling confused or
disorientated, feeling emotional or irritable,
DIARRHOEALOOSESTOOLS VISUALDISTURBANCES
fluttering or pounding heartbeat
PALPITATIONS 
)FYOUHAVEANYFURTHERQUESTIONSONTHEUSEof
THISMEDICINE ASKYOURDOCTORORPHARMACIST

4

Possible side effects

Like all medicines, this medicine can cause
SIDEEFFECTS ALTHOUGHNOTEVERYBODYGETS
THEM
The side effects usually disappear after a
FEWWEEKSOFTREATMENT0LEASEBEAWARE
that many of the effects may also be
symptoms of your illness and therefore will
IMPROVEWHENYOUSTARTTOGETBETTER
If you experience the following side effects
you should contact your doctor or go to the
hospital straight away:
Uncommon (may affect up to 1 in 100 people):
s UNUSUALBLEEDS INCLUDINGGASTROINTESTINAL
BLEEDS
Rare (may affect up to 1 in 1,000 people):
s IFYOUEXPERIENCESWELLINGOFSKIN TONGUE
LIPS ORFACE ORHAVEDIFFICULTIESBREATHINGOR
swallowing (allergic reaction), contact your
doctor or go to a hospital straight away
s IFYOUHAVEAHEADACHE INCREASEDHEART
RATE SHIVERING HIGHFEVER SWEATING
agitation, confusion, nausea or diarrhoea,
trembling and abrupt contractions of
muscles these may be signs of a rare but
POTENTIALLYLIFE THREATENINGCONDITION
CALLEDSEROTONINSYNDROME)FYOUFEELLIKE
THISCONTACTYOURDOCTOR
Some patients have reported (frequency
CANNOTBEESTIMATEDFROMTHEAVAILABLEDATA
s FAST IRREGULARHEARTBEAT FAINTINGWHICH
COULDBESYMPTOMSOFALIFE THREATENING
condition known as Torsades de Pointes
s DIFFICULTIESURINATING
s SEIZURESFITS SEEALSOSECTIONh7ARNINGS
and precautions”
s YELLOWINGOFTHESKINANDTHEWHITEINTHE
EYESARESIGNSOFLIVERFUNCTIONIMPAIRMENT
HEPATITIS
In addition to above the following side
effects have been reported:
Very common (may affect more than 1 in 10
people):
s FEELINGSICKNAUSEA
s HEADACHE
Common (may affect up to 1 in 10 people):
s BLOCKEDORRUNNYNOSESINUSITIS
s DECREASEDORINCREASEDAPPETITE
s ANXIETY RESTLESSNESS ABNORMALDREAMS
difficulties falling asleep, feeling sleepy,
dizziness, yawning, tremors, prickling of
the skin
s DIARRHOEA CONSTIPATION VOMITING DRY
mouth
s INCREASEDSWEATING
s PAININMUSCLEANDJOINTSARTHRALGIAAND
myalgia)

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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