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ESCITALOPRAM 15 MG FILM-COATED TABLETS

Active substance(s): ESCITALOPRAM / ESCITALOPRAM OXALATE

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TEVA UK Ref:

231-30-86398-G LEA ESCITALOPRAM A/S FC TAB TUK Dimensions:
Length:
Width:

Version:

1

Colours Used:

26 April 2016

Template

845 mm
148 mm

PANTONE® GREEN C
BLACK

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.
• Keep this leaflet. You may need to
read it again.
• If you have any further questions,
ask your doctor or pharmacist.
• 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.
• 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.
What is in this leaflet:

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
• if you are allergic to escitalopram
or any of the other ingredients of
this medicine (listed in section 6)
• if you take other medicines that
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)
• if you are born with or have had an
episode of abnormal heart rhythm
(seen at ECG; an examination to
evaluate how the heart is
functioning)
• if you take medicines for heart
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:
• if you have epilepsy. Treatment
with 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")
• if you suffer from impaired liver or
kidney function. Your doctor may
need to adjust your dosage
• if you have diabetes. Treatment
with Escitalopram may alter
glycaemic control. Insulin and/or
oral hypoglycaemic dosage may
need to be adjusted
• if you have a decreased level of
sodium in the blood
• if you have a tendency to easily
develop bleedings or bruises
• if you are receiving
electroconvulsive treatment
• if you have coronary heart disease
• if you suffer or have suffered from
heart problems or have recently
had a heart attack
• 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)
• if you experience a fast or irregular
heartbeat, fainting, collapse or
dizziness on standing up, which
may indicate abnormal functioning
of the heart rate
• 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:
• if you have previously had
thoughts about killing or harming
yourself
• if you are a young 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.

Tell your doctor if you are taking any
of the following medicines:
• “non-selective monoamine
oxidase 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
• “reversible, selective MAO-A
inhibitors”, containing
moclobemide (used to treat
depression)
• “irreversible MAO-B inhibitors”,
containing selegiline (used to treat
Parkinson’s disease). These
increase the risk of side effects
• the antibiotic linezolid
• lithium (used in the treatment of
manic-depressive disorder) and
tryptophan
• imipramine and desipramine (both
used to treat depression)
• 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
• 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
• St. John's Wort (hypericum
perforatum) - a herbal remedy
used for depression
• acetylsalicylic acid and
non-steroidal anti-inflammatory
drugs (medicines used for pain
relief or to thin the blood, so called
anti-coagulants). These may
increase bleeding-tendency
• 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
• 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
• neuroleptics/antipsychotics
(medicines to treat schizophrenia,
psychosis) due to a possible risk of
a lowered threshold for seizures,
and antidepressants
• flecainide, propafenone and
metoprolol (used in cardiovascular
diseases) clomipramine and
nortriptyline (antidepressants) and
risperidone, thioridazine and
haloperidol (antipsychotics). The
dosage of Escitalopram may need
to be adjusted
• 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
Escitalopram. When taken during
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

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.

Always take Escitalopram exactly as
your doctor has told you. You should
check with your doctor or pharmacist
if you are not sure.

Other medicines and Escitalopram
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicine.

Generalised anxiety disorder
The normally recommended dose of
Escitalopram is 10 mg taken as one
daily dose. The dose may be

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.

increased by your doctor to a
maximum of 20 mg per day.
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.

• anxiety, restlessness, abnormal
dreams, difficulties falling asleep,
feeling sleepy, dizziness, yawning,
tremors, prickling of the skin
• diarrhoea, constipation, vomiting,
dry mouth
• increased sweating
• pain in muscle and joints
(arthralgia and myalgia)
• sexual disturbances (delayed
ejaculation, problems with
erection, decreased sexual drive
and women may experience
difficulties achieving orgasm)
• fatigue, fever
• increased weight.

Use in children and adolescents
(below 18 years of age)
Uncommon (may affect up to 1 in 100
Escitalopram should not normally be people):
given to children and adolescents.
• nettle rash (urticaria), rash, itching
For further information please see
(pruritus)
section 2 “What you need to know
• grinding one’s teeth, agitation,
before you take Escitalopram”.
nervousness, panic attack,
confusion state
You can take Escitalopram with or
• disturbed sleep, taste disturbance,
without food. Swallow the tablet with
fainting (syncope)
some water. Do not chew them, as
• enlarged pupils (mydriasis), visual
the taste is bitter.
disturbance, ringing in the ears
(tinnitus)
Escitalopram 10 mg Film-coated
• loss of hair
Tablets, Escitalopram 20 mg
• vaginal bleeding at irregular
Film-coated Tablets
intervals, particularly between the
If necessary, you can divide the
expected menstrual periods or an
tablets by firstly placing the tablet on
abnormally heavy and prolonged
a flat surface with the score facing
menstrual period at regular
upwards. The tablets may then be
intervals
broken by pressing down on each
• decreased weight
end of the tablet, using both
• fast heart beat
forefingers as shown in the drawing.
• swelling of the arms or legs
(oedema)
• nosebleeds.

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.

Rare (may affect up to 1 in 1,000
people):
• aggression, depersonalisation,
hallucination
• slow heart beat.

Some patients have reported
(frequency can not be estimated from
the available data):
• thoughts of harming yourself or
thoughts of killing yourself, see
Do not change the dose of your
also section “Warnings and
medicine without talking to your
precautions”
doctor first.
• decreased levels of sodium in the
blood (the symptoms are feeling
Continue to take Escitalopram for as
sick and unwell with weak muscles
long as your doctor recommends. If
or confused)
you stop your treatment too soon,
• dizziness when you stand up due
your symptoms may return. It is
to low blood pressure (orthostatic
recommended that treatment should
hypotension)
be continued for at least 6 months
• abnormal liver function test
after you feel well again.
(increased amounts of liver
enzymes in the blood)
If you take more Escitalopram than
• movement disorders (involuntary
you should
movements of the muscles)
• painful erections (priapism)
If you take more than the prescribed
• bleeding disorders including skin
dose of Escitalopram, contact your
and mucous bleeding (ecchymosis)
doctor or nearest hospital emergency
and low level of blood platelets
department immediately. Do this
(thrombocytopenia)
even if there are no signs of
• sudden swelling of skin or mucosa
discomfort. Some of the signs of an
(angioedemas)
overdose could be dizziness, tremor,
• increase in the amount of urine
agitation, convulsion, coma, nausea,
excreted (inappropriate ADH
vomiting, change in heart rhythm,
secretion)
decreased blood pressure and
• flow of milk in women that are not
change in body fluid/salt balance.
nursing
Take the Escitalopram box/container
• mania
with you when you go to the doctor
• an increased risk of bone fractures
or hospital.
has been observed in patients
If you forget to take Escitalopram
taking this type of medicine
• alteration of the heart rhythm
Do not take a double dose to make
(called “prolongation of QT
up for forgotten doses. If you do
interval”, seen on ECG, electrical
forget to take a dose and you
activity of the heart).
remember before you go to bed, take
it straight away. Carry on as usual the In addition, a number of side effects
next day. If you only remember
are known to occur with drugs that
during the night, or the next day,
work in a similar way to escitalopram
leave out the missed dose and carry (the active ingredient of Escitalopram
on as usual.
Film-coated Tablets). These are:
• motor restlessness (akathisia)
If you stop taking Escitalopram
• anorexia.
Do not stop taking Escitalopram until
Reporting of side effects
your doctor tells you to do so. When
If you get any side effects, talk to
you have completed your course of
your doctor or pharmacist. This
treatment, it is generally advised that
includes any possible side effects not
the dose of Escitalopram is gradually
listed in this leaflet.
reduced over a number of weeks.
You can also report side effects
When you stop taking Escitalopram, directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard
especially if it is abruptly, you may
feel discontinuation symptoms. These
By reporting side effects you can help
are common when treatment with
provide more information on the
Escitalopram is stopped. The risk is
safety of this medicine.
higher, when Escitalopram has been
used for a long time or in high doses
5 How to store Escitalopram
or when the dose is reduced too
Keep this medicine out of the sight
quickly. Most people find that the
symptoms are mild and go away on and reach of children.
their own within two weeks.
However, in some patients they may Blisters:Store below 30ºC. Store in
be severe in intensity or they may be the original package (carton) in order
to protect from light and moisture.
prolonged (2-3 months or more). If
Bottles: Store below 25ºC. Store in
you get severe discontinuation
the original package (carton) in order
symptoms when you stop taking
to protect from light and moisture.
Escitalopram, please contact your
doctor. He or she may ask you to
Do not use this medicine after the
start taking your tablets again and
expiry date which is printed on the
come off them more slowly.
blister and carton after the
abbreviation EXP.
Discontinuation symptoms include:
Feeling dizzy (unsteady or
off-balance), feelings like pins and
needles, burning sensations and (less
commonly) electric shock sensations,
including in the head, sleep
disturbances (vivid dreams,
nightmares, inability to sleep),
feeling anxious, headaches, feeling
sick (nausea), sweating (including
night sweats), feeling restless or
agitated, tremor (shakiness), feeling
confused or disorientated, feeling
emotional or irritable, diarrhoea
(loose stools), visual disturbances,
fluttering or pounding heartbeat
(palpitations).

Bottles: After first opening use within
100 days.
Do not throw away any medicines via
wastewater or household waste. Ask
your 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

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

What Escitalopram contains
The active substance is escitalopram.
Each Escitalopram Film-coated Tablet
contains 5 mg, 10 mg, 15 mg or 20 mg
escitalopram (as oxalate).
• The other ingredients are:
Core: microcrystalline cellulose,
colloidal silica anhydrous,
croscarmellose sodium, stearic acid
and magnesium stearate.
Coating: hypromellose (E464),
macrogol 400, and titanium dioxide
(E171).

The side effects usually disappear
after a few weeks of treatment.
Please be aware that many of the
effects may also be symptoms of
your illness and therefore will
improve when you start to get better.

What Escitalopram looks like and
contents of the pack
Escitalopram 5 mg is a white, round,
biconvex film-coated tablet, marked
“93” on one side and “7414” on the
other.

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

4

Possible side effects

If you experience the following side
effects you should contact your
doctor or go to the hospital straight
away:

Escitalopram 10 mg is a white, round,
biconvex film-coated tablet, scored
on one side and marked “9” on one
side and “3” on the other. The other
Uncommon (may affect up to 1 in 100 side of the tablet is marked “7462”.
The tablet can be divided into equal
people):
halves.
• unusual bleeds, including
Escitalopram 15 mg is a white, round,
gastrointestinal bleeds.
biconvex film-coated tablet, scored
on one side and marked “S” on one
Rare (may affect up to 1 in 1,000
side and “C” on the other. The other
people):
side of the tablet is marked “15”.
• if you experience swelling of skin, The score line is only to facilitate
tongue, lips, or face, or have
breaking for ease of swallowing and
difficulties breathing or swallowing not to divide into equal doses.
(allergic reaction), contact your
doctor or go to a hospital straight Escitalopram 20 mg is a white, round,
biconvex film-coated tablet, scored
away
• if you have a headache, increased on one side and marked “9” on one
side and “3” on the other. The other
heart rate, shivering, high fever,
side of the tablet is marked “7463”.
sweating, agitation, confusion,
The tablet can be divided into equal
nausea or diarrhoea, trembling
and abrupt contractions of muscles halves.
these may be signs of a rare but
Escitalopram 5 mg, 10 mg, 15 mg &
potentially life-threatening
20 mg comes in blister packs of 7, 10,
condition called serotonin
14, 20, 28, 30, 49, 50, 56, 60, 90, 98,
syndrome. If you feel like this
100, 112, 120, 200 and 500 film-coated
contact your doctor.
tablets and perforated unit dose
blister 49x1, 50x1, 100x1 and 500x1
Some patients have reported
(frequency cannot be estimated from film-coated tablets.
PVC/PVdC–Aluminium blisters are in
the available data)
the carton.
• fast, irregular heart beat, fainting
Escitalopram 5 mg, 10 mg & 20 mg
which could be symptoms of a
comes in plastic bottle of 100
life-threatening condition known
film-coated tablets.
as Torsades de Pointes
Not all pack sizes may be marketed.
• difficulties urinating
• seizures (fits), see also section
Marketing Authorisation Holder and
“Warnings and precautions”
• yellowing of the skin and the white Manufacturer
in the eyes are signs of liver
Teva UK Limited, Eastbourne,
function impairment/hepatitis.
BN22 9AG, UK
In addition to above the following
side effects have been reported:

This leaflet was last revised in
04/2016

Very common (may affect more than
1 in 10 people):
• feeling sick (nausea)
• headache.

PL 00289/1724
PL 00289/1725
PL 00289/1726
PL 00289/1727

Common (may affect up to 1 in 10
people):
• blocked or runny nose (sinusitis)
• decreased or increased appetite
86398-G

TEVA UK Ref:

231-30-91411-E LEA ESCITALOPRAM A/S TAB TUK
Dimensions:
Length:
Width:

323 mm
320 mm

1

26 April 2016

Colours Used:

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

www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety of
this medicine.

5 How to store Escitalopram
Keep this medicine out of the sight and
reach of children.
Blisters:Store below 30ºC. Store in the
original package (carton) in order to protect
from light and moisture.
Bottles: Store below 25ºC. Store in the
original package (carton) in order to protect
from light and moisture.
Do not use this medicine after the expiry
date which is printed on the blister and
carton after the abbreviation EXP.
Bottles: After first opening use within 100 days.

6 Contents of the pack and other
information

What Escitalopram contains
The active substance is escitalopram. Each
Escitalopram Film-coated Tablet contains
5 mg, 10 mg, 15 mg or 20 mg escitalopram
(as oxalate).
• The other ingredients are:
Core: microcrystalline cellulose, colloidal
silica anhydrous, croscarmellose sodium,
stearic acid and magnesium stearate.
Coating: hypromellose (E464), macrogol
400, and titanium dioxide (E171).
What Escitalopram looks like and contents
of the pack
Escitalopram 5 mg is a white, round,
biconvex film-coated tablet, marked “93” on
one side and “7414” on the other.
Escitalopram 10 mg is a white, round,
biconvex 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.
Escitalopram 15 mg is a white, round,
biconvex film-coated tablet, scored on one
side and marked “S” on one side and “C”
on the other. The other side of the tablet is
marked “15”.
The score line is only to facilitate breaking
for ease of swallowing and not to divide into
equal doses.
Escitalopram 20 mg is a white, round,
biconvex 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 “7463”.
The tablet can be divided into equal halves.
Escitalopram 5 mg, 10 mg, 15 mg & 20 mg
comes in blister packs of 7, 10, 14, 20, 28, 30,
49, 50, 56, 60, 90, 98, 100, 112, 120, 200 and
500 film-coated tablets and perforated unit
dose blister 49x1, 50x1, 100x1 and 500x1
film-coated tablets.
PVC/PVdC–Aluminium blisters are in the
carton.
Escitalopram 5 mg, 10 mg & 20 mg comes
in plastic bottle of 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG, UK
This leaflet was last revised in 04/2016
Reporting of side effects
If you get any side effects, talk to your
PL 00289/1724
doctor or pharmacist. This includes any
PL 00289/1725
possible side effects not listed in this leaflet. PL 00289/1726
You can also report side effects directly via
PL 00289/1727
91411-E
the Yellow Card Scheme at:
320 x 323

BLACK

FOLD
LINE.

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

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.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
• 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.
• 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.
What is in this leaflet:

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
• if you are allergic to escitalopram or any
of the other ingredients of this medicine
(listed in section 6)
• if you take other medicines that 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)
• if you are born with or have had an
episode of abnormal heart rhythm (seen
at ECG; an examination to evaluate how
the heart is functioning)
• if you take medicines for heart 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:
• if you have epilepsy. Treatment with
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")
• if you suffer from impaired liver or
kidney function. Your doctor may need
to adjust your dosage
• if you have diabetes. Treatment with
Escitalopram may alter glycaemic
control. Insulin and/or oral
hypoglycaemic dosage may need to be
adjusted

• if you have a decreased level of sodium
in the blood
• if you have a tendency to easily develop
bleedings or bruises
• if you are receiving electroconvulsive
treatment
• if you have coronary heart disease
• if you suffer or have suffered from heart
problems or have recently had a heart
attack
• 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)
• if you experience a fast or irregular
heartbeat, fainting, collapse or dizziness
on standing up, which may indicate
abnormal functioning of the heart rate
• 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:
• if you have previously had thoughts
about killing or harming yourself
• if you are a young 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.
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Pharma code 868 (101100101)
First bar is 105mm from top edge.

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Common (may affect up to 1 in 10 people):
• blocked or runny nose (sinusitis)
• decreased or increased appetite
• anxiety, restlessness, abnormal dreams,
difficulties falling asleep, feeling sleepy,
dizziness, yawning, tremors, prickling of
the skin
• diarrhoea, constipation, vomiting, dry
mouth
• increased sweating
• pain in muscle and joints (arthralgia and
myalgia)
• sexual disturbances (delayed
ejaculation, problems with erection,
decreased sexual drive and women may
experience difficulties achieving orgasm)
• fatigue, fever
• increased weight.
Uncommon (may affect up to 1 in 100 people):
• nettle rash (urticaria), rash, itching
(pruritus)
• grinding one’s teeth, agitation,
nervousness, panic attack, confusion state
• disturbed sleep, taste disturbance,
fainting (syncope)
• enlarged pupils (mydriasis), visual
disturbance, ringing in the ears (tinnitus)
• loss of hair
• vaginal bleeding at irregular intervals,
particularly between the expected
menstrual periods or an abnormally
heavy and prolonged menstrual period
at regular intervals
• decreased weight
• fast heart beat
• swelling of the arms or legs (oedema)
• nosebleeds.
Rare (may affect up to 1 in 1,000 people):
• aggression, depersonalisation,
hallucination
• slow heart beat.
Some patients have reported (frequency can
not be estimated from the available data):
• thoughts of harming yourself or
thoughts of killing yourself, see also
section “Warnings and precautions”
• decreased levels of sodium in the blood
(the symptoms are feeling sick and
unwell with weak muscles or confused)
• dizziness when you stand up due to low
blood pressure (orthostatic
hypotension)
• abnormal liver function test (increased
amounts of liver enzymes in the blood)
• movement disorders (involuntary
movements of the muscles)
• painful erections (priapism)
• bleeding disorders including skin and
mucous bleeding (ecchymosis) and low
level of blood platelets
(thrombocytopenia)
• sudden swelling of skin or mucosa
(angioedemas)
• increase in the amount of urine excreted
(inappropriate ADH secretion)
• flow of milk in women that are not
nursing
• mania
• an increased risk of bone fractures has
been observed in patients taking this
type of medicine
• alteration of the heart rhythm (called
“prolongation of QT interval”, seen on
ECG, electrical activity of the heart).
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:
• motor restlessness (akathisia)
• anorexia.

Version:

TEVA UK Ref:

231-30-91411-E LEA ESCITALOPRAM A/S TAB TUK
Dimensions:
Length:
Width:

323 mm
320 mm

Tell your doctor if you are taking any of the
following medicines:

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Other medicines and Escitalopram
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicine.

Version:

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
• “non-selective monoamine oxidase
inhibitors (MAOIs)”, containing phenelzine, interact with alcohol.
iproniazid, isocarboxazid, nialamide and Pregnancy, breast-feeding and fertility
tranylcypromine as active ingredients. If
If you are pregnant or breast-feeding, think
you have taken any of these medicines
you will need to wait 14 days before you you may be pregnant or are planning to
start taking Escitalopram. After stopping have a baby, ask your doctor for advice
before taking this medicine. Do not take
Escitalopram you must allow 7 days
Escitalopram if you are pregnant or
before taking any of these medicines
• “reversible, selective MAO-A inhibitors”, breast-feeding unless you and your doctor
have discussed the risks and benefits
containing moclobemide (used to treat
involved.
depression)
• “irreversible MAO-B inhibitors”,
Citalopram, a medicine like escitalopram,
containing selegiline (used to treat
has been shown to reduce the quality of
Parkinson’s disease). These increase the sperm in animal studies. Theoretically, this
risk of side effects
could affect fertility, but impact on human
• the antibiotic linezolid
fertility has not been observed as yet.
• lithium (used in the treatment of
If you take Escitalopram during the last 3
manic-depressive disorder) and
months of your pregnancy you should be
tryptophan
• imipramine and desipramine (both used aware that the following effects may be
seen in your newborn baby: trouble with
to treat depression)
breathing, bluish skin, fits, body
• sumatriptan and similar medicines
temperature changes, feeding difficulties,
(used to treat migraine) and tramadol
(used against severe pain). These increase vomiting, low blood sugar, stiff or floppy
the risk of a rare but potentially serious muscles, vivid reflexes, tremor, jitteriness,
side effect known as serotonin syndrome irritability, lethargy, constant crying,
• cimetidine, omeprazole, esomeprazole, sleepiness and sleeping difficulties. If your
newborn baby has any of these symptoms,
lansoprazole (used to treat stomach
please contact your doctor immediately.
ulcers), fluvoxamine (antidepressant)
and ticlopidine (used to reduce the risk
Make sure your midwife and/or doctor know
of stroke). These may cause increased
you are on Escitalopram. When taken during
blood levels of Escitalopram
pregnancy, particularly in the last 3 months
• St. John's Wort (hypericum perforatum) of pregnancy, medicines like Escitalopram
- a herbal remedy used for depression
may increase the risk of a serious condition
• acetylsalicylic acid and non-steroidal
in babies, called persistent pulmonary
anti-inflammatory drugs (medicines
hypertension of the newborn (PPHN),
used for pain relief or to thin the blood, making the baby breathe faster and appear
so called anti-coagulants). These may
bluish. These symptoms usually begin
increase bleeding-tendency
during the first 24 hours after the baby is
• warfarin, dipyridamole, acenocumarol and born. If this happens to your baby you
phenprocoumon (medicines used to thin
should contact your midwife and/or doctor
the blood, so called anti-coagulants).
immediately.
Your doctor will probably check the
If used during pregnancy Escitalopram
coagulation time of your blood when
should never be stopped abruptly.
starting and discontinuing Escitalopram
It is expected that Escitalopram will be
in order to verify that your dose of
excreted into breast milk.
anti-coagulant is still adequate
• mefloquin (used to treat malaria),
Ask your doctor or pharmacist for advice
bupropion (used to treat depression)
before taking any medicine.
and tramadol (used to treat severe pain)
Driving and using machines
due to a possible risk of a lowered
threshold for seizures
You are advised not to drive a car or operate
• neuroleptics/antipsychotics (medicines
machinery until you know how Escitalopram
to treat schizophrenia, psychosis) due to affects you.
a possible risk of a lowered threshold
for seizures, and antidepressants
3 How to take Escitalopram
• flecainide, propafenone and metoprolol
Always
take Escitalopram exactly as your
(used in cardiovascular diseases)
doctor
has
told you. You should check with
clomipramine and nortriptyline
your doctor or pharmacist if you are not
(antidepressants) and risperidone,
sure.
thioridazine and haloperidol
Adults
(antipsychotics). The dosage of
Depression
Escitalopram may need to be adjusted
• medicines that decrease blood levels of The normally recommended dose of
Escitalopram is 10 mg taken as one daily
potassium or magnesium as these
dose. The dose may be increased by your
conditions increase the risk of
doctor to a maximum of 20 mg per day.
life-threatening heart rhythm disorder.
Panic disorder
Do not take Escitalopram if you take
The starting dose of Escitalopram is 5 mg as
medicines for heart rhythm problems or
one daily dose for the first week before
medicines that may affect the heart’s
increasing the dose to 10 mg per day. The
rhythm, such as Class IA and III
dose may be further increased by your
antiarrhythmics, antipsychotics (e.g.
doctor to a maximum of 20 mg per day.
phenothiazine derivatives, pimozide,
haloperidol), tricyclic antidepressants,
Social anxiety disorder
certain antimicrobial agents (e.g.
The normally recommended dose of
sparfloxacin, moxifloxacin, erythromycin IV, Escitalopram is 10 mg taken as one daily
pentamidine, anti-malarian treatment
dose. Your doctor can either decrease your
particularly halofantrine), certain
dose to 5 mg per day or increase the dose to
antihistamines (astemizole, mizolastine). If
a maximum of 20 mg per day, depending on
you have any further questions about this
how you respond to the medicine.
you should speak to your doctor.

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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.
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.
Use in children and adolescents (below 18
years of age)
Escitalopram should not normally be given
to children and adolescents. For further
information please see section 2 “What you
need to know before you take Escitalopram”.
You can take Escitalopram with or without
food. Swallow the tablet with some water.
Do not chew them, as the taste is bitter.
Escitalopram 10 mg Film-coated Tablets,
Escitalopram 20 mg Film-coated Tablets
If necessary, you can divide the tablets by
firstly placing the tablet on a flat surface
with the score facing upwards. The tablets
may then be broken by pressing down on
each end of the tablet, using both
forefingers as shown in the drawing.

When you stop taking Escitalopram,
especially if it is abruptly, you may feel
discontinuation symptoms. These are
common when treatment with Escitalopram
is stopped. The risk is higher, when
Escitalopram has been used for a long time
or in high doses or when the dose is
reduced too quickly. Most people find that
the symptoms are mild and go away on
their own within two weeks. However, in
some patients they may be severe in
intensity or they may be prolonged (2-3
months or more). If you get severe
discontinuation symptoms when you stop
taking Escitalopram, please contact your
doctor. He or she may ask you to start taking
your tablets again and come off them more
slowly.
Discontinuation symptoms include: Feeling
dizzy (unsteady or off-balance), feelings like
pins and needles, burning sensations and
(less commonly) electric shock sensations,
including in the head, sleep disturbances
(vivid dreams, nightmares, inability to
sleep), feeling anxious, headaches, feeling
sick (nausea), sweating (including night
sweats), feeling restless or agitated, tremor
(shakiness), feeling confused or disorientated,
feeling emotional or irritable, diarrhoea
(loose stools), visual disturbances, fluttering
or pounding heartbeat (palpitations).
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.
The side effects usually disappear after a
few weeks of treatment. Please be aware
that many of the effects may also be
symptoms of your illness and therefore will
improve when you start to get better.
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):
• unusual bleeds, including
gastrointestinal bleeds.
Rare (may affect up to 1 in 1,000 people):
• if you experience swelling of skin,
tongue, lips, or face, or have difficulties
breathing or swallowing (allergic
reaction), contact your doctor or go to a
hospital straight away
• if you have a headache, increased heart
rate, shivering, high fever, sweating,
agitation, confusion, nausea or
diarrhoea, trembling and abrupt
contractions of muscles these may be
signs of a rare but potentially
life-threatening condition called
serotonin syndrome. If you feel like this
contact your doctor.

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.
Do not change the dose of your medicine
without talking to your doctor first.
Continue to take Escitalopram for as long as
your doctor recommends. If you stop your
treatment too soon, your symptoms may
return. It is recommended that treatment
should be continued for at least 6 months
after you feel well again.
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. Do this even if there are no
signs of discomfort. Some of the signs of an
overdose could be dizziness, tremor,
agitation, convulsion, coma, nausea,
vomiting, change in heart rhythm,
decreased blood pressure and change in
body fluid/salt balance. Take the
Some patients have reported (frequency
Escitalopram box/container with you when
cannot be estimated from the available
you go to the doctor or hospital.
data)
If you forget to take Escitalopram
• fast, irregular heart beat, fainting which
Do not take a double dose to make up for
could be symptoms of a life-threatening
forgotten doses. If you do forget to take a
condition known as Torsades de Pointes
dose and you remember before you go to
• difficulties urinating
bed, take it straight away. Carry on as usual
• seizures (fits), see also section
the next day. If you only remember during
“Warnings and precautions”
the night, or the next day, leave out the
• yellowing of the skin and the white in
missed dose and carry on as usual.
the eyes are signs of liver function
impairment/hepatitis.
If you stop taking Escitalopram
In
addition
to above the following side
Do not stop taking Escitalopram until your
effects have been reported:
doctor tells you to do so. When you have
Very common (may affect more than 1 in 10
completed your course of treatment, it is
people):
generally advised that the dose of
• feeling sick (nausea)
Escitalopram is gradually reduced over a
• headache.
number of weeks.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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