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ESCITALOPRAM 15 MG FILM-COATED TABLETS

Active substance(s): ESCITALOPRAM / ESCITALOPRAM OXALATE / ESCITALOPRAM / ESCITALOPRAM OXALATE

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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).

No
845 mm
148 mm
N/A
N/A

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
Please note
studies. Theoretically, this could affect
Some patients with manic-depressive fertility, but impact on human fertility
illness may enter into a manic phase. has not been observed as yet.
This is characterised by unusual and
rapidly changing ideas, inappropriate If you take Escitalopram during the
happiness and excessive physical
last 3 months of your pregnancy you
activity. If you experience this,
should be aware that the following
contact your doctor.
effects may be seen in your newborn
baby: trouble with breathing, bluish
Symptoms such as restlessness or
skin, fits, body temperature changes,
difficulty to sit or stand still can also feeding difficulties, vomiting, low
occur during the first weeks of the
blood sugar, stiff or floppy muscles,
treatment. Tell your doctor
vivid reflexes, tremor, jitteriness,
immediately if you experience these irritability, lethargy, constant crying,
symptoms.
sleepiness and sleeping difficulties. If
your newborn baby has any of these
Thoughts of suicide and worsening
symptoms, please contact your
of your depression or anxiety
doctor immediately.
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.
Other medicines and Escitalopram
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicine.

Teva Pharmaceuticals Europe B.V
Effective Date: TBD

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

Version:

EBNUK2272b LEA ESCITALOPRAM 5, 10, 15 & 20MG FC TAB TUK
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.

4

09 May 2017

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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.

• 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
Use in children and adolescents
people):
(below 18 years of age)
• nettle rash (urticaria), rash, itching
Escitalopram should not normally be
(pruritus)
given to children and adolescents.
• grinding one’s teeth, agitation,
For further information please see
nervousness, panic attack,
section 2 “What you need to know
confusion state
before you take Escitalopram”.
• disturbed sleep, taste disturbance,
fainting (syncope)
You can take Escitalopram with or
• enlarged pupils (mydriasis), visual
without food. Swallow the tablet with
disturbance, ringing in the ears
some water. Do not chew them, as
(tinnitus)
the taste is bitter.
• loss of hair
• vaginal bleeding at irregular
Escitalopram 10 mg Film-coated
intervals, particularly between the
Tablets, Escitalopram 20 mg
expected menstrual periods or an
Film-coated Tablets
abnormally heavy and prolonged
If necessary, you can divide the
menstrual period at regular
tablets by firstly placing the tablet on
intervals
a flat surface with the score facing
• decreased weight
upwards. The tablets may then be
• fast heart beat
broken by pressing down on each
• swelling of the arms or legs
end of the tablet, using both
(oedema)
forefingers as shown in the drawing.
• nosebleeds.
Rare (may affect up to 1 in 1,000
people):
• aggression, depersonalisation,
hallucination
• slow heart beat.
Duration of treatment

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
Do not change the dose of your
blood (the symptoms are feeling
medicine without talking to your
sick and unwell with weak muscles
doctor first.
or confused)
• dizziness when you stand up due
Continue to take Escitalopram for as
to low blood pressure (orthostatic
long as your doctor recommends. If
hypotension)
you stop your treatment too soon,
• abnormal liver function test
your symptoms may return. It is
(increased amounts of liver
recommended that treatment should
enzymes in the blood)
be continued for at least 6 months
• movement disorders (involuntary
after you feel well again.
movements of the muscles)
• painful erections (priapism)
If you take more Escitalopram than
• bleeding disorders including skin
you should
and mucous bleeding (ecchymosis)
and low level of blood platelets
If you take more than the prescribed
(thrombocytopenia)
dose of Escitalopram, contact your
• sudden swelling of skin or mucosa
doctor or nearest hospital emergency
(angioedemas)
department immediately. Do this
• increase in the amount of urine
even if there are no signs of
excreted (inappropriate ADH
discomfort. Some of the signs of an
secretion)
overdose could be dizziness, tremor,
• flow of milk in women that are not
agitation, convulsion, coma, nausea,
nursing
vomiting, change in heart rhythm,
• mania
decreased blood pressure and
• an increased risk of bone fractures
change in body fluid/salt balance.
has been observed in patients
Take the Escitalopram box/container
taking this type of medicine
with you when you go to the doctor
• alteration of the heart rhythm
or hospital.
(called “prolongation of QT
If you forget to take Escitalopram
interval”, seen on ECG, electrical
activity of the heart).
Do not take a double dose to make
up for forgotten doses. If you do
In addition, a number of side effects
forget to take a dose and you
are known to occur with drugs that
remember before you go to bed, take work in a similar way to escitalopram
it straight away. Carry on as usual the (the active ingredient of Escitalopram
next day. If you only remember
Film-coated Tablets). These are:
during the night, or the next day,
• motor restlessness (akathisia)
leave out the missed dose and carry
• anorexia.
on as usual.
Reporting of side effects
If you stop taking Escitalopram
If you get any side effects, talk to
your doctor or pharmacist. This
Do not stop taking Escitalopram until
includes any possible side effects not
your doctor tells you to do so. When
listed in this leaflet.
you have completed your course of
You can also report side effects
treatment, it is generally advised that
directly via the Yellow Card Scheme
the dose of Escitalopram is gradually
at: www.mhra.gov.uk/yellowcard
reduced over a number of weeks.
By reporting side effects you can help
When you stop taking Escitalopram,
provide more information on the
especially if it is abruptly, you may
safety of this medicine.
feel discontinuation symptoms. These
are common when treatment with
5 How to store Escitalopram
Escitalopram is stopped. The risk is
higher, when Escitalopram has been Keep this medicine out of the sight
used for a long time or in high doses and reach of children.
or when the dose is reduced too
Blisters:Store below 30ºC. Store in
quickly. Most people find that the
symptoms are mild and go away on the original package (carton) in order
to protect from light and moisture.
their own within two weeks.
However, in some patients they may Bottles: Store below 25ºC. 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
you get severe discontinuation
Do not use this medicine after the
symptoms when you stop taking
expiry date which is printed on the
Escitalopram, please contact your
blister and carton after the
doctor. He or she may ask you to
abbreviation EXP.
start taking your tablets again and
come off them more slowly.
Bottles: After first opening use within
100 days.
Discontinuation symptoms include:
Feeling dizzy (unsteady or
Do not throw away any medicines via
off-balance), feelings like pins and
wastewater or household waste. Ask
needles, burning sensations and (less your pharmacist how to throw away
commonly) electric shock sensations, medicines you no longer use. These
including in the head, sleep
measures will help protect the
disturbances (vivid dreams,
environment.
nightmares, inability to sleep),
feeling anxious, headaches, feeling
6 Contents of the pack and
other information
sick (nausea), sweating (including
night sweats), feeling restless or
What Escitalopram contains
agitated, tremor (shakiness), feeling The active substance is escitalopram.
confused or disorientated, feeling
Each Escitalopram Film-coated Tablet
emotional or irritable, diarrhoea
contains 5 mg, 10 mg, 15 mg or 20 mg
(loose stools), visual disturbances,
escitalopram (as oxalate).
fluttering or pounding heartbeat
• The other ingredients are:
(palpitations).
Core: microcrystalline cellulose,
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.

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.

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
Escitalopram 10 mg is a white, round,
improve when you start to get better. biconvex film-coated tablet, scored on
one side and marked “9” on one side
If you experience the following side
and “3” on the other. The other side of
effects you should contact your
the tablet is marked “7462”. The tablet
doctor or go to the hospital straight can be divided into equal halves.
away:
Escitalopram 15 mg is a white, round,
Uncommon (may affect up to 1 in 100 biconvex film-coated tablet, scored
people):
on one side and marked “S” on one
side and “C” on the other. The other
• unusual bleeds, including
side of the tablet is marked “15”.
gastrointestinal bleeds.
The score line is only to facilitate
breaking for ease of swallowing and
Rare (may affect up to 1 in 1,000
not to divide into equal doses.
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.

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.

Some patients have reported
(frequency cannot be estimated from Escitalopram 5 mg, 10 mg & 20 mg
comes in plastic bottle of 100
the available data)
film-coated tablets.
Not all pack sizes may be marketed.
• fast, irregular heart beat, fainting
which could be symptoms of a
Marketing Authorisation Holder and
life-threatening condition known
Manufacturer
as Torsades de Pointes
• difficulties urinating
Marketing Authorisation Holder
• seizures (fits), see also section
“Warnings and precautions”
Teva UK Limited, Eastbourne,
• yellowing of the skin and the white BN22 9AG, UK
in the eyes are signs of liver
Manufacturer
function impairment/hepatitis.
In addition to above the following
side effects have been reported:

Teva Operations Poland Sp.z.o.o., ul.
Mogilska 80, 31-546 Krakow, POLAND

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

This leaflet was last revised in 05/2017

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

REG0116354
Valid For 7 Days from 15-May-2017

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

EBNUK2272b

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Teva Pharmaceuticals Europe B.V
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ated-tablets-krakow

APPROVALS
Signed by
Mohammad Zaher Shehab

Meaning of Signature
Regulatory Affairs Approval

Teva Pharmaceuticals Europe B.V
Effective Date: TBD

Server Date

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Valid For 7 Days from 15-May-2017

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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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