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ESCITALOPRAM 15MG FILM-COATED TABLETS

Active substance(s): ESCITALOPRAM OXALATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Escitalopram 5 mg film-coated tablets
Escitalopram 10 mg film-coated tablets
Escitalopram 15 mg film-coated tablets
Escitalopram 20 mg film-coated tablets
Escitalopram
Read all of this leaflet carefully before you start
taking this medicine.
- 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. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
1. What Escitalopram is and what it is used for
2. Before you take Escitalopram
3. How to take Escitalopram
4. Possible side effects
5. How to store Escitalopram
6. Further information
1. WHAT ESCITALOPRAM IS AND WHAT IT IS
USED FOR
Escitalopram film-coated tablets contains escitalopram
and is used to treat depression (major depressive
episodes) and anxiety disorders (such as panic disorder
with or without agoraphobia which is fear of being in
places where help might not be available, social anxiety
disorder, generalised anxiety disorder and obsessivecompulsive disorder).
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.
2. BEFORE YOU TAKE ESCITALOPRAM
Do not take Escitalopram film-coated tablets
• if you are allergic (hypersensitive) to escitalopram
or any of the other ingredients of Escitalopram filmcoated-tablets (see section 6 “Further information”).
• if you take other medicines which 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
“Taking other medicines”
Take special care with Escitalopram film-coated
tablets
Please tell your doctor if you have any other condition
or illness, as your doctor may need to take this into
consideration. In particular, tell your doctor:
• if you have epilepsy. Treatment with escitalopram
should be stopped if seizures occur 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 (the level of sugar in the
blood). 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
(treatment by electroshock).
• 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
As with other medicines used to treat depression or
related diseases, the improvement is not achieved
immediately. After the start of escitalopram treatment
it may take several weeks before you experience any
improvement. In the treatment of panic disorder it
usually takes 2-4 weeks before any improvement is
seen. In the beginning of the treatment certain patients
may experience increased anxiety, which will disappear
during the continued treatment. Therefore, it is very
important that you follow exactly your doctor’s orders
and do not stop the treatment or change the dose without
consulting your doctor.
Some patients with manic-depressive illness may enter
into a manic phase. This is characterized 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.
Sometimes you may be unaware of the above-mentioned
symptoms and therefore you may find it helpful to ask
a friend or relative to help you to observe the possible
signs of change in your behaviour.
Tell your doctor immediately or contact the nearest
hospital if you have distressing thoughts or experiences
or if any of the above-mentioned symptoms occurs
during the treatment.
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 young 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.
Use in 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



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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.
Taking other medicines
Please tell your doctor if you are taking or have recently
taken any other medicines, including medicines obtained
without prescription.
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 film-coated tablets. After
stopping Escitalopram film-coated tablets 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 side effects.
• Cimetidine and omeprazole (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 (aspirin) and non-steroidal antiinflammatory drugs (medicines used for pain relief or
to thin the blood, so called anti-coagulant).
• Warfarin, dipyridamole, and phenprocoumon
(medicines used to thin the blood, so called anticoagulant). 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 (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 film-coated tablets 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 disorders.
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.
phenophiazine 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 you doctor.
Taking Escitalopram film coated- with food and
drink
Escitalopram film-coated tablets 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 and breast-feeding
Inform your doctor if you are pregnant or planning to
become pregnant. Do not Escitalopram film-coatedtablets if you are pregnant unless you and your doctor
have discussed the risks and benefits involved.
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 new-born 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 new-born baby has any of
these symptoms, please contact your doctor immediately.
Make sure your midwife and/or doctor know you
are on Escitalopram film-coated tablets. When taken
during pregnancy, particularly in the last 3 months of
pregnancy, medicines like Escitalopram film-coated
tablets may increase the risk of a serious condition in
babies, called persistent pulmonary hypertension of the
new-born (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.
Do not take escitalopram if you are 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.
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 Escitalopram film-coated tablets 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 filmcoated tablets is 10 mg taken as one daily dose. The dose
may be increased by your doctor to a maximum of
20 mg per day.

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Panic disorder
The starting dose of Escitalopram film-coated tablets 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 filmcoated tablets 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 filmcoated tablets 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 filmcoated tablets is 10 mg taken as one daily dose. The dose
may be increased by your doctor to a maximum of 20
mg per day.
Elderly patients (above 65 years of age)
The recommended starting dose of Escitalopram filmcoated tablets is 5 mg taken as one daily dose. The dose
may be increased by your doctor to 10 mg per day.
Children and adolescents (below 18 years of age)
Escitalopram film-coated tablets should not normally
be given to children and adolescents. For further
information please see section 2 “Before you take
Escitalopram”.
You can take Escitalopram film-coated tablets with or
without food. Swallow the tablet with some water. Do
not chew them, as the taste is bitter.
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.
Duration of treatment
It may take a couple of weeks before you start to feel
better. Continue to take Escitalopram film-coated
tablets 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 film-coated tablets 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 film-coated tablets, 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 Escitalopram filmcoated tablets box/container with you when you go to
the doctor or hospital.
If you forget to take Escitalopram film-coated tablets
Do not take a double dose to make up for forgotten
doses. If you do forget to take a dose, and you remember
before you go to bed, take it straight away. Carry on
as usual the next day. If you only remember during the
night, or the next day, leave out the missed dose and
carry on as usual.
If you stop taking Escitalopram film-coated tablets
Do not stop taking Escitalopram film-coated tablets
until your doctor tells you to do so. When you have
completed your course of treatment, it is generally
advised that the dose of Escitalopram film-coated tablets
is gradually reduced over a number of weeks.
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 film-coated tablets,
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
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Escitalopram film-coated tablets 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.
See your doctor if you get any of the following side
effects during treatment:
Uncommon (affects 1 to 10 users in 1,000):
• Unusual bleeds, including gastrointestinal bleeds
Rare (affects 1 to 10 users in 10,000):
• 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 high fever, agitation, confusion,
trembling and abrupt contractions of muscles these
may be signs of a rare condition called serotonin
syndrome. If you feel like this, contact your doctor.
If you experience the following side affects you should
contact your doctor or go to the hospital straight away:
• Difficulties urinating
• Seizures (fits), see also section Take special care with
Escitalopram film-coated tablets
• Yellowing of the skin and the white in the eyes are
signs of liver function impairment/hepatitis
• Fast irregular heartbeat, fainting which could be
symptoms of a life-threatening condition known as
Torsades de Pointes.
In addition to above the following side effects have
been reported:
Very common (affects more than 1 user in 10):
• Feeling sick (nausea)
• Headache
Common (affects 1 to 10 users in 100):
• 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



15.04.14

with erection, decreased sexual drive and women
may experience difficulties achieving orgasm)
• Fatigue, fever
• Increased weight
Uncommon (affects 1 to 10 users in 1,000):
• 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
• Decreased weight
• Fast heart beat
• Swelling of the arms or legs
• Nosebleeds
Rare (affects 1 to 10 users in 10,000):
• Aggression, depersonalisation, hallucination
• Slow heart beat
• Suicide-related events, see also section “Take special
care with Escitalopram“
Some patients have reported (frequency not known):
• Thoughts of harming yourself or thoughts of
killing yourself (cases of suicidal ideation and
suicidal behaviours) have been reported during
escitalopram (the active ingredient of Escitalopram
film-coated tablets) therapy or early treatment
discontinuation, see also section “Take special care
with Escitalopram”)
• 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
An increased risk of bone fractures has been observed in
patients taking this type of medicines.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
5. HOW TO STORE ESCITALOPRAM
Keep out of the reach and sight of children.
Do not use Escitalopram film-coated tablets after the
expiry date, which is stated on the blister or carton after
EXP. The expiry date refers to the last day of the month.
This medicinal product does not require any special
storage conditions.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
to protect the environment.
6. FURTHER INFORMATION
What Escitalopram film-coated tablets 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:
Tablet core:
Cellulose, microcrystalline (E460), Croscarmellose
sodium (E468), Magnesium Stearate (E572), Colloidal
Anhydrous Silica and Talc
Tablet coating:
Hypromellose (E464), Titanium dioxide (E171),
Macrogol 400
What Escitalopram film-coated tablets looks like and
contents of the pack
Escitalopram film-coated tablets is presented as 5 mg, 10
mg, 15 mg and 20 mg film-coated tablets.
The tablets are described below.
5 mg: White to off-white, circular, biconvex, film coated
tablets with ‘E 1’ debossed on one side and plain on the
other side.
10 mg: White to off-white, oval, biconvex, film coated
tablets with ‘E 2’ debossed on one side and scoreline
on the other side. The tablet can be divided into equal
halves.
15 mg: White to off-white, oval, biconvex, film coated
tablets with ‘E 3’ debossed on one side and scoreline
on the other side. The tablet can be divided into equal
halves.
20 mg: White to off-white, oval, biconvex, film coated
tablets with “E 4” debossed on one side and scoreline
on the other side. The tablet can be divided into equal
halves.
The tablets are packed in either plain Aluminium/
Aluminium blisters or clear PVC-Aclar/Aluminium
blisters
Escitalopram film-coated tablets is available in the
following pack sizes:
5 mg film-coated tablets
Blister: 14, 20, 28, 50 and 100
10 mg film-coated tablets
Blister: 14 , 20, 28, 50 and 100
15 mg film-coated tablets
Blister: 20, 28, 50 and 100
20 mg film-coated tablets
Blister: 14, 20, 28, 50 and 100
Not all pack sizes may be marketed
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2 B Draycott Avenue,
Kenton, Middlesex HA3 0BU,
United Kingdom
Manufacturer
Glenmark Pharmaceuticals Europe Limited.
Building 2, Croxley Green Business Park,
Croxley Green
Hertfordshire, WD18 8YA
United Kingdom
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b, 140 78 Prague 4,
Czech Republic
Tillomed Laboratories Limited
3 Howard Road, Eaton Socon,
St. Neots, Cambridgeshire, PE19 8ET
United Kingdom
This leaflet was last approved in April 2014

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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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