Escitalopram 10mg tablets

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:
Escitalopram oxalate
Available from:
Mylan
ATC code:
N06AB10
INN (International Name):
Escitalopram oxalate
Dosage:
10mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04030300; GTIN: 5016695002583
Authorization number:
; PL 04569/0777

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Myriad Pro

9 pt

9 pt

Escitalopram_5mg_10mg_20mg_28

Leaflet

2034370

2034370

PL 04569/0776-0778

Tjoapack Netherlands

BV (Etten-Leur - NL)

400519140;400519139;

400519141

103419736/0170

United Kingdom

maket 170x560 DEMAX s

pregavane

148 x 592 mm

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v3/Jul 2017

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09:05

21 Feb 20

Package leaflet: Information for the patient

Escitalopram 5 mg

film-coated tablets

Escitalopram 10 mg

film-coated tablets

Escitalopram 20 mg

film-coated tablets

escitalopram

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:

What Escitalopram is and what it is used for

What you need to know before you take

Escitalopram

How to take Escitalopram

Possible side effects

How to store Escitalopram

Contents of the pack and other information.

1. What Escitalopram is and what it is

used for

Escitalopram belongs to a group of medicines

called Selective Serotonin Re-uptake Inhibitor

(SSRI) antidepressants. 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 can be given to treat the following

conditions:

depression (major depressive episodes)

anxiety disorders (such as panic disorder with

or without agoraphobia (fear of open spaces),

social anxiety disorder, generalised anxiety

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 monoamine oxidase

(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 were 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 suffer from impaired liver or kidney

function. Your doctor may need to adjust your

dosage

if you are elderly

if you have epilepsy or have a history of fits

(seizures). Treatment with escitalopram should

be stopped if seizures occur for the first time,

or if there is an increase of seizure frequency

(see also section 4 “Possible side effects”)

if you have a history of mania (overactive

behaviour or thoughts) or hypomania

(elevated or irritable mood associated with

extreme energy, talkativeness, confidence and

assertiveness)

if you are receiving electro-convulsive

therapy (ECT)

if you have a tendency to easily develop

bleeding or bruising

if you suffer from diabetes. Treatment with

escitalopram may alter glycaemic control

(control of blood sugar levels). Your dosage of

insulin and/ or oral hypoglycaemic medicine

may need to be adjusted.

if you have a decreased level of sodium,

magnesium or potassium in the blood.

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 heart beat,

fainting, collapse or dizziness on standing up,

which may indicate abnormal functioning of

the heart rate

if you suffer 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 in

sitting or standing 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 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.

Sexual dysfunction

Medicines like escitalopram (so called SSRIs/SNRIs)

may cause symptoms of sexual dysfunction (see

section 4). In some cases, these symptoms have

continued after stopping treatment.

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

(predominantly 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 get worse when patients under 18 are taking

Escitalopram. Also, the long term safety effects of

escitalopram concerning growth, maturation and

cognitive and behavioural development 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

medicines.

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, risperidone,

thioridazine), tricyclic antidepressants

(e.g. desipramine, clomipramine, nortripytiline,

imipramine), certain antimicrobial

agents (e.g. sparfloxacin, moxifloxacin,

erythromycin IV, pentamidine, anti-malarial

treatment particularly halofantrine), certain

antihistamines (e.g. astemizole, mizolastine).

‘Non-selective monoamine oxidase (MAO)

inhibitors’, 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

If you have any further questions about this you

should speak to your doctor.

It is especially important to tell your doctor

if you are using some of the following

medicines:

Sumatriptan and similar medicines (used to

treat migraine) and tramadol (used against

severe pain). These increase the risk of side

effects.

Cimetidine, omeprazole, esomeprazole and

lansoprazole (used to treat stomach ulcers),

fluconazole (used to treat fungal infections),

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

anti-inflammatory drugs (NSAIDS) (medicines

used for pain relief or to thin the blood, so

called anti-coagulant). These may increase

bleeding-tendency.

Warfarin, dipyridamole and phenprocoumon

or other anticoagulants (medicines used to

thin the blood). Your doctor will probably

check the coagulation time of your blood

when starting and discontinuing escitalopram

to make sure that your dose of anti-coagulant

is still adequate.

Mefloquine (used to treat malaria) and

bupropion (used when trying to stop smoking

or treat depression) due to a possible risk of

a lowered threshold for seizures (fits).

Other SSRI antidepressants, due to a possible

risk of a lowered threshold for seizures.

Flecainide, propafenone and metoprolol (used

in cardio-vascular diseases). Your dosage of

escitalopram may need to be adjusted.

Lithium (used in the treatment of

manic-depressive disorder) and tryptophan.

Medicines that decrease blood levels of

potassium or magnesium, as these conditions

increase the risk of life-threatening heart

rhythm disorders.

Escitalopram with alcohol

You should avoid alcohol while you are taking this

medicine.

Pregnancy, breast-feeding and fertility

Tell your doctor if you are pregnant, think you

may be pregnant or are planning to have a baby.

Do not take Escitalopram if you are pregnant or

breast-feeding, 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 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.

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.

Driving and using machines

Do not drive or use machines until you know how

Escitalopram affects you.

Escitalopram contains lactose

If you have been told by your doctor that you

have an intolerance to some sugars, contact your

doctor before taking this medicine.

3. How to take Escitalopram

Always take this medicine exactly as your doctor

or pharmacist has told you. Check with your

doctor or pharmacist if you are not sure:

Remember that you may need to take

escitalopram tablets for 2 or more weeks

before you begin to feel better.

Myriad Pro

9 pt

9 pt

Escitalopram_5mg_10mg_20mg_28

Leaflet

2034370

2034370

PL 04569/0776-0778

Tjoapack Netherlands

BV (Etten-Leur - NL)

400519140;400519139;

400519141

103419736/0170

United Kingdom

maket 170x560 DEMAX s

pregavane

148 x 592 mm

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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 and 20 mg tablets contain

a break line. The tablet can be divided into equal

doses.

ADULTS

Depression - The recommended dose is 10 mg

of escitalopram a day. Your doctor may increase

this dose to a maximum of 20 mg a day. It may

take 2 to 4 weeks before you start to feel better.

Treatment should last for at least 6 months after

you feel better.

Panic disorder – The recommended starting

dose is 5 mg of escitalopram a day. After the

first week, this dose may be increased by your

doctor to 10 mg a day, and if necessary up to

a maximum dose of 20 mg a day. The maximum

effect is reached after 3 months.

Social anxiety disorder

The recommended dose is 10 mg of escitalopram

a day. Your doctor can either decrease your dose

to 5 mg a day or increase the dose to a maximum

of 20 mg a day, depending on how you respond to

the medicine.

Generalised anxiety disorder

The recommended dose is 10 mg of escitalopram

a day. The dose may be increased by your doctor

to a maximum of 20 mg a day.

Obsessive-compulsive disorder

The recommended dose is 10 mg of escitalopram

a day. The dose may be increased by your doctor

to a maximum of 20 mg a day.

ELDERLY PATIENTS (above 65 years of age)

Your doctor will give you a lower dose to that

stated above, as elderly patients may be more

sensitive to the effects of escitalopram. 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 under the age of 18. For

further information please see section 2 “What

you need to know before you take Escitalopram”.

PATIENTS WITH LIVER OR KIDNEY PROBLEMS

If you have liver or severe kidney problems, your

doctor will give you a lower dose than stated

above.

How long to take Escitalopram for?

Keep on taking your tablets for as long as your

doctor recommends, even after you start to feel

better. This should be for at least six months after

you recover to stop your symptoms coming back.

If you take more Escitalopram than you should

Contact your doctor or nearest hospital

casualty department immediately. Do this

even if there are no signs of discomfort. Some

symptoms of the signs of overdose could be

dizziness, shaking, agitation, convulsion, coma,

feeling and being sick, change in heart rhythm

(slower or faster heartbeat), decreased blood

pressure and change in body fluid/salt balance.

Take the container and any remaining tablets with

you when you go to the doctor or hospital.

If you forget to take Escitalopram

Do not take a double dose to make up for

a forgotten dose. 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

Do not stop taking Escitalopram 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 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,

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 electric

shock sensations, including in the head, sleep

disturbances (vivid dreams, nightmares, inability

to sleep), feeling anxious, headaches, feeling

sick (nausea), being sick (vomiting), sweating

(including night sweats), feeling restless or

agitated, tremor (shakiness), feeling confused

or disorientated, feeling emotional or irritable,

diarrhoea (loose stools), visual disturbances and

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 any of the following

symptoms you should contact your doctor or

go to the hospital straight away:

Uncommon (may affect up to 1 in 100 people):

Unusual bleeds, including bleeds from the

stomach, gut and rectum (back passage).

You may notice fresh blood, or you may have

a sticky, tarry poo or, if you are sick, it may

contain particles that look like coffee grounds

Rare (may affect up to 1 in 1,000 people):

Swelling of skin, tongue, lips, or face, or

difficulty breathing or swallowing (serious

allergic reactions)

High fever, agitation, confusion, trembling and

abrupt contractions of muscles - these may

be signs of a rare condition called serotonin

syndrome

Not known (frequency cannot be estimated from

the available data):

Difficulties urinating

Seizures (fits), see also section 2 “Warnings and

precautions”

A lower than normal level of sodium in the

blood, which may make you feel weak and

confused with aching of muscles. This may

be due to inappropriate ADH secretion,

a hormone that causes the body to retain

water and dilute the blood, reducing the

amount of sodium

Yellowing of the skin and the white in the

eyes, which may be signs of liver function

impairment/hepatitis

Fast, irregular heart beat, fainting, which could

be symptoms of a life-threatening condition

known as torsade de pointes

Thoughts of harming or killing yourself, see

also section 2 “Warnings and precautions”

Alteration of the heart rhythm (called

“prolongation of QT interval”, seen on ECG,

electrical activity of the heart)

In addition to above the following side effects

have been reported:

Very common (may affect more than 1 in 10 people):

headache

feeling sick (nausea)

Common (may affect up to 1 in 10 people):

lack of appetite

increased appetite

weight increase

feeling anxious or restless

difficulty falling asleep

feeling sleepy

abnormal dreams

tingling or numbness of the hands and feet

shaking (tremors)

feeling dizzy

yawning

inflamed swollen sinuses causing pain, high

temperature, tenderness (known as sinusitis)

diarrhoea

constipation

vomiting

dry mouth

increased sweating

fever

muscle or joint pain

feeling unusually tired

sexual problems (delayed ejaculation,

problems with erection, decreased sexual

drive and women may experience difficulties

achieving orgasm)

Uncommon (may affect up to 1 in 100 people):

feeling confused

agitated

nervous

grinding teeth while asleep

panic attack

taste disturbance

change in your sleep pattern

fainting

enlarged pupils (mydriasis), visual disturbance

ringing in the ears (tinnitus)

fast heart beat

nose bleed

decreased weight

hair loss

nettle rash or hives

rash

itchy skin

heavy periods or bleeding between periods

swelling of the arms or legs

Rare (may affect up to 1 in 1,000 people):

feeling aggressive or detached from yourself

hallucinations

slow heart beat

Some patients have reported (frequency

cannot be estimated from the available data):

thrombocytopenia (reduction in blood

platelets which increases risk of bleeding and

bruising)

mania (feeling elated or over-excited, which

causes unusual behaviour)

abnormal muscle movements

dizziness when you stand up due to low blood

pressure (orthostatic hypotension)

changes to the results of liver enzyme tests

persistent painful erection of the penis

flow of milk in women that are not nursing

an increased risk of bone fractures has been

observed in patients taking this type of

medicine

In addition, other side effects are known to

occur with drugs that work in a similar way as

escitalopram. These are:

restlessness or difficulty sitting still

(psychomotor restlessness/akathisia)

anorexia

Reporting of side effects

If you get any side effects, talk to your doctor or

pharmacist. This includes any possible side effects

not listed in this leaflet.

You can also report side effects directly via

Yellow Card Scheme at:

www.mhra.gov.uk/

yellowcard or search

for MHRA Yellow Card in the Google Play or

Apple App Store.

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.

Do not use this medicine after the expiry date

which is stated on the tablet container /blister and

the carton after ‘EXP’ used for the expiry date. The

expiry date refers to the last day of that month.

Store below 25 °C.

Do not use this medicine if you notice visible signs

of deterioration.

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

What Escitalopram contains

The active substance is escitalopram.

One tablet contains 5 mg, 10 mg or 20 mg

of escitalopram (as oxalate). The other

ingredients are:

Tablet core:

microcrystalline cellulose, colloidal anhydrous

silica, talc, croscarmellose sodium and magnesium

stearate.

The coating contains lactose monohydrate,

macrogol 4000, titanium dioxide (E171) and

hypromellose.

What Escitalopram looks like and contents of

the pack

Escitalopram is a film-coated tablet.

The 5 mg film-coated tablets are white, round

and marked ‘EC 5’ on one side and ‘G’ on the other

side.

The 10 mg film-coated tablets are white, oblong,

scored and marked with “EC|10” on one side and

“G” on the other.

The 20 mg film-coated tablets are white, oblong,

scored and marked with “EC|20” on one side and

“G” on the other.

Escitalopram is available in blisters of 28 film-coated

tablets.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL,

United Kingdom.

Manufacturer

Gerard Laboratories, 35/36 Baldoyle Industrial

Estate, Grange Road, Dublin 13, Ireland.

Mylan Hungary Kft.,

Mylan utca 1, Komárom, 2900, Hungary.

This leaflet was last revised in 02/2020

2034370

Read the complete document

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Escitalopram 10 mg film-coated tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Escitalopram 10 mg film-coated tablets: each tablet contains 10 mg escitalopram (as

oxalate)

(referred to as Escitalopram tablets throughout this document)

Excipient with known effect:

10 mg film-coated tablets contain 0.8 mg lactose (as lactose monohydrate)

For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

Film-coated tablet.

Escitalopram 10 mg film-coated tablets: oblong, white, scored, film-coated

tablet marked with "EC|10" on one side and “G” on the other. The tablet can

be divided into equal doses.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Treatment of major depressive episodes.

Treatment of panic disorder with or without agoraphobia.

Treatment of social anxiety disorder (social phobia).

Treatment of generalised anxiety disorder.

Treatment of obsessive-compulsive disorder.

4.2

Posology and method of administration

Posology

Safety of daily doses above 20 mg has not been demonstrated.

Major depressive episodes

Usual dosage is 10 mg once daily. Depending on individual patient response,

the dose may be increased to a maximum of 20 mg daily.

Usually 2-4 weeks are necessary to obtain antidepressant response. After the

symptoms resolve, treatment for at least 6 months is required for consolidation

of the response.

Panic disorder with or without agoraphobia

An initial dose of 5 mg is recommended for the first week before increasing

the dose to 10 mg daily. The dose may be further increased, up to a maximum

of 20 mg daily, dependent on individual patient response.

Maximum effectiveness is reached after about 3 months. The treatment lasts

several months.

Social anxiety disorder

Usual dosage is 10 mg once daily. Usually 2-4 weeks are necessary to obtain

symptom relief. The dose may subsequently, depending on individual patient

response, be decreased to 5 mg or increased to a maximum of 20 mg daily.

Social anxiety disorder is a disease with a chronic course, and treatment for 12

weeks is recommended to consolidate response. Long-term treatment of

responders has been studied for 6 months and can be considered on an

individual basis to prevent relapse; treatment benefits should be re-evaluated at

regular intervals.

Social anxiety disorder is a well-defined diagnostic terminology of a specific

disorder, which should not be confounded with excessive shyness.

Pharmacotherapy is only indicated if the disorder interferes significantly with

professional and social activities.

The place of this treatment compared to cognitive behavioural therapy has not

been assessed. Pharmacotherapy is part of an overall therapeutic strategy.

Generalised anxiety disorder

Initial dosage is 10 mg once daily. Depending on the individual patient

response, the dose may be increased to a maximum of 20 mg daily.

Long-term treatment of responders has been studied for at least 6 months in

patients receiving 20 mg daily. Treatment benefits and dose should be re-

evaluated at regular intervals (see section 5.1).

Obsessive-compulsive disorder

Initial dosage is 10 mg once daily. Depending on the individual patient

response, the dose may be increased to a maximum of 20 mg daily.

As OCD is a chronic disease, patients should be treated for a sufficient period

to ensure that they are symptom free.

Treatment benefits and dose should be re-evaluated at regular intervals (see

section 5.1).

Elderly patients (> 65 years of age)

Initial dosage is 5 mg once daily. Depending on individual patient response the

dose may be increased to 10 mg daily (see section 5.2).

The efficacy of escitalopram in social anxiety disorder has not been studied in

elderly patients.

Paediatric population

Escitalopram should not be used in the treatment of children and adolescents

under 18 years of age (see section 4.4).

Reduced renal function

Dosage adjustment is not necessary in patients with mild or moderate renal

impairment. Caution is advised in patients with severely reduced renal

function (CL

less than 30 ml/min.) (see section 5.2).

Reduced hepatic function

An initial dose of 5 mg daily for the first two weeks of treatment is

recommended in patients with mild or moderate hepatic impairment.

Depending on individual patient response, the dose may be increased to 10 mg

daily. Caution and extra careful dose titration is advised in patients with

severely reduced hepatic function (see section 5.2).

Poor metabolisers of CYP2C19

For patients who are known to be poor metabolisers with respect to CYP2C19,

an initial dose of 5 mg daily during the first two weeks of treatment is

recommended. Depending on individual patient response, the dose may be

increased to 10 mg daily (see section 5.2).

Discontinuation symptoms seen when stopping treatment.

Abrupt discontinuation should be avoided. When stopping treatment with

escitalopram the dose should be gradually reduced over a period of at least one

to two weeks in order to reduce the risk of discontinuation symptoms (see

sections 4.4 and 4.8). If intolerable symptoms occur following a decrease in

the dose or upon discontinuation of treatment, then resuming the previously

prescribed dose may be considered. Subsequently, the physician may continue

decreasing the dose, but at a more gradual rate.

Method of administration

For oral use.

Escitalopram tablets are administered as a single daily dose and may be taken

with or without food.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section

6.1.

Concomitant treatment with non-selective, irreversible monoamine oxidase inhibitors

(MAO-inhibitors) is contraindicated due to the risk of serotonin syndrome with

agitation, shaking (tremor), hyperthermia etc. (see section 4.5).

The combination of escitalopram with reversible MAO-A inhibitors (e.g.

moclobemide) or the reversible non-selective MAO-inhibitor linezolid is

contraindicated due to the risk of onset of a serotonin syndrome (see section 4.5).

Escitalopram is contraindicated in patients with known QT-interval prolongation or

congenital long QT syndrome.

Escitalopram is contraindicated together with medicinal products that are known to

prolong the QT-interval (see section 4.5).

4.4

Special warnings and precautions for use

The following special warnings and precautions apply to the therapeutic class of SSRIs

(Selective Serotonin Re-uptake Inhibitors).

Paediatric population (children and adolescents under 18 years of age).

Escitalopram should not be used in the treatment of children and adolescents under the age of

18 years. Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility

(predominantly aggression, oppositional behaviour and anger) were more frequently observed

in clinical trials among children and adolescents treated with antidepressants compared to

those treated with placebo. If, based on clinical need, a decision to treat is nevertheless taken,

the patient should be carefully monitored for the appearance of suicidal symptoms. In

addition, long-term safety data in children and adolescents concerning growth, maturation and

cognitive and behavioural development are lacking.

Paradoxical anxiety

Some patients with panic disorder may experience increased anxiety symptoms at the

beginning of treatment with antidepressants. This paradoxical reaction usually subsides within

two weeks during continued treatment. A low starting dose is advised to reduce the likelihood

of an anxiogenic effect (see section 4.2).

Seizures

Escitalopram should be discontinued if a patient develops seizures for the first time, or if there

is an increase in seizure frequency (in patients with a previous diagnosis of epilepsy). SSRIs

should be avoided in patients with unstable epilepsy and patients with controlled epilepsy

should be closely monitored.

Mania

SSRIs should be used with caution in patients with a history of mania/hypomania. SSRIs

should be discontinued in any patient entering a manic phase.

Diabetes

In patients with diabetes, treatment with an SSRI may alter glycaemic control (hypoglycaemia

or hyperglycaemia). Insulin and/or oral hypoglycaemic dosage may need to be adjusted.

Suicide/suicidal thoughts or clinical worsening

Depression is associated with an increased risk of suicidal thoughts, self harm and suicide

(suicide-related events). This risk persists until significant remission occurs. As improvement

may not occur during the first few weeks or more of treatment, patients should be closely

monitored until such improvement occurs. It is general clinical experience that the risk of

suicide may increase in the early stages of recovery.

Other psychiatric conditions, for which escitalopram is prescribed can also be associated with

an increased risk of suicide-related events. In addition, these conditions may be co-morbid

with major depressive disorder. The same precautions observed when treating patients with

major depressive disorder should therefore be observed when treating patients with other

psychiatric disorders.

Patients with a history of suicide-related events, or those exhibiting a significant degree of

suicidal ideation prior to commencement of treatment, are known to be at greater risk of

suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.

A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients

with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants

compared to placebo in patients less than 25 years old.

Close supervision of patients and in particular those at high risk should accompany drug

therapy especially in early treatment and following dose changes.

Patients (and caregivers of patients) should be alerted about the need to monitor for any

clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to

seek medical advice immediately if these symptoms present.

Akathisia/psychomotor restlessness

The use of SSRIs/SNRIs has been associated with the development of akathisia, characterised

by a subjectively unpleasant or distressing restlessness and need to move often accompanied

by an inability to sit or stand still. This is most likely to occur within the first few weeks of

treatment

In patients who develop these symptoms, increasing the dose may be detrimental.

Hyponatraemia

Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has

been reported rarely with the use of SSRIs and generally resolves on discontinuation of

therapy. Caution should be exercised in patients at risk, such as the elderly, or patients with

cirrhosis, or if used in combination with other medications which may cause hyponatraemia.

Haemorrhage

There have been reports of cutaneous bleeding abnormalities, such as ecchymoses and

purpura, with SSRIs. Caution is advised in patients taking SSRIs, particularly in concomitant

use with oral anticoagulants, with medicinal products known to affect platelet function (e.g.

atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid

and non-steroidal anti-inflammatory medicinal products (NSAIDs), ticlopidine and

dipyridamole) and in patients with known bleeding tendencies.

ECT (electroconvulsive therapy)

There is limited clinical experience of concurrent administration of SSRIs and ECT, therefore

caution is advisable.

Serotonin syndrome

Caution is advisable if escitalopram is used concomitantly with medicinal products with

serotonergic effects such as sumatriptan or other triptans, tramadol and tryptophan. In rare

cases, serotonin syndrome has been reported in patients using SSRIs concomitantly with

serotonergic medicinal products. A combination of symptoms, such as agitation, tremor,

myoclonus and hyperthermia may indicate the development of this condition. If this occurs

treatment with the SSRI and the serotonergic medicinal product should be discontinued

immediately and symptomatic treatment initiated.

St. John's Wort

Concomitant use of SSRIs and herbal remedies containing St. John's Wort (Hypericum

perforatum) may result in an increased incidence of adverse reactions (see section 4.5).

Discontinuation symptoms seen when stopping treatment

Discontinuation symptoms when stopping treatment are common, particularly if

discontinuation is abrupt (see section 4.8). In clinical trials adverse events seen on treatment

discontinuation occurred in approximately 25% of patients treated with escitalopram and 15%

of patients taking placebo.

The risk of discontinuation symptoms may be dependent on several factors including the

duration and dose of therapy and the rate of dose reduction. Dizziness, sensory disturbances

(including paraesthesia and electric shock sensations), sleep disturbances (including insomnia

and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion,

sweating, headache, diarrhoea, palpitations, emotional instability, irritability, and visual

disturbances are the most commonly reported reactions. Generally these symptoms are mild

to moderate; however, in some patients they may be severe in intensity.

They usually occur within the first few days of discontinuing treatment, but there have been

very rare reports of such symptoms in patients who have inadvertently missed a dose.

Generally these symptoms are self-limiting and usually resolve within 2 weeks, though in

some individuals they may be prolonged (2-3 months or more). It is therefore advised that

escitalopram should be gradually tapered when discontinuing treatment over a period of

several weeks or months, according to the patient’s needs (see “Discontinuation symptoms

seen when stopping treatment”, section 4.2).

Coronary heart disease

Due to limited clinical experience, caution is advised in patients with coronary heart disease

(see section 5.3).

QT interval prolongation

Escitalopram has been found to cause a dose-dependent prolongation of the QT-interval.

Cases of QT interval prolongation and ventricular arrhythmia including torsade de pointes

have been reported during the post-marketing period, predominantly in patients of female

gender, with hypokalaemia, or with pre-existing QT interval prolongation or other cardiac

diseases (see sections 4.3, 4.5, 4.8, 4.9 and 5.1).

Caution is advised in patients with significant bradycardia; or in patients with recent acute

myocardial infarction or uncompensated heart failure.

Electrolyte disturbances such as hypokalaemia and hypomagnesaemia increase the risk for

malignant arrhythmias and should be corrected before treatment with escitalopram is started.

If patients with stable cardiac disease are treated, an ECG review should be considered before

treatment is started.

If signs of cardiac arrhythmia occur during treatment with escitalopram, the treatment should

be withdrawn and an ECG should be performed.

Angle-Closure Glaucoma

SSRIs including escitalopram may have an effect on pupil size resulting in mydriasis. This

mydriatic effect has the potential to narrow the eye angle resulting in increased intraocular

pressure and angle-closure glaucoma, especially in patients pre-disposed. Escitalopram should

therefore be used with caution in patients with angle-closure glaucoma or history of

glaucoma.

Sexual dysfunction

Selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors

(SNRIs) may cause symptoms of sexual dysfunction (see section 4.8). There have been

reports of long-lasting sexual dysfunction where the symptoms have continued despite

discontinuation of SSRIs/SNRI.

Lactose

This product contains lactose. Patients with rare hereditary problems of galactose intolerance,

the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5

Interaction with other medicinal products and other forms of interaction

Pharmacodynamic interactions

Contraindicated combinations:

Irreversible non-selective MAOIs

Cases of serious reactions have been reported in patients receiving an SSRI in

combination with a non-selective, irreversible monoamine oxidase inhibitor (MAOI),

and in patients who have recently discontinued SSRI treatment and have been started

on such MAOI treatment (see section 4.3). In some cases, the patient developed

serotonin syndrome (see section 4.8).

Escitalopram is contra-indicated in combination with non-selective irreversible

MAOIs. Escitalopram may be started 14 days after discontinuing treatment with an

irreversible MAOI. At least 7 days should elapse after discontinuing escitalopram

treatment, before starting a non-selective irreversible MAOI.

Reversible, selective MAO-A inhibitor (moclobemide)

Due to the risk of serotonin syndrome, the combination of escitalopram with a MAO-

A inhibitor such as moclobemide is contraindicated (see section 4.3). If the

combination proves necessary, it should be started at the minimum recommended

dosage and clinical monitoring should be reinforced.

Reversible, non-selective MAO-inhibitor (linezolid)

The antibiotic linezolid is a reversible non-selective MAO-inhibitor and should not be

given to patients treated with escitalopram. If the combination proves necessary, it

should be given with minimum dosages and under close clinical monitoring (see

section 4.3).

Irreversible, selective MAO-B inhibitor (selegiline)

In combination with selegiline (irreversible MAO-B inhibitor), caution is required

due to the risk of developing serotonin syndrome. Selegiline doses up to 10 mg/day

have been safely co-administered with racemic citalopram.

QT interval prolongation

Pharmacokinetic and pharmacodynamic studies of escitalopram combined with other

medicinal products that prolong the QT interval have not been performed. An

additive effect of escitalopram and these medicinal products cannot be excluded.

Therefore, co-administration of escitalopram with medicinal products that prolong the

QT interval, 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-malarial treatment particularly halofantrine), certain antihistamines (e.g.

astemizole, mizolastine), is contraindicated.

Combinations requiring precautions for use

Serotonergic medicinal products

Co-administration with serotonergic medicinal products (e.g. tramadol, sumatriptan

and other triptans) may lead to serotonin syndrome.

Medicinal products lowering the seizure threshold

SSRIs can lower the seizure threshold. Caution is advised when concomitantly using

other medicinal products capable of lowering the seizure threshold (e.g.

antidepressants (tricyclics, SSRIs), neuroleptics (phenothiazines, thioxanthenes and

butyrophenones), mefloquine, bupropion and tramadol).

Lithium, tryptophan

There have been reports of enhanced effects when SSRIs have been given together

with lithium or tryptophan, therefore concomitant use of SSRIs with these medicinal

products should be undertaken with caution.

St. John's Wort

Concomitant use of SSRIs and herbal remedies containing St. John's Wort

(Hypericum perforatum) may result in an increased incidence of adverse reactions

(see section 4.4).

Haemorrhage

Altered anti-coagulant effects may occur when escitalopram is combined with oral

anticoagulants. Patients receiving oral anticoagulant therapy should receive careful

coagulation monitoring when escitalopram is started or stopped (see section 4.4).

Concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) may increase

bleeding-tendency (see section 4.4).

Alcohol

No pharmacodynamic or pharmacokinetic interactions are expected between

escitalopram and alcohol. However, as with other psychotropic medicinal products,

the combination with alcohol is not advisable.

Medicinal products inducing hypokalaemia/hypomagnesaemia

Caution is warranted for concomitant use of hypokalaemia/hypomagnesaemia

inducing medicinal products as these conditions increase the risk of malignant

arrhythmias (see section 4.4).

Pharmacokinetic interactions

Influence of other medicinal products on the pharmacokinetics of escitalopram

The metabolism of escitalopram is mainly mediated by CYP2C19. CYP3A4 and

CYP2D6 may also contribute to the metabolism although to a smaller extent. The

metabolism of the major metabolite S-DCT (demethylated escitalopram) seems to be

partly catalysed by CYP2D6.

Co-administration of escitalopram with omeprazole 30 mg once daily (a CYP2C19

inhibitor) resulted in moderate (approximately 50%) increase in the plasma

concentrations of escitalopram.

Co-administration of escitalopram with cimetidine 400 mg twice daily (moderately

potent general enzyme-inhibitor) resulted in a moderate (approximately 70%)

increase in the plasma concentrations of escitalopram. Caution is advised when

administering escitalopram in combination with cimetidine. Dose adjustment may be

warranted.

Thus, caution should be exercised when used concomitantly with CYP2C19

inhibitors (e.g. omeprazole, esomeprazole, fluconazole, fluvoxamine, lansoprazole,

ticlopidine) or cimetidine. A reduction in the dose of escitalopram may be necessary

based on monitoring of side effects during concomitant treatment.

Effect of escitalopram on the pharmacokinetics of other medicinal products

Escitalopram is an inhibitor of the enzyme CYP2D6. Caution is recommended when

escitalopram is co-administered with medicinal products that are mainly metabolised

by this enzyme, and that have a narrow therapeutic index, e.g. flecainide, propafenone

and metoprolol (when used in cardiac failure), or some CNS acting medicinal

products that are mainly metabolised by CYP2D6, e.g. antidepressants such as

desipramine, clomipramine and nortriptyline or antipsychotics like risperidone,

thioridazine and haloperidol. Dosage adjustment may be warranted.

Co-administration with desipramine or metoprolol resulted in both cases in a twofold

increase in the plasma levels of these two CYP2D6 substrates.

In vitro studies have demonstrated that escitalopram may also cause weak inhibition

of CYP2C19. Caution is recommended with concomitant use of medicinal products

that are metabolised by CYP2C19.

4.6

Fertility, pregnancy and lactation

Pregnancy

For escitalopram only limited clinical data are available regarding exposed

pregnancies.

Animal studies have shown reproductive toxicity (see section 5.3). Escitalopram

tablets should not be used during pregnancy unless clearly necessary and only after

careful consideration of the risk/benefit.

Neonates should be observed if maternal use of Escitalopram continues into the later

stages of pregnancy, particularly in the third trimester. Abrupt discontinuation should

be avoided during pregnancy.

The following symptoms may occur in the neonate after maternal SSRI/SNRI use in

later stages of pregnancy: respiratory distress, cyanosis, apnoea, seizures, temperature

instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia,

hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence

and difficulty sleeping. These symptoms could be due to either serotonergic effects or

discontinuation symptoms. In a majority of instances the complications begin

immediately or soon (<24 hours) after delivery.

Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly

in late pregnancy, may increase the risk of persistent pulmonary hypertension in the

newborn (PPHN). The observed risk was approximately 5 cases per 1000

pregnancies. In the general population 1 to 2 cases of PPHN per 1000 pregnancies

occur.

Breast-feeding

It is expected that escitalopram will be excreted into human milk.

Consequently, breast-feeding is not recommended during treatment.

Fertility

Animal data have shown that citalopram may affect sperm quality (see section 5.3).

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