PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet; the information on the immediate packaging is in a foreign language!
Escitil
10 mg, film-coated tablets
Escitalopram
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Escitil is and what it is used for
Important information before taking Escitil
How to take Escitil
Possible side effects
How to store Escitil
Contents of the pack and other information

1. What Escitil is and what it is used for

Escitil contains escitalopram and is used to treat depression (major depressive episodes) and
anxiety disorders (such as panic attacks with or without agoraphobia – fear of open spaces,
social phobia, generalized anxiety disorder, and obsessive-compulsive disorder).
Escitalopram belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).
These medicines act on the serotoninergic system in the brain by increasing serotonin levels.
Disturbances in the serotoninergic system are considered to play an important role in the development of depression and related disorders.
You may not feel better until after several weeks of treatment.
You should continue taking Escitil even if you do not feel improvement for some time.
If there is no improvement or if you feel worse, contact your doctor.

2. Important information before using Escitil

When not to use Escitil

If the patient is allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).
If the patient is taking other medicines belonging to a group called monoamine oxidase inhibitors (MAOIs), including selegiline (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression), or linezolid (an antibiotic).
If the patient has a congenital heart rhythm disorder or has experienced an episode of heart rhythm disturbances (visible on ECG; a test assessing heart function).
If the patient is taking medicines used for heart rhythm disorders or that may affect heart rhythm (see section 2. “Escitil with other medicines”).

Warnings and precautions
Before starting treatment with Escitil, discuss this with your doctor.
Inform your doctor if the patient has any other disorders or diseases, as the doctor should take such information into account. In particular, inform the doctor:

If the patient experiences seizures for the first time in life, or if the frequency of seizures increases in a patient with epilepsy. Treatment with Escitil should be discontinued (see also section 4 “Possible side effects”).
If the patient has impaired liver or kidney function. Dose adjustment by the doctor may be required.
If the patient has diabetes. Treatment with Escitil may alter blood glucose control (glycaemia). Adjustment of insulin and/or oral glucose-lowering medications may be necessary.
If the patient has low sodium levels in the blood.
If the patient has an increased tendency to bleed or bruise easily.
If the patient is undergoing electroconvulsive therapy.
If the patient has ischemic heart disease.
If the patient has heart function disorders or has recently suffered a heart attack.
If the patient has a slow resting heart rate and/or is known to have electrolyte deficiency due to prolonged severe diarrhoea and vomiting or diuretic use (diuretics).
If the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart function.
If the patient has or has had eye disorders, such as certain types of glaucoma (increased eye pressure).

Note
As with other medicines used in the treatment of depression or similar conditions, improvement in the patient's condition does not occur immediately. The patient may notice improvement only after several weeks of treatment with Escitil.
In the treatment of panic attacks, it usually takes 2–4 weeks before improvement becomes evident. During the initial treatment period, some patients may experience increased anxiety, which subsides with continued treatment. It is therefore very important that the patient follows the doctor’s instructions exactly and does not stop treatment or change the dose without consulting the doctor.
Some patients with bipolar disorder (manic-depressive disorder) may experience a manic phase.
This is characterized by unusual and rapidly changing thoughts, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, contact the doctor.
During the first weeks of treatment, restlessness and difficulty sitting or standing still may also occur.
If such symptoms appear, inform the doctor immediately.
Sometimes the patient may not be aware of the symptoms described above, so it may be helpful to ask a friend or family member to assist in observing any changes in the patient’s behaviour.
If the patient has disturbing thoughts or experiences, or if any of the above symptoms occur during treatment, the patient should immediately contact their doctor or the nearest hospital.
Medicines such as escitalopram (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.
Suicidal thoughts and worsening of depression or anxiety disorder
Depression and/or anxiety disorders may be associated with thoughts of self-harm or suicidal thoughts. These symptoms may worsen during the initial phase of treatment with antidepressant medicines, as these medicines usually take about two weeks to start working. Sometimes this period may be longer.
Patients more at risk of experiencing such symptoms include:

Individuals who previously had suicidal thoughts or thoughts related to self-harm.
Younger adult patients. Clinical trial data indicate an increased risk of suicidal behaviour in adult patients under 25 years of age with psychiatric disorders treated with antidepressant medicines. If thoughts of self-harm or suicidal thoughts occur, contact the treating doctor immediately or go to the hospital. It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to report relevant information if they notice worsening depression or anxiety or disturbing changes in behaviour.

Children and adolescents
Escitil should generally not be used in children and adolescents under 18 years of age.
It should also be noted that patients under 18 years of age taking medicines of this class are at increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and anger). Nevertheless, a doctor may prescribe Escitil to patients under 18 years of age if they decide it is in the patient’s best interest.
If your doctor has prescribed Escitil for a patient under 18 years of age and you wish to discuss this, please contact the doctor again. If any of the above symptoms occur or worsen in patients under 18 years of age taking Escitil, inform your doctor. The long-term safety of Escitil use in this age group with regard to growth, maturation, and cognitive and behavioural development has not yet been established.

Escitil with other medicines
Inform your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform your doctor if the patient is taking any of the following medicines:

“Non-selective monoamine oxidase inhibitors (MAOIs)” containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine as active substances. If the patient has taken any of these medicines, they must wait 14 days before starting Escitil. After stopping Escitil, wait 7 days before taking any of these medicines;
“Reversible selective monoamine oxidase A (MAO-A) inhibitors” containing moclobemide (used in the treatment of depression);
“Irreversible monoamine oxidase B (MAO-B) inhibitors” containing selegiline (used in the treatment of Parkinson’s disease). These medicines increase the risk of adverse effects;
The antibiotic linezolid;
Lithium (used in the treatment of bipolar disorder) and tryptophan;
Imipramine and desipramine (both used in the treatment of depression);
Sumatriptan and similar medicines (used in the treatment of migraine) and tramadol (used for severe pain). These medicines may increase the risk of adverse effects;
Cimetidine, lansoprazole, and omeprazole (used in the treatment of stomach ulcers), fluconazole (used in the treatment of fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase the concentration of Escitil in the blood;
St. John’s wort (Hypericum perforatum) – a herbal medicine used in the treatment of depression;
Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (painkillers or blood-thinning medicines, known as anticoagulants). These may increase the tendency to bleed;
Warfarin, dipyridamole, and phenprocoumon (blood-thinning medicines, known as anticoagulants). The doctor will likely recommend monitoring blood clotting time at the start of Escitil treatment and after discontinuation to ensure the anticoagulant dose remains appropriate;
Mefloquine (used in the treatment of malaria), bupropion (used in the treatment of depression), and tramadol (used for severe pain) due to the possible risk of lowering the seizure threshold;
Neuroleptics (medicines used in the treatment of schizophrenia, psychosis), and antidepressants (tricyclic antidepressants and selective serotonin reuptake inhibitors (SSRIs)), due to the possible risk of lowering the seizure threshold;
Neuroleptics (medicines used in the treatment of schizophrenia, psychosis) due to the possible risk of lowering the seizure threshold, and antidepressants (tricyclic antidepressants and selective serotonin reuptake inhibitors);
Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), desipramine, clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Escitil may be required.
Medicines that reduce potassium and magnesium levels in the blood, as these conditions increase the risk of life-threatening heart rhythm disturbances.
DO NOT USE Escitil if the patient is taking medicines used for heart rhythm disorders or that may affect heart rhythm, such as class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine). If you have further questions on this topic, consult your doctor.

Taking Escitil with food, drink, and alcohol
Escitil may be taken with or without food (see section 3 “How to take Escitil”).
As with other medicines, it is not recommended to consume alcohol while taking Escitil, although no interaction between Escitil and alcohol is expected.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
A pregnant woman or a woman who is breastfeeding should not use Escitil unless she has discussed the risks and benefits of treatment with her doctor.
If the patient takes Escitil during the last three months of pregnancy, she should be aware that the newborn may experience the following symptoms: breathing difficulties, bluish skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood glucose levels, muscle stiffness or floppiness, increased reflex excitability, tremors, jitteriness, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping.
If the newborn shows any of these symptoms, contact a doctor immediately.
During pregnancy, Escitil should never be stopped abruptly.
Inform your doctor and/or midwife about taking Escitil. Taking medicines such as Escitil during pregnancy, especially during the last three months, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN). It is characterized by rapid breathing and cyanosis. These symptoms usually appear within the first day after birth. If such symptoms occur in the newborn, contact a doctor and/or midwife immediately.
Escitil is expected to be excreted in breast milk.
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces semen quality.
This may theoretically affect fertility, but such an effect has not been observed in humans to date.
Before taking any medicine, consult a doctor or pharmacist.

Escitil contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered “sodium-free”.

Driving and using machines
The patient should not drive or operate machinery until they know how Escitil affects them.

3. How to use the medicine Escitil

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Available on the market are: Escitil 10 mg and Escitil 20 mg.

Adults

Depression
The usual recommended dose of Escitil is 10 mg taken once daily. Your doctor may increase the dose up to a maximum of 20 mg per day.

Panic disorder
The initial dose of Escitil is 5 mg once daily during the first week of treatment, after which the dose is increased to 10 mg daily. Your doctor may then further increase the dose up to a maximum of 20 mg per day.

Social phobia
The usual recommended dose of Escitil is 10 mg taken once daily. Your doctor may then reduce the dose to 5 mg per day or increase it up to a maximum of 20 mg per day, depending on the patient's response to treatment.

Generalized anxiety disorder
The usual recommended dose of Escitil is 10 mg taken once daily. Your doctor may increase the dose up to a maximum of 20 mg per day.

Obsessive-compulsive disorder
The usual recommended dose of Escitil is 10 mg taken once daily. Your doctor may increase the dose up to a maximum of 20 mg per day.

Elderly patients (over 65 years of age)
The usual recommended starting dose of Escitil is 5 mg taken once daily.
Your doctor may increase the dose to 10 mg per day.

Use in children and adolescents (under 18 years of age)
Escitil should not be used in children and adolescents. For additional information, see section “Important information before using Escitil”.

Renal impairment
Caution is recommended in patients with severe renal impairment. Use as directed by your doctor.

Hepatic impairment
Patients with liver disease should not receive more than 10 mg per day. Use as directed by your doctor.

Patients known to be poor metabolizers of the enzyme CYP2C19
Patients with this known genotype should not receive more than 10 mg per day. Use as directed by your doctor.

Escitil may be taken with or without food. Swallow the tablet with water.
Do not chew the tablet, as it has a bitter taste.

If necessary, tablets may be divided into two equal parts by first placing the tablet on a flat surface with the score line facing upwards. The tablet can then be broken by pressing down with the index fingers of both hands on each end.

Duration of treatment
It may take several weeks of treatment before the patient feels better. Therefore, continue taking Escitil even if improvement takes some time.
Do not change the dose without first discussing it with your doctor.
Continue taking Escitil for as long as your doctor recommends. If treatment is stopped too early, symptoms may return. It is therefore recommended to continue treatment for at least 6 months after improvement occurs.

Taking more Escitil than recommended
If you have taken more Escitil than prescribed, contact your doctor immediately or go to the nearest hospital emergency department. This should be done even if you do not feel unwell. Symptoms of overdose may include dizziness, tremors, agitation, seizures, coma, nausea, vomiting, cardiac arrhythmias, hypotension, and disturbances in fluid and electrolyte balance. Bring the Escitil packaging with you to the doctor's office or hospital.

If you miss a dose of Escitil
Do not take a double dose to make up for a missed dose. If you forget to take a dose and remember before going to sleep, take the missed dose immediately and take your usual dose the next day. If you remember about the missed dose during the night or the next day, skip the missed dose and take the next dose at the usual time.

Stopping treatment with Escitil
Do not stop taking Escitil unless your doctor tells you to. When completing a full course of treatment, it is usually recommended to gradually reduce the dose of Escitil over a period of several weeks.
After stopping Escitil, especially if stopped abruptly, you may experience withdrawal symptoms.
These symptoms are common when stopping treatment with Escitil. The risk is higher if Escitil has been taken for a long time, at high doses, or if the dose has been reduced too quickly. In most patients, symptoms are mild and resolve spontaneously within two weeks. However, in some patients, symptoms may be more severe or last longer (2–3 months or more). If you experience severe withdrawal symptoms after stopping Escitil, contact your doctor. Your doctor may recommend restarting the medicine and tapering it more slowly.

Withdrawal symptoms may include: dizziness (unsteadiness, loss of balance), tingling sensations, burning sensations, and (less commonly) a sensation of electric shocks, also in the head; sleep disturbances (vivid dreams, nightmares, insomnia); feelings of anxiety; headache; nausea; sweating (including night sweats); psychomotor agitation or restlessness; tremors; feelings of disorientation; emotional instability or irritability; diarrhea (loose stools); visual disturbances; palpitations (fluttering or pounding in the chest).

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions usually resolve within a few weeks of treatment. It should be remembered that many
of these adverse reactions may also be symptoms of the patient's illness and therefore may resolve
as the patient's condition improves.
If any of the following adverse reactions occur during treatment,
contact your doctor immediately:
Uncommon (may occur in up to 1 in 100 patients):

unusual bleeding, including gastrointestinal bleeding (including from the rectum)

Rare (may occur in up to 1 in 1000 patients):

swelling of the skin, tongue, lips, throat or face, or difficulty breathing or swallowing (severe allergic reaction),
high fever, agitation, confusion, disorientation, tremors and violent muscle contractions, which may be symptoms of a rare condition called serotonin syndrome.

Not known (frequency cannot be estimated from available data):

difficulty passing urine
seizures, see also section "Warnings and precautions"
yellowing of the skin and whites of the eyes, indicating liver dysfunction/hepatitis
rapid or irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called Torsade de Pointes
thoughts of self-harm or suicidal thoughts, see also section "Warnings and precautions"
sudden onset of swelling of the skin or mucous membranes (angioedema)

In addition to the reactions listed above, the following adverse reactions have also been reported:
Very common (may occur in more than 1 in 10 people):

nausea
headache

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

nasal congestion or runny nose (sinusitis)
decreased or increased appetite
anxiety, psychomotor agitation, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, tingling sensations in the skin
diarrhoea, constipation, vomiting, dry mouth
excessive sweating
muscle and joint pain
sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty achieving orgasm in women)
feeling of fatigue, fever
weight gain

Uncommon (may occur in up to 1 in 1000 people):

urticaria, rash, itching
teeth grinding, agitation, nervousness, panic attack, confusion
sleep disturbances, taste disturbances, fainting
pupil dilation, visual disturbances, ringing in the ears (tinnitus)
hair loss
heavy menstrual bleeding
irregular menstruation
weight loss
rapid heartbeat
swelling of the upper or lower limbs
nosebleeds

Rare (may occur in up to 1 in 1000 people):

aggression, depersonalization, hallucinations
slow heartbeat

Not known (frequency cannot be estimated from available data):

decreased sodium blood concentration (symptoms include nausea, general malaise, muscle weakness or confusion)
dizziness upon standing due to low blood pressure (orthostatic hypotension)
abnormal liver function tests (increased liver enzyme activity in blood)
movement disorders (involuntary muscle movements)
painful penile erection (priapism)
bleeding, including petechiae on the skin and mucous membranes, and reduced platelet count (thrombocytopenia)
increased urine output (inappropriate antidiuretic hormone secretion)
milk production in men and in women who are not currently breastfeeding (galactorrhoea)
mania
heart rhythm abnormalities (known as QT interval prolongation, visible on ECG – electrocardiogram recording of the heart's electrical activity)

During treatment with escitalopram or shortly after discontinuation of treatment, suicidal thoughts or
thoughts of self-harm (including suicidal ideation and suicidal behaviour) have been reported. (See
also section "Warnings and precautions").
Moreover, numerous adverse reactions are known to occur with other drugs having a similar mechanism
of action to escitalopram (the active substance in Escitil). These include:

psychomotor restlessness (akathisia)
loss of appetite

In patients taking medicines in this class, an increased risk of bone fractures has been observed.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your
doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of
Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and
Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301 Fax: + 48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Escitil

There are no special requirements for storage of this medicine.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Escitil contains:
The active substance is escitalopram. Each Escitil tablet contains 10 mg or 20 mg of
escitalopram (as escitalopram oxalate).
The other ingredients are:
Core: microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica,
magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E 171), and macrogol 400.

What Escitil tablets look like and contents of the pack
Escitil is available as 10 mg film-coated tablets.
Escitil 10 mg – oval (8.1 x 5.6 mm), white, film-coated tablets, with a breakline on one side.
The tablets can be divided into two equal parts.
Escitil is available in the following pack sizes:
OPA/Alu/PVC-Aluminium blisters in cardboard cartons.
Packages containing 14, 28, or 56 tablets. Not all pack sizes may be marketed.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Bulgaria, the country of export:
Egis Pharmaceuticals PLC
Keresztúri út 30-38.
1106 Budapest
Hungary

Manufacturer:
Egis Pharmaceuticals PLC
Bökényföldi út 118-120.
1165 Budapest
Hungary
HBM Pharma s.r.o.
Sklabinská 30
036 80 Martin
Slovakia

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland

Marketing Authorisation Number in Bulgaria (country of export): 20090354
Parallel Import Authorisation Number: 398/22

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Bulgaria Есцитил 5 mg, 10 mg, 15 mg, 20 mg филмирани таблетки
Czech Republic Escitil 10 mg, 20 mg potahované tablety
Hungary Escitil 5 mg, 10 mg, 15 mg, 20 mg filmtabletta
Lithuania Escitil 5 mg, 10 mg, 15 mg, 20 mg plėvele dengtos tabletės
Latvia Escitil 10 mg, 20 mg apvalkotās tabletes
Poland Escitil, 10 mg, 20 mg, tabletki powlekane
Slovakia Escitil 5 mg, 10 mg, 15 mg, 20 mg filmom obalené tablety