Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Escitil, 10 mg, film-coated tablets
Escitalopram
Please read the entire leaflet carefully before using this 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 pass it on to others. This medicine may harm other people, 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:

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).
You may not feel better until several weeks after starting 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 congenital heart rhythm disorders or has experienced episodes 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. Specifically, inform the doctor:

If the patient experiences seizures for the first time in life or if a patient with epilepsy has an increased frequency of seizures. 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 medication doses 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, or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility").
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 there is a slow resting heart rate and/or if it is known that the patient may have salt deficiency due to prolonged severe diarrhoea and vomiting or use of diuretics (water pills).
If there are rapid or irregular heartbeats, 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).
If the patient is being treated with opioids such as buprenorphine or buprenorphine in combination with naloxone, pethidine, tramadol. Taking these medicines together with Escitil may lead to serotonin syndrome, which may be life-threatening (see "Escitil with other medicines").

If the patient takes escitalopram with certain antidepressants or opioids, or even alone, a condition called serotonin syndrome may develop. The risk is small. Consult a doctor immediately if the patient experiences any symptoms related to this serious syndrome (see section 4).
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, usually 2–4 weeks must pass before improvement becomes evident. In the initial phase of treatment, some patients may experience increased anxiety, which subsides during continued treatment. Therefore, it is very important that the patient follows the doctor's instructions exactly and does not stop treatment or change the dose without consulting the doctor.
In some patients with bipolar disorder (manic-depressive illness), a manic phase may occur. It is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, contact the doctor.
In the first weeks of treatment, restlessness, 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 help monitor 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 the doctor or the nearest hospital.
Medicines such as escitalopram (so-called SSRIs) may cause sexual dysfunction symptoms (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 in the initial phase of treatment with antidepressants, as these medicines usually start to work only after about two weeks. Sometimes this period may be longer.
Patients more at risk of experiencing such symptoms include:

Patients who previously had suicidal thoughts or thoughts related to self-harm;
Young 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 antidepressants. 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 relatives 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 is generally not recommended for use in children and adolescents under 18 years of age.
It should also be noted that when taking medicines belonging to this class, patients under 18 years of age are at increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (especially aggression, oppositional behaviour, and anger). Nevertheless, a doctor may prescribe Escitil to patients under 18 years of age if they decide it is in their 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 regarding growth, maturation, cognitive development, and behavioural development has not yet been established.
Escitil with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform the 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 reactions;
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 opioids such as tramadol (used for severe pain), buprenorphine (a medicine used in the treatment of severe pain or drug addiction), or buprenorphine combined with naloxone (medicines used in the treatment of drug addiction), pethidine. These medicines may increase the risk of adverse reactions.
Escitil may interact with buprenorphine or buprenorphine combined with naloxone, with pethidine or tramadol, and serotonin syndrome may occur (see section 4). If the patient notices symptoms of this syndrome, they should contact the doctor;
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 (medicines used for pain relief or to thin the blood, known as anticoagulants). They may increase the tendency to bleed;
Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, known as anticoagulants). The doctor will likely order blood clotting time tests at the beginning of Escitil treatment and after its discontinuation to determine whether 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 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 possible risk of lowering the seizure threshold;
Neuroleptics (medicines used in the treatment of schizophrenia, psychosis) due to 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), certain antihistamines (astemizole, hydroxyzine, mizolastine). If you have further questions on this topic, consult your doctor.

Taking Escitil with food, drink, and alcohol
Escitil can be taken with or without food (see section 3. "How to take Escitil").
As with other medicines, it is not recommended to take Escitil together with alcohol, 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 plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
A pregnant or breastfeeding patient should not use Escitil without first discussing 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, shakiness, irritability, lethargy, constant crying, drowsiness, and difficulty falling asleep. If any of these symptoms occur in the newborn, contact the doctor immediately.
During pregnancy, Escitil should never be stopped abruptly.
Inform the 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 manifests as rapid breathing and cyanosis. These symptoms usually appear within the first day after birth. If such symptoms occur in the newborn, contact the doctor and/or midwife immediately.
Taking Escitil towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Escitil, she should inform the doctor or midwife so they can provide appropriate advice.
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.
Driving and operating machinery
The patient should not drive or operate machinery until they know how Escitil affects them.
Escitil contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Escitil

This medicine should always be taken exactly as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Escitil is available in the following strengths: 10 mg, 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 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 initial 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
Escitil should not be used in children and adolescents. For further information, see section “Important information before taking Escitil”.

Renal impairment
Caution is advised in patients with severe renal impairment. Use should be in accordance with your doctor's instructions.

Hepatic impairment
Patients with liver disease should not receive more than 10 mg per day. Use should be in accordance with your doctor's instructions.

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 should be in accordance with your doctor's instructions.

How to take the tablets
Escitil tablets can be taken with or without food. Swallow the tablet with water. Do not chew the tablet, as it has a bitter taste.
If necessary, the tablet can be divided into two equal parts. Place the tablet on a flat surface with the score line facing upwards. Then break the tablet by pressing down with both index fingers on each end of the tablet.

Duration of treatment
It may take several weeks of treatment before the patient starts to feel better. Therefore, continue taking Escitil even if improvement in well-being takes some time.
Do not change the dose of this medicine without first discussing it with your doctor.
Take Escitil for as long as your doctor recommends. If treatment is stopped too early, symptoms may return. Therefore, treatment should be continued for at least 6 months after improvement occurs.

Taking more Escitil than prescribed
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, irregular heartbeat, low blood pressure, and disturbances in fluid and electrolyte balance. Bring the medicine pack with you when visiting the doctor 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 bed, take the missed dose immediately. Take your next dose at the usual time. If you remember about the missed dose during the night or the following 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, your doctor will usually recommend gradually reducing 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 greater if Escitil has been taken for a long time, at high doses, or if the dose was 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 include: dizziness (unsteadiness, balance disturbances), tingling sensations, burning sensations, and (less commonly) electric shock-like sensations, 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 heartbeats).

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects usually resolve within a few weeks of treatment. It should be remembered that many
of these adverse effects may also be symptoms of the patient's illness and therefore may subside
as the patient's condition improves.
If any of the following adverse effects occur during treatment,
you should contact your doctor:
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, urticaria, or difficulty breathing or swallowing (severe allergic reaction),
high fever, agitation, confusion, disorientation, tremors and muscle spasms, which may be symptoms of a rare condition called serotonin syndrome.

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

difficulty urinating,
seizures, see also section "Warnings and precautions",
yellowing of the skin and whites of the eyes, indicating liver dysfunction/hepatitis,
rapid, 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 swelling of the skin or mucous membranes (angioedema),
severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection "Pregnancy, breastfeeding and fertility" in section 2.

In addition to the above, the following adverse effects have 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 sensation 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 100 people):

urticaria, rash, itching,
bruxism (teeth grinding), agitation, nervousness, panic attack, confusion,
sleep disturbances, taste disturbances, fainting,
dilated pupils, 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 concentration in the blood (symptoms include nausea, 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),
increased prolactin levels in blood,
galactorrhea in men and women who are not currently breastfeeding,
mania,
heart rhythm disturbances (referred to as QT interval prolongation, visible on ECG - electrocardiogram).

During treatment with escitalopram or shortly after discontinuation of treatment, suicidal thoughts or
thoughts of self-harm (including cases of suicidal ideation and suicidal behaviour) have been reported.
(See also section 2 "Warnings and precautions").
Moreover, numerous adverse effects are known to occur with medicines having a similar mechanism
of action to escitalopram (active substance in Escitil). These include:

psychomotor agitation (akathisia),
loss of appetite.

In patients taking medicines from this group, an increased risk of bone fractures has been observed.
Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl .
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Escitil

No special storage instructions are required.
Keep the medicine out of the 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Escitil contains
The active substance is escitalopram. Each tablet of Escitil contains 10 mg of escitalopram
(in the form of escitalopram oxalate).
The other ingredients are:
Core: microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica,
magnesium stearate.
Tablet coating: hypromellose (E 464), 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. The tablets are described as follows:
oval (8.1 x 5.6 mm), white, film-coated tablets with a score line on one side. The tablets can be divided into two equal parts.
Escitil is available in the following pack sizes:
Blister packs made of OPA/Aluminium/PVC/Aluminium in cardboard boxes containing 14, 28 or 56 film-coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Latvia, country of export:
EGIS Pharmaceuticals PLC
Keresztúri út 30-38
H-1106 Budapest
Hungary

Manufacturer:
EGIS Pharmaceuticals PLC
Bökényföldi út 118-120, H-1165 Budapest, Hungary
HBM Pharma s.r.o.
Sklabinská 30, 036 80 Martin, Slovak Republic
Delorbis Pharmaceuticals LTD.
17 Athinon Street, Ergates Industrial Area, Ergates, Lefkosia, 2643, Cyprus

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Latvia, country of export: 09-0417
Parallel Import Marketing Authorisation Number: 271/17

This medicinal product is authorised in 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