Escitil

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Escitil

10 mg, coated tablets

Escitalopram

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Escitil and what is it used for
• 2. Important information before taking Escitil
• 3. How to take Escitil
• 4. Possible side effects
• 5. How to store Escitil
• 6. Contents of the pack and other information

1. What is Escitil and what is it used for

Escitil contains escitalopram and is used to treat depression (episodes of major depression) and anxiety disorders (such as panic attacks with or without agoraphobia - fear of being in open spaces, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder).
Escitalopram belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines work on the serotonin system in the brain by increasing the level of serotonin. Disruptions in the serotonin system are considered a significant factor in the development of depression and related diseases.
The patient may start to feel better only after a few weeks of therapy. You should continue taking Escitil, even if you don't feel better for a while.
If there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before taking Escitil

When not to take 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 to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).
• If the patient has congenital heart rhythm disorders or has had episodes of heart rhythm disorders (visible on an ECG - a test that evaluates heart function).
• If the patient is taking medicines used to treat heart rhythm disorders or that may affect heart rhythm (see section 2. "Escitil and other medicines").

Warnings and precautions

Before starting to take Escitil, the patient should discuss it with their doctor.
The patient should tell their doctor if they have any other disorders or diseases, as the doctor should take this information into account. In particular, the patient should inform their doctor:

• If they have had seizures for the first time in their life or if the frequency of seizures has increased in patients with epilepsy. The therapy with Escitil should be discontinued (see also section 4 "Possible side effects").
• If they have liver or kidney function disorders. Dose adjustment by the doctor may be required.
• If they have diabetes. Treatment with Escitil may change blood glucose control (glycemia). It may be necessary to adjust the dose of insulin and/or oral hypoglycemic agents.
• If they have low sodium levels in the blood.
• If they have an increased tendency to bleed and bruise easily.
• If they are being treated with electroconvulsive therapy.
• If they have coronary heart disease.
• If they have heart rhythm disorders or have recently had a heart attack.
• If they have slow heart rate at rest and/or it is known that the patient may have a salt deficiency due to prolonged severe diarrhea and vomiting or taking diuretics (diuretic drugs).
• If they have fast or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate abnormal heart function.
• If they have eye disorders, such as certain types of glaucoma (increased eye pressure).

Warning

As with other medicines used to treat depression or similar diseases, improvement in the patient's condition does not occur immediately. The patient may only feel it after a few weeks of treatment with Escitil.
In the treatment of panic attacks, it usually takes 2-4 weeks before an improvement in the patient's condition is visible. In the initial period of treatment, some patients may experience increased anxiety, which subsides during continued treatment. Therefore, it is very important for the patient to follow the doctor's instructions exactly and not stop treatment or change the dose without consulting their doctor.
In some patients with bipolar disorder (manic-depressive), a manic phase may occur.
This is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, the patient should contact their doctor.
In the first few weeks of treatment, anxiety, difficulty sitting or standing in one place, and restlessness may also occur.
If such symptoms appear, the patient should immediately inform their doctor.
Sometimes the patient may not be aware of the above symptoms, and therefore, it may be helpful to ask a friend or family member for help in observing any changes in the patient's behavior.
If the patient has disturbing thoughts or experiences, or if any of the above symptoms occur during treatment, they should immediately contact their doctor or the nearest hospital.
Medicines like 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 accompanied by thoughts of self-harm or suicidal thoughts. These symptoms may worsen in the initial phase of therapy with antidepressant medicines, as these medicines usually start to work only after about two weeks. Sometimes this period is longer.
The following are more likely to experience such symptoms:

• People who have had suicidal thoughts or self-harm thoughts before.
• Younger adult patients. Information obtained during clinical trials indicates an increased risk of suicidal behavior in adult patients under 25 years of age with mental disorders treated with antidepressant medicines. If suicidal thoughts or self-harm thoughts occur, the patient should immediately contact their attending doctor 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 can ask them to pass on the relevant information if they notice that the depression or anxiety has worsened or if there are disturbing changes in the patient's behavior.

Children and adolescents

Escitil should not normally be used in children and adolescents under 18 years of age.
It should also be remembered that in the case of taking medicines belonging to this class, patients under 18 years of age are at increased risk of adverse reactions, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and expressions of anger). Nevertheless, the doctor may prescribe Escitil to patients under 18 years of age, as they decide that it is in their best interest.
If the doctor has prescribed Escitil to a patient under 18 years of age and you want to discuss this, please contact the doctor again. If the above symptoms worsen or appear in patients under 18 years of age taking Escitil, the doctor should be informed. The long-term safety of using Escitil in this age group regarding growth, maturation, and cognitive and behavioral development has not been established yet.

Escitil and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should inform their doctor if they are taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substances. If the patient has taken any of these medicines, they must wait 14 days before starting to take Escitil. After stopping treatment with Escitil, they should wait 7 days before taking any of these medicines;
• Reversible selective monoamine oxidase A inhibitors (RIMAs) containing moclobemide (used to treat depression);
• Irreversible monoamine oxidase B inhibitors (MAO-B) containing selegiline (used to treat Parkinson's disease). These medicines increase the risk of adverse reactions;
• The antibiotic linezolid;
• Lithium (used to treat bipolar disorder) and tryptophan;
• Imipramine and desipramine (both used to treat depression);
• Sumatriptan and similar medicines (used to treat migraines) and tramadol (used to treat severe pain). These medicines may increase the risk of adverse reactions;
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may cause an increase in the level of Escitil in the blood;
• St. John's Wort (Hypericum perforatum) - a herbal medicine used to treat depression;
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (used as painkillers 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 prescribe a blood clotting test at the start of treatment with Escitil and after its discontinuation to determine if the dose of the anticoagulant is still appropriate;
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the possible risk of lowering the seizure threshold;
• Neuroleptics (medicines used to treat 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 to treat 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 to treat cardiovascular diseases), desipramine, clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotic medicines). Dose adjustment of Escitil may be required.
• Medicines that lower potassium and magnesium levels in the blood, as these conditions increase the risk of life-threatening heart rhythm disorders.
• DO NOT TAKE ESCITILif the patient is taking medicines used to treat heart rhythm disorders or that may affect heart rhythm, such as antiarrhythmic drugs of class IA and III, antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antibacterial drugs (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial drugs, especially halofantrine), and some antihistamines (astemizole, hydroxyzine, mizolastine). In case of further questions on this, the patient should consult their doctor.

Taking Escitil with food, drinks, 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 and drink alcohol at the same time, although no interaction between Escitil and alcohol is expected.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
A pregnant or breastfeeding patient should not take Escitil unless they have discussed the risks and benefits of treatment with their doctor.
If the patient takes Escitil in the last three months of pregnancy, they should be aware that the following symptoms may occur in the newborn: breathing difficulties, blue skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood sugar, muscle stiffness or weakness, increased reflexes, tremors, tremors, irritability, lethargy, constant crying, and sleep disturbances.
If any of these symptoms occur in the newborn, the patient should immediately contact their doctor.
Pregnancy should never be terminated abruptly while taking Escitil.
The patient should inform their doctor and/or midwife about taking Escitil. Taking medicines like Escitil during pregnancy, especially in the last three months, may increase the risk of serious complications in the newborn, called persistent pulmonary hypertension of the newborn (PPHN). This is characterized by rapid breathing and blue skin. These symptoms usually appear in the first day after birth. If such symptoms occur in the newborn, the patient should immediately contact their doctor and/or midwife.
It is assumed that Escitil will be excreted into breast milk.
In animal studies, it has been shown that citalopram, a medicine similar to escitalopram, reduces sperm quality.
Theoretically, this could affect fertility, but so far, no such effect has been observed in humans.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Escitil contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e., 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 take Escitil

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Escitil 10 mg and Escitil 20 mg are available on the market.
Adults
Depression
The recommended dose of Escitil is 10 mg, taken as one dose per day. The doctor may increase the dose of Escitil to a maximum of 20 mg per day.
Panic disorder
The initial dose of Escitil is 5 mg per day for the first week of treatment, then the dose is increased to 10 mg per day. The doctor may then increase the dose of Escitil to a maximum of 20 mg per day.
Social phobia
The recommended dose of Escitil is 10 mg, taken as one dose per day. The doctor may then decrease the dose to 5 mg per day or increase it to a maximum of 20 mg per day, depending on the patient's response to treatment.
Generalized anxiety disorder
The recommended dose of Escitil is 10 mg, taken as one dose per day. The doctor may increase the dose of Escitil to a maximum of 20 mg per day.
Obsessive-compulsive disorder
The recommended dose of Escitil is 10 mg, taken as one dose per day. The doctor may increase the dose of Escitil to a maximum of 20 mg per day.
Elderly patients (over 65 years of age)
The recommended initial dose of Escitil is 5 mg, taken as one dose per day.
The 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 more information, see the section "Important information before taking Escitil".
Renal impairment
Caution is recommended in patients with severe renal impairment. The patient should take Escitil as prescribed by their doctor.
Hepatic impairment
Patients with liver disease should not receive more than 10 mg per day. The patient should take Escitil as prescribed by their doctor.
Patients known to be poor metabolizers of CYP2C19
Patients with this known genotype should not receive more than 10 mg per day. The patient should take Escitil as prescribed by their doctor.
Escitil can be taken with or without food. The tablet should be swallowed with water.
It should not be chewed, as it tastes bitter.
If necessary, the tablets can be broken into two parts by placing the tablet on a flat surface with the dividing line facing upwards. The tablets can then be broken by pressing each end of the tablet downwards with the index fingers of both hands.

Duration of treatment

It may take a few weeks of treatment before the patient starts to feel better. Therefore, the patient should continue taking Escitil, even if it takes some time before they feel better.
The patient should not change the dose of the medicine without first talking to their doctor.
Escitil should be taken for as long as the doctor prescribes it. If the patient stops treatment too early, the symptoms may return. Therefore, it is recommended to continue treatment for at least 6 months after the symptoms have improved.

Taking a higher dose of Escitil than recommended

If the patient has taken a higher dose of Escitil than prescribed, they should immediately contact their doctor or go to the emergency department of the nearest hospital. This should be done even if the patient does not feel any discomfort. The symptoms of overdose include dizziness, tremors, restlessness, seizures, coma, nausea, vomiting, heart rhythm disorders, low blood pressure, and electrolyte imbalance. When visiting the doctor or hospital, the patient should take the packaging of Escitil with them.

Missing a dose of Escitil

The patient should not take a double dose to make up for a missed dose. If the patient has forgotten to take a dose and remembers before going to bed, they should take the missed dose immediately. The patient should take their usual dose the next day. If the patient remembers that they have missed a dose at night or the next day, they should skip the missed dose and take the next dose at the usual time.

Stopping treatment with Escitil

The patient should not stop taking Escitil unless their doctor tells them to. When the patient finishes the entire treatment cycle, it is usually recommended to gradually reduce the dose of Escitil over a period of several weeks.
After stopping treatment with Escitil, especially if it is stopped abruptly, the patient may experience withdrawal symptoms.
These symptoms are common when treatment with Escitil is discontinued. The risk is higher if Escitil has been taken for a long time, in high doses, or if the dose has been reduced too quickly. In most patients, the symptoms are mild and resolve on their own within two weeks. However, in some patients, they may be more severe or last longer (2-3 months or longer). If severe withdrawal symptoms occur after stopping treatment with Escitil, the patient should contact their doctor. The doctor may recommend restarting treatment with Escitil and tapering it off more slowly.
The withdrawal symptoms include: dizziness (unsteady gait, balance disorders), tingling sensation, burning sensation, and (less often) a sensation of electric shock, including in the head, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headaches, nausea (nausea), sweating (including night sweats), psychomotor restlessness or agitation, tremors, disorientation, emotional instability or irritability, diarrhea (loose stools), vision disturbances, heart palpitations or arrhythmias.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Escitil can cause side effects, although not everybody gets them.
Side effects usually resolve after a few weeks of treatment. It should be remembered that many of these side effects may also be symptoms of the patient's disease and will therefore resolve as the patient's condition improves.

If any of the following side effects occur during treatment, the patient should contact their doctor:

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

• Unusual bleeding, including bleeding from the gastrointestinal tract (including rectal bleeding)

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

• Swelling of the skin, tongue, lips, throat, or face, or difficulty breathing or swallowing (severe allergic reaction),
• High fever, restlessness, confusion, disorientation, tremors, and sudden muscle contractions, which may be symptoms of a rare disorder called serotonin syndrome.

Unknown (cannot be estimated from the available data):

• Difficulty urinating
• Seizures, see also section "Warnings and precautions"
• Yellowing of the skin and whites of the eyes, which is a symptom of liver dysfunction/liver inflammation
• Rapid, irregular heartbeat, fainting, which may be symptoms of a life-threatening heart rhythm disorder called Torsade de Pointes
• Suicidal thoughts or self-harm thoughts, see also section "Warnings and precautions"
• Sudden onset of swelling of the skin or mucous membranes (angioedema)

In addition to the above, the following side effects have been reported:

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

• Nausea (nausea)
• Headaches

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

• Nasal congestion or sinusitis (sinusitis)
• Decreased or increased appetite
• Anxiety, restlessness, abnormal dreams, sleep disturbances, drowsiness, dizziness, yawning, tremors, tingling sensation
• Diarrhea, constipation, vomiting, dry mouth
• Increased sweating
• Muscle and joint pain
• Sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty achieving orgasm in women)
• Fatigue, fever
• Weight gain

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

• Hives, rash, itching
• Teeth grinding, restlessness, nervousness, panic attacks, confusion
• Sleep disturbances, taste disorders, fainting
• Dilated pupils, vision disturbances, ringing in the ears (tinnitus)
• Hair loss
• Increased menstrual bleeding
• Irregular menstrual periods
• Weight loss
• Rapid heartbeat
• Swelling of the arms or legs
• Nosebleeds

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

• Aggression, depersonalization, hallucinations
• Slow heartbeat

Unknown (cannot be estimated from the available data):

• Decreased sodium levels in the blood (symptoms include nausea and malaise with muscle weakness or confusion)
• Dizziness when standing up due to low blood pressure (orthostatic hypotension)
• Abnormal liver function test results (increased liver enzyme activity in the blood)
• Movement disorders (involuntary muscle movements)
• Painful erection of the penis (priapism)
• Bleeding, including bruising on the skin and mucous membranes, and decreased platelet count (thrombocytopenia)
• Increased urine production (inappropriate antidiuretic hormone secretion)
• Milk production in men and women who are not currently breastfeeding
• Mania
• Heart rhythm disorder (called QT interval prolongation, visible on an ECG - a record of the heart's electrical activity)

During treatment with escitalopram or shortly after stopping treatment, suicidal thoughts or self-harm thoughts have been reported (including suicidal thoughts and behaviors). (See also section "Warnings and precautions").
Additionally, it is known that medicines with a similar mechanism of action to escitalopram (the active substance of Escitil) can cause the following side effects:

• Psychomotor restlessness (akathisia)
• Anorexia

Patients taking medicines from this group have been observed to have an increased risk of fractures.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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.
By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Escitil

There are no special precautions for storing the 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 month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Escitil contains:

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

What Escitil looks like and contents of the pack

Escitil is available as 10 mg coated tablets.
Escitil 10 mg - oval (8.1 x 5.6 mm), white, coated tablets with a dividing line on one side.
The tablets can be broken into two equal parts.
Escitil is available in the following packs:
OPA/Alu/PVC-Aluminum blisters in a cardboard box.
Packs containing 14, 28, 56 tablets. Not all pack sizes may be marketed.
For more information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization 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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Bulgaria, the country of export: 20090354

Parallel import authorization number: 398/22

This medicinal product is authorized 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
Date of leaflet approval: 07.11.2022
[Information about the trademark]