Escitil

Package Leaflet: Information for the User

Escitil, 10 mg, coated tablets
Escitil, 20 mg, coated tablets
Escitalopram

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 (major depressive episodes) and anxiety disorders (such as panic attacks with or without agoraphobia, 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 serotonin levels. Disruptions in the serotonin system are thought to be an important factor in the development of depression and related disorders.
The patient may start to feel better after a few weeks of treatment. You should continue to take Escitil even if you do not feel better immediately.
If you do not feel better or feel worse, you should contact your doctor.

2. Important information before taking Escitil

When not to take Escitil

• If you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).
• If you are taking other medicines that belong 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 you have congenital heart rhythm disorders or have had episodes of heart rhythm disorders (visible on an ECG; a test that evaluates heart function).
• If you are taking medicines that affect heart rhythm or may affect heart rhythm (see section 2 "Escitil and other medicines").

Warnings and precautions

Before starting to take Escitil, you should discuss this with your doctor.
You should tell your doctor if you have other disorders or diseases, as your doctor should take this information into account. In particular, you should inform your doctor:

• If you have had seizures for the first time in your life or if you have epilepsy and the frequency of seizures increases. You should stop taking Escitil (see also section 4 "Possible side effects").
• If you have liver or kidney problems. Your doctor may need to adjust the dose.
• If you have diabetes. Treatment with Escitil may affect blood sugar control (glycemia). You may need to adjust the dose of insulin and/or oral hypoglycemic agents.
• If you have low sodium levels in your blood.
• If you have a tendency to bleed easily or bruise easily, or if you are pregnant (see "Pregnancy, breastfeeding, and fertility").
• If you are undergoing electroconvulsive therapy.
• If you have coronary heart disease.
• If you have heart rhythm disorders or have recently had a heart attack.
• If you have slow heart rate at rest and/or if you know you have low salt levels due to prolonged severe diarrhea and vomiting or taking diuretics (water pills).
• If you experience fast or irregular heartbeat, fainting, or dizziness when standing up, which may indicate abnormal heart function.
• If you have eye disorders, such as certain types of glaucoma (increased eye pressure).

Caution

As with other medicines used to treat depression or similar diseases, improvement in the patient's condition does not occur immediately. The patient may not feel better until 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. During the initial treatment period, some patients 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 a doctor.
In some patients with bipolar disorder (manic-depressive disorder), 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, you should contact your doctor.
In the first few weeks of treatment, anxiety, difficulty sitting or standing still, or restlessness may also occur. If such symptoms appear, you should immediately inform your doctor.
Sometimes the patient may not be aware of the above symptoms, and therefore, it may be helpful to ask someone from their friends or family to help observe any changes in the patient's behavior.
If the patient has worrying 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 (see section 4). In some cases, these symptoms persist after treatment has stopped.

• In some cases, these symptoms persist after treatment has stopped.

Suicidal thoughts and worsening of depression or anxiety disorder

Depression and/or anxiety disorders can be accompanied by suicidal thoughts or thoughts of self-harm. These symptoms may worsen during the initial phase of treatment 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 thoughts of self-harm before.
• Younger adults. Information from 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 thoughts of self-harm occur, you should immediately contact your doctor or go to the hospital. It may be helpful to inform relatives or friends about your depression or anxiety disorder and ask them to read this leaflet. You can ask them to pass on the relevant information if they notice that your depression or anxiety has worsened or if you have worrying changes in behavior.

Children and adolescents

Escitil is not usually given to children and adolescents under 18 years of age.
You should also remember that in the case of taking medicines of this class, patients under 18 years of age are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and expressions of anger). Nevertheless, your 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 to a patient under 18 years of age and you want to discuss this, please contact your doctor again. If the above symptoms worsen or appear in patients under 18 years of age taking Escitil, you should inform your doctor. The long-term safety of Escitil in this age group regarding growth, maturation, and cognitive and behavioral development has not been established yet.

Escitil and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should inform your doctor if you are taking any of the following medicines:

• "Non-selective monoamine oxidase inhibitors (MAOIs)" containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If you have taken any of these medicines, you must wait 14 days before starting to take Escitil. After stopping treatment with Escitil, you 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" containing selegiline (used to treat Parkinson's disease). These medicines increase the risk of side effects;
• 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 side effects;
• 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 Escitil levels 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 risk of bleeding;
• warfarin, dipyridamole, and phenprocoumon (used to thin the blood, known as anticoagulants). Your doctor will probably ask you to have your blood clotting time checked at the start of treatment with Escitil and after stopping it, to make sure that 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;
• antipsychotics (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;
• antipsychotics (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 heart conditions), desipramine, clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). It may be necessary to adjust the dose of Escitil.
• 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 you are taking medicines used to treat heart rhythm disorders or that may affect heart rhythm, such as anti-arrhythmic medicines of class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial medicines, especially halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine). If you have any further questions on this, ask 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 with alcohol, although no interaction between Escitil and alcohol is expected.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnant or breastfeeding women should not take Escitil unless they have discussed the risks and benefits with their doctor.
If you take Escitil during the last 3 months of pregnancy, you should be aware that the following symptoms may occur in the newborn: breathing difficulties, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, stiffness or floppiness, increased reflexes, tremors, jitteriness, irritability, lethargy, constant crying, and sleep disturbances. If the newborn experiences any of these symptoms, you should immediately contact your doctor.
Escitil should never be stopped abruptly during pregnancy.
You should inform your doctor and/or midwife that you are taking Escitil. Taking medicines like Escitil, especially in the last 3 months of pregnancy, may increase the risk of the newborn developing a condition called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and blue skin and usually appears in the first day after birth. If such symptoms occur in the newborn, you should immediately contact your doctor and/or midwife.
Taking Escitil towards the end of pregnancy may increase the risk of serious bleeding from the uterus, occurring shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Escitil, you should inform your doctor or midwife so that they can give you appropriate advice.
It is assumed that Escitil will pass into breast milk.
In animal studies, it has been shown that citalopram, a medicine similar to escitalopram, reduces sperm quality. This could theoretically affect fertility, but so far, no such effect has been observed in humans.
Before taking any medicine, you should consult your doctor or pharmacist.

Driving and using machines

You should not drive or operate machinery until you know how Escitil affects you.
Escitil contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is essentially "sodium-free".

3. How to take Escitil

This medicine should always be taken exactly as your doctor has instructed you. If you are unsure, ask your doctor or pharmacist.
Adults
Depression
The recommended dose of Escitil is 10 mg, taken as one dose per day. Your doctor may increase the dose to a maximum of 20 mg per day.
Panic disorder
The initial dose of Escitil is 5 mg per day for the first week, then the dose is increased to 10 mg per day. Your doctor may then increase the dose to a maximum of 20 mg per day.
Social anxiety disorder
The recommended dose of Escitil is 10 mg, taken as one dose per day. Your doctor may then decrease the dose to 5 mg per day or increase it to a maximum of 20 mg per day, depending on your response to treatment.
Generalized anxiety disorder
The recommended dose of Escitil is 10 mg, taken as one dose per day. Your doctor may increase the dose 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. Your doctor may increase the dose 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. 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 given to children and adolescents. For more information, see section "Important information before taking Escitil".
Renal impairment
Caution is advised in patients with severe renal impairment. You should take Escitil as directed by your doctor.
Hepatic impairment
Patients with liver disease should not receive more than 10 mg per day. You should take Escitil as directed by your doctor.
Patients known to be poor metabolizers of CYP2C19
Patients with this known genotype should not receive more than 10 mg per day. You should take Escitil as directed by your doctor.
Escitil can be taken with or without food. The tablet should be swallowed with water. Do not chew it, as it tastes bitter.
If necessary, the tablets can be broken into two halves by placing the tablet on a flat surface with the score line facing upwards. The tablet can then be broken by pressing down on each end of the tablet with your index fingers.

Duration of treatment

It may take a few weeks of treatment before you start to feel better. You should therefore continue to take Escitil even if you do not feel better immediately.
You should not change the dose of the medicine without consulting your doctor first.
Escitil should be taken for as long as your doctor recommends. If you stop treatment too early, your symptoms may return. It is recommended to continue treatment for at least 6 months after you start to feel better.

Overdose

If you have taken more than the prescribed dose of Escitil, you should immediately contact your doctor or go to the emergency department of the nearest hospital. You should do this even if you do not feel any discomfort. Symptoms of overdose include dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, heart rhythm disturbances, low blood pressure, and electrolyte disturbances. You should bring the package leaflet and any remaining tablets with you to the hospital.

Missed dose

You should not take a double dose to make up for a forgotten dose. If you forget to take a dose and remember before going to bed, you should take the missed dose immediately. You should take your normal dose the next day. If you remember you have missed a dose in the night or the next day, you should skip the missed dose and take your next dose at the usual time.

Stopping treatment

You should not stop taking Escitil unless your doctor tells you to. When you finish your treatment, your doctor will usually advise you to reduce the dose gradually over a few weeks.
After stopping treatment with Escitil, especially if it is stopped abruptly, you may experience withdrawal symptoms. These symptoms are common when Escitil is stopped. 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 disappear on their own within two weeks. In some patients, however, they can be more severe or longer-lasting (2-3 months or longer). If you experience severe withdrawal symptoms after stopping Escitil, you should contact your doctor. Your doctor may advise you to start taking Escitil again and to reduce the dose more slowly.
Withdrawal symptoms include dizziness (unsteady gait, balance disturbances), tingling sensations, burning sensations, and (less commonly) electric shock-like sensations, including in the head, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headaches, nausea (feeling sick), sweating (including night sweats), restlessness or agitation, tremors, confusion, unsteadiness or emotional instability, diarrhea (loose stools), visual disturbances, palpitations or rapid heartbeat.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Escitil can cause side effects, although not everybody gets them.
Side effects usually disappear after a few weeks of treatment. You should remember that many of these side effects can also be symptoms of your illness and will therefore improve as you get better.

If you experience any of the following side effects during treatment, you should contact your doctor:

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

• unusual bleeding, including bleeding from the digestive 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, agitation, confusion, trembling, and sudden contractions of muscles, these 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, indicating liver damage or hepatitis
• fast, irregular heartbeat, fainting, which can be symptoms of a life-threatening heart rhythm disorder called Torsades de Pointes. suicidal thoughts or thoughts of self-harm, see also section "Warnings and precautions"
• sudden swelling of the skin or mucous membranes (angioedema)
• severe bleeding from the uterus, occurring shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2.

The following side effects have also been reported:

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

• nausea (feeling sick)
• headaches

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

• nasal congestion or sinusitis (sinus infection)
• decreased or increased appetite
• anxiety, restlessness, abnormal dreams, difficulty sleeping, sleepiness, dizziness, yawning, tremors, tingling sensations
• diarrhea, constipation, vomiting, dry mouth
• increased sweating
• muscle and joint pain
• sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty reaching orgasm in women)
• feeling tired, fever
• weight gain

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

• hives, rash, itching
• grinding of the teeth, restlessness, nervousness, panic attacks, confusion
• sleep disturbances, taste disturbances, fainting
• dilated pupils, vision disturbances, ringing in the ears (tinnitus)
• hair loss
• heavy 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 tests (increased liver enzyme activity in the blood)
• movement disorders (involuntary movements)
• painful erection of the penis (priapism)
• bleeding, including bruising and low platelet count (thrombocytopenia)
• increased urine production (inappropriate antidiuretic hormone secretion)
• milky discharge from the breasts in men and women who are not breastfeeding
• mania
• abnormal heart rhythm (called QT prolongation, visible on an ECG - a recording of the electrical activity of the heart)

During treatment with escitalopram or after stopping treatment, suicidal thoughts or thoughts of self-harm have been reported (see also section "Warnings and precautions").
Additionally, the following side effects are known to occur with medicines of the same class as escitalopram (the active substance in Escitil):
restlessness (akathisia)
loss of appetite
It is known that patients taking medicines like escitalopram have an increased risk of fractures.
Reporting side effects
If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety, 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, you can help provide more information on the safety of this medicine.

5. How to store Escitil

There are no special storage instructions for this medicine.
You should keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label or carton after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Escitil contains:

The active substance is escitalopram. Each tablet contains 10 mg or 20 mg of escitalopram (as oxalate).
The other ingredients are:
Core: microcrystalline cellulose, sodium carboxymethylcellulose, silicon dioxide, magnesium stearate.
Coating: hypromellose 6 cP, titanium dioxide (E 171), and macrogol 400.

What Escitil looks like and contents of the pack:

Escitil is available as 10 mg and 20 mg coated tablets. The tablets are described below:
Escitil 10 mg - oval (8.1 x 5.6 mm), white, coated tablets with a score line on one side.
The tablets can be broken into two equal halves.
Escitil 20 mg - oval (11.6 x 7.1 mm), white, coated tablets with a score line on one side.
The tablets can be broken into two equal halves.
Escitil is available in the following packs:
Blister packs (OPA/Aluminum/PVC/Aluminum) containing 7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 200, 500 tablets (blister packs)
30 x 1, 49 x 1, 100 x 1 tablets (unit dose blisters)
In Poland, packs containing 14, 28, 56 tablets are registered.
Not all pack sizes may be marketed.

Marketing authorization holder

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
Delorbis Pharmaceuticals LTD.
17 Athinon Street,
Ergates Industrial Area,
Ergates, Lefkosia, 2643
Cyprus

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 last revision of the package leaflet: 25.11.2024