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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

• 1. What Escitil is and what it is used for
• 2. Before you take 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 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 disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder).
Escitalopram belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines work by increasing the levels of serotonin in the brain. Serotonin disturbances are believed to be important in the development of depression and related disorders.
You may not feel better immediately after taking the medicine. It may take several weeks before you start to feel better. 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. Before you take Escitil

When not to take Escitil

• If you are allergic to escitalopram or any of the other ingredients of this medicine.
• 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 defects or have had episodes of abnormal heart rhythms (visible on an ECG).
• If you are taking medicines that affect the heart rhythm or may affect the heart rhythm (see section 2 "Escitil and other medicines").

Warnings and precautions

Before taking Escitil, you should discuss it with your doctor.
You should tell your doctor if you have any other conditions or diseases, as your doctor should take this 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 disease. Your doctor may need to adjust the dose.
• If you have diabetes. Treatment with Escitil may affect blood sugar control. You may need to adjust the dose of insulin and/or oral hypoglycemic agents.
• If you have low sodium levels in the blood.
• If you have a tendency to bleed easily or have a history of bleeding, or if you are pregnant (see "Pregnancy, breastfeeding, and fertility").
• If you are being treated with 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 know that you may 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 pressure in the eye).

Caution

As with other medicines used to treat depression or similar conditions, improvement of the patient's condition may not occur immediately. The patient may feel better only after several weeks of treatment with Escitil. In the treatment of panic disorder, it usually takes 2-4 weeks before an improvement in the patient's condition is noticeable. During the initial treatment period, 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 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 insomnia may also occur. If such symptoms occur, you should inform your doctor immediately.
Sometimes the patient may not be aware of the above symptoms, and 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 contact their doctor or the nearest hospital immediately.
Medicines like escitalopram (so-called SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.

• In some cases, these symptoms may persist after stopping treatment.

Suicidal thoughts and worsening of depression or anxiety disorder

Depression and/or anxiety disorders can be associated with suicidal thoughts or 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 can be longer.
The following are more likely to experience these types of symptoms:

• People who have had suicidal thoughts or self-harm in the past.
• 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 self-harm occur, you should contact your doctor immediately. It may be helpful to inform relatives or friends about depression or anxiety disorders and ask them to read this leaflet. The patient may ask them to pass on the relevant information if they notice that depression or anxiety has worsened or if there are worrying changes in behavior.

Children and adolescents

Escitil is not usually given to children and adolescents under 18 years of age. It is also important to 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 anger). However, the doctor may prescribe Escitil to patients under 18 years of age if they decide it is in their best interest. If the doctor prescribes Escitil to a patient under 18 years of age and you want to discuss this, please contact the doctor again. If the above symptoms occur or worsen 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 taking now or have taken recently, 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 Escitil. After stopping 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 (MAO-B) 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 increased levels of Escitil in the blood;
• St. John's Wort (Hypericum perforatum) - a herbal medicine used to treat depression;
• Aspirin and non-steroidal anti-inflammatory medicines (used to relieve pain or 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 likely check your blood clotting time at the start of Escitil treatment and after stopping it to ensure that the anticoagulant dose 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). Dose adjustment of Escitil may be necessary.
• 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 may affect heart rhythm, such as antiarrhythmic medicines 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, 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 and drink alcohol at the same time, 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 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: difficulty breathing, blue skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, muscle stiffness or floppiness, increased reflexes, tremors, tremors, irritability, lethargy, constant crying, and sleep disturbances. If any of these symptoms occur in the newborn, you should contact your doctor immediately.
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 three 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 discoloration of the skin. These symptoms usually appear within the first day of life. If such symptoms occur in the newborn, you should contact your doctor and/or midwife immediately.
Taking Escitil near the end of pregnancy may increase the risk of severe bleeding from the vagina, which occurs shortly after delivery, especially if the patient has a history of bleeding disorders. If you take Escitil, you should inform your doctor or midwife so that they can provide you with 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 may 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 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, ask your doctor or pharmacist.
Adults
Depression
The recommended dose of Escitil is 10 mg, taken as a single dose once daily. 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 a single dose once daily. Your doctor may 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 a single dose once daily. 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 a single dose once daily. Your doctor may increase the dose to a maximum of 20 mg per day.
Elderly patients (over 65 years)
The recommended initial dose of Escitil is 5 mg, taken as a single dose once daily. Your doctor may increase the dose to 10 mg per day.
Use in children and adolescents (under 18 years)
Escitil should not be used in 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 with your index fingers.

Duration of treatment

It may take a few weeks of treatment before you feel better. You should therefore continue to take Escitil even if you do not feel better immediately. Do not change the dose of the medicine without talking to 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.

Taking more than the recommended dose of Escitil

If you have taken more than the prescribed dose of Escitil, you should contact your doctor or go to the emergency department of the nearest hospital immediately. 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 take the Escitil packaging with you to the doctor or hospital.

Forgetting to take a dose of Escitil

You should not take a double dose to make up for a forgotten dose. If you forget to take a dose and remember before bedtime, you should take the missed dose immediately. You should take your usual dose the next day. If you remember that 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 with Escitil

You should not stop taking Escitil unless your doctor tells you to. When you finish the treatment, your doctor will usually recommend that you gradually reduce the dose of Escitil 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 treatment 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 may be more severe or last longer (2-3 months or longer). If you experience severe withdrawal symptoms after stopping Escitil, you should contact your doctor. Your doctor may recommend that you start taking the medicine again and reduce the dose more slowly.
Withdrawal symptoms include dizziness (unsteady gait, balance disturbances), tingling sensation, burning sensation, and (less commonly) electric shock sensations, including in the head, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headaches, nausea (feeling sick), sweating (including night sweats), restlessness or agitation, tremors, disorientation, emotional instability or irritability, diarrhea (loose stools), vision disturbances, heart palpitations or rapid heartbeat, and ringing in the ears (tinnitus).
If you have any further questions about taking this medicine, 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. It should be remembered that many of these side effects can also be symptoms of the patient's illness and will therefore disappear as the patient's condition improves.

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 gastrointestinal bleeding (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 the muscles, these may be symptoms of a rare condition 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 may be a sign of liver damage or hepatitis
• Rapid or irregular heartbeat, fainting, which may be symptoms of a life-threatening heart rhythm disorder called Torsade de Pointes
• Suicidal thoughts or self-harm, see also section "Warnings and precautions"
• Sudden swelling of the skin or mucous membranes (angioedema)
• Severe bleeding from the vagina, which occurs 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, yawning, tremors, tingling sensation
• Diarrhea, constipation, vomiting, dry mouth
• Increased sweating
• Muscle and joint pain
• Sexual disturbances (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
• Teeth grinding, agitation, 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 test results (increased liver enzyme activity in the blood)
• Movement disorders (involuntary muscle movements)
• Painful erection of the penis (priapism)
• Bleeding, including bruising and bleeding from 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
• Abnormal heart rhythm (a condition called QT interval prolongation, visible on an electrocardiogram)

During treatment with escitalopram or shortly after stopping treatment, suicidal thoughts or self-harm have been reported (suicidal thoughts and behaviors). (See also section "Warnings and precautions").
In addition, many side effects have been reported with medicines of the same class as escitalopram (the active substance in Escitil). These include:
Restlessness (akathisia)
Anorexia
It is known that patients taking medicines of this class have an increased risk of fractures.
Reporting side effects
If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Monitoring, 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.
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 stated.
Medicines should not be disposed of via wastewater or household waste. 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 Escitil tablet contains 10 mg or 20 mg of escitalopram (as oxalate).
Other ingredients are:
Core: microcrystalline cellulose, sodium carboxymethylcellulose, anhydrous colloidal silica, 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. Below is a description of the tablets:
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 of 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 leaflet: 25.11.2024