Elicea

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Elicea, 20 mg, coated tablets

Escitalopram

Before taking the medicine, carefully read the contents of this leaflet, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, 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 those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Elicea and what is it used for

Elicea contains escitalopram and is used to treat depression (episodes of major depression) and anxiety disorders [such as anxiety disorder with panic attacks (panic disorder) 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 the level of serotonin. Disorders of the serotonin system in the brain play an important role in the development of depression and related disorders. It may take several weeks before the patient feels an improvement. Therefore, the patient should continue taking Elicea, even if they do not feel better initially. The patient should talk to their doctor if they do not feel better or feel worse while taking this medicine.

2. Important information before taking Elicea

When not to take Elicea

• 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 the group of MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic);
• in patients with congenital heart rhythm disorders or if the patient has had an episode of heart rhythm disorders (in ECG; a test that evaluates heart function);
• if the patient is taking medicines for heart rhythm disorders or that may affect heart rhythm (see section 2. "Elicea and other medicines").

Warnings and precautions

Before starting treatment with Elicea, the patient should consult a doctor or pharmacist. The patient should inform their doctor about all other diseases and disorders, as they may need to be taken into account. In particular, the patient should inform their doctor:

• if they have epilepsy. If seizures occur or their frequency increases, treatment with Elicea should be discontinued (see also section 4. "Possible side effects");
• if they have liver or kidney function disorders. The doctor may need to adjust the dose;
• if they have diabetes. Taking Elicea may affect blood sugar control. The dose of insulin and/or oral hypoglycemic agents may need to be adjusted;
• if they have low sodium levels in the blood;
• if they have an increased tendency to bleed or bruise easily or if they are pregnant (see section "Pregnancy, breastfeeding, and fertility");
• if they are being treated with electroconvulsive therapy;
• if they have coronary heart disease;
• if they have or have had heart disease or have recently had a heart attack;
• if they have low resting heart rate and/or know they may have a salt deficiency due to prolonged, severe diarrhea, vomiting, or the use of diuretics;
• if they experience rapid or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate heart rhythm disorders;
• if they currently have or have had eye diseases, such as certain types of glaucoma (increased pressure in the eye);
• if they are taking this medicine with buprenorphine. This combination may lead to serotonin syndrome, a life-threatening condition (see section "Elicea and other medicines").

Warning!

In some patients with manic-depressive disorders, a manic phase may occur. It is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive motor activity. If such symptoms occur, the patient should contact their doctor. In the first few weeks of treatment, symptoms such as anxiety or difficulty sitting still or standing in one place may occur. The patient should immediately inform their doctor if they experience any of these symptoms. Medicines like Elicea (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was discontinued.

Suicidal thoughts and worsening of depression or anxiety disorders

If the patient has depression and/or anxiety disorders, they may experience suicidal thoughts or behaviors. These symptoms may worsen at the beginning of treatment with antidepressant medicines, as they usually start working after about 2 weeks, sometimes later. These symptoms are more likely:

• in patients who have had suicidal thoughts or self-harm before,
• in young adult patients. Clinical trial data show an increased risk of suicidal behavior in people under 25 with mental disorders treated with antidepressant medicines.

If the patient experiences suicidal thoughts or self-harm they must immediatelyinform their doctor or contact the nearest healthcare center.It may be helpful to inform relatives or friendsabout the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to monitor their condition and inform them if they notice any worsening of depression or anxiety or any disturbing changes in behavior.

Children and adolescents

Elicea should not be used in children and adolescents under 18 years of age. When taking medicines from this group, 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). However, the doctor may prescribe Elicea to a patient under 18 years of age if they consider it necessary. If the doctor prescribes Elicea to a patient under 18 years of age, and this causes any concerns, the patient should contact the doctor again. Additionally, as of now, there is a lack of data on the safety of long-term use of Elicea in this age group regarding growth, maturation, and cognitive and behavioral development.

Elicea and other medicines

The patient should tell their doctor or pharmacist 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) (used to treat depression), containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substances. If the patient has taken any of these medicines, they should wait 14 days after stopping them before starting treatment with Elicea. After stopping Elicea, the patient should wait 7 days before taking any of these medicines;
• reversible selective MAO-A inhibitors, containing moclobemide (used to treat depression);
• irreversible MAO-B inhibitors, including selegiline (used to treat Parkinson's disease). They increase the risk of side effects;
• the antibiotic linezolid;
• lithium (used to treat manic-depressive disorders) and tryptophan (used to treat depression);
• imipramine and desipramine (used to treat depression);
• sumatriptan and similar medicines (used to treat migraines) and tramadol or buprenorphine (used to treat severe pain). These medicines may interact with Elicea and cause symptoms such as involuntary, rhythmic muscle contractions, including those that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, high body temperature above 38°C. If the patient experiences such symptoms, they should contact their doctor;
• cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (an antifungal medicine), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may cause an increase in escitalopram 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 (medicines used to treat pain or to "thin" the blood, known as anticoagulants). This may increase the risk of bleeding;
• warfarin, dipyridamole, and phenprocoumon (used to "thin" the blood, known as anticoagulants). The doctor may order a blood clotting test at the beginning and after stopping treatment with Elicea 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 risk of lowering the seizure threshold;

Antipsychotics (used to treat schizophrenia and psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the risk of lowering the seizure threshold; flecainide, propafenone, and metoprolol (used to treat cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). It may be necessary to adjust the dosage of Elicea; medicines that lower potassium or magnesium levels in the blood increase the risk of life-threatening heart rhythm disorders. DO NOT TAKE Eliceaif the patient is taking medicines used to treat heart rhythm disorders or that may affect heart rhythm, such as antiarrhythmic medicines of class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, antimalarial medicines, mainly halofantrine), and certain antihistamines (astemizole, mizolastine). In case of any further doubts, the patient should consult their doctor.

Elicea with food, drinks, and alcohol

Elicea can be taken with or without food (see section 3. "How to take Elicea"). Like other medicines, Elicea should not be taken with alcohol, although no interaction between Elicea and alcohol has been shown.

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 or pharmacist before taking this medicine. If the patient is pregnant, they should not take Elicea unless they have discussed the risks and benefits with their doctor. If the patient takes Elicea in the last 3 months of pregnancy, they should be aware that the newborn may experience the following symptoms: breathing difficulties, blue discoloration of the skin, seizures, fluctuations in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or weakness, increased reflexes, tremors, sweating, and sleep disturbances. If the newborn experiences any of these symptoms, the patient should immediately contact their doctor. The patient should ensure that the midwife and/or doctor knows they are taking Elicea. Medicines like Elicea, taken during pregnancy, especially in the last 3 months, may increase the risk of a serious condition in the child, called persistent pulmonary hypertension of the newborn (PPHN), characterized by increased breathing rate and blue discoloration of the skin. These symptoms usually occur within the first 24 hours after birth. If these symptoms occur, the patient should immediately contact their doctor or midwife. When taking Elicea during pregnancy, the patient should never stop taking it abruptly. Taking Elicea at the end of pregnancy may increase the risk of severe postpartum hemorrhage, which occurs shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Elicea, they should inform their doctor or midwife so they can provide appropriate advice. It is assumed that escitalopram passes into breast milk. The patient should not take Elicea during breastfeeding without first considering the risks and benefits of treatment with their doctor. In animal studies, it has been shown that citalopram, a medicine similar to escitalopram, reduces sperm quality in animals. This effect may theoretically affect fertility, although it has not been observed in humans yet.

Driving and using machines

The patient should not drive or operate machinery until they know how the medicine affects them.

Elicea contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking Elicea.

3. How to take Elicea

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. Elicea is available in the following doses: 5 mg, 10 mg, 20 mg. Adults DepressionThe recommended dose of Elicea is 10 mg in a single dose once a day. The doctor may increase the dose to a maximum of 20 mg per day. Panic disorderThe initial dose is 5 mg in a single dose once a day for the first week of treatment, then the dose may be increased to 10 mg per day. The doctor may then increase the dose to a maximum of 20 mg per day. Social phobiaThe recommended dose of Elicea is 10 mg in a single dose once a day. The doctor may reduce 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 the medicine. Generalized anxiety disorderThe recommended dose of Elicea is 10 mg in a single dose once a day. The doctor may increase the dose to a maximum of 20 mg per day. Obsessive-compulsive disorderThe recommended dose of Elicea is 10 mg in a single dose once a day. Depending on the patient's response, the 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 Elicea is 5 mg per day. The doctor may increase the dose to 10 mg per day.

Use in children and adolescents

Elicea is not usually used in children and adolescents. For more information, see section 2. "Important information before taking Elicea".

Method of administration

Elicea can be taken with or without food. The tablet should be swallowed with water. The tablets should not be chewed, as they have a bitter taste. The tablet can be divided into equal doses.

Duration of treatment

It may take several weeks before the patient feels an improvement. Therefore, the patient should continue taking Elicea, even if they do not feel better initially. The patient should not change the dose without consulting their doctor. Elicea should be taken for as long as the doctor recommends. If the patient stops treatment too early, the symptoms of the disease may return. It is recommended to continue treatment for at least 6 months after improvement.

Taking a higher dose of Elicea than recommended

In case of taking a higher dose of Elicea than recommended, the patient should immediately contact their doctor or the nearest emergency department, even if they do not feel any symptoms. Symptoms of overdose include dizziness, tremors, agitation, seizures, coma, nausea, vomiting, heart rhythm disorders, low blood pressure, and electrolyte imbalance. When visiting the doctor or going to the hospital, the patient should take the Elicea packaging with them.

Missing a dose of Elicea

In case of missing a dose, the patient should not take a double dose to make up for the missed dose. If the patient forgets to take the medicine and remembers on the same day, they should take it as soon as possible. The next day, they should take the next dose at the usual time. The patient should not take the missed dose at night or the next day but continue taking the medicine at the usual time.

Stopping treatment with Elicea

The patient should not stop taking Elicea without consulting their doctor. When the patient finishes treatment, it is usually recommended to gradually reduce the dose of Elicea over several weeks. After stopping Elicea, especially suddenly, the patient may experience withdrawal symptoms. These symptoms often occur after stopping treatment with Elicea. The risk is higher when the medicine has been taken for a long time or in high doses or when the dose has been reduced too quickly. In most cases, withdrawal symptoms are mild and resolve on their own within 2 weeks. However, in some patients, they may be severe or persist for longer (2-3 months or longer). If the patient experiences severe withdrawal symptoms, they should contact their doctor. The doctor may recommend restarting the medicine and then tapering it off more slowly. Withdrawal symptoms include dizziness (unsteady gait, balance disorders), tingling sensation, burning sensation, and (less frequently) a sensation similar to an electric shock, also in the head, sleep disturbances (vivid dreams, nightmares, and insomnia), anxiety, headache, nausea, excessive sweating (including night sweats), restlessness, agitation, tremors, confusion or disorientation, emotional instability or irritability, diarrhea (loose stools), vision disturbances, palpitations (heart palpitations). In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Elicea can cause side effects, although not everybody gets them. Usually, side effects are mild and resolve after a few weeks of treatment. The patient should be aware that some of these side effects may also be symptoms of the disease and will resolve as their condition improves.

The patient should contact their doctor in case of the following side effects during treatment:

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

• unusual bleeding, including gastrointestinal bleeding.

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

• swelling of the skin, tongue, lips, or face, or difficulty breathing or swallowing (allergic reaction),
• high fever, restlessness (agitation), confusion, tremors, and sudden muscle contractions; these may be symptoms of a rare disorder called serotonin syndrome.

Frequency not known(frequency cannot be estimated from the available data):

• urination difficulties,
• seizures, see also section "Warnings and precautions",
• yellowing of the skin and whites of the eyes; signs of liver function disorders and/or hepatitis,
• rapid, irregular heartbeat, fainting, which may be symptoms of life-threatening disorders called torsades de pointes,
• suicidal thoughts and behaviors, see also section "Warnings and precautions".

Additionally, the following side effects have been reported with medicines with a similar mechanism of action to escitalopram:

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

• nausea,
• headache.

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

• nasal congestion or sinusitis (sinus infection),
• decreased or increased appetite,
• anxiety, agitation, unusual dreams, sleep disturbances, drowsiness, dizziness, yawning, tremors, burning sensation of the skin,
• diarrhea, constipation, vomiting, dry mouth,
• excessive sweating,
• joint pain and muscle pain,
• sexual disturbances (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty reaching orgasm in women),
• fatigue, fever,
• weight gain.

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

• hives, rash, itching (pruritus),
• teeth grinding, restlessness (agitation), nervousness, panic attacks, confusion (disorientation),
• sleep disturbances, taste disturbances, fainting (loss of consciousness),
• pupil dilation, vision disturbances, tinnitus,
• hair loss,
• heavy menstrual bleeding,
• irregular menstrual periods,
• weight loss,
• rapid heartbeat,
• swelling of the upper or lower limbs,
• nosebleeds.

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

• aggression, depersonalization, hallucinations,
• slow heartbeat.

Frequency not known(frequency cannot be estimated from the available data):

• decreased sodium levels in the blood (symptoms include nausea, weakness, and 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 (priapism),
• symptoms of increased bleeding in the skin and mucous membranes (ecchymoses),
• sudden swelling of the skin or mucous membranes (angioedema),
• increased urine output (inappropriate antidiuretic hormone secretion),
• galactorrhea in men and in women who are not breastfeeding,
• mania,
• heart rhythm disorders (prolonged QT interval, observed in ECG; heart electrical activity),
• severe postpartum hemorrhage, see also section "Pregnancy, breastfeeding, and fertility".

Additionally, it is known that medicines with a similar mechanism of action to escitalopram have the following side effects:

• restlessness (akathisia),
• loss of appetite (anorexia).

It has been observed that patients taking medicines from this group have an increased risk of fractures.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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 the medicine.

5. How to store Elicea

The medicine should be stored out of sight and reach of children. The patient should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. There are no special storage instructions regarding temperature. The patient should store Elicea in its original packaging to protect it from moisture. 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 Elicea contains

• The active substance of Elicea is escitalopram. Each coated tablet contains 20 mg of escitalopram (as 25.56 mg of escitalopram oxalate).
• The other ingredients of the medicine are lactose monohydrate, crospovidone, povidone, microcrystalline cellulose, cornstarch, and magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol 3000, and triacetin in the coating.

What Elicea looks like and contents of the pack

White, oval, biconvex coated tablets with a score line on one side. The tablet can be divided into equal doses. Packaging: 28 or 56 coated tablets in OPA/Aluminum/PVC/Aluminum blisters, in a cardboard box. For more detailed information on the medicine, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Lithuania, the country of export:

Krka, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia

Manufacturer:

Krka, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia

Parallel importer:

InPharm Sp. z o.o. ul. Strumykowa 28/11 03-138 Warszawa

Repackaged by:

InPharm Sp. z o.o. Services sp. k. ul. Chełmżyńska 249 04-458 Warszawa Lithuanian, the country of export, marketing authorization number:LT/1/09/1743/024 LT/1/09/1743/027

Parallel import authorization number: 63/24

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of approval of the leaflet: 13.02.2024

[Information about the trademark]