Elicea

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Elicea, 5 mg, coated tablets
Escitalopramum

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

• The patient should keep this leaflet, so that they can read it again if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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. Package contents 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 at first. 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. It may be necessary to adjust the dose by the doctor;
• if they have diabetes. Taking Elicea may affect blood sugar control. 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 bleeding and easy bruising;
• if they are being treated with electroconvulsive therapy;
• if they have ischemic 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 use of diuretics;
• if they experience rapid or irregular heartbeats, 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 eye pressure).

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.

Suicidal thoughts and worsening of depression or anxiety symptoms

If the patient has depression and/or anxiety disorders, they may be accompanied by thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually start working only 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 should immediately
inform their doctor or contact the nearest healthcare center.
It may be helpful to inform relatives or friendsabout depression or anxiety disorders and ask them to read this leaflet. The patient may ask them to monitor their condition and inform them if they notice that depression or anxiety has worsened or if there are any worrying changes in behavior.

Children and adolescents

Elicea should not be used in children and adolescents under 18 years of age. In the case of 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 manifestations of anger). Nevertheless, the doctor may prescribe Elicea to a patient under 18 years of age if they consider it necessary. If the doctor has prescribed Elicea to a patient under 18 years of age, and this causes any concerns, the patient should contact the doctor again. If any of the above symptoms occur or worsen in patients under 18 years of age taking Elicea, the patient should inform their doctor. Additionally, there is currently no 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 the above medicines, they should wait 14 days after stopping them before starting treatment with Elicea. After stopping Elicea, 7 days should pass 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 (used to treat severe pain). They increase the risk of side effects;
• cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), 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 (NSAIDs) (medicines used to treat pain or to "thin" the blood, known as anticoagulants). This may increase the tendency to 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 dose 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), or certain antihistamines (astemizole, mizolastine). In case of any further doubts, the patient should consult their doctor.

Elicea with food, drink, and alcohol

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

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 following symptoms may occur in the newborn: breathing difficulties, blue skin color, seizures, fluctuations in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or weakness, increased reflexes, trembling, tremors, irritability, lethargy, sleepiness, and difficulty sleeping. If any of these symptoms occur in the newborn, the patient should immediately contact their doctor. The patient should ensure that their midwife and/or doctor know that they are taking Elicea. Medicines like Elicea, taken during pregnancy, especially in the last 3 months of pregnancy, may increase the risk of a serious condition in the child, called persistent pulmonary hypertension in newborns (PPHN), characterized by increased breathing rate and blue skin color. 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. It is assumed that escitalopram passes into breast milk. Elicea should not be taken during breastfeeding without the doctor considering the risk and benefit of treatment. 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 no effect on fertility has been observed in humans so far.

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 strengths: 5 mg, 10 mg, and 20 mg.

Adults

Depression
The recommended dose of Elicea is 10 mg once daily. The doctor may increase the dose to a maximum of 20 mg daily.

Panic disorder
The initial dose is 5 mg once daily for the first week of treatment, then the dose may be increased to 10 mg daily. The doctor may then increase the dose to a maximum of 20 mg daily.

Social phobia
The recommended dose of Elicea is 10 mg once daily. The doctor may reduce the dose to 5 mg daily or increase it to a maximum of 20 mg daily, depending on the patient's response to the medicine.

Generalized anxiety disorder
The recommended dose of Elicea is 10 mg once daily. The doctor may increase the dose to a maximum of 20 mg daily.

Obsessive-compulsive disorder
The recommended dose of Elicea is 10 mg once daily. Depending on the patient's response, the doctor may increase the dose to a maximum of 20 mg daily.

Elderly patients (over 65 years of age)
The recommended initial dose of Elicea is 5 mg daily. The doctor may increase the dose to 10 mg daily.

Use in children and adolescents

Elicea is not usually used in children and adolescents. For further 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.

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 at first. 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.

Overdose of Elicea

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, restlessness, 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.

Missed 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 has forgotten to take the medicine and remembers on the same day, they should take it immediately. 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, withdrawal symptoms may occur. 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, the symptoms are mild and disappear on their own within 2 weeks. However, in some patients, they may be severe or persist for longer (2-3 months or longer). If severe withdrawal symptoms occur, the patient should contact their doctor. The doctor may recommend restarting the medicine and then reducing it more slowly. Withdrawal symptoms include: dizziness (unsteady gait, balance disorders), tingling sensation, burning sensation, and (less often) a sensation similar to an electric shock, also in the head, sleep disturbances (vivid dreams, nightmares, and insomnia), restlessness, headache, nausea, excessive sweating (including night sweats), psychomotor agitation, excitement, 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 disappear 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 disappear as their condition improves.

The patient should contact their doctor if they experience any of the following side effects during treatment:

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

• unusual bleeding, including bleeding from the gastrointestinal tract.

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):

• difficulty urinating,
• 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 or irregular heartbeat, fainting, which may be a sign of life-threatening heart rhythm disorders called torsades de pointes,
• suicidal thoughts and behaviors, see also section "Warnings and precautions".

Other side effects have also been reported:

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

• nausea,
• headache.

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

• nasal congestion or cold (sinusitis),
• decreased or increased appetite,
• restlessness, agitation, unusual dreams, difficulty sleeping, 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 achieving orgasm in women),
• feeling tired, fever,
• weight gain.

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

• hives, rash, itching (pruritus),
• grinding of the teeth, 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, poor condition with muscle 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 of the penis (priapism),
• symptoms of increased frequency of bleeding in the skin and mucous membranes (ecchymoses),
• sudden swelling of the skin or mucous membranes (angioedema),
• increased urine output (inappropriate secretion of antidiuretic hormone),
• galactorrhea in men and in women who are not breastfeeding,
• mania,
• heart rhythm disorders (so-called QT interval prolongation, observed in ECG; heart electrical activity).

Additionally, numerous side effects of medicines with a similar mechanism of action to escitalopram are known. These include:

• restlessness (inability to remain still, akathisia),
• loss of appetite (anorexia).

An increased risk of bone fractures has been observed in patients taking medicines from this group.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 Elicea

The medicine should be stored out of sight and reach of children. This medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. The medicine should be stored in its original packaging to protect it from moisture.

6. Package contents and other information

What Elicea contains

• The active substance of Elicea is escitalopram. Each coated tablet contains 5 mg of escitalopram (in the form of 6.39 mg of escitalopram oxalate).
• The other ingredients of the medicine are: lactose monohydrate, crospovidone, povidone K30, microcrystalline cellulose, and magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E171), lactose monohydrate, macrogol 3000, and triacetin in the coating.

What Elicea looks like and contents of the pack

White, round, biconvex tablets with beveled edges. The packaging includes 28, 30, 56, or 60 coated tablets in blisters, in a cardboard box. For more detailed information, the patient should contact the marketing authorization holder or the parallel importer:

Marketing authorization holder in the Czech Republic, 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:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź. Marketing authorization number in the Czech Republic, the country of export: 30/602/08-C

Parallel import authorization number: 117/18 Date of leaflet approval: 15.03.2023

[Information about the trademark]