Elicea

Package Leaflet: Information for the Patient

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

Elicea

20 mg, film-coated tablets
Escitalopram

The leaflet should be read carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for 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 those not listed in this leaflet, they should inform 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. Contents of the pack and other information

1. What is Elicea and what is it used for

Elicea contains the active substance escitalopram. Escitalopram belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs).
Elicea is used to treat depression (major depressive episodes) and anxiety disorders [such as panic disorder (panic attacks) with or without agoraphobia, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder].
It may take several weeks before the patient feels an improvement. Therefore, Elicea should be continued even if the patient does 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 that belong 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 a heart rhythm disorder episode (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 their 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 for the first time or their frequency increases, Elicea treatment should be discontinued (see also section 4 "Possible side effects");
• if they have liver or kidney function disorders. The dose may need to be adjusted by the doctor;
• 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 bleeding and easy bruising or if they are pregnant (see section "Pregnancy, breastfeeding, and fertility");
• 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 the use of diuretics (water pills);
• 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 eye pressure).

Warning

In some patients with manic-depressive illness, 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 restlessness 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 self-harm.
Such symptoms or behavior 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 should immediately
inform their doctor or contact the nearest healthcare center
for help.
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 worrying 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 manifestations 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. If any of the above symptoms occur or worsen in patients under 18 years of age taking Elicea, the doctor should be informed. 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, 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 discontinuing them before starting treatment with Elicea. After stopping Elicea, at least 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;
• imipramine and desipramine (used to treat depression);
• sumatriptan and similar medicines (used to treat migraines) and tramadol and similar opioid medicines (used to treat severe pain). They may increase the risk of side effects;
• 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 (NSAIDs, 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 start and after stopping Elicea to determine if 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 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 Elicea dose;
• 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, hydroxyzine, mizolastine). If there are any further doubts, the doctor should be consulted.

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 interactions (interactions) between Elicea and alcohol are not expected.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The patient should not take Elicea during pregnancy or breastfeeding unless they have discussed the risks and benefits with their doctor.
If the patient takes Elicea during the last 3 months of pregnancy, they should be aware that the newborn may experience symptoms such as difficulty breathing, blue skin color, seizures, body temperature fluctuations, feeding difficulties, vomiting, low blood sugar, muscle stiffness or flaccidity, increased reflexes, trembling, tremors, irritability, lethargy, crying, and sleep disturbances. If the newborn experiences any of these symptoms, 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 during 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 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.
Taking Elicea at the end of pregnancy may increase the risk of severe postpartum hemorrhage, especially if the patient has a history of bleeding disorders. If the patient is taking Elicea, they should inform their doctor or midwife so that they can provide appropriate advice.
Elicea should never be stopped abruptly during pregnancy.
It is assumed that escitalopram passes into breast milk.
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 Elicea affects them.

Elicea contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should consult 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 doctor or pharmacist should be consulted.
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 (panic attacks)
The initial dose is 5 mg once daily for the first week, 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 more information, see section 2 "Warnings and precautions".
Renal impairment
Caution should be exercised in patients with severe renal impairment. The medicine should be used as directed by the doctor.
Hepatic impairment
Patients with hepatic impairment should not exceed a dose of 10 mg daily. The medicine should be used as directed by the doctor.
Poor metabolizers of medicines via the CYP2C19 isoenzyme
Patients with this known genotype should not exceed a dose of 10 mg daily. The medicine should be used as directed by the doctor.

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.
10 mg and 20 mg tablets: the tablet can be divided into equal doses.

Duration of treatment

It may take several weeks before the patient feels an improvement. Therefore, Elicea should be continued even if the patient does not feel better initially.
The dose should not be changed without consulting the doctor.
Elicea should be taken for as long as prescribed by the doctor. 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 overdose, 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. The patient should take the Elicea packaging with them to the doctor's visit or hospital.

Missed dose of Elicea

If a dose is missed, the patient should not take a double dose to make up for the missed dose. If the patient remembers before bedtime, they should take the missed dose immediately. The next day, they should take the next dose at the usual time.
If the patient remembers in the night or the next day, they should skip the missed dose and take the next dose at the usual time.

Stopping Elicea treatment

The patient should not stop taking Elicea without consulting their doctor. When the patient stops treatment, it is usually recommended to gradually reduce the Elicea dose 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 if the medicine was taken for a long time or in high doses or if the dose was 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 severe withdrawal symptoms occur, the patient 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 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), restlessness, agitation, tremors, confusion or disorientation, mood swings or irritability, diarrhea (loose stools), vision disturbances, palpitations (heart palpitations).

4. Possible side effects

Like all medicines, Elicea can cause side effects, although not everybody gets them.
Side effects usually 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 the patient's condition improves.

If any of the following side effects occur during treatment, the patient should contact their doctor or go to the hospital immediately:

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, throat, or face, hives, or difficulty breathing or swallowing (severe allergic reaction),
• high fever, 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, irregular heartbeat, fainting, which may be symptoms of life-threatening heart rhythm disorders called torsades de pointes,
• suicidal thoughts and behaviors, see also section "Warnings and precautions";
• sudden swelling of the skin or mucous membranes (angioedema).

The following 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 sinusitis (sinus infection),
• 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 dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty achieving orgasm in women),
• fatigue, fever,
• weight gain.

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

• hives, rash, itching (pruritus),
• teeth grinding, agitation, nervousness, panic attacks, confusion (disorientation),
• sleep disturbances, taste disorders, 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, malaise 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 unusual bleeding, such as skin and mucous membrane bleeding (ecchymoses) and low platelet count (thrombocytopenia),
• increased secretion of antidiuretic hormone (ADH), leading to water retention in the body, dilutional hyponatremia (inappropriate ADH secretion),
• increased prolactin levels in the blood,
• galactorrhea in men and women who are not breastfeeding,
• mania,
• patients taking medicines from this group have been observed to have an increased risk of fractures,
• heart rhythm disorders (prolonged QT interval, observed in ECG; heart electrical activity),
• severe postpartum hemorrhage, occurring shortly after delivery (postpartum hemorrhage), for more information, see section 2 "Pregnancy, breastfeeding, and fertility".

In addition, numerous side effects of medicines with a similar mechanism of action to escitalopram (the active substance of Elicea) are known. These include:

• restlessness (akathisia),
• loss of appetite.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 the medicine.

5. How to store Elicea

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
There are no special storage instructions. The medicine should be stored 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 film-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 K 30, 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 film-coated tablets with a score line on one side. The tablet can be divided into equal doses.
Packaging: 28 or 56 film-coated tablets in blisters, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or 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:

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
Lithuanian, export country marketing authorization number:
LT/1/09/1743/024
LT/1/09/1743/027

Parallel import authorization number: 128/25

This medicine is authorized in the Member States of the European Economic Area under the following names:
Austria
Escitalopram Krka
Bulgaria, Czech Republic, Estonia, Lithuania,
Latvia, Slovenia, Slovakia, Hungary
Elicea

Date of leaflet approval: 04.04.2025

[Information about the trademark]