Elicea

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Elicea

10 mg, coated tablets

Escitalopram

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

• Keep this leaflet, so that you can read it again if necessary.
• 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 any side effects not listed in this leaflet, they should tell 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. 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 anxiety) 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, Elicea should be continued, even if there is no improvement in well-being at first. If the patient does not feel better or feels worse while taking this medicine, they should talk to their doctor.

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, consult a doctor or pharmacist. Inform the doctor about all other diseases and disorders, as they may need to be taken into account. In particular, inform the doctor:

• if the patient has epilepsy. If seizures occur or their frequency increases, Elicea therapy should be discontinued (see also section 4 "Possible side effects");
• if the patient has liver or kidney function disorders. The dose may need to be adjusted by the doctor;
• if the patient has diabetes. Taking Elicea may affect blood sugar control. The dose of insulin and/or oral hypoglycemic agents may need to be adjusted;
• if the patient has low sodium levels in the blood;
• if the patient has an increased tendency to bleeding and easy bruising;
• if the patient is being treated with electroconvulsive therapy;
• if the patient has coronary heart disease;
• if the patient has or has had heart disease or has recently had a heart attack;
• if the patient has low resting heart rate and/or knows that they may have a salt deficiency due to prolonged, severe diarrhea, vomiting, or the use of diuretics;
• if the patient experiences rapid or irregular heart rate, fainting, collapse, or dizziness when standing up, which may indicate heart rhythm disorders;
• if the patient currently has or has 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, consult a doctor. In the first few weeks of treatment, symptoms such as anxiety or difficulty sitting still or standing in one place may occur. If any of these symptoms occur, the doctor should be informed immediately.

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 start 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 immediatelytell 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 inform them if they notice that depression or anxiety has worsened or if there are worrying changes in behavior.

Children and adolescents

Elicea should not be used in children and adolescents under 18 years of age. For more information, see section 2 "Important information before taking Elicea".

Elicea and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take. Inform the doctor if the patient is 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, 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 (medicines used to treat pain or to "thin" the blood, known as anticoagulants). This may increase the tendency to bleed;
• 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 treatment with 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;
• neuroleptics (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, tiordazine, and haloperidol (antipsychotic medicines). 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, antipsychotic medicines (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial medicines (e.g. sparfloxacin, moxifloxacin, erythromycin i.v., antimalarial medicines, mainly halofantrine), certain antihistamines (astemizole, mizolastine). In case of any further doubts, consult a 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 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 a 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 is taking Elicea in the last 3 months of pregnancy, they should be aware that the following symptoms may occur in the newborn: breathing difficulties, blue discoloration of the skin, seizures, fluctuations in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or flaccidity, increased reflexes, trembling, tremors, irritability, lethargy, sleepiness, and difficulty sleeping. If any of these symptoms occur in the newborn, the doctor should be contacted immediately. The patient should make sure that the midwife and/or doctor knows that 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 in newborns (PPHN), characterized by increased breathing rate and blue discoloration of the skin. Symptoms usually occur within the first 24 hours after birth. If these symptoms occur, the doctor or midwife should be contacted immediately. Elicea should never be stopped abruptly during pregnancy. It is assumed that escitalopram passes into breast milk. Elicea should not be taken during breastfeeding without the doctor's prior consideration of the risks and benefits of treatment. In animal studies, citalopram, a medicine similar to escitalopram, has been shown to decrease 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. If the patient has any doubts, they should consult their doctor or pharmacist. Elicea is available in the following doses: 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 per day.

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 per day. The doctor may then increase the dose to a maximum of 20 mg per day.

Social phobia

The recommended dose of Elicea is 10 mg once daily. 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 disorder

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

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 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, Elicea should be continued, even if there is no improvement in well-being at first. The dose should not be changed without consulting the 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 overdose, the patient should immediately contact a 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 disorders. When visiting the doctor or going to the hospital, the patient should take the Elicea packaging with them.

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 forgets to take the medicine and remembers on the same day, they should take it immediately. The next day, the next dose should be taken at the usual time. The missed dose should not be taken at night or the next day, but the patient should 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 occur frequently 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 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 doctor should be contacted. 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), 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). If the patient has any further doubts about taking this medicine, they 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 if they experience any 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, 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 heart rate, 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".

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 cold (sinusitis),
• decreased or increased appetite,
• anxiety, agitation, unusual dreams, difficulty sleeping, sleepiness, 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, 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 well-being 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 production (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).

In addition, 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 any side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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. Do 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 temperature recommendations. Store in the original packaging to protect 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. Package contents and other information

What Elicea contains

• The active substance of Elicea is escitalopram. Each coated tablet contains 10 mg of escitalopram (in the form of 12.78 mg of escitalopram oxalate).
• The other ingredients of the medicine are: lactose monohydrate, crospovidone, povidone K 30, microcrystalline cellulose, maize starch, magnesium stearate. Coating:hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol 3000, triacetin.

What Elicea looks like and contents of the pack

White, oval, biconvex coated tablets with a notch on one side. The tablet can be divided into equal doses. Available in: 28, 30, 56, 60, and 90 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:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź

Repackaged by:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź, Laboratorium Galenowe Olsztyn Sp. z o.o., ul. Spółdzielcza 25A, 11-001 Dywity, CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warszawa, Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warszawa, IVA Pharm Sp. z o.o., ul. Drawska 14/1, 02-202 Warszawa, CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź

Marketing authorization number in the Czech Republic, the country of export: 30/603/08-C, Parallel import authorization number: 236/18, Date of leaflet approval: 11.05.2023, [Information about the trademark]