Elicea

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

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

Elicea

10 mg, coated tablets

Escitalopram

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. 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. Contents of the packaging 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, you should continue taking Elicea, even if you do not feel better at first. You should talk to your doctor if you are taking this medicine and do not feel better or feel worse.

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

• if the patient has epilepsy. If seizures or an increased frequency of seizures occur, treatment with Elicea should be discontinued (see also section 4 "Possible side effects");
• if the patient has liver or kidney function disorders. It may be necessary to adjust the dose by the doctor;
• if the patient has diabetes. Taking Elicea may affect blood glucose control. It may be necessary to adjust the dose of insulin and/or oral glucose-lowering medicines;
• 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 diuretic medicines;
• if the patient experiences rapid or irregular heartbeat, fainting, 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, you should contact your doctor. In the first few weeks of treatment, symptoms such as restlessness or difficulty sitting still or standing in one place may occur. You should immediately inform your doctor if any of these symptoms occur.

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. Data from clinical trials show an increased risk of suicidal behavior in people under 25 years of age 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

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. You should inform your doctor if you are taking any of the following medicines:

• non-selective monoamine oxidase inhibitors (MAOIs) (used to treat depression), containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substances. If you have taken any of these medicines, you should wait 14 days after stopping them before starting treatment with Elicea. After stopping treatment with Elicea, you 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;
• antibiotics;
• 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 anticoagulant medicines). This may increase the risk of bleeding;
• warfarin, dipyridamole, and phenprocoumon (used to "thin" the blood, known as anticoagulant medicines). Your doctor may order a blood clotting test at the start and after stopping treatment with Elicea to determine if the dose of the anticoagulant medicine 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 antidepressant medicines (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 (antipsychotic medicines). 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 you are 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, intravenous erythromycin, antimalarial medicines, mainly halofantrine), and certain antihistamines (astemizole, mizolastine). If you have any further doubts, you should consult your 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, you should not take Elicea with alcohol, although no interaction between Elicea and alcohol has been shown.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine. If you are pregnant, you should not take Elicea unless you have discussed the risks and benefits with your doctor. If you are taking Elicea in the last 3 months of pregnancy, you 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 glucose levels, muscle stiffness or flaccidity, increased reflexes, trembling, tremors, irritability, lethargy, sleepiness, and difficulty sleeping. If any of these symptoms occur in the newborn, you should contact your doctor immediately. You should make sure that your midwife and/or doctor know that you 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 skin color. These symptoms usually occur within the first 24 hours after birth. If these symptoms occur, you should contact your doctor or midwife immediately. You should never stop taking Elicea suddenly during pregnancy. It is assumed that escitalopram passes into breast milk. You should not take Elicea during breastfeeding without first considering the risks and benefits of treatment with your doctor. In animal studies, citalopram, a medicine similar to escitalopram, has been shown to reduce 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

You should not drive or operate machinery until you know how the medicine affects you.

Elicea contains lactose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking Elicea.

3. How to take Elicea

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist. Adults DepressionThe recommended dose of Elicea is 10 mg once daily. Your doctor may increase the dose to a maximum of 20 mg daily. Anxiety disorder with panic attacks (panic anxiety)The initial dose is 5 mg once daily for the first week of treatment, then the dose may be increased to 10 mg daily. Your doctor may then increase the dose to a maximum of 20 mg daily. Social phobiaThe recommended dose of Elicea is 10 mg once daily. Your 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 disorderThe recommended dose of Elicea is 10 mg once daily. Your doctor may increase the dose to a maximum of 20 mg daily. Obsessive-compulsive disorderThe recommended dose of Elicea is 10 mg once daily. Depending on the patient's response, your doctor may increase the dose to a maximum of 20 mg daily. Elderly patients (over 65 years) The recommended initial dose of Elicea is 5 mg daily. Your 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 "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. 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, you should continue taking Elicea, even if you do not feel better at first. You should not change the dose without consulting your doctor. Elicea should be taken for as long as your doctor recommends. If you stop 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 of Elicea, you should immediately contact your doctor or the nearest emergency department, even if you do not feel any symptoms. Symptoms of overdose include: dizziness, trembling, agitation, seizures, coma, nausea, vomiting, heart rhythm disorders, low blood pressure, and electrolyte imbalance. You should take the packaging of Elicea with you to the doctor's visit or to the hospital.

Missed dose of Elicea

In case of a missed dose of Elicea, you should not take a double dose to make up for the missed dose. If you remember that you missed a dose on the same day, you should take it immediately. The next day, you should take the next dose at the usual time. You 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

You should not stop taking Elicea without consulting your doctor. When you finish 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 if the medicine has been taken for a long time or in high doses or if 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 you experience severe withdrawal symptoms, you should contact your doctor. Your doctor may recommend restarting treatment with Elicea and then reducing the dose 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, trembling, confusion or disorientation, emotional instability 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. Usually, side effects are mild and resolve after a few weeks of treatment. You should be aware that some of these side effects may also be symptoms of the disease and will resolve as your condition improves.

You should contact your doctor if you 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, restlessness, confusion, trembling, 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".

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, trembling, 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, anxiety 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, 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 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 fractures has been observed in patients taking medicines from this group.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. You can report side effects 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, you can help provide more information 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 requirements. Store in the original packaging to protect from moisture. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Elicea contains

• The active substance of Elicea is escitalopram. Each coated tablet contains 10 mg of escitalopram (as 12.78 mg of escitalopram oxalate).
• The other ingredients of the medicine are lactose monohydrate, crospovidone, povidone, microcrystalline cellulose, 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

10 mg tablets - white, oval, biconvex coated tablets with a score line on one side. The tablet can be divided into equal doses. Packaging: 28 and 56 coated tablets in blisters, in a cardboard box. For more detailed information, you 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:

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

Repackaged by:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź, CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warszawa, SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów, CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź, Marketing authorization number in Lithuania, the country of export: LT/1/09/1743/012, LT/1/09/1743/013, LT/1/09/1743/016, LT/1/09/1743/019

Parallel import authorization number: 435/22 Date of leaflet approval: 20.12.2022

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