Elicea Q-tab

Package Leaflet: Information for the Patient

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

Elicea Q-Tab, 10 mg, Oral Disintegrating Tablets

Escitalopram

Before Taking the Medication, Carefully Read the Contents of This Leaflet, as it Contains Important Information for the Patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medication has been prescribed for a specific person. It should not be given to others. The medication may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any 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 Q-Tab and what is it used for
• 2. Important information before taking Elicea Q-Tab
• 3. How to take Elicea Q-Tab
• 4. Possible side effects
• 5. How to store Elicea Q-Tab
• 6. Contents of the packaging and other information

1. What is Elicea Q-Tab and what is it used for

Escitalopram belongs to a group of antidepressant medications called selective serotonin reuptake inhibitors (SSRIs). These medications work on the serotonin system in the brain by increasing serotonin levels. Disruptions in the serotonin system in the brain play a significant role in the development of depression and related disorders. Elicea Q-Tab contains escitalopram and is used to treat depression (episodes of major depression) and anxiety disorders [such as panic disorder with or without agoraphobia, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder]. The patient should talk to their doctor if they do not feel improvement or feel worse while taking this medication.

2. Important information before taking Elicea Q-Tab

When Not to Take Elicea Q-Tab

• If the patient is allergic to escitalopram or any of the other ingredients of this medication (listed in section 6),
• If the patient is taking other medications belonging to the group of MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic),
• If the patient has congenital heart rhythm disorders or has had them in the past (detected in an ECG - a test evaluating heart function),
• If the patient is taking medications for heart rhythm disorders or that may affect heart rhythm (see section 2 "Elicea Q-Tab and other medications").

Warnings and Precautions

Before starting to take Elicea Q-Tab, the patient should discuss it with their doctor or pharmacist. The patient should tell their doctor if they have any other disorders or diseases, as the doctor should take this information 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, the patient should stop taking Elicea Q-Tab (see also section 4 "Possible side effects").
• If they have liver or kidney function disorders. It may be necessary for the doctor to adjust the dose.
• If they have diabetes. Taking Elicea Q-Tab may affect blood glucose control. It may be necessary to adjust the dose of insulin and/or oral medications that lower blood glucose levels.
• If they have low sodium levels in the blood.
• If they have an increased tendency to bleed or bruise 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 a slow resting heart rate and/or know they may have a salt deficiency due to prolonged, severe diarrhea, vomiting, or the use of diuretic medications.
• 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 problems, such as certain types of glaucoma (increased eye pressure).
• If they are taking this medication in combination with buprenorphine. This combination may lead to a life-threatening condition called serotonin syndrome (see section "Elicea Q-Tab and other medications").

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. Medications like Elicea Q-Tab (so-called SSRIs or SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persisted after the medication was stopped.

Suicidal Thoughts and Worsening of Depression or Anxiety Disorders

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 medications, as these medications usually start working after about 2 weeks, sometimes later. These symptoms are more likely in:

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

If the patient experiences thoughts of self-harm or suicide, they should immediately
inform 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 their depression or anxiety worsens or if they notice worrying changes in behavior. Children and adolescents under 18 years of age Elicea Q-Tab should not be used in children and adolescents under 18 years of age. When taking medications 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 Q-Tab to a patient under 18 years of age if they consider it necessary. If the doctor prescribes Elicea Q-Tab to a patient under 18 years of age, and this causes any concerns, the patient should contact their doctor again. If any of the above symptoms worsen in patients under 18 years of age taking Elicea Q-Tab, the doctor should be informed. Additionally, there is currently a lack of data on the long-term safety of Elicea Q-Tab in this age group regarding growth, maturation, and cognitive and behavioral development.

Elicea Q-Tab and Other Medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take. The patient should inform their doctor if they are taking any of the following medications:

• 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 medications, they should wait 14 days after stopping them before starting treatment with Elicea Q-Tab. After stopping Elicea Q-Tab, at least 7 days should pass before taking any of these medications.
• 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 medications (used to treat migraines) and tramadol or buprenorphine (used to treat severe pain). These medications may interact with Elicea Q-Tab and cause symptoms such as involuntary, rhythmic muscle contractions, including those that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, 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 medication), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medications may cause an increase in escitalopram levels in the blood.
• St. John's Wort (Hypericum perforatum) - a herbal remedy used to treat depression.
• acetylsalicylic acid and non-steroidal anti-inflammatory medications (medications used to treat pain or to "thin" blood, known as anticoagulants). This may increase the tendency to bleed.
• warfarin, dipyridamole, and phenprocoumon (medications used to "thin" blood, known as anticoagulants). The doctor may order a blood clotting test at the beginning and after stopping treatment with Elicea Q-Tab to determine if the dose of the anticoagulant medication 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) due to the risk of lowering the seizure threshold and antidepressant medications.
• flecainide, propafenone, and metoprolol (used to treat cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotic medications). It may be necessary to adjust the dosage of Elicea Q-Tab.
• medications that cause hypokalemia/hypomagnesemia.

Elicea Q-Tab should not be taken if the patient is taking medications used to treat heart rhythm disorders or that may affect heart rhythm, such as antiarrhythmic medications of class IA and III, antipsychotic medications (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial medications (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial medications, mainly halofantrine), and certain antihistamines (astemizole, mizolastine). In case of any further doubts, the doctor should be consulted.

Elicea Q-Tab with Food, Drink, and Alcohol

Elicea Q-Tab should not be taken with a meal (see section 3 "How to take Elicea Q-Tab"). Like other medications, Elicea Q-Tab should not be taken with alcohol, although no interaction between Elicea Q-Tab 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 medication. If the patient takes Elicea Q-Tab in the last 3 months of pregnancy, they should be aware that the following symptoms may occur in the newborn: breathing difficulties, blue skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood glucose levels, muscle stiffness or flaccidity, increased reflexes, tremors, irritability, lethargy, constant crying, and sleep disturbances. If any of these symptoms occur in the newborn, the patient should immediately contact their doctor. The patient should inform their doctor and/or midwife about taking Elicea Q-Tab. Taking medications like Elicea Q-Tab, especially in the last three months of pregnancy, may increase the risk of severe complications in the newborn, called persistent pulmonary hypertension of the newborn (PPHN). It is characterized by rapid breathing and blue discoloration. These symptoms usually appear within the first day of life. If such symptoms occur in the newborn, the patient should immediately contact their doctor and/or midwife. When taking Elicea Q-Tab during pregnancy, the medication should never be stopped abruptly. Taking Elicea Q-Tab at the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient takes Elicea Q-Tab, they should inform their doctor or midwife so that they can provide appropriate advice. In animal studies, it has been shown that citalopram, a medication similar to escitalopram, reduces sperm quality in animals. This may theoretically affect fertility, although no effect on fertility has been observed in humans so far.

Driving and Operating Machines

The patient should not drive or operate machines until they know how the medication affects them.

Elicea Q-Tab Contains Lactose Monohydrate and Sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking Elicea Q-Tab. This medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to Take Elicea Q-Tab

This medication should always be taken as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted. Elicea Q-Tab is available in the following strengths: 5 mg, 10 mg, 15 mg, 20 mg. Adults

Depression

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

Panic Disorder with Agoraphobia

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 Q-Tab 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 medication.

Generalized Anxiety Disorder

The recommended dose of Elicea Q-Tab 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 Q-Tab 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 Q-Tab is 5 mg per day. The doctor may increase the dose to 10 mg per day. Use in children and adolescents Elicea Q-Tab is not usually used in children and adolescents. For more information, see section 2 "Important information before taking Elicea Q-Tab".

Duration of Treatment

It may take several weeks before the patient feels an improvement. Therefore, the patient should continue taking Elicea Q-Tab, even if they do not feel better at first. The patient should not change the dosage without consulting their doctor. Elicea Q-Tab 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.

Method of Administration

• Elicea Q-Tab is taken once daily, in a single dose.
• The tablets should not be taken with a meal.

The oral disintegrating tablets of Elicea Q-Tab are fragile. The tablets should not be pushed out of the blister pack, as they may be damaged. They should not be touched with wet hands, as the tablet may disintegrate. The tablet has no dividing line and cannot be divided into equal doses. To remove a tablet from the packaging, the patient should:

• 1. Hold the edge of the blister pack and gently tear off one of its squares at the perforation.
• 2. Pull the marked edge of the foil and completely remove it.
• 3. Shake the tablet onto their hand.
• 4. Immediately after removing it from the packaging, place the tablet on the tongue.

After a few seconds, the tablet will disintegrate in the mouth and can be swallowed without water. The mouth should be empty before placing the tablet on the tongue.

Overdose of Elicea Q-Tab

In case of taking a higher dose of Elicea Q-Tab 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 disturbances, low blood pressure, and electrolyte imbalance. When visiting the doctor or going to the hospital, the patient should take the packaging of Elicea Q-Tab with them.

Missed Dose of Elicea Q-Tab

The patient should not take a double dose to make up for a missed dose. If the patient forgets to take the medication and remembers before going to bed, they should take it 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 that they missed a dose, they should skip the missed dose and continue taking the medication according to the established dosage schedule.

Stopping Treatment with Elicea Q-Tab

The patient should not stop taking Elicea Q-Tab without consulting their doctor. When the patient finishes treatment, it is usually recommended to gradually reduce the dose of Elicea Q-Tab over several weeks. After stopping Elicea Q-Tab, especially suddenly, withdrawal symptoms may occur. These symptoms are common. The risk is higher when the medication was taken for a long time or in high doses, or when the dose was reduced too quickly. In most cases, the 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 medication and then tapering it off more slowly. Withdrawal symptoms include: dizziness (unsteady gait, balance disturbances), tingling and burning sensations, and (less commonly) 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 medication, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Elicea Q-Tab can cause side effects, although not everyone gets them. Usually, side effects 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 resolve as their condition improves.

The Patient Should Contact Their Doctor in Case of the Following Side Effects:

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

• Abnormal bleeding, including gastrointestinal bleeding.

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

• If the patient experiences skin swelling, tongue, lip, or face swelling, difficulty breathing or swallowing (allergic reaction), they should immediately contact their doctor or go to the hospital.
• If the patient experiences high fever, agitation, confusion, tremors, and sudden muscle contractions; these may be symptoms of a rare disorder called serotonin syndrome. If such symptoms occur, the patient should contact their doctor.

In Case of the Following Side Effects, the Patient Should Immediately Go to the Doctor or Hospital:

• difficulty urinating;
• seizures, see also section "Warnings and precautions";
• yellowing of the skin and whites of the eyes - symptoms of liver dysfunction and/or hepatitis;
• rapid, irregular heartbeat, fainting, which may be symptoms of life-threatening heart rhythm disorders called torsades de pointes.

The Following Side Effects Have Also Been Observed:

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, restlessness, unusual dreams, sleep disturbances, drowsiness, dizziness, yawning, tremors, burning sensations 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)
• Feeling tired, fever
• Weight gain.

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

• Hives, rash, itching (pruritus)
• Teeth grinding, agitation, nervousness, panic attacks, confusion
• Sleep disturbances, taste disorders, fainting (loss of consciousness)
• Dilated pupils, vision disturbances, tinnitus
• Hair loss
• Vaginal bleeding
• Weight loss
• Rapid heartbeat
• Swelling of the upper or lower limbs
• Nosebleeds.

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

• Aggression, feeling of loss of identity (depersonalization), hallucinations
• Slow heartbeat.

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

• Thoughts of self-harm or suicide, see also section "Warnings and precautions"
• Decreased sodium levels in the blood (symptoms include nausea, 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)
• Bleeding disorders, including bleeding from the gastrointestinal tract and bruising, as well as a decrease in platelet count (thrombocytopenia)
• Sudden swelling of the skin or mucous membranes (angioedema)
• Increased urine output (inappropriate antidiuretic hormone secretion)
• Milk secretion in non-breastfeeding women
• Mania
• An increased risk of bone fractures has been observed in patients taking medications from this group.
• Heart rhythm disorders (so-called QT interval prolongation, observed in an ECG that images the heart's electrical activity).
• Severe vaginal bleeding shortly after delivery (postpartum hemorrhage), for more information, see section "Pregnancy, breastfeeding, and fertility".

Additionally, numerous side effects of medications with a similar mechanism of action to escitalopram are known, including:

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

Reporting Side Effects

If the patient experiences any side effects, including any 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 the medication.

5. How to Store Elicea Q-Tab

The medication should be stored out of sight and reach of children. The medication should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month. The medication should be stored in its original packaging to protect it from light. Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

Translation of Some Information on the Immediate Packaging:

• 1. Preklopite i otrgnite - fold and break
• 2. Odlijepite – peel off.

6. Contents of the Packaging and Other Information

What Elicea Q-Tab Contains

• The active substance of Elicea Q-Tab is escitalopram. Each oral disintegrating tablet contains 10 mg of escitalopram, in the form of escitalopram oxalate.
• Other ingredients are polacrilin potassium, concentrated hydrochloric acid, lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, potassium acesulfame, neohesperidin dihydrochalcone, peppermint flavor [containing maltodextrin (corn), modified starch (corn), and peppermint oil], magnesium stearate. See section 2 "Elicea Q-Tab contains lactose monohydrate and sodium".

What Elicea Q-Tab Looks Like and What the Packaging Contains

Elicea Q-Tab 10 mg is a white to almost white, flat tablet with beveled edges, 9 mm in diameter, and engraved with the number "10" on one side. Packaging:28, 56, and 84 oral disintegrating tablets in blister packs, in a cardboard box. For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing Authorization Holder in Croatia, the Country of Export:

Krka, d.o.o. Radnička cesta 48 10 000 Zagreb, Croatia

Manufacturer:

Krka, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto, Slovenia Krka, d.o.o. Radnička cesta 48 10 000 Zagreb, Croatia

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 Authorization number in Croatia, the country of export: HR-H-799948138-01 HR-H-799948138-03 HR-H-799948138-05

Parallel Import Authorization Number: 222/23

This Medication is Authorized for Marketing in the Member States of the European Economic Area

Under the Following Names:

Czech Republic Elicea Oro Tab Estonia, Slovakia, Hungary Elicea Q-Tab Lithuania Elicea

Date of Approval of the Leaflet: 09.10.2023

[Information about the trademark]