Elicea Q-tab

Package Leaflet: Information for the Patient

Elicea Q-Tab, 5 mg, Oral Disintegrating Tablets

Elicea Q-Tab, 10 mg, Oral Disintegrating Tablets

Elicea Q-Tab, 15 mg, Oral Disintegrating Tablets

Elicea Q-Tab, 20 mg, Oral Disintegrating Tablets

Escitalopram

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

• Keep this leaflet, as you may need to read it again.
• In case of any doubts, consult your doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. 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 pack and other information

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

Elicea Q-Tab contains the active substance escitalopram. Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs).
Elicea Q-Tab is used to treat depression (major depressive episodes) and anxiety disorders [such as panic disorder with or without agoraphobia, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder].
It may take several weeks before you feel better. Therefore, you should continue taking Elicea Q-Tab, even if you do not feel better initially.
Talk to your doctor if you do not feel better or feel worse while taking this medication.

2. Important information before taking Elicea Q-Tab

When Not to Take Elicea Q-Tab

• if you are allergic to escitalopram or any of the other ingredients of this medication (listed in section 6),
• if you are taking other medications 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),
• if you have congenital heart rhythm disorders or have had them in the past (detected in an ECG - a test that evaluates heart function),
• if you are 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, discuss it with your doctor or pharmacist.
Tell your doctor if you have other disorders or diseases, as the doctor should consider this information. In particular, inform your doctor:

• If you have epilepsy. If you experience seizures for the first time or an increase in their frequency, you should stop taking Elicea Q-Tab (see also section 4 "Possible side effects").
• If you have liver or kidney function disorders. It may be necessary to adjust the dose by your doctor.
• If you have diabetes. Taking Elicea Q-Tab may affect blood sugar control. It may be necessary to adjust the dose of insulin and/or oral medications that lower blood sugar.
• If you have low sodium levels in the blood.
• If you have an increased tendency to bleeding or bruising or if you are pregnant (see section "Pregnancy, breastfeeding, and fertility").
• If you are being treated with electroconvulsive therapy.
• If you have coronary heart disease.
• If you have or have had heart disease or have recently had a heart attack.
• If you have a slow resting heart rate and/or know that you may have a salt deficiency due to prolonged, severe diarrhea, vomiting, or the use of diuretic medications.
• If you experience rapid or irregular heartbeats, fainting, or dizziness when standing up, which may indicate heart rhythm disorders.
• If you currently have or have had eye problems, such as certain types of glaucoma (increased eye pressure),

Caution

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

Suicidal Thoughts and Worsening of Depression or Anxiety Symptoms

If you have depression and/or anxiety disorders, you may experience suicidal thoughts or self-harm. These symptoms, or behaviors, may worsen at the beginning of antidepressant treatment, as these medications 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;
• young adult patients.Clinical trial data show an increased risk of suicidal behavior in people under 25 years of age with mental disorders who were treated with antidepressants.

If you experience suicidal thoughts or self-harm immediately
tell your doctor or contact the nearest healthcare center.
It may be helpful to inform your relatives or friendsabout your depression or anxiety disorders and ask them to read this leaflet. You may ask them to monitor you and inform you if your depression or anxiety worsens or if you experience 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, your doctor may prescribe Elicea Q-Tab to a patient under 18 years of age if they consider it necessary. If your doctor has prescribed Elicea Q-Tab to a patient under 18 years of age and this causes any concerns, you should contact your doctor again. If the above symptoms worsen in patients under 18 years of age taking Elicea Q-Tab, you should inform your doctor. 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

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Tell your doctor if you 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 you have taken any of these medications, you should wait 14 days after stopping them before starting treatment with Elicea Q-Tab. After stopping Elicea Q-Tab, you should wait 7 days 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 and similar opioids (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 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 (used to treat pain or to "thin" the blood, known as anticoagulants). This may increase the risk of bleeding.
• warfarin, dipyridamole, and phenprocoumon (medications used to "thin" the blood, known as anticoagulants). Your 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 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, thioridazine, and haloperidol (antipsychotic medications). It may be necessary to adjust the dose of Elicea Q-Tab.
• medications that lower potassium or magnesium levels in the blood increase the risk of life-threatening heart rhythm disorders.

DO NOT TAKEElicea Q-Tab if you are 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, hydroxyzine, mizolastine). In case of any further doubts, consult your doctor.

Elicea Q-Tab with Food, Drink, and Alcohol

Elicea Q-Tab can be taken with or without food (see section 3 "How to take Elicea Q-Tab").
As with other medications, Elicea Q-Tab should not be taken with alcohol, although interactions between Elicea Q-Tab and alcohol are not expected.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication. You should not take Elicea Q-Tab during pregnancy or breastfeeding unless you have discussed the risks and benefits with your doctor.
If you take Elicea Q-Tab during the last 3 months of pregnancy, you should be aware that the following symptoms may occur in the newborn: breathing difficulties, blue skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood sugar, stiffness or floppiness, increased reflexes, tremors, tremors, irritability, lethargy, constant crying, and sleep disturbances. If any of these symptoms occur in the newborn, you should immediately contact your doctor.
You should inform your 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 serious 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, you should immediately contact your doctor and/or midwife.
Taking Elicea Q-Tab at the end of pregnancy may increase the risk of severe postpartum hemorrhage, which occurs shortly after delivery, especially if you have a history of bleeding disorders. If you take Elicea Q-Tab, you should inform your doctor or midwife so that they can provide you with appropriate advice.
Never stop taking Elicea Q-Tab abruptly during pregnancy.
It is assumed that escitalopram passes into breast milk.
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 Using Machines

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

Elicea Q-Tab Contains Lactose and Sodium

If you have been diagnosed with intolerance to some sugars, you should contact your 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

Always take this medication exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Adults
Depression
The recommended dose of Elicea Q-Tab is 10 mg once daily. Your 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. Your 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. Your doctor may reduce the dose to 5 mg per day or increase it to a maximum of 20 mg per day, depending on your response to the medication.
Generalized Anxiety Disorder
The recommended dose of Elicea Q-Tab is 10 mg once daily. Your 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 your response to the medication, your 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. Your 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 further information, see section 2 "Warnings and Precautions".
Renal Impairment
Caution should be exercised in patients with severe renal impairment. The medication should be used as directed by your doctor.
Hepatic Impairment
Patients with hepatic impairment should not exceed a dose of 10 mg per day. The medication should be used as directed by your doctor.
Poor Metabolizers of CYP2C19
Patients with this known genotype should not exceed a dose of 10 mg per day. The medication should be used as directed by your doctor.

Duration of Treatment

It may take several weeks before you feel better. Therefore, you should continue taking Elicea Q-Tab, even if you do not feel better initially.
Do not change the dose without consulting your doctor.
Elicea Q-Tab should be taken for as long as your doctor recommends. If you stop treatment too early, your symptoms 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 food.

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 score line and cannot be divided into equal doses. To remove a tablet from the packaging, follow these steps:

• 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 your hand.
• 4. Immediately after removal from the packaging, place the tablet on your tongue.

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

Overdose of Elicea Q-Tab

In case of overdose, immediately contact your doctor or the nearest emergency department, even if you 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. Bring the packaging of Elicea Q-Tab with you to the doctor's visit or hospital.

Missed Dose of Elicea Q-Tab

Do not take a double dose to make up for a missed dose.
If you forget to take the medication and remember before bedtime, you should take it immediately. The next day, take the next dose at the usual time. If you remember in the night or the next day that you missed a dose, skip the missed dose and continue taking the medication according to the established dosing schedule.

Stopping Treatment with Elicea Q-Tab

Do not stop taking Elicea Q-Tab without consulting your doctor. When you finish treatment, it is usually recommended to gradually reduce the dose of Elicea Q-Tab over several weeks.
After stopping Elicea Q-Tab, especially abruptly, you may experience withdrawal symptoms. These symptoms are common. The risk is higher if the medication was taken for a long time or in high doses, or if 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 you experience severe withdrawal symptoms, you should contact your doctor. Your 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, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Elicea Q-Tab can cause side effects, although not everybody gets them.
Side effects usually resolve after a few weeks of treatment. Be aware that some of these side effects may also be symptoms of the disease and will resolve as your condition improves.

If You Experience Any of the Following Side Effects During Treatment, Contact Your 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 (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 - symptoms 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 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
• 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 (itching)
• Teeth grinding, agitation, nervousness, panic attacks, confusion
• Sleep disturbances, taste disturbances, fainting (loss of consciousness)
• Dilated pupils, vision disturbances, ringing in the ears
• Hair loss
• Heavy menstrual bleeding
• Irregular menstrual periods
• Weight loss
• Rapid heartbeat
• Swelling of the arms or legs
• Nosebleeds.

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

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

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

• Decreased sodium levels in the blood (symptoms include: nausea, 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 (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, and decreased sodium levels
• Increased prolactin levels in the blood
• Milk secretion in men and in non-breastfeeding women
• Mania
• An increased risk of bone fractures has been observed in patients taking medications from this group
• Heart rhythm disorders (prolonged QT interval, observed in an ECG that images the heart's electrical activity)
• Severe postpartum hemorrhage, which occurs shortly after delivery, for more information, see section "Pregnancy, breastfeeding, and fertility".

Additionally, the following side effects are known for medications with a similar mechanism of action to escitalopram (the active substance of Elicea Q-Tab):

• restlessness (akathisia)
• loss of appetite.

Reporting Side Effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Elicea Q-Tab

Keep the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the packaging after the abbreviation EXP. The expiration date refers to the last day of the specified month.
There are no special storage temperature recommendations for this medication.
Store in the original packaging to protect from moisture and light.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the Pack and Other Information

What Elicea Q-Tab Contains

• The active substance of Elicea Q-Tab is escitalopram. Each oral disintegrating tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of escitalopram, in the form of escitalopram oxalate. The other ingredients are polyacrylate potassium, concentrated hydrochloric acid, lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, potassium acesulfame, neohesperidin dihydrochalcone, peppermint flavor [containing corn maltodextrin, modified corn starch, and peppermint oil], magnesium stearate. See section 2 "Elicea Q-Tab contains lactose and sodium".

What Elicea Q-Tab Looks Like and Contents of the Pack

5 mg: white to almost white, flat tablets with beveled edges, 7 mm in diameter, and printed with the number "5" on one side
10 mg: white to almost white, flat tablets with beveled edges, 9 mm in diameter, and printed with the number "10" on one side
15 mg: white to almost white, flat tablets with beveled edges, 11 mm in diameter, and printed with the number "15" on one side
20 mg: white to almost white, flat tablets with beveled edges, 12 mm in diameter, and printed with the number "20" on one side
Packaging:28, 30, 56, 60, 84, and 90 oral disintegrating tablets in blister packs, in a cardboard box
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

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
Genepharm S.A., Marathonos Av., 15351 Pallini Attiki, Greece
This medication is authorized in the European Economic Area member states under the following names:
To obtain more detailed information about this medication, contact your local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Phone: 22 57 37 500
Date of the last revision of the leaflet:15.12.2024