Elicea Q-tab

Leaflet accompanying the packaging: patient information

Elicea Q-Tab, 5 mg, orally disintegrating tablets

Elicea Q-Tab, 10 mg, orally disintegrating tablets

Elicea Q-Tab, 15 mg, orally disintegrating tablets

Elicea Q-Tab, 20 mg, orally disintegrating tablets

Escitalopram

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

• Keep this leaflet, you may need to read it again.
• 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 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 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

Elicea Q-Tab contains the active substance escitalopram. Escitalopram belongs to a group of antidepressant medicines 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 a few 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 talk to their doctor if they do not feel better or feel worse while taking this medicine.

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 medicine (listed in section 6),
• if the patient is taking other medicines that belong to the group of MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic),
• if the patient has congenital heart rhythm disorders or has had them in the past (detected in an 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 Q-Tab and other medicines").

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 other disorders or diseases, as the doctor should take this information into account. In particular, the patient should inform their doctor:

• If the patient has 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 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 Q-Tab may affect blood sugar control. It may be necessary to adjust the dose of insulin and/or oral medicines that lower blood sugar.
• If the patient has low sodium levels in the blood.
• If the patient has an increased tendency to bleed or bruise or if the patient is pregnant (see section "Pregnancy, breastfeeding, and fertility").
• 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 a slow resting heart rate and/or knows they may have a salt deficiency due to prolonged, severe diarrhea, vomiting, or the use of diuretics.
• If the patient experiences rapid or irregular heartbeats, fainting, collapse, or dizziness when standing up, which may indicate heart rhythm disorders.
• If the patient currently has or has had eye problems, such as certain types of glaucoma (increased eye pressure),

Caution

In some patients with manic-depressive illness, a manic phase may occur.
It is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If such symptoms occur, the patient should contact their doctor.
In the first few weeks of treatment, symptoms such as restlessness or difficulty sitting still or standing in one place may occur. The patient should immediately inform their doctor if they experience any of these symptoms.
Medicines like Elicea Q-Tab (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after the treatment was stopped.

Suicidal thoughts and worsening of depressive or anxiety symptoms

If the patient has depression and/or anxiety disorders, they may be accompanied by suicidal thoughts or self-harm.
Such symptoms or behavior may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually start working after about 2 weeks, sometimes later.
These symptoms are more likely to occur 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 antidepressant medicines.

If the patient experiences suicidal thoughts or self-harm they must immediately
tell 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 inform them if they notice that the depression or anxiety has worsened or if there are 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 medicines from this group, patients under 18 years of age are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and expressions 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 the above symptoms worsen in patients under 18 years of age taking Elicea Q-Tab, the doctor should be informed. Additionally, there is currently no data on the long-term safety of using Elicea Q-Tab in this age group regarding growth, maturation, and cognitive and behavioral development.

Elicea Q-Tab and other medicines

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

• non-selective monoamine oxidase inhibitors (MAOIs) (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 Q-Tab. After stopping Elicea Q-Tab, it should be 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.
• the antibiotic linezolid.
• lithium (used to treat manic-depressive illness) and tryptophan (used to treat depression).
• imipramine and desipramine (used to treat depression).
• sumatriptan and similar medicines (used to treat migraines) and tramadol and similar opioid medicines (used to treat severe pain). They may increase the risk of side effects.
• cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (an antifungal medicine), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may cause an increase in escitalopram levels in the blood.
• St. John's Wort (Hypericum perforatum) - a herbal medicine used to treat depression.
• acetylsalicylic acid and non-steroidal anti-inflammatory medicines (medicines used to treat pain or to "thin" the blood, known as anticoagulants). This may increase the tendency to bleed.
• warfarin, dipyridamole, and phenprocoumon (medicines used to "thin" the 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 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 Q-Tab.
• medicines that lower potassium or magnesium levels in the blood, increasing the risk of life-threatening heart rhythm disorders.

DO NOT TAKEElicea Q-Tab if 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, intravenous erythromycin, pentamidine, antimalarial medicines, mainly halofantrine), and certain antihistamine medicines (astemizole, hydroxyzine, mizolastine). In case of any further doubts, the patient should consult their 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 medicines, 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The patient should not take Elicea Q-Tab during pregnancy or breastfeeding unless they have discussed the risks and benefits of treatment with their doctor.
If the patient takes Elicea Q-Tab during the last 3 months of pregnancy, they should be aware that the following symptoms may occur in the newborn: breathing difficulties, blue skin, seizures, fluctuations in body temperature, difficulties in sucking, vomiting, low blood sugar, muscle stiffness or flaccidity, increased reflex excitability, tremors, tremors, irritability, lethargy, constant crying, and sleep disturbances. If any of these symptoms occur in the newborn, the patient should immediately consult their doctor.
The patient should inform their doctor and/or midwife about taking Elicea Q-Tab. Taking medicines like Elicea Q-Tab, especially in the last three months of pregnancy, may increase the risk of severe complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN). It is characterized by rapid breathing and blue discoloration. These symptoms usually occur within the first day of life. If such symptoms occur in the newborn, the patient should immediately contact their 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 the patient has a history of coagulation disorders. If the patient takes Elicea Q-Tab, they should inform their doctor or midwife so that they can provide appropriate advice.
The patient should 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 medicine 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

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

Elicea Q-Tab contains lactose and sodium

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

3. How to take Elicea Q-Tab

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Adults
Depression
The recommended dose of Elicea Q-Tab is 10 mg in a single dose once a day. The doctor may increase the dose to a maximum of 20 mg per day.
Panic disorder
The initial dose is 5 mg in a single dose once a day 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 in a single dose once a day. 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 Q-Tab is 10 mg in a single dose once a day. 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 in a single dose once a day. Depending on the patient's response, the doctor may increase the dose to a maximum of 20 mg per day.
Patient 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 further information, see section 2 "Warnings and precautions".
Kidney function disorders
Caution should be exercised in patients with severe kidney function disorders. The medicine should be taken as prescribed by the doctor.
Liver function disorders
Patients with liver function disorders should not exceed a dose of 10 mg per day. The medicine should be taken as prescribed by the doctor.
Patients who are slow metabolizers of medicines involving the CYP2C19 isoenzyme
Patients with this known genotype should not exceed a dose of 10 mg per day. The medicine should be taken as prescribed by the doctor.

Duration of treatment

It may take a few 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 dose without consulting their doctor.
Elicea Q-Tab should be taken for as long as prescribed by the doctor. If the patient stops treatment too early, the symptoms of the disease may return. It is recommended to continue treatment for at least 6 months after improvement.

Method of administration

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

The orally disintegrating tablets of Elicea Q-Tab are fragile. The tablets should not be pushed out of the blister pack, as they may be damaged. The patient should not touch them 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 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 the patient's 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.

Taking a higher dose of Elicea Q-Tab than recommended

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. The symptoms of overdose include: dizziness, tremors, restlessness, seizures, coma, nausea, vomiting, heart rhythm disorders, low blood pressure, and electrolyte imbalance. On the visit to the doctor or hospital, the patient should take the packaging of Elicea Q-Tab with them.

Missing a 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 medicine 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 medicine according to the established dosing 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 abruptly, the patient may experience withdrawal symptoms. These symptoms occur frequently. The risk is higher if the medicine was taken for a long time or in high doses, or if the dose was reduced too quickly. In most cases, 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 treatment and then stopping it more slowly.
Withdrawal symptoms include: dizziness (unsteady gait, balance disorders), tingling and burning sensations (and less frequently) 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, heart palpitations.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Elicea Q-Tab can cause side effects, although not everybody 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 disappear as the patient's condition improves.

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

Uncommon (may occur in up to 1 in 100 patients):

• Unusual bleeding, including bleeding from the gastrointestinal tract.

Rare (may occur in up to 1 in 1,000 patients):

• Swelling of the skin, tongue, lips, throat, or face, hives, or difficulty breathing or swallowing (severe allergic reaction.
• High fever, restlessness, 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 - 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 occur in more than 1 in 10 patients):

• Nausea
• Headache.

Common (may occur in up to 1 in 10 patients):

• Nasal congestion or sinusitis (sinus infection)
• Decreased or increased appetite
• Anxiety, restlessness, unusual dreams, sleep disturbances, dizziness, yawning, tremors, burning sensations
• 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 occur in up to 1 in 100 patients):

• Hives, rash, itching (itching)
• Teeth grinding, restlessness, nervousness, panic attacks, confusion
• Sleep disturbances, taste disorders, 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 upper or lower limbs
• Nosebleeds.

Rare (may occur in up to 1 in 1,000 patients):

• Aggression, feeling of loss of one's own identity (depersonalization), hallucinations
• Slow heartbeat.

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

• Decreased sodium levels in the blood (symptoms include: nausea, weakness with muscle weakness, and confusion)
• Dizziness when standing up due to low blood pressure (orthostatic hypotension)
• Abnormal liver function test results (increased liver enzyme activity in the blood)
• Movement disorders (involuntary muscle movements)
• Painful erection of the penis (priapism)
• Symptoms of unusual bleeding, e.g., in the skin and mucous membranes (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 women who are not breastfeeding
• Mania
• An increased risk of bone fractures has been observed in patients taking medicines from this group
• Heart rhythm disorders (so-called QT interval prolongation, observed in an ECG that images the heart's electrical activity)
• Severe postpartum hemorrhage, which occurs shortly after delivery, to obtain more information, see section "Pregnancy, breastfeeding, and fertility".

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

• restlessness (akathisia)
• loss of appetite.

Reporting side effects
If 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 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, it is possible to gather more information on the safety of this medicine.

5. How to store Elicea Q-Tab

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 after the abbreviation EXP. The expiry date refers to the last day of the month stated.
There are no special recommendations for the storage temperature of the medicinal product.
Store in the original packaging to protect from moisture and light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Elicea Q-Tab contains

• The active substance of Elicea Q-Tab is escitalopram. Each orally disintegrating tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of escitalopram, in the form of escitalopram oxalate. The other ingredients are polyacrylic 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 what the packaging contains

5 mg: white to almost white, flat tablets with beveled edges, 7 mm in diameter, and the number "5" printed on one side
10 mg: white to almost white, flat tablets with beveled edges, 9 mm in diameter, and the number "10" printed on one side
15 mg: white to almost white, flat tablets with beveled edges, 11 mm in diameter, and the number "15" printed on one side
20 mg: white to almost white, flat tablets with beveled edges, 12 mm in diameter, and the number "20" printed on one side
Packaging:28, 30, 56, 60, 84, and 90 orally 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 medicine is authorized in the Member States of the European Economic Area under the following names:
To obtain more detailed information about this medicine, the patient should contact the 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 last revision of the leaflet:15.12.2024