Elicea q-tab

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Elicea Q-Tab, 10 mg, orodispersible tablets
Escitalopram
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

Escitalopram belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs - Serotonin Reuptake Inhibitors). These medicines act on the serotonin system in the brain by increasing serotonin levels. Dysfunction of the serotonin system in the brain plays an important role in the development of depression and related disorders.
Elicea Q-Tab contains escitalopram and is used in the treatment of depression (major depressive episodes) and anxiety disorders [such as panic disorder with or without agoraphobia, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder].
Talk to your doctor if you do not feel better or feel worse while taking this medicine.

2. Important information before using Elicea Q-Tab

When not to use 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 belonging to the group of MAO inhibitors, including selegiline (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression), or linezolid (an antibiotic),
• if the patient has congenital heart rhythm disorders or has had them in the past (detected on ECG - a test assessing heart function),
• if the patient is taking medicines for heart rhythm disorders or medicines that may affect heart rhythm (see section 2 "Elicea Q-Tab and other medicines").

Warnings and precautions
Before starting treatment with Elicea Q-Tab, discuss this with your doctor or pharmacist.
Inform your doctor if the patient has any other disorders or diseases, as the doctor should take such information into account. In particular, inform the doctor:

• If the patient has epilepsy. If seizures occur for the first time or increase in frequency, treatment with Elicea Q-Tab should be discontinued (see also section 4 "Possible side effects").
• If the patient has impaired liver or kidney function. Dose adjustment by the doctor may be necessary.
• If the patient has diabetes. Treatment with Elicea Q-Tab may affect blood glucose control. Adjustment of insulin and (or) oral glucose-lowering medicines may be necessary.
• If the patient has low sodium levels in the blood.
• If the patient has an increased tendency to bleeding or bruising, or if the patient is pregnant (see section "Pregnancy, breastfeeding and effect on fertility").
• If the patient is undergoing electroconvulsive therapy.
• If the patient has ischemic heart disease.
• If the patient has heart disease or has recently had a myocardial infarction.
• If the patient has a slow resting heart rate and (or) knows they may have salt deficiency due to prolonged, severe diarrhea, vomiting, or use of diuretics.
• If the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate heart rhythm disturbances.
• If the patient currently has or has previously had eye problems, such as certain types of glaucoma (increased eye pressure).
• If the patient is taking this medicine together with buprenorphine. This combination may lead to serotonin syndrome, a potentially life-threatening condition (see section "Elicea Q-Tab and other medicines").

Note
Some patients with bipolar disorder may experience a manic phase.
It is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If such symptoms occur, contact your doctor.
In the first weeks of treatment, symptoms such as restlessness or difficulty sitting still or standing still may occur. Inform your doctor immediately if any of these symptoms occur.
Medicines such as Elicea Q-Tab (so-called SSRIs or SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
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 beginning of treatment with antidepressants, as these medicines usually start to work only after about 2 weeks, sometimes later.
These symptoms are more likely in:

• patients who previously had thoughts of self-harm or suicide;
• young adult patients. Clinical trial data show an increased risk of suicidal behavior in individuals under 25 years of age with psychiatric disorders who were treated with antidepressant medicines.

If the patient experiences thoughts of self-harm or suicide, you should immediately
inform your doctor or contact the nearest healthcare facility.
It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to inform him or her if they notice worsening depression or anxiety or concerning 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 adverse reactions such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behavior, and expressions of anger). Nevertheless, the doctor may prescribe Elicea Q-Tab to a patient under 18 years of age if they consider it necessary. If the doctor has prescribed Elicea Q-Tab to a patient under 18 years of age and this causes any doubts, contact the doctor again. If any of the above-mentioned symptoms occur or worsen in patients under 18 years of age taking Elicea Q-Tab, inform the doctor. Furthermore, there are currently no 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 medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Inform your doctor if the patient is taking any of the following medicines:

• non-selective monoamine oxidase inhibitors (MAO inhibitors) (used in the treatment of depression), containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine as active substances. If the patient has taken any of these medicines, they should wait 14 days after discontinuation before starting treatment with Elicea Q-Tab. After stopping Elicea Q-Tab, 7 days must pass before any of these medicines can be used.
• reversible selective MAO-A inhibitors, containing moclobemide (used in the treatment of depression).
• irreversible MAO-B inhibitors, including selegiline (used in the treatment of Parkinson's disease). These increase the risk of adverse reactions.
• the antibiotic linezolid.
• lithium (used in the treatment of bipolar disorder) and tryptophan (used in the treatment of depression).
• imipramine and desipramine (used in the treatment of depression).
• sumatriptan and similar medicines (used in the treatment of migraine) and tramadol or buprenorphine (used in the treatment of severe pain). These medicines may interact with Elicea Q-Tab and cause symptoms such as involuntary, rhythmic muscle contractions, including those affecting eye movement, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, and body temperature above 38°C. If such symptoms occur, contact your doctor;
• cimetidine, lansoprazole, and omeprazole (used in the treatment of peptic ulcer disease), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase escitalopram blood levels.
• St. John's wort (Hypericum perforatum) - a herbal medicine used in the treatment of depression.
• acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to treat pain or to "thin" the blood, known as blood-thinning medicines). This may increase the tendency to bleeding.
• warfarin, dipyridamole, and phenprocoumon (medicines used to "thin" the blood, known as anticoagulants). Your doctor may order blood clotting time tests at the beginning and after discontinuation of Elicea Q-Tab to determine whether the anticoagulant dose is still appropriate.
• mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the risk of lowering the seizure threshold.
• neuroleptics (used to treat schizophrenia and psychosis) due to the risk of lowering the seizure threshold and antidepressants.
• flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Elicea Q-Tab may be necessary.
• medicines causing hypokalemia/hypomagnesemia.

Do not use Elicea Q-Tab if the patient is taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm, such as class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials, mainly halofantrine), and certain antihistamines (astemizole, mizolastine). If you have any further doubts, consult your doctor.
Elicea Q-Tab with food, drink, and alcohol
Do not take Elicea Q-Tab with food (see section 3 "How to take Elicea Q-Tab").
As with other medicines, Elicea Q-Tab should not be taken together with alcohol, although no interaction between Elicea Q-Tab and alcohol has been demonstrated.
Pregnancy, breastfeeding, and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
If the patient takes Elicea Q-Tab during the last 3 months of pregnancy, she should be aware that the newborn may experience the following symptoms: breathing difficulties, bluish skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood glucose levels, muscle stiffness or floppiness, increased reflex excitability, tremors, jitteriness, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. If any of these symptoms occur in the newborn, seek medical attention immediately.
Inform your doctor and (or) midwife about taking Elicea Q-Tab. Taking medicines such as Elicea Q-Tab during pregnancy, especially during the last three months, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN). It is characterized by rapid breathing and cyanosis. Symptoms usually appear within the first day after birth. If such symptoms occur in the newborn, contact your doctor and (or) midwife immediately.
If Elicea Q-Tab is taken during pregnancy, never stop taking it suddenly. Taking Elicea Q-Tab late in pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Elicea Q-Tab, she should inform her doctor or midwife so they can provide appropriate advice.
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces semen quality in animals. This may theoretically affect fertility, although no effect on human fertility has been observed to date.
Driving and operating machinery
Do not drive or operate machinery until the patient knows how the medicine affects them.
Elicea Q-Tab contains lactose monohydrate and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking Elicea Q-Tab.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Elicea Q-Tab

This medicine should always be used exactly as recommended by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
Elicea Q-Tab is available in the following strengths: 5 mg, 10 mg, 15 mg, 20 mg.
Adults
Depression
The usual recommended dose of Elicea Q-Tab is 10 mg as a single dose once daily. Your doctor may
increase the dose up to a maximum of 20 mg per day.
Panic disorder (anxiety disorder with panic attacks)
The initial dose is 5 mg as a single dose once daily during the first week of treatment, after which the dose
may be increased to 10 mg per day. Your doctor may then increase the dose up to a maximum of 20 mg
per day.
Social phobia
The usual recommended dose of Elicea Q-Tab is 10 mg as a single dose once daily. Your doctor may
reduce the dose to 5 mg once daily or increase it up to a maximum of 20 mg per day, depending on the
patient's response to the medicine.
Generalized anxiety disorder
The usual recommended dose of Elicea Q-Tab is 10 mg as a single dose once daily. Your doctor may
increase the dose up to a maximum of 20 mg per day.
Obsessive-compulsive disorder
The usual recommended dose of Elicea Q-Tab is 10 mg as a single dose once daily. Depending on the
patient's response, your doctor may increase the dose up to a maximum of 20 mg per day.
Elderly patients (aged over 65 years)
The recommended starting dose of Elicea Q-Tab is 5 mg once daily. Your doctor may increase the dose
to 10 mg per day.
Use in children and adolescents
Elicea Q-Tab is generally not used in children and adolescents. For further information, see section 2
"Important information before taking Elicea Q-Tab".
Duration of treatment
It may take several weeks before the patient notices improvement. Therefore, continue taking Elicea
Q-Tab even if there is no initial improvement in well-being.
Do not change the dosage without consulting your doctor.
Elicea Q-Tab should be taken for as long as your doctor recommends. If treatment is stopped too early,
symptoms may return. It is recommended to continue treatment for at least 6 months after improvement
is achieved.
Method of administration

• Elicea Q-Tab tablets should be taken daily as a single dose.
• Do not take the tablets with food.

Elicea Q-Tab orally disintegrating tablets are fragile. Do not push the tablets out of the blister foil, as they
may be damaged. Do not touch them with wet hands, as the tablet may disintegrate. The tablet does not
have a break line and cannot be divided into equal doses. To remove the tablet from the packaging, follow
these steps:

1. Hold the edge of the blister and gently peel off one square at the perforation site.
2. Pull the marked edge of the foil and completely remove it.
3. Shake the tablet onto your hand.
4. Immediately place the tablet on your tongue after removing it from the packaging.

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 more Elicea Q-Tab than recommended
If you take more Elicea Q-Tab than recommended, contact your doctor or the nearest emergency
department immediately, even if you do not feel any symptoms. Symptoms of overdose include: dizziness,
tremor, agitation, seizures, coma, nausea, vomiting, cardiac arrhythmias, hypotension, and disturbances of
water and electrolyte balance. Bring the Elicea Q-Tab packaging with you to the doctor's office or hospital.
If you miss a dose of Elicea Q-Tab
Do not take a double dose to make up for a missed dose.
If you forget to take your medicine and remember before going to bed, take it immediately. Take the next
dose at the usual time the following day. If you remember during the night or the next day that you missed
a dose, skip the missed dose and continue taking the medicine according to the prescribed schedule.
Stopping Elicea Q-Tab
Do not stop taking this medicine without consulting your doctor. When treatment is to be discontinued,
your doctor will usually recommend gradually reducing the dose of Elicea Q-Tab over several weeks.
After stopping Elicea Q-Tab, especially abruptly, withdrawal symptoms may occur. These symptoms
are common. The risk is greater if the medicine has been taken for a long time or in high doses, or if the
dose was reduced too quickly. In most cases, withdrawal symptoms are mild and resolve spontaneously
within 2 weeks. However, in some patients, they may be severe or persist longer (2–3 months or more). If
severe withdrawal symptoms occur, contact your doctor. Your doctor may recommend restarting the
medicine and then tapering it more slowly.
Withdrawal symptoms include: dizziness (unsteady gait, balance disturbances), tingling and burning
sensations, and (less commonly) electric shock-like sensations, also in the head, sleep disturbances
(vivid dreams, nightmares, and insomnia), anxiety, headache, nausea, excessive sweating (including
night sweats), psychomotor agitation, restlessness, tremor, confusion or disorientation, emotional
instability or irritability, diarrhea (loose stools), visual disturbances, palpitations (fluttering or pounding
heart).
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions usually resolve after a few weeks of treatment. It should be noted that some of these
adverse reactions may also be symptoms of the underlying illness and will resolve as the patient's
condition improves.
Contact your doctor if any of the following adverse reactions occur during treatment:
Uncommon (may affect up to 1 in 100 patients):

• Abnormal bleeding, including gastrointestinal bleeding.

Rare (may affect up to 1 in 1000 patients):

• If the patient develops swelling of the skin, tongue, lips or face, difficulty breathing or swallowing (an allergic reaction), seek immediate medical attention or go to hospital.
• If the patient develops high fever, agitation, confusion, tremor and sudden muscle contractions; these may be symptoms of a rare condition called serotonin syndrome. If such symptoms occur, contact your doctor.

If any of the following adverse reactions occur, seek immediate medical attention or go to
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 or irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsade de pointes.

The following adverse reactions have also been observed:
Very common (may affect more than 1 in 10 patients):

• Nausea
• Headache.

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

• Nasal congestion or cold symptoms (sinusitis)
• Decreased or increased appetite
• Anxiety, restlessness, unusual dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, skin burning sensation
• Diarrhoea, 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 of fatigue, fever
• Weight gain.

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

• Urticaria, rash, itching (pruritus)
• Teeth grinding, agitation, nervousness, panic attacks, confusion
• Sleep disturbances, taste disturbances, fainting (loss of consciousness)
• Pupil dilation, visual 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 1000 patients):

• Aggression, feeling of detachment from self (depersonalization), hallucinations
• Slow heartbeat.

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

• Thoughts of self-harm or suicide, see also section "Warnings and precautions"
• Decreased sodium blood concentration (symptoms include: nausea, malaise with muscle weakness, and confusion)
• Dizziness upon standing due to low blood pressure (orthostatic hypotension)
• Abnormal liver function tests (increased liver enzyme activity in blood)
• Movement disorders (involuntary muscle movements)
• Painful penile erection (priapism)
• Bleeding disorders, including skin and mucosal petechiae and reduced platelet count (thrombocytopenia)
• Sudden swelling of the skin or mucous membranes (angioedema)
• Increased urine volume (inappropriate ADH secretion)
• Galactorrhea in non-lactating women
• Mania
• Increased risk of bone fractures has been observed in patients taking medicines in this class.
• Cardiac arrhythmias (so-called QT interval prolongation, observed on ECG showing electrical activity of the heart).
• Severe postpartum vaginal bleeding (postpartum haemorrhage); for additional information, see section 2 "Pregnancy, breastfeeding and fertility".

Additionally, numerous adverse reactions are known with medicines having a similar mechanism of action to
escitalopram. These include:

• Akathisia [inability to remain still],
• Anorexia.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Elicea Q-Tab

Keep this medicine 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 stated month.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
Translation of some information on the immediate packaging:

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

6. Contents of the packaging and other information

What Elicea Q-Tab contains

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

What Elicea Q-Tab looks like and contents of the pack
Elicea Q-Tab 10 mg is a white to almost white, flat tablet with bevelled edges, 9 mm in diameter, with the number "10" engraved on one side.
Pack sizes: 28, 56, and 84 orodispersible tablets in blisters, packed in a cardboard box.
For further information, contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Croatia, the country of export:
Krka - farma d.o.o.
Radnička cesta 48
10 000 Zagreb, Croatia
Manufacturer:
Krka d.d. Novo mesto
Šmarješka cesta 6
8501 Novo mesto, Slovenia
Krka - farma 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, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Marketing Authorisation numbers in Croatia, the country of export: HR-H-799948138-01
HR-H-799948138-03
HR-H-799948138-05
Parallel Import Licence Number: 222/23
This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic Elicea Oro Tab
Estonia, Slovakia, Hungary Elicea Q-Tab
Lithuania Elicea