Elicea q-tab

Package leaflet: Information for the patient

Elicea Q-Tab, 5 mg, orodispersible tablets
Elicea Q-Tab, 10 mg, orodispersible tablets
Elicea Q-Tab, 15 mg, orodispersible tablets
Elicea Q-Tab, 20 mg, orodispersible tablets
escitalopram
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

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 several weeks before the patient feels improvement. Therefore, treatment with Elicea Q-Tab should be continued even if there is no initial improvement in well-being.
Talk to your doctor if, while taking this medicine, the patient does not feel better or feels worse.

2. 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.
Tell 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 blood sodium levels.
• If the patient has an increased tendency to bleeding or bruising, or if the patient is pregnant (see section "Pregnancy, breastfeeding and 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 diarrhoea, 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 had eye problems, such as certain types of glaucoma (increased eye pressure),

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 the doctor.
During the first weeks of treatment, symptoms such as restlessness or difficulty sitting still or standing still may occur. Inform the 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, suicidal or self-harming thoughts may occur. These symptoms or behaviours 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 experienced thoughts of self-harm or suicide;
• young adult patients. Clinical trial data show an increased risk of suicidal behaviour in individuals under 25 years of age with psychiatric disorders treated with antidepressants.

If the patient experiences thoughts of self-harm or suicide, the patient should immediately
inform their doctor or contact the nearest healthcare facility.
Informing relatives or friends about the depression or anxiety disorder and asking them to read this leaflet may be helpful. The patient may ask them to inform the patient if they notice worsening of depression or anxiety or concerning changes in behaviour.
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 behaviour, and 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, cognitive development, and behavioural development.
Elicea Q-Tab and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Inform the 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 effects.
• 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 and similar medicines (opioids, used for severe pain). These may increase the risk of adverse effects.
• 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 anticoagulants). This may increase the tendency to bleeding.
• warfarin, dipyridamole, and phenprocoumon (medicines used to "thin" the blood, known as anticoagulants). The 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 in the treatment of malaria), bupropion (used in the treatment of depression), and tramadol (used in the treatment of severe pain) due to the risk of lowering the seizure threshold.
• neuroleptics (used in the treatment of schizophrenia and psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the risk of lowering the seizure threshold.
• 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 that lower blood potassium or magnesium levels, which increase the risk of life-threatening heart rhythm disturbances.

DO NOT USE Elicea Q-Tab if the patient is taking medicines used to treat heart rhythm disorders or 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), or certain antihistamines (astemizole, hydroxyzine, mizolastine). If in doubt, consult the doctor.
Elicea Q-Tab with food, drink and alcohol
Elicea Q-Tab may 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 (effects) between Elicea Q-Tab and alcohol are not expected.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. The patient should not use Elicea Q-Tab during pregnancy or breastfeeding unless she has discussed the risks and benefits of treatment with her doctor.
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, 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 the 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 the doctor and (or) midwife immediately.
Taking Elicea Q-Tab towards the end of pregnancy may increase the risk of severe vaginal bleeding occurring 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.
If Elicea Q-Tab is taken during pregnancy, the medicine should never be stopped abruptly.
Escitalopram is expected to pass into breast milk.
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces semen quality in animals. This could theoretically affect fertility, although no effect on fertility has been observed in humans to date.
Driving and operating machinery
The patient should not drive or operate machinery until they know how the medicine affects them.
Elicea Q-Tab contains lactose 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 take Elicea Q-Tab

This medicine should always be taken exactly as directed by the physician or pharmacist. If in doubt, consult the physician or pharmacist.

Adults

Depression
The usual recommended dose of Elicea Q-Tab is 10 mg as a single dose once daily. The physician 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, then the dose may be increased to 10 mg per day. The physician may subsequently 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. The physician 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. The physician 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, the physician 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. The physician 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 "Warnings and precautions".

Renal impairment
Caution should be exercised in patients with severe renal impairment. The medicine should be used according to the physician's instructions.

Hepatic impairment
Patients with hepatic impairment should not exceed a dose of 10 mg per day. The medicine should be used according to the physician's instructions.

Patients who are poor metabolizers via the CYP2C19 isoenzyme
Patients with this known genotype should not exceed a dose of 10 mg per day. The medicine should be used according to the physician's instructions.

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 the physician.
Elicea Q-Tab should be taken for as long as directed by the physician. If treatment is stopped too early, symptoms may return. It is recommended to continue treatment for at least 6 months after improvement has been achieved.

Method of administration

• Elicea Q-Tab tablets are 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.
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 the 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 more Elicea Q-Tab has been taken than recommended, contact a physician or the nearest emergency department immediately, even if no symptoms are present. Symptoms of overdose include: dizziness, tremor, agitation, seizures, coma, nausea, vomiting, cardiac arrhythmias, low blood pressure, and disturbances in fluid and electrolyte balance. Bring the Elicea Q-Tab packaging to the doctor's appointment or hospital visit.

Missed dose of Elicea Q-Tab
Do 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 the dose immediately. The next dose should be taken at the usual time the following day. If the patient remembers during the night or the next day, the missed dose should be skipped and the patient should continue taking the medicine according to the prescribed schedule.

Stopping Elicea Q-Tab
Do not stop taking this medicine without consulting the physician. When discontinuing treatment, a gradual reduction of the Elicea Q-Tab dose over several weeks is usually recommended.
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 at high doses, or if the dose has been 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 the physician. The physician 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) an electric shock-like sensation, also in the head; sleep disturbances (vivid dreams, nightmares, insomnia); anxiety; headache; nausea; excessive sweating (including night sweats); psychomotor agitation; restlessness; tremor; feelings of 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 physician 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 within 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 subside as
the patient's condition improves.

If any of the following adverse reactions occur during treatment, contact a doctor or go to hospital immediately:

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

• Unusual bleeding, including gastrointestinal bleeding.

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

• Swelling of the skin, tongue, lips, larynx or face, urticaria, or difficulty breathing or swallowing (severe allergic reaction).
• High fever, agitation, confusion, tremor, and sudden muscle contractions; these may be symptoms of a rare condition called serotonin syndrome.

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

• Difficulty urinating;
• Seizure attacks; 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 indicate life-threatening arrhythmias known as torsade de pointes;
• Suicidal thoughts and behaviour; see also section “Warnings and precautions”;
• Sudden swelling of the skin or mucous membranes (angioedema).

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 runny nose (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 disorders (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
• Heavy menstrual bleeding
• Irregular menstruation
• Weight loss
• Rapid heartbeat
• Swelling of upper or lower limbs
• Nosebleeds

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

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

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

• Decreased sodium concentration in blood (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)
• Signs of unusual bleeding, e.g. in the skin and mucous membranes (petechiae) and low platelet count (thrombocytopenia)
• Increased secretion of antidiuretic hormone (ADH), leading to water retention, blood dilution, and reduced sodium levels (inappropriate ADH secretion)
• Increased blood levels of prolactin hormone
• Galactorrhea in men and in women who are not breastfeeding
• Mania
• An increased risk of bone fractures has been observed in patients taking medicines of this class
• Heart rhythm disturbances (so-called QT interval prolongation, observed on ECG showing the heart's electrical activity)
• Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage); for additional information, see section 2 “Pregnancy, breastfeeding and fertility”

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

• Restless movement (akathisia)
• Loss of appetite

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this 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 after the word
EXP. The expiry date refers to the last day of the stated month.
There are no special recommendations regarding the storage temperature of the medicinal product.
Store in the original packaging to protect from moisture and light.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the pack and other information

What Elicea Q-Tab contains

• The active substance is escitalopram. Each orodispersible tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of escitalopram in the form of escitalopram oxalate. The other ingredients are potassium polyacrylate, hydrochloric acid concentrated, lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, acesulfame potassium, neohesperidin dihydrochalcone, peppermint flavour [containing maltodextrin (corn), modified starch (corn), 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 bevelled edges, 7 mm in diameter, printed with the number "5" on one side
10 mg: white to almost white, flat tablets with bevelled edges, 9 mm in diameter, printed with the number "10" on one side
15 mg: white to almost white, flat tablets with bevelled edges, 11 mm in diameter, printed with the number "15" on one side
20 mg: white to almost white, flat tablets with bevelled edges, 12 mm in diameter, printed with the number "20" on one side
Pack(s): 28, 30, 56, 60, 84 and 90 orodispersible tablets in blisters, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:

For further detailed information about this medicinal product, please contact the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Tel. +48 22 57 37 500