Elicea

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Elicea
10 mg, film-coated 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. This medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Elicea is and what it is used for
2. Important information before taking Elicea
3. How to take Elicea
4. Possible side effects
5. How to store Elicea
6. Contents of the pack and other information

1. What Elicea is and what it is used for

Elicea contains escitalopram and 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].
Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors ( SSRI - Serotonin Reuptake Inhibitors ). These medicines act on the brain's serotonin system by increasing serotonin levels. Dysfunction of the brain's serotonin system plays an important role in the development of depression and associated disorders.
It may take several weeks before the patient feels improvement. Therefore, continue taking Elicea 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. Important information before using Elicea

When not to use Elicea

• 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);
• in patients with congenital heart rhythm disorders or if the patient has experienced an episode of heart rhythm disturbances (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 with other medicines").

Warnings and precautions
Before starting treatment with Elicea, consult a doctor or pharmacist.
Inform your doctor about all other diseases and disorders, as they may need to be taken into account. In particular, inform your doctor:

• if the patient has epilepsy. If seizures occur or increase in frequency, treatment with Elicea 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 may affect blood glucose control. Adjustment of insulin dose 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 bleed or bruise easily;
• if the patient is undergoing electroconvulsive therapy;
• if the patient has ischemic heart disease;
• if the patient has or has had heart disease or recently suffered a myocardial infarction;
• if the patient has a low resting heart rate and (or) knows they may have salt deficiency due to prolonged, severe diarrhea, vomiting, or use of diuretics (water pills);
• 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 disorders, such as certain types of glaucoma (increased pressure in the eye).

Note
Some patients with bipolar disorder may experience a manic phase. This is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If such symptoms occur, contact your doctor.
During 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 appear.
Suicidal thoughts and worsening of depression or anxiety symptoms
If the patient suffers from depression and (or) anxiety disorders, they may experience thoughts of self-harm or suicide. Such symptoms or behaviors may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, sometimes longer, to start working.
These symptoms are more likely:

• in patients who previously experienced suicidal thoughts or self-harm,
• in young adult patients. Clinical trial data show an increased risk of suicidal behavior in individuals under 25 years of age with psychiatric disorders treated with antidepressants.

If the patient experiences suicidal thoughts or self-harm they 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 him or her if they notice worsening of depression or anxiety or concerning changes in behavior.
Children and adolescents
Elicea must not be used in children and adolescents under 18 years of age. When taking medicines of this class, patients under 18 years of age are at increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (especially aggression, defiant behaviors, and expressions of anger). Nevertheless, a doctor may prescribe Elicea to a patient under 18 years of age if they consider it necessary. If Elicea has been prescribed to a patient under 18 years of age and causes any doubts, contact the prescribing doctor again. If any of the above-mentioned symptoms occur or worsen in patients under 18 years of age taking Elicea, inform the doctor immediately.
Moreover, there are currently no data on the long-term safety of Elicea in this age group regarding growth, maturation, cognitive development, and behavioral development.
Elicea with other medicines
Inform your doctor or pharmacist about all medicines currently 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 the above-mentioned medicines, they must wait 14 days after discontinuation before starting treatment with Elicea. After stopping Elicea, 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;
• antibiotics;
• 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 (used in the treatment of severe pain). These increase the risk of adverse effects;
• cimetidine, lansoprazole, and omeprazole (used in the treatment of peptic ulcer disease), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may increase the blood concentration of escitalopram;
• St. John's wort (Hypericum perforatum) – a herbal remedy 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 anticoagulant medicines). This may increase the tendency to bleed;
• warfarin, dipyridamole, and phenprocoumon (used to "thin" the blood, known as anticoagulant medicines). Your doctor may order blood clotting time tests at the beginning and after discontinuation of Elicea 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 may be necessary;
• medicines that lower potassium or magnesium levels in the blood, which increase the risk of life-threatening heart rhythm disturbances.

DO NOT USE Elicea 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 antibacterial agents (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, antimalarials, mainly halofantrine), or certain antihistamines (astemizole, mizolastine). If in doubt, consult your doctor.
Elicea with food, drink, and alcohol
Elicea can be taken with or without food (see section 3 "How to take Elicea").
As with other medicines, Elicea should not be taken with alcohol, although no interaction between Elicea and alcohol has been demonstrated.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
If the patient is pregnant, she should not take Elicea without first discussing the risks and benefits with her doctor.
If the patient takes Elicea 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 reflexes, tremors, jitteriness, irritability, lethargy, crying, drowsiness, and difficulty sleeping. If any of these symptoms occur in the newborn, contact a doctor immediately.
The patient should ensure that the midwife and (or) doctor know she is taking Elicea. Medicines such as Elicea, taken during pregnancy, particularly during the last 3 months, may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), characterized by increased breathing rate and bluish skin. Symptoms usually occur within the first 24 hours after birth. If these symptoms occur, contact your doctor or midwife immediately.
If Elicea is used during pregnancy, the medicine must never be stopped abruptly.
It is believed that escitalopram passes into breast milk.
Elicea should not be taken during breastfeeding without prior evaluation by the doctor of the risks and benefits of treatment.
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces sperm quality in animals. This effect 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 this medicine affects them.
Elicea contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking Elicea.

3. How to take Elicea

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
Adults
Depression
The usual recommended dose of Elicea 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 (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 further increase the
dose, up to a maximum of 20 mg per day.
Social phobia
The usual recommended dose of Elicea 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 your response to the medicine.
Generalised anxiety disorder
The usual recommended dose of Elicea 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 is 10 mg as a single dose once daily. Depending on your
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 is 5 mg once daily. Your doctor may increase the dose to 10
mg per day.
Use in children and adolescents
Elicea is generally not used in children and adolescents. For further information,
see section 2, "Important information before taking Elicea".
Method of administration
Elicea may be taken with or without food. Swallow the tablet with water. Do not chew the tablet, as it has a bitter taste. Tablets of 10 mg and 20 mg: the tablet may be divided into equal doses.
Duration of treatment
It may take several weeks before you notice improvement. Therefore, you should continue taking
Elicea even if you do not initially feel better.
Do not change the dose without consulting your doctor.
Elicea 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
symptoms have improved.
Taking more Elicea than recommended
If you take more Elicea than you should, contact your doctor or the nearest emergency department immediately, even if you do not feel any symptoms. Symptoms of overdose may include: dizziness,
tremor, agitation, seizures, coma, nausea, vomiting, cardiac arrhythmias, low blood pressure, and disturbances in water and electrolyte balance. Take the medicine pack with you when visiting the doctor or going to hospital.
If you miss a dose of Elicea
Do not take a double dose to make up for a forgotten dose. If you forget to take your dose and remember later the same day, take it as soon as possible. Take your next dose at the usual time the following day. Do not take the missed dose at night or the next day; continue taking the medicine at your usual time.
Stopping Elicea
Do not stop taking Elicea without consulting your doctor. When stopping treatment, it is usually recommended to gradually reduce the dose of Elicea over several weeks.
After stopping Elicea, especially if stopped suddenly, withdrawal symptoms may occur.
These symptoms are common after discontinuation of Elicea. The risk is greater if the medicine has been taken for a long time, 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 you experience severe withdrawal symptoms, contact your doctor.
Your doctor may recommend restarting the medicine and then reducing it more slowly.
Withdrawal symptoms include: dizziness (unsteady gait, balance disturbances), tingling sensations, burning sensations, and (less commonly) electric shock-like sensations, including in the head, sleep disturbances (vivid dreams, nightmares, and insomnia), anxiety, headache, nausea, excessive sweating (including night sweats), psychomotor agitation, restlessness, tremor, feelings of confusion or disorientation, emotional instability or irritability, diarrhoea (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 experiences them.
Adverse reactions are usually mild and 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 resolve as the patient's condition improves.
Contact your doctor if any of the following adverse reactions occur during treatment:
Uncommon (may occur in up to 1 in 100 patients):

• Unusual bleeding, including gastrointestinal bleeding.

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

• Swelling of the skin, tongue, lips or face, or difficulty breathing or swallowing (allergic reaction),
• High fever, motor restlessness (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 in passing urine,
• Seizures, see also section “Warnings and precautions”,
• Yellowing of the skin or 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”.

In addition to the adverse reactions listed above, the following have also been reported:
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 cold symptoms (sinusitis),
• Decreased or increased appetite,
• Anxiety, agitation, 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 occur in up to 1 in 100 patients):

• Urticaria, rash, itching (pruritus),
• Teeth grinding, motor agitation (restlessness), nervousness, anxiety attacks, confusion (disorientation),
• Sleep disturbances, taste disturbances, fainting (loss of consciousness),
• Pupil dilation, visual disturbances, tinnitus,
• Hair loss,
• Heavy menstrual bleeding,
• Irregular menstruation,
• Weight loss,
• Fast heartbeat,
• Swelling of the upper or lower limbs,
• Nosebleeds.

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

• Aggression, depersonalization, hallucinations,
• Slow heartbeat.

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

• 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),
• Symptoms of increased bleeding tendency in the skin and mucous membranes (petechiae),
• Sudden swelling of the skin or mucous membranes (angioedema),
• Increased urine volume (inappropriate ADH secretion),
• Galactorrhea in men and in women who are not breastfeeding,
• Mania,
• Heart rhythm disorders (so-called QT interval prolongation, observed on ECG; electrical activity of the heart).

Additionally, numerous adverse reactions have been reported with medicines having a similar mechanism of action to escitalopram. These include:

• Motor restlessness [inability to remain still (akathisia)],
• Loss of appetite (anorexia).

An increased risk of bone fractures has been observed in patients taking medicines from this group.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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 the medicine Elicea

Keep the 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.
There are no special requirements regarding storage temperature.
Store in the original packaging to protect from moisture.
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 packaging and other information

What Elicea contains

• The active substance is escitalopram. Each film-coated tablet contains 10 mg of escitalopram (as 12.78 mg escitalopram oxalate).
• Other components of the medicine are monohydrate lactose, crospovidone, povidone, microcrystalline cellulose, pregelatinized maize starch, and magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E 171), monohydrate lactose, macrogol 3000, and triacetin in the coating.

What Elicea looks like and contents of the pack
10 mg tablets – white, oval, biconvex film-coated tablets with a score line on one side.
The tablet can be divided into equal doses.
Pack sizes: 28 and 56 film-coated tablets in blisters, packed in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Lithuania, country of export:
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
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorisation numbers in Lithuania, country of export: LT/1/09/1743/012
LT/1/09/1743/013
LT/1/09/1743/016
LT/1/09/1743/019
Parallel import authorisation number: 435/22