ELICEA

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Elicea
10 mg, film-coated tablets
Escitalopram
Please read carefully the entire leaflet 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, 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 others, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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 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].
Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors ( SSRI - Serotonin Reuptake Inhibitors ). These medicines act on the serotoninergic system in the brain by increasing serotonin levels. Dysfunction of the brain's serotoninergic 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 immediate improvement in well-being.
Talk to your doctor if you do not feel better or feel worse while taking this medicine.

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 and 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 these may need to be taken into account. In particular, inform your doctor:

• if the patient has epilepsy. If seizures occur or their frequency increases, 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 and (or) oral glucose-lowering medications may be necessary;
• if the patient has low blood sodium levels;
• 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;
• 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 disorders such as certain types of glaucoma (increased eye pressure).

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 has depression and (or) anxiety disorders, they may be accompanied by thoughts of self-harm or suicide. These 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, seek immediate medical advice from your doctor or contact the nearest healthcare facility.
Informing family members 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 (particularly aggression, defiant behavior, and anger). Nevertheless, a doctor may prescribe Elicea to a patient under 18 years of age if they consider it necessary. If a doctor has prescribed Elicea 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, inform the doctor immediately.
Furthermore, 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 and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has 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 should 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 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 (used in the treatment of severe pain). These increase the risk of adverse reactions;
• cimetidine, lanzoprazole, 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 escitalopram blood levels;
• 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 "thin" the blood, known as anticoagulants). This may increase the tendency to bleed;
• warfarin, dipyridamole, and phenprocoumon (used to "thin" the blood, known as anticoagulants). The doctor may order blood clotting time tests at the beginning and after stopping Elicea to determine whether the anticoagulant dose remains 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 reduce blood potassium or magnesium levels, 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 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 may be taken during meals or independently of meals (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 have a baby, 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 three 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 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 that she is taking Elicea. Medicines such as Elicea, taken during pregnancy, especially during the last three 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 a doctor or midwife immediately.
If Elicea is used during pregnancy, it must never be stopped abruptly.
Escitalopram is expected to pass into breast milk.
Elicea should not be taken during breastfeeding without the doctor first considering the risks and benefits of treatment.
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces semen quality in animals. This effect could 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 monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking Elicea.

3. How to use 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.
Elicea is available in the following strengths: 5 mg, 10 mg and 20 mg.
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 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 the patient's 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
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 is 5 mg once daily. Your doctor may increase the dose to 10
mg per day.
Method of administration
Elicea may be taken with or without food. Swallow the tablet with water. Do not chew the tablets,
as they have a bitter taste.
The tablet may be divided into equal doses.
Duration of treatment
It may take several weeks before the patient feels improvement. Therefore, continue taking
Elicea even if there is no initial improvement in well-being.
Do not change the dosage without consulting your doctor.
Elicea should be taken for as long as your doctor recommends. If treatment is stopped too early,
symptoms of the illness may return. Treatment should be continued for at least 6 months after
improvement is achieved.
Taking more Elicea than prescribed
If you take more Elicea than prescribed, 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, heart rhythm disturbances, low blood
pressure, and disturbances in fluid and electrolyte balance. Take the Elicea packaging with you
to the doctor’s appointment or to the hospital.
If you miss a dose of Elicea
If you miss a dose of Elicea, do not take a double dose to make up for the missed dose. If you
forget to take your medicine and remember later the same day, take it as soon as possible.
Take the next dose at the usual time the following day. Do not take the missed dose at night or
the next day; instead, continue taking the medicine at the usual time.
Stopping Elicea
Do not stop taking this medicine without consulting your doctor. When stopping treatment,
your doctor will usually recommend gradually reducing the dose of Elicea over several weeks.
After stopping Elicea, especially abruptly, 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 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 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,
confusion or disorientation, emotional instability or irritability, diarrhoea (loose stools),
visual disturbances, palpitations (fluttering or pounding heartbeat).
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 everybody will experience 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 subside as the patient's condition improves.
Contact a doctor if any of the following adverse reactions occur during treatment:
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 or face, or difficulty breathing or swallowing (allergic reaction),
• High fever, motor agitation (restlessness), confusion, tremor, and sudden muscle contractions; these may be symptoms of a rare condition called serotonin syndrome.

Not known frequency (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 dysfunction and/or hepatitis,
• Rapid or irregular heartbeat, fainting, which may indicate a life-threatening arrhythmia called torsade de pointes,
• Suicidal thoughts and behaviour, see also section "Warnings and precautions".

In addition to the reactions listed above, the following adverse reactions have also been reported:
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 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, skin rash, itching (pruritus),
• Teeth grinding, motor agitation (restlessness), nervousness, panic 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,
• Rapid heartbeat,
• Swelling of the upper or lower limbs,
• Nosebleeds.

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

• Aggression, depersonalization, hallucinations,
• Slow heartbeat.

Not known frequency (frequency cannot be estimated from the 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),
• 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,
• Cardiac arrhythmias (so-called QT interval prolongation, observed on ECG; electrical activity of the heart).

Additionally, numerous adverse reactions are known 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 effects occur, including any adverse effects not listed in this leaflet, inform a 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
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 the 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. Such measures 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 ingredients are: monohydrate lactose, crospovidone, povidone K 30, microcrystalline cellulose, pregelatinized corn starch, magnesium stearate. Coating: hypromellose, titanium dioxide (E 171), monohydrate lactose, macrogol 3000, triacetin.

What Elicea looks like and contents of the packaging
White, oval, biconvex film-coated tablets with a score line on one side. The tablet can be divided into equal doses.
Packaging: 28, 30, 56, 60 and 90 film-coated tablets in blisters, in a cardboard box.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing authorization holder in the Czech Republic, the 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
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o. o.
ul. Jagiellońska 76
03-301 Warszawa
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warszawa
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in the Czech Republic, the country of export: 30/603/08-C
Parallel import authorization number: 236/18