Elicea

Patient Information Leaflet

Warning! Keep this leaflet. The packaging information is in a foreign language.
Elicea, 5 mg, film-coated tablets
Escitalopram
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of Contents

1. What Elicea is and what it is used for
2. What you need to know 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 known as selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain by increasing serotonin levels. Dysfunction of the brain's serotonin system plays an important role in the development of depression and related disorders.
It may take several weeks before you notice improvement. Therefore, you should continue taking Elicea even if you do not initially feel better.
Please 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 the doctor about all other diseases and conditions, as these may need to be taken into account. In particular, inform the 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. The doctor may need to adjust the dose;
• 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 bleeding and bruising;
• 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 a 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 appear.
Suicidal thoughts and worsening of depression or anxiety symptoms
Patients with depression and/or anxiety disorders may experience 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 have previously experienced suicidal or self-harming thoughts,
• 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 antidepressant medicines.

If the patient experiences suicidal or self-harming thoughts, they should immediately inform their doctor or contact the nearest healthcare center.
It may be helpful to inform relatives or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to inform him/her if they notice worsening depression or anxiety, or concerning behavioral changes.
Children and adolescents
Elicea 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 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 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. 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
Tell 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 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 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 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 (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 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 for pain or to "thin" the blood, known as blood-thinning medicines). These may increase the tendency to bleeding;
• 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 if 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 lower 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 a doctor.
Elicea with food, drink, and alcohol
Elicea can 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 effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a 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, excessive 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, especially during the last three months, may increase the risk of a serious condition in the child called persistent pulmonary hypertension of the newborn (PPHN), characterized by increased breathing rate and skin blueness.
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 should never be stopped abruptly.
Escitalopram is expected to pass into breast milk.
Elicea should not be taken during breastfeeding without prior evaluation by a 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 monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking Elicea.

3. How to take Elicea

This medicine should always be taken exactly as your doctor or pharmacist has told you.
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 (anxiety disorder with panic attacks)
The starting 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 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 tablets, as they have a bitter taste.

Duration of treatment
It may take several weeks before you start to feel better. Therefore, continue taking Elicea even if you do not initially feel any improvement in your condition.
Do not change the dose without consulting your doctor.
Take Elicea 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 improvement is achieved.

Taking more Elicea than prescribed
If you take more Elicea than prescribed, contact your doctor or nearest emergency department immediately, even if you do not feel any symptoms. Symptoms of overdose may include: dizziness, tremor, agitation, seizures, coma, nausea, vomiting, heart rhythm disturbances, low blood pressure, and disturbances in fluid and electrolyte balance. Bring the Elicea packaging with you when visiting the doctor or hospital.

If you miss a dose of Elicea
If you miss a dose, 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 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 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 stopping treatment with 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 the dose 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, and 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 everybody will experience them.
Adverse reactions are usually mild and resolve within a few weeks of treatment.
It is important to be aware that some of these adverse reactions may also be symptoms of the illness itself and will resolve as your condition improves.
You should contact your doctor if you experience any of the following adverse reactions 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 agitation (restlessness), confusion, tremor, and sudden muscle contractions; these may be symptoms of a rare condition called serotonin syndrome.

Frequency unknown (frequency cannot be estimated from available data):

• Difficulty in passing urine,
• 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 life-threatening arrhythmias known as 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 occur in more than 1 in 10 patients):

• Nausea,
• Headache.

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

• Urticaria, rash, itching (pruritus),
• Teeth grinding, motor restlessness (agitation), 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 occur in up to 1 in 1000 patients):

• Aggression, depersonalization, hallucinations,
• Slow heartbeat.

Frequency unknown (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 indicating increased tendency to bleeding 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 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 you experience any adverse effects, including any not listed in this leaflet, you should inform 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
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Elicea

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 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 coated tablet contains 5 mg of escitalopram (as 6.39 mg escitalopram oxalate).
• Other ingredients are: lactose monohydrate, crospovidone, povidone K 30, microcrystalline cellulose, pregelatinized maize starch, and magnesium stearate in the tablet core; hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol 3000, and triacetin in the coating.

What Elicea looks like and contents of the packaging
White, round, biconvex coated tablets with bevelled edges.
Packaging: blisters containing 28, 30, 56 or 60 coated tablets in a cardboard box.
For further information, please contact the responsible party or parallel importer:
Marketing Authorisation Holder in the Czech Republic, 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaging performed by:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in the Czech Republic, country of export: 30/602/08-C
Parallel Import Licence number: 117/18