Elicea

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Elicea
20 mg, film-coated tablets
Escitalopram
Please read the entire leaflet carefully before taking this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• 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 the active substance escitalopram. Escitalopram belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs).
Elicea 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, continue taking Elicea even if there is no initial improvement in well-being.
Talk to your doctor if, while taking this medicine, you do not feel better or feel 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 and other medicines").

Warnings and precautions
Before starting treatment with Elicea, consult a doctor or pharmacist.
Inform the doctor about all other diseases and disorders, as these may need to be taken 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 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 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, or if the patient is pregnant (see section "Pregnancy, breastfeeding and effect on fertility");
• if the patient is undergoing electroconvulsive therapy;
• if the patient has ischemic heart disease;
• if the patient has or has had heart disease or recently suffered a myocardial infarction;
• if the patient has low resting heart rate and/or suspects 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 previously 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.
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 (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (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 thoughts or self-harm ideation may occur. 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 antidepressant medicines.

If the patient experiences thoughts of self-harm or suicide, seek immediate medical advice from your doctor or contact the nearest healthcare facility.
It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to inform him/her if they notice worsening depression or anxiety, or concerning changes in behavior.
Children and adolescents
Elicea should not be used in children and adolescents under 18 years of age. When medicines from this group are used, patients under 18 years of age are at increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, oppositional behavior, and anger). Nevertheless, a doctor may prescribe Elicea to a patient under 18 years of age if deemed necessary. If Elicea has been prescribed to a patient under 18 years of age, and this 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. 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 the doctor or pharmacist about all medicines currently taken 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) containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine as active substances. If the patient has taken any of the above-mentioned medicines, a 14-day interval must be observed before starting treatment with Elicea. After discontinuation of Elicea, a 7-day interval must pass before starting any of these medicines;
• 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;
• 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 reactions;
• cimetidine, lansoprazole, and omeprazole (used in the treatment of peptic ulcer disease), fluconazole (an antifungal medicine), 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 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 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 discontinuation of 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 disorders), 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, particularly halofantrine), or certain antihistamines (astemizole, hydroxyzine, mizolastine). If in doubt, consult the 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 interactions (effects) between Elicea and alcohol are not expected.
Pregnancy, breastfeeding, and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. The patient should not use Elicea during pregnancy or breastfeeding without discussing the risks and benefits of treatment with the 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, tremor, jitteriness, irritability, lethargy, crying, sleepiness, and difficulty falling asleep. If any of these symptoms occur in the newborn, contact the doctor immediately.
The patient should ensure that the midwife and/or doctor know that she is taking Elicea. Medicines such as Elicea, when taken during pregnancy, particularly 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 the doctor or midwife immediately.
Taking Elicea towards the end of pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Elicea, she should inform her doctor or midwife so they can provide appropriate advice.
When taking Elicea during pregnancy, the medicine should never be stopped abruptly.
Escitalopram is expected to pass into human milk.
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces semen quality in animals. This effect may theoretically affect fertility, although no effect on fertility in humans has been observed to date.
Driving and using machines
The patient should not drive or operate machinery until it is known how Elicea 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 take Elicea

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
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.
Anxiety disorder with panic attacks (panic disorder)
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.
Use in children and adolescents
Elicea is generally not used in children and adolescents. For further information, see section 2
“Warnings and precautions”.
Renal impairment
Caution is required in patients with severe renal impairment. The medicine should be used according
to your doctor's instructions.
Hepatic impairment
Patients with impaired liver function should not exceed a dose of 10 mg per day. The medicine should
be used according to your doctor's instructions.
Poor metabolisers of drugs 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 your doctor's instructions.
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.
10 mg and 20 mg tablets: the tablet may be divided into equal doses.
Duration of treatment
It may take several weeks before the patient notices 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 may return. Continuing treatment for at least 6 months after improvement is recommended.
Taking more Elicea than recommended
If you take more Elicea than recommended, contact your doctor or the nearest emergency
department immediately, even if you do not feel any symptoms. Symptoms of overdose include:
dizziness, tremor, agitation, seizures, coma, nausea, vomiting, cardiac arrhythmias, low blood pressure,
and disturbances in fluid and electrolyte balance. Take the medicine packaging with you when
visiting your doctor or going to 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 before going to sleep, take it immediately. The next dose should be
taken at the usual time. If you remember about the missed dose during the night or the next day,
skip the missed dose and take the next dose 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 commonly occur when 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 was reduced too quickly. In most
cases, withdrawal symptoms are mild and resolve spontaneously within 2 weeks. However, in some
patients, they may be severe or persist longer (2–3 months or more).
If severe withdrawal symptoms occur, contact your doctor. Your doctor may recommend restarting
the medicine, followed by a slower tapering schedule.
Withdrawal symptoms include: dizziness (unsteady gait, balance disturbances), tingling sensations,
burning sensations, and (less commonly) electric shock-like sensations, also in the head, sleep
disturbances (vivid dreams, nightmares, and insomnia), anxiety, headache, nausea, excessive
sweating (including night sweats), psychomotor agitation, restlessness, tremor, confusion or
disorientation, emotional instability or irritability, diarrhoea (loose stools), visual disturbances,
palpitations (fluttering or pounding of the heart).
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects usually resolve after a few weeks of treatment.
It should be noted that some of these adverse effects may also be symptoms of the illness itself and may improve as the patient's condition gets better.
If any of these adverse effects occur during treatment, you should
contact your doctor or go immediately to hospital:

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, larynx or face, urticaria (hives), 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 in passing urine,
• Seizures, see also section “Warnings and precautions”,
• Yellowing of the skin and whites of the eyes; signs of liver dysfunction and/or hepatitis,
• Rapid or irregular heartbeat, fainting, which may indicate a life-threatening condition known as torsade de pointes,
• Suicidal thoughts and behaviour, see also section “Warnings and precautions”,
• Sudden swelling of the skin or mucous membranes (angioedema).

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

Additionally, numerous adverse effects are known with medicines having a similar mechanism of action to escitalopram (the active substance in Elicea). These include:

• Akathisia (restlessness),
• Loss of appetite.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects 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
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of this 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. This will help protect the environment.

6. Contents of the pack and other information

What Elicea contains

• The active substance is escitalopram. Each film-coated tablet contains 20 mg of escitalopram (as 25.56 mg escitalopram oxalate).
• The other ingredients in the medicine are monohydrate lactose, crospovidone, povidone K 30, microcrystalline cellulose, pregelatinized starch, corn 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
White, oval, biconvex film-coated tablets with a score line on one side. The tablet can be divided into equal doses.
Pack sizes: 28 or 56 film-coated tablets in blisters, packed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Lithuania, 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation numbers in Lithuania, the country of export: LT/1/09/1743/024
LT/1/09/1743/027
Parallel import authorisation number: 128/25
This medicinal product is authorised for sale in the European Economic Area under the following names:
Austria Escitalopram Krka
Bulgaria, Czech Republic, Estonia, Lithuania,
Latvia, Slovenia, Slovakia, Hungary Elicea