Elicea

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Elicea, 20 mg, film-coated tablets
Escitalopram
Please read this leaflet carefully before using 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 another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your 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 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 antidepressant medicines called selective serotonin reuptake inhibitors ( SSRI - Serotonin Reuptake Inhibitors ). These medicines act on the serotoninergic system in the brain by increasing the concentration of serotonin. 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 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 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 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 bleeding and bruising, 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 heart disease or has previously had a heart attack;
• 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);
• if the patient is taking this medicine concomitantly with buprenorphine. This combination may lead to serotonin syndrome, a potentially life-threatening condition (see section "Elicea and other medicines").

Warning!
Some patients with bipolar disorder may experience a manic phase. This is characterized by unusual and rapidly changing thoughts, 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.
Medicines such as Elicea (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.
Suicidal thoughts and worsening of depression or anxiety symptoms
If the patient has depression and/or anxiety disorders, these may be accompanied by 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 have 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 center.
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 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, oppositional behavior, and manifestations 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 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
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 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 or buprenorphine (used in the treatment of severe pain). These medicines may interact with Elicea and cause symptoms such as involuntary, rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tone, body temperature above 38°C. If the patient experiences such symptoms, contact a doctor;
• cimetidine, lansoprazole, and omeprazole (used in the treatment of peptic ulcer disease), fluconazole (used in the treatment of fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase escitalopram blood levels;
• St. John's wort (Hypericum perforatum) – a herbal medicine used in the treatment of depression;
• acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to treat pain or to "thin" the blood, known as anticoagulants). This may increase the tendency to bleeding;
• warfarin, dipyridamole, and phenprocoumon (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 if 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, antimalarial medicines, mainly halofantrine), and certain antihistamines (astemizole, mizolastine). If in doubt, consult a 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 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.
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, tremor, jitteriness, irritability, lethargy, crying, sleepiness, 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 three months, may increase the risk of a serious condition in the child, known as 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. Taking Elicea towards the end of pregnancy may increase the risk of severe 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.
Escitalopram is thought to pass into breast milk.
Elicea should not be taken during breastfeeding without prior consideration by the doctor of the risks and benefits of treatment.
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 has been observed in humans to date.
Driving and operating machinery
Do not drive or operate machinery until the patient knows how the 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 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, 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 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
decrease 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
"Important information before taking Elicea".
Method of administration
Elicea may be taken with food or independently of meals. 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. Continuing treatment for at least 6 months after improvement
is recommended.
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, cardiac arrhythmias, low blood pressure, and
disturbances in fluid and electrolyte balance. Take the Elicea packaging with you to the doctor's
appointment or hospital.
Missed 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 dose and remember later the same day, take it immediately. The next dose
should be taken at the usual time the following day. Do not take the missed dose at night or the
next day; continue taking the medicine at the usual time.
Stopping Elicea
Do not stop taking Elicea without consulting your doctor. When ending treatment, your doctor
usually recommends 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 longer).
If severe withdrawal symptoms occur, contact your doctor. Your doctor may recommend
resuming 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, also 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 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 everybody will get them.
Adverse effects are usually mild and resolve within a few weeks of treatment.
Please be aware that some of these adverse effects may also be symptoms of the underlying illness and will improve as your condition gets better.
Contact your doctor if you experience any of the following adverse effects 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 and whites of the eyes; symptoms of liver dysfunction and/or hepatitis,
• Rapid or irregular heartbeat, fainting, which may indicate a life-threatening condition called torsade de pointes,
• Suicidal thoughts and behaviour, see also section “Warnings and precautions”.

In addition to the adverse effects listed above, the following adverse effects 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, 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 tiredness, 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 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 test results (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 volume of urine excreted (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),
• Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage); for additional information, see section 2 “Pregnancy, breastfeeding and effects on fertility”.

Additionally, numerous adverse effects 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 in this class.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Elicea

Keep this 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 storage temperature requirements. 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 coated tablet contains 20 mg of escitalopram (in the form of 25.56 mg escitalopram oxalate).
• The other ingredients are lactose monohydrate, crospovidone, povidone, microcrystalline cellulose, pregelatinized starch, corn starch and magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol 3000 and triacetin in the coating.

What Elicea looks like and contents of the pack
White, oval, biconvex coated tablets with a score line on one side. The tablet can be divided into equal doses.
Pack sizes: 28 or 56 coated tablets in OPA/Aluminum/PVC/Aluminum blisters, in a cardboard box.
For further information about the medicine, 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation numbers in Lithuania, the country of export: LT/1/09/1743/024
LT/1/09/1743/027
Parallel Import Authorisation Number: 63/24
This medicine is authorised for sale in the European Economic Area countries under the following names: