Package leaflet: information for the patient

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Elicea
10 mg, film-coated tablets
Escitalopram
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm other people, even if their symptoms are identical.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Elicea is and what it is used for
Important information before taking Elicea
How to take Elicea
Possible side effects
How to store Elicea
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 notices 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 with other medicines").

Warnings and precautions
Before starting treatment with Elicea, consult a doctor or pharmacist.
Inform your doctor about all other diseases and conditions, as these may need to be taken into account. In particular, inform your 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. 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 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 effects 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 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 diseases, such as certain types of glaucoma (increased eye pressure).

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 appear.
Medicines such as Elicea (so-called SSRIs or SNRIs) may cause sexual dysfunction symptoms (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 or self-harming thoughts may occur. Such symptoms or behaviors may worsen at the beginning of antidepressant treatment, as these medicines usually take about 2 weeks, sometimes longer, to start working.
These symptoms are more likely:

in patients who 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 antidepressants.

If the patient experiences thoughts of self-harm or suicide, contact the doctor immediately or seek help at the nearest healthcare facility.
Informing relatives or friends about the depression or anxiety disorder and asking them to read this leaflet may be helpful. The patient may ask them to inform him or her if they notice worsening 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 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 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 with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Inform your doctor if the patient is taking any of the following medicines:

non-selective monoamine oxidase inhibitors (MAO inhibitors) 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;
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 effects;
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 may increase escitalopram blood levels;
St. John's wort (Hypericum perforatum) – an herbal medicine used in the treatment of depression;
acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used for pain or "blood thinning," known as anticoagulant medicines). This may increase the tendency to bleeding;
warfarin, dipyridamole, and phenprocoumon (used for "blood thinning," 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 diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Elicea may be necessary;
medicines that reduce potassium or magnesium levels in the blood, which increase the risk of life-threatening heart rhythm disturbances.

DO NOT USE Elicea if the patient is taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm, such as class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial agents (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, antimalarials, mainly halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine). If you have any further doubts, consult your 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 interactions (effects) between Elicea and alcohol are not expected.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine. The patient should not use Elicea during pregnancy or breastfeeding unless she has discussed the risks and benefits of treatment 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, 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 knows 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 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 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.
During pregnancy, Elicea should never be stopped abruptly.
Escitalopram is believed to pass into breast 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 human fertility has been observed to date.
Driving and operating machinery
The patient should not drive or operate machinery until they know how Elicea 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 you are unsure,
you should consult your doctor or pharmacist.
Adults
Depression
The usual recommended dose of Elicea is 10 mg as a single dose once daily. Your doctor may
increase the dose up to a maximum of 20 mg per day.
Panic disorder (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 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 should be exercised in patients with severe renal impairment. The medicine should be used according to the doctor's instructions.
Hepatic impairment
Patients with hepatic impairment should not exceed a dose of 10 mg per day. The medicine should be used according to the doctor's instructions.
Patients who are 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 the doctor's instructions.
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.
Tablets of 10 mg and 20 mg strength: 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. 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 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 water and electrolyte balance. Take the medicine packaging with you to the doctor's office or 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 before going to sleep, you should 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, you should skip the missed dose and take the next dose at the usual time.
Stopping Elicea
Do not stop taking Elicea without consulting your doctor. When stopping treatment, a gradual reduction in the dose of Elicea over several weeks is usually recommended.
After stopping Elicea, especially abruptly, withdrawal symptoms may occur.
These symptoms are common after discontinuation of Elicea treatment. 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 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, feelings of confusion or disorientation, emotional instability or irritability, diarrhoea (loose stools), 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 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 is important to remember that some of these adverse effects may also be symptoms of the illness itself and may improve as your condition gets better.
If any of the following adverse effects occur during treatment, you should
contact your doctor or go to hospital immediately:

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, 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 unknown (frequency cannot be estimated from 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 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 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, skin rash, itching (pruritus),
Teeth grinding, 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 occur in up to 1 in 1000 patients):

Aggression, depersonalization, hallucinations,
Slow heartbeat.

Frequency unknown (frequency cannot be estimated from 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),
Signs of unusual bleeding, e.g. under the skin and mucous membranes (petechiae), and low platelet count (thrombocytopenia),
Increased secretion of antidiuretic hormone (ADH), causing water retention, blood dilution, and reduced sodium levels (syndrome of inappropriate antidiuretic hormone secretion),
Elevated blood levels of prolactin hormone,
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 childbirth (postpartum haemorrhage); for additional information, see section 2 "Pregnancy, breastfeeding and fertility".

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

Restless movement (akathisia),
Loss of appetite.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring 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 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 in use. 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 10 mg of escitalopram (equivalent to 12.78 mg of escitalopram oxalate).
Other components of the medicine are lactose monohydrate, crospovidone, povidone K 30, microcrystalline cellulose, pregelatinized starch, corn starch, and magnesium stearate in the tablet core, and hypromellose 6 cP, titanium dioxide (E 171), lactose monohydrate, macrogol 3000, and triacetin in the coating.

What Elicea looks like and contents of the packaging
White, oval, biconvex coated tablets with a score line on one side. The tablet can be divided into equal doses.
Packaging: 28 or 56 coated tablets in blisters, packed in a cardboard box.
For more detailed information, please contact the responsible party 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
Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland
Marketing Authorisation numbers in Lithuania, the country of export: LT/1/09/1743/013
LT/1/09/1743/016
Parallel Import Authorisation number: 642/15