Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Elicea (Escitalopram Krka 20 mg)
20 mg, film-coated tablets
Escitalopramum
Elicea and Escitalopram Krka 20 mg are different trade names for the same medicine.
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 questions, 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 someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell 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 feels improvement. Therefore, continue taking Elicea even if there is no initial improvement in well-being.
Talk to your doctor if you do not feel better or feel worse while taking this medicine.

2. Important information before using Elicea

When not to use Elicea:

if the patient is allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6);
if the patient is taking other medicines belonging to the group of MAO inhibitors, including selegiline (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression), or linezolid (an antibiotic);
in patients with congenital heart rhythm disorders or if the patient has experienced an episode of heart rhythm disturbances (on ECG; a test assessing heart function);
if the patient is taking medicines for heart rhythm disorders or medicines that may affect heart rhythm (see section 2, "Elicea with 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 they 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 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 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 (water pills);
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 conditions, such as certain types of glaucoma (increased eye pressure).

Note
Some patients with bipolar disorder may experience a manic phase.
This is characterized by unusually 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.
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, these may be associated with 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 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, they should immediately inform their 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 of 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 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, defiant behaviors, 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 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 immediately. Furthermore, there are currently no data on the long-term safety of Elicea in this age group regarding growth, maturation, and cognitive and behavioral development.
Elicea with 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 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 stopping before starting treatment with Elicea. After stopping Elicea, 7 days must pass before any of these medicines are 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 disorders) 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 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 "thin" the blood, known as blood-thinning medicines). This may increase the tendency to bleed;
warfarin, dipyridamole, and phenprocoumon (used to "thin" the blood, known as anticoagulants). The doctor may order blood clotting time tests at the beginning and after stopping Elicea to determine whether the anticoagulant dose remains appropriate;
mefloquine (used in the treatment of malaria), bupropion (used in the treatment of depression), and tramadol (used in the treatment of severe pain) due to the risk of lowering the seizure threshold;
neuroleptics (used in the treatment of schizophrenia and psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the risk of lowering the seizure threshold;
flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Elicea may be necessary;
medicines that lower potassium or magnesium levels in the blood 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, hydroxyzine, 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 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 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 without discussing 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 levels, muscle stiffness or floppiness, increased reflexes, tremor, 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, 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 skin blueness.
Symptoms usually occur within the first 24 hours after birth. If these symptoms occur, contact a 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 bleeding disorders. If the patient is taking Elicea, she should inform her doctor or midwife so they can provide appropriate advice.
Elicea should never be stopped abruptly during pregnancy.
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 fertility has been observed in humans to date.
Driving and operating machinery
The patient should not drive or operate machinery until they know how Elicea affects them.
Elicea contains lactose monohydrate
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 have any doubts,
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.

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 should be exercised 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.

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 your doctor's instructions.

Method of administration
Elicea can be taken with or without food. Swallow the tablet with water. Do not chew the tablet, as it has 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 immediate 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 recommended
If you take more Elicea than you should, contact your doctor or the nearest emergency department immediately, even if you do not feel any symptoms. Symptoms of overdose include: dizziness, tremor, agitation, seizures, coma, nausea, vomiting, heart rhythm disturbances, low blood pressure, and disturbances in water and electrolyte balance. Take the medicine packaging with you to the doctor's appointment 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 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, you should 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 longer).
If severe withdrawal symptoms occur, contact your doctor. Your doctor may advise restarting the medicine and then tapering it more slowly.
Withdrawal symptoms include: dizziness (unsteady gait, balance disturbances), tingling sensations, burning sensations, and (less commonly) electric shock-like sensations, including in the head, sleep disturbances (vivid dreams, nightmares, and insomnia), anxiety, headache, nausea, excessive sweating (including night sweats), psychomotor agitation, restlessness, tremor, confusion or disorientation, emotional instability or irritability, diarrhoea (loose stools), visual disturbances, palpitations (fluttering or pounding 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.
Usually, adverse effects subside after a few weeks of treatment.
It is important to be aware that some of these adverse effects may also be symptoms of the illness itself and will resolve as your condition improves.
If any of the following 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, or difficulty breathing or swallowing (severe allergic reaction),
High fever, agitation, confusion, tremor, and sudden muscle spasms; these may be symptoms of a rare condition called serotonin syndrome.

Frequency not known (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 life-threatening arrhythmias 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,
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 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, agitation, nervousness, anxiety 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 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 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), leading to water retention, blood dilution, and reduced sodium levels (inappropriate ADH secretion),
Elevated blood levels of prolactin hormone,
Galactorrhoea (milk production) 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 mechanism of action similar to escitalopram (the active substance in Elicea). These include:

Motor restlessness (akathisia),
Loss of appetite.

Reporting of adverse effects
If any adverse symptoms 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 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 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 required. Such measures help protect the environment.

6. Package contents 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 are lactose monohydrate, crospovidone, povidone K 30, microcrystalline cellulose, pregelatinized starch, corn starch and magnesium stearate in the tablet core; hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol 3000 and triacetin in the coating. The black ink contains: shellac (E 904), iron oxide black (E 172), propylene glycol (E 1520).

What Elicea looks like and contents of the pack
White, oval, biconvex film-coated tablets measuring 12 x 7.5 mm, with a score line on one side and a black imprint "20" on both sides of the tablet. The tablet can be divided into equal doses.
Pack sizes: 28 or 56 film-coated tablets in blisters, packed in a cardboard box.
For further information, contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Ireland, 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 number in Ireland, the country of export: PA 1347/046/004
Parallel Import Licence Number: 225/25
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, Poland, Slovenia, Slovakia, Hungary Elicea