Escitalopram lek-am: detailed information

Package leaflet: Information for the patient

Escitalopram LEK-AM, 5 mg, film-coated tablets
Escitalopram LEK-AM, 10 mg, film-coated tablets
Escitalopram LEK-AM, 15 mg, film-coated tablets
Escitalopram LEK-AM, 20 mg, film-coated tablets
Escitalopramum
< logo of the marketing authorisation holder>
Please read this leaflet carefully before taking this medicine because it
contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

What Escitalopram LEK-AM is and what it is used for
What you need to know before taking Escitalopram LEK-AM
How to take Escitalopram LEK-AM
Possible side effects
How to store Escitalopram LEK-AM
Contents of the pack and other information

1. What Escitalopram LEK-AM is and what it is used for

Escitalopram LEK-AM contains the active substance escitalopram. Escitalopram LEK-AM
belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs).
These medicines act on the serotonin system in the brain by increasing the concentration of serotonin.
Escitalopram LEK-AM 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 of treatment before you notice improvement. You should continue taking Escitalopram LEK-AM even if it takes some time before you feel better.

If there is no improvement or if you feel worse, please consult your doctor.

2. Important information before using Escitalopram LEK-AM

When not to use Escitalopram LEK-AM:
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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 called MAO inhibitors, including selegiline (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression), or linezolid (an antibiotic);
If the patient was born with a congenital abnormal heart rhythm or if the patient has experienced an episode of abnormal heart rhythm (visible on ECG, a test evaluating heart function);
If the patient is taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see section 2 “Escitalopram LEK-AM and other medicines”).

Warnings and precautions
Before starting treatment with Escitalopram LEK-AM, discuss this with your doctor.
Inform your doctor if the patient has any other disorders or diseases, as the doctor should take such information 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 Escitalopram LEK-AM 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 Escitalopram LEK-AM may alter blood glucose levels. Adjustment of insulin dose 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 bleed or bruise easily, or if the patient is pregnant (see “Pregnancy, breastfeeding and fertility”);
If the patient is undergoing electroconvulsive therapy;
If the patient has ischemic heart disease;
If the patient has or has had heart problems, or if the patient recently suffered a heart attack;
If the patient has a slow resting heart rate and/or if the patient may have low electrolyte levels due to prolonged, severe diarrhoea, vomiting, or use of diuretics (water tablets);
If the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate heart rhythm disturbances;
If the patient has or has had eye disorders, such as certain types of glaucoma (increased intraocular pressure).

Note
In some patients with bipolar affective disorder, a manic phase may occur. This is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, consult a doctor.
During the first weeks of treatment, restlessness or inability to sit or stand still may also occur. If such symptoms appear, inform the doctor immediately.
Medicines such as Escitalopram LEK-AM (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 disorder
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If the patient has depression and/or anxiety disorders, they may sometimes have thoughts of self-harm or suicide. These symptoms may worsen at the beginning of treatment with an antidepressant, as such medicines take time to start working. Usually, this takes about 2 weeks, but sometimes it may take longer.
The likelihood of such thoughts is higher if:

The patient has previously experienced thoughts of suicide or self-harm;
The patient is a young adult. Clinical studies have shown an increased risk of suicidal behaviour in young adults (under 25 years of age) with psychiatric disorders who were taking antidepressants.

If thoughts of self-harm or suicidal thoughts occur, contact a doctor immediately or go to a hospital.
It may be helpful to talk about your depression or anxiety disorder with a family member or close friend; you may ask this person to read this leaflet. You may ask them to inform you if they notice worsening of depression or anxiety, or any concerning changes in behaviour.
Children and adolescents
Escitalopram LEK-AM should not be used in children and adolescents under 18 years of age. It should also be emphasized that patients under 18 years of age taking medicines from this group are at increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and anger). Nevertheless, a doctor may prescribe Escitalopram LEK-AM to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Escitalopram LEK-AM for a patient under 18 years of age and you have any doubts, please contact the doctor. If the mentioned symptoms develop or worsen in patients under 18 years of age taking Escitalopram LEK-AM, inform the doctor.
Furthermore, there is a lack of data on the long-term safety of Escitalopram LEK-AM in this age group regarding growth, puberty, cognitive development, and behavioural development.
Escitalopram LEK-AM and other medicines
Inform your doctor about all medicines currently used, recently used, or planned for use.
Inform your doctor if the patient is taking any of the following medicines:

Non-selective monoamine oxidase inhibitors (MAO) containing active substances such as: phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If the patient has taken any of these medicines, they should wait 14 days before starting Escitalopram LEK-AM. After stopping Escitalopram LEK-AM, wait 7 days before taking any of these medicines;
Reversible, selective monoamine oxidase A (MAO-A) inhibitors containing moclobemide (used in the treatment of depression);
Irreversible monoamine oxidase B (MAO-B) inhibitors containing selegiline (used in the treatment of Parkinson's disease). These medicines increase the risk of adverse reactions;
The antibiotic linezolid;
Lithium (used in the treatment of bipolar affective 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 in the treatment of severe pain). These medicines may increase the risk of adverse reactions;
Cimetidine, lansoprazole, and omeprazole (used in the treatment of stomach ulcers), fluconazole (used in the treatment of fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase the blood concentration of escitalopram;
St. John's wort (Hypericum perforatum) – a herbal medicine used for depression;
Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used for pain relief or blood thinning, so-called anticoagulants). These may increase the tendency to bleed;
Warfarin, dipyridamole, and phenprocoumon (medicines used for blood thinning, so-called anticoagulants). The doctor may order blood clotting time tests at the beginning and after stopping Escitalopram LEK-AM 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 possible risk of lowering the seizure threshold;
Neuroleptics (medicines used in the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to possible 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 Escitalopram LEK-AM may be required;
Medicines that lower potassium or magnesium levels in the blood, which increase the risk of life-threatening heart rhythm disturbances.

Do not use Escitalopram LEK-AM simultaneously with medicines used for heart rhythm disorders or medicines that may affect heart rhythm, such as: antiarrhythmic medicines of class IA and class III, antipsychotic medicines (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial medicines (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarials, especially halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine). Consult your doctor if you have any further questions.
Escitalopram LEK-AM with food, drink, and alcohol
Escitalopram LEK-AM may be taken with or without food (see section 3 “How to use Escitalopram LEK-AM”).
As with other medicines, it is not recommended to take Escitalopram LEK-AM together with alcohol, although interactions (effects) between Escitalopram LEK-AM and alcohol are not expected.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine. The patient should not use Escitalopram LEK-AM during pregnancy or while breastfeeding unless she has discussed the risks and benefits of treatment with her doctor.
Taking Escitalopram LEK-AM during the last 3 months of pregnancy may cause the following symptoms in the newborn: breathing difficulties, bluish skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood glucose levels, muscle stiffness or floppiness, increased reflex excitability, tremor, shakiness, irritability,
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lethargy, persistent crying, drowsiness, and difficulty sleeping. If any of these symptoms occur in the newborn, contact a doctor immediately.
Inform the doctor and/or midwife about the use of Escitalopram LEK-AM.
Taking medicines such as Escitalopram LEK-AM during pregnancy, especially during the last 3 months, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN).
It manifests as rapid breathing and cyanosis (bluish skin), and usually appears within the first 24 hours after birth. If such symptoms occur in the newborn, contact a doctor and/or midwife immediately.
Taking Escitalopram LEK-AM 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 Escitalopram LEK-AM, she should inform her doctor or midwife so they can provide appropriate advice.
Do not stop taking Escitalopram LEK-AM suddenly during pregnancy.
Escitalopram is expected to pass into human milk.
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans so far.
Driving and operating machinery
The patient should not drive or operate machinery until they know how Escitalopram LEK-AM affects them.
Escitalopram LEK-AM contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, meaning the medicine is considered “sodium-free”.

3. How to use Escitalopram LEK-AM

This medicine should always be taken as directed by the doctor. In case of doubt, consult
your doctor or pharmacist.
Adults
Depression
The usual recommended dose of Escitalopram LEK-AM is 10 mg once daily. The dose may be
increased by the doctor up to a maximum of 20 mg per day.
Panic disorder with agoraphobia
The initial dose of Escitalopram LEK-AM is 5 mg once daily during the first
week of treatment, after which the dose is increased to 10 mg once daily. The dose may then be
further increased by the doctor up to a maximum of 20 mg per day.
Social phobia
The usual recommended dose of Escitalopram LEK-AM is 10 mg once daily. The dose may then be
reduced by the doctor to 5 mg per day or increased up to a maximum of
20 mg per day, depending on the patient's response to the medicine.
Generalized anxiety disorder
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The usual recommended dose of Escitalopram LEK-AM is 10 mg once daily. The dose may be
increased by the doctor up to a maximum of 20 mg per day.
Obsessive-compulsive disorder
The usual recommended dose of Escitalopram LEK-AM is 10 mg once daily. The dose may be
increased by the doctor up to a maximum of 20 mg per day.
Elderly patients (over 65 years of age)
The recommended starting dose of Escitalopram LEK-AM is 5 mg once daily. The doctor may
recommend increasing the dose to 10 mg once daily.
Children and adolescents
Escitalopram LEK-AM is generally not recommended for use in children and adolescents. Additional
information is provided in section 2 “Important information before using Escitalopram LEK-AM”.
How to use Escitalopram LEK-AM
Escitalopram LEK-AM may be taken with or without food.
The tablet should be swallowed with water. Do not chew the tablets.
Tablets with a score line may be divided into equal doses.
Patients with impaired kidney function
Caution should be exercised in patients with severe renal impairment. The medicine should be used
according to the doctor's instructions.
Patients with impaired liver function
Patients with impaired liver function 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 metabolizers 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.
Duration of treatment
The patient may not feel better until several weeks of treatment have passed. Therefore, continue
taking Escitalopram LEK-AM as prescribed, even if it takes some time before improvement
in well-being occurs.
Do not change the dosage without medical advice.
Continue taking the medicine for as long as your doctor recommends. If treatment is stopped too early,
symptoms may return. Therefore, it is recommended to continue treatment for at least 6
months after regaining good well-being.
Taking more Escitalopram LEK-AM than prescribed
If the patient has taken more Escitalopram LEK-AM than prescribed, contact your doctor immediately
or go to the nearest hospital emergency department.
This should be done even if the patient does not feel unwell. Symptoms of overdose include:
dizziness, tremor, agitation, seizures, coma, nausea, vomiting, cardiac arrhythmias,
low blood pressure, and disturbances in water and electrolyte balance. Bring the Escitalopram LEK-AM
packaging to the doctor's appointment or hospital visit.
Missing a dose of Escitalopram LEK-AM
Do not take a double dose to make up for a missed dose. If the patient forgets to take a dose and
remembers before going to sleep, they should take the missed dose immediately. The next dose should be taken
at the usual time the following day.
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If the patient remembers about the missed dose during the night or the next day, they should
skip the missed dose and take the next dose as usual.
Stopping treatment with Escitalopram LEK-AM
Do not stop taking Escitalopram LEK-AM unless advised by your doctor.
When discontinuing treatment, it is usually recommended to gradually reduce the dose of
Escitalopram LEK-AM over a period of several weeks.
After stopping Escitalopram LEK-AM, especially if stopped abruptly, the patient may experience
withdrawal symptoms. These symptoms are common when treatment is discontinued. The risk is higher
if Escitalopram LEK-AM has been taken for a long time, at high doses, or if the dose was reduced too quickly.
In most patients, symptoms are mild and resolve spontaneously within two weeks. However, in some
patients, symptoms may be more severe or may persist longer (2–3 months or longer). If severe
withdrawal symptoms occur after stopping Escitalopram LEK-AM, contact your doctor. The doctor may
recommend restarting the medicine and 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, insomnia), feelings of anxiety, headache, nausea,
sweating (including night sweats), psychomotor agitation or restlessness, tremor, feelings of disorientation,
emotional instability or irritability, diarrhoea (loose stools), visual disturbances, palpitations
or rapid heartbeat (palpitations).
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will
experience them. Adverse reactions usually subside after a few weeks of treatment. It should
be remembered that some of these reactions may also be symptoms of the illness being
treated and will resolve as the patient's condition improves.
If any of the following adverse reactions occur during treatment, contact a doctor or go to
hospital immediately:
Uncommon (may occur in up to 1 in 100 people):

unusual bleeding, including gastrointestinal bleeding.

Rare (may occur in up to 1 in 1000 people):

swelling of the skin, tongue, lips, throat or face, hives or difficulty breathing or swallowing (severe allergic reaction),
high fever, agitation, confusion (disorientation), tremor and severe muscle spasms, which may be symptoms of a rare condition called serotonin syndrome.

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

difficulty passing urine,
seizures, see also section “Warnings and precautions”,
yellowing of the skin and whites of the eyes, indicating liver dysfunction/hepatitis,
rapid or irregular heartbeat, fainting which may be symptoms of a life-threatening condition called 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 reactions listed above, the following adverse reactions have also been
reported:
Very common (may occur in more than 1 in 10 people):

nausea,
headache.

Common (may occur in up to 1 in 10 people):

nasal congestion or runny nose (sinusitis),
decreased or increased appetite,
anxiety, psychomotor agitation, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, tingling sensation in the skin,
diarrhoea, constipation, vomiting, dry mouth,
excessive sweating,
muscle and joint 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 people):

hives, rash, itching,
teeth grinding, agitation, nervousness, panic attack, confusion (disorientation),
sleep disturbances, taste disturbances, fainting (syncope),
dilated pupils, visual disturbances, ringing in the ears (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 people):

aggression, depersonalization (feeling of loss of self-identity, feeling detached from oneself), hallucinations,
slow heartbeat.

Frequency unknown (cannot be estimated from available data):

decreased sodium concentration in blood (manifesting as nausea, malaise, muscle weakness or 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 in the skin and mucous membranes (petechiae),
increased secretion of antidiuretic hormone (ADH), causing water retention in the body, blood dilution and reduced sodium levels (syndrome of inappropriate antidiuretic hormone secretion),
galactorrhea in men and women who are not breastfeeding,
mania,
increased risk of bone fractures,
change in heart rhythm (known as “QT interval prolongation”, visible on ECG, a test assessing heart function),
severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection “Pregnancy, breastfeeding and fertility” in section 2.

Additionally, adverse reactions associated with medicines having a similar mechanism of action to escitalopram (the active substance in Escitalopram LEK-AM) are known. These include:

psychomotor restlessness (akathisia),
loss of appetite.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions 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
Tel.: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Escitalopram LEK-AM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Escitalopram LEK-AM contains

The active substance is escitalopram. Each tablet of Escitalopram LEK-AM contains 5 mg, 10 mg, 15 mg, or 20 mg of escitalopram (as oxalate).
The other ingredients are:

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Tablet core: microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, sodium stearyl fumarate.
Tablet coating: Opadry White Y-1-7000: hypromellose 0.5 mPa (E464), macrogol 400, titanium dioxide (E171).

What Escitalopram LEK-AM looks like and contents of the pack
Escitalopram LEK-AM 5 mg is available as round, biconvex, film-coated tablets, white in colour.
Escitalopram LEK-AM 10 mg is available as oval, biconvex, film-coated tablets, white in colour, with a central groove.
Escitalopram LEK-AM 15 mg is available as oval, biconvex, film-coated tablets, white in colour.
Escitalopram LEK-AM 20 mg is available as oval, biconvex, film-coated tablets, white in colour, with a central groove and engraved with the letter "E" on both sides of the groove on one side of the tablet.

Escitalopram LEK-AM is available in blister packs containing 7 or 14 tablets, placed in a cardboard box.
The cardboard box contains 28 or 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.
ul. Ostrzykowizna 14A
05-170 Zakroczym
Poland
Tel.: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106
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