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 responsible entity >
Please read this leaflet carefully before using the medicine, because
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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What is Escitalopram LEK-AM and what is it used for
Important information 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 is Escitalopram LEK-AM and what is it used for

Escitalopram LEK-AM belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotoninergic system in the brain by increasing the concentration of serotonin. Dysfunction of the serotoninergic system in the brain plays a key role in the development of depression and related disorders.
Escitalopram LEK-AM contains the active substance escitalopram, which 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).
It may take several weeks of treatment before the patient notices improvement. You should continue taking Escitalopram LEK-AM even if it takes some time for your condition to improve.
If there is no improvement or if the patient feels worse, consult your doctor.
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2. Important information before using Escitalopram LEK-AM

When not to use Escitalopram LEK-AM:

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 a 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 an abnormal heart rhythm or has experienced an episode of irregular heart rhythm (visible on ECG, a test assessing 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 affect blood glucose control. Adjustment of insulin dose and/or oral antidiabetic 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 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 heart problems or has recently had a heart attack.
If the patient has a slow resting heart rate and/or may have electrolyte imbalances due to prolonged, severe diarrhoea and vomiting (during illness) 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 has eye problems, such as certain types of glaucoma (increased pressure inside the eyeball).

Note
Some patients with bipolar affective disorder may experience a manic phase. This is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, contact the 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.
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 about self-harm or suicide. These symptoms may worsen at the beginning of treatment with an antidepressant, as such medicines take time to become effective. Usually about 2 weeks are needed, but sometimes it may take longer.
The likelihood of such thoughts is higher if:

The patient has previously experienced suicidal or self-harming thoughts;
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 the doctor immediately or go to hospital.
It may be helpful to tell a family member or close friend about the depression or anxiety disorder; you may ask that person to read this leaflet. You may ask that person to inform the patient if they notice worsening of depression or anxiety, or any worrying 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 effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and expressions of anger). Nevertheless, the doctor may prescribe Escitalopram LEK-AM to patients under 18 years of age if they consider it to be in the patient's best interest. If the doctor has prescribed Escitalopram LEK-AM to a patient under 18 years of age and you have any doubts, please contact the doctor. If any of the mentioned symptoms develop or worsen in patients under 18 years of age taking Escitalopram LEK-AM, inform the doctor.
Furthermore, there are no 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 the doctor about all medicines currently used or recently taken, as well as any medicines the patient plans to use.
Inform the 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 effects.
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 (used in the treatment of severe pain). These medicines increase the risk of adverse effects.

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Cimetidine and omeprazole (used in the treatment of stomach ulcers), fluconazole (used to treat 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) – an 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 bleeding.
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 dose of anticoagulant 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), due to possible risk of lowering the seizure threshold, and antidepressants.
Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). A change in the dosage of Escitalopram LEK-AM may be required.
Medicines that lower blood potassium or magnesium levels, 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: class IA and class III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials, especially halofantrine), certain antihistamines (astemizole, mizolastine). Consult the doctor if you have any further questions.
Escitalopram LEK-AM with food, drink or alcohol
Escitalopram LEK-AM can be taken with or without food (see section 3 "How to take Escitalopram LEK-AM").
As with other medicines, it is not recommended to drink alcohol while taking Escitalopram LEK-AM, 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 the doctor before using this medicine. The patient should not use Escitalopram LEK-AM during pregnancy or breastfeeding unless she has discussed the risks and benefits of treatment with the doctor.
Taking Escitalopram LEK-AM during the last three months of pregnancy may cause the following symptoms in the newborn: breathing difficulties, bluish skin, seizures, temperature fluctuations, sucking difficulties, vomiting, low blood glucose levels, muscle stiffness or floppiness, increased reflex excitability, tremor, jitteriness, irritability, lethargy, constant crying, drowsiness, or difficulty falling asleep. If any of these symptoms occur in the newborn, contact the 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 three
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months, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN).
It is characterized by rapid breathing and cyanosis, and usually appears within the first day after birth. If such symptoms occur in the newborn, contact the doctor and/or midwife immediately.
Taking Escitalopram LEK-AM towards the end of pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Escitalopram LEK-AM, she should inform the doctor or midwife so that appropriate advice can be provided.
It is believed that escitalopram passes into human milk.
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces semen quality. This could theoretically affect fertility, although no effect on fertility has been observed in humans so far.
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.
Driving and operating machinery
The patient should not drive or operate machinery until they know how Escitalopram LEK-AM affects them.

3. How to take Escitalopram LEK-AM

This medicine should always be taken exactly as prescribed by your doctor. If in doubt,
consult your doctor or pharmacist.
Escitalopram LEK-AM may be taken with or without food.
The tablet should be swallowed whole with water. Do not chew the tablet.
Tablets with a score line may be divided into equal doses.

Adults
Depression
The usual dose of Escitalopram LEK-AM is 10 mg once daily. Your doctor may increase the
dose up to a maximum of 20 mg per day.
Panic disorder with or without 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 be further
increased by your 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. Your doctor
may subsequently reduce the dose to 5 mg per day 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 dose of Escitalopram LEK-AM is 10 mg once daily. The dose may be increased
by your doctor up to a maximum of 20 mg per day.
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Obsessive-compulsive disorder
The usual dose of Escitalopram LEK-AM is 10 mg once daily. The dose may be increased
by your doctor up to a maximum of 20 mg per day.

Elderly patients (over 65 years of age)
The usual recommended starting dose of Escitalopram LEK-AM is 5 mg once daily. Your
doctor may recommend increasing the dose to 10 mg once daily.

Use in children and adolescents
Escitalopram LEK-AM is not generally recommended for use in children and adolescents.
Further information is provided in section 2, “Important information before taking Escitalopram LEK-AM.”

Duration of treatment
Improvement may take several weeks. Therefore, continue taking Escitalopram LEK-AM even
if it takes some time before you feel better.
Do not change the dose without first consulting your doctor.
Take the medicine for as long as your doctor prescribes. If treatment is stopped too early,
symptoms may return. Therefore, treatment should be continued for at least 6 months after
recovery.

Taking more Escitalopram LEK-AM than prescribed
If you have 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 you do not feel ill. Symptoms of overdose may include: dizziness, tremor, agitation,
seizures, coma, nausea, vomiting, cardiac arrhythmia, hypotension, and disturbances in
water and electrolyte balance. Bring the medicine pack of Escitalopram LEK-AM with you to
the doctor’s visit or hospital.

If you miss a dose of Escitalopram LEK-AM
Do not take a double dose to make up for a missed dose. If you forget to take a dose and
remember before going to bed, take the missed dose immediately and take the next dose at
the usual time the following day. If you remember about the missed dose during the night or
the next day, skip the missed dose and take the next dose at the usual time.

Stopping Escitalopram LEK-AM
Do not stop taking Escitalopram LEK-AM unless your doctor tells you to. When stopping
treatment, a gradual reduction of the dose of Escitalopram LEK-AM over several weeks is
usually recommended.
After stopping Escitalopram LEK-AM, especially if stopped abruptly, you may experience
withdrawal symptoms. These are common. The risk is greater if Escitalopram LEK-AM has
been taken for a long time, at high doses, or if the dose has been 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 persist longer (2–3 months or more). If you
experience severe withdrawal symptoms after stopping Escitalopram LEK-AM, contact your
doctor. Your doctor may recommend restarting the medicine and tapering it more slowly.
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Withdrawal symptoms may include: dizziness (unsteady gait, balance disturbances),
tingling, 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 fluttering of the heart (palpitations).

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 subside after a few weeks of treatment. It should be remembered that some of these effects may also be symptoms of the condition being treated and will resolve as the patient's well-being improves.
You should contact your doctor or go to hospital if any of the following adverse effects occur during treatment:

Not very common (occurring in not more than 1 in 100 people):

unusual bleeding, including gastrointestinal bleeding.

Rare (occurring in not more than 1 in 1,000 people):

swelling of the skin, tongue, lips or face, or difficulty breathing or swallowing (allergic reaction); patients should contact their doctor immediately or go to hospital.
high fever, agitation, confusion (disorientation), tremor and severe muscle contractions, which may be symptoms of a rare condition called serotonin syndrome.

Frequency unknown (frequency cannot be determined 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 and/or 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”;
severe vaginal bleeding shortly after childbirth (postpartum haemorrhage), see additional information in subsection “Pregnancy, breastfeeding and fertility” in section 2.

In addition to those listed above, the following adverse effects have also been reported:

Very common (occurring in more than 1 in 10 people):

nausea;
headache.

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Common (occurring in not more than 1 in 10 people):

nasal congestion or cold (sinusitis);
decreased or increased appetite;
anxiety, psychomotor agitation, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, skin tingling;
diarrhoea, constipation, vomiting, dry mouth;
increased sweating;
muscle and joint pain;
sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty achieving orgasm in women);
feeling of fatigue, fever;
weight gain.

Not very common (occurring in not more than 1 in 100 people):

urticaria, rash, itching;
teeth grinding, agitation, nervousness, panic attack, confusion (disorientation);
sleep disturbances, taste disturbances, fainting;
pupil dilation, 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 (occurring in not more than 1 in 1,000 people):

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

Frequency unknown – frequency cannot be determined 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);
bleeding, including petechiae in the skin and mucous membranes, and decreased platelet count (thrombocytopenia);
sudden swelling of the skin or mucous membranes (angioedema);
increased urine output (inappropriate antidiuretic hormone secretion);
milk production in men and in women who are not breastfeeding (galactorrhoea);
mania;
increased risk of bone fractures;
change in heart rhythm (known as “QT interval prolongation” visible on ECG, a test assessing heart function).

Additionally, adverse effects known with drugs having a similar mechanism of action to escitalopram (the active substance in Escitalopram LEK-AM) include:

restlessness (akathisia);
loss of appetite.

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Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects 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 cardboard box.
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 the sewage system 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 pack 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:
Tablet core: microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, sodium stearyl fumarate.
Tablet coating: Opadry White Y-1-7000: hypromellose 0.5 mPa (E464), polyethylene glycol 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.
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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
LEK-AM Pharmaceutical Company 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
11.12.2020
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