Escitalopram Lek-am

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

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

Escitalopram

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Escitalopram LEK-AM and what is it used for
• 2. Important information before taking Escitalopram LEK-AM
• 3. How to take Escitalopram LEK-AM
• 4. Possible side effects
• 5. How to store Escitalopram LEK-AM
• 6. 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 work on the serotonin system in the brain by increasing the levels of serotonin. Disturbances in the serotonin system in the brain are thought to play a key role in the development of depression and related disorders.
Escitalopram LEK-AM contains the active substance escitalopram, which 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 the patient notices an improvement. The patient should continue taking Escitalopram LEK-AM, even if it takes some time to feel better.
If there is no improvement or the patient feels worse, they should consult their doctor.
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2. Important information before taking Escitalopram LEK-AM

When not to take 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 the group of monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic);
• If the patient was born with a heart rhythm disorder or if the patient has had an episode of abnormal heart rhythm (visible on an ECG, a test that assesses 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, the patient should discuss it with their doctor.
The patient should tell their doctor if they have any other disorders or diseases, as the doctor should take this information into account. In particular, the patient should inform their doctor:

• If they have epilepsy. If seizures occur for the first time or their frequency increases, treatment with Escitalopram LEK-AM should be discontinued (see also section 4 "Possible side effects").
• If they have liver or kidney function disorders. It may be necessary to adjust the dose by the doctor.
• If they have diabetes. Taking Escitalopram LEK-AM may affect blood sugar control. It may be necessary to adjust the dose of insulin and/or oral antidiabetic medicines.
• If they have low sodium levels in the blood.
• If they have an increased tendency to bleed or bruise easily or if they are pregnant (see "Pregnancy, breastfeeding, and fertility").
• If they are being treated with electroconvulsive therapy.
• If they have coronary heart disease.
• If they have had heart problems or have recently had a heart attack.
• If they have a slow resting heart rate and/or if they may have electrolyte deficiencies due to prolonged, severe diarrhea and vomiting (during illness) or the use of diuretic medicines;
• If they experience rapid or irregular heartbeat, fainting, collapse, dizziness when standing up, which may indicate heart rhythm disorders.
• If they have eye problems, such as certain types of glaucoma (increased pressure inside the eyeball).

Caution

In some patients with bipolar affective disorder, a manic phase may occur. It is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, the patient should consult their doctor.
In the first few weeks of treatment, restlessness or inability to sit or stand still may also occur. If such symptoms appear, the patient should immediately inform their doctor.

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. Such symptoms may worsen when starting treatment with an antidepressant, as the medicine starts to work with some delay. It usually takes about 2 weeks, but sometimes it may take longer.
The likelihood of such thoughts occurring is higher if:

• the patient has had suicidal thoughts or self-harm in the past;
• the patient is a young adult. Clinical trials have shown an increased risk of suicidal behavior in young adults (under 25 years old) with mental disorders who took antidepressant medicines.

In case of suicidal thoughts or self-harm, the patient should immediately contact their doctor or go to the hospital.
It may be helpful for the patient to tell someone about their depression or anxiety disorder, such as a family member or someone close; they can ask that person to read this leaflet. They can ask that person to inform them if they notice that their depression or anxiety disorder is worsening or if worrying changes in behavior occur.

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 in the case of taking medicines from this group, patients under 18 years of age are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (including aggression, rebellious behavior, and manifestations of anger). Nevertheless, the doctor may prescribe Escitalopram LEK-AM to patients under 18 years of age if they consider it to be in their best interest. If the doctor has prescribed Escitalopram LEK-AM to a patient under 18 years of age and there are any doubts, please contact the doctor. In case of development or worsening of the mentioned symptoms in patients under 18 years of age taking Escitalopram LEK-AM, the doctor should be informed.
Additionally, there is a lack of data on the long-term safety of using Escitalopram LEK-AM in this age group, regarding growth, maturation, and cognitive and behavioral development.

Escitalopram LEK-AM and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should inform their doctor if they are taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs) containing 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 treatment with Escitalopram LEK-AM. After stopping treatment with Escitalopram LEK-AM, the patient should wait 7 days before taking any of these medicines.
• Reversible, selective monoamine oxidase A inhibitors (MAO-A) containing moclobemide (used to treat depression).
• Irreversible monoamine oxidase B inhibitors (MAO-B) containing selegiline (used to treat Parkinson's disease). These medicines increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used to treat bipolar affective disorders) and tryptophan.
• Imipramine and desipramine (used to treat depression).
• Sumatriptan and similar medicines (used to treat migraines) and tramadol (used to treat severe pain). These medicines increase the risk of side effects.

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• Cimetidine and omeprazole (used to treat stomach ulcers), fluconazole (an antifungal medicine), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may cause an increase in escitalopram levels in the blood.
• St. John's Wort ( Hypericum perforatum) - a herbal medicine used to treat depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory medicines (used as painkillers or to thin the blood, so-called anticoagulants). They may increase the tendency to bleed.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so-called anticoagulants). The doctor may order a blood clotting test at the beginning and after stopping treatment with Escitalopram LEK-AM to determine if the dose of the anticoagulant medicine is still appropriate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the possible risk of lowering the seizure threshold.
• Antipsychotics (medicines used to treat schizophrenia, psychosis), due to the possible risk of lowering the seizure threshold, and antidepressant medicines.
• Flecainide, propafenone, and metoprolol (used to treat heart conditions), clomipramine and nortriptyline (antidepressant medicines), and risperidone, thioridazine, and haloperidol (antipsychotic medicines). A dose adjustment of Escitalopram LEK-AM may be necessary.
• Medicines that lower potassium or magnesium levels in the blood, which increase the risk of life-threatening heart rhythm disorders.

Escitalopram LEK-AM should not be usedat the same time as medicines used to treat 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 antidepressant medicines, certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, erythromycin administered intravenously, pentamidine, antimalarial medicines, especially halofantrine), and certain antihistamine medicines (astemizole, mizolastine). The patient should consult their doctor if they have any further questions.

Escitalopram LEK-AM with food and 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 take Escitalopram LEK-AM and drink alcohol at the same time, although interactions (effects) of Escitalopram LEK-AM with alcohol are not expected.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. The patient should not take Escitalopram LEK-AM during pregnancy and breastfeeding, unless they have discussed the risks and benefits of treatment with their doctor.
Taking Escitalopram LEK-AM in the last 3 months of pregnancy may cause the following symptoms in the newborn: breathing difficulties, blue skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood sugar, muscle stiffness or flaccidity, increased reflexes, trembling, irritability, lethargy, constant crying, or sleep disturbances. If the newborn experiences any of these symptoms, the patient should immediately consult their doctor.
The patient should inform their doctor and/or midwife about taking Escitalopram LEK-AM.
Taking medicines like Escitalopram LEK-AM, especially in the last 3 months of pregnancy, may increase the risk of serious complications in the newborn, called persistent pulmonary hypertension of the newborn (PPHN). It is characterized by rapid breathing and blue skin, and usually occurs in the first day after birth. If such symptoms occur in the newborn, the patient should immediately consult their doctor and/or midwife.
Taking Escitalopram LEK-AM at 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 Escitalopram LEK-AM, they should inform their doctor or midwife so that they can provide appropriate advice.
It is assumed that escitalopram passes into breast milk.
In animal studies, it has been 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.
Medicines like Escitalopram LEK-AM (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after stopping treatment.

Driving and using machines

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 as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Escitalopram LEK-AM can be taken with or without food.
The tablet should be swallowed with water. The tablets should not be chewed.
The scored tablet can be divided into equal doses.
Adults
Depression
The usual dose of Escitalopram LEK-AM is 10 mg once daily. The dose may be increased by the doctor to a maximum of 20 mg daily.
Panic disorder
The initial dose of Escitalopram LEK-AM is 5 mg once daily in the first week of treatment, then the dose is increased to 10 mg daily. The dose may be further increased by the doctor to a maximum of 20 mg daily.
Social phobia
The recommended dose of Escitalopram LEK-AM is 10 mg once daily. The dose may then be decreased by the doctor to 5 mg daily or increased to a maximum of 20 mg daily, depending on the patient's response to the medicine.
Generalized anxiety disorder
The usual dose of Escitalopram LEK-AM is 10 mg once daily. The dose may be increased by the doctor to a maximum of 20 mg daily.
Obsessive-compulsive disorder
The usual dose of Escitalopram LEK-AM is 10 mg once daily. The dose may be increased by the doctor to a maximum of 20 mg daily.
Elderly patients (over 65 years of age)
The recommended initial dose of Escitalopram LEK-AM is 5 mg once daily. The doctor may recommend increasing the dose to 10 mg once daily.

Use in children and adolescents

Escitalopram LEK-AM should not normally be used in children and adolescents. Additional information is provided in section 2 "Important information before taking Escitalopram LEK-AM.”

Duration of treatment

The patient may feel better only after a few weeks of treatment. Therefore, they should continue taking Escitalopram LEK-AM, even if it takes some time to feel better.
The patient should not change the dose without consulting their doctor.
The medicine should be taken for as long as the doctor has prescribed. If the patient stops treatment too early, the symptoms may return. Therefore, it is recommended to continue treatment for at least 6 months after feeling better.

Taking a higher dose of Escitalopram LEK-AM than recommended

If the patient has taken a higher dose of Escitalopram LEK-AM than prescribed, they should immediately contact their doctor or go to the emergency room.
This should be done even if the patient does not feel any discomfort. Symptoms of overdose include: dizziness, tremors, agitation, seizures, coma, nausea, vomiting, heart rhythm disorders, low blood pressure, and electrolyte disturbances. When visiting the doctor or going to the hospital, the patient should take the packaging of Escitalopram LEK-AM with them.

Missing a dose of Escitalopram LEK-AM

The patient should not take a double dose to make up for a missed dose. If the patient has forgotten to take a dose and remembers before bedtime, they should take the missed dose immediately. The next dose should be taken at the usual time the next day.
If the patient remembers missing a dose at night or the next day, they should skip the missed dose and take the next dose as usual.

Stopping treatment with Escitalopram LEK-AM

The patient should not stop taking Escitalopram LEK-AM unless their doctor advises them to do so.
When the patient stops treatment, it is usually recommended to gradually reduce the dose of Escitalopram LEK-AM over a period of several weeks.
After stopping treatment with Escitalopram LEK-AM, especially if it is sudden, the patient may experience withdrawal symptoms. These symptoms are common. The risk is higher if Escitalopram LEK-AM was taken for a long time, in high doses, or if the dose was reduced too quickly. In most patients, the symptoms are mild and disappear on their own within two weeks. However, in some patients, the symptoms may be more severe or may last longer (2-3 months or longer). If the patient experiences severe withdrawal symptoms after stopping treatment with Escitalopram LEK-AM, they should contact their doctor. The doctor may recommend restarting treatment with the medicine and tapering it off more slowly.
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The withdrawal symptoms include: dizziness (unsteady gait, balance disorders), tingling sensation, burning sensation, and (less often) a sensation of electric shock, also in the head, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headache, nausea (nausea), sweating (including night sweats), psychomotor agitation or excitement, tremors, disorientation, emotional instability or irritability, diarrhea (loose stools), vision disturbances, heart palpitations or arrhythmias.
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Escitalopram LEK-AM can cause side effects, although not everybody gets them.
The side effects usually disappear after a few weeks of treatment. It should be remembered that some of these side effects may also be symptoms of the treated disease and will disappear as the patient's condition improves.
The patient should contact their doctor or go to the hospital if they experience any of the following side effects during treatment:

• Uncommon (occurring in less than 1 in 100 people):
• Unusual bleeding, including bleeding from the gastrointestinal tract.

Rare(occurring in less than 1 in 1,000 people):

• Swelling of the skin, tongue, lips, or face, or difficulty breathing or swallowing (allergic reaction), the patient should immediately contact their doctor or go to the hospital.
• High fever, agitation, confusion (disorientation), tremors, and sudden muscle contractions, which may be symptoms of a rare disorder called serotonin syndrome.

Frequency not known(frequency cannot be estimated from the available data).

• Difficulty urinating;
• Seizures, see also section "Warnings and precautions";
• Yellowing of the skin and whites of the eyes, which is a sign of liver function disorders and/or hepatitis.
• Rapid, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsade de pointes.
• Suicidal thoughts and behaviors, see also section "Warnings and precautions";
• Severe vaginal bleeding shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2.

In addition to the above, the following side effects have been reported:

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

• Nausea
• Headache

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Common(occurring in less than 1 in 10 people):

• Nasal congestion or runny nose (sinusitis);
• Decreased or increased appetite;
• Restlessness, psychomotor agitation, abnormal dreams, sleep disturbances, drowsiness, dizziness, yawning, tremors, tingling sensation in the skin;
• Diarrhea, constipation, vomiting, dry mouth;
• Increased sweating;
• Muscle and joint pain;
• Sexual disturbances (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty achieving orgasm in women);
• Feeling tired, fever;
• Weight gain.

Uncommon(occurring in less than 1 in 100 people):

• Hives, rash, itching;
• Grinding of the teeth, agitation, nervousness, panic attack, confusion (disorientation);
• Sleep disturbances, taste disorders, fainting;
• Dilated pupils, vision disturbances, ringing in the ears (tinnitus);
• Hair loss;
• Heavy menstrual bleeding;
• Irregular menstrual periods;
• Weight loss;
• Rapid heartbeat;
• Swelling of the arms or legs;
• Nosebleeds.

Rare(occurring in less than 1 in 1,000 people):

• Aggression, depersonalization (feeling of losing one's identity, the person feels they are not themselves), hallucinations;
• Slow heartbeat.

Frequency not known- cannot be estimated from the available data:

• Decreased sodium levels in the blood (manifested by nausea and malaise with muscle weakness or confusion);
• Dizziness when standing up due to low blood pressure (orthostatic hypotension);
• Abnormal liver function test results (increased liver enzyme activity in the blood);
• Movement disorders (involuntary muscle movements);
• Painful erection of the penis (priapism);
• Bleeding, including bruising in the skin and mucous membranes, and decreased platelet count (thrombocytopenia);
• Sudden swelling of the skin or mucous membranes (angioedema);
• Increased urine production (inappropriate antidiuretic hormone secretion);
• Milk secretion in men and in women who are not breastfeeding;
• Mania;
• Increased risk of bone fractures;
• Change in heart rhythm (called "QT interval prolongation" visible on an ECG, a test that assesses heart function).

In addition to the above, the following side effects are known for medicines with a similar mechanism of action to escitalopram (the active substance of Escitalopram LEK-AM):

• Psychomotor agitation (akathisia);
• Anorexia.

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Reporting side effects
If side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
phone: 22 49-21-301
fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Escitalopram LEK-AM

The medicine should be stored out of sight and reach of children.
This medicine should not be taken after the expiry date stated on the carton.
The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Escitalopram LEK-AM contains

• The active substance of Escitalopram LEK-AM is escitalopram. Each tablet of Escitalopram LEK-AM contains 5 mg, 10 mg, 15 mg, or 20 mg of escitalopram (in the form of oxalate).
• The other ingredients are: Tablet core: microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal 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 in the form of round, biconvex, film-coated tablets, white in color.
Escitalopram LEK-AM, 10 mg is available in the form of oval, biconvex, film-coated tablets, white in color, with a score line in the middle.
Escitalopram LEK-AM, 15 mg is available in the form of oval, biconvex, film-coated tablets, white in color.
Escitalopram LEK-AM, 20 mg is available in the form of oval, biconvex, film-coated tablets, white in color, with a score line in the middle, with the letter "E" engraved on both sides of the score line on one side of the tablet.
Escitalopram LEK-AM is available in blisters containing 7 or 14 tablets, packed in a cardboard box.
The cardboard box contains: 28 or 56 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14A
05-170 Zakroczym
Poland
Phone: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106

Date of last revision of the leaflet:

• 11.12.2020

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