Escitalopram Lek-am

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

Escitalopram

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

• You should keep this leaflet, so you can read it again later.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 contains the active substance escitalopram. Escitalopram LEK-AM belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines work on the serotonin system in the brain by increasing serotonin levels. 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 a few weeks before you feel better. You should continue to take Escitalopram LEK-AM even if it takes some time before you feel an improvement in your condition. If you do not feel better or feel worse, you should consult your doctor.

2. Important information before taking Escitalopram LEK-AM

When not to take Escitalopram LEK-AM:

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• If you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6);
• If you are taking other medicines that belong to a group called MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic);
• If you have been born with a heart condition or have had episodes of abnormal heart rhythm;
• If you are taking medicines for heart rhythm problems or medicines that may affect the heart rhythm (see section 2 "Escitalopram LEK-AM and other medicines").

Warnings and precautions

Before starting treatment with Escitalopram LEK-AM, you should discuss it with your doctor. You should tell your doctor if you have other conditions or diseases, as your doctor should take this information into account. In particular, you should inform your doctor:

• if you have epilepsy. If you experience seizures for the first time or if their frequency increases, you should stop taking Escitalopram LEK-AM (see also section 4 "Possible side effects");
• if you have liver or kidney problems. Your doctor may need to adjust the dose;
• if you have diabetes. Taking Escitalopram LEK-AM may change your blood sugar levels. You may need to adjust your insulin dose and/or oral hypoglycemic medications;
• if you have low sodium levels in your blood;
• if you have a tendency to bleed easily or bruise easily, or if you are pregnant (see "Pregnancy, breastfeeding, and fertility");
• if you are undergoing electroconvulsive therapy;
• if you have coronary heart disease;
• if you have had heart problems or have recently had a heart attack;
• if you have a slow resting heart rate and/or if you may have low levels of electrolytes due to prolonged, severe diarrhea, vomiting, or use of diuretics (water pills);
• if you experience rapid or irregular heartbeat, fainting, collapse, dizziness when standing up, which may indicate heart rhythm problems;
• if you 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, you should consult your doctor. In the first few weeks of treatment, restlessness or inability to sit or stand still may also occur. If such symptoms appear, you should immediately inform your doctor. Medicines like Escitalopram LEK-AM (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was stopped.

Suicidal thoughts and worsening of depression or anxiety disorder

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If you have depression and/or anxiety disorders, you may sometimes have thoughts of self-harm or suicide. These thoughts 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:

• you have had suicidal thoughts or self-harm in the past;
• you are an adult in your young age. Clinical studies have shown an increased risk of suicidal behavior in adults in young age (below 25 years) with mental disorders who took antidepressants.

If you experience thoughts of self-harm or suicidal thoughts, you should immediately contact your doctor or go to the hospital.

It may be helpful to tell someone about your depression or anxiety disorder

to a family member or someone close to you; you can ask this person to read this leaflet. You can ask them to inform you if they notice that your depression or anxiety disorder is worsening or if worrying changes in your 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 noted that in the case of taking medicines from this group, patients under 18 years of age are at increased risk of adverse reactions, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). However, your 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 to a patient under 18 years of age and you have any doubts, please contact your doctor. If the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Escitalopram LEK-AM, you should inform your doctor.
Additionally, there is a lack of data on the long-term safety of Escitalopram LEK-AM in this age group, regarding growth, maturation, and cognitive and behavioral development.

Escitalopram LEK-AM and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should inform your doctor if you are taking any of the following medicines:

• non-selective monoamine oxidase inhibitors (MAOIs) containing active substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If you have taken any of these medicines, you should wait 14 days before starting to take Escitalopram LEK-AM. After stopping treatment with Escitalopram LEK-AM, you should wait 7 days before taking any of these medicines;
• reversible, selective monoamine oxidase A inhibitors (RIMAs) containing moclobemide (used to treat depression);
• irreversible monoamine oxidase B inhibitors (MAO-B inhibitors) containing selegiline (used to treat Parkinson's disease). These medicines increase the risk of adverse reactions;
• the antibiotic linezolid;
• lithium (used to treat bipolar affective disorder) and tryptophan;
• imipramine and desipramine (used to treat depression);

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• sumatriptan and similar medicines (used to treat migraines) and tramadol and similar medicines (opioids used to treat severe pain). These medicines may increase the risk of adverse reactions;
• cimetidine, lansoprazole, 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 drugs (NSAIDs) (medicines used for pain relief or to thin the blood, so-called anticoagulants). They may increase the risk of bleeding;
• warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so-called anticoagulants). Your doctor may order a blood clotting test at the beginning and after stopping treatment with Escitalopram LEK-AM to determine if the anticoagulant dose 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;
• neuroleptics (medicines used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the seizure threshold;
• flecainide, propafenone, and metoprolol (used to treat heart conditions), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotic medicines). A 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 disorders.

Do not take Escitalopram LEK-AMat the same time as medicines used to treat heart rhythm problems or medicines that may affect the heart rhythm, such as: antiarrhythmic medicines 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, antimalarial medicines, especially halofantrine), certain antihistamines (astemizole, hydroxyzine, mizolastine). You should consult your doctor if you have any further questions.

Escitalopram LEK-AM with food, drinks, and 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor before taking this medicine. You should not take Escitalopram LEK-AM during pregnancy and breastfeeding, unless you have discussed the risks and benefits of treatment with your 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, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or flaccidity, increased reflexes, tremors, jitteriness, irritability, lethargy, constant crying, sleepiness, and difficulty sleeping. If your baby experiences any of these symptoms, you should immediately consult your doctor.
You should inform your 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 your baby, you should immediately consult your doctor and/or midwife.
Taking Escitalopram LEK-AM at the end of pregnancy may increase the risk of severe bleeding from the vagina, occurring shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Escitalopram LEK-AM, you should inform your doctor or midwife so that they can provide you with appropriate advice.
You should not stop taking Escitalopram LEK-AM during pregnancy.
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.

Driving and using machines

You should not drive or operate machinery until you know how Escitalopram LEK-AM affects you.

Escitalopram LEK-AM contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, which means it is essentially "sodium-free".

3. How to take Escitalopram LEK-AM

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, you should consult your doctor or pharmacist.

Adults

Depression
The recommended dose of Escitalopram LEK-AM is 10 mg once daily. The dose may be increased by your doctor to a maximum of 20 mg daily.
Panic disorder with agoraphobia
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 your 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 your doctor to 5 mg daily or increased to a maximum of 20 mg daily, depending on your response to the medicine.
Generalized anxiety disorder
The recommended dose of Escitalopram LEK-AM is 10 mg once daily. The dose may be increased by your doctor to a maximum of 20 mg daily.
Obsessive-compulsive disorder
The recommended dose of Escitalopram LEK-AM is 10 mg once daily. The dose may be increased by your 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. Your doctor may recommend increasing the dose to 10 mg once daily.

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".

How to take Escitalopram LEK-AM

Escitalopram LEK-AM can be taken with or without food.
The tablet should be swallowed with water. The tablets should not be chewed.
A tablet with a score line can be divided into equal doses.

Patients with renal impairment

Caution should be exercised in patients with severe renal impairment. The medicine should be taken as directed by your doctor.

Patients with hepatic impairment

Patients with hepatic impairment should not exceed a dose of 10 mg daily. The medicine should be taken as directed by your doctor.

Patients who are poor metabolizers of medicines via the CYP2C19 enzyme

Patients with this known genotype should not exceed a dose of 10 mg daily. The medicine should be taken as directed by your doctor.

Duration of treatment

You may feel better only after a few weeks of treatment. Therefore, you should continue to take Escitalopram LEK-AM, even if it takes some time before you feel an improvement in your condition.
You should not change the dose without consulting your doctor.
The medicine should be taken for as long as your doctor has prescribed. If you stop treatment too early, your symptoms may return. Therefore, it is recommended to continue treatment for at least 6 months after you have recovered.

Taking a higher dose of Escitalopram LEK-AM than prescribed

If you have taken more than the prescribed dose of Escitalopram LEK-AM, you should immediately contact your doctor or go to the emergency department of the nearest hospital.
This should be done even if you do not feel any discomfort. Symptoms of overdose include: dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, heart rhythm disturbances, low blood pressure, and electrolyte disturbances. When visiting your doctor or the hospital, you should bring the packaging of Escitalopram LEK-AM with you.

Missing a dose of Escitalopram LEK-AM

You should not take a double dose to make up for a missed dose. If you have forgotten to take a dose and remember before bedtime, you should take the missed dose immediately. You should take the next dose at the usual time the next day.
If you remember that you have missed a dose in the night or the next day, you should omit the missed dose and take the next dose as usual.

Stopping treatment with Escitalopram LEK-AM

You should not stop taking Escitalopram LEK-AM unless your doctor advises you to do so.
When you stop 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 stopped abruptly, you may experience withdrawal symptoms. These symptoms are common when treatment is stopped. The risk is higher when Escitalopram LEK-AM has been taken for a long time, in high doses, or when the dose has been 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 you experience severe withdrawal symptoms after stopping treatment with Escitalopram LEK-AM, you should consult your doctor. Your doctor may recommend restarting treatment with Escitalopram LEK-AM and tapering it off more slowly.
Withdrawal symptoms include: dizziness (unsteady gait, balance disturbances), tingling sensation, burning sensation, and (less commonly) electric shock-like sensations, also in the head, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headache, nausea (feeling sick), sweating (including night sweats), agitation or excitement, tremors, disorientation, emotional instability or irritability, diarrhea (loose stools), vision disturbances, heart palpitations or rapid heartbeat.
If you have any further questions about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Escitalopram LEK-AM can cause side effects, although not everybody gets them. Side effects usually disappear after a few weeks of treatment. You should remember that some of these side effects may also be symptoms of the disease being treated and will disappear as your condition improves.

If you experience any of the following side effects during treatment, you should contact your doctor or go to the hospital immediately:

Uncommon(may affect up to 1 in 100 people):

• unusual bleeding, including bleeding from the gastrointestinal tract.

Rare(may affect up to 1 in 1,000 people):

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

Frequency not known(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 dysfunction/liver inflammation,

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• rapid or irregular heartbeat, fainting, which may be a sign of a life-threatening condition called torsades de pointes,
• suicidal thoughts and behaviors, see also section "Warnings and precautions",
• sudden swelling of the skin or mucous membranes (angioedema).

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

Very common(may affect more than 1 in 10 people):

• nausea,
• headache.

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

• nasal congestion or sinusitis (sinus infection),
• decreased or increased appetite,
• anxiety, restlessness, abnormal dreams, sleep disturbances, drowsiness, dizziness, yawning, tremors, tingling sensation,
• diarrhea, constipation, vomiting, dry mouth,
• increased sweating,
• muscle and joint pain,
• sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty achieving orgasm in women),
• fatigue, fever,
• weight gain.

Uncommon(may affect up to 1 in 100 people):

• hives, rash, itching,
• grinding of the teeth, agitation, nervousness, panic attacks, confusion (disorientation),
• sleep disturbances, taste disturbances, fainting (syncope),
• 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(may affect up to 1 in 1,000 people):

• aggression, depersonalization (feeling of losing one's identity, feeling of not being oneself), hallucinations,
• slow heartbeat.

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

• decreased sodium levels in the blood (symptoms include nausea and malaise with muscle weakness or confusion),
• dizziness when standing up due to low blood pressure (orthostatic hypotension),
• abnormal liver function test results (elevated liver enzymes in the blood),
• movement disorders (involuntary muscle movements),
• painful erection (priapism),
• symptoms of unusual bleeding in the skin and mucous membranes (ecchymoses),

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• increased secretion of antidiuretic hormone (ADH), leading to water retention in the body, dilutional hyponatremia (low sodium levels in the blood),
• galactorrhoea (milk secretion) in men and in women who are not breastfeeding,
• mania,
• increased risk of fractures,
• changes in heart rhythm (called "QT interval prolongation", visible on an ECG, a test that assesses heart function),
• severe bleeding from the vagina, occurring 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 are known for medicines with a similar mechanism of action to escitalopram (the active substance of Escitalopram LEK-AM):

• restlessness (akathisia),
• loss of appetite.

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Escitalopram LEK-AM

The medicine should be stored 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 month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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:

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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 a white, round, biconvex film-coated tablet.
Escitalopram LEK-AM, 10 mg is a white, oval, biconvex film-coated tablet with a score line in the middle.
Escitalopram LEK-AM, 15 mg is a white, oval, biconvex film-coated tablet.
Escitalopram LEK-AM, 20 mg is a white, oval, biconvex film-coated tablet with a score line in the middle and 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 carton box.
A carton 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:

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