Pralex

Package Leaflet: Information for the User

Warning! The package leaflet should be kept. Information on the immediate packaging in a foreign language.

Pralex (Escitalopram Orion)

10 mg, coated tablets

Escitalopramum
Pralex and Escitalopram Orion are different trade names for the same medicine.

Before taking the medicine, the package leaflet should be read carefully, as it contains important information for the patient.

• The package leaflet should be kept so that it can be read again if necessary.
• In case of any further doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Pralex and what is it used for
• 2. Important information before taking Pralex
• 3. How to take Pralex
• 4. Possible side effects
• 5. How to store Pralex
• 6. Contents of the pack and other information

1. What is Pralex and what is it used for

Escitalopram 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. Disruptions to the serotonin system are thought to be a major factor in the development of depression and related disorders. Pralex contains the active substance escitalopram and is used to treat depression (major depressive episodes), anxiety disorders (such as panic disorder with or without agoraphobia, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder). Improvement may occur only after several weeks of treatment. The patient should continue taking Pralex even if it takes some time before they start to feel better. If the patient does not feel better or feels worse, they should tell their doctor.

2. Important information before taking Pralex

When not to take Pralex

• 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 non-selective monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic)

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• if the patient has a congenital or previously diagnosed abnormal heart rhythm (identified by an ECG - a test used to evaluate heart function)
• if the patient is taking medicines for heart rhythm disturbances or medicines that may disturb heart rhythm (see also section 2 "Pralex and other medicines")

Warnings and precautions

The patient should talk to their doctor or pharmacist before taking Pralex. 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 they experience seizures for the first time or an increase in seizure frequency, they should stop taking Pralex (see also section 4 "Possible side effects")
• if they have liver or kidney disease. The dose may need to be adjusted by the doctor
• if they have diabetes. Taking Pralex may affect blood sugar control. The dose of insulin and/or oral hypoglycemic medicines may need to be adjusted
• if they have low sodium levels in the blood
• if they have a tendency to easy bruising, a history of bleeding disorders, or are pregnant (see "Pregnancy, breastfeeding, and fertility")
• if they are undergoing electroconvulsive therapy
• if they have coronary heart disease
• if they currently have or have a history of heart disease or have had a heart attack
• if they have a slow heart rate at rest and/or may have low levels of salts in the body due to severe diarrhea or vomiting (with nausea) or due to the use of diuretic medicines
• if they experience fast or irregular heartbeats, fainting, collapse, or dizziness when standing up, which may be symptoms of abnormal heart rhythm
• if they have or have had eye problems, such as certain types of glaucoma (increased pressure in the eye)

Medicines like Pralex (SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Warning:

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, the patient should consult their doctor. In the first few weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still may also occur. If these symptoms appear, the patient should immediately inform their doctor or pharmacist.

Suicidal thoughts, worsening of depression or anxiety disorders

People with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the start of treatment with antidepressant medicines, as these medicines usually start to work after 2 weeks, sometimes later. The occurrence of suicidal thoughts, self-harm, or suicidal behavior is more likely if:

• the patient has had suicidal thoughts or self-harm in the past

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• the patient is a young adult; clinical trial data indicate an increased risk of suicidal behavior in people under 25 years of age with mental disorders who are being treated with antidepressant medicines

If the patient experiences suicidal thoughts or self-harm, they should immediatelycontact their doctor or go to the hospital. It may be helpful to inform relatives or friendsabout their depression or anxiety disorder and ask them to read this leaflet. The patient may ask their relatives or friends to help them and ask them to inform them if they notice that their depression or anxiety has worsened or if they notice any worrying changes in their behavior. Children and adolescents under 18 years of age Pralex 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 of this class, patients under 18 years of age are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). Nevertheless, the doctor may prescribe Pralex to patients under 18 years of age, considering that it is in their best interest. If the doctor has prescribed Pralex to a patient under 18 years of age and there are any doubts, please contact the doctor. If the patient under 18 years of age taking Pralex develops or worsens the above symptoms, they should inform their doctor.

Pralex and other medicines

The patient should tell their doctor or pharmacist 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 active substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine (used to treat depression). If the patient has taken any of these medicines, they should wait 14 days before starting to take Pralex. After stopping treatment with Pralex, they should wait 7 days before taking any of these medicines.
• reversible, selective monoamine oxidase A (MAO-A) inhibitors containing moclobemide (used to treat depression)
• irreversible monoamine oxidase B (MAO-B) inhibitors 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 migraine), buprenorphine, and tramadol (used to treat severe pain). These medicines may increase the risk of side effects.
• 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 (aspirin) and non-steroidal anti-inflammatory medicines (used to treat pain or to thin the blood, known as anticoagulants). These medicines may increase the risk of bleeding.
• warfarin, dipyridamole, and phenprocoumon (used to thin the blood, known as anticoagulants). The doctor may order a blood clotting test at the start and after stopping treatment with Pralex to determine if the dose of the anticoagulant is still appropriate.

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• 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 (used to treat schizophrenia, psychosis) and antidepressant medicines (tricyclics, SSRIs due to the possible risk of lowering the seizure threshold
• flecainide, propafenone, and metoprolol (used to treat heart conditions), desipramine, clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of Pralex may need to be adjusted.
• medicines that lower potassium or magnesium levels in the blood, due to the increased risk of life-threatening heart rhythm disturbances.

DO NOT TAKE PRALEX if the patient is taking medicines for heart rhythm disturbances or medicines that may disturb heart rhythm, such as:

anti-arrhythmic medicines of class IA and III, antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressant medicines, certain antibiotics (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial treatment mainly halofantrine), certain antihistamines (e.g., astemizole, hydroxyzine, mizolastine). If there are any doubts, the patient should consult their doctor.

Pralex with food, drink, and alcohol

Pralex can be taken with or without food (see section 3 "How to take Pralex"). As with other medicines, it is not recommended to take Pralex and drink alcohol at the same time, although no interaction (effect) of Pralex with alcohol has been demonstrated.

Pregnancy, breastfeeding, and fertility

In pregnancy and breastfeeding, or if the patient is pregnant or plans to become pregnant, they should consult their doctor or pharmacist before taking this medicine. Pralex should not be taken during pregnancy without discussing the risks and benefits of treatment with the doctor. The patient should inform their midwife and/or doctor that they are taking Pralex. It is assumed that Pralex will pass into breast milk. Page 4 10In 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. Before taking any medicine, the patient should consult their doctor or pharmacist. The patient should not stop taking Pralex during pregnancy.

Driving and using machines

The patient should not drive or operate machinery until they know how Pralex affects them.

Excipients

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Pralex

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist. Pralex is available in the following strengths: 5 mg, 10 mg, 15 mg, 20 mg. Adults Depression The usual recommended dose is 10 mg, taken as one dose per day. The dose may be increased by the doctor to a maximum of 20 mg per day. Panic disorder The initial dose is 5 mg per day for the first week of treatment, then the dose is increased to 10 mg per day. The dose may then be increased by the doctor to a maximum of 20 mg per day. Social phobia The usual recommended dose is 10 mg, taken as one dose per day. The dose may then be decreased by the doctor to 5 mg per day or increased to a maximum of 20 mg per day, depending on the patient's response to the medicine. Obsessive-compulsive disorder The usual recommended dose of Pralex is 10 mg, taken as one dose per day. The dose may be increased by the doctor to a maximum of 20 mg per day. Elderly patients (over 65 years) The usual recommended initial dose is 5 mg, taken as one dose per day. The dose may be increased by the doctor to 10 mg per day. Children and adolescents (under 18 years) Pralex should not normally be used in children and adolescents. Additional information is provided in section 2 "Important information before taking Pralex". Renal impairment Caution should be exercised in patients with severe renal impairment. The medicine should be taken as prescribed by the doctor. Hepatic impairment Patients with hepatic impairment should not exceed a dose of 10 mg per day. The medicine should be taken as prescribed by the doctor. Page 5 10Patients who are poor metabolizers of medicines via the CYP2C19 isoenzyme Patients with this known genotype should not exceed a dose of 10 mg per day. The medicine should be taken as prescribed by the doctor.

How to take Pralex

Pralex can be taken with or without food (see section 3 "How to take Pralex"). The tablets should be swallowed with water. They should not be chewed, as they have a bitter taste. If necessary, the tablets can be divided into two halves by placing the tablet on a flat surface with the groove facing upwards. The tablets can then be broken in half by pressing each end downwards with the index fingers of both hands, as shown in the picture.

Duration of treatment

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

Overdose

If the patient has taken more than the prescribed dose of Pralex, they should immediately contact their doctor or go to the emergency department of the nearest hospital. This should be done even if the patient does not feel any symptoms. Symptoms of overdose include dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, heart rhythm disturbances, low blood pressure, and electrolyte disturbances. When visiting the doctor or hospital, the patient should take the Pralex packaging with them.

Missed dose

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 going to bed, they should take the missed dose immediately. The next dose should be taken the next day. If the patient remembers that they have missed a dose in the night or the next day, they should omit the missed dose and take the next dose as usual.

Stopping treatment

The patient should not stop taking Pralex without consulting their doctor. When the patient finishes treatment, it is usually recommended to gradually reduce the dose of Pralex over a period of several weeks. After stopping treatment with Pralex, especially if it is stopped suddenly, the patient may experience withdrawal symptoms. These symptoms are common when treatment with Pralex is stopped. The risk is higher when Pralex 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. In some patients, however, they may be more severe or last longer (2-3 months or longer). If the patient experiences severe withdrawal symptoms after stopping treatment with Pralex, they should contact their doctor. The doctor may recommend restarting treatment with Pralex and reducing the dose more slowly. Page 6 10Withdrawal symptoms include dizziness (unsteady gait, balance disturbances), tingling sensation, burning sensation, and (less commonly) electric shock sensations, also in the head, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headache, nausea (feeling sick), sweating (including night sweats), restlessness or agitation, tremors, feeling disoriented, emotional instability or irritability, diarrhea (loose stools), vision disturbances, heart palpitations or irregular heartbeats. If the patient has any doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Pralex can cause side effects, although not everybody gets them. Side effects are usually mild and usually disappear after a few weeks of treatment. It should be remembered that some of these side effects may also be symptoms of the disease, and they will disappear as the patient's condition improves.

In case of any of the following side effects, the patient should immediately contact their doctor or go to the hospital:

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. These may be symptoms of a rare disorder called serotonin syndrome

Unknown (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 dysfunction and/or hepatitis
• Fast or irregular heartbeats, fainting, which may be symptoms of life-threatening heart rhythm disturbances 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 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, difficulty sleeping, drowsiness, dizziness, yawning, tremors, tingling sensation
• Diarrhea, constipation, vomiting, dry mouth
• Excessive sweating
• Muscle and joint pain
• Sexual disturbances (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty achieving orgasm in women)

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• Feeling tired, 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
• Dilated pupils, vision disturbances, ringing in the ears (tinnitus)
• Hair loss
• Excessive menstrual bleeding
• Irregular menstrual periods
• Weight loss
• Fast heart rate
• Swelling of the arms or legs
• Nosebleeds

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

• Aggression, depersonalization (feeling of loss of identity, feeling of not being oneself), hallucinations
• Slow heart rate

Unknown (frequency cannot be estimated from the available data):

• Low 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)
• Symptoms of unusual bleeding, such as bruising or low platelet count (thrombocytopenia)
• Sudden swelling of the skin or mucous membranes (angioedema)
• Increased secretion of antidiuretic hormone (ADH), leading to water retention in the body, dilutional hyponatremia (inappropriate antidiuretic hormone secretion - SIADH)
• Milk secretion in men and women who are not breastfeeding
• Mania
• An increased risk of bone fractures has been observed in patients taking medicines of this type
• Heart rhythm disturbances (called "QT interval prolongation", diagnosed by an ECG - a test used to evaluate heart function)
• Severe bleeding from the uterus, occurring shortly after childbirth (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2

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

• Restlessness (akathisia)
• Loss of appetite

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warszawa, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl Page 8 10By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Pralex

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 packaging. The expiry date refers to the last day of the month stated. There are no special storage precautions. 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 Pralex contains

• The active substance is escitalopram. Each tablet contains 10 mg of escitalopram (as escitalopram oxalate).
• The other ingredients are:
• Core: microcrystalline cellulose, siliconized microcrystalline cellulose, butylhydroxytoluene (E 321), butylhydroxyanisole (E 320), sodium croscarmellose, colloidal anhydrous silica, talc, and magnesium stearate.
• Coating: hypromellose, macrogol 400, and titanium dioxide (E 171).

What Pralex looks like and contents of the pack

White or almost white, oval, film-coated tablets, convex on both sides, marked with the letter "F" on one side and the number "54" on the other side with a deep groove separating the "5" and "4". Pack sizes: PVC/Aclar-Aluminium blister: 28 and 56 film-coated tablets. For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Lithuania, the country of export:

Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland

Manufacturer:

Orion Corporation, Orion Pharma, Orionintie 1, FI-02200 Espoo, Finland APL Swift Services (Malta) Ltd., HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia BBG 3000, Malta

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź License number in Lithuania, the country of export: LT/1/10/2306/026 LT/1/10/2306/023 LT/1/10/2306/030

Parallel import license number: 93/24

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This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of approval of the package leaflet: 07.03.2024

[Information about the trademark]

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