Pralex

Package Leaflet: Information for the User

Pralex, 5 mg, coated tablets
Pralex, 10 mg, coated tablets
Pralex, 15 mg, coated tablets
Pralex, 20 mg, coated tablets
Escitalopram

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

• Keep this leaflet, you may need to read it again.
• 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 tell your doctor or pharmacist. 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 act on the serotonin system in the brain by increasing the level of serotonin.
Disorders of 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. You should continue to take Pralex even if you do not feel better immediately.
Tell your doctor if you do not feel better or feel worse.

2. Important information before taking Pralex

When not to take Pralex

• 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 non-selective monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic)
• if you have congenital or a history of abnormal heart rhythm (diagnosed on the basis of an electrocardiogram - a test used to evaluate heart function)
• if you are taking medicines for heart rhythm disorders or medicines that may affect heart rhythm (see also section 2 "Pralex and other medicines")

Warnings and precautions

You should talk to your doctor or pharmacist before taking Pralex.
Tell your doctor if you have other disorders or diseases, as your doctor should take this information into account.
In particular, tell your doctor:

• if you have epilepsy. If you experience seizures for the first time or an increase in seizure frequency, you should stop taking Pralex (see also section 4 "Possible side effects")
• if you have liver or kidney disease. Your doctor may need to adjust the dose
• if you have diabetes. Taking Pralex may affect blood sugar control. 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 easy bruising, a history of bleeding disorders, or are pregnant (see "Pregnancy, breastfeeding, and fertility")
• if you are undergoing electroconvulsive therapy
• if you have coronary heart disease
• if you currently have or have a history of heart disease or have had a heart attack
• if you have a slow heart rate at rest and/or may have low levels of potassium or magnesium in your blood due to severe diarrhea or vomiting (with nausea) or due to the use of diuretics
• if you have a fast or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may be a sign of abnormal heart rhythm
• if you 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.

Caution:

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 you experience these symptoms, you should contact your doctor.
In the first few weeks of treatment, you may also experience symptoms such as restlessness or difficulty sitting or standing still. If you experience these symptoms, you should contact your doctor or pharmacist immediately.

Suicidal thoughts, worsening of depression or anxiety disorders

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

• you have had suicidal thoughts or self-harm in the past
• you are 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 you experience suicidal thoughts or self-harm, you should contact your doctor or go to the hospital immediately.
It may be helpful to inform your relatives or friends about your depression or anxiety disorder and ask them to read this leaflet.You can ask your relatives or friends to help you and ask them to tell you if they notice that your depression or anxiety has worsened or if you have any worrying changes in your 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 patients under 18 years of age, taking medicines of this class may increase the risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and expressions of anger). However, your doctor may prescribe Pralex to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Pralex to a patient under 18 years of age and you have any concerns, please contact your doctor. If a patient under 18 years of age taking Pralex develops or worsens any of the above symptoms, you should inform your doctor.
Additionally, there is currently no data on the long-term safety of Pralex in this age group regarding growth, maturation, and cognitive and behavioral development.

Pralex and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
Tell 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 (used to treat depression). If you have taken any of these medicines, you should wait 14 days before starting to take Pralex. After stopping treatment with Pralex, 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) 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), 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 the level of escitalopram 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 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). Your doctor may need to monitor your blood clotting time at the start and after stopping treatment with Pralex to determine if the dose of the anticoagulant is still appropriate.

and after stopping treatment with Pralex in order to determine if the dose of the anticoagulant 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 (used to treat schizophrenia, psychosis) and antidepressants (tricyclics, 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 (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 disorders.

DO NOT TAKE PRALEXif you are taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm, such as anti-arrhythmic medicines of class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibiotics (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial treatment mainly halofantrine), or certain antihistamines (e.g., astemizole, hydroxyzine, mizolastine). If you have any doubts, consult your 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 has been demonstrated between Pralex and alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant, planning to become pregnant, or breastfeeding, you should consult your doctor or pharmacist before taking this medicine. Do not take Pralex during pregnancy without discussing the risks and benefits with your doctor.
You should inform your midwife and/or doctor that you are taking Pralex. It is assumed that Pralex will pass into breast milk.
In animal studies, citalopram, a medicine similar to escitalopram, has been shown to reduce sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans so far.
Before taking any medicine, you should consult your doctor or pharmacist.

Driving and using machines

You should not drive or operate machinery until you know how Pralex affects you.

Excipients

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

3. How to take Pralex

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Adults
Depression
The recommended dose is 10 mg, taken as a single dose once daily. The dose may be increased by your doctor to a maximum of 20 mg once daily.
Panic disorder
The initial dose is 5 mg once daily for the first week of treatment, then the dose is increased to 10 mg once daily. The dose may then be increased by your doctor to a maximum of 20 mg once daily.
Social phobia
The recommended dose is 10 mg, taken as a single dose once daily. The dose may then be decreased by your doctor to 5 mg once daily or increased to a maximum of 20 mg once daily, depending on your response to the medicine.
Generalized anxiety disorder or obsessive-compulsive disorder
The recommended dose of Pralex is 10 mg, taken as a single dose once daily. The dose may be increased by your doctor to a maximum of 20 mg once daily.
Elderly patients (over 65 years of age)
The recommended initial dose is 5 mg, taken as a single dose once daily. The dose may be increased by your doctor to 10 mg once daily.
Children and adolescents (under 18 years of age)
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 directed by your doctor.
Hepatic impairment
Patients with hepatic impairment should not exceed a dose of 10 mg once daily. The medicine should be taken as directed by your doctor.
Poor metabolizers of medicines that are metabolized by the CYP2C19 enzyme
Patients with this known genotype should not exceed a dose of 10 mg once daily. The medicine should be taken as directed by your doctor.

How to take Pralex

Pralex can be taken with or without food. The tablets should be swallowed with water. Do not chew them, as they have a bitter taste.
Pralex 10 mg, 15 mg, and 20 mg: If necessary, the tablets can be divided into two halves by placing the tablet on a flat surface with the score line facing upwards. The tablets can then be broken in half by pressing each end downwards with your index fingers, as shown in the picture.

Duration of treatment

You may start to feel better after a few weeks of treatment. You should therefore continue to take Pralex even if you do not feel better immediately.
Do not change the dose without consulting your doctor.
The medicine should be taken for as long as your doctor recommends. If you stop treatment too early, your symptoms may return. It is recommended to continue treatment for at least 6 months after you have recovered.

Overdose of Pralex

If you have taken more than the prescribed dose of Pralex, you should contact your doctor or go to the emergency department of the nearest hospital immediately. You should do this even if you do not feel any symptoms. Symptoms of overdose include dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, heart rhythm disorders, low blood pressure, and electrolyte disturbances. When visiting your doctor or going to the hospital, you should take the Pralex packaging with you.

Missed dose of Pralex

Do not take a double dose to make up for a missed dose. If you have missed a dose and remember before going to bed, 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 skip the missed dose and take the next dose as usual.

Stopping treatment with Pralex

Do not stop taking Pralex without consulting your doctor. When you stop 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 abruptly, you 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 longer-lasting (2-3 months or longer). If you experience severe withdrawal symptoms after stopping treatment with Pralex, you should contact your doctor. Your doctor may recommend that you start taking the medicine again and taper it off more slowly.
Withdrawal symptoms include dizziness (unsteady gait, balance disorders), 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), vomiting, diarrhea (loose stools), visual disturbances, palpitations or irregular heartbeats, and tremors, disorientation, emotional instability, or irritability.
If you have any doubts about taking this medicine, you should consult your 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. You should remember that some of these side effects may also be symptoms of your illness and will improve as you get better.

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

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

• unusual bleeding, including gastrointestinal bleeding.

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 may be a sign of liver dysfunction and/or hepatitis
• fast or irregular heartbeat, fainting, which may be symptoms of life-threatening heart rhythm disorders called torsades de pointes
• suicidal thoughts and behavior, see also section "Warnings and precautions"
• sudden swelling of the skin or mucous membranes (angioedema).

In addition, the following side effects have been reported with medicines that have a similar mechanism of action to escitalopram (the active substance of Pralex):

• psychomotor restlessness (akathisia)
• loss of appetite.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
You can also report side effects 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 Pralex

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label or carton. The expiry date refers to the last day of the month.
There are no special storage requirements.
Medicines should not be disposed of via wastewater or household waste. 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 Pralex contains

• The active substance is escitalopram. Each tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of escitalopram (as escitalopram oxalate).
• The other ingredients are:
• Core: microcrystalline cellulose, butylhydroxytoluene (E 321), butylhydroxyanisole (E 320), sodium croscarmellose, silicon dioxide, talc, and magnesium stearate.
• Coating: hypromellose 5 cPs, macrogol 400, and titanium dioxide (E 171).

What Pralex looks like and contents of the pack

5 mg:White or almost white, round, film-coated tablets, convex on both sides, marked with the letter "F" on one side and the number "53" on the other side.
10 mg: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 score line between "5" and "4".
15 mg:White or almost white, oval, film-coated tablets, convex on both sides, marked with the letter "F" on one side and the number "55" on the other side with a deep score line between "5" and "5".
20 mg:White or almost white, oval, film-coated tablets, convex on both sides, marked with the letter "F" on one side and the number "56" on the other side with a deep score line between "5" and "6".
Pack sizes:
PVC/Aclar/Aluminum blister packs: 28, 56, and 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

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
To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]

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

Date of last revision of the leaflet:10.01.2025