Pralex

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Pralex (Escitalopram Orion 10 mg), 10 mg, coated tablets

Escitalopram
Pralex and Escitalopram Orion 10 mg are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any further doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to 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 tell their doctor or pharmacist. See section 4.

Table of contents of the 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 packaging 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. Disorders of the serotonin system are thought to be a major factor in the development of depression and related diseases.
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. Therefore, Pralex should be continued even if it takes some time before the patient feels better.
The patient should tell their doctor if they do not feel better or feel worse.

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)
• if the patient has a congenital or history of abnormal heart rhythm (diagnosed on the basis of an ECG - a test to assess heart function)
• if the patient is taking medicines for heart rhythm disorders or medicines that may affect 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 seizures occur for the first time or their frequency increases, Pralex treatment should be discontinued (see also section 4 "Possible side effects")
• if they have liver or kidney disease. It may be necessary to adjust the dose by the doctor
• if they have diabetes. Taking Pralex may affect blood sugar control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic agents
• 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 being treated with electroconvulsive therapy
• if they have ischemic 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 loss of salts in the body due to severe diarrhea or vomiting (with nausea) or due to the use of diuretic medicines
• if they have a fast or irregular heartbeat, 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 (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.

Warning:

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, symptoms such as anxiety or difficulty sitting or standing still may also occur. If such 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 working after 2 weeks, sometimes later.
Suicidal thoughts, self-harm, or suicidal behavior are more likely to occur if:

• the patient has had suicidal thoughts or self-harm in the past
• the patient is a young adult; clinical trial data indicate an increased risk of suicidal behavior in people under 25 with mental disorders who were 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 the depression or anxiety disorder and ask them to read this leaflet. The patient may ask their relatives or friends for help and ask them to inform them if they notice that the depression or anxiety has worsened or if there are worrying changes in 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 emphasized that in the case of taking medicines of this class, 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, 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 attending 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 (medicines used to treat depression). If the patient has taken any of these medicines, they should wait 14 days before starting Pralex. After stopping 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 adverse reactions.
• 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). They 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 (aspirin) and non-steroidal anti-inflammatory medicines (used as painkillers or to thin the blood, known as anticoagulants). They may increase the risk of bleeding.
• warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, known as anticoagulants). The doctor may order a blood clotting test at the start and after stopping Pralex to determine if the anticoagulant dose is still appropriate.

and after stopping Pralex in order 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, SSRI due to the possible risk of lowering the seizure threshold.
• flecainide, propafenone, and metoprolol (used to treat cardiovascular diseases), desipramine, clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). It may be necessary to adjust the Pralex dose.
• 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 the patient is 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 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 used in 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. The use of medicines like Pralex during pregnancy, especially in the last 3 months, may increase the risk of a serious condition in children called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and bluish skin in the baby. Such symptoms usually occur within the first 24 hours after birth. If the patient notices these symptoms in their baby, they should immediately contact their midwife and/or doctor.
If the patient is taking Pralex in the last 3 months of pregnancy, they should be aware that the newborn may experience the following symptoms: difficulty breathing, bluish skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, stiffness or floppiness, increased reflexes, tremors, tremors, irritability, lethargy, constant crying, and sleep disturbances. If the newborn experiences any of these symptoms, the patient should immediately contact their doctor.
Stopping Pralex during pregnancy should not be done abruptly.
If the patient is breastfeeding, they should not take Pralex without discussing the risks and benefits of treatment with their doctor. It is assumed that Pralex will pass 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.
Before taking any medicine, the patient should consult their doctor or pharmacist.

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 recommended dose is 10 mg, taken as a single dose once daily. The dose may be increased by the doctor to a maximum of 20 mg 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 the doctor to a maximum of 20 mg daily.
Social phobia
The recommended dose is 10 mg, taken as a single dose 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.
Obsessive-compulsive disorder
The recommended dose of Pralex is 10 mg, taken as a single dose once daily. The dose may be increased by the doctor to a maximum of 20 mg daily.
Elderly patients (over 65 years)
The recommended initial dose is 5 mg, taken as a single dose once daily. The dose may be increased by the doctor to 10 mg daily.
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
Care should be taken 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 the dose of 10 mg daily. The medicine should be taken as prescribed by the doctor.
Poor metabolizers of medicines via the CYP2C19 isoenzyme
Patients with this known genotype should not exceed the dose of 10 mg daily. The medicine should be taken as prescribed by the doctor.

How to take Pralex

Pralex can be taken with or without food. 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, Pralex should be continued, even if it takes some time before the patient feels 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.

Taking a higher dose of Pralex than recommended

If the patient has taken a higher dose of Pralex than prescribed, 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 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 hospital, the patient should take the Pralex packaging with them.

Missing a dose of Pralex

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 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 Pralex

The patient should not stop taking Pralex without consulting their doctor. When the patient stops treatment, it is usually recommended to gradually reduce the dose of Pralex over a period of several weeks.
After stopping Pralex, especially if it is stopped abruptly, the patient may experience withdrawal symptoms. These symptoms are common when Pralex treatment is discontinued. 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 resolve on their own within two weeks. In some patients, however, they may be more severe or persist for longer (2-3 months or longer). If the patient experiences severe withdrawal symptoms after stopping Pralex, they should contact their doctor. The doctor may recommend restarting Pralex and tapering it off more slowly.
Withdrawal symptoms include dizziness (unsteady gait, balance disorders), tingling sensation, burning sensation, and (less commonly) a sensation of electric shock, also in the head, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headache, nausea (nausea), sweating (including night sweats), psychomotor restlessness or agitation, tremors, disorientation, emotional instability or irritability, diarrhea (loose stools), vision disturbances, heart palpitations or arrhythmias.
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 resolve on their own 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 resolve as the patient's condition improves.

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

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

• Unusual bleeding, including gastrointestinal bleeding.

Rare ( may occur in 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
• Rapid or irregular heartbeat, fainting, which may be symptoms of life-threatening heart rhythm disorders 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 adverse reactions have been reported with medicines with a similar mechanism of action to escitalopram (the active substance of Pralex):

• Psychomotor 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 or pharmacist. 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 181C, 02-222 Warszawa, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By 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.
The patient should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
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 packaging and other information

What Pralex contains

• The active substance of the medicine is escitalopram. Each tablet contains 10 mg of escitalopram (as escitalopram oxalate).
• Other ingredients of the medicine 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 what the packaging contains

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 dividing between "5" and "4".
Pack sizes:
PVC/Aclar-Aluminum blisters: 28 and 56 film-coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warszawa

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warszawa
Lithuanian, the country of export, marketing authorization number:LT/1/10/2306/026

Parallel import authorization number: 176/23

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

Date of approval of the leaflet: 30.08.2023