Pralex

Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Pralex (Escitalopram Orion)
10 mg, film-coated tablets
Escitalopram
Pralex and Escitalopram Orion are different trade names of the same medicinal product.
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

1. What Pralex is and what it is used for
2. What you need to know 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 Pralex is and what it is used for

Escitalopram belongs to a group of antidepressant medicines known as selective serotonin reuptake inhibitors (SSRIs).
These medicines act on the serotonin system in the brain by increasing serotonin levels. Dysfunction of the serotonin system is considered a significant factor in the development of depression and related disorders.
Pralex contains the active substance escitalopram and is used in the treatment of depression (major depressive episodes) and 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. It is important to continue taking Pralex even if it takes some time before you feel better.
Tell your doctor if you do not feel better or if you feel worse.

2. Important information before using Pralex

When not to use 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 the group called non-selective monoamine oxidase inhibitors (MAO), including selegiline (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression), or linezolid (an antibiotic)

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• if the patient has congenital or a previously diagnosed abnormal heart rhythm (diagnosed by ECG – a test used to assess heart function)
• if the patient is taking medicines for heart rhythm disorders or medicines that affect heart rhythm (see also section 2 "Pralex with other medicines")

Warnings and precautions
Talk to your doctor or pharmacist before taking Pralex.
Tell your doctor if the patient has any other disorders or medical conditions, as the doctor should take such information into account. In particular, inform the doctor:

• if the patient has epilepsy. If seizures occur for the first time or increase in frequency, treatment with Pralex should be discontinued (see also section 4 "Possible side effects")
• if the patient suffers from impaired liver or kidney function. The doctor may need to adjust the dose
• if the patient has diabetes. Treatment with Pralex may affect blood glucose control. Adjustment of insulin dose and/or oral glucose-lowering medicines may be necessary
• if the patient has low sodium levels in the blood
• if the patient has a tendency to bruise easily, has a history of bleeding disorders, or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility")
• if the patient is undergoing electroconvulsive therapy
• if the patient has ischemic heart disease
• if the patient currently has or has a history of heart disease or has had a heart attack
• if the patient has a slow resting heart rate and/or may be losing body salts due to severe diarrhoea or vomiting (with nausea) or due to the use of diuretics
• if the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate abnormal heart rhythm
• if the patient has or has had eye problems, such as certain types of glaucoma (increased pressure in the eye)

Medicines such as 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.
Note:
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, consult a doctor.
During the first weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still may also occur. If such symptoms appear, inform your doctor or pharmacist immediately.
Suicidal thoughts, worsening of depression or anxiety disorders
Patients with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. These symptoms or behaviors may worsen at the beginning of treatment with antidepressants, as these medicines usually take at least 2 weeks, sometimes longer, to start working.
The risk of suicidal thoughts, thoughts of self-harm, or suicide attempts is higher if:

• the patient has previously experienced suicidal thoughts or self-harm

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• the patient is a young adult; clinical trial data indicate an increased risk of suicidal behavior in individuals under 25 years of age with psychiatric disorders who are treated with antidepressants

If the patient experiences suicidal thoughts or thoughts of self-harm, seek medical help immediately
It may be helpful to inform relatives or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask relatives or friends for help and request them to inform him or her if they notice worsening of depression or anxiety, or concerning 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 patients under 18 years of age taking medicines of this class are at increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behavior, and manifestations of anger). Nevertheless, the doctor may prescribe Pralex to patients under 18 years of age if he or she considers it to be in their best interest. If Pralex has been prescribed to a patient under 18 years of age and you have any concerns, please contact the treating doctor. If the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Pralex, inform your doctor immediately.
Furthermore, there are currently no data on the long-term safety of Pralex in this age group regarding growth, maturation, cognitive development, and behavioral development.
Pralex with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform the doctor if the patient is taking any of the following medicines:

• non-selective monoamine oxidase inhibitors (MAO) containing active substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine (medicines used in the treatment of depression). If the patient has taken any of these medicines, they should wait 14 days before starting Pralex. After stopping Pralex, wait 7 days before taking any of these medicines.
• reversible, selective monoamine oxidase A (MAO-A) inhibitors containing moclobemide (used in the treatment of depression).
• irreversible monoamine oxidase B (MAO-B) inhibitors containing selegiline (used in the treatment of Parkinson's disease). These medicines increase the risk of adverse effects.
• the antibiotic linezolid.
• lithium (used in the treatment of bipolar affective disorders) and tryptophan.
• imipramine and desipramine (used in the treatment of depression).
• sumatriptan and similar medicines (used in the treatment of migraine), buprenorphine, and tramadol (used for severe pain). These may increase the risk of adverse effects.
• cimetidine, lansoprazole, and omeprazole (used in the treatment of stomach ulcers), fluconazole (an antifungal medicine), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may increase escitalopram blood levels.
• St. John's wort ( Hypericum perforatum ) – an herbal medicine used for depression.
• acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (painkillers or blood-thinning medicines known as anticoagulants). These may increase the tendency to bleed.
• warfarin, dipyridamole, and phenprocoumon (blood-thinning medicines known as anticoagulants). The doctor may order blood clotting time tests at the beginning and after stopping Pralex to determine whether the anticoagulant dose remains appropriate.

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• mefloquine (used in the treatment of malaria), bupropion (used in the treatment of depression), and tramadol (used for severe pain) due to possible risk of lowering the seizure threshold.
• neuroleptics (medicines used in the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants, SSRIs) due to possible risk of lowering the seizure threshold.
• flecainide, propafenone, and metoprolol (used in cardiovascular diseases), desipramine, clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Pralex may be necessary.
• medicines that reduce potassium or magnesium levels in the blood, due to increased risk of life-threatening heart rhythm disturbances.

DO NOT TAKE PRALEX if the patient is taking medicines used for heart rhythm disorders or medicines that may affect heart rhythm, such as antiarrhythmic class IA and III drugs, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibiotics (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine), antimalarial treatments (mainly halofantrine), or certain antihistamines (e.g. astemizole, hydroxyzine, mizolastine). If in doubt, consult a 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 consume alcohol while taking Pralex, although no interaction (interaction) between Pralex and alcohol has been demonstrated.
Pregnancy, breastfeeding and fertility
During pregnancy, while breastfeeding, if pregnancy is suspected, or if planning a pregnancy, consult a doctor or pharmacist before using this medicine. Do not use Pralex during pregnancy without discussing the risks and benefits of treatment with your doctor.
Inform the midwife and/or doctor about taking Pralex. Use during pregnancy, especially during the last 3 months, of medicines such as Pralex may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing rapid breathing and cyanosis in the baby. These symptoms usually occur within the first 24 hours after birth. If the patient notices these symptoms in their baby, contact the midwife and/or doctor immediately.
If the patient takes Pralex during the last 3 months of pregnancy, be aware that the newborn may experience the following symptoms: breathing difficulties, bluish skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood glucose, muscle stiffness or floppiness, increased reflex excitability, tremors, jitteriness, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. If any of these symptoms occur in the newborn, seek medical help immediately.
Taking Pralex towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Pralex, inform the doctor or midwife so they can provide appropriate advice.
Do not suddenly stop taking Pralex during pregnancy.
If the patient is breastfeeding, do not take Pralex before discussing the risks and benefits of treatment with the doctor. Pralex is expected to pass into breast milk.
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Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces semen quality. This may theoretically affect fertility, although no effect on human fertility has been observed to date.
Before taking any medicine, consult a doctor or pharmacist.
Driving and operating machinery
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, meaning the medicine is considered "sodium-free".

3. How to take Pralex

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Pralex is available in the following doses: 5 mg, 10 mg, 15 mg, 20 mg.

Adults

Depression
The usual recommended dose is 10 mg taken once daily. The dose may be increased by the doctor up to a maximum of 20 mg per day.

Panic disorder with agoraphobia
The initial dose is 5 mg once daily during the first week of treatment. The dose is then increased to 10 mg per day. The dose may subsequently be increased by the doctor up to a maximum of 20 mg per day.

Social phobia
The usual recommended dose is 10 mg taken once daily. The dose may then be reduced by the doctor to 5 mg per day or increased up 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 once daily. The dose may be increased by the doctor up to a maximum of 20 mg per day.

Elderly patients (over 65 years)
The usual recommended starting dose is 5 mg once daily. The dose may be increased at the doctor's discretion to 10 mg per day.

Children and adolescents (under 18 years of age)
Pralex should not usually be used in children and adolescents. Additional information is provided in section 2, "Important information before taking Pralex".

Renal impairment
Exercise caution in patients with severe renal impairment. Use this medicine exactly as directed by your doctor.

Hepatic impairment
Patients with impaired liver function should not exceed a dose of 10 mg per day. Use this medicine exactly as directed by your doctor.

Patients who are poor metabolizers via the CYP2C19 isoenzyme
Patients with this known genotype should not exceed a dose of 10 mg per day. Use this medicine exactly as directed by your doctor.

How to take Pralex
Pralex tablets may be taken with or without food. Swallow the tablets with water. Do not chew the tablets, as they have a bitter taste.

If necessary, the tablets can be divided into two equal parts. Place the tablet on a flat surface with the score line facing upwards. The tablet can then be broken in half by pressing down with the index fingers of both hands on each end, as shown in the illustration.

Duration of treatment
Improvement in symptoms may take several weeks. Therefore, continue taking Pralex even if it takes some time before you feel better. Do not change the dose without consulting your doctor.

Continue taking the medicine for as long as your doctor recommends. Stopping treatment too early may cause symptoms to return. It is therefore recommended to continue treatment for at least 6 months after recovery.

Taking more Pralex than prescribed
If you take more Pralex than prescribed, contact your doctor immediately or go to the nearest hospital emergency department. Do this even if you do not feel unwell. Symptoms of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, cardiac arrhythmias, low blood pressure, and disturbances in water and electrolyte balance. Bring the medicine package with you to the doctor's office or hospital.

If you miss a dose of Pralex
Do not take a double dose to make up for a missed dose. If you remember before going to sleep, take the missed dose immediately and take the next dose the following day as usual. If you remember during the night or the next day, skip the missed dose and take the next dose at the usual time.

Stopping Pralex
Do not stop taking Pralex unless your doctor tells you to do so. When stopping treatment, your doctor will usually recommend gradually reducing the dose over several weeks.

After stopping Pralex, especially if stopped abruptly, you may experience withdrawal symptoms. These symptoms are common when stopping Pralex treatment. The risk is greater if Pralex has been taken for a long time, at high doses, or if the dose was reduced too quickly. In most patients, symptoms are mild and resolve spontaneously within two weeks. However, in some patients, symptoms may be more severe or last longer (2–3 months or more). If you experience severe withdrawal symptoms after stopping Pralex, contact your doctor. Your doctor may recommend restarting the medicine and tapering it more slowly.

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Withdrawal symptoms may include dizziness (unsteady gait, balance disturbances), tingling sensations, burning sensations, and (less commonly) electric shock-like sensations, including in the head, sleep disturbances (vivid dreams, nightmares, insomnia), feelings of anxiety, headache, nausea, sweating (including night sweats), psychomotor agitation or restlessness, tremor, feelings of disorientation, emotional instability or irritability, diarrhea (loose stools), visual disturbances, palpitations, or rapid heartbeat.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Adverse effects are usually mild and typically resolve after a few weeks of treatment. It should be
remembered that some of these effects may also be symptoms of the illness itself and will subside as
the patient's condition improves.
If any of the following adverse events occur, contact a doctor immediately or go to hospital:
Uncommon ( may occur in up to 1 in 100 people ):

• Unusual bleeding, including gastrointestinal bleeding

Rare ( may occur in up to 1 in 1000 people ):

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

Not known ( frequency cannot be determined from available data ):

• Difficulty urinating
• Seizures, see also section "Warnings and precautions"
• Yellowing of the skin and whites of the eyes, indicating liver dysfunction and/or hepatitis
• Rapid or irregular heartbeat, fainting, which may be symptoms of life-threatening heart rhythm disorders known as torsade de pointes
• Suicidal thoughts and behaviours, see also section "Warnings and precautions"
• Sudden swelling of the skin or mucous membranes (angioedema)

In addition to the above, the following adverse effects have been reported:
Very common ( may occur in more than 1 in 10 people ):

• Nausea
• Headache

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

• Nasal congestion or runny nose (sinusitis)
• Decreased or increased appetite
• Anxiety, psychomotor agitation, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, skin tingling sensations
• Diarrhoea, constipation, vomiting, dry mouth
• Excessive sweating
• Muscle and joint pain
• Sexual disorders (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty achieving orgasm in women)

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• Feeling of fatigue, fever
• Weight gain

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

• Urticaria, rash, itching
• Teeth grinding, agitation, nervousness, panic attacks, confusion (disorientation)
• Sleep disturbances, taste disturbances, fainting
• Pupil dilation, visual disturbances, ringing in the ears (tinnitus)
• Hair loss
• Heavy menstrual bleeding
• Irregular menstruation
• Weight loss
• Rapid heartbeat
• Swelling of the upper or lower limbs
• Nosebleeds

Rare ( may occur in up to 1 in 1000 people ):

• Aggression, depersonalization (feeling of loss of self-identity, the person feels detached from themselves), hallucinations
• Slow heartbeat

Not known ( frequency cannot be determined from available data ):

• Decreased sodium levels in blood (manifesting as nausea, malaise, muscle weakness or confusion)
• Dizziness upon standing due to low blood pressure (orthostatic hypotension)
• Abnormal liver function tests (increased liver enzyme activity in blood)
• Movement disorders (involuntary muscle movements)
• Painful penile erection (priapism)
• Signs of unusual bleeding, e.g. under the skin and mucous membranes (petechiae), and reduced platelet count (thrombocytopenia)
• Sudden swelling of the skin or mucous membranes (angioedema)
• Increased secretion of antidiuretic hormone (ADH), leading to water retention, blood dilution, and reduced sodium concentration (syndrome of inappropriate antidiuretic hormone secretion - SIADH)
• Galactorrhea in men and in women who are not breastfeeding
• Mania
• Increased risk of bone fractures has been observed in patients taking this type of medicine
• Heart rhythm disorders (called "QT interval prolongation", diagnosed by ECG - a test to assess heart function)
• Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection "Pregnancy, breastfeeding and effects on fertility" in section 2.

Additionally, adverse effects associated with medicines having a similar mechanism of action to escitalopram
(active substance in Pralex) are known. These include:

• Psychomotor restlessness (akathisia)
• Loss of appetite

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the 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
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Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Pralex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Pralex contains

• The active substance is escitalopram. Each tablet contains 10 mg of escitalopram (as escitalopram oxalate).
• Other ingredients are:
• Core: microcrystalline cellulose, silicified 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, biconvex, marked with the letter "F" on one side and the number "54" on the other side, with a deep score line separating "5" and "4".
Pack sizes:
PVC/Aclar-Aluminium blister packs: 28 and 56 film-coated tablets.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Lithuania, the exporting country:
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, Poland
Relabeled in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation numbers in Lithuania, the exporting country: LT/1/10/2306/026
LT/1/10/2306/023
LT/1/10/2306/030
Parallel Import Licence number: 93/24
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This medicinal product is authorised in the European Economic Area countries under the following names:

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