Pralex

Patient Information Leaflet

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

• Keep this leaflet so that you can read it again if necessary.
• 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. It may harm someone else even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of 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. Disturbances in the serotonin system are considered a significant factor in the development of depression and related disorders.
Pralex contains the active substance escitalopram and is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder).
Improvement may take several weeks of treatment. You should 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 a group called non-selective monoamine oxidase inhibitors (MAO inhibitors), including selegiline (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression), and linezolid (an antibiotic)
• if the patient has a congenital or previously diagnosed abnormal heart rhythm (identified by ECG – a test to assess heart function)
• if the patient is taking medicines for heart rhythm disorders or medicines that affect heart rhythm (also see 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 has impaired liver or kidney function. Dose adjustment by the doctor may be necessary
• 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 heart rate at rest and/or if the patient may experience salt loss due to severe diarrhoea or vomiting (with nausea) or due to diuretic medicines
• if the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, 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, contact your doctor.
In 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 about 2 weeks, sometimes longer, to start working.
The occurrence of suicidal thoughts, thoughts of self-harm, or suicide attempts is more likely if:

• the patient has previously experienced suicidal thoughts or self-harm
• 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 or suicide, seek immediate medical help
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 for help from relatives or friends and ask them to inform the patient if they notice worsening 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 this class of medicines are at increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behavior, and manifestations of anger). Nevertheless, a doctor may prescribe Pralex to patients under 18 years of age if they determine it is in their best interest. If your doctor has prescribed Pralex to a patient under 18 years of age and you have any doubts, please contact your treating doctor. If the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Pralex, inform your doctor.
Moreover, there are currently no data on the long-term safety of Pralex use 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 your doctor if the patient is taking any of the following medicines:

• non-selective monoamine oxidase inhibitors (MAO inhibitors) 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, lanzoprazole, 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 ) – a herbal remedy 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 (medicines used to thin the blood, known as anticoagulants). Your doctor may order blood clotting time tests at the beginning

and after stopping Pralex to determine whether the anticoagulant dose
is still appropriate.

• 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 treatment mainly halofantrine), certain antihistamines (e.g., astemizole, hydroxyzine, mizolastine). If you have any doubts regarding this, consult your doctor.
Pralex with food, drink, and alcohol
Pralex can be taken during meals or independently of meals (see section 3 "How to take Pralex").
As with other medicines, it is not recommended to consume alcohol while taking Pralex, although no interaction between Pralex and alcohol has been demonstrated.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, consult your 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 your midwife and/or doctor that you are 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 infant. These symptoms usually occur within the first 24 hours after birth. If the patient notices these symptoms in her child, she should contact her midwife and/or doctor immediately.
If the patient takes Pralex during the last 3 months of pregnancy, she should be aware that the newborn may experience the following symptoms: breathing difficulties, bluish skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood glucose levels, muscle stiffness or floppiness, increased reflex excitability, tremors, jitteriness, irritability, lethargy, constant crying, drowsiness, and difficulty falling asleep. If any of these symptoms occur in the newborn, seek immediate medical attention.
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, she should inform her doctor or midwife so they can provide appropriate advice.
Do not abruptly stop taking Pralex during pregnancy.
If the patient is breastfeeding, she should not take Pralex without discussing the risks and benefits of treatment with her doctor. Pralex is expected to pass into breast milk.
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 your doctor or pharmacist.
Driving and operating machinery
The patient should not drive or operate machinery until it is known 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 use 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.
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 as a single dose. Your doctor may increase the dose
up to a maximum of 20 mg per day.

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

Social phobia
The usual recommended dose is 10 mg taken once daily as a single dose. Depending on the patient's
response to the medicine, your doctor may reduce the dose to 5 mg per day or increase it up to a maximum
of 20 mg per day.

Obsessive-compulsive disorder
The usual recommended dose of Pralex is 10 mg taken once daily as a single dose. Your doctor may
increase the dose up to a maximum of 20 mg per day.

Elderly patients (over 65 years)
The usual recommended starting dose is 5 mg taken once daily as a single dose. Your doctor may decide to
increase the dose 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
Caution should be exercised in patients with severe renal impairment. Pralex should be used according to
your doctor's instructions.

Hepatic impairment
Patients with impaired liver function should not exceed a dose of 10 mg per day. Pralex should be used
according to your doctor's instructions.

Patients who are poor metabolizers via the CYP2C19 isoenzyme
Patients with this known genotype should not exceed a dose of 10 mg per day. Pralex should be used
according to your doctor's instructions.

How to take Pralex
Pralex can 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 by placing the tablet on a flat surface with the
score side up. 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
You may not start feeling better until several weeks after starting treatment. Therefore, continue taking
Pralex as prescribed, even if it takes some time before you feel improvement.
Do not change the dose without consulting your doctor.
Continue taking Pralex for as long as your doctor recommends. If you stop treatment too early, symptoms
may return. Therefore, it is recommended to continue treatment for at least 6 months after recovery of
well-being.

Taking more Pralex than prescribed
If you take more Pralex than prescribed, contact your doctor immediately or go to the emergency
department of your nearest hospital. This should be done even if you do not feel unwell. Symptoms of
overdose may include dizziness, tremors, agitation, seizures, coma, nausea, vomiting, cardiac arrhythmias,
low blood pressure, and disturbances in water and electrolyte balance. Bring the Pralex packaging with you
when visiting the doctor or hospital.

If you miss a dose of Pralex
Do not take a double dose to make up for a missed dose. If you forget to take a dose and remember before
going to bed, take the missed dose immediately and take the next dose the following day as usual. If you
remember about the missed dose 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 advises you to do so. When stopping treatment, your doctor
will usually recommend gradually reducing the dose of Pralex over several weeks.
After stopping Pralex, especially if stopped abruptly, you may experience withdrawal symptoms. These
symptoms are common when stopping Pralex. 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.

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, tremors, feelings of disorientation, emotional
instability or irritability, diarrhoea (loose stools), visual disturbances, palpitations, or awareness of your
heartbeat.

If you have any doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions are usually mild and generally resolve within a few weeks of treatment. It should be
remembered that some of these reactions may also be symptoms of the underlying illness 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 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 violent muscle contractions. These may be symptoms of a rare condition called serotonin syndrome.

Not known ( 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, indicating impaired liver function and/or hepatitis
• Rapid, irregular heartbeat, fainting, which may be symptoms of life-threatening heart rhythm disorders called torsade de pointes
• Suicidal thoughts and behaviour, see also section “Warnings and precautions”
• Sudden swelling of the skin or mucous membranes (angioedema).

In addition to those listed above, the following adverse reactions have also 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, tremor, tingling sensation in the skin
• 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)
• Feeling of fatigue, fever
• Weight gain.

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

• Hives, 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 1,000 people ):

• Aggression, depersonalization (feeling of loss of self-identity, feeling detached from oneself), hallucinations
• Slow heartbeat.

Not known ( frequency cannot be estimated from the available data ):

• Decreased sodium concentration in blood (manifesting as nausea and malaise with 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 medicines of this type
• 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 reactions known for medicines with a similar mechanism of action to escitalopram
(active substance in Pralex) include:

• Psychomotor agitation (akathisia)
• Loss of appetite.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Pralex

Keep this medicine out of 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 conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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 oxalate).
• The other ingredients are:
• Core: microcrystalline cellulose, butylhydroxytoluene (E 321), butylhydroxyanisole (E 320), sodium croscarmellose, colloidal anhydrous silica, talc, and magnesium stearate.
• Coating: hypromellose 5 cPs, polyethylene glycol 400, and titanium dioxide (E 171).

What Pralex looks like and contents of the pack
White or almost white, oval, film-coated tablets, biconvex on both sides, 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 blisters: 28 and 56 film-coated tablets.
For more detailed information, please contact the responsible party or the 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Lithuania, the exporting country: LT/1/10/2306/026
Parallel Import Authorisation Number: 176/23
This medicinal product is authorised for marketing in the European Economic Area countries under the following names: