Pralex

Package leaflet: Information for the user

Pralex, 5 mg, film-coated tablets
Pralex, 10 mg, film-coated tablets
Pralex, 15 mg, film-coated tablets
Pralex, 20 mg, film-coated tablets
Escitalopram
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• 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. This medicine may harm others, 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.

Leaflet contents:

1. What Pralex is and what it is 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 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 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. Continue taking Pralex even if it takes some time before you feel better.
Inform 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), including selegiline (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression), or linezolid (an antibiotic)
• if the patient has congenital or previously diagnosed abnormal heart rhythm (identified 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.
Inform 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 experience salt loss 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 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 persist 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
People with depression or anxiety disorders may sometimes have thoughts about 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 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, contact a doctor immediately or go to a hospital.
It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask family or friends for help and request them to inform him/her 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 medicines of this class are at increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, oppositional behavior, and expressions of anger). Nevertheless, a doctor may prescribe Pralex to patients under 18 years of age if he/she considers 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 doubts, please contact the treating doctor. If any of 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, puberty, cognitive development, and behavioral development.
Pralex with other medicines
Inform 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, a 14-day interval should be observed before starting Pralex. After discontinuing Pralex, a 7-day interval should be observed 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 the blood concentration of escitalopram.

• 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 (medicines used to thin the blood, known as anticoagulants). The doctor may order blood clotting time tests at the beginning of and after stopping Pralex to determine whether the anticoagulant dose remains 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), 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, e.g., antiarrhythmics of class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibiotics (e.g., sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarial treatment mainly halofantrine), certain antihistamines (e.g., astemizole, hydroxyzine, mizolastine). In case of any doubts, 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 drink 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 plans to become pregnant, consult a doctor or pharmacist before using this medicine. Do not use Pralex during pregnancy without discussing the risks and benefits of treatment with a 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 her baby, she should contact the 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, muscle stiffness or floppiness, increased reflex excitability, tremors, shakiness, irritability, lethargy, constant crying, sleepiness, and difficulty sleeping. If any of these symptoms occur in the newborn, seek medical attention immediately.
Taking Pralex towards the end of pregnancy may increase the risk of serious 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 a doctor. Pralex is expected to pass into breast milk.
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces semen quality. This could theoretically affect fertility, although no effect on human fertility has been observed to date.
Consult a doctor or pharmacist before taking any medicine.
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 take Pralex

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Adults
Depression
The usual recommended dose is 10 mg taken once daily. The dose may be increased by your doctor
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, after which the dose is increased
to 10 mg per day. The dose may then be increased by your 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 your
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.
Generalized anxiety disorder or obsessive-compulsive disorder
The usual recommended dose of Pralex is 10 mg taken once daily. The dose may be increased by
your doctor up to a maximum of 20 mg per day.
Elderly patients (over 65 years of age)
The usual recommended starting dose is 5 mg taken 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. Further information is provided in
section 2, "Important information before taking Pralex".
Renal impairment
Caution should be exercised in patients with severe renal impairment. This medicine should be used
according to the doctor's instructions.
Hepatic impairment
Patients with impaired liver function should not exceed a dose of 10 mg per day. The medicine should
be used according to the doctor's instructions.
Patients who are poor metabolizers of drugs mediated by the CYP2C19 isoenzyme
Patients with this known genotype should not exceed a dose of 10 mg per day. The medicine should
be used according to the 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.
Pralex 10 mg, 15 mg and 20 mg: If necessary, the tablets can be divided into two equal parts by
placing the tablet on a flat surface with the groove facing upwards. The tablet can then be broken
in half by pressing down with both index fingers on each end, as shown in the illustration.

Duration of treatment
You may not start to feel better until after several weeks of treatment. Therefore, continue taking
Pralex as prescribed, even if it takes some time before you feel improvement.
Do not change the dose without first consulting your doctor.
Continue taking this medicine for as long as your doctor recommends. If treatment is stopped too
early, symptoms may return. Therefore, it is recommended to continue treatment for at least
6 months after recovery.
Taking more Pralex than prescribed
If you have taken 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, tremors, agitation, seizures, coma, nausea, vomiting, heart rhythm disturbances,
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 sleep, 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 tells you to. When ending 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 treatment with Pralex is discontinued. The risk is greater if
Pralex has been taken for a long time, at high doses, or if the dose has been 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
rapid heartbeat.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects are usually mild and generally resolve within a few weeks of treatment. It should be
remembered that some of these effects 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, seek immediate medical attention 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, urticaria (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 available data ):

• difficulty passing urine
• seizures, see also section “Warnings and precautions”
• yellowing of the skin or 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 behaviour, 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, tingling sensations in the skin
• diarrhoea, constipation, vomiting, dry mouth
• excessive sweating
• muscle and joint pain
• sexual dysfunction (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 ):

• urticaria (hives), rash, itching
• teeth grinding, agitation, nervousness, panic attacks, confusion (disorientation)
• sleep disturbances, taste disturbances, fainting
• dilated pupils, visual disturbances, tinnitus (ringing in the ears)
• 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, depersonalisation (feeling of loss of self-identity, feeling detached from oneself), hallucinations
• slow heartbeat.

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

• decreased sodium concentration in blood (manifested by 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 or mucous membranes (petechiae), and reduced platelet count (thrombocytopenia)
• increased secretion of antidiuretic hormone (ADH), leading to water retention, blood dilution, and reduced sodium levels (syndrome of inappropriate antidiuretic hormone secretion – SIADH)
• increased blood levels of prolactin hormone
• galactorrhea (milk production) in men and in women who are not breastfeeding
• mania
• increased risk of bone fractures observed in patients taking this type of medicine
• heart rhythm disorders (known as "QT interval prolongation", diagnosed by ECG – a test to assess heart function)
• severe vaginal bleeding shortly after childbirth (postpartum haemorrhage), see additional information in subsection “Pregnancy, breastfeeding and 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 agitation (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 Adverse Drug Reactions,
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
Adverse effects may also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store the medicine 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 the cardboard package. 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 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 5 mg, 10 mg, 15 mg, or 20 mg of escitalopram (as oxalate).
• Other ingredients are:
• Core: microcrystalline cellulose, butylated hydroxytoluene (E 321), butylated hydroxyanisole (E 320), sodium croscarmellose, colloidal anhydrous silica, 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 coated tablets, biconvex, marked with the letter "F"
on one side and the number "53" on the other side.
10 mg: White or almost white, oval 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".
15 mg: White or almost white, oval coated tablets, biconvex, marked with the letter "F"
on one side and the number "55" on the other side, with a deep score line separating "5" and "5".
20 mg: White or almost white, oval coated tablets, biconvex, marked with the letter "F"
on one side and the number "56" on the other side, with a deep score line separating "5" and "6".
Pack sizes:
PVC/Aclar/Aluminium blister packs: 28, 56, and 90 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For more detailed information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorised in the European Economic Area countries under the following names: