DEPRALIN 20 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Depralin ODT, 5 mg, orally disintegrating tablets
3. Depralin ODT, 10 mg, orally disintegrating tablets
4. Depralin ODT, 20 mg, orally disintegrating tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Table of Contents of the Package Leaflet
5. What is Depralin ODT and what is it used for
6. Important information before taking Depralin ODT
   1. When not to take Depralin ODT
   2. Warnings and precautions
   3. Caution
   4. Suicidal thoughts and worsening of depression or anxiety disorders
   5. Children and adolescents
   6. Depralin ODT and other medicines
   7. Depralin ODT with food, drink, and alcohol
   8. Pregnancy, breastfeeding, and fertility
   9. Driving and using machines
   10. Depralin ODT contains lactose
   11. Depralin ODT contains sodium
7. How to take Depralin ODT
   1. Duration of treatment
   2. Taking a higher dose of Depralin ODT than prescribed
   3. Missing a dose of Depralin ODT
   4. Stopping treatment with Depralin ODT
8. Possible side effects
   1. If you experience any of the following side effects during treatment, you should contact your doctor or go to the hospital immediately:
   2. The following side effects have also been reported:
   3. Reporting side effects
9. How to store Depralin ODT
10. Contents of the pack and other information
    1. What Depralin ODT contains
    2. What Depralin ODT looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer
    5. This medicine is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the Patient

Depralin ODT, 5 mg, orally disintegrating tablets

Depralin ODT, 10 mg, orally disintegrating tablets

Depralin ODT, 20 mg, orally disintegrating tablets

Escitalopram

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

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Depralin ODT and what is it used for
• 2. Important information before taking Depralin ODT
• 3. How to take Depralin ODT
• 4. Possible side effects
• 5. How to store Depralin ODT
• 6. Contents of the pack and other information

1. What is Depralin ODT and what is it used for

Depralin ODT 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. Disruption of the serotonin system in the brain is thought to be a factor in the development of depression and related disorders.

Depralin ODT contains escitalopram and is used to treat depression (major depressive episodes) and anxiety disorders (such as panic attacks with or without agoraphobia, social anxiety disorder (social phobia), generalized anxiety disorder, obsessive-compulsive disorder).

It may take a few weeks of treatment before you start to feel better. You should continue to take Depralin ODT even if you do not feel better immediately. If you do not feel better or feel worse, you should consult your doctor.

2. Important information before taking Depralin ODT

When not to take Depralin ODT

• if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6);
• if you are taking other medicines that belong to a group called MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic);
• if you have been born with a heart rhythm disorder or if you have had an episode of irregular heart rhythm (visible on an ECG);
• if you are taking medicines used to treat irregular heart rhythms or medicines that may affect the heart rhythm (see section 2 "Depralin ODT and other medicines").

Warnings and precautions

Before starting treatment with Depralin ODT, you should discuss it with your doctor or pharmacist.

You should tell your doctor if you have any other disorders or diseases, as they may need to be taken into account. In particular, you should inform your doctor if:

• you have epilepsy. You should stop taking Depralin ODT if you have seizures or if the frequency of seizures increases (see also section 4 "Possible side effects");
• you have liver or kidney problems. Your doctor may need to adjust the dose;
• you have diabetes. Treatment with Depralin ODT may affect blood sugar control. You may need to adjust the dose of insulin and/or oral antidiabetic medicines;
• you have low sodium levels in the blood;
• you have an increased tendency to bleed or bruise, or if you are pregnant (see "Pregnancy, breastfeeding, and fertility");
• you are being treated with electroconvulsive therapy;
• you have coronary heart disease;
• you have had heart problems or have recently had a heart attack;
• you have low resting heart rate and/or may have electrolyte disturbances due to prolonged, persistent diarrhea and vomiting or the use of diuretic medicines;
• you experience rapid or irregular heartbeat, fainting, collapse, or dizziness when standing, which may indicate abnormal heart function;
• you have had eye problems, such as certain types of glaucoma (increased pressure in the eye);
• you have chronic pain that requires treatment with buprenorphine. Taking this medicine with Depralin ODT may lead to a life-threatening condition called serotonin syndrome (see section "Depralin ODT and other medicines").

Caution

In some patients with bipolar disorder (manic-depressive disorder), a manic phase may occur.

This is characterized by unusual, rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If you experience any of these symptoms, you should contact your doctor.

In the first few weeks of treatment, you may experience symptoms such as restlessness or inability to sit or stand still. If such symptoms occur, you should contact your doctor immediately.

Medicines like Depralin ODT (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Suicidal thoughts and worsening of depression or anxiety disorders

If you have depression and/or anxiety disorders, you may sometimes have thoughts of self-harm or suicide.

These thoughts may worsen at the start of treatment with antidepressant medicines, as these medicines usually start to work after about 2 weeks, and sometimes even longer.

The risk of such thoughts is higher if:

• you have had suicidal thoughts or self-harm in the past;
• you are an adult under the age of 25. Information from clinical trials indicates an increased risk of suicidal behavior in adults under the age of 25 with mental disorders who were treated with antidepressant medicines.

If you experience suicidal thoughts or thoughts of self-harm at any time, you should contact your doctor or go to the hospital immediately.

It may be helpful to tell someone in your family or a close friend about your depression or anxiety disorder and ask them to read this leaflet.

You can ask them to tell you if they notice that your depression or anxiety is getting worse or if you are experiencing any disturbing changes in your behavior.

Children and adolescents

Depralin ODT should not be used in children and adolescents under the age of 18.

It is important to remember that in patients under the age of 18 who are taking medicines of this group, there is a greater risk of side effects, such as suicidal attempts and suicidal thoughts, as well as hostility (especially aggression, rebellious behavior, and manifestations of anger).

However, your doctor may prescribe Depralin ODT to patients in this age group if they consider it necessary.

If your doctor has prescribed Depralin ODT to a patient under the age of 18 and you have concerns, you should consult your doctor again.

You should contact the treating doctor if any of the above symptoms occur or worsen in patients under the age of 18 taking Depralin ODT.

The long-term safety of Depralin ODT regarding its impact on growth, maturation, and cognitive and behavioral development in this age group has not been established yet.

Depralin ODT and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

You should inform your doctor if you are taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (IMAOs) containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine. You should wait 14 days before starting Depralin ODT. After stopping Depralin ODT, you should wait 7 days before starting any of these medicines.
• Reversible inhibitors of MAO-A, including moclobemide (used to treat depression).
• Irreversible inhibitors of MAO-B, including selegiline (used to treat Parkinson's disease). These medicines increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used to treat manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (used to treat depression).
• Sumatriptan and similar medicines (used to treat migraines) and tramadol, buprenorphine (opioid medicines used to treat acute or chronic pain). You should not take escitalopram with these medicines without consulting your doctor first. These medicines may interact with Depralin ODT and cause symptoms such as involuntary, rhythmic muscle contractions, including those that affect eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle stiffness, and body temperature above 38°C. If you experience such symptoms, you should contact your doctor.
• 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 increase the levels of Depralin ODT in the blood.
• St. John's Wort (Hypericum perforatum) - a herbal medicine used to treat depression.
• Aspirin and non-steroidal anti-inflammatory medicines (used to treat pain or to thin the blood, so-called blood thinners). These medicines may increase the risk of bleeding.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so-called anticoagulants). Your doctor will likely monitor your blood clotting time before and after stopping treatment with Depralin ODT to check if the dose of anticoagulant medicine is still appropriate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the risk of lowering the seizure threshold.
• Antipsychotics (used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the risk of lowering the seizure threshold.
• Flecainide, propafenone, metoprolol (used to treat cardiovascular diseases), desipramine, clomipramine, and nortriptyline (antidepressants), risperidone, thioridazine, and haloperidol (antipsychotics). Your doctor may need to adjust the dose of Depralin ODT.
• Medicines that may lower potassium or magnesium levels in the blood, due to the increased risk of life-threatening heart rhythm disorders.

You should not take Depralin ODT if you are taking medicines used to treat irregular heart rhythms or medicines that affect the heart rhythm, such as:

anti-arrhythmic medicines of class IA and III, antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibiotics (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medicines - especially halofantrine), and certain antihistamines (astemizole, mizolastine). If you have any further doubts, you should consult your doctor.

Depralin ODT with food, drink, and alcohol

Depralin ODT should not be taken with food (see section 3 "How to take Depralin ODT").

As with many other medicines, it is not recommended to consume alcohol during treatment with Depralin ODT, although no interaction with alcohol is expected.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, you should consult your doctor before taking this medicine.

You should not take Depralin ODT if you are pregnant or breastfeeding, unless your doctor has discussed the risks and benefits of taking the medicine with you.

Pregnancy

Taking Depralin ODT at the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Depralin ODT, you should inform your doctor or midwife so that they can give you appropriate advice.

If you are taking Depralin ODT in the last three months of pregnancy, you should be aware that the following symptoms may occur in the newborn: difficulty breathing, blue discoloration of the skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, stiffness or floppiness of the muscles, increased reflexes, tremors, tremors, lethargy, irritability, constant crying, or difficulty sleeping.

If any of these symptoms occur in the newborn, you should contact your doctor immediately.

You should ensure that your midwife and/or doctor know that you are taking Depralin ODT.

Taking Depralin ODT during pregnancy, especially in the last three months, may increase the risk of a serious condition called persistent pulmonary hypertension in newborns (PPHN). This condition causes rapid breathing and blue discoloration of the skin in the newborn. These symptoms usually appear in the first day after birth. If you notice these symptoms in your newborn, you should contact your midwife and/or doctor immediately.

You should not stop taking Depralin ODT during pregnancy unless your doctor advises you to do so.

Breastfeeding

It is assumed that Depralin ODT passes into breast milk.

Fertility

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 yet.

Driving and using machines

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

Depralin ODT contains lactose

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking Depralin ODT.

Depralin ODT contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is considered to be "sodium-free".

3. How to take Depralin ODT

This medicine should always be taken exactly as your doctor has told you.

Depralin ODT, orally disintegrating tablets, should be taken once daily, in one dose. The medicine should not be taken with food.

The orally disintegrating tablets are fragile, so you should handle them carefully. You should not touch the tablets with wet hands, as they may break apart.

• 1. Holding the blister by the edges, separate one tablet from the rest of the blister by gently tearing it off along the perforation.
• 2. Carefully peel off the rear foil.
• 3. Place the tablet on your tongue. The tablet will dissolve very quickly and can be swallowed without water.

Adults

Depression

The usual dose is 10 mg once daily. Your doctor may increase the dose to a maximum of 20 mg once daily.

Anxiety disorder with panic attacks

The recommended initial dose of Depralin ODT is 5 mg once daily for the first week, which is then increased to 10 mg once daily. Your doctor may recommend further increases in dose to a maximum of 20 mg once daily.

Social anxiety disorder

The usual dose of Depralin ODT is 10 mg once daily. Depending on your response to the medicine, your doctor may reduce the dose to 5 mg once daily or increase the dose to a maximum of 20 mg once daily.

Generalized anxiety disorder

The usual dose of Depralin ODT is 10 mg once daily. Your doctor may increase the dose to a maximum of 20 mg once daily.

Obsessive-compulsive disorder

The usual dose of Depralin ODT is 10 mg once daily. Your doctor may increase the dose to a maximum of 20 mg once daily.

Elderly patients (over 65 years of age)

The recommended initial dose of Depralin ODT is 5 mg once daily. Your doctor may increase the dose to 10 mg once daily.

Children and adolescents

Depralin ODT should not be used in children and adolescents. For more information, see section 2 "Important information before taking Depralin ODT".

Duration of treatment

It may take a few weeks of treatment before you feel better. You should continue to take the medicine, even if you do not feel better immediately.

You should never change the dose of the medicine without consulting your doctor first.

You should continue to take Depralin ODT for as long as your doctor has prescribed it. If you stop treatment too early, your symptoms may return. It is recommended that treatment be continued for at least 6 months after you start to feel better.

Taking a higher dose of Depralin ODT than prescribed

If you have taken more Depralin ODT than prescribed, you should contact your doctor or go to the hospital immediately. You should do this even if you do not feel any discomfort. Some of the symptoms of overdose are: dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, heart rhythm disturbances, low blood pressure, and disturbances in the body's water and electrolyte balance. You should take the package (box) of Depralin ODT with you to the doctor or hospital.

Missing a dose of Depralin ODT

You should not take a double dose of the medicine to make up for a missed dose. If you have forgotten to take a dose and you remember before going to bed, you should take the missed dose immediately. You should take the next dose at the usual time the next day. If you remember that you have missed a dose in the night or the next day, you should skip the missed dose and take the next dose at the usual time.

Stopping treatment with Depralin ODT

You should not stop taking Depralin ODT unless your doctor advises you to do so.

If you are ending the prescribed treatment cycle, your doctor will usually recommend gradually reducing the dose of Depralin ODT over a few weeks.

If you stop taking Depralin ODT, especially if you stop suddenly, you may experience withdrawal symptoms. These symptoms are common when treatment with escitalopram is stopped. The risk is higher if the medicine has been taken for a long time or in high doses, or if the dose has been reduced too quickly. In most patients, the symptoms are mild and go away on their own within two weeks. However, in some patients, they may be severe and last longer (2 to 3 months or longer). If you experience severe withdrawal symptoms, you should contact your doctor. Your doctor may recommend that you start taking the medicine again and then stop it more slowly.

Withdrawal symptoms include: dizziness (unsteady gait, balance disturbances), tingling, numbness, and (less commonly) electric shock-like sensations, including in the head, sleep disturbances (vivid dreams, nightmares, insomnia), anxiety, headaches, nausea, excessive sweating (including night sweats), agitation or restlessness, tremors, confusion or disorientation, mood swings or irritability, diarrhea (loose stools), vision disturbances, palpitations (heart palpitations). If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Depralin ODT can cause side effects, although not everybody gets them.

Side effects usually go away after a few weeks of treatment. You should be aware that many symptoms can also be symptoms of the underlying disease and will improve as you feel better.

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

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

• Abnormal bleeding, including gastrointestinal bleeding.

Rare (may affect up to 1 in 1,000 people):

Allergic reactions (such as swelling of the skin, tongue, lips, or throat, or difficulty breathing or swallowing)

High fever, agitation, confusion (disorientation), tremors, and sudden muscle contractions, which can be symptoms of a rare disorder called serotonin syndrome.

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• Difficulty urinating
• Seizures (see also "Warnings and precautions")
• Yellowing of the skin and whites of the eyes, which are symptoms of liver dysfunction and/or hepatitis
• Rapid or irregular heartbeat, fainting, which can be symptoms of a life-threatening condition called Torsades de Pointes
• Suicidal thoughts and behaviors, see also "Warnings and precautions"
• Severe vaginal bleeding shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2.

The following side effects have also been reported:

Very common (may affect more than 1 in 10 people):

• Nausea
• Headache.

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

• Stuffy or runny nose or sinusitis (sinus infection)
• Increased or decreased appetite
• Anxiety, restlessness, unusual dreams, difficulty sleeping, sleepiness, dizziness, yawning, tremors, tingling sensation in the skin
• Diarrhea, constipation, vomiting, dry mouth
• Excessive sweating
• Muscle and joint pain
• Sexual disturbances (delayed ejaculation, erectile dysfunction, decreased libido, difficulty achieving orgasm in women)
• Feeling tired, fever
• Weight gain.

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

• Hives, rash, itching
• Grinding of the teeth, restlessness, agitation, panic attacks, confusion
• Sleep disturbances, taste disturbances, fainting
• Dilated pupils, vision disturbances, ringing in the ears
• Hair loss
• Heavy menstrual bleeding
• Irregular menstrual periods
• Weight loss
• Rapid heartbeat
• Swelling of the hands or feet
• Nosebleeds.

Rare (may affect up to 1 in 1,000 people):

• Aggression, depersonalization (feeling of being a stranger to oneself), hallucinations
• Slow heartbeat.

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• Low sodium levels in the blood (symptoms may include nausea and malaise with muscle weakness or confusion)
• Dizziness when standing up due to low blood pressure (orthostatic hypotension)
• Abnormal liver function test results (increased liver enzyme activity in the blood)
• Movement disorders (involuntary muscle movements)
• Painful and persistent erection (priapism)
• Symptoms of increased bleeding in the skin and mucous membranes (ecchymoses) and decreased platelet count (thrombocytopenia)
• Sudden swelling of the skin and mucous membranes (angioedema)
• Increased urine production (inappropriate secretion of antidiuretic hormone - SIADH)
• Milk production in men and women who are not breastfeeding
• Mania
• Patients taking medicines of this group have been observed to have an increased risk of fractures
• Changes in heart rhythm (called "QT interval prolongation", visible on an ECG)

The following side effects have also been reported with medicines of the same mechanism of action as escitalopram (the active substance of Depralin ODT):

• Restlessness (akathisia)
• Loss of appetite.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety Monitoring 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Depralin ODT

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton.

The expiry date refers to the last day of the month.

The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.

There are no special storage instructions; store in the original packaging to protect from moisture and light.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Depralin ODT contains

• The active substance of Depralin ODT is escitalopram. Depralin ODT 5 mg: Each tablet contains 5 mg of escitalopram, equivalent to 6.3875 mg of escitalopram oxalate. Depralin ODT 10 mg: Each tablet contains 10 mg of escitalopram, equivalent to 12.775 mg of escitalopram oxalate. Depralin ODT 20 mg: Each tablet contains 20 mg of escitalopram, equivalent to 25.55 mg of escitalopram oxalate.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium carboxymethylcellulose, potassium polacrylate, acesulfame potassium, neohesperidin dihydrochalcone, magnesium stearate, peppermint flavor containing maltodextrin (corn), modified starch, and peppermint oil; concentrated hydrochloric acid.

The medicine also contains:

What Depralin ODT looks like and contents of the pack

Depralin ODT 5 mg: White or almost white, flat, beveled-edge tablet, 7 mm in diameter, with "5" embossed on one side.

Depralin ODT 10 mg: White or almost white, flat, beveled-edge tablet, 9 mm in diameter, with "10" embossed on one side.

Depralin ODT 20 mg: White or almost white, flat, beveled-edge tablet, 12 mm in diameter, with "20" embossed on one side.

Depralin ODT is available in packs of 7, 28, 30, and 90 orally disintegrating tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Polpharma S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Manufacturer

Genepharm S.A.

18th km Marathonos Ave,

Pallini Attiki, 15351

Greece

PharmaPath S.A.

28is Oktovriou 1,

Agia Varvara, 123 51,

Greece

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

Netherlands - Escitalopram Polpharma 5 mg orodispergeerbare tabletten

Escitalopram Polpharma 10 mg orodispergeerbare tabletten

Escitalopram Polpharma 15 mg orodispergeerbare tabletten

Escitalopram Polpharma 20 mg orodispergeerbare tabletten

Date of last revision of the leaflet:November 2023