Depralin

Package Leaflet: Information for the Patient

Depralin, 10 mg, Film-Coated Tablets

Escitalopram

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for your current condition 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 Leaflet

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

1. What is Depralin and what is it used for

Depralin contains the active substance escitalopram.
Depralin 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 serotonin levels. Disruption of the serotonin system in the brain is thought to be a factor in the development of depression and related disorders.
Depralin is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder).
It may take a few weeks of treatment before you start to feel better. You should continue to take Depralin 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

When not to take Depralin

• 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 monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic)
• if you have an abnormal heart rhythm (visible on an ECG; a test that evaluates heart function)
• if you are taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see section 2 "Depralin and other medicines").

Warnings and precautions

Before starting treatment with Depralin, 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. If you experience seizures for the first time or an increase in seizure frequency, you should stop therapy with Depralin (see also section 4 "Possible side effects").
• you have liver or kidney function disorders. Your doctor may need to adjust the dose.
• you have diabetes. Treatment with Depralin 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 or have had heart disease, or if you have recently had a heart attack.
• you have low resting heart rate and/or may experience 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 or have had eye problems, such as certain types of glaucoma (increased pressure inside the eyeball).
• you have acute or chronic pain requiring treatment with buprenorphine. Taking this medicine with Depralin may lead to a life-threatening condition called serotonin syndrome (see section "Depralin and other medicines").

Caution

In some patients with bipolar affective disorder, a manic phase may occur. It is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, you should consult your doctor.
In the first few weeks of treatment, you may also experience symptoms such as restlessness or difficulty sitting or standing still. If you experience these symptoms, you should immediately inform your doctor.
Medicines like Depralin (so-called SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of 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 later.
The risk of these thoughts is higher if:

• you have had suicidal thoughts or self-harm in the past;
• you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years of age 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 friend about your depression or anxiety disorder and ask them to read this leaflet. You may want to ask them to tell you if they notice that your depression or anxiety is getting worse or if you are experiencing disturbing changes in your behavior.

Children and adolescents

Depralin should not normally be used for children and adolescents under 18 years of age. You should be aware that in patients under 18 years of age, who are taking medicines of this type, there is a greater risk of side effects, such as attempted suicide and suicidal thoughts, and hostility (especially aggression, rebellious behavior, and anger). Nevertheless, your doctor may prescribe Depralin to patients in this age group if he/she decides that it is necessary.
If your doctor has prescribed Depralin for a patient under 18 years of age, and you have concerns, you should discuss them with your doctor again. You should contact the doctor who is treating the patient if any of the above symptoms occur or worsen in patients under 18 years of age who are taking Depralin. The long-term safety of Depralin in terms of its effects on growth, maturation, and cognitive and behavioral development in this age group has not been established yet.

Depralin and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, 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 (MAOIs) containing the active substances phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If you are taking any of these, you should wait 14 days before starting treatment with Depralin. After stopping Depralin, you should wait 7 days before starting any of these medicines.
• Reversible inhibitors of monoamine oxidase A (RIMAs) such as moclobemide (used to treat depression).
• Irreversible inhibitors of monoamine oxidase B (MAO-B) such as 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 migraine) and tramadol and 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 and cause symptoms such as involuntary, rhythmic contractions of muscles, including muscles that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased muscle tone, and body temperature above 38°C. If you experience these 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 in the blood.
• St. John's Wort (Hypericum perforatum) - a herbal medicine used to treat depression.
• Acetylsalicylic acid 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 probably check your blood clotting time before and after stopping treatment with Depralin to ensure that 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.
• Medicines that lower potassium or magnesium levels in the blood, due to the increased risk of life-threatening heart rhythm disorders.

Do not take Depralinif you are taking medicines used to treat heart rhythm disorders or medicines that affect heart rhythm, such as antiarrhythmic medicines of class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibiotics (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medicines - especially halofantrine), and certain antihistamines (astemizole, mizolastine). If you have any further questions, you should consult your doctor.

Depralin with food, drink, and alcohol

Depralin can be taken with or without food (see section 3 "How to take Depralin").
As with many other medicines, it is not recommended to drink alcohol while being treated with Depralin, 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 baby, ask your doctor for advice before taking this medicine.
Do not take Depralin if you are pregnant or breastfeeding, unless your doctor has discussed the risks and benefits of taking it with you.
Pregnancy
Taking Depralin at the end of pregnancy may increase the risk of severe bleeding from the vagina, occurring shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Depralin, you should inform your doctor or midwife so that they can give you appropriate advice.
If you are taking Depralin in the last three months of pregnancy, you should be aware that your newborn baby may experience the following symptoms: difficulty breathing, bluish discoloration of the skin, seizures, fluctuations in body temperature, difficulty feeding, vomiting, low blood sugar, muscle stiffness or floppiness, increased muscle tone, tremors, tremors, irritability, lethargy, constant crying, sleepiness, or difficulty sleeping. If your baby experiences any of these symptoms, you should contact your doctor immediately.
Make sure that your midwife and/or doctor know that you are taking Depralin.
Taking Depralin during pregnancy, especially in the last three months, may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN). This condition causes rapid breathing and bluish discoloration of the skin in the newborn. These symptoms usually appear in the first day after birth. If you notice these symptoms in your baby, you should contact your midwife and/or doctor immediately.
Do not stop taking Depralin during pregnancy without consulting your doctor.
Breastfeeding
It is assumed that Depralin passes into breast milk.
Fertility
In animal studies, it has been shown that citalopram, a medicine similar to escitalopram, reduces sperm quality. This could theoretically affect fertility, although no effect on fertility has been observed in humans yet.

Driving and using machines

Do not drive or operate machinery until you know how Depralin affects you.

Depralin contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

3. How to take Depralin

Take this medicine always as directed by your doctor. If you are not sure, ask your doctor or pharmacist.
Adults
Depression
The usual dose is 10 mg once daily. Your doctor may increase the dose to a maximum of 20 mg once daily.
Panic disorder
The recommended initial dose of Depralin is 5 mg once daily for the first week, which is then increased to 10 mg once daily. Your doctor may recommend further dose increases to a maximum of 20 mg once daily.
Social anxiety disorder
The usual dose of Depralin 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 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 is 10 mg once daily. Your doctor may increase the dose to a maximum of 20 mg once daily.
Elderly patients (65 years and over)
The recommended initial dose of Depralin is 5 mg once daily. Your doctor may increase the dose to 10 mg once daily.
Children and adolescents
Depralin should not normally be used for children and adolescents. For more information, see section 2 "Important information before taking Depralin".
Depralin can be taken with or without food. You should swallow the tablet with water. Do not chew the tablets, as they have a bitter taste.
If necessary, the tablet can be divided. To do this, place the tablet on a flat surface with the dividing line facing upwards. You can then break the tablet by pressing down on each end with your index fingers.

Duration of treatment

It may take a few weeks of treatment before you feel better. Therefore, you should continue to take the medicine, even if you do not feel better immediately. Never change the dose of the medicine without consulting your doctor first.
Continue to take Depralin for as long as your doctor recommends. If you stop treatment too early, your symptoms may return. It is recommended that treatment be continued for at least 6 months after you have started to feel better.

Taking more than the prescribed dose of Depralin

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

Forgetting to take a dose of Depralin

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose and 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

Do not stop treatment with Depralin unless your doctor tells you to.
When stopping treatment with Depralin, your doctor will usually recommend that you reduce the dose gradually over a few weeks.
If you stop taking Depralin, especially suddenly, you may experience withdrawal symptoms. This happens frequently when treatment with Depralin 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 disappear 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 disorders), tingling, prickling, burning sensations, 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), restlessness or agitation, tremors, confusion, and disorientation, mood swings or irritability, diarrhea (loose stools), and vision disturbances, palpitations (rapid or irregular heartbeat).

Further questions on the use of this medicine

If you have any further questions on the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Depralin can cause side effects, although not everybody gets them.
Side effects usually disappear after a few weeks of treatment. You should be aware that many symptoms can also be symptoms of the underlying disease and will disappear as your condition improves.

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):

• Swelling of the skin, tongue, lips, or face, or difficulty breathing or swallowing (allergic reaction)
• 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 is a sign of liver function disorders 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 section "Warnings and precautions"
• Severe bleeding from the vagina, occurring shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2
• 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 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
• Increased sweating
• Muscle and joint pain
• Sexual disturbances (delayed ejaculation, erectile dysfunction, decreased libido, difficulty reaching orgasm in women)
• Feeling tired, fever
• Weight gain.

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

• Hives, rash, itching
• Teeth grinding, agitation, irritability, panic attacks, confusion
• Sleep disturbances, taste disorders, 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):

• Decreased 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, prolonged erections (priapism)
• Bleeding, including skin and mucous membrane bleeding (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
• In patients taking medicines of this type, an increased risk of bone fractures has been observed
• Changes in heart rhythm (called "QT interval prolongation", visible on an ECG, a test that evaluates the electrical activity of the heart).

The following side effects have also been reported for medicines with a similar mechanism of action to escitalopram (the active substance of Depralin):

• Restlessness (akathisia)
• Loss of appetite.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects 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

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the month stated.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Depralin contains

• The active substance of Depralin is escitalopram. Each tablet contains 10 mg of escitalopram (as oxalate).
• The other ingredients are: Tablet core: microcrystalline cellulose, sodium carboxymethylcellulose, silicon dioxide, magnesium stearate. Tablet coating: hypromellose 6 cP, titanium dioxide (E171), macrogol 400.

What Depralin looks like and contents of the pack

Depralin is available as film-coated tablets containing 10 mg of escitalopram (as oxalate).
Depralin 10 mg is an oval, white, film-coated tablet with a dividing line on one side. The tablet can be divided into equal doses.
Depralin is available in packs of 28 tablets.

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
HBM Pharma s.r.o.
Sklabinská 30
036 80 Martin, Slovakia

Date of last revision of the leaflet: