Package leaflet: Information for the patient

Depralin, 10 mg, coated tablets
Escitalopram
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any 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.

Table of contents

What Depralin is and what it is used for
Important information before taking Depralin
How to take Depralin
Possible side effects
How to store Depralin
Contents of the pack and other information

1. What Depralin is and what it is used for

Depralin contains escitalopram as the active substance.
Depralin 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. Disturbance of the brain's serotonin system is considered an important 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 (social phobia), generalized anxiety disorder, and obsessive-compulsive disorder].
It may take several weeks of treatment before improvement begins. You should continue taking Depralin even if it takes some time for your condition to improve.
If no improvement occurs, or if you feel worse, consult your doctor.

2. Information before using Depralin

When not to use Depralin

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 monoamine oxidase inhibitors (MAOIs), 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 or has ever had an abnormal heart rhythm (visible on ECG; a test used to assess heart function)
if the patient is taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see section 2 "Depralin with other medicines").

Warnings and precautions
Before starting treatment with Depralin, discuss this with your doctor or pharmacist. You should
inform your doctor if the patient has any other disorders or diseases, as these may need to be taken
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 Depralin should be discontinued (see also section 4 "Possible side effects").
the patient has impaired liver or kidney function. The doctor may need to adjust the dosage.
the patient has diabetes. Treatment with Depralin may alter blood glucose control. Adjustment of insulin and/or oral antidiabetic drugs may be necessary.
the patient has low sodium levels in the blood.
the patient has an increased tendency to bleed or bruise, or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility").
the patient is undergoing electroconvulsive therapy.
the patient has ischemic heart disease.
the patient has heart disorders or has had a recent myocardial infarction.
the patient has a slow resting heart rate and/or may develop electrolyte imbalances due to prolonged, persistent diarrhoea and vomiting or use of diuretics.
the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart function.
the patient has or has had eye problems, such as certain types of glaucoma (increased pressure inside the eye).
the patient has acute or chronic pain requiring treatment with buprenorphine. Using this medicine together with Depralin may lead to serotonin syndrome, a potentially life-threatening condition (see section "Depralin with other medicines").

Note
In some patients with bipolar affective disorder, a manic phase may occur. It is characterised by
unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical
activity. If these symptoms occur, consult a 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 the doctor immediately.
Medicines such as Depralin (so-called SSRIs) may cause sexual dysfunction symptoms (see section 4).
In some cases, these symptoms persisted after discontinuation of treatment.
Suicidal thoughts and worsening of depression or anxiety symptoms
If the patient has depression and/or anxiety disorders, they may sometimes have thoughts about
self-harm or suicide. These thoughts may worsen at the beginning of treatment with antidepressants,
as these medicines usually start working after about 2 weeks, sometimes later.
The likelihood of such thoughts is higher if:

the patient has previously experienced suicidal or self-harming thoughts;
the patient is a young adult. Clinical trial data indicate an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who were treated with antidepressant medicines.

If the patient ever experiences suicidal thoughts or thoughts of self-harm, seek immediate medical
attention from a doctor or go to hospital.
It may be helpful to tell a family member or friend about the depression or anxiety disorder and ask
them to read this leaflet. The patient may ask them to inform him or her if they notice worsening of
depression or anxiety symptoms or concerning changes in behaviour.
Children and adolescents
Depralin should generally not be used in children and adolescents under 18 years of age. It should be
noted that in patients under 18 years of age taking medicines from this group, there is an increased
risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (particularly
aggression, defiant behaviour, and anger). Nevertheless, the doctor may prescribe Depralin to
patients in this age group if deemed necessary.
If the doctor has prescribed Depralin to a patient under 18 years of age and you have any doubts,
consult the doctor again. Contact the treating doctor if any of the above-mentioned symptoms occur
or worsen in patients under 18 years of age taking Depralin. The long-term safety of Depralin with
regard to effects on growth, maturation, and cognitive and behavioural development in this age
group has not yet been established.
Depralin with other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to
be taken by the patient.
Inform the doctor if the patient is taking any of the following medicines:

Non-selective monoamine oxidase inhibitors (MAOIs) containing as active substances: phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine. If any of these are being used, wait 14 days before starting Depralin. After stopping Depralin, wait 7 days before starting any of these medicines.
Selective, reversible MAO-A inhibitors, including moclobemide (used in the treatment of depression).
Irreversible MAO-B inhibitors, including selegiline (used in the treatment of Parkinson's disease). These medicines increase the risk of adverse reactions.
The antibiotic linezolid.
Lithium (used in the treatment of bipolar disorder) and tryptophan.
Imipramine and desipramine (used in the treatment of depression).
Sumatriptan and similar medicines (used in the treatment of migraine) and tramadol, buprenorphine (opioid medicines used in the treatment of acute or chronic pain). Do not use escitalopram together with these medicines without prior consultation with a doctor. These medicines may interact with Depralin and may cause symptoms such as involuntary, rhythmic muscle contractions, including those affecting eye movements, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tone, body temperature above 38°C. If such symptoms occur, contact the doctor.
Cimetidine, lansoprazole, and omeprazole (used in the treatment of peptic ulcer disease), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase the blood concentration of Depralin.
St. John's wort (Hypericum perforatum) – a herbal remedy used in the treatment of depression.
Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to treat pain or to thin the blood, so-called anticoagulants). These medicines may increase the tendency to bleed.
Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so-called anticoagulants). The doctor will likely monitor blood clotting time before starting and after stopping treatment with Depralin to ensure the dose of anticoagulant remains 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.
Neuroleptics (used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the risk of lowering the seizure threshold.
Flecainide, propafenone, metoprolol (used in cardiovascular diseases), desipramine, clomipramine, and nortriptyline (antidepressants), risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Depralin may be necessary.
Medicines that lower blood potassium or magnesium levels, due to the increased risk of life-threatening heart rhythm disturbances.

Do not use Depralin if the patient is taking medicines used for heart rhythm disorders or
medicines affecting heart rhythm, such as class IA and III antiarrhythmics, antipsychotics (e.g.
phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibiotics (e.g.
sparfloxacin, moxifloxacin, IV erythromycin, pentamidine), antimalarial medicines (especially
halofantrine), or certain antihistamines (astemizole, mizolastine). If in doubt, consult the treating
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, alcohol consumption is not recommended during treatment with
Depralin, although no interaction with alcohol is expected.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor before using this medicine.
Do not use Depralin if the patient is pregnant or breastfeeding unless the doctor has discussed the
risks and benefits of treatment with her.
Pregnancy
Taking Depralin towards the end of pregnancy may increase the risk of severe vaginal bleeding
shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient
is taking Depralin, she should inform her doctor or midwife so they can provide appropriate advice.
If the patient takes Depralin during the last three months of pregnancy, she should be aware that the
newborn may experience the following symptoms: breathing difficulties, cyanosis, seizures,
temperature fluctuations, feeding difficulties, vomiting, low blood sugar, muscle stiffness or
flaccidity, increased reflexes, tremor, jitteriness, irritability, lethargy, constant crying, drowsiness, or
difficulty sleeping. If any of these symptoms occur in the newborn, contact the doctor immediately.
Ensure that the midwife and/or doctor know that the patient is taking Depralin.
Taking Depralin during pregnancy, especially during the last three months, may increase the risk of
a serious condition in the child called persistent pulmonary hypertension of the newborn (PPHN).
This causes rapid breathing and bluish skin in the newborn. These symptoms usually appear within
the first 24 hours after birth. If the patient notices these symptoms in her child, contact the midwife
and/or doctor immediately.
Do not abruptly stop taking Depralin during pregnancy.
Breastfeeding
Depralin is expected to pass into breast milk.
Fertility
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces semen
quality. This may theoretically affect fertility, although no effect on fertility has been observed in
humans to date.
Driving and operating machinery
Do not drive or operate machinery until the patient knows how Depralin affects them.
Depralin contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is
considered "sodium-free".

3. How to use Depralin

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Adults
Depression
The usual dose is 10 mg once daily. Your doctor may increase the dose up to the maximum dose of 20 mg per day.

Anxiety disorder with panic attacks (panic anxiety)
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 up to the maximum dose of 20 mg per day.

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

Generalized anxiety disorder
The usual recommended dose of Depralin is 10 mg once daily. Your doctor may increase the dose up to the maximum dose of 20 mg per day.

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

Elderly patients (over 65 years of age)
The recommended initial dose of Depralin is 5 mg once daily. The treating doctor may increase the dose to 10 mg once daily.

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

Depralin may be taken with or without food. Swallow the tablet with water. Do not chew the tablets, as they have a bitter taste.

If necessary, the tablet may be divided. To do this, place the tablet on a flat, even surface with the score line facing upwards. The tablet can then be broken by pressing down with the index fingers of both hands on each end.

Duration of treatment
It may take several weeks of treatment before the patient starts to feel better. Therefore, continue taking the medicine even if there is no immediate improvement in well-being.

Never change the dose of the medicine without first consulting your doctor.

Continue taking Depralin for as long as your doctor has instructed. If treatment is stopped too early, symptoms may return. It is recommended that treatment continues for at least 6 months after improvement occurs.

Taking more Depralin than prescribed
If you have taken more Depralin than prescribed, contact your doctor immediately or go to the nearest hospital emergency department. Do this even if you do not have any symptoms. Some symptoms of overdose include: dizziness, tremor, agitation, seizures, coma, nausea, vomiting, irregular heartbeat, low blood pressure, and disturbances in the body's water-electrolyte balance. When going to the doctor or hospital, bring the medicine pack (box) of Depralin with you.

Missed dose of Depralin
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. Take the next dose at the usual time the following day. 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 Depralin
Do not stop treatment with Depralin unless your doctor advises you to do so.

When ending a prescribed course of treatment, it is usually recommended to gradually reduce the dose of Depralin over several weeks.

If you stop taking Depralin, especially abruptly, you may experience withdrawal symptoms. This commonly occurs when treatment with Depralin is discontinued. The risk is greater if the medicine has been taken for a long time or in high doses, or if the dose is reduced too quickly. In most patients, symptoms are mild and resolve spontaneously within two weeks. However, in some patients, symptoms may be severe and last longer (2 to 3 months or more). If you experience severe withdrawal symptoms, contact your doctor. The doctor may advise you to restart taking the medicine and then taper it more slowly.

Withdrawal symptoms may include: dizziness (unsteady gait, balance disturbances), tingling, pricking sensations, burning sensations, and (less commonly) an electric shock-like sensation, also in the head; sleep disturbances (vivid dreams, nightmares, insomnia); anxiety, headache, nausea, excessive sweating (including night sweats), restlessness or agitation, tremor, confusion and disorientation, emotional instability or irritability, diarrhoea (loose stools), visual disturbances, palpitations (fluttering or pounding heart).

If you have any further questions about 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 usually subside after a few weeks of treatment. It is important to be aware that
many symptoms may also be symptoms of the illness being treated and will resolve as your
condition improves.

If any of the following adverse reactions occur during treatment, you should
contact your doctor or go to hospital immediately:

Uncommon (may affect less than 1 in 100 patients):

Abnormal bleeding, including gastrointestinal bleeding.

Rare (may affect less than 1 in 1000 patients):

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

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

Difficulty urinating.
Seizures (see also section "Warnings and precautions").
Yellowing of the skin and whites of the eyes, which may indicate liver dysfunction and/or hepatitis.
Rapid or irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsade de pointes.
Suicidal thoughts and behaviour (see also section "Warnings and precautions").
Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage); see additional information in subsection "Pregnancy, breastfeeding and fertility" in section 2.

In addition to the above, the following adverse reactions have been reported:

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

Nausea.
Headache.

Common (may affect less than 1 in 10 patients):

Stuffy nose or runny nose (sinusitis).
Increased or decreased appetite.
Anxiety, restlessness, unusual dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, tingling sensation in the skin.
Diarrhoea, constipation, vomiting, dry mouth.
Increased sweating.
Muscle and joint pain.
Sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, difficulty achieving orgasm in women).
Feeling of fatigue, fever.
Weight gain.

Uncommon (may affect less than 1 in 100 patients):

Urticaria, rash, itching.
Teeth grinding, agitation, nervousness, panic attacks, confusion.
Sleep disturbances, taste disturbances, fainting.
Pupil dilation, visual disturbances, tinnitus.
Hair loss.
Heavy menstrual bleeding.
Irregular menstruation.
Weight loss.
Rapid heartbeat.
Swelling of hands or feet.
Nosebleeds.

Rare (may affect less than 1 in 1000 patients):

Aggression, depersonalisation (feeling of detachment from oneself), hallucinations.
Slow heartbeat.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

Low blood sodium levels (symptoms may include nausea, malaise, muscle weakness or confusion).
Dizziness upon standing due to low blood pressure (orthostatic hypotension).
Abnormal liver function test results (increased liver enzyme activity in blood).
Movement disorders (involuntary muscle movements).
Painful and prolonged erection (priapism).
Bleeding, including under the skin and mucous membranes (petechiae), and reduced platelet count (thrombocytopenia).
Sudden swelling of the skin and mucous membranes (angioedema).
Increased urine production (due to abnormal antidiuretic hormone [vasopressin] secretion).
Galactorrhoea (milk production) in men and in women who are not breastfeeding.
Mania.
In patients taking medicines of this class, an increased risk of bone fractures has been observed.
Changes in heart rhythm (known as "QT interval prolongation", visible on ECG, a test assessing the electrical activity of the heart).

Additionally, adverse reactions known from other medicines with a similar mechanism of action to escitalopram (the active substance in Depralin) include:

Restless movement (akathisia).
Loss of appetite.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Depralin

Keep the medicine out of the sight and reach of children.
No special storage conditions apply for this medicine.
Do not use this medicine after the expiry date stated on the outer carton.
The expiry date refers to the last day of the stated month.
The label on the packaging shows EXP indicating the expiry date, and Lot/LOT indicating the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Depralin contains

The active substance in Depralin is escitalopram. Each Depralin tablet contains 10 mg of escitalopram (as oxalate).
The other ingredients are: Tablet core: microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, 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 breakline on one side. The tablet can be divided into equal doses.
Depralin is available in packs containing 28 tablets.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
HBM Pharma s r.o.
Sklabinská 30
036 80 Martin, Slovakia