Package leaflet: Information for the patient

Depralin ODT, 5 mg, orodispersible tablets
Depralin ODT, 10 mg, orodispersible tablets
Depralin ODT, 20 mg, orodispersible 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 questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

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

Depralin ODT belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonergic system in the brain by increasing the concentration of serotonin. Dysfunction of the serotonergic system in the brain is considered an important factor in the development of depression and associated disorders.
Depralin ODT contains escitalopram and is used in the treatment of depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder (social phobia), generalized anxiety disorder, obsessive-compulsive disorder).
It may take several weeks of treatment before improvement begins. You should continue taking Depralin ODT even if it takes some time before your condition improves.
If there is no improvement or if you feel worse, consult your doctor.

2. Important information before using Depralin ODT

When not to use Depralin ODT

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 MAO inhibitors, including selegiline (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression), or linezolid (an antibiotic);
if the patient was born with a congenital abnormal heart rhythm or if the patient has experienced an episode of abnormal heart rhythm (visible on ECG – a test assessing 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 ODT and other medicines").

Warnings and precautions
Before starting treatment with Depralin ODT, discuss this with your doctor or pharmacist.
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. Treatment with Depralin ODT should be discontinued if seizures occur or if the frequency of seizures increases (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 ODT may interfere with blood glucose control. A change in insulin and/or oral antidiabetic medication dosage 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 current or previous heart conditions, or if the patient recently suffered a myocardial infarction;
the patient has a low resting heart rate and/or if electrolyte imbalances may occur due to prolonged, persistent diarrhoea and vomiting or use of diuretics;
the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness when standing, which may indicate abnormal heart function;
the patient has current or previous eye problems, such as certain types of glaucoma (increased pressure inside the eyeball);
the patient has chronic pain requiring treatment with buprenorphine. Concurrent use of this medicine with Depralin ODT may lead to serotonin syndrome, a potentially life-threatening condition (see section "Depralin ODT and other medicines").

Note
In some patients with bipolar disorder (manic-depressive illness), a manic phase may occur.
It is characterized by unusual, rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If any of the above symptoms occur, contact your doctor.
During the first weeks of treatment, the patient may experience symptoms such as motor restlessness or inability to sit or stand still. If such symptoms occur, inform the doctor immediately.
Medicines such as Depralin ODT (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (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 of self-harm or suicide. These may worsen at the beginning of treatment with antidepressants, as these medicines usually start to work after about 2 weeks, and sometimes even longer.
The likelihood of such thoughts is higher if:

the patient previously experienced suicidal thoughts or self-harm;
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, contact a doctor immediately or go to hospital.
It may be helpful to inform a family member or close friend about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to inform him/her if they notice worsening of depression or anxiety symptoms or concerning changes in behaviour.
Children and adolescents
Depralin ODT 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 is associated with a higher risk of adverse reactions, such as suicide attempts and suicidal thoughts, as well as hostility (particularly aggression, defiant behaviour, and expressions of anger). Nevertheless, the doctor may prescribe Depralin ODT to patients in this age group if deemed necessary. If your doctor has prescribed Depralin ODT to a patient under 18 years of age and you have any doubts, consult your doctor again. Contact the treating doctor if any of the above symptoms occur or worsen in patients under 18 years of age taking Depralin ODT. Long-term safety of Depralin ODT regarding effects on growth, maturation, and cognitive and behavioural development has not been established in this age group.
Depralin ODT and other medicines
Inform your doctor about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.
Inform your doctor if the patient is taking any of the following medicines:

Non-selective monoamine oxidase inhibitors (MAOIs), containing as active substance: phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine. If any of these are being used, wait 14 days before starting Depralin ODT. After discontinuation of Depralin ODT, wait 7 days before starting any of the above-mentioned 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 effects.
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). Escitalopram should not be used together with these medicines without prior consultation with a doctor. These medicines may interact with Depralin ODT and may cause symptoms such as involuntary, rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, body temperature above 38°C. If such symptoms occur, contact your doctor.
Cimetidine, lanzoprazole and omeprazole (used in the treatment of peptic ulcer disease), fluconazole (used in the treatment of fungal infections), fluvoxamine (an antidepressant) and ticlopidine (used to reduce the risk of stroke). The above medicines may increase the blood concentration of Depralin ODT.
St. John's wort ( Hypericum perforatum ) – a herbal medicine 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 ODT to ensure the dose of anticoagulant remains appropriate.
Mefloquine (used in the treatment of malaria), bupropion (used in the treatment of depression) and tramadol (used in the treatment of severe pain) due to the risk of lowering the seizure threshold.
Neuroleptics (used in the treatment of 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 ODT may be necessary.
Medicines that may reduce potassium or magnesium levels in the blood, due to increased risk of life-threatening heart rhythm disturbances.

Do not use Depralin ODT 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, erythromycin IV, pentamidine), antimalarials (particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further doubts, consult your treating 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, alcohol consumption is not recommended during treatment with Depralin ODT, 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 her doctor before using this medicine.
Do not use Depralin ODT if the patient is pregnant or breastfeeding unless the doctor has discussed the risks and benefits of treatment with her.
Pregnancy
Taking Depralin ODT towards the end of pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Depralin ODT, she should inform her doctor or midwife so they can provide appropriate advice.
If the patient takes Depralin ODT 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 floppiness, increased reflexes, tremor, jitteriness, lethargy, irritability, constant crying, drowsiness or difficulty sleeping. If any of the above symptoms occur in the newborn, contact a doctor immediately.
Ensure that the midwife and/or doctor know that the patient is taking Depralin ODT.
Taking Depralin ODT during pregnancy, especially during the last three months, may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN). This causes rapid breathing and bluish skin colouration in the newborn. These symptoms usually appear within the first 24 hours after birth. If the patient notices these symptoms in the newborn, she should report them immediately to the midwife and/or doctor.
Do not abruptly discontinue Depralin ODT during pregnancy.
Breastfeeding
Depralin ODT 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 ODT affects him.
Depralin ODT contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, consult a doctor before taking Depralin ODT.
Depralin ODT contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Depralin ODT

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Depralin ODT, orally disintegrating tablets, should be taken daily as a single dose. The medicine should not be taken with food.
Orally disintegrating tablets are fragile and should therefore be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.

Holding the blister pack by the edges, carefully separate one tablet from the rest of the strip by gently tearing along the perforation.
Carefully peel back the backing foil.
Place the tablet on the tongue. The tablet will dissolve very quickly and can be swallowed without water.

Three instruction diagrams: 1. peeling open the packaging, 2. removing the tablet from the blister pack, 3. placing the tablet into open mouth

Adults
Depression
The usual dose is 10 mg once daily. Your doctor may increase the dose to the maximum dose of 20 mg once daily.
Anxiety disorder with panic attacks (panic disorder)
The recommended starting 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 increasing the dose up to the maximum dose of 20 mg once daily.
Social phobia
The usual recommended dose of Depralin ODT 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 once daily.
Generalized anxiety disorder
The usual recommended dose of Depralin ODT is 10 mg once daily. Your doctor may increase the dose up to the maximum dose of 20 mg once daily.
Obsessive-compulsive disorder
The usual recommended dose of Depralin ODT is 10 mg once daily. Your doctor may increase the dose up to the maximum dose of 20 mg once daily.
Elderly patients (aged over 65 years)
The recommended starting dose of Depralin ODT is 5 mg once daily. The treating doctor may increase the dose to 10 mg once daily.
Children and adolescents
Depralin ODT should generally not be used in children and adolescents. For additional information, see section 2, "Important information before taking Depralin ODT".
Duration of treatment
It may take several weeks of treatment before the patient feels better. Therefore, continue taking the medicine even if there is no improvement in well-being at first.
Never change the dose of this medicine without first consulting your doctor.
Treatment with Depralin ODT should be continued for as long as your doctor recommends. 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 than the prescribed dose of Depralin ODT
If you have taken more than the prescribed dose of Depralin ODT, contact your doctor immediately or go to the nearest hospital emergency department. This should be done even if you have no symptoms. Some symptoms of overdose include: dizziness, tremor, agitation, seizures, coma, nausea, vomiting, heart rhythm disturbances, low blood pressure, and disturbances in the body's water and electrolyte balance. Take the medicine pack (box) of Depralin ODT with you to the doctor's office or hospital.
Missed dose of Depralin ODT
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 at night or the next day, skip the missed dose and take the next dose at the usual time.
Stopping treatment with Depralin ODT
Do not stop treatment with Depralin ODT unless your doctor advises you to do so.
When ending a prescribed course of treatment, it is generally recommended to gradually reduce the dose of Depralin ODT over several weeks.
If you stop taking Depralin ODT, especially if the discontinuation is sudden, you may experience withdrawal symptoms. These are commonly observed when treatment with escitalopram is stopped. The risk is greater 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, 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. Your doctor may advise you to restart taking the medicine and then taper it off more slowly.
Withdrawal symptoms 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, diarrhea (loose stools), visual disturbances, palpitations (fluttering or pounding of the heart).
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not everyone will experience them.
Adverse effects usually subside after a few weeks of treatment. It should be noted that
many symptoms may also be symptoms of the illness being treated and will resolve as the
patient's condition improves.

If any of the following adverse effects occur during treatment, contact a doctor or go immediately to hospital:

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

Abnormal bleeding, including gastrointestinal bleeding.

Rare (may occur in 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 sudden muscle contractions,
which may be symptoms of a rare condition called serotonin syndrome.

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

Difficulty passing urine
Seizures (see also "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 those listed above, the following adverse effects have also been reported:

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

Nausea
Headache.

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

Stuffy nose or cold-like symptoms (sinusitis)
Increased or decreased appetite
Anxiety, restlessness, unusual dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, skin tingling
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 occur in less than 1 in 100 patients):

Hives, 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 occur in less than 1 in 1000 patients):

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

Adverse effects 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 tests (increased liver enzyme activity in blood)
Movement disorders (involuntary muscle movements)
Painful and prolonged erection (priapism)
Symptoms of increased tendency to bleed in the skin and mucous membranes (petechiae) and decreased platelet count (thrombocytopenia)
Sudden swelling of the skin and mucous membranes (angioedema)
Increased urine output (inappropriate antidiuretic hormone secretion - vasopressin)
Milk production in men and 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 (electrocardiogram)).

In addition, adverse effects known to occur with medicines having a similar mechanism of action to escitalopram (the active substance in Depralin ODT) include:

Restlessness (akathisia)
Loss of appetite.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Depralin ODT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box.
The expiry date refers to the last day of the stated month.
The labelling on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot.
No special temperature storage instructions are required; store in the original packaging to protect from moisture and light.
Medicines must not be disposed of via sewage systems or household waste. Ask a 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 Depralin ODT contains

The active substance 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.
Other ingredients are: microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, potassium polyacrylate, potassium acesulfame, neohesperidine dihydrochalcone, magnesium stearate, peppermint flavour containing maltodextrin (corn), modified starch and peppermint oil; concentrated hydrochloric acid.

What Depralin ODT looks like and contents of the pack
Depralin ODT 5 mg: round, white or almost white, flat tablet with bevelled edges, 7 mm in diameter, with the number "5" embossed on one side.
Depralin ODT 10 mg: round, white or almost white, flat tablet with bevelled edges, 9 mm in diameter, with the number "10" embossed on one side.
Depralin ODT 20 mg: round, white or almost white, flat tablet with bevelled edges, 12 mm in diameter, with the number "20" embossed on one side.
Depralin ODT is available in packs of 7, 28, 30 and 90 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne 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 medicinal product is authorised in the European Economic Area countries 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

Depralin odt