APOESCITAXIN 10 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
2. What is ApoEscitaxin ORO and what is it used for
3. Important information before taking ApoEscitaxin ORO
   1. When not to take ApoEscitaxin ORO:
   2. Warnings and precautions
   3. Note
   4. Suicidal thoughts and worsening of depression or anxiety disorders
   5. Children and adolescents
   6. ApoEscitaxin ORO and other medicines
   7. ApoEscitaxin ORO with food, drink, and alcohol
   8. Pregnancy, breastfeeding, and fertility
   9. Driving and using machines
   10. ApoEscitaxin ORO contains lactose monohydrate
   11. ApoEscitaxin ORO contains sodium
4. How to take ApoEscitaxin ORO
   1. Use in children and adolescents
   2. Duration of treatment
   3. Taking a higher dose of ApoEscitaxin ORO than recommended
   4. Missing a dose of ApoEscitaxin ORO
   5. Stopping treatment with ApoEscitaxin ORO
5. 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
6. How to store ApoEscitaxin ORO
7. Contents of the pack and other information
   1. What ApoEscitaxin ORO contains
   2. What ApoEscitaxin ORO looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Aurovitas Pharma Polska Sp. z o.o.
   5. Genepharm S.A.
   6. Pharmadox Healthcare Ltd.
   7. Rontis Hellas S.A.
   8. Pharmapath S.A.
   9. Date of last revision of the leaflet: 02/2024

Leaflet attached to the packaging: patient information

ApoEscitaxin ORO, 5 mg, orally disintegrating tablets
ApoEscitaxin ORO, 10 mg, orally disintegrating tablets
ApoEscitaxin ORO, 20 mg, orally disintegrating tablets
Escitalopram

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is ApoEscitaxin ORO and what is it used for

ApoEscitaxin ORO contains the active substance escitalopram. ApoEscitaxin ORO 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. It is thought that disturbances in the serotonin system are involved in the development of depression and related disorders.
ApoEscitaxin ORO contains escitalopram and is used to treat depression (severe depressive episodes), anxiety disorders (such as panic disorder with or without agoraphobia, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder).
It may take several weeks of treatment before you start to feel better. You should continue to take ApoEscitaxin ORO 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 ApoEscitaxin ORO

When not to take ApoEscitaxin ORO:

Warnings and precautions

Before starting to take ApoEscitaxin ORO, you should discuss it with your doctor or pharmacist.
Tell your doctor about all other symptoms or illnesses you have, as they may need to be taken into account. In particular, tell your doctor:

Medicines like ApoEscitaxin ORO (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after the medicine was stopped.

Note

In some patients with bipolar affective disorder, a manic phase may occur. This is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, you should consult your doctor.
In the first few weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still may also occur. If such symptoms occur, you should inform your doctor immediately.

Suicidal thoughts and worsening of depression or anxiety disorders

People with depression and/or anxiety disorders may sometimes have thoughts of self-harm or suicide. These symptoms or behaviors may worsen at the start of treatment with antidepressant medicines, as these medicines start to work usually after about 2 weeks, sometimes later.
These symptoms are more likely to occur in:

• patients who have had suicidal thoughts or self-harm before.
• young adult patients.Clinical trial data have shown an increased risk of suicidal behavior in people under 25 with mental disorders who were treated with antidepressant medicines.

If you experience thoughts of self-harm or suicide, you should contact your doctor or go to the hospital immediately.
It may be helpful to inform a relative or 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 has worsened or if you have any worrying changes in your behavior.

Children and adolescents

ApoEscitaxin ORO should not be used in children and adolescents under 18 years of age. You should also be aware that in patients under 18 years of age taking medicines of this group, there is an increased risk of side effects, such as attempted suicide, suicidal thoughts, and hostility (mainly aggression, rebellious behavior, and signs of anger). However, your doctor may prescribe ApoEscitaxin ORO to patients under 18 years of age if they decide that it is beneficial for them. If your doctor has prescribed ApoEscitaxin ORO to a patient under 18 years of age and you have any doubts, you should contact the doctor again. If a patient under 18 years of age taking ApoEscitaxin ORO experiences or worsens any of the above symptoms, you should inform the doctor. Additionally, the long-term safety of ApoEscitaxin ORO regarding growth, maturation, and cognitive and behavioral development in this age group has not been established yet.

ApoEscitaxin ORO and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Tell your doctor if you are taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs) containing substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If you have taken any of these medicines, you should wait 14 days before starting to take ApoEscitaxin ORO. After stopping ApoEscitaxin ORO, you should wait 7 days before starting to take any of these medicines.
• Reversible, selective monoamine oxidase A (MAO-A) inhibitors, including moclobemide (used to treat depression).
• Irreversible monoamine oxidase B (MAO-B) inhibitors, 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 disorders) and tryptophan.
• Imipramine and desipramine (used to treat depression).
• Sumatriptan and similar medicines (used to treat migraines) and tramadol (used to treat severe pain). These medicines increase the risk of side effects.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase the levels of escitalopram in your blood.
• St. John's Wort (Hypericum perforatum) - a herbal medicine used to treat depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory medicines (used to relieve pain or thin the blood, known as anticoagulants). They may increase the risk of bleeding.
• Warfarin, dipyridamole, and phenprocoumon (used to thin the blood, known as anticoagulants). Your doctor may order a blood test to check your blood clotting time when you start or stop taking ApoEscitaxin ORO to see if your anticoagulant dose is still appropriate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the possible 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, and metoprolol (used to treat heart conditions), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). A dose adjustment of ApoEscitaxin ORO may be necessary.
• Medicines that lower potassium or magnesium levels in the blood, as this may increase the risk of a life-threatening heart rhythm disorder.

Some medicines may increase the side effects of ApoEscitaxin ORO and sometimes may cause very serious reactions. While taking ApoEscitaxin ORO, do not take any other medicines without consulting your doctor first, especially:

• medicines containing buprenorphine. These medicines may interact with ApoEscitaxin ORO and may cause symptoms such as involuntary, rhythmic muscle contractions, including those that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle stiffness, fever above 38°C. If you experience such symptoms, you should contact your doctor.

Do not take ApoEscitaxin ORO at the same time as medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm, such as anti-arrhythmic medicines of class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medicines, especially halofantrine), or certain antihistamines (astemizole, mizolastine).
If you have any further doubts about taking this medicine, you should consult your doctor.

ApoEscitaxin ORO with food, drink, and alcohol

ApoEscitaxin ORO can be taken with or without food (see section 3 "How to take ApoEscitaxin ORO").
As with many medicines, it is not recommended to take ApoEscitaxin ORO with alcohol, although interactions between ApoEscitaxin ORO and alcohol are not expected.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine. You should not take ApoEscitaxin ORO if you are pregnant or breastfeeding unless you have discussed the risks and benefits with your doctor.
If you take ApoEscitaxin ORO during the last 3 months of pregnancy, you should be aware that the newborn may experience the following symptoms: difficulty breathing, blue skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, stiffness or floppiness, increased reflexes, tremors, jitteriness, irritability, lethargy, constant crying, and sleep disturbances. If the newborn experiences any of these symptoms, you should contact your doctor immediately.
You should inform your doctor and/or midwife about taking ApoEscitaxin ORO.
Taking the medicine during pregnancy, especially during the last 3 months, may increase the risk of the newborn developing a serious condition called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and blue skin, and usually occurs in the first day after birth. If such symptoms occur in the newborn, you should contact your doctor and/or midwife immediately.
Do not stop taking ApoEscitaxin ORO during pregnancy without consulting your doctor first.
Taking ApoEscitaxin ORO at the end of pregnancy may increase the risk of severe postpartum hemorrhage, especially if you have a history of bleeding disorders. If you take ApoEscitaxin ORO, you should inform your doctor or midwife so they can give you appropriate advice.
It is assumed that escitalopram passes into breast milk.
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 ApoEscitaxin ORO affects you.

ApoEscitaxin ORO contains lactose monohydrate

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

ApoEscitaxin ORO contains sodium

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

3. How to take ApoEscitaxin ORO

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, you should consult your doctor or pharmacist.
ApoEscitaxin ORO, orally disintegrating tablets, are taken once daily, in a single dose. ApoEscitaxin ORO can be taken with or without food (see section 2 "Important information before taking ApoEscitaxin ORO").
ApoEscitaxin ORO tablets are fragile, so you should handle them carefully. Do not touch the tablets with wet hands, as they may break.

• 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 recommended dose of ApoEscitaxin ORO is 10 mg once daily. Your doctor may increase the dose to a maximum of 20 mg once daily.
Panic disorder (panic attacks)
The initial dose of ApoEscitaxin ORO is 5 mg once daily for the first week of treatment, then the dose is increased to 10 mg once daily. Your doctor may increase the dose to a maximum of 20 mg once daily.
Social phobia
The recommended dose of ApoEscitaxin ORO is 10 mg once daily. Your doctor may reduce the dose to 5 mg once daily or increase it to a maximum of 20 mg once daily, depending on your response to the medicine.
Generalized anxiety disorder
The recommended dose of ApoEscitaxin ORO is 10 mg once daily. Your doctor may increase the dose to a maximum of 20 mg once daily.
Obsessive-compulsive disorder
The recommended dose of ApoEscitaxin ORO is 10 mg once daily. Your doctor may increase the dose to a maximum of 20 mg once daily.
Elderly patients (over 65 years)
The recommended initial dose of ApoEscitaxin ORO is 5 mg once daily. Your doctor may increase the dose to 10 mg once daily.

Use in children and adolescents

ApoEscitaxin ORO is not usually given to children and adolescents. Additional information can be found in section 2 "Important information before taking ApoEscitaxin ORO".

Duration of treatment

You may not feel better until after a few weeks of treatment. Therefore, you should continue to take ApoEscitaxin ORO even if you do not feel better immediately.
Do not change the dose without consulting your doctor first.
Take the medicine for as long as your doctor has prescribed it. If you stop taking the medicine too early, your symptoms may return. It is recommended to continue treatment for at least 6 months after you have started to feel better.

Taking a higher dose of ApoEscitaxin ORO than recommended

If you have taken more ApoEscitaxin ORO than your doctor prescribed, you should contact your doctor or go to the emergency room immediately, even if you do not feel any discomfort. Symptoms of overdose include dizziness, tremors, agitation, seizures, coma, nausea, vomiting, heart rhythm disturbances, decreased blood pressure, and disturbances in water and electrolyte balance. When going to the doctor or hospital, take the ApoEscitaxin ORO packaging with you.

Missing a dose of ApoEscitaxin ORO

Do not take a double dose to make up for a missed dose. If you forget to take a dose and remember before bedtime, you should take the missed dose immediately. Take the next dose the following 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 ApoEscitaxin ORO

Do not stop taking ApoEscitaxin ORO unless your doctor tells you to.
When you stop treatment, it is usually recommended to gradually reduce the dose of ApoEscitaxin ORO over a few weeks.
After stopping ApoEscitaxin ORO, especially if it is stopped abruptly, you may experience withdrawal symptoms. These symptoms often occur when ApoEscitaxin ORO is stopped. The risk is higher if ApoEscitaxin ORO 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. In some patients, however, they may be more severe or longer-lasting (2-3 months or longer). If you experience severe withdrawal symptoms after stopping ApoEscitaxin ORO, you should contact your doctor. Your doctor may recommend that you start taking the medicine again and reduce the dose more slowly.
Withdrawal symptoms include: dizziness (unsteady gait, balance disturbances), tingling sensation, burning sensation, and (less often) a sensation like an electric shock, also in the head, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headaches, nausea (feeling sick), excessive sweating (including night sweats), anxiety or agitation, tremors, confusion or disorientation, mood swings or irritability, diarrhea (loose stools), vision disturbances, heart palpitations or arrhythmias.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, ApoEscitaxin ORO can cause side effects, although not everybody gets them.
Side effects usually disappear after a few weeks of treatment. Remember that some of these side effects may also be symptoms of your illness and will disappear as you get better.

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

Uncommon (less than 1 in 100 people):

• unusual bleeding, including bleeding from the digestive tract.

Rare (less than 1 in 1,000 people):

• skin swelling, tongue, lip, or face swelling, or difficulty breathing or swallowing (allergic reaction)
• high fever, agitation, confusion (disorientation), tremors, and sudden muscle contractions, which may be symptoms of a rare disorder called serotonin syndrome.

Frequency not known (cannot be estimated from the available data):

• difficulty urinating
• seizures, see also section "Warnings and precautions"
• yellowing of the skin and whites of the eyes, which is a sign of liver dysfunction/liver inflammation
• fast or irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsades de pointes
• suicidal thoughts and behaviors, see also section "Warnings and precautions".

The following side effects have also been reported:

Very common (more than 1 in 10 people):

• nausea
• headache.

Common (less than 1 in 10 people):

• nasal congestion or sinusitis (sinus infection)
• decreased or increased appetite
• anxiety, restlessness, vivid dreams, difficulty sleeping, drowsiness, dizziness, yawning, tremors, tingling sensation
• diarrhea, constipation, vomiting, dry mouth
• excessive sweating
• muscle and joint pain
• sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty reaching orgasm in women)
• fatigue, fever
• weight gain.

Uncommon (less than 1 in 100 people):

• hives, rash, itching (itching)
• grinding of the teeth, agitation, nervousness, panic attacks, confusion (disorientation)
• sleep disturbances, taste disturbances, fainting
• pupil dilation, vision disturbances, ringing in the ears (tinnitus)
• hair loss
• heavy menstrual bleeding
• irregular menstrual periods
• weight loss
• rapid heartbeat
• swelling of the arms or legs
• nosebleeds.

Rare (less than 1 in 1,000 people):

• aggression, depersonalization (feeling of losing one's identity, feeling of not being oneself), hallucinations
• slow heartbeat.

Frequency not known (cannot be estimated from the available data):

• decreased sodium levels in the blood (symptoms include nausea and malaise with weakness of muscles and 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 erection of the penis (priapism)
• symptoms of increased bleeding, such as bleeding into the skin and mucous membranes (ecchymoses)
• sudden swelling of the skin or mucous membranes (angioedema)
• increased urine production (inappropriate antidiuretic hormone secretion - SIADH)
• milky discharge from the breasts in men and women who are not breastfeeding
• mania
• patients taking medicines of this group have been observed to have an increased risk of bone fractures
• change in heart rhythm (called "QT interval prolongation", visible on an ECG, a test that assesses heart function).
• heavy postpartum bleeding, see also section "Pregnancy, breastfeeding, and fertility".

The following side effects are also known for medicines with a similar mechanism of action to escitalopram (the active substance of ApoEscitaxin ORO):

• restlessness (inability to stay still, akathisia)
• loss of appetite.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should consult your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, e-mail: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ApoEscitaxin ORO

Keep the medicine out of the sight and reach of children.
Do not take this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated.
The batch number is stated after the word "Lot".
There are no special storage instructions for the medicinal product.
Store in the original packaging to protect from moisture and light.
Medicines should not be disposed of via wastewater or household waste. 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 ApoEscitaxin ORO contains

The active substance is escitalopram.
Each orally disintegrating tablet of ApoEscitaxin ORO contains 5 mg of escitalopram, which corresponds to 6.3875 mg of escitalopram oxalate.
Each orally disintegrating tablet of ApoEscitaxin ORO contains 10 mg of escitalopram, which corresponds to 12.775 mg of escitalopram oxalate.
Each orally disintegrating tablet of ApoEscitaxin ORO contains 20 mg of escitalopram, which corresponds to 25.55 mg of escitalopram oxalate.
The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium carmellose, potassium polacrilin, potassium acesulfame, neohesperidin dihydrochalcone, magnesium stearate, peppermint flavor [containing corn maltodextrin, modified corn starch, and peppermint oil], concentrated hydrochloric acid (for pH adjustment).

What ApoEscitaxin ORO looks like and contents of the pack

ApoEscitaxin ORO, 5 mg: white or almost white, round, flat tablets with beveled edges, 7 mm in diameter, with the number "5" embossed on one side.
ApoEscitaxin ORO, 10 mg: white or almost white, round, flat tablets with beveled edges, 9 mm in diameter, with the number "10" embossed on one side.
ApoEscitaxin ORO, 20 mg: white or almost white, round, flat tablets with beveled edges, 12 mm in diameter, with the number "20" embossed on one side.
ApoEscitaxin ORO is available in packs containing 28 orally disintegrating tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok.27
01-909 Warszawa
Polska
Manufacturer:

Genepharm S.A.

18km Marathon Avenue
15351 Pallini Attikis
Greece

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park
Paola, PLA 3000
Malta

Rontis Hellas S.A.

Medical and Pharmaceutical Products
Industrial Area of Larissa
P.O. Box 3012, GR41004 Larissa
Greece

Pharmapath S.A.

28is Oktovriou 1
Agia Varvara, 123 51
Greece

Date of last revision of the leaflet: 02/2024