Esscitaxin

Leaflet accompanying the packaging: patient information

Esscitaxin, 10 mg, coated tablets

Esscitaxin, 20 mg, coated tablets

Escitalopram

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet

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

1. What is Esscitaxin and what is it used for

Esscitaxin contains the active substance escitalopram.
Esscitaxin belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain, increasing serotonin levels. Disruption of the serotonin system in the brain is thought to be an important factor in the development of depression and related disorders.
Esscitaxin is used to treat depression (major depressive episodes) and 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 Esscitaxin 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 Esscitaxin

When not to take Esscitaxin

Warnings and precautions

Before starting treatment with Esscitaxin, you should discuss it with your doctor or pharmacist.
You should tell your doctor if you have any other disorders or diseases, as they may need to be taken into account. In particular, you should inform your doctor if:

• you have epilepsy. If you experience a seizure for the first time or if the frequency of seizures increases, you should stop taking Esscitaxin (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 Esscitaxin 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 (a psychiatric treatment that uses electric currents to relieve severe depression or bipolar disorder by inducing controlled seizures in the brain under anesthesia).
• you have coronary heart disease.
• you have or have had heart problems, 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).

Caution

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, 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 Esscitaxin (so-called SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after treatment was stopped.

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 such thoughts is higher if:

• you have had suicidal thoughts or self-harm in the past;
• you are a young adult. Information from clinical trials indicates 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 disorderand ask them to read this leaflet. You may want to ask them to tell you if they notice that your depression or anxiety symptoms worsen or if you experience disturbing changes in behavior.

Children and adolescents

Esscitaxin should not normally be used in children and adolescents under 18 years of age. You should remember that in patients under 18 years of age who are taking medicines of this group, there is a greater risk of side effects, such as suicidal attempts and suicidal thoughts, as well as hostility (especially aggression, rebellious behavior, and expressions of anger). However, your doctor may prescribe Esscitaxin to patients in this age group if they consider it necessary.
If your doctor has prescribed Esscitaxin to a patient under 18 years of age and you have concerns, you should consult your doctor again.
You should contact the treating doctor if any of the above symptoms occur or worsen in patients under 18 years of age taking Esscitaxin. The long-term safety of Esscitaxin regarding its impact on growth, maturation, and cognitive and behavioral development in this age group has not been established yet.

Esscitaxin and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should inform your doctor if you are taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine. If you are taking any of these, you should wait 14 days before starting to take Esscitaxin. After stopping Esscitaxin, you should wait 7 days before starting to take 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 migraines) and tramadol (opioid medicines used to treat acute or chronic pain). These medicines increase the risk of side effects.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (a medicine used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase the levels of Esscitaxin in the blood.
• St. John's Wort (Hypericum perforatum) - a herbal medicine used to treat depression.
• Acetylsalicylic acid and nonsteroidal 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 Esscitaxin 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), clomipramine, and nortriptyline (antidepressants), risperidone, thioridazine, and haloperidol (antipsychotics). It may be necessary to adjust the dose of Esscitaxin.
• Medicines that lower potassium or magnesium levels in the blood, due to the increased risk of life-threatening heart rhythm disorders.

You should not take Esscitaxin if 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, hydroxyzine, mizolastine). If you have any further doubts, you should consult your doctor.

Esscitaxin with food, drink, and alcohol

Like many other medicines, it is not recommended to drink alcohol while taking Esscitaxin, although no interaction with alcohol is expected.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
You should not take Esscitaxin if you are pregnant or breastfeeding, unless your doctor has discussed the risks and benefits of taking the medicine with you.
Pregnancy
If you take Esscitaxin during the last three months of pregnancy, you should be aware that the following symptoms may occur in the newborn: breathing difficulties, blue discoloration of the skin, seizures, fluctuations in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, increased reflexes, trembling, shaking, irritability, lethargy, constant crying, or sleepiness. If the newborn experiences any of these symptoms, you should immediately contact your doctor.
You should ensure that your midwife and/or doctor know that you are taking Esscitaxin.
Taking Esscitaxin 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 blue discoloration of the skin in the newborn. These symptoms usually appear within the first 24 hours after birth. If you notice these symptoms in your baby, you should immediately inform your midwife and/or doctor.
Taking Esscitaxin at the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. If you take Esscitaxin, you should inform your doctor or midwife so that they can provide you with appropriate advice.
You should not stop taking Esscitaxin suddenly during pregnancy.
Breastfeeding
It is assumed that Esscitaxin passes into human milk.
Fertility
In animal studies, it has been shown that citalopram, a medicine similar to escitalopram, reduces sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans yet.

Driving and using machines

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

Esscitaxin 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 Esscitaxin

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, you should consult 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 with or without agoraphobia

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

Social phobia

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

Elderly patients (over 65 years of age)

The recommended initial dose of Esscitaxin is 5 mg (half a 10 mg tablet) once daily. Your doctor may increase the dose to 10 mg once daily.

Children and adolescents

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

Renal impairment

Caution should be exercised in patients with severe renal impairment. The medicine should be taken as directed by your doctor.

Hepatic impairment

Patients with hepatic impairment should not take more than 10 mg once daily. The medicine should be taken as directed by your doctor.

Patients who are poor metabolizers of medicines via the CYP2C19 enzyme

Patients with this known genotype should not take more than 10 mg once daily. The medicine should be taken as directed by your doctor.

How to take Esscitaxin

Esscitaxin 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.

Duration of treatment

It may take several weeks of treatment before you feel better. Therefore, you should continue to take the medicine, even if you do not feel better immediately. You should never change the dose of the medicine without consulting your doctor first.
You should continue to take Esscitaxin for as long as your doctor has prescribed. If you stop treatment too early, your symptoms may return. It is recommended that treatment be continued for at least 6 months after you start to feel better.

Taking more than the prescribed dose of Esscitaxin

If you have taken more than the prescribed dose of Esscitaxin, you should immediately contact your doctor or go to the emergency department of the nearest hospital. You should do this even if you do not feel any symptoms. Some of the symptoms of overdose are dizziness, trembling, restlessness, seizures, coma, nausea, vomiting, heart rhythm disorders, low blood pressure, and electrolyte disturbances. You should take the packaging (box/blister) of Esscitaxin with you to the doctor or hospital.

Missing a dose of Esscitaxin

You should not take a double dose of the medicine to make up for a missed dose. If you have missed 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 Esscitaxin

You should not stop taking Esscitaxin without consulting your doctor first.
When you finish the prescribed treatment cycle, it is usually recommended to gradually reduce the dose of Esscitaxin over several weeks.
If you stop taking Esscitaxin, especially suddenly, you may experience withdrawal symptoms. This happens often when treatment with Esscitaxin 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, numbness, and burning sensations, as well as (less often) electric shock sensations, also in the head, sleep disturbances (vivid dreams, nightmares, insomnia), anxiety, headaches, nausea, excessive sweating (including night sweats), restlessness or agitation, trembling, confusion, and disorientation, mood swings or irritability, diarrhea (loose stools), vision disturbances, and palpitations (heart palpitations).
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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, throat, or face, or difficulty breathing or swallowing (allergic reaction)
• High fever, restlessness, confusion, trembling, 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 symptom 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"
• Sudden swelling of the skin or mucous membranes (angioedema).

In addition to the above, the following side effects have been reported for medicines with a similar mechanism of action to escitalopram (the active substance of Esscitaxin):

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

• Nausea
• Headache.

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

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

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

• Hives, rash, itching
• Grinding of the teeth, restlessness, agitation, panic attacks, confusion
• Sleep disturbances, taste 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 and persistent erection (priapism)
• Bleeding, including skin and mucous membrane bleeding (ecchymoses) and decreased platelet count (thrombocytopenia)
• Increased secretion of antidiuretic hormone (ADH), leading to water retention in the body, dilutional hyponatremia, and decreased sodium levels
• Milk secretion in men and women who are not breastfeeding
• Mania
• In patients taking medicines of this group, an increased risk of fractures has been observed
• Changes in heart rhythm (so-called QT interval prolongation, visible on an ECG, a test that evaluates the electrical activity of the heart)
• Severe vaginal bleeding shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2.

In addition to the above, the following side effects are known for medicines with a similar mechanism of action to escitalopram (the active substance of Esscitaxin):

• 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 report side effects directly to the Department of Monitoring of Adverse Reactions to 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 Esscitaxin

The medicine should be stored out of sight and reach of children.
You should not take this medicine after the expiry date stated on the carton, blister, or bottle. The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Esscitaxin contains

• The active substance of Esscitaxin is escitalopram. Each tablet contains 10 mg or 20 mg of escitalopram (as oxalate).
• The other ingredients are: Tablet core: microcrystalline cellulose, sodium carboxymethylcellulose, talc, anhydrous colloidal silica, magnesium stearate. Tablet coating: hypromellose (E464), titanium dioxide (E171), talc, macrogol 400.

What Esscitaxin looks like and contents of the pack

Esscitaxin is available as coated tablets containing 10 mg or 20 mg of escitalopram (as oxalate). Below is a description of the tablets.
Esscitaxin 10 mg: white to off-white, oval, biconvex, coated tablet with a diameter of 7.8 x 5.3 - 8.2 x 5.7 mm with the inscription "C4" on one side and a dividing line on the other side. The tablet can be divided into equal doses.

Esscitaxin 20 mg: white to off-white, oval, biconvex, coated tablet with a diameter of 11.3 x 6.8 -11.7 x 7.2 mm with the inscription "C3" on one side and a dividing line on the other side. The tablet can be divided into equal doses.

Esscitaxin 10 mg and 20 mg coated tablets are available in transparent blisters of PVDC/PVC/Aluminum, packed in cardboard boxes containing 20, 28, 30, 50, 56, 60, 84, 90, 98, or 100 coated tablets.
Esscitaxin 10 mg and 20 mg coated tablets are available in HDPE bottles with a PP cap with a child-resistant closure containing 28, 30, 50, 100, or 500 coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
phone: +48 17 865 51 00

Importer

Misom Labs Ltd.
Malta Life Sciences Park
LS 2.01.06, Industrial Estate
SGN 3000, San Gwann, Malta

Date of last revision of the leaflet: