Esscitaxin

Package Leaflet: Information for the Patient

Esscitaxin, 10 mg, Film-Coated Tablets

Esscitaxin, 20 mg, Film-Coated Tablets

Escitalopram

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

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you; do not pass it on to others. The medication may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Package 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 pack 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 medications called selective serotonin reuptake inhibitors (SSRIs). These medications work on the serotonin system in the brain by 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 the patient starts to feel better. The patient should continue taking Esscitaxin even if they do not feel better immediately. If there is no improvement or if the patient feels worse, they should consult their doctor.

2. Important information before taking Esscitaxin

When Not to Take Esscitaxin

• If the patient is allergic to escitalopram or any of the other ingredients of this medication (listed in section 6).
• If the patient is taking other medications that belong to a group called monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).
• If the patient has an abnormal heart rhythm (visible on an ECG, a test that evaluates heart function).
• If the patient is taking medications used to treat heart rhythm disorders or medications that may affect heart rhythm (see section 2 "Esscitaxin and other medications").

Warnings and Precautions

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

• The patient has epilepsy. If the patient experiences seizures for the first time or if the frequency of seizures increases, they should stop taking Esscitaxin (see also section 4 "Possible side effects").
• The patient has liver or kidney function disorders. The doctor may need to adjust the dosage.
• The patient has diabetes. Treatment with Esscitaxin may affect blood sugar control. The patient may need to adjust their insulin or oral antidiabetic medication dosage.
• 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 (a psychiatric treatment that uses electric currents to alleviate severe depression or bipolar disorder by inducing controlled seizures in the brain under anesthesia).
• The patient has coronary heart disease.
• The patient has or has had heart disease, or if the patient has recently had a heart attack.
• The patient has low resting heart rate and/or may experience electrolyte disturbances due to prolonged, persistent diarrhea and vomiting or the use of diuretic medications.
• The patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness when standing, which may indicate abnormal heart function.
• The patient has or has had eye problems, such as certain types of glaucoma (increased pressure within 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, the patient should consult their doctor.
In the first few weeks of treatment, the patient may also experience symptoms such as restlessness or difficulty sitting or standing still. If these symptoms occur, the patient should immediately inform their doctor.
Medications like Esscitaxin (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 the patient has depression and/or anxiety disorders, they may sometimes have thoughts of self-harm or suicide. These thoughts may worsen at the start of treatment with antidepressant medications, as these medications usually start to work after about 2 weeks, and sometimes later.
The risk of such thoughts is higher if:

• The patient has had suicidal thoughts or self-harm in the past;
• The patient is a young adult. Clinical trial data indicate an increased risk of suicidal behavior in adults under 25 years of age with mental disorders who were treated with antidepressant medications.

If the Patient Experiences Suicidal Thoughts or Self-Harm at Any Time, They Should Immediately Contact Their Doctor or Go to the Hospital.

It May Be Helpful for the Patient to Tell Someone in Their Family or a Friend About Their Depression or

Anxiety Disorderand ask them to read this package leaflet. The patient may ask them to keep an eye on them and inform them if they notice any worsening of depression or anxiety symptoms or any disturbing changes in behavior.

Children and Adolescents

Esscitaxin should not normally be used for children and adolescents under 18 years of age. The patient should be aware that in patients under 18 years of age, who are taking medications 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, the doctor may prescribe Esscitaxin to patients in this age group if they consider it necessary.
If the doctor has prescribed Esscitaxin to a patient under 18 years of age and there are any doubts, the patient should consult their doctor again.
The patient should contact their treating doctor if any of the above symptoms worsen or appear in patients under 18 years of age taking Esscitaxin. The long-term safety of Esscitaxin regarding its effects on growth, maturation, and cognitive and behavioral development in this age group has not been established yet.

Esscitaxin and Other Medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
The patient should inform their doctor if they are taking any of the following medications:

• Non-selective monoamine oxidase inhibitors (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine. If the patient is taking any of these, they should wait 14 days before starting Esscitaxin. After stopping Esscitaxin, the patient should wait 7 days before starting any of these medications.
• Reversible inhibitors of monoamine oxidase A (RIMAs) such as moclobemide (used to treat depression).
• Irreversible monoamine oxidase inhibitors (MAOIs), such as selegiline (used to treat Parkinson's disease). These medications 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 medications (used to treat migraines) and tramadol (opioid medications used to treat acute or chronic pain). These medications increase the risk of side effects.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (an antifungal medication), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medications may increase the levels of Esscitaxin in the blood.
• St. John's Wort (Hypericum perforatum), a herbal remedy used to treat depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory medications (used to treat pain or to thin the blood, so-called anticoagulant medications). These medications may increase the risk of bleeding.
• Warfarin, dipyridamole, and phenprocoumon (medications used to thin the blood, so-called anticoagulant medications). The doctor will likely monitor the patient's blood clotting time before starting and after stopping treatment with Esscitaxin to ensure that the anticoagulant medication dosage 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). The dosage of Esscitaxin may need to be adjusted.
• Medications that lower potassium or magnesium levels in the blood, due to the increased risk of life-threatening heart rhythm disorders.

The patient should not take Esscitaxin if they are taking medications used to treat heart rhythm disorders or medications that affect heart rhythm, such as antiarrhythmic medications of class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibiotics (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medications - especially halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine). If the patient has any further doubts, they should consult their doctor.

Esscitaxin with Food, Drink, and Alcohol

As with many medications, it is not recommended to consume alcohol during treatment with Esscitaxin, although no interactions with alcohol are expected.

Pregnancy, Breastfeeding, and Fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.
Esscitaxin should not be taken if the patient is pregnant or breastfeeding, unless the doctor has discussed the risks and benefits of taking the medication with the patient.
Pregnancy
If the patient is taking Esscitaxin during the last three months of pregnancy, they should be aware that the newborn may experience the following symptoms: breathing difficulties, bluish 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, the patient should immediately contact their doctor.
The patient should ensure that their midwife and/or doctor know that they are taking Esscitaxin.
Taking Esscitaxin during pregnancy, especially during the last three months, may increase the risk of the baby developing a serious condition called persistent pulmonary hypertension of the newborn (PPHN). This condition causes rapid breathing and bluish discoloration of the skin in the newborn. These symptoms usually appear within the first 24 hours after birth. If the patient notices these symptoms in their baby, they should immediately inform their midwife and/or doctor.
Taking Esscitaxin at the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Esscitaxin, they should inform their doctor or midwife so that they can provide appropriate advice.
The patient should not stop taking Esscitaxin suddenly during pregnancy.
Breastfeeding
It is assumed that Esscitaxin passes into human breast milk.
Fertility
In animal studies, citalopram, a medication similar to escitalopram, has been shown to decrease sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans yet.

Driving and Using Machines

The patient should not drive or operate machinery until they know how Esscitaxin affects them.

Esscitaxin Contains Sodium

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

3. How to Take Esscitaxin

This medication should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

Adults

Depression

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

Panic Disorder with Agoraphobia

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

Social Phobia

The usual dose of Esscitaxin is 10 mg once daily. Depending on the patient's response to the medication, the doctor may decrease 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. The 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. The 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 of a 10 mg tablet) once daily. The treating doctor may increase the dose to 10 mg once daily.

Children and Adolescents

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

Renal Impairment

Care should be exercised in patients with severe renal impairment. The medication should be taken as directed by the doctor.

Hepatic Impairment

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

Poor Metabolizers of CYP2C19

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

How to Take Esscitaxin

Esscitaxin can be taken with or without food. The patient should swallow the tablet with water. The tablets should not be chewed, as they have a bitter taste.

Duration of Treatment

It may take several weeks of treatment before the patient feels better. Therefore, the patient should continue taking the medication, even if they do not feel better immediately. The patient should never change the dose of the medication without consulting their doctor first.
The patient should continue taking Esscitaxin for as long as their doctor recommends. If the patient stops treatment too early, their symptoms may return. It is recommended that treatment be continued for at least 6 months after the patient's symptoms have improved.

Overdose of Esscitaxin

If the patient has taken more than the prescribed dose of Esscitaxin, they should immediately contact their doctor or go to the emergency department of the nearest hospital. The patient should do this even if they 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 in the body. On the way to the doctor or hospital, the patient should take the packaging (box/blister) of Esscitaxin with them.

Missing a Dose of Esscitaxin

The patient should not take a double dose of the medication to make up for a missed dose. If the patient has forgotten to take a dose and remembers before going to bed, they should take the missed dose immediately. The patient should take the next dose at the usual time the next day. If the patient remembers they have missed a dose in the night or the next day, they should skip the missed dose and take the next dose at the usual time.

Stopping Treatment with Esscitaxin

The patient should not stop taking Esscitaxin without consulting their doctor first.
When the patient finishes the prescribed treatment cycle, it is usually recommended to gradually decrease the dose of Esscitaxin over several weeks.
If the patient stops taking Esscitaxin, especially suddenly, they may experience withdrawal symptoms. This happens often when treatment with Esscitaxin is stopped. The risk is higher if the medication was taken for a long time or in high doses, or if the dose was decreased 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 the patient experiences severe withdrawal symptoms, they should contact their doctor. The doctor may recommend that the patient start taking the medication again and then stop it more slowly.
Withdrawal symptoms include dizziness (unsteady gait, balance disorders), tingling, numbness, and (less often) electric shock sensations, including in the head, sleep disturbances (vivid dreams, nightmares, insomnia), anxiety, headaches, nausea, excessive sweating, restlessness or agitation, trembling, confusion, or disorientation, mood swings or irritability, diarrhea (loose stools), vision disturbances, or heart palpitations (palpitations).
If the patient has any further doubts about taking this medication, they should consult their doctor or pharmacist.

4. Possible Side Effects

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

If the Patient Experiences Any of the Following Side Effects During Treatment, They Should Contact Their 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.

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

• Difficulty urinating.
• Seizures (see also "Warnings and precautions").
• Yellowing of the skin and whites of the eyes, which is a sign of liver function disorders and/or hepatitis.
• Rapid or irregular heartbeat, fainting, which can be symptoms of a life-threatening condition called torsades de pointes.
• Suicidal thoughts and behaviors, see also section "Warnings and precautions".
• Sudden swelling of the skin or mucous membranes (angioedema).

In Addition to the Above, the Following Side Effects Have Been Reported for Medications 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, sleep disturbances, drowsiness, dizziness, yawning, trembling, tingling sensation in the skin.
• Diarrhea, constipation, vomiting, dry mouth.
• Excessive sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual disturbances (delayed ejaculation, erectile dysfunction, decreased libido, difficulty reaching orgasm in women).
• Feeling tired, fever.
• Weight gain.

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

• Hives, rash, itching.
• Grinding of the teeth, restlessness, agitation, panic attacks, confusion.
• Sleep disturbances, taste disturbances, fainting, 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.

Frequency not known (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.
• Patients taking medications from this group have been observed to have an increased risk of fractures.
• Changes in heart rhythm (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 medications with a similar mechanism of action to escitalopram (the active substance of Esscitaxin):

• Akathisia (restlessness).
• Loss of appetite.

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of this medication.

5. How to Store Esscitaxin

The medication should be stored out of sight and reach of children.
The patient should not take this medication 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 medication.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer use. This will help protect the environment.

6. Contents of the Pack and Other Information

What Esscitaxin Contains

• The active substance of Esscitaxin is escitalopram. Each film-coated tablet of Esscitaxin 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 film-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 film-coated tablet with a diameter of 7.8 x 5.3 - 8.2 x 5.7 mm, with "C4" engraved on one side and a score line on the other side. The tablet can be divided into equal doses.

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

Esscitaxin 10 mg and 20 mg film-coated tablets are available in transparent blisters made of PVDC/PVC/Aluminum, packaged in cardboard boxes containing 20, 28, 30, 50, 56, 60, 84, 90, 98, or 100 film-coated tablets.
Esscitaxin 10 mg and 20 mg film-coated tablets are also available in HDPE bottles with a PP cap with a child-resistant closure, containing 28, 30, 50, 100, or 500 film-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 Package Leaflet: