Esscitaxin

Patient Information Leaflet

Esscitaxin, 10 mg, film-coated tablets
Esscitaxin, 20 mg, film-coated tablets
Escitalopram
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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 escitalopram as the active substance.
Esscitaxin belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain by increasing serotonin levels. Dysfunction of the brain's serotonin system is considered 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 improvement begins. You should continue taking Esscitaxin even if it takes some time before your condition improves.
If no improvement occurs or if you feel worse, consult your doctor.

2. Important information before using Esscitaxin

When not to use Esscitaxin

• 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 has or has ever had an irregular heart rhythm (visible on ECG; a test used to assess heart function)
• if the patient is taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see section 2 "Esscitaxin with other medicines").

Warnings and precautions
Before starting treatment with Esscitaxin, 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. If seizures occur for the first time or increase in frequency, treatment with Esscitaxin should be discontinued (see also section 4 "Possible side effects").
• the patient has impaired liver or kidney function. The doctor may need to adjust the dosage.
• the patient has diabetes. Treatment with Esscitaxin may alter blood glucose control. Adjustment of insulin and/or oral antidiabetic drugs may be necessary.
• the patient has low sodium levels in the blood.
• the patient has an increased tendency to bleed or bruise, or if the patient is pregnant (see "Pregnancy, breastfeeding and effect on fertility").
• the patient is undergoing electroconvulsive therapy (a psychiatric treatment using electric currents to relieve severe depression or bipolar affective disorder by inducing controlled seizures in the brain under anesthesia).
• the patient has ischemic heart disease.
• the patient has heart conditions or has recently had a myocardial infarction.
• the patient has a low resting heart rate and/or may have electrolyte deficiencies due to prolonged persistent diarrhea and vomiting or use of diuretics.
• the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart function.
• the patient has or has had eye problems, such as certain types of glaucoma (increased pressure within the eyeball). Note: In some patients with bipolar affective disorder, a manic phase may occur. It is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, consult a doctor.

In the first weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still may also occur. If such symptoms appear, inform the doctor immediately.
Medicines such as Esscitaxin (so-called SSRIs) 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 antidepressant treatment, as these medicines usually start working after about 2 weeks, sometimes later.
The likelihood of such thoughts is higher if:

• the patient has previously had suicidal or self-harming thoughts;
• the patient is a young adult. Clinical trial data indicate an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders treated with antidepressants.

If the patient ever experiences suicidal thoughts or thoughts of self-harm, seek immediate medical help by contacting a doctor or going to hospital.
It may be helpful to tell a family member or friend about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to inform them if they notice worsening of depression or anxiety symptoms or concerning changes in behavior.
Children and adolescents
Esscitaxin 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 in this class, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behavior, and anger). Nevertheless, 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 concerns, consult the doctor again.
Contact the treating doctor if any of the above-mentioned symptoms occur or worsen in patients under 18 years of age taking Esscitaxin. The long-term safety of Esscitaxin regarding its effect on growth, maturation, and cognitive and behavioral development in this age group has not yet been established.
Esscitaxin with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform the doctor if the patient is taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs), containing the active substances: phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine. If any of these are being taken, wait 14 days before starting Esscitaxin. After stopping Esscitaxin, wait 7 days before starting any of these medicines.
• Selective, reversible MAO-A inhibitors, including moclobemide (used in the treatment of depression).
• Irreversible MAO-B inhibitors, including selegiline (used in the treatment of Parkinson's disease). These medicines increase the risk of adverse 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 (opioid medicines used to treat acute or chronic pain). These medicines increase the risk of adverse effects.
• Cimetidine, lansoprazole, and omeprazole (used in the treatment of peptic ulcer disease), 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 concentration of Esscitaxin in the blood.
• 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 Esscitaxin 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), clomipramine and nortriptyline (antidepressants), risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Esscitaxin may be necessary.
• Medicines that reduce potassium or magnesium levels in the blood, due to increased risk of life-threatening heart rhythm disturbances.

Do not use Esscitaxin if the patient is taking medicines used for heart rhythm disorders or medicines affecting heart rhythm, such as antiarrhythmic class IA and III drugs, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibiotics (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials—particularly halofantrine), or certain antihistamines (astemizole, hydroxyzine, mizolastine). If there are any further doubts, consult the treating doctor.
Esscitaxin with food, drink, and alcohol
As with many other medicines, alcohol consumption is not recommended during treatment with Esscitaxin, although interactions with alcohol are not expected.
Pregnancy, breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not use Esscitaxin if the patient is pregnant or breastfeeding unless the doctor has discussed the risks and benefits of treatment with her.
Pregnancy
If the patient takes Esscitaxin 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, irritability, lethargy, constant crying, sleepiness, or difficulty sleeping. If any of these symptoms occur in the newborn, contact a doctor immediately.
Ensure that the midwife and/or doctor know that the patient is taking Esscitaxin.
Taking Esscitaxin during pregnancy, especially during the last three months, may increase the risk of a serious condition in the child called persistent pulmonary hypertension of the newborn (PPHN). This causes rapid breathing and bluish skin discoloration in the newborn. These symptoms usually appear within the first 24 hours after birth. If the patient notices these symptoms in her child, contact the midwife and/or doctor immediately.
Taking Esscitaxin towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Esscitaxin, she should inform her doctor or midwife so they can provide appropriate advice.
Do not abruptly stop taking Esscitaxin during pregnancy.
Breastfeeding
Esscitaxin is expected to pass into human milk.
Effect on fertility
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces semen quality. This could theoretically affect fertility, although no effect on human fertility has been observed to date.
Driving and operating machinery
Do not drive or operate machinery until the patient knows how Esscitaxin affects them.
Esscitaxin contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., the medicine is considered "sodium-free".

3. How to take Esscitaxin

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Adults

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

Panic disorder with anxiety
The recommended starting 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. Your doctor may further increase the dose up to the maximum dose of 20 mg per day.

Social phobia
The usual recommended dose of Esscitaxin 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 to the maximum dose of 20 mg per day.

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

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

Elderly patients (over 65 years of age)
The recommended starting dose of Esscitaxin is 5 mg (half of a 10 mg tablet) once daily. The treating doctor may increase the dose to 10 mg per day.

Children and adolescents
Esscitaxin is generally not recommended for use in children and adolescents. For additional information, see section 2 "Important information before taking Esscitaxin".

Renal impairment
Exercise caution in patients with severe renal impairment. The medicine should be taken as directed by your doctor.

Hepatic impairment
Patients with impaired liver function should not take a dose exceeding 10 mg per day. The medicine should be taken as directed by your doctor.

Patients who are poor metabolizers of drugs via the CYP2C19 isoenzyme
Patients with this known genotype should not take a dose exceeding 10 mg per day. The medicine should be taken as directed by your doctor.

How to take Esscitaxin
Esscitaxin may be taken with or without food. 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 the patient feels better. Therefore, continue taking the medicine even if there is no initial improvement in well-being.
Never change the dose of the medicine without first consulting your doctor.
Continue taking Esscitaxin for as long as your doctor has instructed. If treatment is stopped too early, symptoms may return. It is recommended that treatment continues for at least 6 months after improvement occurs.

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

Missed dose of Esscitaxin
Do not take a double dose to make up for a missed dose. If you forget to take a dose and remember before going to bed, take the missed dose immediately. Take the next dose at the usual time the following day. If you remember about the missed dose during the night or the next day, skip the missed dose and take the next dose at the usual time.

Stopping treatment with Esscitaxin
Do not stop treatment with Esscitaxin unless your doctor advises you to do so.
When completing a prescribed course of treatment, it is generally recommended to gradually reduce the dose of Esscitaxin over several weeks.
If you stop taking Esscitaxin, especially abruptly, you may experience withdrawal symptoms. This commonly occurs when treatment with Esscitaxin is discontinued. 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 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 all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Adverse effects usually resolve after a few weeks of treatment. It should be noted that
many of these symptoms may also be symptoms of the illness being treated and will subside as your condition improves.
If any of these adverse effects occur during treatment, you should
contact your doctor or go to hospital immediately:
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, larynx (the part of the throat behind the mouth and nose), or face, or difficulty breathing or swallowing (allergic reaction)
• High fever, agitation, confusion (disorientation), tremors, and violent muscle contractions, which may be symptoms of a rare condition called serotonin syndrome.

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

• Difficulty urinating
• Seizures (see also section "Warnings and precautions")
• Yellowing of the skin and whites of the eyes, which may indicate liver dysfunction and/or hepatitis
• Rapid, 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")
• Sudden swelling of the skin or mucous membranes (angioedema).
  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 runny nose (sinusitis)
• Increased or decreased appetite
• Anxiety, restlessness, unusual dreams, difficulty sleeping, drowsiness, dizziness, yawning, tremor, tingling sensation in the skin
• Diarrhoea, constipation, vomiting, dry mouth
• Excessive sweating
• Muscle and joint pain (arthralgia and myalgia)
• 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):

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

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

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

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

• Decreased sodium concentration in blood (symptoms may include nausea, malaise with 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, prolonged erection (priapism)
• Bleeding, including under the skin and mucous membranes (petechiae), and decreased platelet count (thrombocytopenia)
• Increased secretion of antidiuretic hormone (ADH), leading to water retention in the body, blood dilution, and decreased sodium levels (syndrome of inappropriate antidiuretic hormone secretion)
• Galactorrhea in men and in women who are not breastfeeding
• Mania
• In patients taking medicines of this class, an increased risk of bone fractures has been observed
• Changes in heart rhythm (known as "QT interval prolongation", visible on ECG, a test assessing the electrical activity of the heart)
• Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection "Pregnancy, breastfeeding and fertility" in section 2.

Additionally, adverse effects of medicines with a similar mechanism of action to escitalopram
(active substance in Esscitaxin) are known. These include:

• Restless movement (akathisia)
• Loss of appetite.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Esscitaxin

The medicine should be stored in a place that is out of sight and out of reach of children.
Do not use this medicine after the expiry date stated on the cardboard box,
blister pack, or bottle. The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Esscitaxin contains

• The active substance in Esscitaxin is escitalopram. Each coated tablet of Esscitaxin contains 10 mg or 20 mg of escitalopram (as oxalate).
• The other ingredients are:
  Tablet core: microcrystalline cellulose, sodium croscarmellose, talc, colloidal anhydrous silica, magnesium stearate.
  Tablet coating: hypromellose (E464), titanium dioxide (E171), talc, polyethylene glycol 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). The tablets are described below.
Esscitaxin 10 mg: white to off-white, oval, biconvex coated tablet with dimensions of 8.0 x 5.5 - 8.5 x 6.0 mm, embossed with the code "C4" on one side and a division 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 dimensions of 11.5 x 7.0 - 12.0 x 7.5 mm, embossed with the code "C3" on one side and a division 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 made of PVDC/PVC/Aluminium, 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 also available in HDPE bottles with PP child-resistant caps, containing 28, 30, 50, 100 or 500 coated tablets, packed in cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel.: +48 17 865 51 00

Importer
Bausch Health Poland Sp. z o.o.,
ul. Kosztowska 21,
41-409 Mysłowice,
Poland
or
Misom Labs Ltd.
Malta Life Sciences Park
LS 2.01.06, Industrial Estate
SGN 3000, San Gwann, Malta