ESERTIA 15 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Esertia 15 mg Film-Coated Tablets

escitalopram

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Esertia and what is it used for

1. What you need to know before you take Esertia
2. How to take Esertia
3. Possible side effects
4. Storing Esertia

1. Contents of the pack and other information

1. What is Esertia and what is it used for

Esertia contains the active substance escitalopram. Esertia belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs).

Esertia contains escitalopram and is indicated for the treatment of depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder).

It may take a couple of weeks before you start to feel better. Continue to take Esertia even if it takes some time to notice an improvement.

You should consult a doctor if you get worse or do not improve.

2. What you need to know before you take Esertia

Do not take Esertia

• If you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).
  • If you are taking other medicines that belong to the group of medicines called MAOIs, including selegiline (used for the treatment of Parkinson's disease), moclobemide (used for the treatment of depression), and linezolid (an antibiotic).
  • If you have had a heart problem or have suffered an episode of irregular heart rhythm (detected on an ECG, a test that evaluates heart function).
  • If you are taking medicines for heart rhythm problems or that may affect heart rhythm (see section 2 "Using Esertia with other medicines").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Esertia.

Please inform your doctor if you have any other disorder or disease, as your doctor may need to take it into account. In particular, inform your doctor:

• If you have epilepsy. Treatment with Esertia should be discontinued if you experience seizures for the first time or observe an increase in the frequency of seizures (see also section 4 "Possible side effects").
• If you have liver or kidney failure. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Esertia may alter blood sugar control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic.
• If you have a low level of sodium in the blood.
• If you tend to develop bleeding or bruising easily, or if you are pregnant (see "Pregnancy, breastfeeding, and fertility").
• If you are receiving electroconvulsive therapy.

• If you have coronary artery disease.

• If you have or have had heart problems or have recently suffered a heart attack.
• If your resting heart rate is slow and/or you know you may have low levels of salt as a result of severe and prolonged diarrhea and vomiting (being sick) or use of diuretics.

• If you experience rapid or irregular heartbeats, fainting, collapse, or dizziness when standing up, which may indicate abnormal heart rhythm.
• If you have or have had eye problems, such as certain types of glaucoma (increased pressure in the eye).

Please note:

Some patients with manic-depressive illness may enter a manic phase. This is characterized by an uncommon and rapid change of ideas, excessive joy, and excessive physical activity. If you experience this, contact your doctor.

Symptoms such as restlessness or difficulty sitting or standing, may also occur during the first few weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Some medicines in the group to which Esertia belongs (called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may sometimes have thoughts of harming or killing yourself. These may increase when you first start taking antidepressants, as all these medicines take time to start working, usually around two weeks, although in some cases it may be longer. Youwould be more likely to have these thoughts:

• If you have previously had thoughts of killing yourself or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders who were treated with an antidepressant.

If at any time you have thoughts of harming or killing yourself, contact your doctor or go directly to a hospital.

It may be helpful for you to tell a relative or close friendthat you are depressed or have an anxiety disorder and ask them to read this leaflet. You can ask them if they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your attitude.

Children and adolescents

Esertia should not normally be used in the treatment of children and adolescents under 18 years. Also, you should know that in patients under 18 years, there is a greater risk of adverse effects such as suicidal attempts, suicidal ideas, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this class of medicines. Nevertheless, your doctor may prescribe Esertia to patients under 18 years when they decide what is best for the patient. If the doctor who prescribed Esertia to a patient under 18 years wants to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms described above worsen or if you experience complications when patients under 18 years are taking Esertia. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Esertia in this age group have not yet been demonstrated.

Other medicines and Esertia

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Tell your doctor if you are taking any of the following medicines:

• "Non-selective monoamine oxidase inhibitors (MAOIs)" that contain phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substances. If you have taken any of these medicines, you will need to wait 14 days before starting to take Esertia. After finishing Esertia, 7 days must pass before taking any of these medicines.

• "Reversible MAO-A inhibitors", which contain moclobemide (used in the treatment of depression).

• "Irreversible MAO-B inhibitors", which contain selegiline (used in the treatment of Parkinson's disease). These increase the risk of side effects.

• The antibiotic linezolid.

• Lithium (used in the treatment of manic-depressive disorder) and tryptophan.

• Imipramine and desipramine (both used for the treatment of depression).

• Sumatriptan and similar medicines (used for the treatment of migraine) and tramadol and similar medicines (opioids, used for severe pain). These increase the risk of side effects.

• Cimetidine, lansoprazole, and omeprazole (used for the treatment of stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause an increase in blood levels of escitalopram.

• St. John's Wort (Hypericum perforatum) - a medicinal plant used for depression.

• Aspirin and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or reduce the risk of thrombosis, also called anticoagulants). These may increase the tendency to bleeding.

• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably check your blood clotting time at the start and end of treatment with Esertia to ensure that the dose of anticoagulant is still adequate.

• Mefloquine (used for the treatment of malaria), bupropion (used for the treatment of depression), and tramadol (used for the treatment of severe pain) due to the possible risk of lowering the seizure threshold.

• Neuroleptics (medicines used for the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the seizure threshold.

• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). It may be necessary to adjust the dose of Esertia.

• Medicines that lower potassium or magnesium levels in the blood, as this increases the risk of heart rhythm disturbances, which can be life-threatening.

Do not take Esertia if you are taking medicines for heart rhythm problems or that may affect heart rhythm, e.g., antiarrhythmics Class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobials (e.g., sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarial treatment, particularly halofantrine), some antihistamines (astemizole, hydroxyzine, mizolastine). Contact your doctor for any additional questions.

Taking Esertia with food, drinks, and alcohol

Esertia can be taken with or without food (see section 3 "How to take Esertia").

As with many medicines, it is not recommended to combine Esertia and alcohol, although it is not expected that Esertia will interact with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Esertia if you are pregnant or breastfeeding unless you and your doctor have discussed the risks and benefits involved.

If you take Esertia during the last 3 months of your pregnancy, be aware that the following effects may be observed in the newborn baby: difficulty breathing, blue skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, stiffness or floppiness, intense reflexes, tremors, restlessness, irritability, lethargy, constant crying, and difficulty sleeping.

If your newborn baby has any of these symptoms, please contact your doctor immediately.

Make sure your midwife and/or doctor know that you are being treated with Esertia.

During pregnancy, particularly in the last 3 months, medicines like Esertia may increase the risk of a serious condition in newborns called persistent pulmonary hypertension (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually start during the first 24 hours after birth. If they appear in your baby, you should contact your midwife and/or doctor immediately.

If you take Esertia in the final stages of pregnancy, there may be a greater risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Esertia so they can advise you.

If Esertia is used during pregnancy, it should never be stopped abruptly.

It is expected that Esertia will be excreted in breast milk.

Citalopram, a medicine similar to escitalopram, has been shown to reduce sperm quality in animal models. This effect could theoretically affect fertility, but to date, no impact on human fertility has been observed.

Driving and using machines

It is recommended that you do not drive or use machinery until you know how Esertia affects you.

Esertia contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per tablet; this is essentially "sodium-free".

3. How to take Esertia

Follow your doctor's administration instructions for this medication exactly. If in doubt, consult your doctor or pharmacist again.

Adults

Depression

The normally recommended dose of Esertia is 10 mg taken as a single dose per day. Your doctor may increase it up to a maximum of 20 mg per day.

Anxiety Disorder

The initial dose of Esertia is 5 mg as a single dose per day during the first week before increasing the dose to 10 mg per day. Your doctor may increase it later up to a maximum of 20 mg per day.

Social Anxiety Disorder

The normally recommended dose of Esertia is 10 mg taken as a single dose per day. Your doctor may decrease your dose to 5 mg per day or increase the dose up to a maximum of 20 mg per day, depending on how you respond to the medication.

Generalized Anxiety Disorder

The normally recommended dose of Esertia is 10 mg taken as a single dose per day. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Obsessive-Compulsive Disorder

The normally recommended dose of Esertia is 10 mg taken as a single dose per day. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Elderly patients (over 65 years old)

The initial recommended dose of Esertia is 5 mg taken as a single dose per day. The dose may be increased by your doctor up to 10 mg per day.

Children and adolescents

Esertia should not normally be administered to children and adolescents. For additional information, please see section 2 "What you need to know before taking Esertia".

Renal insufficiency

Cautiousness is advised in patients with severely decreased renal function. Take as prescribed by your doctor.

Hepatic insufficiency

Patients with liver problems should not receive more than 10 mg per day. Take as prescribed by your doctor.

Patients considered as slow metabolizers of CYP2C19

Patients with this known genotype should not receive more than 10 mg per day. Take as prescribed by your doctor.

You can take Esertia with or without food. Swallow the tablets with water. Do not chew them, as they have a bitter taste.

If necessary, you can divide the 10, 15, and 20 mg tablets by placing the tablet on a flat surface with the score line facing up. The tablets can be broken by pressing down on each end of the tablet with your index fingers, as shown in the figure.

The 10, 15, and 20 mg tablets can be divided into equal doses.

Duration of treatment

It may take a couple of weeks before you start to feel better. Continue taking Esertia even if you start to feel better before the expected time.

Do not change the dose of the medication without talking to your doctor first.

Continue taking Esertia for the time recommended by your doctor. If you interrupt treatment too early, symptoms may reappear. It is recommended that treatment continue for at least 6 months after you feel better.

If you take more Esertia than you should

If you take more doses of Esertia than prescribed, contact your doctor immediately, go to the emergency department of the nearest hospital, or consult the Toxicology Information Service, phone 915 620 420. Do this even if you do not notice discomfort or signs of intoxication. Some signs of overdose may be dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rate, decreased blood pressure, and changes in body water balance. Bring the Esertia package if you go to the doctor or hospital.

If you forget to take Esertia

Do not take a double dose to make up for forgotten doses. If you forgot to take a dose and remember before going to bed, take it immediately. The next day, follow your usual routine. If you remember during the night or the next day, skip the forgotten dose and follow your usual routine.

If you stop taking Esertia

Do not stop taking Esertia until your doctor tells you to. When you finish your treatment course, it is generally recommended that the dose of Esertia be gradually reduced over several weeks.

When you stop taking Esertia, especially if it is sudden, you may feel withdrawal symptoms. These are common when treatment with Esertia is suspended. The risk is greater when Esertia has been used for a long time, in high doses, or when the dose is reduced too quickly. Most people find that these symptoms are mild and disappear on their own within two weeks. However, in some patients, they can be intense or prolonged (2-3 months or more). If you have severe withdrawal symptoms when you stop taking Esertia, please contact your doctor. He or she may ask you to start taking your tablets again and stop them more slowly.

Withdrawal symptoms include:

Feeling of dizziness (unstable or without balance), feeling of tingling, feeling of itching, and (less frequently) electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of dizziness (nausea), sweating (including night sweats), feeling of unease or agitation, tremors (instability), feeling of confusion or disorientation, feelings of emotion or irritation, diarrhea (loose stools), visual disturbances, rapid or irregular heartbeat.

If you have any other doubts about using this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them.

Side effects usually disappear after a few weeks of treatment. Please be aware that many of the effects can be symptoms of your illness and will improve as you start to feel better.

If you experience any of the following symptoms, contact your doctor or go to the hospital immediately:

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

• Unusual bleeding, including gastrointestinal bleeding.

Rare (may affect up to 1 in 1,000 people):

• Swelling of the skin, tongue, lips, or face, or difficulty breathing or swallowing (allergic reaction).
• High fever, agitation, confusion, tremors, and sudden muscle contractions can be signs of a rare condition called serotonin syndrome.

Unknown (cannot be determined from available data):

• Difficulty urinating.
• Seizures (attacks), see also the "Warnings and precautions" section.
• Yellow skin and eyes, signs of liver function alteration/hepatitis.
• If you experience rapid or irregular heartbeats or fainting, symptoms that may indicate a life-threatening condition known as Torsade de Pointes.
• Thoughts of harming yourself or thoughts of killing yourself, see also the "Warnings and precautions" section.

In addition to the above, the following side effects have been reported:

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

• Feeling nauseous.
• Headache.

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

• Nasal congestion or mucous (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty sleeping, feeling drowsy, dizziness, yawning, tremors, skin itching.

• Diarrhea, constipation, vomiting, dry mouth.

• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual disturbances (delayed ejaculation, erection problems, decreased sexual behavior, and women may experience difficulty reaching orgasm).
• Fatigue, fever.
• Weight gain.

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

• Hives, skin rash, itching (pruritus).
• Teeth grinding, agitation, nervousness, anxiety attacks, confusion.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbance, ringing in the ears (tinnitus).
• Hair loss.
• Excessive menstrual bleeding.
• Irregular menstrual period.
• Weight loss.
• Rapid heartbeat.
• Swelling of arms and legs.
• Nosebleeds.

Rare (may affect up to 1 in 1,000 people):

• Aggression, depersonalization, hallucinations.
• Slow heartbeat.

Unknown (cannot be determined from available data):

• Decreased sodium levels in the blood (symptoms are feeling dizzy and discomfort with muscle weakness or confusion).
• Dizziness when standing up due to low blood pressure (orthostatic hypotension).
• Altered liver function tests (increased liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Signs of increased bleeding, e.g., from the skin or mucous membranes (ecchymosis) and low platelet count in the blood (thrombocytopenia).
• Sudden swelling of the skin or mucous membranes (angioedema).
• Increased secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, reducing the amount of sodium (inadequate ADH secretion).
• Increased levels of the hormone prolactin in the blood.
• Milk flow in men and in women who are not breastfeeding.
• Mania.
• An increased risk of bone fractures has been observed in patients treated with this type of medication.
• Alteration of heart rhythm (called "prolongation of the QT interval", observed in the ECG, heart electrical activity).
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

Other side effects are known to occur with drugs that work similarly to escitalopram (the active ingredient in Esertia). These are:

• Motor restlessness (akathisia).
• Lack of appetite.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Esertia

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

6. Package contents and additional information

Esertia composition

The active ingredient is escitalopram.

Each Esertia tablet contains 15 mg of escitalopram (as oxalate).

The other components are:

Core: silicified microcrystalline cellulose, talc, sodium croscarmellose, and magnesium stearate.

Coating: hypromellose, macrogol 400, and titanium dioxide (E-171).

Product appearance and package contents

Esertia 15 mg is presented in the form of film-coated tablets.

The tablets are oval, white, scored, coated, and marked with "E" and "M" on each side of the score line on one face of the tablet.

The 15 mg tablets can be divided into equal doses.

Esertia 15 mg is presented in:

Transparent blister pack, included in a box: 14, 28, 56, and 98 tablets.

White blister pack, included in a box: 14, 20, 28, 50, 100, and 200 tablets.

Polyethylene bottle: 100 and 200 tablets.

Single dose: 49x1, 56x1, 98x1, 100x1, and 500x1 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Holder

Almirall, S.A.

General Mitre 151

08022 Barcelona

Spain

Manufacturer

• Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

This medication was authorized in the EEA Member States with the following names:

Spain: Esertia

Italy: Entact

Sweden: Prilect

Date of the last revision of this prospectus: December 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/