Leaflet: information for the user

Esertia 10 mg film-coated tablets

escitalopram

Read this leaflet carefully before you start taking this medicine, becauseit contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribedonlyfor you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What you need to know before you start taking Esertia
2. How to take Esertia
3. Possible side effects
4. Storage of Esertia

6. Contents of the pack and additional information

Esertia contains the active ingredient 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 feeling better. Continue taking Esertia even if it takes time to notice any improvement.

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

Do not take Esertia

-If you are allergic to escitalopram or any of the other ingredients of this medication (listed in section 6).

• If you are taking other medications that belong to the group called MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).
• If you have a history of or have experienced an episode of abnormal heart rhythm (detected on an ECG, a test that evaluates heart function).
• If you are taking medications for heart rhythm problems or that may affect heart rhythm (see section 2 “Taking 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 medical condition 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 interrupted if seizures occur for the first time or if you observe an increase in seizure frequency (see also section 4 “Possible side effects”).
• If you have liver or kidney insufficiency. Your doctor may need to adjust your dose.
• If you have diabetes.Esertia treatment may alter blood sugar control. You may need to adjust your insulin and/or oral hypoglycemic medication dose.
• If you have low sodium levels in your blood.
• If you are prone to 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 had a heart attack.
• If your resting heart rate is slow and/or you know that you may have low sodium levels as a result of severe and prolonged diarrhea and vomiting (being ill) or use of diuretics.

• If you experience rapid or irregular heartbeats, dizziness, fainting, or lightheadedness 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 unusual and rapid changes in ideas, excessive happiness, 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 medications in the group to which Esertia belongs (called ISRS/IRSN) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may occasionally have thoughts of harming yourself or committing suicide. These may increase when taking antidepressants for the first time, as all these medications require time to start working, usually around two weeks, although in some cases it may take longer.Youmay be more prone to having these types of thoughts:

• If you have previously had thoughts of harming yourself or committing suicide.
• If you are ayoung adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years old with psychiatric illnesses treated with an antidepressant.

If you ever have thoughts of harming yourself or committing suicide,contact your doctor or go directly to a hospital.

It may be helpful for you to tell a family member or close friend that 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 be used normally in the treatment of children and adolescents under 18 years old. Also, be aware that in patients under 18 years old, there is a higher risk of side effects such as suicidal thoughts, suicidal ideation, and hostility (primarily aggression, confrontational behavior, and irritability) when taking this type of medication. However, your doctor may prescribe Esertia for patients under 18 years old when they decide what is best for the patient. If your doctor has prescribed Esertia for a patient under 18 years old and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms described above progress or if you experience complications when patients under 18 years old 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

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Inform your doctor if you are taking any of the following medications:

• “Non-selective monoamine oxidase inhibitors (MAOIs)”, containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranilcipromine as active ingredients. If you have taken any of these medications, you will need to wait 14 days before starting to take Esertia. After stopping Esertia, 7 days should pass before taking any of these medications.

• “Reversible selective MAO-A inhibitors”, containing moclobemide (used to treat depression).

• “Irreversible MAO-B inhibitors”, containing selegiline (used to treat Parkinson's disease). These increase the risk of side effects.

• Linezolid (an antibiotic).

• Lithium (used to treat manic-depressive disorder) and tryptophan.

• Imipramine and desipramine (both used to treat depression).

• Sumatriptan and similar medications (used to treat migraines) and tramadol and similar medications (opioids, used for severe pain). These increase the risk of side effects.

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

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

• Aspirin and nonsteroidal anti-inflammatory drugs (medications used to relieve pain or reduce the risk of blood clots, also called anticoagulants). These may increase the risk of bleeding.

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

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

• Neuroleptics (medications used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and ISRSs) 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). You may need to adjust your Esertia dose.

• Medications that lower potassium or magnesium levels in the blood, as this increases the risk of abnormal heart rhythm, which is life-threatening.

Do not take Esertia if you are taking medications for heart rhythm problems or that may affect heart rhythm, e.g. antiarrhythmic Class IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, particular antimalarial treatment halofantrine), some antihistamines (astemizol, hydroxyzine, mizolastine).Contact your doctor for any additional consultation.

Taking Esertia with food, drinks, and alcoholand alcohol

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

As with many medications, it is not recommended to combine Esertia and alcohol, although no interaction with alcohol is expected.

Pregnancy, breastfeeding, and fertilityand fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not take Esertia if you are pregnant or breastfeeding unless you and your doctor have analyzed 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:difficulty breathing, blue skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, muscle stiffness or weakness, intense reflexes, tremors, restlessness, irritability, drowsiness, and difficulty falling asleep.

If your newborn 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, medications like Esertia may increase the risk of a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually start within the first 24 hours after birth. If they appear in your baby, contact your midwife and/or doctor immediately.

If you take Esertia in the final stages of pregnancy, there may be an increased 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 to be able to advise you.

Esertia should not be stopped abruptly.

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

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

Driving and operating machinery

It is recommended that you do not drive or operate machinery until you know how Esertia may affect you.

Esertia contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of 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 further 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.

Older adults (65 years and older)

The recommended initial 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 the section 2 “What you need to know before starting to take Esertia”.

Renal impairment

Caution is advised in patients with severely impaired renal function. Take as prescribed by your doctor.

Liver impairment

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 takeEsertiawith or without food. Swallow the tablets with water. Do not chew them, as their taste is bitter.

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

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

Treatment duration

You may feel better in a couple of weeks. Continue takingEsertiaeven if you start feeling better before the expected time.

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

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

If you take more Esertia than you should

If you take more doses of Esertia than prescribed, contact your doctor immediately, go to the nearest hospital emergency department, or consult the Toxicology Information Service, phone 915 620 420. Do it even if you do not observe any discomfort or signs of overdose. Some signs of overdose may be dizziness, tremor, agitation, convulsion, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and changes in the body's electrolyte balance. Bring the Esertia packaging with you to the doctor or hospital.

If you forget to take Esertia

Do not take a double dose to compensate for the missed doses. If you forget to take a dose and remember before bedtime, take it immediately. The next day, follow your usual schedule. If you remember during the night or the next day, leave the missed dose and follow your usual schedule.

If you interrupt treatment with Esertia

Do not interrupt treatment with Esertia until your doctor tells you to. When you have finished your treatment course, it is usually recommended that the Esertia dose be gradually reduced over several weeks.

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

Withdrawal symptoms include:

Dizziness (unstable or loss of balance), tingling sensation, prickling sensation, and (less frequently) electric shock sensation, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, dizziness (nausea), sweating (including night sweats), feeling of anxiety or agitation, tremor (instability), feeling of confusion or disorientation, feelings of emotion or irritability, diarrhea (loose stools), visual disturbances, rapid heartbeat or palpitations.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

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

Rare (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, which may 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.
• Yellowish skin and whitening of the eyes, which are signs of liver function impairment/hepatitis.
• Fast or irregular heartbeats or dizziness, symptoms that may indicate a life-threatening condition known as Torsade de Pointes.
• Thoughts of self-harm or suicidal thoughts, 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 dizzy (nausea).
• Headache.

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

• Blockage or nasal mucus (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty falling asleep, feeling drowsy, dizziness, yawning, tremors, skin itching.

• Diarrhea, constipation, vomiting, dry mouth.

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

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

• Urticaria, skin rash, itching (pruritus).
• Teeth chattering, agitation, nervousness, anxiety attacks, confusion.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Hair loss.
• Excessive menstrual bleeding.
• Irregular menstrual period.
• Weight loss.
• Fast heart rate.
• Swelling of arms and legs.
• Nasal bleeding.

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

• Aggression, depersonalization, hallucinations.
• Low heart rate.

Unknown (cannot be determined from available data):

• Decreased sodium levels in the blood (symptoms are feeling dizzy and feeling unwell with muscle weakness or confusion).
• Dizziness when standing due to low blood pressure (orthostatic hypotension).
• Altered liver function tests (elevated liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Signs of increased bleeding, such as skin or mucous membrane bleeding (ecchymosis) and low platelet count in the blood (thrombocytopenia).
• Sudden swelling of the skin or mucous membranes (angioedema).
• Increase in the secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, reducing sodium levels (inadequate secretion of ADH).
• Increased levels of the hormone prolactin in the blood.
• Milk flow in men and 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 the heart rhythm (known as "prolongation of the QT interval", observed on the ECG, heart electrical activity).
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

Other side effects that have been reported with medications that act similarly to escitalopram (the active ingredient in Esertia) are:

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

Reporting of 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 leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Esertia

The active principle is escitalopram.

Each Esertia tablet contains 10 mg of escitalopram (as oxalate).

The other components are:

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

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

Appearance of the product and contents of the packaging

Esertia 10 mgis presented in the form offilm-coated tablets.

The tablets are oval, white, scored, coated, and marked with “E” and “L” on each side of the score on one face of the tablet.

The 10 mg tablets can be divided into equal doses.

Esertia 10 mg is presented in packaging of:

Blister (transparent), included in a case: 14, 28, 56, and 98 tablets.

Blister (white), included in a case: 14, 20, 28, 50, 100, and 200 tablets.

Polyethylene bottle: 100 and 200 tablets.

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

Only some sizes of packaging may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Almirall, S.A.

General Mitre 151

08022 Barcelona

Spain

Responsible manufacturer

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

This medicine was authorized in the EEA member states with the following names:

Spain: Esertia

Italy: Entact

Sweden: Prilect

Last review date of this leaflet: December 2023

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