ESERTIA 20 mg/ml ORAL SOLUTION DROPS

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 been born with or have had 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 "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 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 glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic.
• If you have a low sodium level in your 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 heart 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 you may have a decrease in salt levels in your blood 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, disproportionate 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 that Esertia belongs to (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 of age 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 of age. However, you should know that in patients under 18 years of age, there is a greater risk of adverse effects such as suicidal attempts, suicidal ideas, and hostility (predominantly aggression, confrontational behavior, and irritation) when taking this type of medicine. Nevertheless, the doctor who prescribes Esertia to patients under 18 years of age may decide that it is the most convenient for the patient. If the doctor who prescribes Esertia to a patient under 18 years of age wants to discuss this decision, please go back 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 of age are taking Esertia. Also, 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), which contain phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substances. If you are taking 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) - herbal remedy 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 coagulation 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 decrease potassium and 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, muscle stiffness or floppiness, intense reflexes, tremors, trembles, 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 disease 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 stage 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 advised that you should not drive or use machinery until you know how Esertia affects you.

Esertia 20 mg/ml Oral Drops in Solution contains alcohol.

This medicine contains 4.7 mg of alcohol (ethanol) in each drop. The amount in 10 mg of this medicine is equivalent to less than 3 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine does not produce any noticeable effect.

Esertia 20 mg/ml Oral Drops in Solution contains sodium

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

3. How to take Esertia

Follow the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Place the bottle completely upside down. If drops do not come out, gently tap the base of the bottle to start the flow.

Introduce the required number of drops into your drink (water, orange juice, or apple juice), shake gently, and then drink it all.

Esertia Oral Drops should not be mixed with other liquids or other medications.

Adults

Depression

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

Anxiety Disorder

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

Social Anxiety Disorder

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

Generalized Anxiety Disorder

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

Obsessive-Compulsive Disorder

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

Elderly patients (over 65 years old)

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

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

Hepatic impairment

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

Poor metabolizers of CYP2C19

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

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 recommended time by your doctor. If you interrupt the treatment too early, the symptoms may reappear. It is recommended that treatment continues for at least 6 months after feeling 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 observe discomfort or signs of intoxication. Some signs of overdose may be dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rate, decrease in blood pressure, and changes in body hydro-saline balance. Bring the Esertia packaging 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 the usual routine. If you remember during the night or the next day, skip the forgotten dose and follow the usual routine.

If you stop taking Esertia

Do not stop taking Esertia until your doctor tells you to. When you have finished 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 drops again and leave them more slowly.

Withdrawal symptoms include: feeling dizzy (unstable or without balance), feeling tingling, feeling itchy, and (less frequently) electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling restless, headache, feeling nauseous (nausea), sweating (including night sweats), feeling anxious or agitated, tremors (instability), feeling confused or disoriented, feelings of emotion or irritation, diarrhea (loose stools), vision changes, palpitations.

If you have any other doubts about the use of this medication, 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 when you start to feel better.

If you have 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 having 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 (frequency cannot be determined from available data):

• Difficulty urinating.
• Seizures (attacks), see also the "Warnings and precautions" section.
• Yellowish skin and whitening of the 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 (nausea).
• Headache.

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

• Nasal congestion or runny nose (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty falling asleep, feeling sleepy, dizziness, yawning, tremors, itching of the skin.
• 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 heart rate.
• Swelling of arms and legs.
• Nosebleeds.

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

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

Unknown (frequency cannot be determined from available data):

• Decrease in 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 a hormone called ADH, which causes the body to retain water and dilute 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, electrical activity of the heart).
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

Additionally, 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 leaflet. 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.

Once the packaging is opened, the drops can be used for 8 weeks and should be stored at a temperature below 25°C.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Esertia composition

Each ml of Esertia oral drops contains 20 mg of the active ingredient escitalopram (as escitalopram oxalate).

1 drop contains 1 mg of escitalopram

The other components are:

Propyl gallate

Anhydrous citric acid

96% ethanol

Sodium hydroxide

Purified water

Product appearance and packaging contents

Esertia oral drops in solution are presented in a 15 ml amber glass bottle with a dropper.

Esertia 20 mg/ml Oral Drops in solution is a clear, almost colorless to yellowish solution.

Marketing authorization holder and manufacturer

Marketing authorization 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 leaflet: 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/