Esertia 20 mg/ml oral solution drops

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Esertia 20 mg/ml oral solution drops in solution

escitalopram

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Esertia is and what it is used for
2. What you need to know before taking Esertia
3. How to take Esertia
4. Possible adverse effects
5. How to store Esertia
6. Contents of the pack and other information

1. What Esertia is and what it is used for

Esertia contains the active substance escitalopram. Esertia belongs to a group of antidepressants known as 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) in adults over 18 years of age.

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

You should consult a doctor if your condition worsens or if you do not improve.

2. What you need to know before taking Esertia

Do not take Esertia

• if you are allergic to escitalopram or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking other medicines belonging to the group known as monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).
• if you have a congenital or previously experienced episode of heart rhythm disorder (detected on an ECG, a test evaluating 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

Talk to your doctor or pharmacist before starting to take Esertia.

Please inform your doctor if you have any other disorders or illnesses, as your doctor may need to take them into account. Specifically, tell your doctor:

• If you have epilepsy. Treatment with Esertia should be discontinued if you experience seizures for the first time or notice an increase in seizure frequency (see also section 4 “Possible side effects”).
• If you have hepatic or renal impairment. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Esertia may alter glycaemic control. Adjustment of insulin and/or oral hypoglycaemic agent dosage may be necessary.
• If you have low sodium levels in the 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 recently suffered a heart attack.
• If your resting heart rate is slow and/or you know you may have low salt levels due to severe and prolonged diarrhoea and vomiting (while ill) or use of diuretics.
• If you experience rapid or irregular heartbeats, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm.
• If you have or have previously had eye problems, such as certain types of glaucoma (increased pressure in the eye).

Please note:

Some patients with bipolar disorder may enter a manic phase. This is characterized by unusually rapid and frequent changes in thoughts, excessive happiness, and excessive physical activity. If you experience this, contact your doctor.

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

Some medicines in the same group as Esertia (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may occasionally have thoughts of harming or killing yourself. These may increase when first taking antidepressants, as all such medicines require time to become effective—usually about two weeks, although in some cases it may take longer. You are more likely to have such thoughts:

• If you have previously had thoughts of harming or killing yourself.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age 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 friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them whether they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your behaviour.

Children and adolescents

Esertia should not normally be used to treat children and adolescents under 18 years of age. Also, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (predominantly aggression, confrontation behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Esertia to patients under 18 years of age if they decide it is in the patient’s best interest. If your doctor has prescribed Esertia to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You must inform your doctor if any of the symptoms described above worsen or develop complications while patients under 18 years of age are taking Esertia. In addition, the long-term effects on safety, and on growth, maturation, and cognitive and behavioural development with Esertia in this age group have not yet been established.

Other medicines and Esertia

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• “Non-selective monoamine oxidase inhibitors (MAOIs)” containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine as active ingredients. If you are taking any of these medicines, you must wait 14 days before starting Esertia. After stopping Esertia, 7 days must pass before starting any of these medicines.

• “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.

• The antibiotic linezolid.

• Lithium (used to treat bipolar disorder) and tryptophan.

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

• Sumatriptan and similar medicines (used to treat migraine) and tramadol and similar medicines (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 increased blood levels of escitalopram.

• St. John’s wort (Hypericum perforatum) – a herbal remedy used for depression.

• Acetylsalicylic acid 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 bleed.

• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will likely monitor your blood clotting time at the start and end of Esertia treatment to ensure the anticoagulant dose remains appropriate.

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

• Flecainide, propafenone, and metoprolol (used for cardiovascular conditions), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of Esertia may need to be adjusted.

• Medicines that reduce potassium and magnesium levels in the blood, as this increases the risk of life-threatening heart rhythm disturbances.

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

Taking Esertia with food, drinks and alcohol

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

As with many medicines, combining Esertia with alcohol is not recommended, although no interaction between Esertia and alcohol is expected.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using 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 pregnancy, the following effects may occur in the newborn baby: breathing difficulties, bluish skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, exaggerated reflexes, tremors, shaking, irritability, lethargy, constant crying, drowsiness, and sleep disturbances.

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

Ensure that your midwife and/or doctor know 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 of the newborn (PPHN), in which the baby breathes rapidly and appears blue. These symptoms usually begin within the first 24 hours after birth. If they occur in your baby, contact your midwife and/or doctor immediately.

If you take Esertia late in 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 be aware that you are taking Esertia so they can advise you appropriately.

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

Esertia is expected to be excreted in breast milk.

Citalopram, a medicine 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 using machines

It is advised not to drive or operate machinery until you know how Esertia affects you.

Esertia 20 mg/ml oral drops solution contains alcohol.

This medicine contains 4.7 mg of alcohol (ethanol) per 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 solution contains sodium

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

3. How to take Esertia

Follow exactly the instructions for administration of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Turn the bottle completely upside down. If no drops come out, gently tap the base of the bottle to start the flow.

Add the required number of drops to your drink (water, orange juice, or apple juice), gently stir, and then drink it all.

Esertia Oral Drops must not be mixed with other liquids or with other medicines.

Adults

Depression

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

Panic disorder

The initial dose of Esertia is 5 mg (5 drops) as a single daily dose for the first week before increasing the dose to 10 mg (10 drops) per day. Your doctor may subsequently increase it 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 daily dose. Your doctor may reduce your dose to 5 mg (5 drops) per day or increase it up to a maximum of 20 mg (20 drops) per day, depending on your response to the medicine.

Generalized anxiety disorder

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

Elderly patients (over 65 years of age)

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

Children and adolescents

Esertia should not normally be given to children and adolescents. For further information, please see section 2 “What you need to know before you start taking Esertia”.

Renal impairment

Caution is advised in patients with severely reduced 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.

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.

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 medicine without first speaking to your doctor.

Continue taking Esertia for the length of time recommended by your doctor. If you stop treatment too early, symptoms may return. It is recommended that treatment continues for at least 6 months after you feel well again.

If you take more Esertia than you should

If you take more Esertia than prescribed, contact your doctor immediately, go to the nearest hospital emergency department, or contact the Poison Information Service at telephone number 915 620 420. Do this even if you do not notice any discomfort or signs of poisoning. Some of the signs of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rate, decreased blood pressure, and disturbances in the body's fluid and electrolyte balance. Take the Esertia packaging with you if you go to the doctor or hospital.

If you forget to take Esertia

Do not take a double dose to make up for missed doses. If you forget to take a dose and remember before going to bed, take it immediately. The next day, continue as usual. If you remember during the night or the following day, skip the missed dose and continue as usual.

If you stop taking Esertia

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

When you stop taking Esertia, especially if abruptly, you may experience withdrawal symptoms. These are common when treatment with Esertia is stopped. The risk is greater when Esertia has been used for a long time, at high doses, or when the dose is reduced too quickly. Most people find these symptoms are mild and resolve on their own within two weeks. However, in some patients, they may be severe 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 restart your drops and taper off more slowly.

Withdrawal symptoms include: dizziness (unsteadiness or loss of balance), tingling sensations, burning sensations, and (less frequently) electric shock-like sensations, even in the head; sleep disturbances (vivid dreams, nightmares, inability to sleep); restlessness; headache; nausea (dizziness); sweating (including night sweats); feelings of unease or agitation; tremor (shakiness); feelings of confusion or disorientation; emotional or irritable feelings; diarrhea (loose stools); visual disturbances; palpitations.

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

4. Possible adverse effects

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

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

If you experience any of the following symptoms, you must contact your doctor or go to 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 breathing or swallowing difficulties (allergic reaction).
• High fever, agitation, confusion, tremors, and sudden muscle contractions, which may be signs of a rare condition called serotonin syndrome.

Not known (frequency cannot be estimated from available data):

• Difficulty urinating.
• Seizures (fits); see also section “Warnings and precautions”.
• Yellowing of the skin and whites of the eyes, signs of liver dysfunction/hepatitis.
• If you experience rapid or irregular heartbeats or fainting, symptoms which may indicate a life-threatening condition known as Torsade de Pointes.
• Thoughts of harming yourself or thoughts of killing yourself; see also section “Warnings and precautions”.

In addition to the above, the following adverse 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 runny nose (sinusitis).
• Decreased or increased appetite.
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, feeling drowsy, dizziness, yawning, tremors, skin itching.
• Diarrhoea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual disturbances (delayed ejaculation, problems with erection, reduced sexual interest, and women may experience difficulty achieving orgasm).
• Fatigue, fever.
• Weight gain.

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

• Hives, skin rash, itching (pruritus).
• Teeth grinding, restlessness, nervousness, panic 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 periods.
• Weight loss.
• Fast heart rate.
• Swelling of arms and legs.
• Nosebleeds.

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

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

Not known (frequency cannot be estimated from available data):

• Decreased sodium levels in the blood (symptoms include dizziness and malaise with muscle weakness or confusion).
• Dizziness upon standing due to low blood pressure (orthostatic hypotension).
• Abnormal liver function tests (increased liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Signs of increased bleeding, e.g. bruising or mucosal bleeding (ecchymoses) and low platelet count in the blood (thrombocytopenia).
• Sudden swelling of the skin or mucous membranes (angioedema).
• Increased secretion of a hormone called ADH, causing the body to retain water and dilute the blood, thereby reducing sodium levels (inappropriate ADH secretion).
• Increased levels of the hormone prolactin in the blood.
• Milk discharge 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 medicine.
• Changes in heart rhythm (known as “prolongation of the QT interval”, seen on ECG, the electrical activity of the heart).
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2 “Pregnancy, breastfeeding and fertility” for further information.

Additionally, other adverse effects are known to occur with drugs that act similarly to escitalopram (the active substance in Esertia). These include:

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

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Esertia

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

After opening the container, the drops may be used for 8 weeks and should be stored below 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Esertia

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

1 drop contains 1 mg of escitalopram.

The other components are:

Propyl gallate
Anhydrous citric acid
Ethanol 96%
Sodium hydroxide
Purified water

Appearance of the product and contents of the pack

Esertia oral drops solution is supplied in a 15 ml amber glass bottle with a dropper.

Esertia 20 mg/ml Oral Drops Solution is a clear, almost colourless 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 medicine has been authorised in the EEA Member States under the following names:

Spain: Esertia
Italy: Entact
Sweden: Prilect

Date of the most recent review of this summary: December 2023

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