Essential 20 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Essential 20 mg/ml oral solution drops EFG

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 could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Essential is and what it is used for

Essential belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). SSRIs act on the serotonergic system in the brain, increasing the level of serotonin. Disturbances in the serotonergic system are considered an important factor in the development of depression and related disorders.

Essential contains escitalopram which is used to treat:

• depression (major depressive episodes)
• anxiety disorders (such as panic disorder with or without agoraphobia (fear of crowds/bridges/outdoor spaces))
• social anxiety disorder
• generalized anxiety disorder
• obsessive-compulsive disorder.

2. What you need to know before taking Essential

Do not take Essential:

• if you are allergic to escitalopram or to any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”)
• if you are taking other medicines belonging to the group known as monoamine oxidase inhibitors (MAO inhibitors), including selegiline (used for the treatment of Parkinson’s disease), moclobemide (used for the treatment of depression), or linezolid (an antibiotic)
• if you have a congenital condition or have experienced an episode of abnormal heart rhythm (detected on an ECG; a test that evaluates heart function)
• if you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm (see section 2 “Using Essential with other medicines”).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Essential.

Please inform your doctor if you have any of the following conditions or illnesses, as your doctor may need to take them into account. Specifically, tell your doctor:

• If you have epilepsy. Treatment with Essential 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 suicidal thoughts or thoughts of self-harm. Please see below under: ‘Suicidal thoughts and worsening of depression or anxiety disorder’
• If you have liver or kidney problems. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Essential may affect blood glucose control. Adjustment of insulin and/or oral hypoglycemic agent dosage may be necessary.
• If you have low sodium levels in your blood.
• If you are under 18 years of age.
• If you have a history of mania or bipolar disorder (manic-depressive illness).
• If you are prone to bleeding or bruising, or if you are pregnant (see “Pregnancy, breastfeeding and fertility”).
• If you are taking any other medication, including herbal remedies. Please see below under: ‘Other medicines and Essential’
• If you are receiving electroconvulsive therapy (ECT).
• If you have narrow-angle glaucoma or a history of glaucoma.
• If you have coronary heart disease.
• If you are pregnant or breastfeeding.
• If you have heart problems or have recently had a heart attack.
• If your resting heart rate is slow and/or you know you may have low levels of salt due to severe and prolonged diarrhea and vomiting (being unwell) or use of diuretics.
• If you experience rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm.

If you have bipolar disorder, you may enter a manic phase. This is characterized by unusually rapid and frequent shifts 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 (akathisia) may also occur during the first few weeks of treatment. Inform your doctor immediately if you experience these symptoms.

If you have a panic disorder, you may experience increased anxiety symptoms at the beginning of treatment. Contact your doctor immediately if you experience these symptoms.

Some medicines in the same group as escitalopram (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms may 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 yourself or ending your life. These thoughts may increase when you first start taking antidepressants, as all such medicines take time to become effective—usually about two weeks, although sometimes 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 behavior 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 help to tell a close family member or 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 has worsened, or if they are concerned about changes in your behavior.

Use in pediatric population (under 18 years of age)

Essential should not normally be used in the treatment of pediatric patients (under 18 years of age). You should also be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontation, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe escitalopram to patients under 18 years of age if they decide it is the most appropriate treatment. If your doctor has prescribed Essential 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 complications arise while patients under 18 years of age are taking Essential. In addition, the long-term effects on safety, and on growth, maturation, and cognitive and behavioral development in this age group have not yet been fully established.

Taking Essential with other medicines

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

Tell 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 Essential. After stopping Essential, you must wait 7 days before taking any of these medicines.
• Selective and reversible 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 adverse effects.
• The antibiotic linezolid.
• Lithium (used to treat bipolar disorder) and tryptophan (an amino acid).
• Other medicines used to treat depression such as tricyclic antidepressants or other selective serotonin reuptake inhibitors (SSRIs) such as imipramine, desipramine, and fluvoxamine.
• Sumatriptan and similar medicines (used to treat migraine), tramadol and buprenorphine (used to treat severe pain). These increase the risk of adverse effects.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers or dyspepsia (indigestion)), 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 for pain relief or to reduce the risk of thrombosis, also known as anticoagulants).
• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also known as anticoagulants). Your doctor will likely monitor your blood clotting time at the beginning and end of treatment with Essential to ensure your anticoagulant dose remains appropriate.
• Mefloquine (used to treat malaria), tricyclic antidepressants or selective serotonin reuptake inhibitors (SSRIs), bupropion (used to treat depression), tramadol (used to treat severe pain), and antipsychotics (medicines used to treat schizophrenia, psychosis). These may increase the risk of lowered seizure threshold.
• Flecainide, propafenone, and metoprolol (used for cardiovascular conditions), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dosage of Essential may need to be adjusted.
• Medicines that reduce blood levels of potassium or magnesium, as these conditions increase the risk of life-threatening heart rhythm disorders.

DO NOT TAKE Essential if you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm, such as 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 treatment, especially halofantrine), or certain antihistamines (astemizole, hydroxyzine, mizolastine). If you have any doubts, consult your doctor.

Taking Essential with food, drinks, and alcohol

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

As with many medicines, it is not recommended to combine Essential with alcohol, although interactions with alcohol are expected to be minimal.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

If you take Essential during the last 3 months of pregnancy, be aware that 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 difficulty sleeping. 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 Essential. During pregnancy, particularly in the last 3 months, medicines like Essential 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 Essential is used during pregnancy, it should never be stopped abruptly.

If you take Essential 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 Essential so they can advise you appropriately.

Citalopram, a medicine similar to escitalopram, has been shown in animal studies to reduce sperm quality. Theoretically, this could affect fertility, but no impact on human fertility has been observed so far.

Driving and using machines

It is advised that you do not drive or operate machinery until you know how Essential affects you.

Essential 20 mg/ml oral drops solution contains ethanol and sodium

This medicine contains 4.8 mg of alcohol (ethanol) per drop. The amount in 5 drops (24 ml) of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.

This small amount of alcohol in this medicine will have no notable effect.

This medicine contains less than 1 mmol of sodium (23 mg) per ml (20 drops), i.e., essentially “sodium-free”.

3. How to take Essential

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

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

Instructions for use:

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

Essential oral drops solution must not be mixed with liquids other than water, orange juice, or apple juice, or with other medicines.

Adults

Depression

The recommended dose of Essential is 10 mg (10 drops) taken as a single daily dose. Your doctor may increase your dose up to a maximum of 20 mg (20 drops) daily.

Panic disorder

The initial dose of Essential is 5 mg (5 drops) daily for the first week, before increasing the dose to 10 mg (10 drops) daily. Your doctor may increase the dose up to a maximum of 20 mg (20 drops) daily.

Social anxiety disorder

The recommended dose of Essential is 10 mg (10 drops) taken as a single daily dose. Your doctor may reduce your dose to 5 mg (5 drops) daily or increase it up to a maximum of 20 mg (20 drops) daily, depending on your response to the medicine.

Generalized anxiety disorder

The recommended dose of Essential is 10 mg (10 drops) taken as a single daily dose. Your doctor may increase the dose up to a maximum of 20 mg (20 drops) daily.

Obsessive-compulsive disorder

The recommended dose of Essential is 10 mg (10 drops) taken as a single daily dose. Your doctor may increase the dose up to a maximum of 20 mg (20 drops) daily.

Elderly patients (over 65 years of age)

The recommended initial dose of Essential is 5 mg (5 drops) taken as a single daily dose. Your doctor may increase the dose up to 10 mg (10 drops) daily.

Paediatric population (under 18 years of age)

Essential is not normally recommended for children and adolescents. For further information, please see section 2 “What you need to know before taking Essential”.

Duration of treatment

It may take a few weeks before you start to feel better. Continue taking Essential even if you start to feel better before the expected time.

Do not change the dose of this medicine without first speaking to your doctor.

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

If you take more Essential than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, stating the medicine and the amount taken. Do this even if you do not notice any discomfort or signs of poisoning. Some signs of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and disturbances in the body's fluid and electrolyte balance. Take the Essential packaging with you if you go to the doctor or hospital.

If you forget to take Essential

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 Essential

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

When you stop taking Essential, especially if abruptly, you may experience the following symptoms:

Dizziness (feeling unsteady or off balance), tingling sensations, burning sensations, and (less frequently) electric shock-like sensations, even in the head; sleep disturbances (overly vivid dreams, nightmares, inability to sleep); restlessness, headache, dizziness (nausea), sweating (including night sweats), feelings of unease or agitation, tremor (shakiness), confusion or disorientation, emotional lability or irritability, diarrhoea (loose stools), visual disturbances, palpitations.

These symptoms are common when stopping treatment with Essential. The risk is greater when Essential 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 resolve on their own within two weeks. However, in some patients, they may be severe or prolonged (2–3 months or longer). If you experience severe withdrawal symptoms when stopping Essential, please contact your doctor. Your doctor may advise you to restart your drops and taper off more slowly.

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

4. Possible adverse effects

Like all medicines, Essential may cause adverse effects, although not everyone experiences them.

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

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

• Difficulty urinating.
• Seizures (fits) – see also section "Warnings and precautions".
• Yellowing of the skin and whitening of the eyes, which are signs of liver dysfunction/hepatitis.
• Irregular and rapid heartbeat, fainting, which could be symptoms of a life-threatening condition known as Torsades de Pointes.

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

• Unusual bleeding, including gastrointestinal and rectal bleeding.

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

• If you experience swelling of the skin, tongue, lips, or face, or have difficulty breathing or swallowing (allergic reaction).
• If you have high fever, restlessness, confusion, tremors, and sudden muscle contractions, which could be signs of a very rare condition called serotonin syndrome.

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

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

• Feeling dizzy (nausea).
• Headache.

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

• Stuffy nose or nasal discharge (sinusitis).
• Changes in appetite (increased or decreased), weight gain.
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, tingling of the skin.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual problems (delayed ejaculation, erection problems, reduced sexual desire, and in women, difficulty achieving orgasm).
• Feeling tired (fatigue), fever.

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

• Hives (urticaria), rash, itching (pruritus).
• Teeth grinding, restlessness, nervousness, panic attacks, confusion.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Hair loss.
• Vaginal bleeding disorders (metrorrhagia and menorrhagia).
• Weight loss.
• Rapid heartbeat (tachycardia).
• Swelling in arms and legs.
• Nosebleeds.

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

• Aggression, depersonalization/derealization, seeing or hearing things that are not real (hallucinations).
• Slow heartbeat (bradycardia).

Frequency not known (frequency cannot be estimated from the available data):

• Thoughts of self-harm or suicidal ideation – see also section "Warnings and precautions".
• Low levels of sodium in the blood (symptoms include: dizziness, nausea, muscle weakness, or confusion).
• Dizziness upon standing due to low blood pressure (orthostatic hypotension).
• Abnormal liver function tests (increased blood levels of liver enzymes) and abnormal ECG (electrocardiogram) readings.
• Movement disorders (involuntary muscle movements, dyskinesia).
• Painful erection (priapism).
• Bleeding disorders including bleeding into the skin and mucous membranes (ecchymosis) and low platelet count (thrombocytopenia).
• Sudden swelling of the skin or mucous membranes (angioedema).
• Increased urine output (inappropriate ADH secretion).
• Increased blood levels of prolactin hormone.
• Milk production in women who are not breastfeeding.
• Mania.
• Increased risk of bone fractures in patients taking this type of medicine.
• Changes in heart rhythm (known as "QT interval prolongation", seen on ECG, electrical activity of the heart).
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage) – see "Pregnancy, breastfeeding and fertility" in section 2 for more information.

In addition, a number of adverse effects are known to occur with drugs that work in a similar way to escitalopram (the active substance in Essential). These include:

• Psychomotor agitation, urge or need to move in order to relieve an unpleasant sensation (akathisia).
• Loss of appetite (anorexia).

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 Essential

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

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

After opening the container, the drops can be used for 8 weeks and should be stored at a temperature below 25°C.

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

6. Contents of the container and additional information

Composition of Essential

The active substance is escitalopram. Each ml of Essential contains 20 mg escitalopram (as 25.55 mg escitalopram oxalate).

Each drop contains 1 mg escitalopram.

The other components are:

Propyl gallate

Citric acid

Ethanol 96%

Sodium hydroxide

Purified water.

Appearance of Essential and contents of the container

Essential oral drops solution is a clear, almost colourless to yellow solution.

It is supplied in an amber glass bottle containing 15 ml, with a dropper.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

Laguna, 66-68-70. Poligono Industrial Urtinsa II

28923, Alcorcón (Madrid)

Spain

Manufacturer:

Doppel Farmaceutici S.r.l.

Via Martiri delle Foibe, 1

29016 Cortemaggiore (PC)

Italy

or

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-68-70, Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Essential 20 mg/ml Oral Drops Solution EFG

Italy: ESCITALOPRAM TEVA GENERICS

Date of the most recent review of this leaflet: November 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/