ESSENTIAL 20 mg/ml ORAL DROPS IN SOLUTION

Introduction

Package Leaflet: Information for the Patient

Essential 20 mg/ml Oral Drops in EFG Solution

Escitalopram

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

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

Contents of the pack:

1. What Essential is and what it is used for
2. What you need to know before you take Essential
3. How to take Essential
4. Possible side effects
5. Storage of 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 called selective serotonin reuptake inhibitors (SSRIs). SSRIs act on the serotonin system in the brain, increasing the level of serotonin. Alterations in the serotonin 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, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder).

2. What you need to know before you take Essential

Do not take Essential:

• if you are allergic to escitalopram or 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 that belong to the group of monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic)
• if you have been born with or have had 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 that may affect heart rhythm (see section 2 "Using Essential with other medicines").

Warnings and precautions

Consult your doctor or pharmacist or nurse before starting to take Essential.

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

• If you have epilepsy. Treatment with Essential 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 suicidal thoughts or think about self-harm. Please see below the point: 'Suicidal thoughts and worsening of your 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 alter glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic.
• If you have a decreased sodium level in your blood.
• If you are under 18 years old
• If you have a history of mania or manic-depressive psychosis
• If you have a tendency to develop bleeding or bruising.
• If you are taking any other medication, including herbal remedies. Please see below the point: 'Other medicines and Essential'
• If you are receiving electroconvulsive therapy.
• 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 had heart problems or have recently had a heart attack.
• If your resting heart rate is slow and/or you know you may have low salt levels 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.

Please note:

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

Symptoms such as restlessness or difficulty sitting or standing (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 start of your treatment. Consult your doctor immediately if you experience these symptoms.

Some medicines in the same group as escitalopram (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. You are more likely to have these thoughts:

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

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

It may be helpful for you to tell a relative or close friendthat you are depressed or have an anxiety disorder, and ask them to read this leaflet. You can ask them if they think your depression or anxiety has worsened, or if they are concerned about changes in your attitude. Use in pediatric population (under 18 years old)

Essential should not normally be used in the treatment of pediatric population (under 18 years old). You should also know that in patients under 18 years old, there is a greater risk of adverse effects such as suicidal attempts, suicidal ideas, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this class of medicines. Nevertheless, the doctor in charge may prescribe escitalopram to patients under 18 years old when they decide it is most convenient for the patient. If the doctor in charge has prescribed Essential to a patient under 18 years old and you want 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 old are taking Essential. Also, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Essential in this age group have not yet been demonstrated.

Taking Essential with other medicines

Tell your doctor or pharmacist that you are using, or have recently used, or may need to use any other medicine.

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 ingredients. If you are taking any of these medicines, you will have to wait 14 days before starting to take Essential. After finishing taking Essential, 7 days must pass before taking any of these medicines.
• Reversible inhibitors of MAO-A that contain moclobemide (used in the treatment of depression).
• Irreversible inhibitors of MAO-B that contain selegiline (used in the treatment of Parkinson's disease). These increase the risk of adverse effects.
• The antibiotic linezolid.
• Lithium (used in the treatment of manic-depressive disorder) and tryptophan (amino acid)
• Other medicines used in the treatment of 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 (used to treat severe pain), and buprenorphine. These increase the risk of adverse effects.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers or dyspepsia), fluconazole (used to treat fungal infections), fluvoxamine (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 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 Essential to verify that the anticoagulant dose is still adequate.
• 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 neuroleptics (medicines for treating schizophrenia, psychosis) due to the possible risk of decreased seizure threshold.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dosage of Essential may need to be adjusted.
• Medicines that decrease blood levels of potassium or magnesium, as these conditions increase the risk of life-threatening heart rhythm disorders.

DO NOT TAKE Essentialif you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm, such as antiarrhythmics of classes IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobials (e.g., sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, malaria treatment, especially with halofantrine), 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").

Like many medicines, it is not advisable to combine Essential with alcohol, although it is expected that Essential 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 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 your pregnancy, be aware that the following effects may be observed in the newborn baby: breathing difficulties, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, increased reflexes, trembling, irritability, lethargy, constant crying, and sleep difficulties. 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 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 (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 Essential is used during pregnancy, it should never be stopped abruptly.

Citalopram, a medicine similar to escitalopram, reduces sperm quality in animal studies. This may theoretically affect fertility, but no impact on human fertility has been observed yet.

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

Driving and using machines

It is advised that you should not drive or use machinery until you know how Essential affects you.

Essential 20 mg/ml Oral Drops in Solution contains ethanol and sodium

This medicine contains 96 mg of alcohol (ethanol) in each ml (20 drops). The amount in 20 drops (1 ml) of this medicine is equivalent to less than 3 ml of beer or 1 ml of wine.

This small amount of alcohol in this medicine will not have any noticeable effect.

This medicine contains less than 23 mg of sodium (1mmol) per ml (20 drops), which is essentially "sodium-free".

3. How to take Essential

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

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

Instructions for use:

Invert the bottle completely. If no drops come out, gently tap the bottle to start the flow.

Essential oral drops in solution should not be mixed with liquids other than water or orange or apple juice, or with other medications.

Adults

Depression

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

Social Anxiety Disorder

The recommended dose of Essential is 10 mg (10 drops) taken in a single daily dose. Your doctor may decrease your dose to 5 mg (5 drops) daily or increase the dose to a maximum of 20 mg (20 drops) daily, depending on how you respond to the medication.

Generalized Anxiety Disorder

The recommended dose of Essential is 10 mg (10 drops) taken in a single daily dose. The dose may be increased by your doctor to a maximum of 20 mg (20 drops) daily.

Obsessive-Compulsive Disorder

The recommended dose of Essential is 10 mg (10 drops) taken in a single daily dose. The dose may be increased by your doctor 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 in a single daily dose. The dose may be increased by your doctor to 10 mg (10 drops) daily.

Pediatric population (under 18 years of age)

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

Duration of treatment

It may take a couple of 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 the medication without talking to your doctor first.

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

If you take more Essential than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. 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 hydroelectrolytic balance. Bring the Essential packaging if you go to the doctor or hospital.

If you forget to take Essential

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 interrupt treatment with Essential

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

When you stop taking Essential, especially if it is sudden, you may feel the following symptoms:

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

These are common when treatment with Essential is suspended. The risk is greater when Essential 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 Essential, please contact your doctor. He or she may ask you to start taking your drops again and reduce them more slowly.

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

4. Possible side effects

Like all medications, Essential can produce side effects, although not all people suffer from them.

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

If you experience the following side effects, you should contact your doctor or go to the hospital immediately:

• Difficulty urinating.
• Seizures (attacks), see also the section "Warnings and precautions”
• A yellowish tint to the skin and whitening of the eyes are signs of liver function alteration/hepatitis.
• Irregular and rapid heart rate, 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 skin inflammation, tongue, lip, or face swelling, or have difficulty breathing or swallowing (allergic reaction).
• If you have a high fever, agitation, confusion, tremors, and sudden muscle contractions, these may be signs of a very rare condition called serotonin syndrome.

In addition to the above side effects, the following side 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)
• Appetite alteration, weight gain
• Anxiety, agitation, abnormal dreams, difficulty falling asleep, somnolence, dizziness, yawning, tremors, skin tingling
• 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 of fatigue (fatigue), fever

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

• Hives (urticaria), rash, itching (pruritus)
• Teeth grinding, agitation, nervousness, panic attacks, confusion
• Sleep disturbances, or taste disturbances, fainting (syncope)
• Dilated pupils (mydriasis), visual disturbance, ringing in the ears (tinnitus)
• Hair loss
• Alteration of vaginal bleeding
• Weight loss
• Fast heart rate (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 heart rate (bradycardia).

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

• Thoughts of self-harm or suicidal ideas, see also the section "Warnings and precautions”
• Decreased sodium levels in the blood (symptoms are: feeling dizzy, unwell, with muscle weakness, or confused)
• Dizziness when standing up due to low blood pressure (orthostatic hypotension)
• Abnormal liver function tests (increased liver enzyme levels in blood) and abnormal ECG (electrocardiogram) readings
• Movement disorders (involuntary muscle movements)
• Painful erection (priapism)
• Bleeding disorders, including skin and mucous membrane bleeding (ecchymosis) and low platelet count (thrombocytopenia)
• Sudden inflammation of the skin or mucous membranes (angioedema)
• Increased urine production (inadequate ADH secretion)
• Milk flow in non-breastfeeding women
• Mania
• An increased risk of bone fractures has been observed in patients taking this type of medication
• Alteration of heart rhythm (called "prolongation of the QT interval", seen in the ECG, heart electrical activity).

In addition, it is known that a certain number of side effects occur with drugs that work similarly to escitalopram (the active ingredient of Essential). These are:

• Psychomotor restlessness, urge or need to move to stop an unpleasant sensation (akathisia)
• Lack of appetite (anorexia)

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 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 Essential

Keep this medication out of sight and reach of children.

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

Once the package 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 away in drains or trash. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Essential

The active ingredient 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

96% ethanol

Sodium hydroxide

Purified water.

Appearance of Essential and package contents

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

It comes in a 15 ml amber glass bottle with a dropper.

Marketing authorization holder and manufacturer

Marketing authorization holder:

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

Laguna, 66-70. 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 medication is authorized in the Member States of the European Economic Area with the following names:

Spain: Essential 20 mg/ml Oral drops in Solution EFG

Italy: ESCITALOPRAM TEVA GENERICS

Date of the last revision of this leaflet:March 2021

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