ESCITALOPRAM CINFA 20 mg/ml ORAL SOLUTION DROPS EFG

Introduction

Package Leaflet: Information for the Patient

escitalopram cinfa 20 mg/ml oral drops in solution EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

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

1. What is escitalopram cinfa and what is it used for

escitalopram cinfa contains the active substance escitalopram. Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medications act on the serotonin system in the brain by increasing the level of serotonin. Alterations in the serotonin system are considered a major factor in the development of depression and related diseases.

escitalopram cinfais indicated for the treatment of depression (major depressive episodes) and anxiety disorders (such as anxiety 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 escitalopram even if it takes time to notice any improvement.

You should consult a doctor if your symptoms worsen or do not improve.

2. What you need to know before taking escitalopram cinfa

Do not take escitalopram cinfa

• If you are allergic to escitalopram or any of the other components of this medication (listed in section 6).
• If you are taking other medications that belong to the group called MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).
• If you have been born with or have had an episode of altered heart rate (detected on an electrocardiogram, a test to evaluate heart function).
• If you are taking medications for heart rhythm problems or that may affect heart rhythm (see section 2 "Other medications and escitalopram cinfa").

Warnings and precautions

Consult your doctor or pharmacist before starting to take escitalopram cinfa.

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 escitalopram should be discontinued if seizures occur for the first time or if you notice 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 escitalopram may alter blood sugar control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic medication,
• 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 artery disease,
• If you have or have had heart problems or have recently had a heart attack,
• If your resting heart rate is slow and/or you know you may have a decrease in salt levels as a result of severe and prolonged diarrhea and vomiting (being sick) or the use of diuretics (water tablets),
• 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).

Some medications in the same group as escitalopram (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment is discontinued.

Please note

Some patients with manic-depressive illness may enter a manic phase. This is characterized by an uncommon and rapid change of ideas, excessive 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.

Suicidal thoughts and worsening of your 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 taking antidepressants for the first time, as all these medications require time to start taking effect, usually around two weeks, although in some cases it may take 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. Clinical trial information 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 package 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

Escitalopram should not normally be used in the treatment of children and adolescents under 18 years of age. Also, you should know that in patients under 18 years of age, there is a greater risk of side effects such as suicidal attempts, suicidal ideas, and hostility (predominantly aggression, confrontational behavior, and irritation) when taking this class of medications. Nevertheless, your doctor may prescribe escitalopram to patients under 18 years of age when they decide it is most convenient for the patient. If the doctor who corresponds to you has prescribed escitalopram to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor.

You should inform your doctor if any of the symptoms described above progress or if you experience complications when patients under 18 years of age are taking escitalopram. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of escitalopram in this age group have not yet been demonstrated.

Other medications and escitalopram cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

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

• Non-selective monoamine oxidase inhibitors (MAOIs) that contain phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active ingredients. If you are taking any of these medications, you will need to wait 14 days before starting to take escitalopram. After finishing escitalopram, 7 days must pass before taking any of these medications.
• Reversible MAO-A inhibitors that contain moclobemide (used in the treatment of depression).
• Irreversible MAO-B inhibitors that 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 in the treatment of depression).
• Sumatriptan and similar medications (used in the treatment of migraines) and tramadol (used against severe pain). These increase the risk of side effects.
• Cimetidine, lansoprazole, and omeprazole (used in the treatment of stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke). These may increase escitalopram levels in the blood.
• St. John's Wort (Hypericum perforatum) - a medicinal plant used for depression.
• Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (medications used to relieve pain or reduce the risk of thrombosis, also called anticoagulants). These may increase the tendency to bleeding.
• Warfarin, dipyridamole, and phenprocoumon (medications used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably monitor the blood coagulation time at the start and end of treatment with escitalopram to check that the anticoagulant dose is still adequate.
• Mefloquine (used in the treatment of malaria), bupropion (used in the treatment of depression), and tramadol (used in the treatment of intense pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medications used in 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) and clomipramine and nortriptyline (antidepressants) and risperidone, thioridazine, and haloperidol (antipsychotics). It may be necessary to adjust the dose of escitalopram.
• Medications that decrease potassium or magnesium levels in the blood, as this increases the risk of heart rhythm disorders, which can be life-threatening.

Do not take escitalopram if you are taking medications 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, some antimicrobials (e.g., sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, treatment against malaria, particularly halofantrine), some antihistamines (astemizole, hydroxyzine, mizolastine). Contact your doctor for any additional questions.

Taking escitalopram cinfa with food, drinks, and alcohol

Escitalopram can be taken with or without food (see section 3 "How to take escitalopram cinfa"). As with many medications, it is not recommended to combine escitalopram with alcohol, although it is not expected that escitalopram will interact with alcohol.

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 medication.

Do not take escitalopram if you are pregnant or breastfeeding, unless you and your doctor have analyzed the risks and benefits involved.

If you take escitalopram 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, restlessness, irritability, lethargy, constant crying, and difficulty sleeping. If your newborn baby has any of these symptoms, please contact your doctor immediately.

If you take escitalopram in the final stage of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking escitalopram to advise you.

Make sure your midwife and/or doctor know that you are being treated with escitalopram. During pregnancy, particularly in the last three months, medications like escitalopram 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 within the first 24 hours after birth. If they appear in your baby, you should contact your midwife and/or doctor immediately.

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

It is expected that escitalopram will be excreted in breast milk.

Citalopram, a medication similar to escitalopram, has been shown to reduce sperm quality in animal models. This effect could theoretically affect fertility, but to date, its impact on human fertility has not been observed.

Driving and using machines

During treatment with escitalopram, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how the treatment with escitalopram affects you.

escitalopram cinfa contains ethanol.

This medication contains 4.7 mg of alcohol (ethanol) per drop. The amount in one drop of this medication is equivalent to less than 0.117 ml of beer or 0.047 ml of wine. The small amount of alcohol in this medication does not produce any noticeable effect.

escitalopram cinfa contains sodium.

This medication contains less than 1 mmol of sodium (23 mg) per drop; it is essentially "sodium-free".

3. How to take escitalopram cinfa

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

escitalopram cinfa oral drops in solution come in a 15 ml bottle with a dropper.

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

Do not mix escitalopram cinfa oral drops with other liquids or with other medications.

Adults

Depression

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

Anxiety disorder

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

Social anxiety disorder

The recommended dose of escitalopram 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 to a maximum of 20 mg (20 drops) per day, depending on how you respond to the medication.

Generalized anxiety disorder

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

Obsessive-compulsive disorder

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

Elderly patients (over 65 years old)

The recommended dose of escitalopram is 5 mg (5 drops) taken as a single dose per day.

The dose may be increased by your doctor to 10 mg (10 drops) per day.

Children and adolescents

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

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.

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 escitalopram 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 escitalopram for the time recommended by your doctor. If you interrupt treatment too early, symptoms may reappear. It is recommended that treatment continue for at least 6 months after feeling better again.

If you take more escitalopram cinfa than you should

If you take more escitalopram than you should, notify your doctor or pharmacist immediately.

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 hydro-saline balance. Bring the escitalopram package if you go to the doctor or hospital.

If you forget to take escitalopram cinfa

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, leave the forgotten dose and follow the usual routine.

If you stop taking escitalopram cinfa

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

When you stop taking escitalopram, especially if it is sudden, you may feel withdrawal symptoms. These are common when treatment with escitalopram is suspended. The risk is greater when escitalopram 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 escitalopram, please contact your doctor. He or she may ask you to start taking your drops again and stop them more slowly.

Withdrawal symptoms include: feeling of dizziness (unstable or without balance), feeling of tingling, feeling of itching, and (less frequently) electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of nausea (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.

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people suffer from them.

Adverse 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 adverse effects(may affect up to 1 in 100 patients):

• Unusual bleeding, including gastrointestinal bleeding.

Rare adverse effects(may affect up to 1 in 1000 patients):

• Swelling of the skin, tongue, lips, or face, or has 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.

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

• Difficulty urinating.
• Seizures (attacks), see also the "Warnings and precautions" section.
• Yellowish skin and whitening of the eyes, are 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.
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

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

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

• Feeling nauseous (nausea).
• Headache.

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

• Nasal congestion or runny nose (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty falling asleep, feeling drowsy, 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 adverse effects(may affect up to 1 in 100 patients):

• 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 adverse effects(may affect up to 1 in 1000 patients):

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

Frequency not known(cannot be estimated 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).
• 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).
• 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).

In addition, other adverse effects are known to occur with drugs that work similarly to escitalopram (the active ingredient in escitalopram cinfa). These are:

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse 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 adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of escitalopram cinfa

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the package 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.

Keep the bottle perfectly closed and in a vertical position.

This medication does not require special storage conditions if it is closed.

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

6. Package contents and additional information

Composition of escitalopram cinfa

• The active ingredient is escitalopram. Each ml of escitalopram cinfa oral drops contains 20 mg of escitalopram (as escitalopram oxalate). Each drop contains 1 mg of escitalopram.

• The other components are: propyl gallate, anhydrous citric acid, 96% ethanol, sodium hydroxide, and purified water.

Appearance of the product and package contents

escitalopram cinfa oral drops in solution. It comes in a 15 ml amber glass bottle (Type III), provided with a dropper (polyethylene) and a child-resistant screw cap (polypropylene). It is a clear solution with a bitter taste.

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Chanelle Medical Unlimited Company, Loughrea, Co.

Galway, Ireland

This medication is authorized in the EEA Member States with the following names:

Date of the last revision of this leaflet:June 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/

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76398/P_76398.html

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