Leaflet: information for the patient

escitalopram cinfa 20 mg/ml oral drops in EFG solution

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

escitalopram cinfa contains the active ingredient escitalopram. Escitalopram belongs to a group of antidepressants known as 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 an important 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 panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder) in adults aged 18 years and older.

You may notice an improvement in a couple of weeks. Continue taking escitalopram even if it takes time to notice some improvement.

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

Do not take escitalopram cinfa

• If you are allergic to escitalopram or any of the other ingredients in this medicine (listed in section 6).
• If you are taking other medicines that belong to a group called MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).
• If you have had a birth or have experienced an episode of abnormal heart rhythm (detected by an electrocardiogram, a test to evaluate heart function).
• If you are taking medicines for heart rhythm problems or that may affect heart rhythm (see section 2 “Other medicines 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 condition 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 interrupted if seizures occur for the first time or if you observe an increase in seizure frequency (see also section 4 “Possible side effects”),
• If you have liver or kidney insufficiency. Your doctor may need to adjust your dose,
• If you have diabetes. Treatment with escitalopram may alter blood sugar control. You may need to adjust your insulin and/or oral hypoglycemic dose,
• If you have low sodium levels in your 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 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 low sodium levels as a result of severe and prolonged diarrhea and vomiting (being ill) or the use of diuretics (tablets that dissolve in water),
• If you experience rapid or irregular heartbeats, dizziness, fainting, 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 medicines in the group to which escitalopram belongs (called ISRS/IRSN) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Please note

Some patients with manic-depressive illness may enter a manic phase. This is characterized by unusual and rapid changes in 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 weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may occasionally have thoughts of harming yourself or committing suicide. These may increase when taking antidepressants for the first time, as all these medicines take time to start working, usually around two weeks, although in some cases it may take longer.Youmay be more prone to having these thoughts:

• If you have previously had thoughts of harming yourself or committing suicide.
• If you are ayoung adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years old with psychiatric illnesses who were treated with an antidepressant.

If you ever have thoughts of harming yourself or committing suicide, contact your doctor or go directly to a hospital.

It may be helpful for you to tell a family member or close friendthat you are depressed or have an anxiety disorder and ask them to read this leaflet. You can ask them if they think your depression or anxiety disorder has worsened. Or if they are concerned about changes in your attitude.

Children and adolescents

Escitalopramshould not be used normally in the treatment of children and adolescents under 18 years old. Also, be aware that in patients under 18 years old, there is a higher risk of adverse effects such as suicidal behavior, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. However, your doctor may prescribe escitalopram to patients under 18 years old when they decide it is the best option for the patient. If your doctor has prescribed escitalopram to a patient under 18 years old and wants to discuss this decision, please return to your doctor.

Please inform your doctor if any of the symptoms described above progress or if you experience complications when patients under 18 years old are taking escitalopram.Also, the long-term effects regarding safety and related to growth, maturity, and cognitive and behavioral development of escitalopramin this age group have not yet been demonstrated.

Other medicines and escitalopram cinfa

Please inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

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

• “Non-selective monoamine oxidase inhibitors (MAOIs)”, containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active ingredients. If you are taking any of these medicines, you will need to wait 14 days before starting to take escitalopram. After stopping escitalopram, 7 days should pass before taking any of these medicines.
• "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 side effects.
• The antibiotic linezolid.
• Lithium (used to treat manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medicines (used to treat migraines) and tramadol (used to treat 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). They may increase escitalopram levels in the blood.
• St. John's Wort (Hypericum perforatum) – a medicinal plant used to treat depression.
• Aspirin and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or reduce the risk of blood clots, also called anticoagulants). They may increase the risk of bleeding.
• Warfarin, dipiridamol, and phenprocoumon (medicines used to reduce the risk of blood clots, also called anticoagulants). Your doctor will probably monitor your blood clotting time at the start and end of treatment with escitalopram to check that the anticoagulant dose is still adequate.
• 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 ISRSs) 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). You may need to adjust your escitalopram dose.
• Medicines that lower potassium or magnesium levels in the blood, as this increases the risk of abnormal heart rhythm, which is life-threatening.

Do not take escitalopram if you are taking medicines for heart rhythm problems or that may affect heart rhythm, e.g. antiarrhythmics of Class IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, treatment for malaria, particularly halofantrine), some antihistamines (astemizole, hydroxyzine, mizolastine). Contact your doctor for any additional consultation.

Taking escitalopram cinfa with food, drinks, and alcohol

Escitalopramcan be taken with or without food (see section 3 “How to take escitalopram cinfa”). As with many medicines, it is not recommended to combine escitalopram with alcohol, although it is not expected to interact with alcohol.

Pregnancy, breastfeeding, and fertility

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

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: difficulty breathing, blue skin, convulsions, changes in body temperature, difficulty feeding, vomiting, low blood sugar, muscle stiffness or weakness, intense reflexes, tremors, restlessness, irritability, drowsiness, and difficulty sleeping. If your newborn has any of these symptoms, please contact your doctor immediately.

If you take escitalopram in the final stages 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 be able to advise you.

Ensure that your midwife and/or doctor know that you are being treated with escitalopram. During pregnancy, particularly in the last three months, medicines like escitalopram 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 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.

Escitalopram should not be stopped abruptly during pregnancy.

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

Citalopram, a similar medicine to escitalopram, has been shown to reduce sperm quality in animal models. Theoretically, this effect could affect fertility, but to date, it has not been observed in human fertility.

Driving and operating machinery

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

Escitalopram cinfa contains ethanol.

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

Escitalopram cinfa contains sodium.

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

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 are presented in a 15 ml bottle with a dropper.

Insert 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 other medications.

Adults

Depression

The recommended dose of escitalopram 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.

Anxiety Disorder

The initial dose of escitalopram 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 increase it further up 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 daily dose. Your doctor may decrease the dose to 5 mg (5 drops) per day or increase the dose up to a maximum of 20 mg (20 drops) per day, depending on how you respond to the medication.

Generalized Anxiety Disorder

The recommended dose of escitalopram 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 recommended dose of escitalopram 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.

Older Adults (65 years and older)

The recommended dose of escitalopram 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

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

Renal Insufficiency

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

Liver Insufficiency

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.

Treatment Duration

It may take a couple of weeks before you start feeling better. Continue taking escitalopram even if you start feeling better before the expected time.

Do not change the medication dose without talking to your doctor first.

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

If you take more escitalopram cinfa than you should

If you take more escitalopram than you should, inform 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 it even when you do not observe discomfort or signs of intoxication. Some signs of overdose may be dizziness, tremor, agitation, convulsion, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and changes in the body's electrolyte balance. Bring the escitalopram bottle with you to the doctor or hospital.

If you forgot to take escitalopram cinfa

Do not take a double dose to compensate for the missed doses. If you forgot to take a dose, and remember before going to bed, take it immediately. The next day, follow your usual schedule. If you remember during the night or the next day, leave the missed dose and follow your usual schedule.

If you interrupt the treatment with escitalopram cinfa

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

When you stop taking escitalopram, especially if it is done abruptly, you may experience withdrawal symptoms. These are common when escitalopram treatment is suspended. The risk is higher when escitalopram 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 disappear on their own in two weeks. However, in some patients, they can be intense or prolonged (2-3 months or more). If you experience severe withdrawal symptoms when stopping escitalopram, please contact your doctor. They may ask you to take your drops again and taper them off more slowly.

Withdrawal symptoms include: feeling of dizziness (unstable or loss of balance), feeling of tingling, feeling of prickling, and (less frequently) electric shock, even in the head, sleep disturbances (too intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of nausea (dizziness), sweating (including night sweats), feeling of anxiety or agitation, tremor (instability), feeling of confusion or disorientation, feelings of emotion or irritability, diarrhea (loose stools), vision disturbances, palpitations.

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

Like all medicines, this medicinecan cause side effects, although not everyone will experience them.

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

If you have any of the following symptoms, contact your doctor or go to the hospital immediately:

Rare side effects(may affect up to 1 in 100 patients):

• Unusual bleeding, including gastrointestinal bleeding.

Very rare side effects(may affect up to 1 in 1000 patients):

• Swelling of the skin, tongue, lips, or face, or difficulty breathing or swallowing (allergic reaction).
• High fever, agitation, confusion, tremors, and sudden muscle contractions, which may 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, which are signs of liver function impairment/hepatitis.
• Fast or irregular heartbeats or dizziness, symptoms that may indicate a life-threatening condition known as Torsade de Pointes.
• Thoughts of self-harm or suicidal thoughts, see also the "Warnings and precautions" section.
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

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

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

• Feeling dizzy (nausea).
• Headache.

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

• Stuffy nose or nasal discharge (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty falling asleep, feeling drowsy, dizziness, yawning, tremors, skin itching.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual difficulties (delayed ejaculation, erection problems, decreased sexual behavior, and women may experience difficulty reaching orgasm).
• Fatigue, fever.
• Weight gain.

Rare side effects(may affect up to 1 in 100 patients):

• Hives, skin rash, itching (pruritus).
• Teeth chattering, agitation, nervousness, anxiety attack, confusion.
• Sleep disturbances, taste alterations, 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.
• Nasal bleeding.

Very rare side effects(may affect up to 1 in 1000 patients):

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

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

• Decreased sodium levels in the blood (symptoms are feeling dizzy and experiencing muscle weakness or confusion).
• Dizziness when standing due to low blood pressure (orthostatic hypotension).
• Abnormal liver function tests (elevated liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Signs of increased bleeding, such as skin or mucous membrane bleeding (ecchymosis).
• Sudden swelling of skin or mucous membranes (angioedema).
• Inadequate secretion of the ADH hormone, which causes the body to retain water and dilute the blood, reducing sodium levels.
• Milk flow in men and 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 (known as "prolongation of the QT interval," observed on the ECG, heart electrical activity).

In addition, other side effects are known to occur with medications that act similarly to escitalopram (the active ingredient in escitalopram cinfa). These are:

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

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 System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Keep the bottle perfectly closed and in an upright position.

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

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of escitalopram cinfa

• The active ingredient is escitalopram. Each milliliter of oral drops of escitalopram cinfa 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 content of the container

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

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) – Spain

Responsible for manufacturing

Chanelle Medical Unlimited Company, Loughrea, Co.

Galway, Ireland

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

Last review date of this leaflet: June 2021

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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

QR code to: https://cima.aemps.es/cima/dochtml/p/76398/P_76398.html