Leaflet: Information for the user

Cipralex 20 mg/ml Oral Solution

escitalopram

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.

Cipralex contains the active ingredient escitalopram. Cipralex belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).

Cipralex contains escitalopram and is indicated for the treatment of depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder) in adults aged 18 years and older.

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

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

No take Cipralex

• If you are allergic to escitalopram or any of the other components of this medication (including those listed in section 6).

• If you are taking other medications that belong to the group called monoamine oxidase inhibitors, including selegiline (used for the treatment of Parkinson's disease), moclobemide (used for the treatment of depression), and linezolid (an antibiotic).

• If you have a history of birth or have experienced an episode of arrhythmia (detected in an ECG, a test that evaluates the heart's function).

• If you are taking medications for heart rhythm problems or that may affect heart rhythm (see section 2 "Use of Cipralex with other medications").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cipralex.

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 Cipralex 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 Cipralex may alter blood sugar control. You may need to adjust your insulin and/or oral hypoglycemic medication dose.
• If you have low sodium levels in your blood.
• If you have a history of bleeding disorders or if you develop unusual bleeding or bruising, 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 that you may have a low sodium level due to severe and prolonged diarrhea and vomiting (being ill) or use of diuretics.
• If you experience rapid or irregular heartbeats, dizziness, fainting, or lightheadedness 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).

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 few weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Medications like Cipralex (also called ISRS/IRSN) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

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 medications require time to start working, usually around two weeks, although in some cases it may take longer.Yourrisk of having these thoughts is higher:

• 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 at any time you 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 friend that 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

Cipralex should 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 attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. However, your doctor may prescribe Cipralex to patients under 18 years old when they decide it is the best option for the patient. If your doctor has prescribed Cipralex to a patient under 18 years old and wants 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 old are taking Cipralex. Additionally, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Cipralex in this age group have not yet been demonstrated.

Use of Cipralex with other medications

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

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

• "Non-selective monoamine oxidase inhibitors (IMAOs)", which contain phenelzine, iproniazid, isocarboxazid, nialamide, and tranilcipromina as active ingredients. If you have taken any of these medications, you will need to wait 14 days before starting to take Cipralex. After finishing Cipralex, 7 days should pass before taking any of these medications.
• "Reversible selective MAO-A inhibitors", which contain moclobemide (used in the treatment of depression).
• "Irreversible MAO-B inhibitors", which 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 for the treatment of depression).
  • Sumatriptan and similar medications (used for the treatment of migraines) and tramadol and similar medications (opioids, used for severe pain). These increase the risk of side effects.
  • Cimetidine, lansoprazole, and omeprazole (used for the treatment of stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause an increase in escitalopram blood levels.
  • St. John's Wort (Hypericum perforatum) - a medicinal plant used for depression.
  • Aspirin and nonsteroidal anti-inflammatory drugs (medications used to relieve pain or reduce the risk of thrombosis, also called anticoagulants). These may increase the risk of bleeding.

• Warfarin, dipiridamol, and phenprocoumon (medications used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably monitor your blood clotting time at the start and end of treatment with Cipralex to check that your anticoagulant dose is still adequate.
• Mefloquine (used for the treatment of malaria), bupropion (used for the treatment of depression), and tramadol (used for the treatment of severe pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medications used for the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and ISRSs) due to the possible risk of lowering the seizure threshold
• Flecainide, propafenone, and metoprolol (used for cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). You may need to adjust your Cipralex dose.
• Medications 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 Cipralex if you are taking medications for heart rhythm problems or that may affect heart rhythm, e.g. antiarrhythmic Class IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, particular antimalarial treatment halofantrine), some antihistamines (astemizole, hydroxyzine, mizolastine). Contact your doctor for any additional consultation.

Taking Cipralex with food, drinks, and alcohol

Cipralex can be taken with or without food (see section 3 "How to take Cipralex").

As with many medications, it is not recommended to combine Cipralex and 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 medication.

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

If you take Cipralex during the last 3 months of your pregnancy, be aware that the following effects may be observed in the newborn: difficulty breathing, blue skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, muscle stiffness or weakness, intense reflexes, tremors, restlessness, irritability, drowsiness, and difficulty falling asleep. If your newborn has any of these symptoms, please contact your doctor immediately.

Make sure your midwife and/or doctor know that you are being treated with Cipralex.

During pregnancy, particularly in the last 3 months, medications like Cipralex 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, contact your midwife and/or doctor immediately.

If you take Cipralex 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 Cipralex to be able to advise you.

Cipralex should not be stopped abruptly during pregnancy.

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

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

Driving and operating machinery

It is recommended that you do not drive or operate machinery until you know how Cipralex may affect you.

Cipralex 20 mg/ml oral drops in solution contain alcohol.

This medication contains 100 mg of alcohol (ethanol 96%) per ml, which is equivalent to 11.8% v/v. The amount in 1 ml of this medication is equivalent to less than 3 ml of beer or 1 ml of wine. The small amount of alcohol in this medication will have no noticeable effect.

Cipralex 20 mg/ml oral drops in solution contain sodium

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

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

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

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

Cipralex Oral Drops should not be mixed with other liquids or other medications.

Adults

Depression

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

Anxiety Disorder

The initial dose of Cipralex 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 further up to a maximum of 20 mg (20 drops) per day.

Social Anxiety Disorder

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

Generalized Anxiety Disorder

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

Obsessive-Compulsive Disorder

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

Children and Adolescents

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

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 Cipralex even if you start feeling better before the expected time.

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

Continue taking Cipralex 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 you feel well again.

If you take more Cipralex than you should

If you take more doses of Cipralex than prescribed, contact your doctor immediately, go to the nearest hospital emergency room, or consult the Toxicology Information Service, phone 915.620.420. Do it even when you do not observe discomforts 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 Cipralex bottle with you to the doctor or hospital.

If you forget to take Cipralex

Do not take a double dose to compensate for the missed doses. If you forget 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 Cipralex

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

When you stop taking Cipralex, especially if it is done abruptly, you may experience withdrawal symptoms. These are common when Cipralex treatment is suspended. The risk is higher when Cipralex 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 Cipralex, 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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can have side effects, although not everyone will experience them.

The 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 improve when you start to feel better.

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

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

• Unusual bleeding, including gastrointestinal bleeding.

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

• Swelling of the skin, tongue, lips, or face, or difficulty breathing or swallowing (severe allergic reaction).
• High fever, agitation, confusion, tremors, and sudden muscle contractions, which may be signs of a rare condition called serotonin syndrome.

Unknown (cannot be determined from available data):

• Difficulty urinating.
• Seizures (attacks), see also the "Warnings and precautions" section.
• Yellowing of the skin and the white 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.
• Sudden swelling of the skin or mucous membranes (angioedema).

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

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

• Feeling dizzy (nausea).
• Headache.

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

• Blockage 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 dysfunction (delayed ejaculation, erectile dysfunction, decreased sexual behavior, and women may experience difficulty reaching orgasm).
• Fatigue, fever.

• Weight gain.

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

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

• Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Hair loss.
• Excessive menstrual bleeding.
• Irregular menstrual period
• Weight loss.
• Fast heart rate.
• Swelling of the arms and legs.
• Nasal bleeding.

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

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

Unknown (cannot be determined from available data):

• Decreased sodium levels in the blood (symptoms are feeling dizzy and feeling unwell with 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) and low platelet count in the blood (thrombocytopenia).
• Sudden swelling of the 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.
• Increased levels of prolactin hormone in the blood.
• 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).
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

In addition, other side effects are known to appear with medications that act similarly to escitalopram (the active ingredient in Cipralex). 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 medication after 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.

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

Composition of Cipralex

The active ingredient is escitalopram. Each ml of Cipralex oral drops contains 20 mg of the active ingredient escitalopram (as escitalopram oxalate).

1 drop contains 1 mg of escitalopram.

The other components are:

Propyl gallate

Anhydrous citric acid

96% ethanol

Sodium hydroxide

Purified water

Appearance of the product and contents of the package

Cipralex Oral Drops in solution are presented in a topaz-colored glass bottle with a 15 ml dropper.

Cipralex Oral Drops in solution is a transparent, almost colorless to yellowish solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Lundbeck España, S.A.

Av. Diagonal, 605,7º 2ª

08028 Barcelona

Spain

Responsible for manufacturing

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

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

Republic of Czechia:Cipralex 20mg/ml

Denmark:Cipralex

Finland:Cipralex

France:Seroplex

Germany:Cipralex 20mg/ml Tropfen zum Einnehmen, Lösung

Greece:Cipralex

Italy:Cipralex

Norway:Cipralex

Portugal:Cipralex

Spain:Cipralex

Sweden:Cipralex

United Kingdom:Cipralex

Last review date of this leaflet: December 2023

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