Package Leaflet: Information for the User

Cipralex 20 mg Film-Coated Tablets

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, ask your doctor or pharmacist.

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

1. What Cipralex is and what it is used for

2. What you need to know before you start taking Cipralex

3. How to take Cipralex

4. Possible side effects

5. Storage of Cipralex

6. Contents of the pack and additional information

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

Cipralex 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).

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 get worse or do not improve.

Do not take Cipralex

• 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 a history of birth or have experienced an episode of heart rhythm alteration (detected by an ECG, a test that evaluates heart function).

• If you are taking medications for heart rhythm problems or that may affect heart rhythm (see section 2 “Taking 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. Specifically, 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 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 that you may have low sodium levels as a result of 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 eye pressure).

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.

Medicines 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.Youmay be more prone to having these types of 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 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 side effects such as suicidal behavior, suicidal thoughts, and hostility (primarily 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. At the same time, 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.

Taking 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)”, containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranilcipromine as active ingredients. If you have taken any of these medications, you will need to wait 14 days before starting to takeCipralex. After stoppingCipralex, 7 days should pass before taking any of these medications.
• “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 medications (used to treat migraines) and tramadol and similar medications (opioids, used for 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). These may cause an increase inescitalopramblood levels.
  • St. John's Wort (Hypericum perforatum) – a medicinal plant used to treat depression.
  • 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 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 withCipralex, 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 (medications 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), 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 (astemizol, 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 contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Adults

Depression

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

Anxiety Disorder

The initial dose of Cipralex is 5 mg as a single dose per day during the first week before increasing the dose to 10 mg per day. Your doctor may increase it further up to a maximum of 20 mg per day.

Social Anxiety Disorder

The normally recommended dose of Cipralex is 10 mg taken as a single dose per day. Your doctor may decrease your dose to 5 mg per day or increase the dose up to a maximum of 20 mg per day, depending on how you respond to the medication.

Generalized Anxiety Disorder

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

Obsessive-Compulsive Disorder

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

Older Adults (65 years and older)

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

Use in Children and Adolescents

Cipralex should not normally be administered to children and adolescents. For additional information, please see the section 2 “Warnings and Precautions”.

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.

How to Take the Tablets

You can take Cipralex with or without food. Swallow the tablets with water. Do not chew them, as their taste is bitter.

If necessary, you can divide the 20 mg tablets by placing the tablet on a flat surface with the notch facing upwards. The tablets can be broken by pressing down on each end of the tablet with your two index fingers, as shown in the figure.

The 20 mg tablets can be divided into equal doses.

Treatment Duration

You may feel better in a couple of weeks. 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 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 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 this even if you do not observe any discomfort or signs of overdose. Some signs of overdose may include 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 packaging 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 Treatment with Cipralex

Do not interrupt 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 tablets again and taper off them 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 nocturnal sweating), feeling of anxiety or agitation, tremor (instability), feeling of confusion or disorientation, feelings of emotion or irritability, diarrhea (loose stools), visual disturbances, rapid heartbeat or 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.

Side effects usually disappear after a few weeks of treatment. Please be aware that many of the side 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:

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

• Unusual bleeding, including gastrointestinal bleeding.

Very rare (may affect up to 1 in 10,000 people):

• Swelling of the skin, tongue, lips, pharynx, or face, urticaria, 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 mucus (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 (may affect up to 1 in 1,000 people):

• Urticaria, skin rash, itching (pruritus).
• Teeth chattering, agitation, nervousness, anxiety attacks, confusion.
• Sleep disturbances, taste alterations, 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 arms and legs.
• Nasal bleeding.

Very rare (may affect up to 1 in 10,000 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).
• Altered liver function tests (elevated liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Signs of abnormal bleeding, e.g., from the skin or mucous membranes (ecchymosis) and low platelet count in the blood (thrombocytopenia).
• Inadequate secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, reducing sodium levels (inadequate secretion of ADH).
• Increased levels of prolactin hormone in the blood.
• Milk flow in men and in women who are not lactating.
• 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, lactation, and fertility" in section 2 for more information.

Other side effects that have been reported with medications that act similarly to escitalopram (the active ingredient in Cipralex) are:

• 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 Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of 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 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 Cipralex tablet contains 20 mg of escitalopram (as oxalate).

The other components are:

Core: microcrystalline cellulose silicified, talc, sodium croscarmellose, and magnesium stearate.

Coating: hypromellose, macrogol 400, and titanium dioxide (E-171).

Appearance of the product and contents of the package

Cipralex 20 mg is presented in the form of film-coated tablets.

The tablets are oval, white, scored, coated, 11.5x7 mm, and marked with “E” and “N” on each side of the score in one face of the tablet.

The 20 mg tablets can be divided into equal doses.

Cipralex 20 mg is presented in packages of:

Blister (transparent), included in a case: 14, 28, 56, and 98 tablets.

Blister (white), included in a case: 14, 20, 28, 50, 100, and 200 tablets.

Single dose: 49x1, 56x1, 98x1, 100x1, and 500x1 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holderof 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 EEA member states with the following names:

Austria:Cipralex

Bélgica:Sipralexa

Bulgaria:Cipralex

Chipre:Cipralex

República Checa:Cipralex

Dinamarca:Cipralex

Estonia:Cipralex

Finlandia:Cipralex

Francia:Seroplex

Alemania:Cipralex

Grecia:Cipralex

Holanda:Lexapro

Hungría:Cipralex

Islandia:Cipralex

Irlanda:Lexapro

Italia:Cipralex
Latvia:Cipralex

Lituania:Cipralex
Luxemburgo:Sipralexa
Malta:Cipralex
Noruega:Cipralex
Polonia:Cipralex
Portugal:Cipralex

Rumania:Cipralex
Eslovaquia:Cipralex
Eslovenia:Cipralex
España:Cipralex
Suecia:Cipralex
Reino Unido: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/