Leaflet: information for the user

Escitalopram pensa 10 mg film-coated tablets EFG

escitalopram oxalate

Read this leaflet carefully before you start taking this medicine, as 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, and you must not give it 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.

1. What is Escitalopram Pensa and what it is used for

2. What you need to know before taking Escitalopram Pensa

3. How to take Escitalopram Pensa

4. Possible side effects

5. Storage of Escitalopram Pensa

6. Contents of the pack and additional information

Pensa Escitalopramcontains 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).

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 an important factor in the development of depression and related diseases.

You may notice an improvement in a couple of weeks. Continue taking Pensa Escitalopram even if you do not notice any improvement right away.

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

Do not takeEscitalopram Pensa:

- If you are allergic to escitalopram or any of the other ingredients of 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 any type of heart rhythm disorder since birth or have had any episodes of this type (this is observed with an electrocardiogram, a test that evaluates how the heart works).

- If you are taking medicines for heart rhythm disorders or that may affect heart rhythm (see section 2 “Use of other medicines”).

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Escitalopram Pensa.

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 Pensa should be interrupted if seizures occur 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 Pensa may affect 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 (history of bleeding disorders), or if you are pregnant (see “Pregnancy, breastfeeding and fertility”).

• If you are receiving electroconvulsive therapy.

• If you have coronary heart disease.

• If you have or have had any heart problems or have recently had a heart attack.

• If, when at rest, your heart beats slowly (this is known as bradycardia) and/or you think your body may be losing salt, for example, because you have had intense diarrhea and vomiting for several days or because you have taken diuretics (medicines to urinate).

• If you have noticed that your heartbeats are rapid or irregular or have had fainting or dizziness when getting up from a sitting or lying position. This could indicate that you have a heart rhythm disorder.

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

Some medicines in the group to which Escitalopram Pensa belongs (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 self-harm or suicide. These may increase when taking antidepressants for the first time, as all these medicines require time to start working, usually around two weeks, although in some cases it may take longer.

You would be more prone to having these thoughts:

• If you have previously had thoughts of self-harm or suicide.

• If you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric disorders who were treated with an antidepressant.

If you ever have thoughts of self-harm or suicide, contact your doctor or go directly to a hospital.

Telling a family member or close friend that you are depressed or have an anxiety disorder and asking them to read this leaflet may be helpful. You can ask them if they think your depression or anxiety disorder has worsened or if they are concerned about changes in your behavior.

Population of children and adolescents under 18 years

Escitalopram Pensa should not be used normally in the treatment of children and adolescents under 18 years. Also, be aware that in patients under 18 years, there is a higher risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. However, your doctor may prescribe Escitalopram Pensa to patients under 18 years if they decide it is the best option for the patient. If the doctor who prescribed Escitalopram Pensa to a patient under 18 years 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 are taking Escitalopram Pensa. Also, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Escitalopram Pensa in this age group have not yet been demonstrated.

Use of Escitalopram Pensa with other medicines:

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

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

• “Non-selective monoamine oxidase inhibitors (IMAOs)”, containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active ingredients. If you have taken any of these medicines, you will need to wait 14 days before starting to take Escitalopram Pensa. After finishing Escitalopram Pensa, 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 (antidepressant) and ticlopidine (used to reduce the risk of stroke). These may cause an increase in Escitalopram Pensa blood levels.

• 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 to reduce the risk of thrombosis, also called anticoagulants). These may increase the risk of bleeding.
• Warfarin, dipiridamol, and phenprocoumon (medicines 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 Escitalopram Pensa 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), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). You may need to adjust your Escitalopram Pensa dose.
• Medicines that lower potassium or magnesium levels in the blood, as this increases the risk of heart rhythm disorders that are life-threatening.

Do not take Escitalopram Pensa:

If you are taking medicines for any heart rhythm disorder or if you are taking medicines that may affect heart rhythm, for example, antiarrhythmic class IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, medicines against malaria, particularly halofantrine), certain antihistamines (astemizol, mizolastine). If you are unsure about this, consult your doctor.

Taking Escitalopram Pensa with food, drinks, and alcohol:

Escitalopram Pensa can be taken with or without food (see section 3 “How to take Escitalopram Pensa”).

As with many medicines, it is not recommended to combine Escitalopram Pensa 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 medicine.

Pregnancy:

Do not take Escitalopram Pensa if you are pregnant unless you and your doctor have analyzed the risks and benefits involved.

If you take Escitalopram Pensa 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.

If you take Escitalopram Pensa 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 so they can advise you.

Escitalopram Pensa should not be stopped abruptly.

Make sure your midwife and/or doctor know that you are taking Escitalopram Pensa. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Escitalopram Pensa may increase the risk of a serious disease in newborns, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start within the first 24 hours after the baby is born. If this happens to your baby, contact your midwife and/or doctor immediately.

Breastfeeding:

Do not take Escitalopram Pensa if you are breastfeeding unless you and your doctor have analyzed the risks and benefits involved.

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

Fertility:

Citalopram, a medicine like escitalopram, has been shown in animal studies to reduce sperm quality. Theoretically, this could affect fertility, but the impact on human fertility has not been observed so far.

Driving and operating machinery:

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

Important information about some of the components of Escitalopram Pensa:

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

Adults

Depression

The normally recommended dose of Escitalopram Pensa 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 Escitalopram Pensa is 5 mg as a single dose per day for 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 Escitalopram Pensa 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 Escitalopram Pensa 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 Escitalopram Pensa 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)

It is recommended to start with a dose of escitalopram of 5 mg per day. If necessary, your doctor may increase this dose up to a maximum of 10 mg per day.

Pediatric and adolescent population (under 18 years)

Escitalopram Pensa should not normally be administered to the pediatric and adolescent population. For additional information, please see the section 2. ("What you need to know before starting to take Escitalopram Pensa")

Administration form:

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

If necessary, you can break the tablets by placing the tablet on a flat surface with the notch facing upwards. The tablets can be broken by pressing with the two index fingers downwards, on each end of the tablet.

Treatment duration:

It may take a couple of weeks before you start feeling better. Continue taking Escitalopram Pensa 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 Pensa for the recommended time by your doctor. If you interrupt the treatment too soon, symptoms may reappear. It is recommended that the treatment continue for at least 6 months after you feel well again.

If you take more Escitalopram Pensa than you should:

If you take more doses of Escitalopram Pensa than prescribed, contact your doctor immediately, go to the nearest hospital emergency room, or consult the Toxicological Information Service (phone: 91 562 04 20).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 Pensa packaging if you go to the doctor or hospital.

If you forget to take Escitalopram Pensa:

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 Escitalopram Pensa:

Do not interrupt the treatment with Escitalopram Pensa until your doctor tells you to. When you have finished your treatment course, it is usually recommended to gradually reduce the dose of Escitalopram Pensa over several weeks.

When you stop taking Escitalopram Pensa, especially if it is suddenly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram Pensa is suspended. The risk is higher when Escitalopram Pensa 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 Pensa, please contact your doctor. They may ask you to take your tablets again and taper off them more slowly.

Withdrawal symptoms include:

Dizziness (unstable or loss of balance), tingling sensation, prickling sensation, and (less frequently) electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, dizziness (nausea), sweating (including nocturnal sweating), feeling of anxiety or agitation, tremor (unsteadiness), 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 medicinecan cause side effects, although not everyone will experience them.

Side effects are generally mild and 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.

Visit your doctor if you experience any of the following side effects during treatment:

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

• Unusual bleeding, including gastrointestinal bleeding.

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

• If you notice swelling of the skin, tongue, lips, pharynx, or face, urticaria, or have difficulty breathing or swallowing (allergic reaction), contact your doctor or go to the hospital immediately.
• If you have a high fever, agitation, confusion, tremors, and sudden muscle contractions, they may be signs of a rare condition called serotonin syndrome. If you feel this way, contact your doctor.

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

• Difficulty urinating.
• Seizures (convulsions), see also the section “Be especially careful withEscitalopram Pensa”.
• Yellowish skin and whitening of the eyes, which are signs of liver function alteration/hepatitis.
• Fast and irregular heartbeats or a feeling of dizziness, as they may be symptoms of a serious heart condition known as torsade de pointes.
• Thoughts of self-harm or suicidal thoughts, see also the section “Warnings and precautions”.
• Sudden swelling of the skin or mucous membranes (angioedemas).

In addition to what is mentioned 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 (arthritis 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 100 people):

• Urticaria, skin rash, itching (pruritus).
• Teeth chattering, agitation, nervousness, anxiety attacks, state of 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 (may affect up to 1 in 1,000 people):

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

Frequency not known (cannot be determined 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).
• Altered liver function tests (increased 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).
• Inadequate secretion of the ADH hormone, causing water retention in the body and dilution of the blood, reducing the amount of sodium.
• Milk flow in men and in women who are not breastfeeding.
• Mania.
• A higher risk of bone fractures has been observed in patients treated with this type of medication.
• Alteration of the heart rhythm (called prolongation of the QT interval, observed through electrocardiogram).
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy, breastfeeding, and fertility” in section 2 for more information.

Other side effects have been reported with medications that work similarly to escitalopram (the active ingredient inEscitalopram Pensa). These are:

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

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 Pharmacovigilance 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.

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointof 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 Escitalopram Pensa:

The active ingredient is escitalopram.Each tablet contains 10 mg of escitalopram (as oxalate).

The other components are:

- Tablet core: colloidal anhydrous silica, lactose monohydrate, povidone, microcrystalline cellulose, sodium croscarmellose, talc, and magnesium stearate.

- Coating: hypromellose, titanium dioxide, and macrogol 400.

Appearance of the product and content of the packaging:

Escitalopram Pensais presented in the form of cylindrical, biconvex, scored, coated tablets, white in color, and marked with the code “ES1”.

Escitalopram Pensais presented in packaging with 28 or 56 tablets.

Only some packaging sizes may be marketed.

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Laboratorios Cinfa, S.A.

Olaz-Chipi, 10 – Polígono Areta

31620 Huarte-Pamplona (Navarra)

Spain

This leaflet has been reviewed in September 2021.

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