ESCITALOPRAM PENSA 15 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Escitalopram Pensa 15 mg Film-Coated Tablets EFG

escitalopram oxalate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

Escitalopram Pensa 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).

Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medications work on the serotonin system in the brain by increasing the level of serotonin. Alterations of the serotonin system are considered an important factor in the development of depression and related diseases.

It may take a couple of weeks before you start to feel better. Continue taking Escitalopram Pensa even if it takes time to notice any improvement.

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

2. What you need to know before you take Escitalopram Pensa

Do not takeEscitalopram Pensaif:

• You are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).
• You are taking other medicines that belong to the group of MAO 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 been born with any type of heart rhythm disorder or have ever suffered any episode of this type (this is observed with an electrocardiogram, a test that serves to evaluate how the heart works).

- If you are taking medications for heart rhythm disorders or that may affect the heart rhythm (see section 2 "Use of other medications").

Warnings and precautions:

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

Please inform your doctor if you have any other disorder or disease, as your doctor may need to take it into account. In particular, inform your doctor:

• If you have epilepsy. Treatment with Escitalopram Pensa should be discontinued if seizures occur or if you observe an increase in the frequency of seizures (see also section 4 "Possible side effects").
• If you have liver or kidney failure. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram Pensa may alter glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic.
• If you have a decreased level of sodium in the blood.
• If you tend to develop bleeding or bruising easily (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 suffered a heart attack.
• If your heart beats slowly when you are at rest (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 used diuretics (medicines to urinate).
• If you have noticed that your heartbeats are fast or irregular or if you have fainted or felt dizzy when getting up from a sitting or lying position. This could indicate that you have some 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 a change of ideas that is uncommon and rapid, disproportionate 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.

Some medications in the group to which Escitalopram Pensa belongs (called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuing treatment.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may sometimes have thoughts of self-harm or suicide. These may increase when taking antidepressants for the first time, as all these medications require time to start taking effect, usually around two weeks, although in some cases it could be longer.

You would be more likely to have these thoughts:

• If you have previously had thoughts of self-harm or suicide.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric disorders who were treated with an antidepressant.

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

It may be helpful for you to tell a relative 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 behavior.

Pediatric population and adolescents under 18 years

Escitalopram Pensa should not normally be used in the treatment of the pediatric population and adolescents under 18 years. Also, you should know that in patients under 18 years, there is a greater risk of adverse effects such as suicidal attempts, suicidal ideas, and hostility (predominantly aggression, confrontational behavior, and irritation) when taking this class of medications. Nevertheless, your doctor may prescribe Escitalopram Pensa to patients under 18 years when they decide what is most convenient for the patient. If the doctor who corresponds to you has prescribed Escitalopram Pensa to a patient under 18 years and you want to discuss this decision, please go back 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. At the same time, 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 medications:

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medication.

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

• "Non-selective monoamine oxidase inhibitors (MAOIs)" that contain phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active ingredients. If you have taken any of these medications, you will need to wait 14 days before starting to take Escitalopram Pensa. After finishing Escitalopram Pensa, 7 days must pass before taking any of these medications.
• "Reversible MAO-A inhibitors" that contain moclobemide (used in the treatment of depression).
• "Irreversible MAO-B inhibitors" that contain selegiline (used in the treatment of Parkinson's disease). These increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used in the treatment of manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (both used for the treatment of depression).
• Sumatriptan and similar medications (used for the treatment of migraine) and tramadol (used against 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 blood levels of Escitalopram Pensa.

• St. John's Wort (Hypericum perforatum) - a medicinal plant used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medications used to relieve pain or reduce the risk of thrombosis, also called anticoagulants). These may increase the tendency to bleeding.
• Warfarin, dipyridamole, and phenprocoumon (medications used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably check the blood coagulation time at the start and end of treatment with Escitalopram Pensa to check that the dose of anticoagulant is still adequate.
• Mefloquine (used for the treatment of malaria), bupropion (used for the treatment of depression), and tramadol (used for the treatment of intense 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 SSRIs), 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). It may be necessary to adjust the dose of Escitalopram Pensa.
• Medications that decrease potassium or magnesium levels in the blood, as this increases the risk of suffering from heart rhythm disorders, which pose a risk to life.

Do not take Escitalopram Pensa:

If you are taking medications for any heart rhythm disorder or if you are taking medications that may affect the heart rhythm, such as antiarrhythmic class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, medications against malaria, particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have doubts 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 medications, it is not recommended to combine Escitalopram Pensa and alcohol, although it is not expected that Escitalopram Pensa will interact with alcohol.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

If you take Escitalopram Pensa in the final stage of pregnancy, there may be a greater risk of abundant 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.

If Escitalopram Pensa is used during pregnancy, it should never be discontinued abruptly.

Make sure your midwife and/or doctor knows that you are taking Escitalopram Pensa. When taken during pregnancy, particularly in the last 3 months of pregnancy, medications like Escitalopram Pensa may increase the risk of a serious disease in babies 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 in breast milk.

Fertility:

Citalopram, a medication like escitalopram, in animal studies has shown that it reduces sperm quality. Theoretically, this could affect fertility, but the impact on human fertility has not been observed yet.

Driving and using machines:

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

Important information about some of the ingredients of Escitalopram Pensa:

This medication contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medication.

3. How to take Escitalopram Pensa

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 during the first week before increasing the dose to 10 mg per day. Your doctor may increase it later 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.

Elderly patients (over 65 years old)

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 old)

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

Method of administration:

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

If necessary, you can split the tablets by placing the tablet on a flat surface with the score line facing up. The tablets can be broken by pressing down with your index fingers on each end of the tablet.

Duration of treatment

It may take a couple of weeks before you start to feel better. Continue taking Escitalopram Pensa even if you start to feel better before the expected time.

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

Continue taking Escitalopram Pensa for the time recommended by your doctor. If you interrupt the treatment too early, the symptoms may reappear. It is recommended that the treatment continues for at least 6 months after you feel better.

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 emergency department of the nearest hospital, or consult the Toxicology Information Service (phone: 91 562 04 20). Do this even if you do not notice discomfort or signs of intoxication.

Some signs of overdose may be dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rate, decrease in blood pressure, and changes in the body's water and salt balance. Bring the package of Escitalopram Pensa if you go to the doctor or hospital.

If you forget to take Escitalopram Pensa:

Do not take a double dose to make up for forgotten doses. If you forget to take a dose and remember before going to bed, take it immediately. The next day, continue as usual.

If you remember during the night or the next day, skip the forgotten dose and continue as usual.

If you stop taking Escitalopram Pensa:

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

When you stop taking Escitalopram Pensa, especially if it is sudden, you may feel withdrawal symptoms. These are common when treatment with Escitalopram Pensa is suspended. The risk is greater when Escitalopram Pensa has been used for a long time, in high doses, or when the dose is reduced too quickly. Most people find that these symptoms are mild and disappear on their own within two weeks. However, in some patients, they can be intense or prolonged (2-3 months or more). If you have severe withdrawal symptoms when you stop taking Escitalopram Pensa, please contact your doctor. He or she may ask you to start taking your tablets again and stop them more slowly.

Withdrawal symptoms include:

Feeling of dizziness (unstable or without balance), feeling of tingling, feeling of itching, and (less frequently) electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of nausea (nausea), sweating (including night sweats), feeling of unease or agitation, tremors (instability), feeling of confusion or disorientation, feelings of emotion or irritation, diarrhea (loose stools), visual disturbances, rapid or irregular heartbeat.

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

4. Possible side effects

Like all medications, this medication can 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 effects may be symptoms of your illness and will improve as you start to feel better.

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

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

• Unusual bleeding, including gastrointestinal bleeding.

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

• If you notice skin swelling, tongue, lips, pharynx, or face, hives, 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 (attacks), see also the section “Special warnings and precautions for use of Escitalopram Pensa”.
• Yellow skin and eyes, are signs of liver function alteration / hepatitis.
• Fast and irregular heartbeat or feeling of fainting, as they may be symptoms of a serious heart problem known as torsades de pointes.
• Thoughts of harming yourself or thoughts of killing yourself, see also the section “Warnings and precautions”.
• 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 nauseous (nausea).
• Headache

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

• Nasal congestion or runny nose (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty falling asleep, feeling sleepy, dizziness, yawning, tremors, itching of the skin.

• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual disturbances (delayed ejaculation, erection problems, decreased sexual behavior, and women may experience difficulty reaching orgasm).

• Fatigue, fever.
• Weight gain.

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

• Hives, skin rash, itching (pruritus).
• Teeth grinding, agitation, nervousness, anxiety attacks, confusion.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbance, ringing in the ears (tinnitus).
• Hair loss.
• Excessive menstrual bleeding.
• Irregular menstrual period.
• Weight loss.
• Fast heart rate.
• Swelling of arms and legs.
• Nosebleeds.

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

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

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

• Decrease in sodium levels in the blood (symptoms are feeling dizzy and discomfort with muscle weakness or confusion).
• Dizziness when standing up due to low blood pressure (orthostatic hypotension).
• Altered liver function tests (increased liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Signs of abnormal bleeding, e.g., from the skin or mucous membranes (ecchymosis)
• Increased secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, reducing the amount of sodium (inadequate secretion of ADH).
• Milk flow in men and in women who are not breastfeeding.
• Mania.
• An increased risk of bone fractures has been observed in patients treated with this type of medication.
• Alteration of heart rhythm (called QT interval prolongation, observed by electrocardiogram).
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see “Pregnancy, breastfeeding, and fertility” in section 2 for more information.

Other side effects are known to occur with drugs that work similarly to escitalopram (the active ingredient of Escitalopram Pensa). These are:

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

If you consider that any of the side effects you are experiencing is serious 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 not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Escitalopram Pensa

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after “EXP”. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in 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. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Escitalopram Pensa:

The active ingredient is escitalopram. Each tablet contains 15 mg of escitalopram (as oxalate).

The other ingredients are:

• Core of the tablet: anhydrous colloidal silica, lactose monohydrate, povidone, microcrystalline cellulose, sodium croscarmellose, talc, and magnesium stearate.
• Coating of the tablet: hypromellose, titanium dioxide, and macrogol 400.

Appearance of the product and package contents:

Escitalopram Pensa is presented in the form of cylindrical, biconvex, scored, coated tablets, white in color, and marked with the code “ES2”.

Escitalopram Pensa is presented in packages containing 28 or 56 tablets.

Only some package sizes may be marketed.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios Cinfa, S.A.

Olaz-Chipi, 10 – Polígono Areta

31620 Huarte-Pamplona (Navarra)

Spain

This leaflet was revised in September 2021.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/