ESCITALOPRAM SUN 15 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Escitalopram SUN 15 mg film-coated tablets EFG

Escitalopram (as 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Contents of the pack and other information:

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

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

Escitalopram SUN belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines work 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 disorders.

Escitalopram SUN 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).

It may take a couple of weeks before you start to feel better. Continue taking Escitalopram Sun, even if it takes some time before you feel any improvement in your condition.

You should talk to a doctor if you do not feel better or if you feel worse.

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

Do not take Escitalopram Sun:

• If you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).

• If you take other medicines that belong to the group called monoamine oxidase inhibitors (MAOIs), 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 or have had an episode of altered heart rhythm
• (detected in an ECG, a test that evaluates heart function).
• If you are taking medicines for heart rhythm disorders or that may affect heart rhythm (see section 2 "Using Escitalopram Sun with other medicines").

Warnings and precautions

Talk to your doctor or pharmacist before taking Escitalopram Sun. Please inform your doctor if you have any other disorder or disease, as your doctor may need to take it into account.

• If you have epilepsy. Treatment with Escitalopram Sun should be discontinued if seizures occur for the first time or if there is an increase in the frequency of seizures (see also section 4 "Possible side effects").
• If you have liver or kidney problems. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram Sun may alter glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic.
• If you have a decreased sodium level in the blood.
• If you tend to develop bleeding or bruising easily, 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 you may have low salt levels as a result of severe and prolonged diarrhea and vomiting (being sick) or use of diuretics.
• If you experience rapid or irregular heartbeats, fainting, collapse, or dizziness when standing up, which may indicate abnormal heart rhythm.
• If you have or have had eye problems, such as certain types of glaucoma (increased pressure in the eye).

Please note:

Some patients with manic-depressive illness may enter a manic phase. This is characterized by an uncommon and rapid change of 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.

Medicines like escitalopram (called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping 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 harming or killing yourself. These may increase when you first start taking antidepressants, as these medicines take time to start working, usually around two weeks, although in some cases it may take longer.

You would be more likely to have these thoughts:

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

If at any time you have thoughts of harming or killing yourself, contact your doctor or go directly to a hospital.

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

Children and adolescents

Escitalopram Sun should not normally be used in the treatment of children 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 medicines.

However, your doctor may prescribe Escitalopram Sun to patients under 18 years when they decide it is the most convenient for the patient. If the doctor who corresponds to you has prescribed escitalopram 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 Sun. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of escitalopram in this age group have not yet been demonstrated.

Using Escitalopram Sun and other medicines

Tell your doctor or pharmacist that you are using, have recently used, or may need to use other medicines.

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

• Non-selective monoamine oxidase inhibitors (MAOIs) that contain 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 Sun. After finishing Escitalopram Sun, 7 days must pass before taking any of these medicines.
• 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 medicines (used for the treatment of migraine) and tramadol and similar medicines (opioids used against severe pain). These increase the risk of side effects.

• Cimetidine, lansoprazole, and omeprazole (used for the treatment of stomach ulcers), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause an increase in blood levels of Escitalopram Sun.

• St. John's Wort (Hypericum perforatum) - a medicinal plant used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or reduce the risk of thrombosis, also called anticoagulants). These may increase the tendency to bleeding.
• Warfarin, dipyridamole, and phenprocoumon (medicines 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 Sun 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 severe pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines 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 Sun.
• "Medicines that decrease blood levels of potassium or magnesium, as these conditions increase the risk of a potentially fatal heart rhythm disorder".

Do not take Escitalopram Sun if you are taking medicines for heart rhythm disorders or that may affect heart rhythm, such as antiarrhythmics class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobials (e.g., sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarial treatment, particularly halofantrine), some antihistamines (astemizole, hydroxyzine, mizolastine). If you have any other questions about this, please contact your doctor.

Using Escitalopram Sun with food, drinks, and alcohol

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

As with many medicines, it is not recommended to combine Escitalopram Sun and alcohol, although it is not expected that Escitalopram Sun 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 taking this medicine.

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

If you take Escitalopram Sun during the last 3 months of your pregnancy, be aware that the following effects may be observed in the newborn: breathing difficulties, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, exaggerated reflexes, tremors, restlessness, irritability, lethargy, constant crying, and sleep difficulties. If your newborn has any of these symptoms, please contact your doctor immediately.

If you take Escitalopram Sun in the final stage 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 Sun so they can advise you.

Make sure your midwife and/or doctor know that you are being treated with Escitalopram Sun. During pregnancy, particularly in the last 3 months, medicines like Escitalopram Sun may increase the risk of a serious disease in newborns called persistent pulmonary hypertension (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually start during the first 24 hours after birth. If they appear in your baby, you should contact your midwife and/or doctor immediately.

If Escitalopram Sun is used during pregnancy, it should never be stopped abruptly.

It is expected that Escitalopram Sun will be excreted in breast milk.

It has been seen that citalopram, a medicine similar to Escitalopram, reduces sperm quality in animal studies. Theoretically, this could affect fertility, but no impact on human fertility has been observed so far.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

It is advised that you do not drive or use machinery until you know how Escitalopram Sun affects you.

Escitalopram Sun contains lactose monohydrate and sodium.

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

3. How to take Escitalopram SUN

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

Adults

Depression

The normally recommended dose of Escitalopram SUN 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 SUN 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 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 SUN 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 (OCD)

The normally recommended dose of Escitalopram SUN 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)

The initial recommended dose of Escitalopram SUN 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

Escitalopram SUN should not normally be administered to children and adolescents. For additional information, please see section 2 "Before taking Escitalopram SUN".

Reduced Renal Function

Caution is recommended in patients with severely reduced renal function. Take it as prescribed by your doctor.

Reduced Hepatic Function

Patients with liver problems should not receive more than 10 mg per day. Take it as prescribed by your doctor.

Patients known to be slow metabolizers of the CYP2C19 enzyme.

Patients with this known genotype should not receive more than 10 mg per day. Take it as prescribed by your doctor.

How to take the tablets

You can take Escitalopram SUN 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 on each end of the tablet with your index fingers, as shown in the figure.

Duration of treatment

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

If you take more Escitalopram SUN than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Do this even if you do not observe discomfort or signs of intoxication. Some signs of overdose may be dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and changes in body hydro-saline balance. Bring the Escitalopram SUN package if you go to the doctor or hospital.

If you forget to take Escitalopram SUN

Do not take a double dose to make up for forgotten doses. If you forgot to take a dose and remember before going to bed, take it immediately. The next day, follow your usual routine. If you remember during the night or the next day, skip the forgotten dose and follow your usual routine.

If you stop treatment with Escitalopram SUN

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

When you stop taking Escitalopram SUN, especially if it is sudden, you may feel withdrawal symptoms. These are common when treatment with Escitalopram SUN is suspended. The risk is greater when Escitalopram SUN 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 SUN, 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, pharmacist, or nurse.

4. Possible adverse effects

Like all medications, Escitalopram SUN can produce adverse effects, although not all people suffer from them.

Adverse effects usually disappear after a few weeks of treatment. Please be aware that many of the effects can be symptoms of your illness and will improve when you start to feel better.

Visit your doctor if you experience any of the following adverse 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):

• Swelling of the skin, tongue, lips, throat, or face, or having difficulty breathing or swallowing (severe allergic reaction).

High fever, agitation, confusion, tremors, and sudden muscle contractions can be signs of a rare condition called serotonin syndrome.

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

• Difficulty urinating.
• Seizures (attacks), see also the "Warnings and precautions" section.
• Yellowish skin and whitening of the eyes, are signs of altered liver function / hepatitis.
• If you experience rapid or irregular heartbeats or fainting, symptoms that may indicate a life-threatening condition known as Torsade de Pointes.
• Thoughts of self-harm or suicide, see also section 2 "Warnings and precautions."
• Sudden swelling of the skin or mucous membranes (angioedema).

In addition to the above, the following adverse 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 sleeping, 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, altered taste, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbance, ringing in the ears (tinnitus).
• Hair loss.
• Excessive menstrual bleeding.
• Irregular menstrual period.
• Weight loss.
• Rapid heartbeat.
• Swelling of arms and legs.
• Nosebleeds.

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

• Aggression, depersonalization, hallucinations.
• Slow heartbeat.

Frequency not known (cannot be estimated 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, including skin and mucous membranes (ecchymosis) and low platelet count in the blood (thrombocytopenia).
• Increased secretion of a hormone called ADH, which causes the body to retain water and dilute the blood, reducing the amount of sodium (inadequate ADH secretion).
• Milk secretion in men and women who are not breastfeeding.
• Mania.
• A higher risk of bone fractures has been observed in patients taking this type of medication.
• Alteration of heart rhythm (called "prolongation of the QT interval", observed in the ECG, electrical activity of the heart).
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

Other adverse effects are known to occur with drugs that work similarly to escitalopram (the active ingredient in Escitalopram SUN). These are:

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

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Escitalopram SUN

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 box after CAD. 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 packages and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Escitalopram Sun

The active ingredient is escitalopram (as oxalate).

Each film-coated tablet contains 15 mg of escitalopram.

The other ingredients are:

Microcrystalline cellulose, lactose monohydrate, copovidone, cornstarch, silicified microcrystalline cellulose, sodium croscarmellose, talc, anhydrous colloidal silica, magnesium stearate.

Coating: Opadry OY-S-58910, which contains hypromellose, titanium dioxide (E-171), macrogol 400, and talc.

Appearance of the product and package contents

Escitalopram Sun 15 mg is presented in the form of film-coated tablets.

The tablets are white or almost white, with a capsule shape and engraved with "E" and "15" on each side of the score line on one face and smooth on the other face.

Escitalopram Sun 15 mg is presented in packages of 28 and 30 tablets.

HDPE bottle: 30 tablets.

PA/Alu/PVC/Alu blister: 28 and 30 film-coated tablets.

PA/Alu/PE+Desiccant/HDPE/Alu blister: 28 and 30 film-coated tablets.

It is possible that only some package sizes are marketed.

Marketing authorization holder and manufacturer

SunPharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

or

Terapia SA

Str. Fabricii nr. 124,

Cluj Napoca

Romania

Local representative

SUN PHARMA LABORATORIOS, S.L.

Address:Rambla de Catalunya 53-55 - Barcelona - 08007 - Spain

Tel.:+34 93 342 78 90

Date of the last revision of this prospectus: August 2024

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/