Package Insert: Information for the User

Escitalopram SUN 15 mg Film-Coated Tablets EFG

Escitalopram (as oxalate)

Read this package insert carefully before starting to take this medicine, as it contains important information for you

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert.

Escitalopram SUN belongs to a group of antidepressants known as 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 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 feeling better. Continue taking Escitalopram Sun, even if it takes some time before you notice any improvement in your condition.

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

Do not take Escitalopram Sun:

• 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 or have experienced an episode of abnormal heart rhythm (detected on an ECG, a test that evaluates the heart's function).
• If you are taking medications for heart rhythm disorders or that may affect heart rhythm (see section 2 "Escitalopram Sun use with other medications").

Warnings and precautions:

Consult your doctor or pharmacist before taking Escitalopram Sun. Please inform your doctor if you have any other condition 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 you observe an increase in seizure frequency (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 affect 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 are prone to 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 a low sodium level due to severe and prolonged diarrhea and vomiting (while 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 few weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Medications like escitalopram (called ISRS/IRSN) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms have continued 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.

You are more likely to have these thoughts:

• If you have previously had thoughts of harming yourself or committing suicide.
• If you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in adults under 25 years old with psychiatric illnesses 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:

Escitalopram Sun should not be used normally in the treatment of children and adolescents under 18 years old.

Also, be aware that in patients under 18 years old, there is a higher risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication.

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

Use of Escitalopram Sun and other medications:

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

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

• "Non-selective monoamine oxidase inhibitors (IMAOs)", containing 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 Escitalopram Sun. After stopping Escitalopram Sun, 7 days must 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 adverse 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 adverse effects.

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

• St. John's Wort (Hypericum perforatum) - a medicinal plant used to treat 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 risk of bleeding.
• Warfarin, dipiridamol, and phenprocoumon (medications used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably check your blood clotting time at the start and end of treatment with Escitalopram Sun to ensure 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 ISRS) 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 Sun dose.
• "Medications that decrease blood potassium or magnesium levels, as these conditions increase the risk of a potentially fatal heart rhythm disorder."

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

Use of 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 medications, it is not recommended to combine Escitalopram Sun 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 taking this medication.

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: 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 sleeping. If your newborn has any of these symptoms, please contact your doctor immediately.

If you take Escitalopram Sun 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 Sun to advise you.

Ensure that your midwife and/or doctor know that you are being treated with Escitalopram Sun. During pregnancy, particularly in the last 3 months, medications like Escitalopram Sun 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, please contact your midwife and/or doctor immediately.

Escitalopram Sun should not be stopped abruptly during pregnancy.

Escitalopram Sun is expected to be excreted in breast milk.

It has been seen that citalopram, a medication 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 medication.

Driving and operating machinery:

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

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

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

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 further 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.

Older adults (65 years and older)

The recommended initial 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 the 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 their taste is bitter.

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

Treatment duration

You may feel better in a couple of weeks. Continue taking Escitalopram SUN 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 SUN 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 you feel well again.

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 it even if 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 SUN packaging if you visit your doctor or hospital.

If you forget to take Escitalopram SUN

Do not take a double dose to compensate for the missed doses. If you forget to take a dose and remember before bedtime, 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 Escitalopram SUN

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

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

Like all medicines, Escitalopram SUN may cause 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 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:

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

• Unusual bleeding, including gastrointestinal bleeding.

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

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

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

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

• Difficulty urinating.
• Seizures (convulsions), see also the "Warnings and precautions" section.
• Yellowish skin and whitening of the eyes, signs of liver function alteration/hepatitis.
• If you experience rapid or irregular heartbeats or dizziness, symptoms that may indicate a life-threatening condition called 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 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 dysfunction (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):

• Hives, skin rash, itching (pruritus).
• Chattering teeth, agitation, nervousness, anxiety attack, 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 period.
• Weight loss.
• Rapid heart rate.
• Swelling of arms and legs.
• Nasal bleeding.

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

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

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

• Decreased sodium levels in the blood (symptoms are feeling dizzy and 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, including skin and mucous membrane bleeding (ecchymosis) and low platelet count in the blood (thrombocytopenia).
• Inadequate secretion of ADH, which causes the body to retain water and dilute the blood, reducing sodium levels.
• 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 (known as "prolongation of the QT interval", observed on the ECG, heart electrical activity).
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

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

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect that does not appear in this leaflet.The information you provide will help to provide more information about the safety of this medication.

Keep this medication out of the 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 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 Escitalopram Sun

The active ingredient is escitalopram (as oxalate).

Each film-coated tablet contains 15 mg of escitalopram.

The other components are:

Microcrystalline cellulose, lactose monohydrate, copovidone, cornstarch, silica, croscarmellose sodium, 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 content of the container

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

The tablets are white or almost white, capsule-shaped, and engraved with “E” and “15” on each side of the notch and smooth on the other side.

Escitalopram Sun 15 mg is presented in containers 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.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible 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

Last review date of this leaflet: August 2024

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/