Package Insert: Information for the User

Escitalopram SUN 10 mg Film-Coated Tablets EFG

escitalopram (as oxalate)

Read this package insert carefully before starting to take the 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. See section 4.

Escitalopram Sun contains the active ingredient escitalopram. 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.

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 even if it takes time to notice any improvement.

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

No take Escitalopram Sun

• If you are allergic to the active ingredient 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 had or were born with an abnormal heart rhythm (seen on ECG; a test to evaluate heart function).
• If you are taking medications for heart rhythm problems or that can affect heart rhythm (see section 2 “Use of other medications”).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Escitalopram Sun. Consult 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 Sun should be interrupted if seizures occur for the first time or if you observe an increase in seizure frequency (see also section 4 “Possible side effects”).
• If you have liver or kidney insufficiency. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram Sun may alter 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 easily, 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 heart problems or recently had a heart attack.
• If you have low heart rate and/or know that you have a decrease in electrolytes due to prolonged diarrhea and vomiting (gastrointestinal upset) or the use of diuretics.
• If you experience rapid or irregular heartbeat, fainting, collapse, or dizziness when standing up that may indicate abnormal heart function.
• If you have or have had eye problems, such as certain types of glaucoma (increased eye pressure).

Please note:

Some patients with manic-depressive illness may enter a manic phase. This is characterized by unusual and rapid changes in ideas, excessive joy, and excessive physical activity. If you experience this, contact your doctor.

Symptoms such as restlessness or difficulty sitting or standing may also occur during the first weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Medicines like Escitalopram Sun (called ISRS) 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 will be more prone to having these types of thoughts:

• If you have previously had thoughts of harming yourself or committing suicide.
• If you are a young adult. Information from clinical trials 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 close relative or 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 under 18 years:

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. However, 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 prescribes Escitalopram Sun to you is under 18 years old and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms described above progress or if you experience complications when patients under 18 years old are taking Escitalopram Sun. At the same time, the long-term effects regarding safety and related to growth, maturity, and cognitive and behavioral development of Escitalopram Sun in this age group have not yet been demonstrated.

Use of Escitalopram Sun with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

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

• Non-selective monoamine oxidase inhibitors (IMAOs), which 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 SUN. After finishing Escitalopram SUN, 7 days should pass before taking any of these medications.

• Reversible selective MAO-A inhibitors, which contain moclobemide (used to treat depression).

• Irreversible MAO-B inhibitors, which contain selegiline (used to treat Parkinson's disease). These increase the risk of side effects.

• The antibiotic linezolid.

• Lithium (used to treat manic-depressive disorder) and tryptophan.

• Imipramine and desipramine (both used to treat depression).

• Sumatriptan and similar medications (used to treat migraines), tramadol and similar medications (opioids, used for severe pain). These increase the risk of side effects.

• Cimetidine, lansoprazole, omeprazole, and esomeprazole (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 blood levels.

• St. John's Wort (Hypericum perforatum) – a medicinal plant used to treat depression.

• Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (medications used to relieve pain or reduce the risk of thrombosis, also called anticoagulants). They may increase the risk of bleeding.

• Warfarin, dipiridamol, and phenprocoumon (medications used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably monitor your blood clotting time at the start and end of treatment with Escitalopram Sun to check that the anticoagulant dose is still adequate.

• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the possible risk of lowering the seizure threshold.

• Neuroleptics (medications used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and ISRS) due to the possible risk of lowering the seizure threshold.

• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases) and desipramine, 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 arrhythmias that can be life-threatening.

Do not take Escitalopram Sunif you are taking medications for heart rhythm or that can affect heart rhythm, such as Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibiotics (e.g. sparfloxacine, moxifloxacine, erythromycin IV, pentamidine, antimalarial treatment particularly halofantrine), certain antihistamines (e.g. astemizole, hydroxyzine, mizolastine).

If you have any doubts, consult your doctor.

Taking 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 using 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 falling asleep. 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 it so they can advise you.

Make sure your midwife and/or doctor know that you are taking Escitalopram Sun. When taken during pregnancy, particularly in the last 3 months of pregnancy, medications like Escitalopram Sun may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and have blue skin. These symptoms usually start within the first 24 hours after the baby's birth. If your baby experiences any of these symptoms at birth, inform your midwife and/or doctor immediately.

Escitalopram Sun should not be stopped abruptly during pregnancy.

It is expected that Escitalopram Sun will be excreted through 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.

Driving and operating machines

During treatment with escitalopram, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how the treatment with 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 medication.

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

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

Adults

Depression

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

Obsessive-compulsive disorder

The normally recommended dose of escitalopram 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 (over 65 years)

The recommended initial dose of escitalopram is 5 mg taken as a single dose per day. Your doctor may increase your dose up to 10 mg per day.

Use in children and adolescents (under 18 years)

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

Renal insufficiency

Caution is advised in patients with severely impaired renal function. Take as prescribed by your doctor.

Liver insufficiency

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

Patients considered as slow metabolizers of CYP2C19

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

You can take escitalopram 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.

Treatment duration

You may feel better in a couple of weeks. Continue taking escitalopram 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 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 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 it even if you do not observe any 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. Carry the Escitalopram Sun packaging with you when you go to the doctor or hospital.

If you forgot to take Escitalopram Sun

Do not take a double dose to compensate for the missed doses. If you forgot 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 Sun

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

When you stop taking escitalopram, especially if it is done abruptly, you may experience withdrawal symptoms. These are common when escitalopram treatment is suspended. The risk is higher when escitalopram 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, 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 night sweats), feeling of anxiety or agitation, tremor (instability), feeling of confusion or disorientation, feelings of emotion or irritability, diarrhea (loose stools), visual disturbances, rapid or strong heartbeat (palpitations).

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

Like all medications, 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 begin to feel better.

If you experience any of the following symptoms, contact your doctor immediately or visit the nearest hospital:

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

• Unusual bleeding, including gastrointestinal bleeding.

Uncommon (may affect up to 1 in 1000 people):

• Swelling of the skin, tongue, lips, or face, urticaria, or difficulty breathing or swallowing (severe allergic reaction).
• High fever, agitation, confusion, tremors, and sudden muscle contractions, which may be signs of a rare condition called serotonin syndrome.

Unknown (cannot be determined from available data)

• Difficulty urinating.
• Seizures (attacks), see the "Warnings and Precautions" section.
• Yellow skin and whitening of the eyes, which are signs of liver function alteration/hepatitis.
• Fast, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition known as Torsade de Pointes.
• Thoughts of self-harm or suicidal thoughts, see also the 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):

• Urticaria, skin rash, itching (pruritus).
• Teeth chattering, agitation, nervousness, anxiety crisis, 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.
• Fast heart rate.
• Swelling of arms and legs.
• Nasal bleeding.

Uncommon (may affect up to 1 in 1000 people):

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

Unknown (the frequency 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, such as skin and mucous membranes (ecchymosis).
• Inadequate secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, reducing sodium levels (inadequate ADH secretion).
• Milk flow in men and women who are not breastfeeding.
• Mania (feeling unusually excited, hyperactive, and uninhibited).
• An increased risk of osteoporotic fractures has been observed in patients taking this type of medication.
• Alteration of heart rhythm (known as "prolongation of the QT interval", seen on the ECG, a measure of 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 that have been reported with medications that act similarly to Escitalopram (the active ingredient of Escitalopram Sun) are:

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

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. 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 medication.

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

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the 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 the 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 10 mg of escitalopram.

The other components are:

Inactive ingredients: microcrystalline cellulose, lactose monohydrate, copovidone (K-90-100), cornstarch (gluten-free).

Extragranular inactive ingredients: microcrystalline cellulose, 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 contents of the package

Escitalopram Sun 10 mg is presented in the form of oval, biconvex, film-coated tablets, white or almost white in color, with an "E" and "8" engraved on each side of the notch on one face, and smooth on the other face. The oval-shaped tablets measure 8.1 mm ± 0.40 mm in length and 5.6 mm ± 0.40 mm in width.

Escitalopram Sun is available in doses of 10 mg and 20 mg film-coated tablets in packaging of 14, 20, 28, 30, 50, 56, or 100 tablets, conditioned in poliamide/Alu/PVC/Alu blisters.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Responsible for manufacturing

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

or

TERAPIA S.A.

124, Fabricii Street

400 632 Cluj-Napoca

Romania

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona. Spain

Tel.: +34 93 342 78 90

This medicine is authorized in the following member states, with the following names:

Last review date of this leaflet:February 2023

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/