ESCITALOPRAM VIATRIS 10 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Escitalopram Viatris 10 mgfilm-coated tablets EFG

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 signs of illness 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 pack and other information:

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

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

Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines work by increasing the level of serotonin in the brain.

Escitalopram can be used to treat the following conditions:

• Major depressive episodes.
• Anxiety disorders with or without agoraphobia (fear of open spaces).
• Social anxiety disorder.
• Generalized anxiety disorder.
• Obsessive-compulsive disorder.

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

Do not take Escitalopram Viatris:

• If you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).
• If you are taking other medicines that belong to 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 or have had a heart rhythm disorder (detected on an ECG, a test to evaluate how your heart works).
• If you are taking medicines for heart rhythm problems or that may affect the heart rhythm (see section 2 “Other medicines and Escitalopram Viatris”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take escitalopram:

• If you have liver or kidney disease. Your doctor may need to adjust your dose.
• If you are an elderly person.
• If you have epilepsy or a history of seizures. Treatment with escitalopram should be discontinued if seizures occur for the first time or if there is an increase in seizure frequency (see also section 4 “Possible side effects”).
• If you are receiving electroconvulsive therapy.
• If you tend to easily develop bleeding or bruising, or if you are pregnant (see “Pregnancy, breastfeeding and fertility”).
• If you have diabetes. Treatment with escitalopram may alter blood sugar control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic.
• If you have low sodium levels in the blood.
• If you have coronary heart disease.
• If you have or have had heart problems or have recently had a heart attack.
• If you have a low resting heart rate and/or know that you may have a salt depletion, such as due to prolonged and intense diarrhea and vomiting (feeling sick) or due to the use of diuretics (water tablets).
• If you experience a fast or irregular heartbeat, fainting, collapse or dizziness when standing up, which may indicate abnormal heart rate function.
• If you have glaucoma (increased eye pressure).

To be considered

Some patients with manic-depressive illness may enter a manic phase. This is characterized by a change in ideas that is uncommon and rapidly changing, disproportionate joy without apparent reason, and excessive physical activity. If you experience this, contact your doctor.

You may experience symptoms such as agitation or difficulty sitting or standing still during the first few weeks of treatment. If you experience these symptoms, contact your doctor immediately.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may, on occasion, have thoughts of harming or killing yourself. These may increase when taking antidepressants for the first time, as all these medicines require time to start working, usually around two weeks, although in some cases it may be 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. Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 years of age 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 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.

Sexual dysfunction

Medicines like escitalopram (also called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.

Children and adolescents under 18 years

Escitalopram should notbe used, normally, 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 (mainly aggression, confrontational behavior, and irritation) when taking this class of medicines. Nevertheless, your doctor may prescribe escitalopram 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 must inform your doctor if any of the symptoms described above progress or if you experience complications when patients under 18 years are taking escitalopram. Additionally, the long-term safety effects of escitalopram on growth, maturity, and cognitive and behavioral development in this age group have not yet been demonstrated.

Other medicines and Escitalopram Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

It is very important that you tell your doctor if you are taking any of the following medicines:

• “Non-selective monoamine oxidase inhibitors (MAOIs)”, which contain phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as the active ingredient (used in the treatment of depression). If you have taken any of these medicines, you will need to wait 14 days before starting to take escitalopram. After stopping escitalopram, 7 days must pass before taking any of these medicines.
• Reversible MAO-A inhibitors, which contain moclobemide (used in the treatment of depression).
• Linezolid (an antibiotic).
• Irreversible MAO-B inhibitors, which contain selegiline (used in the treatment of Parkinson's disease). These increase the risk of adverse effects.
• Sumatriptan and similar medicines (used for the treatment of migraine) or buprenorphine and tramadol (used for severe pain). These medicines may interact with escitalopram, and you may experience symptoms such as involuntary muscle contractions, including the muscles that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor if you experience these symptoms.
• Cimetidine, omeprazole, and lansoprazole (used for the treatment of stomach ulcers), fluconazole (used for the treatment of 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 herb used for depression.
• Lithium or tryptophan (used for depression), as they may increase the effects of escitalopram.
• Acetylsalicylic acid (aspirin) (used to relieve pain or reduce the risk of thrombosis) and non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain). This may increase the tendency to bleeding.
• Warfarin, dipyridamole, phenprocoumon, or other anticoagulants (medicines used to reduce the risk of thrombosis). Your doctor will probably check your blood coagulation time at the start and end of treatment with escitalopram to check that the anticoagulant dose is still adequate.
• Mefloquine (used for the treatment of malaria), bupropion (used for smoking cessation or 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 (medicines used for the treatment of schizophrenia, psychosis) and antidepressants and other SSRIs, due to the possible risk of lowering the seizure threshold.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases) and imipramine, desipramine, clomipramine, and nortriptyline (used for the treatment of depression) and risperidone, thioridazine, and haloperidol (antipsychotics). It may be necessary to adjust the dose of escitalopram.
• Medicines that cause low potassium levels in the blood (hypokalemia) or low magnesium levels in the blood (hypomagnesemia).

Do not take escitalopramif you are taking medicines for heart rhythm problems or medicines that may affect the 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, especially halofantrine), and some antihistamines (e.g., astemizole, hydroxyzine, mizolastine). If you have any doubts about this, you should talk to your doctor.

Escitalopram Viatris with food, drinks, and alcohol

Escitalopram can be taken with or without food (see section 3 “How to take Escitalopram Viatris”). You should avoid drinking alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Tell your doctor if you are pregnant or are planning to have a baby. Do not take escitalopram if you are pregnant unless you and your doctor have discussed the risks and benefits involved. Do not stop treatment with escitalopram suddenly.

Make sure your midwife and/or doctor know that you are taking escitalopram. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like escitalopram may increase the risk of a serious condition in babies called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and appear blue. These symptoms usually start within 24 hours of the baby's birth. If this happens to your baby, you should contact your midwife and/or doctor immediately.

Other symptoms that may occur when taking escitalopram in the later stages of pregnancy are difficulty sleeping and feeding, irregular breathing, being too hot or cold, feeling sick, constant crying, low blood sugar, muscle stiffness or floppiness, hyperreflexia, irritability, lethargy, tremors, trembles, or seizures. If your baby has any of these symptoms at birth, contact your doctor immediately, they will advise you.

If you take escitalopram in the final stage of pregnancy, there may be a greater risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking escitalopram so that they can advise you.

Breastfeeding

Tell your doctor if you are breastfeeding. Escitalopram may be excreted in human milk. Do notbreastfeed if you are taking escitalopram. Your doctor will decide whether you should continue or stop breastfeeding or continue or stop treatment with escitalopram.

Fertility

Citalopram, a medicine similar to escitalopram, has been shown to reduce sperm quality in animal studies. In theory, this could affect fertility, but so far, no impact on human fertility has been observed.

Driving and using machines

Do not drive or use tools or machines until you know how escitalopram affects you.

Escitalopram Viatris contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially “sodium-free”

3. How to take Escitalopram Viatris

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

Remember that you may need to take escitalopram tablets for 2 or more weeks before you start to feel better.

Adults

Depression-The recommended dose is 10 mg of escitalopram per day. Your doctor may increase it to a maximum of 20 mg per day. It may take between 2 and 4 weeks before you start to feel better. It is recommended that treatment continue for at least 6 months after you feel better again.

Anxiety Disorder- The initial recommended dose is 5 mg of escitalopram per day. After the first week, your doctor may increase the dose to 10 mg per day and, if necessary, up to a maximum of 20 mg per day. The maximum effect is achieved after 3 months.

Social Anxiety Disorder- The recommended dose is 10 mg of escitalopram per day. It may take between 2 and 4 weeks before you start to feel better. After this, your dose could be reduced to 5 mg per day or increased to 20 mg per day, depending on how you are responding to the medication. Normally, the recommended treatment is 12 weeks.

Generalized Anxiety Disorder- The recommended dose is 10 mg of escitalopram per day. Your doctor may increase it to a maximum of 20 mg per day. Your doctor should review your dose regularly.

Obsessive-Compulsive Disorder- The recommended dose is 10 mg of escitalopram per day. Your doctor may increase it to a maximum of 20 mg per day. Your doctor should review your dose regularly.

Elderly patients (over 65 years old)

In addition to the above, your doctor will prescribe a lower dose to start with, as elderly patients may be more sensitive to the effects of escitalopram.

The initial recommended dose of escitalopram is 5 mg taken as a single dose per day.

The dose may be increased by your doctor to 10 mg per day.

Children and adolescents (under 18 years old)

Escitalopram should notnormally be administered to children and adolescents under 18 years old. For more information, see section 2 "What you need to know before taking Escitalopram Viatris".

If you have severe liver or kidney problems, your doctor will prescribe a lower dose than indicated above.

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

Do not stop treatment until your doctor tells you to, and do not interrupt it, even after you start to feel better. After your recovery, you should continue treatment for a period of between three and six months to avoid the recurrence of your symptoms.

The tablets can be divided into equal doses.

If you take more Escitalopram Viatris than you should

In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested. Go, even if you do not have symptoms of discomfort.

Some signs of overdose may be dizziness, tremors, agitation, convulsions, coma, feeling unwell (nausea, vomiting), changes in heart rate (slow or faster heartbeat), decrease in blood pressure, and changes in body fluid balance. Bring the packaging and leftover escitalopram tablets if you go to the doctor or hospital.

If you forget to take Escitalopram Viatris

Do not takea double dose to make up for missed doses. If you forget to take a dose and remember before bedtime, take it immediately. The next day, continue as normal. If you remember during the night or the next day, leave the missed dose and continue as usual.

If you interrupt treatment with Escitalopram Viatris

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

When you stop taking escitalopram, especially if it is sudden, you may feel withdrawal symptoms. These are common when treatment with escitalopram is suspended. The risk is greater when escitalopram 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, 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 dizzy (unstable or without balance), feeling tingling, feeling itchy, and (less frequently) feeling like an electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling restless, headache, feeling nauseous, sweating (including night sweats), feeling anxious or agitated, tremors (instability), feeling confused or disoriented, feelings of emotion or irritation, diarrhea, visual disturbances, or strong heartbeats (palpitations).

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

4. Possible side effects

Like all medications, this medication can have side effects, although not everyone will experience them.

Side effects usually disappear after a few weeks of treatment. Keep in mind that some of the effects may also be symptoms of your illness and, therefore, will improve as you start to feel better.

If you experience any of the following symptoms, consult your doctor or go directly to the hospital:

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, or face, or having difficulty breathing or swallowing (severe allergic reaction).
• High fever, agitation, confusion, tremors, or sudden muscle contractions, this could be a sign of a rare condition called serotonin syndrome.

Frequency not known(cannot be estimated from available data)

• Difficulty urinating.
• Seizures (attacks), see also section 2 "Warnings and precautions".
• Yellowing of the skin and the whites of the eyes, signs of liver function deterioration/hepatitis.
• A rapid and irregular heartbeat, fainting, which could be symptoms of a potentially life-threatening condition known as Torsade de Pointes.
• Thoughts of self-harm or suicide, see also section 2 "Warnings and precautions".

In addition to the above, the following side effects have been reported:

Very common(may affect more than 1 in 10 people)

• Headache.
• Feeling nauseous.

Common(may affect up to 1 in 10 people)

• Decreased appetite.
• Increased appetite.
• Weight gain.
• Anxiety, agitation.
• Difficulty sleeping.
• Feeling drowsy.
• Abnormal dreams.
• Feeling tingling or numbness in hands and feet.
• Tremors.
• Dizziness.
• Inflammation or swelling of the paranasal sinuses, causing pain, high fever, sensitivity (known as sinusitis).
• Diarrhea.
• Constipation.
• Vomiting.
• Dry mouth.
• Increased sweating.
• Fever.
• Muscle and joint pain.
• Feeling unusually tired.
• Sexual problems (delayed ejaculation, erection problems, decreased sexual desire, and women may experience difficulty reaching orgasm).

Uncommon(may affect up to 1 in 100 people)

• Weight loss.
• Confusion.
• Agitation.
• Nervousness.
• Teeth grinding while sleeping.
• Panic attack.
• Taste disturbances.
• Sleep disturbances.
• Fainting.
• Pupil dilation (mydriasis), visual disturbance.
• Ringing in the ears (tinnitus).
• Fast heartbeat.
• Nosebleeds.
• Hair loss.
• Hives.
• Rash.
• Itching.
• Heavy or irregular menstrual bleeding.
• Excess fluid in the body.

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

• Feeling aggressive or depersonalized.
• Hallucinations.
• Slow heartbeat.

Frequency not known(cannot be estimated from available data)

• Signs of abnormal bleeding, for example, from the skin and mucous membranes (ecchymosis) and low platelet count in blood (thrombocytopenia). Increase in levels of a hormone (ADH) that causes fluid retention or water retention.
• Increased levels of prolactin hormone in blood.
• Decrease in sodium levels in the blood, symptoms are feeling dizzy and unwell with muscle weakness or confusion.
• Mania (feeling of euphoria or overexcitement, causing unusual behavior).
• Abnormal muscle movements.
• Dizziness when standing up due to low blood pressure (orthostatic hypotension).
• Altered liver function tests.
• Painful and persistent erection of the penis.
• Abnormal milk production in the breasts of men and women.
• A higher risk of bone fractures has been observed in patients taking this class of medications.
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

In addition, other side effects are known to occur with drugs that work similarly to escitalopram. These are:

• Unable to stay still or difficulty staying seated (psychomotor restlessness/akathisia).
• Anorexia.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Escitalopram Viatris

Keep this medication out of sight and reach of children.

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

Store below 25 °C.

Bottles: Keep the bottle tightly closed.

Blister packs: Keep in the original packaging.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Escitalopram Viatris

The active ingredient is escitalopram. One tablet contains 10 mg of escitalopram (as oxalate). The other ingredients are: microcrystalline cellulose, anhydrous colloidal silica, talc, sodium croscarmellose, magnesium stearate, lactose monohydrate, hypromellose, macrogol 400, and titanium dioxide (E-171). See section 2, "Escitalopram Viatris contains lactose and sodium".

Appearance and packaging of the product

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

The film-coated tablet is oval, white, scored, and marked with "EC|10" on one side and "G" on the other. The tablets can be divided into equal halves.

Escitalopram is available in bottles of 28, 49, 100, 200, 250, and 500 film-coated tablets, in blister packs of 10, 14, 20, 28, 30, 49, 50, 56, 60, 90, 100, 180, and 200 film-coated tablets, and in single-dose perforated blister packs of 28 x 1 and 56 x 1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

Or

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Belgium: Escitalopram Viatris 10 mg film-coated tablets

Denmark: Escitalopram Viatris

Slovakia: Escitalopram Viatris 10 mg

Spain: Escitalopram Viatris 10 mg film-coated tablets EFG

France: Escitalopram Viatris 10 mg, scored film-coated tablet

Greece: Escitalopram/Mylan Film-coated Tablets 10mg/TAB

Hungary: Escigen 10 mg film tablet

Ireland: Escitalpro 10 mg film-coated tablets

Italy: Escitalopram Mylan

Luxembourg: Escitalopram Viatris 10 mg film-coated tablets

Norway: Escitalopram Viatris

Netherlands: Escitalopram Mylan 10 mg film-coated tablets

Portugal: Escitalopram Mylan

Czech Republic: Escitalopram Viatris

Sweden: Escitalopram Viatris 10 mg

Date of last revision of this leaflet:February 2025

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