Escitalopram Viatris 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Escitalopram Viatris 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Escitalopram belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonergic system in the brain by increasing the level of serotonin.

Escitalopram may be prescribed to treat the following disorders:

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

2. What you need to know before taking Escitalopram Viatris

Do not take Escitalopram Viatres:

• If you are allergic to escitalopram or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking other medicines belonging 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 were born with an episode of abnormal cardiac arrhythmia or have experienced one (detected on an ECG, a test to assess heart function).
• If you are taking medicines for heart rhythm problems or that may affect heart rhythm (see section 2 “Other medicines and Escitalopram Viatris”).

Warnings and precautions

Talk to your doctor or pharmacist before starting escitalopram:

• If you have liver or kidney impairment. Your doctor may need to adjust your dose.
• If you are elderly.
• If you have epilepsy or a history of seizures. Treatment with escitalopram should be discontinued if you experience seizures for the first time or notice an increase in seizure frequency (see also section 4 “Possible side effects”).
• If you are receiving electroconvulsive therapy.
• If you are prone to bleeding or bruising easily, or if you are pregnant (see “Pregnancy, breastfeeding and fertility”).
• If you have diabetes. Treatment with escitalopram may alter glycaemic control (blood sugar level control). A dose adjustment of insulin and/or oral hypoglycaemic agents may be necessary.
• If you have low sodium levels in the blood.
• If you have coronary artery 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 you may have salt depletion due to prolonged and severe diarrhoea and vomiting (feeling unwell) or due to the use of diuretics (water tablets).
• If you experience a rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm.
• If you have glaucoma (increased eye pressure).

To consider

Some patients with bipolar disorder may enter a manic phase. This is characterized by unusually rapid and changing thoughts, excessive happiness without apparent reason, and excessive physical activity. If you experience this, contact your doctor.

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

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may occasionally have thoughts about harming or killing yourself. These thoughts may increase when starting antidepressants, as all these medicines require time to begin working—usually around two weeks, although in some cases it may take longer.

You are more likely to have these types of thoughts:

• If you have previously had thoughts about killing or harming yourself.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with an antidepressant.

If at any time you have thoughts about harming or killing yourself, contact your doctor or go directly to a hospital. It may be helpful for you to inform a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them whether they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your behaviour.

Sexual dysfunction

Medicines such as escitalopram (also known as SSRIs/SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.

Children and adolescents under 18 years of age

Escitalopram should not normally be used in the treatment of children and adolescents under 18 years of age. Also, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe escitalopram to patients under 18 years of age if they decide it is most appropriate for the patient. If your doctor has prescribed escitalopram to a patient under 18 years of age and you wish to discuss this decision, please contact your doctor again. You must inform your doctor if any of the symptoms described above worsen or become complicated while patients under 18 years of age are taking escitalopram. In addition, the long-term effects of escitalopram on growth, maturation, and cognitive and behavioural development in this age group have not yet been established.

Other medicines and Escitalopram Viatris

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

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

• “Non-selective monoamine oxidase inhibitors (MAOIs)” containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine as active ingredients (used in the treatment of depression). If you have taken any of these medicines, you must wait 14 days before starting escitalopram. After stopping escitalopram, 7 days must pass before taking any of these medicines.
• Reversible selective MAO-A inhibitors containing moclobemide (used in the treatment of depression).
• Linezolid (an antibiotic).
• Irreversible MAO-B inhibitors containing selegiline (used in the treatment of Parkinson’s disease). These increase the risk of adverse effects.
• Sumatriptan and similar medicines (used for migraine treatment) or buprenorphine and tramadol (used for severe pain). These medicines may interact with escitalopram, and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Contact your doctor if you experience these symptoms.
• Cimetidine, omeprazole, and lansoprazole (used for stomach ulcer treatment), fluconazole (used for fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause increased blood levels of escitalopram.
• St. John’s wort (Hypericum perforatum) – a herbal remedy used for depression.
• Lithium or tryptophan (used for depression), as they may enhance the effects of escitalopram.
• Acetylsalicylic acid (aspirin) (used for pain relief or to reduce the risk of thrombosis) and non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used for pain relief). This may increase the tendency to bleed.
• Warfarin, dipyridamole, phenprocoumon, or other anticoagulants (medicines used to reduce the risk of thrombosis). Your doctor will likely monitor your blood clotting time at the beginning and end of escitalopram treatment to ensure your anticoagulant dose remains appropriate.
• Mefloquine (used for malaria treatment), bupropion (used for smoking cessation or depression treatment), and tramadol (used for severe pain treatment), due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines used for schizophrenia, psychosis), antidepressants, and other SSRIs, due to the possible risk of lowering the seizure threshold.
• Flecainide, propafenone, and metoprolol (used for cardiovascular diseases), imipramine, desipramine, clomipramine, and nortriptyline (used for depression treatment), and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of escitalopram may need to be adjusted.
• Medicines that cause low potassium levels in the blood (hypokalaemia) or low magnesium levels in the blood (hypomagnesaemia).

Do not take escitalopram if you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm, such as Class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g., sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarial treatments, especially halofantrine), and certain antihistamines (e.g., astemizole, hydroxyzine, mizolastine). If you have any doubts about this, you should speak with 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 alcohol consumption while taking this medicine.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Inform your doctor if you are pregnant or plan to become pregnant. Do not take escitalopram during pregnancy unless you and your doctor have discussed the risks and benefits involved. Do not stop escitalopram treatment suddenly.

Ensure that your midwife and/or doctor know you are taking escitalopram. When taken during pregnancy, particularly during the last three months, medicines like escitalopram may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear blue. These symptoms usually begin within 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

Other symptoms that may occur when escitalopram is taken in late pregnancy include difficulty sleeping and feeding, irregular breathing, being too hot or too cold, feeling unwell, constant crying, low blood sugar, muscle stiffness or floppiness, hyperreflexia, irritability, lethargy, tremors, shakiness, or seizures. If your baby shows any of these symptoms at birth, contact your doctor immediately; they will advise you.

If you take escitalopram late in 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 be aware that you are taking escitalopram so they can advise you appropriately.

Breastfeeding

Inform your doctor if you are breastfeeding. Escitalopram may be excreted in human milk. Do not breastfeed while taking escitalopram. Your doctor will decide whether you should continue/interrupt breastfeeding or continue/interrupt 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 no impact on human fertility has been observed so far.

Driving and use of machines

Do not drive or operate tools or machinery until you know how escitalopram affects you.

Escitalopram Viatris contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain 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 exactly the instructions for using this medicine given by your doctor or pharmacist. If in 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 up to a maximum of 20 mg per day. It may take between 2 and 4 weeks before you start to feel better. Treatment is recommended to continue for at least 6 months after you feel well again.

Panic disorder – The recommended initial 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. Maximum effect is reached 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 may be reduced to 5 mg per day or increased to 20 mg per day, depending on your response to the medication. Typically, the recommended treatment duration is 12 weeks.

Generalized anxiety disorder – The recommended dose is 10 mg of escitalopram per day. Your doctor may increase it up 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 up to a maximum of 20 mg per day. Your doctor should review your dose regularly.

Elderly patients (over 65 years of age)

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

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

Your doctor may increase the dose to 10 mg per day.

Children and adolescents (under 18 years of age)

Escitalopram should not, normally, be given to children and adolescents under 18 years of age. For more information, please refer to section 2 “What you need to know before taking Escitalopram”.

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

You may 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 do so, and do not interrupt it even after you start to feel better. After recovery, you should continue treatment for a period of between three and six months to prevent the return of your symptoms.

The tablets may be divided into equal doses.

If you take more Escitalopram Viatris than you should

In case of overdose or accidental ingestion, contact your doctor immediately or call the Toxicology Information Service at telephone number 915 620 420, stating the medication and the amount ingested. Go for medical help even if you do not have symptoms of illness.

Some signs of overdose may include dizziness, tremor, agitation, seizures, coma, feeling unwell (nausea, vomiting), changes in heart rhythm (slow or faster heartbeat), decreased blood pressure, and disturbances in the body's fluid and electrolyte balance. Take the packaging and any remaining escitalopram tablets with you if you go to the doctor or hospital.

If you forget to take Escitalopram Viatris

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

If you stop taking Escitalopram Viatris

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

When you stop taking escitalopram, especially if abruptly, you may experience withdrawal symptoms. These are common when treatment with escitalopram is stopped. The risk is greater when escitalopram has been used for a long time, at high doses, or when the dose is reduced too quickly. Most people find these symptoms are mild and disappear on their own within two weeks. However, in some patients, they may be severe 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 restart your tablets and taper off more slowly.

Withdrawal symptoms include: dizziness (feeling unsteady or off balance), tingling sensations, prickling sensations, and (less frequently) electric shock-like sensations, even in the head; sleep disturbances (vivid dreams, nightmares, inability to sleep); restlessness; headache; nausea; sweating (including night sweats); feelings of unease or agitation; tremors (shakiness); feelings of confusion or disorientation; emotional lability or irritability; diarrhoea (loose stools); visual disturbances or strong heartbeats (palpitations).

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects usually disappear after a few weeks of treatment. Keep in mind that some of these effects may also be symptoms of your illness and will therefore 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 difficulty breathing or swallowing (severe allergic reaction).
• High fever, agitation, confusion, tremors, or sudden muscle contractions, which could be signs of a rare condition called serotonin syndrome.

Frequency not known (cannot be estimated from available data)

• Difficulty urinating.
• Seizures (fits), see also section 2 “Warnings and precautions”.
• Yellowing of the skin or whites of the eyes, signs of impaired liver function/hepatitis.
• Fast or 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 adverse effects have been reported:

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

• Headache.
• Feeling dizzy (nausea).

Common (may affect up to 1 in 10 people)

• Decreased appetite.
• Increased appetite.
• Weight gain.
• Anxiety, agitation.
• Difficulty falling asleep.
• Feeling drowsy.
• Abnormal dreams.
• Tingling or numbness in hands and feet.
• Tremors.
• Dizziness.
• Yawning.
• Inflammation or swelling of the 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, erectile problems, decreased sexual desire, and women may experience difficulty achieving orgasm).

Uncommon (may affect up to 1 in 100 people)

• Weight loss.
• Confusional state.
• Agitation.
• Nervousness.
• Teeth grinding during sleep.
• Panic attack.
• Taste disturbances.
• Sleep disturbances.
• Fainting.
• Dilated pupils (mydriasis), visual disturbances.
• Ringing in the ears (tinnitus).
• Fast heartbeat.
• Nosebleeds.
• Hair loss.
• Hives.
• Skin rash.
• Itching.
• Heavy menstrual periods or bleeding between periods.
• Fluid retention 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 (bruising, or ecchymosis) and low platelet count in the blood (thrombocytopenia).
• Increased levels of a hormone (ADH) causing fluid retention or water retention.
• Increased levels of prolactin hormone in the blood.
• Decreased sodium levels in the blood; symptoms include dizziness, malaise, muscle weakness, or confusion.
• Mania (feelings of euphoria or overexcitement leading to unusual behavior).
• Abnormal muscle movements.
• Dizziness upon standing due to low blood pressure (orthostatic hypotension).
• Abnormal liver function tests.
• Persistent, painful erection of the penis (priapism).
• Abnormal production of milk in the breasts of men and women (galactorrhea).
• An increased risk of bone fracture has been observed in patients taking this class of medicines.
• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage); see “Pregnancy” in section 2 for more information.

Additionally, other adverse effects are known to occur with medicines that act similarly to escitalopram. These include:

• Inability to stay still or difficulty remaining seated (psychomotor restlessness/acathisia).
• Anorexia.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Escitalopram Viatris

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

Do not use this medicine after the expiry date stated on the packaging after CAD or EXP. The expiry date refers to 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Escitalopram Viatris

The active substance is escitalopram. One tablet contains 20 mg of escitalopram (as oxalate). The other components are: microcrystalline cellulose, colloidal anhydrous 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 of the product and contents of the pack

Escitalopram is presented as film-coated tablets.

The film-coated tablet is oval, white, scored and marked with "EC|20" on one side and "G" on the other. The tablets may be divided into equal halves.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

Mylan Hungary Kft.
Mylan utca 1
Komárom, 2900
Hungary

Further information on this medicine is available by contacting the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Belgium: Escitalopram Viatris 20 mg filmomhulde tabletten
Denmark: Escitalopram Viatris
Spain: Escitalopram Viatris 20 mg film-coated tablets EFG
France: Escitalopram Viatris 20 mg, comprimé pelliculé sécable
Greece: Escitalopram/Mylan Film-coated Tablets 20mg/TAB
Ireland: Escitalpro 20 mg film-coated tablets
Italy: Escitalopram Mylan
Luxembourg: Escitalopram Viatris 20 mg comprimés pelliculés
Norway: Escitalopram Viatris
Netherlands: Escitalopram Mylan 20 mg filmomhulde tabletten
Portugal: Escitalopram Mylan
Czech Republic: Escitalopram Viatris
Sweden: Escitalopram Viatris 20 mg

Date of the most recent revision of this leaflet: February 2025

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