Escitalopram Vir Pharma 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Escitalopram Vir Pharma 20 mg film-coated tablets EFG

Escitalopram

Read the entire leaflet carefully before you start taking this medicine

• 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 may harm them.
• If you think any of the side effects you experience is serious, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents

1. What Escitalopram Vir Pharma is and what it is used for.
2. Before you take Escitalopram Vir Pharma.
3. How to take Escitalopram Vir Pharma.
4. Possible side effects.
5. How to store Escitalopram Vir Pharma.
6. Further information.

1. What Escitalopram Vir Pharma is and what it is used for

Escitalopram Vir Pharma contains escitalopram and is indicated for the treatment of depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, in which there is fear of being in places where help may not be available, social anxiety disorder, and obsessive-compulsive disorder).

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. Alterations in the serotonergic system are considered an important factor in the development of depression and related conditions.

2. Before taking Escitalopram Vir Pharma

Do not take Escitalopram Vir Pharma

• If you are allergic (hypersensitive) to escitalopram or to any of the other components of
  Escitalopram Vir Pharma (see section 6 “Additional information”).
• 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), or linezolid (an antibiotic).

Take special care with Escitalopram Vir Pharma

Please inform your doctor if you have any other disorders or illnesses, as your doctor may need to take them into account. In particular, inform your doctor:

• If you have epilepsy. Treatment with Escitalopram Vir Pharma should be discontinued if seizures occur or if you notice an increase in the frequency of seizures (see also section 4 “Possible side effects”).
• If you have hepatic or renal impairment. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram Vir Pharma may alter glycaemic control. Adjustment of insulin and/or oral hypoglycaemic agent dosage may be necessary.
• If you have low sodium levels in the blood.
• If you are prone to bleeding or bruising easily, or if you are pregnant (see “Pregnancy”).
• If you are receiving electroconvulsive therapy.
• If you have coronary heart disease.

Please note:

Like other medicines used to treat depression or related conditions, improvement does not occur immediately. It may take several weeks after starting treatment with Escitalopram Vir Pharma before you experience any benefit. In the treatment of panic disorder, improvement is typically observed after 2–4 weeks. At the beginning of treatment,
some patients may experience increased anxiety, which will resolve with continued treatment.
Therefore, it is very important that you follow your doctor’s instructions exactly and do not stop treatment or change your dose without consulting your doctor.

Some medicines in the same class as escitalopram (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.

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 of harming yourself or ending your life. These may increase when first starting
antidepressants, as all these medicines require time to take effect, usually about two weeks, although in some cases it may take longer. You are more likely to have such thoughts:

• If you have previously had thoughts of harming or killing yourself.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age 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 immediately. It may help to tell 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.

Some patients with bipolar disorder may enter a manic phase. This is characterised by unusually rapid and racing thoughts, excessive happiness, and excessive physical activity. If you experience this, contact your doctor.

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

Sometimes, you may not notice the symptoms mentioned above, so it may be helpful to ask a friend or family member to help monitor possible changes in your behaviour.

Inform your doctor immediately or contact the nearest hospital if you have distressing thoughts or experiences, or if any of the symptoms mentioned above occur during treatment.

Use in children and adolescents under 18 years

Escitalopram Vir Pharma 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 (mainly aggression, confrontation behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Escitalopram Vir Pharma to patients under 18 years of age if they decide it is in the patient’s best interest. If your doctor has prescribed Escitalopram Vir Pharma to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You should inform your doctor if any of the symptoms described above worsen or develop complications while patients under 18 years of age are taking Escitalopram Vir Pharma. In addition, the long-term effects on safety, as well as on growth, maturation, and cognitive and behavioural development of Escitalopram Vir Pharma in this age group have not yet been established.

Use of other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

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. If you have taken any of these medicines, you must wait 14 days before starting Escitalopram Vir Pharma. After stopping Escitalopram Vir Pharma, you must wait 7 days before taking any of these medicines.
• “Reversible selective MAO-A inhibitors” containing moclobemide (used in the treatment of depression).
• “Irreversible MAO-B inhibitors” containing selegiline (used in the treatment of Parkinson’s disease). These increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used in the treatment of bipolar disorder) and tryptophan.
• Imipramine and desipramine (both used for the treatment of depression).
• Sumatriptan and similar medicines (used for the treatment of migraine) and tramadol (used for severe pain). These increase the risk of side effects.
• Cimetidine and omeprazole (used for the treatment of stomach ulcers), fluconazole (used to treat fungal infections).
• Fluvoxamine (an antidepressant) and ticlopidine (used to reduce the risk of stroke). These may cause increased blood levels of Escitalopram Vir Pharma.
• St. John’s wort (Hypericum perforatum) – a herbal remedy used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or reduce the risk of thrombosis, also called anticoagulants).
• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will likely monitor your blood clotting time at the beginning and end of treatment with Escitalopram Vir Pharma to ensure that the anticoagulant dose remains appropriate.
• Mefloquine (used for the treatment of malaria), bupropion (used for the treatment of depression), and tramadol (used for the treatment of severe pain), due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines used for the treatment of schizophrenia, psychosis) due to the possible risk of lowering the seizure threshold and antidepressants.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of Escitalopram Vir Pharma may need to be adjusted.

Taking Escitalopram Vir Pharma with food and drink

Escitalopram Vir Pharma can be taken with or without food (see section 3 “How to take Escitalopram Vir Pharma”).

As with many medicines, combining Escitalopram Vir Pharma with alcohol is not recommended, although no interaction between Escitalopram Vir Pharma and alcohol is expected.

Pregnancy and breast-feeding

Pregnancy

Inform your doctor if you are pregnant or plan to become pregnant. Do not take Escitalopram Vir Pharma during pregnancy unless you and your doctor have carefully considered the risks and benefits involved.

If you take Escitalopram Vir Pharma during the last 3 months of pregnancy, the following effects may occur in the newborn baby: breathing difficulties, bluish skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, exaggerated reflexes, tremors, restlessness, irritability, lethargy, constant crying, drowsiness, and sleep disturbances. If your newborn baby shows any of these symptoms, please contact your doctor immediately.

Ensure that your midwife and/or doctor know that you are taking Escitalopram Vir Pharma. When used during pregnancy, especially during the last 3 months, medicines like Escitalopram Vir Pharma may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

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 accordingly.

If Escitalopram Vir Pharma is used during pregnancy, it must never be stopped abruptly.

Breast-feeding

Do not take Escitalopram Vir Pharma while breast-feeding unless you and your doctor have carefully considered the risks and benefits involved.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

It is advised not to drive or operate machinery until you know how Escitalopram Vir Pharma affects you.

3. How to take Escitalopram Vir Pharma

Follow exactly the instructions for using Escitalopram Vir Pharma as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

Adults

Depression

The normally recommended dose of Escitalopram Vir Pharma is 10 mg taken as a single daily dose. Your doctor may increase this up to a maximum of 20 mg per day.

Panic disorder

The initial dose of Escitalopram Vir Pharma is 5 mg as a single daily dose for the first week before increasing the dose to 10 mg per day. Your doctor may subsequently increase the dose up to a maximum of 20 mg per day.

Social anxiety disorder

The normally recommended dose of Escitalopram Vir Pharma is 10 mg taken as a single daily dose.

Your doctor may reduce your dose to 5 mg per day or increase it up to a maximum of 20 mg per day, depending on how you respond to the medication.

Obsessive-compulsive disorder

The normally recommended dose of Escitalopram Vir Pharma is 10 mg taken as a single daily dose. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Elderly (over 65 years)

The normally recommended initial dose of Escitalopram Vir Pharma is 5 mg taken as a single daily dose.

Children and adolescents (under 18 years)

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

You may take Escitalopram Vir Pharma with or without food. Swallow the tablets with water. Do not chew them, as they have a bitter taste.

If necessary, you may split the tablets by placing the tablet on a flat surface with the score line facing upwards. The tablets can be broken by pressing downwards on each end of the tablet with your two index fingers.

Duration of treatment

It may take a few weeks before you start to feel better. Continue taking Escitalopram Vir Pharma even if you start to feel better before the expected time.

Do not change the dose of the medication without first talking to your doctor.

Continue taking Escitalopram Vir Pharma for the length of time recommended by your doctor. If you stop treatment too early, symptoms may return. It is recommended that treatment continues for at least 6 months after you feel well again.

If you take more Escitalopram Vir Pharma than you should

If you take more Escitalopram Vir Pharma than prescribed, contact your doctor immediately, go to the nearest hospital emergency department, or contact the Poison Information Service at telephone number 915.620.420. Do this even if you do not notice any discomfort or signs of poisoning. Some of the signs of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rate, decreased blood pressure, and disturbances in the body's fluid and electrolyte balance. Take the Escitalopram Vir Pharma packaging with you if you go to the doctor or hospital.

If you forget to take Escitalopram Vir Pharma

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. The next day, continue as usual. If you remember during the night or the next day, skip the missed dose and continue as usual.

If you stop taking Escitalopram Vir Pharma

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

When you stop taking Escitalopram Vir Pharma, especially if abruptly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram Vir Pharma is discontinued. The risk is higher when Escitalopram Vir Pharma 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 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 Vir Pharma, please contact your doctor. Your doctor may ask you to resume taking your tablets and taper them more slowly.

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

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Escitalopram Vir Pharma may have adverse effects, although not everyone will experience them.

Adverse effects usually disappear after a few weeks of treatment.

Please be aware that many of these effects may be symptoms of your illness and will therefore improve as you start to feel better.

Visit your doctor if you experience any of the following adverse effects during treatment:

Uncommon (affects between 1 and 10 out of 1,000 people):

• Unusual bleeding, including gastrointestinal bleeding.

Rare (affects between 1 and 10 out of 10,000 people):

• If you notice swelling of the skin, tongue, lips, or face, or have difficulty breathing or swallowing (allergic reaction), contact your doctor or go to the hospital immediately.

• If you develop high fever, agitation, confusion, tremors, and sudden muscle contractions, these may be signs of a rare condition called serotonin syndrome. If you feel this way, contact your doctor.

If you experience any of the following adverse effects, you must contact your doctor or go to the hospital immediately:

• Difficulty urinating.
• Seizures (fits), see also section “Take special care with Escitalopram Vir Pharma”.
• Yellowing of the skin and whites of the eyes, signs of liver function impairment /hepatitis.

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

Very common (affects more than 1 in 10 people): Feeling dizzy (nausea).

Common (affects between 1 and 10 out of 100 people):

• Nasal congestion or mucus (sinusitis).
• Decreased or increased appetite.
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, feeling sleepy, dizziness, yawning, tremors, skin itching.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual disturbances (delayed ejaculation, erection problems, reduced sexual drive; women may experience difficulty reaching orgasm).
• Fatigue, fever.
• Weight gain.

Uncommon (affects between 1 and 10 out of 1,000 patients/people):

• Hives, skin rash, itching (pruritus).
• Teeth grinding, restlessness, nervousness, panic attacks, confusion.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Hair loss.
• Vaginal bleeding.
• Weight loss.
• Fast heartbeat.
• Swelling of arms and legs.
• Nosebleeds.

Rare (affects between 1 and 10 out of 10,000 people):

• Aggression, depersonalization, hallucinations.
• Slow heartbeat.
• Events related to suicide, see also section “Take special care with Escitalopram Vir Pharma”.

Some patients have reported (frequency not known):

• Decreased sodium levels in the blood (symptoms include dizziness and malaise with muscle weakness or confusion).
• Dizziness upon standing due to low blood pressure (orthostatic hypotension).
• Abnormal liver function tests (increased liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Bleeding disorders including skin and mucous membrane bleeding (ecchymosis) and low platelet counts in the blood (thrombocytopenia).
• Sudden swelling of the skin or mucous membranes (angioedema).
• Increased urine output (inappropriate ADH secretion).
• Milk discharge in women who are not breastfeeding.
• Mania.
• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage); see “Pregnancy” in section 2 for more information.

Thoughts of harming yourself or thoughts of suicide (during treatment with escitalopram or early discontinuation of treatment, cases of suicidal ideation and suicidal behavior have been reported). (See also section “Take special care with Escitalopram Vir Pharma”).

Other adverse effects known to occur with drugs that act similarly to escitalopram (the active substance in Escitalopram Vir Pharma) include:

• Motor restlessness (akathisia).
• Anorexia.

In patients taking this type of medication, an increased risk of bone fractures has been observed.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines at: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Escitalopram Vir Pharma

Keep out of the reach and sight of children.

This medicine does not require any special storage conditions.

Do not use Escitalopram Vir Pharma after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional Information

Composition of Escitalopram Vir Pharma

The active substance is escitalopram.

Each tablet of Escitalopram Vir Pharma contains 20 mg of escitalopram (as oxalate). The other components are:

Core: microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, and magnesium stearate.

Coating: hypromellose, macrogol 400, and titanium dioxide (E-171).

Appearance of the medicinal product and contents of the container

Escitalopram Vir Pharma is available as 20 mg film-coated tablets. The tablets are described below:

Escitalopram Vir Pharma 20 mg are white oval tablets, scored on one side. The tablets can be divided into equal halves.

Escitalopram Vir Pharma is available in the following pack sizes:

28 and 30 tablets

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

C/Laguna 66-68-70, Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

Manufacturer

HBM Pharma s.r.o.

Sklabinská 30

036 80 Martin, Slovakia

or

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

C/Laguna 66-68-70, Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

This leaflet was approved in: August 2025