Escitalopram Vir Pharma 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Escitalopram Vir Pharma 10 mg film-coated tablets EFG

Escitalopram

Read all of this leaflet carefully before you start taking this medicine

• 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 other people, even if they have the same symptoms as you, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects 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 experiencing panic attacks 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 illnesses.

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 “Further 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), and linezolid (an antibiotic).

Take special care with Escitalopram Vir Pharma

Please inform your doctor if you have any other disorder or illness, as your doctor may need to take this into account. Specifically, 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 the dose of insulin and/or oral hypoglycaemic agents may be necessary.
• If you have low levels of sodium 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 usually occurs after 2–4 weeks. At the beginning of treatment,
some patients may experience increased anxiety, which will disappear as treatment continues.
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 group to which escitalopram belongs (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may occasionally have thoughts about harming yourself or ending your life. These thoughts may increase when you first start taking
antidepressants, as all these medicines take time to become effective, 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 about 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 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 frequent changes of thought, excessive happiness, and excessive physical activity. If you experience this, contact your doctor.

Symptoms such as restlessness or difficulty sitting 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 be aware of the symptoms mentioned above, and therefore 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. You should also be aware 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, oppositional 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 return to your doctor. You must 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, growth, maturation, and cognitive and behavioural development of Escitalopram Vir Pharma in this age group have not yet been fully established.

Use of other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might use 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 may 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 if you are pregnant unless you and your doctor have discussed 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 has 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 such as 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 bluish. 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.

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

Breast-feeding

Do not take Escitalopram Vir Pharma if you are breast-feeding unless you and your doctor have discussed the risks and benefits involved.

Consult your doctor or pharmacist before using 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 taking 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 the dose 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 given 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 divide the tablets by placing the tablet on a flat surface with the score line facing upwards. The tablets can be split by pressing downwards on each end of the tablet with the 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 speaking 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 Toxicology 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 following 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. 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 stopped. The risk is greater 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 resolve 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. They may ask you to resume taking your tablets and then stop more slowly.

Withdrawal symptoms include: dizziness (unsteadiness or loss of balance), tingling sensations, burning sensations, and (less frequently) electric shock-like sensations, even in the head; sleep disturbances (overly 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 pulse 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 can 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 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 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 dysfunction / 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 drowsy, 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, and 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, agitation, 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, malaise, 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 bleeding of the skin and mucous membranes (bruising, 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 behaviour have been reported). (See also section “Take special care with Escitalopram Vir Pharma”).

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

• Motor restlessness (akathisia).
• Anorexia.

An increased risk of bone fractures has been observed in patients taking this type of medicine.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects 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 refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE Point pharmacy. Ask your pharmacist how to properly 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 10 mg of escitalopram (as oxalate). The other components are:

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

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

Appearance of the product and contents of the pack

Escitalopram Vir Pharma is available as 10 mg film-coated tablets. The tablets are described as follows:

Escitalopram Vir Pharma 10 mg are oval, white tablets with a score line on one side. The tablets can be divided into equal halves.

Escitalopram Vir Pharma is available in the following pack sizes:

28 tablets

Only some 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

Slovak Republic

or

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

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

28923 Alcorcón (Madrid)

Spain

This medicinal product was authorized in the EEA Member States under the following names: Austria:

This leaflet was approved in: August 2025