ESCITALOPRAM VIR PHARMA 15 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Escitalopram Vir Pharma 15 mg film-coated tablets

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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

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

1. What is Escitalopram Vir Pharma and what is it 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, social anxiety disorder, and obsessive-compulsive disorder).

Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medications work on the serotonin system in the brain by increasing the level of serotonin. Alterations of the serotonin system are considered an important factor in the development of depression and related diseases.

2. Before taking Escitalopram Vir Pharma

Do not take Escitalopram Vir Pharma

• If you are allergic (hypersensitive) to escitalopram or any of the other ingredients of Escitalopram Vir Pharma (see section 6 "Further information").

Escitalopram Vir Pharma

• If you are taking other medications that belong 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).

Be cautious when taking Escitalopram Vir Pharma

Please inform your doctor if you have any other disorders or diseases, as your doctor may need to take this 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 liver or kidney failure. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram Vir Pharma may alter blood sugar control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic medication.
• If you have a low level of sodium in the blood.
• If you tend to develop 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:

As with other medications used to treat depression or related diseases, improvement is not immediate. It may take several weeks after starting treatment with Escitalopram Vir Pharma before you experience any improvement. In the treatment of panic disorder, it usually takes 2-4 weeks before you notice any improvement. At the start 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 the dose without consulting your doctor.

Some medications in the same group as escitalopram (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping 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 of harming or killing yourself. These may increase when taking antidepressants for the first time, as these medications require time to start working, usually around two weeks, although in some cases it may be longer. You are 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 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 behavior.

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

Symptoms such as restlessness or difficulty sitting or standing may also occur during the first few 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 you observe any possible signs of change in your behavior.

Inform your doctor immediately or contact the nearest hospital if you have thoughts or experiences of anxiety 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. Additionally, 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 medications. Nevertheless, your doctor may prescribe Escitalopram Vir Pharma to patients under 18 years when they decide it is appropriate for the patient. If the doctor who prescribed Escitalopram Vir Pharma to a patient under 18 years wants to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms described above worsen or if you experience complications when patients under 18 years are taking Escitalopram Vir Pharma. At the same time, the long-term effects on safety, growth, maturity, and cognitive and behavioral development of Escitalopram Vir Pharma in this age group have not yet been demonstrated.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used any other medications, including those obtained without a prescription.

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

• Non-selective monoamine oxidase inhibitors (MAOIs) that contain phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active ingredients. If you have taken any of these medications, you will need to wait 14 days before starting to take Escitalopram Vir Pharma. After finishing Escitalopram Vir Pharma, 7 days must pass before taking any of these medications.
• Reversible selective MAO-A inhibitors that contain moclobemide (used in the treatment of depression).
• Irreversible MAO-B inhibitors that contain 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 manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (both used for the treatment of depression).
• Sumatriptan and similar medications (used for the treatment of migraines) and tramadol (used for severe pain). These increase the risk of side effects.

(used for severe pain). These increase the risk of side effects.

• Cimetidine and omeprazol (used for the treatment of stomach ulcers), fluconazole (used to treat fungal infections)
• fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke). These may cause an increase in the blood levels of Escitalopram Vir Pharma.
• St. John's Wort (Hypericum perforatum) - a medicinal plant used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medications used to relieve pain or reduce the risk of thrombosis, also called anticoagulants).
• Warfarin, dipyridamole, and phenprocoumon (medications used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably monitor your blood coagulation time at the start and end of treatment with Escitalopram Vir Pharma to check that the dose of anticoagulant is still adequate.
• 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 reducing the seizure threshold.

• Neuroleptics (medications used for the treatment of schizophrenia, psychosis) due to the possible risk of reducing the seizure threshold and antidepressants.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). It may be necessary to adjust the dose of Escitalopram Vir Pharma.

Taking Escitalopram Vir Pharma with food and drinks

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

As with many medications, it is not recommended to combine Escitalopram Vir Pharma and alcohol, although it is not expected that Escitalopram Vir Pharma will interact with alcohol.

Pregnancy and breastfeeding

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 analyzed the risks and benefits involved.

If you take Escitalopram Vir Pharma during the last 3 months of your pregnancy, be aware that the following effects may be observed in the newborn: difficulty breathing, blue skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, muscle stiffness or weakness, increased reflexes, tremors, restlessness, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. If your newborn has any of these symptoms, please contact your doctor immediately.

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

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 to advise you accordingly.

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

Breastfeeding

Do not take Escitalopram Vir Pharma if you are breastfeeding unless you and your doctor have analyzed the risks and benefits involved.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

It is recommended that you do not drive or use machinery until you know how Escitalopram Vir Pharma affects you.

3. How to take Escitalopram Vir Pharma

Follow your doctor's instructions for taking Escitalopram Vir Pharma exactly. Consult your doctor or pharmacist if you have any doubts.

Adults

Depression

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

Panic disorder

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

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 dose per day. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Elderly (over 65 years)

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

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 can 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 can split the tablets by placing the tablet on a flat surface with the score line facing up. The tablets can be broken by pressing down on each end of the tablet with your index fingers.

Duration of treatment

It may take a couple of 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 talking to your doctor first.

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

If you take more Escitalopram Vir Pharma than you should

If you take more doses of Escitalopram Vir Pharma than prescribed, contact your doctor immediately, go to the emergency department of the nearest hospital, or consult the Toxicology Information Service, phone 915.620.420. Do this even if you do not notice any discomfort or signs of poisoning. Some signs of overdose may be dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and changes in the body's water and salt balance. Bring the package of Escitalopram Vir Pharma 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 forgotten 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 forgotten dose and continue as usual.

If you stop taking Escitalopram Vir Pharma

Do not stop taking Escitalopram Vir Pharma until your doctor tells you to. When you have finished your course of treatment, it is usually recommended that the dose of Escitalopram Vir Pharma be gradually reduced over several weeks.

When you stop taking Escitalopram Vir Pharma, especially if it is sudden, 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, 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 experience severe withdrawal symptoms when you stop taking Escitalopram Vir Pharma, please contact your doctor. He or she may ask you to start taking your tablets again and stop them more slowly.

The withdrawal symptoms include: feeling of dizziness (unstable or without balance), feeling of tingling, feeling of prickling, and (less frequently) electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of nausea (nausea), sweating (including night sweats), feeling of restlessness or agitation, tremors (instability), feeling of confusion or disorientation, feelings of emotion or irritation, diarrhea (loose stools), visual disturbances, rapid heartbeat or palpitations.

If you have any other 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 all people suffer from them.

Adverse effects usually disappear after a few weeks of treatment.

Please be aware that many of the effects can be symptoms of your illness and will therefore improve when you start to feel better.

Visit your doctor if you have 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 have a 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 the following adverse effects, you should contact your doctor or go to the hospital immediately:

• Difficulty urinating.
• Seizures (attacks), see also the section "Be especially careful with Escitalopram Vir Pharma".
• Yellow skin and whitening of the eyes, are signs of altered liver function

/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 people out of 100):

• Nasal congestion or mucous (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty falling asleep, feeling sleepy, dizziness, yawning, tremors, itching of the skin.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual disorders (delayed ejaculation, erection problems, decreased sexual behavior, 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, anxiety attacks, confusion.
• Sleep disorders, taste disorders, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbance, ringing in the ears (tinnitus).
• Hair loss.
• Vaginal bleeding.
• Weight loss.
• Fast heart rate.
• Swelling of arms and legs.
• Nosebleeds.

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

• Aggression, depersonalization, hallucinations.
• Slow heart rate.
• Suicidal thoughts or behaviors, see also the section "Be especially careful with

Escitalopram Vir Pharma". Some patients have reported (frequency not known):

• Decreased sodium levels in the blood (symptoms are dizziness and discomfort with muscle weakness or confusion).
• Dizziness when standing up due to low blood pressure (orthostatic hypotension).
• Altered liver function tests (increased liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Coagulation disorders including skin and mucous membrane bleeding (ecchymosis) and low platelet count in blood (thrombocytopenia).
• Sudden swelling of the skin or mucous membranes (angioedema).
• Increased amount of urine excreted (inadequate secretion of ADH).
• Milk flow in women who are not breastfeeding.
• Mania.
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

Thoughts of harming oneself or suicidal thoughts (during therapy with escitalopram or early discontinuation of treatment, cases of suicidal ideation and behavior have been reported). (See also the section "Be especially careful with Escitalopram Vir Pharma").

Other adverse effects that occur with drugs that work similarly to escitalopram (the active ingredient of Escitalopram Vir Pharma) are known. These are:

• Motor restlessness (akathisia).
• Anorexia.

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

If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this prospectus, 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 that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, web: www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Escitalopram Vir Pharma

Keep out of the reach and sight of children.

This medicine does not require special storage conditions.

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

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Additional Information

Composition of Escitalopram Vir Pharma

The active ingredient is escitalopram.

Each Escitalopram Vir Pharma tablet contains 10 mg, 15 mg, or 20 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 packaging content

Escitalopram Vir Pharma is presented in the form of film-coated tablets of 10 mg, 15 mg, and 20 mg. The tablets are described below:

Escitalopram Vir Pharma 15 mg are white oval tablets with a notch on one side. The notch is only to allow fractionation and facilitate swallowing.

Escitalopram Vir Pharma is available in the following packaging sizes:

28 tablets

Some packaging sizes may only be marketed.

Marketing authorization holder and manufacturer

Holder

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

C/Laguna 66-70. Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Manufacturer

HBM Pharma s.r.o.

Sklabinská 30

036 80 Martin

Slovak Republic

This medicine was authorized in the EEA Member States with the following names: Austria:

This prospectus was approved in: March 2021