Package Leaflet: Information for the User

Escitalopram Vir Pharma 15 mg Film-Coated Tablets

Escitalopram

Read this leaflet carefully before you start taking this medicine

• Keep this leaflet, as 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 even if their symptoms are the same. It may harm them.

•If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

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

2. Before taking Escitalopram Vir Pharma.

3. How to take Escitalopram Vir Pharma.

4. Possible side effects.

5. Storage of Escitalopram Vir Pharma.

6. Further information.l

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, which is the 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 medications act on the serotonin system in the brain by increasing the level of serotonin. Alterations in the serotonin system are considered an important factor in the development of depression and related conditions.

Do not take Escitalopram Vir Pharma

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

• If you are taking other medicines that belong to the group called monoamine oxidase inhibitors, including selegiline (used for the treatment of Parkinson's disease), moclobemide (used for the treatment of depression) and linezolid (an antibiotic).

Be careful with Escitalopram Vir Pharma

Please inform your doctor if you have any other disorder or disease, as your doctor may need to take this into account. In particular, inform your doctor:

• If you have epilepsy. The treatment with Escitalopram Vir Pharma should be interrupted if seizures occur or if you observe an increase in the frequency of seizures (see also section 4 “Possible side effects”).

• If you have liver or kidney insufficiency. Your doctor may need to adjust your dose.

• If you have diabetes. The treatment with Escitalopram Vir Pharma may alter blood sugar control. You may need to adjust your insulin and/or oral hypoglycaemic dose.

• If you have a low sodium level in your 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 disorders, 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 anxiety disorder, it usually takes 2-4 weeks before you notice any improvement. At the beginning of treatment, some patients may experience an increase in anxiety, which will disappear as you continue treatment. Therefore, it is very important that you follow exactly your doctor's instructions and do not interrupt treatment or change your dose without consulting your doctor.

Some medicines in the group to which escitalopram belongs (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may occasionally have thoughts of harming yourself or taking your own life. These may increase when you first start taking antidepressants, as these medicines take time to start working, usually around 2 weeks, although in some cases it may take longer. You are more likely to have these thoughts:

• If you have previously had thoughts of harming yourself or taking your own life.

• If you are a young adult. Clinical trial information has shown an increased risk of suicidal behaviour in adults under 25 years with psychiatric disorders who were treated with an antidepressant.

If at any time you have thoughts of harming yourself or taking your own life, contact your doctor or go directly to a hospital. It may be helpful to tell a family member or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. They may be able to help you notice if your depression or anxiety disorder has worsened. Or if they are concerned about changes in your attitude.

Some patients with manic-depressive illness may enter a manic phase. This is characterised by unusual and rapid changes in ideas, excessive happiness 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 weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Occasionally, 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 changes in your behaviour.

Inform your doctor immediately or contact the nearest hospital if you have 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. Furthermore, you should be aware that in patients under 18 years, there is a higher risk of adverse effects such as suicidal thoughts, suicidal ideation and hostility (predominantly aggression, confrontational behaviour and irritability) when taking this type of medicine. However, your doctor may prescribe Escitalopram Vir Pharma to patients under 18 years if they decide that it is the best option for the patient. If the doctor who prescribed Escitalopram Vir Pharma to a patient under 18 years wants to discuss this decision, please return 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 safety and effects on growth, maturity and cognitive and behavioural development of Escitalopram Vir Pharma in this age group have not yet been demonstrated.

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

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

• “Non-selective monoamine oxidase inhibitors (IMAOs)” containing phenelzine, iproniazid, isocarboxazid, nialamide and tranylcypromine as active ingredients. If you have taken any of these medicines, you will need to wait 14 days before starting to take Escitalopram Vir Pharma. After stopping Escitalopram Vir Pharma, 7 days must pass before taking any of these medicines.

• “Reversible monoamine oxidase-A inhibitors” containing moclobemide (used in the treatment of depression).

• “Irreversible monoamine oxidase-B inhibitors” containing selegiline (used in the treatment of Parkinson's disease). These increase the risk of adverse effects.

• The antibiotic linezolid.

• Lithium (used in the treatment of manic-depressive disorder) and tryptophan.

• Imipramine and desipramine (both used in the treatment of depression).

• Sumatriptan and similar medicines (used in the treatment of migraine) and tramadol (used for severe pain). These increase the risk of adverse effects.

• Cimetidine and omeprazole (used in 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 concentration of Escitalopram Vir Pharma in the blood.

• St. John's Wort (Hypericum perforatum) – medicinal plant used for depression.

• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or to reduce the risk of thrombosis, also called anticoagulants).

• Warfarin, dipiridamol and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably check your blood clotting time at the beginning and end of treatment with Escitalopram Vir Pharma to ensure that the dose of anticoagulant is still adequate.

• Mefloquine (used in the treatment of malaria), bupropion (used in the treatment of depression) and tramadol (used for severe pain) due to the possible risk of lowering the seizure threshold.

• Neuroleptics (medicines used in 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). You may need to adjust your dose of Escitalopram Vir Pharma.

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”).

Like many medicines, it is not recommended to combine Escitalopram Vir Pharma and alcohol, although it is not expected to 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 weighed up the risks and benefits.

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 baby: difficulty breathing, blue skin, convulsions, changes in body temperature, difficulty feeding, vomiting, low blood sugar, muscle stiffness or weakness, intense reflexes, tremors, restlessness, irritability, drowsiness and difficulty sleeping. If your newborn baby 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, medicines like Escitalopram Vir Pharma may increase the risk of a serious condition in the newborn baby called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe more rapidly and appear blue. These symptoms usually start within the first 24 hours after the baby's birth. If this happens to your baby, you should contact your midwife and/or doctor immediately.

If you take escitalopram during the final stages of 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 know that you are taking escitalopram to be able to advise you.

Do not stop taking Escitalopram Vir Pharma abruptly if you are using it during pregnancy.

Breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Do not drive or use machines until you know how Escitalopram Vir Pharma affects you.

Follow exactly the administration instructions of Escitalopram Vir Pharma as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Adults

Depression

The usual 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.

Anxiety 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 further up to a maximum of 20 mg per day.

Social anxiety disorder

The usually recommended dose of Escitalopram Vir Pharma is 10 mg taken as a single dose per day.

Your doctor may decrease 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 usually 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.

Seniors (65 years of age or older)

The initial usually 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 additional information, please see the 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 their taste is bitter.

If necessary, you can break the tablets by placing the tablet on a flat surface with the notch facing upwards. The tablets can be broken by pressing down on each end of the tablet with your two index fingers.

Treatment duration

You may feel better in a couple of weeks. Continue taking Escitalopram Vir Pharma even if you start feeling better before the expected time.

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

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

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 nearest hospital emergency department, or consult the Toxicology Information Service, phone 915.620.420. Do this even when you do not observe any discomfort or signs of intoxication. Some signs of overdose may include dizziness, tremor, agitation, convulsion, coma, nausea, vomiting, changes in heart rate, decreased blood pressure, and changes in the body's electrolyte balance. Bring the Escitalopram Vir Pharma packaging with you to the doctor or hospital.

If you forget to take Escitalopram Vir Pharma

Do not take a double dose to compensate for the missed doses. If you forget to take a dose and remember before going to bed, take it immediately. The next day, follow your usual schedule. If you remember during the night or the next day, leave the missed dose and follow your usual schedule.

If you interrupt treatment with Escitalopram Vir Pharma

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

When you stop taking Escitalopram Vir Pharma, especially if you do it abruptly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram Vir Pharma is suspended. 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 in two weeks. However, in some patients, they can be intense 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 take your tablets again and taper off them more slowly.

Withdrawal symptoms include: feeling of dizziness (unstable or loss of balance), feeling of tingling, feeling of prickling, and (less frequently) feeling of electric shock, even in the head, sleep disturbances (too intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of nausea (dizziness), sweating (including nocturnal sweating), feeling of anxiety or agitation, tremor (instability), feeling of confusion or disorientation, feelings of emotion or irritability, diarrhea (loose stools), visual disturbances, rapid heartbeat or palpitations.

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

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

The side effects usually disappear after a few weeks of treatment.

Please be aware that many of the side 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 side effects during treatment:

Rare (affects between 1 and 10 in every 10,000 people):

•Unusual bleeding, including gastrointestinal bleeding.

Very rare (affects between 1 and 10 in every 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, they may be signs of a rare condition called serotonin syndrome. If you feel this way, contact your doctor.

Seek immediate medical attention if you experience the following side effects:

•Difficulty urinating.

•Seizures (convulsions), see also the section “Be especially careful with Escitalopram Vir Pharma”.

•Yellowish skin and whitening of the eyes, which are signs of liver dysfunction/hepatitis.

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

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

Common (affects between 1 and 10 people in every 100):

•Blockage or nasal mucus (sinusitis).

•Decreased or increased appetite.

•Anxiety, agitation, abnormal dreams, difficulty falling asleep, feeling drowsy, dizziness, yawning, tremors, skin itching.

•Diarrhea, constipation, vomiting, dry mouth.

•Increased sweating.

•Muscle and joint pain (arthritis and myalgia).

•Sexual dysfunction (delayed ejaculation, erection problems, decreased sexual behavior, and women may experience difficulty reaching orgasm).

•Fatigue, fever.

•Weight gain.

Rare (affects between 1 and 10 in every 1,000 patients/people):

•Hives, skin rash, itching (pruritus).

•Teeth chattering, agitation, nervousness, anxiety crisis, state of confusion.

•Sleep disturbances, taste alterations, fainting (syncope).

•Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus).

•Hair loss.

•Vaginal bleeding.

•Weight loss.

•Fast heart rate.

•Swelling of arms and legs.

•Nasal bleeding.

Rare (affects between 1 and 10 in every 10,000 people):

•Aggression, depersonalization, hallucinations.

•Low heart rate.

•Events related to suicide, see also the section “Be especially careful with Escitalopram Vir Pharma”.

Some patients have reported (unknown frequency):

•Decreased sodium levels in the blood (symptoms are feeling dizzy and muscle weakness or confusion).

•Dizziness when standing 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).

•Blood clotting disorders, including skin and mucous membrane bleeding (ecchymosis) and low platelet count in the blood (thrombocytopenia).

•Sudden swelling of the skin or mucous membranes (angioedema).

•Inadequate ADH secretion, resulting in increased urine production.

•Milk flow in women who are not breastfeeding.

•Mania.

•Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see also the section 2 for more information.

Thoughts of self-harm 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 side effects have been reported with medications that work similarly to escitalopram (the active ingredient in Escitalopram Vir Pharma). These are:

•Restlessness (akathisia).

•Anorexia.

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

If you consider any of the side effects you are experiencing to be severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use, website:www.notificaram.es.

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

Keep out of reach and sight of children.

This medication does not require special conditions for conservation.

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 disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

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, croscarmelose sodium, anhydrous colloidal silica, and magnesium stearate.

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

Appearance of the product and contents of the package

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

Escitalopram Vir Pharma 15 mg are white oval tablets with a groove on one side. The groove is only for splitting and facilitating swallowing.

Escitalopram Vir Pharma is available in the following package sizes:

28 tablets

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

C/Laguna 66-70.Industrial Estate URTINSA II

28923 Alcorcón (Madrid)

Spain

Responsible manufacturer

HBM Pharma s.r.o.

Sklabinská 30

036 80 Martin

Slovak Republic

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

This leaflet was approved in: March 2021