Package Leaflet: Information for the User

Escitalopram Viso Pharmaceutical 20 mg Film-Coated Tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1.What Escitalopram Viso Pharmaceutical is and what it is used for

2.What you need to know before you start taking Escitalopram Viso Pharmaceutical

3.How to take Escitalopram Viso Pharmaceutical

4.Possible side effects

5.Storage of Escitalopram Viso Pharmaceutical

6.Contents of the pack and additional information

Escitalopram Viso Farmacéutica contains the active ingredient, escitalopram.

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 disorders.

Escitalopram Viso Farmacéutica is indicated for the treatment of depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder).

It may take a couple of weeks before you start feeling better. Continue taking Escitalopram Viso Farmacéutica, even if some time passes before you notice any improvement in your condition.

You should consult a doctor if you worsen or do not improve.

No take Escitalopram Viso Farmacéutica

• If you are allergic to escitalopram or any of the other components of this medication (listed in section 6).

• If you are taking any other medication that belongs to a group called monoamine oxidase inhibitors (MAOIs), such as selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).
• If you were born with, or have had an episode of, abnormal heart rhythm (seen on an ECG; a test to evaluate heart function).
• If you are taking medications for heart rhythm problems or that can affect it (see section 2 "Other medications and Escitalopram Viso Farmacéutica").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Escitalopram Viso Farmacéutica.

Inform your doctor if you have any other condition or disease, as your doctor may need to take it into account. Inform your doctor especially if:

• You have epilepsy. Treatment with Escitalopram Viso Farmacéutica will be suspended if you have a seizure for the first time or if there is an increase in seizure frequency (see also section 4 "Possible side effects").
• You have liver or kidney insufficiency. Your doctor may need to adjust your dose.
• You have diabetes. Treatment with Escitalopram Viso Farmacéutica may affect blood sugar control. You may need to adjust your insulin or oral hypoglycemic medication.
• You have low sodium levels in the blood.
• You are prone to easy bleeding or bruising.
• You are receiving electroconvulsive therapy (electroshock treatment).
• You have coronary heart disease.
• You have or have had heart problems, or recently had a heart attack.
• You have low heart rate at rest and/or know that you may have a decreased sodium level as a consequence of prolonged diarrhea and vomiting (due to illness) or the use of diuretics (medications to urinate).
• You experience rapid or irregular heartbeats, dizziness, fainting, or lightheadedness when standing up, which may indicate abnormal heart rhythm.
• You have or have had eye problems, such as certain types of glaucoma (increased eye pressure).
• You have a history of bleeding disorders, or if you are pregnant (see Pregnancy, breastfeeding, and fertility).

Please note that:

Some patients with manic-depressive illness may enter a manic phase. This is characterized by strange and rapidly changing ideas, inappropriate 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.

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

Thoughts of suicide or worsening of depression or anxiety disorder

If you are depressed or have anxiety disorders, you may occasionally have thoughts of harming yourself or committing suicide. This may increase when you start taking antidepressants, as these medications take time to work, usually two weeks, but sometimes longer. You are more likely to think this way:

• If you have had thoughts of harming yourself or committing suicide in the past.
• If you are ayoung adult. Information from clinical trials has shown an increased risk of suicidal behavior in young adults under 25 years old with psychiatric disorders who received treatment with an antidepressant.

If you have thoughts of harming yourself or committing suicide at any time,contact your doctor or go to the hospital immediately.

It may be helpful to tell a family member or close friendthat you are depressed or have an anxiety disorder and ask them to read this leaflet. You could ask them to tell you if they think your depression or anxiety is getting worse or if they are concerned about changes in your behavior.

Use in children and adolescents

Escitalopram Viso Farmacéutica is not usually used in children and adolescents under 18 years old. Additionally, you should know that patients under 18 are at a higher risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behavior, and anger) when taking this type of medication. However, your doctor may prescribe Escitalopram Viso Farmacéutica to patients under 18 if they decide it is best for them. If your doctor has prescribed Escitalopram Viso Farmacéutica to a patient under 18 and wants to discuss it, please speak with them again. Inform your doctor if any of these symptoms appear or worsen in patients under 18 who are taking Escitalopram Viso Farmacéutica. Furthermore, the long-term safety effects of Escitalopram Viso Farmacéutica on growth, maturation, and cognitive and behavioral development in this age group have not been demonstrated.

Other medications and Escitalopram Viso Farmacéutica

Use of Escitalopram Viso Farmacéutica with other medications. Inform your doctor or pharmacist if you are using, have used recently, or may need to take any other medication.

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

• "Non-selective monoamine oxidase inhibitors (MAOIs)" containing 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 Viso Farmacéutica. When you stop taking Escitalopram Viso Farmacéutica, you should wait 7 days before taking any of these medications.

• "Selective and reversible monoamine oxidase-A inhibitors" containing moclobemide (used to treat depression).
• "Irreversible monoamine oxidase-B inhibitors" containing selegiline (used to treat Parkinson's disease). These increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used to treat manic-depressive illness) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medications (used to treat migraines) and tramadol (used to treat severe pain). These increase the risk of side effects.
• Opioids such as buprenorphine. These medications may interact with Escitalopram Viso Farmacéutica and may cause symptoms such as involuntary and rhythmic muscle contractions, including those that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor if you experience these symptoms.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke). They may cause an increase in sodium levels in the blood.
• St. John's Wort (Hypericum perforatum) – a medicinal plant used to treat depression.
• Aspirin and nonsteroidal anti-inflammatory drugs (medications used to relieve pain or thin the blood, called anticoagulants). This may increase the risk of bleeding.
• Warfarin, dipiridamol, and phenprocoumon (medications used to thin the blood, called anticoagulants).

Your doctor will likely check your blood clotting time when starting and stopping Escitalopram Viso Farmacéutica to ensure that your anticoagulant dose is adequate.

• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the possible risk of reduced seizure threshold.
• Neuroleptics (medications to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to a possible risk of reduced seizure threshold.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). You may need to adjust your Escitalopram Viso Farmacéutica dose.
• Medications that decrease potassium or magnesium levels in the blood, as this increases the risk of abnormal heart rhythm, which is life-threatening.

DO NOT TAKE Escitalopram Viso FarmacéuticaIf you are taking medications for heart rhythm problems or medications that can affect it, such as antiarrhythmic medications of classes IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, halofantrine, particularly in antimalarial treatment), certain antihistamines (e.g., astemizole, hydroxyzine, mizolastine). If you have any questions, please consult your doctor.

Taking Escitalopram Viso Farmacéutica with food, drinks, and alcohol

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

Like many medications, it is not recommended to combine Escitalopram Viso Farmacéutica with alcohol, although it is not expected to interact with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. Do not take Escitalopram Viso Farmacéutica if you are pregnant or breastfeeding, unless you and your doctor have discussed the relevant risks and benefits.

If you take Escitalopram Viso Farmacéutica during the last three months of pregnancy, you should know that the following effects may be observed in your newborn: respiratory difficulties, blue skin color, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, intense reflexes, tremors, nervousness, irritability, drowsiness, and difficulty sleeping. If your newborn shows any of these symptoms, contact your doctor immediately.

Make sure your midwife or doctor knows that you are taking Escitalopram Viso Farmacéutica. When taken during pregnancy, especially in the last three months, medications like Escitalopram Viso Farmacéutica may increase the risk of a serious condition in children, called persistent pulmonary hypertension of the newborn (PPHN), which makes the child breathe faster and turn blue. These symptoms usually start within the first 24 hours after the child's birth. If this happens to your child, contact your midwife or doctor immediately.

If you take Escitalopram Viso Farmacéutica in the final stages of pregnancy, there may be a higher risk of excessive 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 Viso Farmacéutica to be able to advise you.

Escitalopram/metabolites are excreted in breast milk.

It has been observed that citalopram, a medication similar to escitalopram, reduces sperm quality in animal studies. In theory, this could affect fertility, but until now, its impact on human fertility has not been appreciated.

Driving and operating machines

You are advised not to drive or operate machines until you know how Escitalopram Viso Farmacéutica affects you.

Escitalopram Viso Farmacéutica contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults

Depression

The recommended dose is 10 mg taken once a day. Your doctor may increase the dose up to a maximum of 20 mg per day.

Panic disorder

The initial dose is 5 mg per day for the first week, before increasing the dose to 10 mg per day. Your doctor may increase the dose further up to a maximum of 20 mg per day.

Social anxiety disorder

The recommended dose is 10 mg taken once a day. Your doctor may reduce the 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.

Generalized anxiety disorder

The recommended dose is 10 mg taken once a day. Your doctor may increase the dose up to a maximum of 20 mg per day.

Obsessive-compulsive disorder

The recommended dose is 10 mg taken once a day. Your doctor may increase the dose up to a maximum of 20 mg per day.

Elderly patients (65 years and older):

The initial dose is 5 mg per day. Your doctor may increase the dose to 10 mg per day.

Use in children and adolescents

Escitalopram Viso Farmacéutica is usually not administered to children or adolescents. For more information, see section 2 “Warnings and precautions”.

Renal insufficiency

Caution is advised in patients with severely impaired renal function. Take it as prescribed by your doctor.

Liver insufficiency

Patients with liver problems should not receive more than 10 mg per day. Take it as prescribed by your doctor.

Patients considered as slow metabolizers of CYP2C19

Patients with this known genotype should not receive more than 10 mg per day. Take it as prescribed by your doctor.

How to take Escitalopram Viso Farmacéutica

You can take Escitalopram Viso Farmacéutica with or without food. Swallow the tablet with a little water. Do not chew it, as it has a bitter taste.

If necessary, you can divide the tablets by placing the first tablet on a flat surface, with the notch facing up. The tablets can be broken by pressing on each end of the tablet, using both index fingers.

Treatment duration

You may take a few weeks to start feeling better. Continue taking Escitalopram Viso Farmacéutica even if it takes some time to notice an improvement in your condition.

Do not modify the dose of your medication without discussing it first with your doctor.

Continue taking Escitalopram Viso Farmacéutica for the time your doctor advises.

If you stop treatment too soon, your symptoms may reappear. It is recommended to continue treatment for at least 6 months after you start feeling better.

If you take more Escitalopram Viso Farmacéutica than you should

If you take more doses of Escitalopram Viso Farmacéutica than prescribed, contact your doctor or the nearest emergency service immediately. Do it even if you do not notice any discomfort. Some signs of overdose may be dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rhythm, reduced blood pressure, and changes in the balance of fluids/salts in the body. Bring the Escitalopram Viso Farmacéutica box/packaging with you when you go to the doctor or hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Escitalopram Viso Farmacéutica

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. Continue as usual the next day. If you remember it already at night or the next day, skip the missed dose and continue as usual.

If you interrupt treatment with Escitalopram Viso Farmacéutica

Do not stop taking Escitalopram Viso Farmacéutica until your doctor tells you to. When you have finished your treatment cycle, it is usually recommended to gradually reduce the dose of Escitalopram Viso Farmacéutica.

When you stop taking Escitalopram Viso Farmacéutica, especially if it is done suddenly, you may experience withdrawal symptoms. They are common when treatment with Escitalopram Viso Farmacéutica is stopped. The risk is higher when Escitalopram Viso Farmacéutica has been used for a long time or at high doses or when the dose is reduced too quickly. Most people notice that the symptoms are mild and disappear on their own in a few 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 Viso Farmacéutica, contact your doctor. They may ask you to start taking the tablets again and withdraw them more slowly.

Withdrawal symptoms include: Dizziness (instability or imbalance), feeling of pins and needles, feeling of burning, and (less frequently) feeling of electric shock (including the head), sleep disturbances (vivid dreams, nightmares, inability to fall asleep), feeling of anxiety, headache, nausea, sweating (including nocturnal sweating), restlessness or agitation, tremors (shaking), feeling of confusion or disorientation, feeling sensitive or irritable, diarrhea (loose stools), visual disturbances, fluttering or strong heartbeats (palpitations).

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effects usually disappear after a few weeks of treatment. Note that many effects can also be symptoms of your illness and will improve as you start to feel better.

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

Rare (may affect 1 in 100 people):

• Unusual bleeding, such as gastrointestinal bleeding

Rare (may affect 1 in 1,000 people):

• Swelling in the skin, tongue, lips, throat, or face, urticaria, or difficulty breathing or swallowing (serious allergic reaction), contact your doctor or go to the hospital immediately.
• High fever, agitation, confusion, tremors, and sudden muscle contractions, which may be signs of a rare condition called serotonin syndrome. If you experience this, contact your doctor.

Unknown (frequency cannot be estimated with available data):

• Difficulty urinating
• Seizures (attacks), see also the Adverse Reactions and Precautions section.
• Yellowing of the skin and white of the eyes are signs of liver function impairment/hepatitis
• Fast or irregular heartbeats, dizziness, which may be symptoms of a life-threatening condition known as Torsades de Pointes
• Thoughts of self-harm or thoughts of suicide (suicidal ideation and behavior), see also the Adverse Reactions and Precautions section
• Sudden inflammation of the skin mucosa (angioedemas)
• Excessive vaginal bleeding shortly after delivery (postpartum hemorrhage), see also the Pregnancy section in section 2 for more information.

In addition to these, the following side effects have been reported:

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

• Dizziness (nausea)
• Headache

Common (may affect 1 in 10 people):

• Conjunctivitis (sinusitis)
• Increased or decreased appetite
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, vertigo, yawning, tremors, skin itching.
• Diarrhea, constipation, vomiting, dry mouth
• Increased sweating.
• Muscle and joint pain (arthritis and myalgia)
• Sexual disorders (delayed ejaculation, erectile dysfunction, reduced libido, and women may experience difficulty reaching orgasm)
• Fatigue, fever
• Weight gain

Rare (may affect 1 in 100 people):

• Urticaria, eczema, itching (pruritus)
• Teeth chattering, agitation, nervousness, panic attack, confusion state
• Sleep disorder, taste perversion, fainting (syncope)
• Pupil dilation (mydriasis), visual disturbance, ringing in the ears (tinnitus)
• Hair loss
• Excessive menstrual bleeding
• Irregular menstrual period
• Weight loss
• Fast heartbeats
• Inflammation of the arms or legs
• Nasal bleeding

Rare (may affect 1 in 1,000 people):

• Aggression, depersonalization, hallucinations
• Slow heart rate

Unknown (frequency cannot be estimated with available data):

• Suicidal ideation and behavior, see also the Adverse Reactions and Precautions section
• Reduction of sodium levels in the blood (symptoms are dizziness and muscle weakness or confusion)
• Dizziness when standing due to low blood pressure (orthostatic hypotension)
• Abnormal liver function test results (increased levels of liver enzymes in the blood)
• Movement disorders (involuntary muscle movements)
• Painful erections (priapism)
• Signs of abnormal bleeding, such as skin or mucous membrane bleeding (ecchymosis)
• Inadequate secretion of a hormone called ADH, causing the body to retain water and dilute the blood, reducing sodium levels (inadequate ADH secretion)
• Milk flow in women who are not lactating
• Mania
• An increased risk of bone fractures has been observed in patients treated with this type of medication.
• Alteration of heart rhythm (called "prolongation of the QT interval", observed on the ECG, heart electrical activity).

Additionally, it is known that a series of side effects occur with medications that act similarly to Escitalopram Viso Farmacéutica. These are:

• Motor restlessness (akathisia)
• Loss of appetite

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the national notification system: Spanish System of Pharmacovigilance of Medicines for Human Use Website:www.notificaRAM.es.

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

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

Do not use this medication after the expiration date that appears on the blister pack and the box after “CAD”. The expiration date is the last day of the month indicated. This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Escitalopram Viso Pharmaceutical

The active ingredient is escitalopram. Each Escitalopram Viso Pharmaceutical tablet contains 20 mg of escitalopram (in the form of oxalate).

The other components are:

Tablet core:

Microcrystalline cellulose (E460), sodium croscarmellose (E468), magnesium stearate (E572), anhydrous colloidal silica, and talc

Coating of the tablets:

Hydroxypropyl methylcellulose (E464), titanium dioxide (E171), and Macrogol 400.

Appearance of the product and contents of the package

Escitalopram Viso Pharmaceutical is presented in 20 mg film-coated tablets. The following descriptions apply:

White to off-white, oval, biconvex film-coated tablets with 'E 4' engraved on one face and scored on the other face. The tablet can be divided into two equal halves.

The tablets are packaged in smooth aluminum/aluminum blisters or PVC/Aclar aluminum blisters.

Escitalopram Viso Pharmaceutical is available in the following package sizes:

Blister: 14, 20, 28, 50, 56, 100, and 200 tablets

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Responsible manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143, 566 17 Vysoké Mýto

Czech Republic

Further information about this medication can be obtained by contacting the local representative of the marketing authorization holder:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7th Floor

28045 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Germany:Escitalopram Glenmark 20 mg Filmtabletten

Austria:Escitalopram Tillomed 20 mg Filmtabletten

Spain:Escitalopram Viso Farmacéutica 20 mg film-coated tablets EFG

Greece:ESPOZA 20 mg film-coated tablets

Ireland:Escitalopram Glenmark 20 mg Film-coated tablets

United Kingdom:Escitalopram 20 mg Film-coated tablets

Sweden:Escitalopram Glenmark 20 mg film-coated tablets

Last review date of this leaflet:June 2021.

Further detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/