ESCITALOPRAM VISO FARMACEUTICA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Escitalopram Viso Farmacéutica 20 mg Film-Coated Tablets EFG

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

• 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 others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Escitalopram Viso Farmacéutica and what is it used for
2. What you need to know before you take Escitalopram Viso Farmacéutica
3. How to take Escitalopram Viso Farmacéutica
4. Possible side effects
5. Storage of Escitalopram Viso Farmacéutica
6. Contents of the pack and other information

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

Escitalopram Viso Farmacéutica contains the active substance escitalopram.

Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines work in the brain by increasing the level of a substance called serotonin. Changes in the levels of serotonin in the brain are thought to be involved in the development of depression and other mood disorders.

Escitalopram Viso Farmacéutica is used to treat 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 to feel better. Continue to take Escitalopram Viso Farmacéutica even if it takes some time before you feel any improvement in your condition.

You should consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Escitalopram Viso Farmacéutica

Do not take Escitalopram Viso Farmacéutica

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

• If you are taking any other medicine 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 have been born with or have had an episode of abnormal heart rhythm (which can be seen on an ECG; a test to evaluate heart function).
• If you are taking medicines for heart rhythm problems or that may affect the heart rhythm (see section 2 "Other medicines and Escitalopram Viso Farmacéutica").

Warnings and precautions

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

Tell your doctor if you suffer from any other disorder or disease, as your doctor may need to take this into account. In particular, tell your doctor:

• If you suffer from epilepsy. Treatment with Escitalopram Viso Farmacéutica will be stopped if you have seizures for the first time or if the frequency of seizures increases (see also section 4 "Possible side effects").
• If you suffer from liver or kidney failure. Your doctor may need to adjust your dose.
• If you suffer from diabetes. Treatment with Escitalopram Viso Farmacéutica may alter blood sugar control. It may be necessary to adjust the dose of insulin or oral hypoglycemic medication.
• If you suffer from low sodium levels in the blood.
• If you are prone to developing bleeding or bruising easily.
• If you are receiving electroconvulsive therapy (treatment by electric shock).
• If you suffer from coronary heart disease.
• If you suffer from or have had heart problems, or have recently had a heart attack.
• If you have a low heart rate at rest and/or know that you may have a decrease in salt levels due to severe and prolonged diarrhea and vomiting (due to illness) or due to the use of diuretics (pills to urinate).
• If you experience rapid or irregular heartbeats, fainting, collapse, or dizziness when standing up, which could indicate abnormal heart rhythm.
• If you have or have had eye problems, such as certain types of glaucoma (increased pressure in the eye).
• If 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 ideas 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 few weeks of treatment. Inform your doctor immediately if you experience these symptoms.

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

Suicidal thoughts or worsening of your depression or anxiety disorder

If you are depressed or have an anxiety disorder, you may sometimes have thoughts of harming or killing yourself. This may increase when you start taking antidepressants, as these medicines take time to work, usually around two weeks, but sometimes more. You are more likely to think this way:

• If you had thoughts of killing or harming yourself in the past.
• If you are an adult under 25. Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 with psychiatric disorders who received antidepressant treatment.

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

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

Use in children and adolescents

Escitalopram Viso Farmacéutica will not normally be used in children and adolescents under 18 years. In addition, 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 medicine. Nevertheless, your doctor may prescribe Escitalopram Viso Farmacéutica to patients under 18 if they decide it is the best for them. If your doctor has prescribed Escitalopram Viso Farmacéutica to a patient under 18 and you want to discuss it, talk to your doctor again. Inform your doctor if any of these symptoms appear or worsen in patients under 18 taking Escitalopram Viso Farmacéutica. Additionally, the long-term safety effects of Escitalopram Viso Farmacéutica regarding growth, maturation, and cognitive and behavioral development in this age group have not yet been demonstrated.

Other medicines and Escitalopram Viso Farmacéutica

Use of Escitalopram Viso Farmacéutica with other medicines. Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• Non-selective monoamine oxidase inhibitors (MAOIs) that contain phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substances. If you have taken any of these medicines, you will have to wait 14 days before starting to take Escitalopram Viso Farmacéutica. When you stop taking Escitalopram Viso Farmacéutica, you will have to wait 7 days before taking any of these medicines.

• Reversible selective MAO-A inhibitors that contain moclobemide (used to treat depression).
• Irreversible MAO-B inhibitors that contain selegiline (used to treat Parkinson's disease). These increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used to treat manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medicines (used to treat migraine) and tramadol (used to treat severe pain). These increase the risk of side effects.
• Opioids such as buprenorphine. These medicines may interact with Escitalopram Viso Farmacéutica and may cause symptoms such as involuntary and rhythmic muscle contractions, including muscles 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). These may cause an increase in blood levels.
• St. John's Wort (Hypericum perforatum) – a medicinal plant used for depression.
• Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (medicines used for pain relief or to thin the blood, called anticoagulants). This may increase the tendency to bleed.
• Warfarin, dipyridamole, and fenprocoumon (medicines used to thin the blood, called anticoagulants).

Your doctor will probably check your blood clotting time when starting and stopping Escitalopram to verify that the 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 reducing the seizure threshold.
• Neuroleptics (medicines used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to a possible risk of reducing the seizure threshold.
• 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 Viso Farmacéutica.
• Medicines that decrease potassium or magnesium levels in the blood, as this increases the risk of heart rhythm disorders, which can be life-threatening.

DO NOT TAKE Escitalopram Viso Farmacéuticaif you take medicines for heart rhythm problems or medicines that may affect the heart rhythm, such as antiarrhythmics of classes IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, halofantrine, particularly in antimalarial treatment), certain antihistamines (e.g., astemizole, hydroxyzine, mizolastine). If you have any further questions, 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").

As with many medicines, it is not recommended to combine Escitalopram Viso Farmacéutica with alcohol, although it is not expected that Escitalopram Viso Farmacéutica will interact with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. 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 3 months of pregnancy, you should know that the following effects may be observed in your newborn: breathing difficulties, blue discoloration of the skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, exaggerated reflexes, tremors, nervousness, irritability, lethargy, constant crying, and sleep disturbances. If your newborn has any of these symptoms, contact your doctor immediately.

Make sure your midwife or doctor knows you are taking Escitalopram Viso Farmacéutica. When taken during pregnancy, especially during the last 3 months, medicines 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 baby breathe faster and turn blue. These symptoms usually start in the first 24 hours after the baby's birth. If this happens to your baby, contact your midwife or doctor immediately.

If you take Escitalopram Viso Farmacéutica in the final stage 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 Viso Farmacéutica so they can advise you.

If Escitalopram Viso Farmacéutica is used during pregnancy, it should never be stopped abruptly.

Escitalopram/metabolites are excreted in breast milk.

Citalopram, a medicine similar to escitalopram, has been shown to reduce sperm quality in animal studies. In theory, this could affect fertility, but to date, no impact on human fertility has been observed.

Driving and using machines

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

Escitalopram Viso Farmacéutica contains sodium

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

3. How to Take Escitalopram Viso Farmacéutica

Follow your doctor's administration instructions for this medication exactly. If in 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 in a single daily dose for the first week, before increasing the dose to 10 mg per day. Your doctor may further increase the dose 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 (over 65 years):

The initial dose is 5 mg, taken in a single daily dose. The doctor may increase the dose to 10 mg per day.

Use in Children and Adolescents

Escitalopram Viso Farmacéutica is not normally administered to children or adolescents. For more information, consult section 2 "Warnings and Precautions".

Renal Insufficiency

Cautious use is advised in patients with severely decreased renal function. Take it as prescribed by your doctor.

Hepatic Insufficiency

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

Poor 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 tablet on a flat surface, with the score line facing up. The tablets can be broken by pressing on each end of the tablet, using both index fingers.

Duration of Treatment

It may take a couple of weeks to start feeling better. Continue taking Escitalopram Viso Farmacéutica even if it takes some time before you notice an improvement in your condition.

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

Continue taking Escitalopram Viso Farmacéutica for the time advised by your doctor.

If you stop treatment too soon, your symptoms may recur. It is recommended to continue treatment for at least 6 months after you feel 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 this even if you do not feel any discomfort. Some signs of overdose could be dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rhythm, reduction of blood pressure, and changes in fluid/salt balance in the body. Bring the box/packaging of Escitalopram Viso Farmacéutica 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 make up for forgotten doses. If you forget to take a dose and remember before bedtime, take it immediately. Continue as usual the next day. If you remember in the evening or the next day, skip the forgotten 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 do so. When you have finished your treatment cycle, it is generally recommended to gradually reduce the dose of Escitalopram Viso Farmacéutica.

When you stop taking Escitalopram Viso Farmacéutica, especially if it is sudden, you may notice withdrawal symptoms. They are common when treatment with Escitalopram Viso Farmacéutica is discontinued. The risk is greater 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 find that the symptoms are mild and disappear on their own within a couple of weeks. However, in some patients, they can be severe or prolonged (2-3 months or more). If you experience severe withdrawal symptoms when you stop taking 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 muscle aches, feeling of burning, and (less frequently) feeling of electric shock (including the head), sleep disorders (vivid dreams, nightmares, inability to stay asleep), feeling of anxiety, headache, dizziness (nausea), sweating (with night sweats), 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.

4. Possible Adverse Effects

Like all medications, this medication can cause adverse effects, although not everyone will experience them.

Adverse 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 should contact your doctor or go to the hospital immediately:

Uncommon (may affect 1 in 100 people):

• Unusual bleeding, such as gastrointestinal bleeding

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

• Inflammation of the skin, tongue, lips, pharynx, or face, hives, or difficulty breathing or swallowing (severe allergic reaction), contact your doctor or go to the hospital immediately.
• High fever, agitation, confusion, tremors, and sudden muscle contractions can be signs of a rare disorder called serotonin syndrome. If you experience this, contact your doctor.

Unknown frequency (cannot be estimated from the available data):

• Difficulty urinating
• Seizures (fits), see also the section Warnings and Precautions.
• Yellowing of the skin and whites of the eyes are signs of liver function alteration/hepatitis
• Fast or irregular heartbeats, fainting, which could be symptoms of a life-threatening disorder known as Torsades de Pointes
• Thoughts of self-harm or thoughts of suicide (cases of suicidal ideation and behavior), see also section "Warnings and Precautions"
• Sudden inflammation of the skin mucosa (angioedema)
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy" 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):

• Feeling of dizziness (nausea)
• Headache

Common (may affect 1 in 10 people):

• Nasal congestion (sinusitis)
• Increased or decreased appetite
• Anxiety, restlessness, abnormal dreams, difficulty staying asleep, somnolence, dizziness, yawning, tremors, skin itching.
• Diarrhea, constipation, vomiting, dry mouth
• Increased sweating.
• Pain in muscles and joints (arthralgia and myalgia)
• Sexual disorders (delayed ejaculation, erectile dysfunction, reduced sexual desire, and women may have difficulty achieving orgasm).
• Fatigue, fever
• Weight gain

Uncommon (may affect 1 in 100 people):

• Hives, eczema, itching (pruritus)
• Grinding of the teeth, agitation, nervousness, panic attack, state of confusion
• 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
• Nosebleeds

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

• Aggression, depersonalization, hallucinations
• Slow heartbeat

Unknown frequency (cannot be estimated from the available data):

• Cases of suicidal ideation and behavior, see also section "Warnings and Precautions"
• Decrease in sodium levels in the blood (symptoms are dizziness and malaise with muscle weakness or confusion)
• Dizziness when standing up due to low blood pressure (orthostatic hypotension)
• Alterations in liver function tests (increase in liver enzyme levels in the blood)
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism)
• Signs of abnormal bleeding, for example, from the skin or mucous membranes (ecchymosis).
• Increased secretion of a hormone called ADH, causing the body to retain water and dilute the blood, reducing sodium levels (inappropriate ADH secretion)
• Milk flow in non-lactating women
• 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 in the ECG, electrical activity of the heart).

In addition, it is known that a series of side effects occur with drugs that work similarly to Escitalopram Viso Farmacéutica. These are:

• Motor restlessness (akathisia)
• Lack of appetite

Reporting of Adverse Effects

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

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

5. Storage of Escitalopram Viso Farmacéutica

Keep this medication out of sight and reach of children.

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

Medications should not be thrown away through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Escitalopram Viso Farmacéutica

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

The other components are:

Core of the tablet:

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

Coating of the tablets:

Hypromellose (E464), titanium dioxide (E171), Macrogol 400.

Appearance of the Product and Package Contents

Escitalopram Viso Farmacéutica is presented in 20 mg film-coated tablets. They are described below:

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 Farmacéutica is available in the following package sizes:

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

566 17 Vysoké Mýto

Czech Republic

You can request more information about this medication by contacting the local representative of the Marketing Authorization Holder:

Glenmark 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 under 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

Ireland: Escitalopram Glenmark 20 mg Film-coated tablets

Sweden: Escitalopram Glenmark 20 mg film-coated tablets

Date of the Last Revision of this Leaflet:June 2021.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/