Escitalopram Viso Farmaceutica 15 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Escitalopram Viso Farmacéutica 15 mg film-coated tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Escitalopram Viso Farmacéutica contains the active substance escitalopram.

Escitalopram belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). These medicines work on the serotonin system in the brain by increasing serotonin levels. 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 to feel better. Continue taking Escitalopram Viso Farmacéutica, even if it takes some time before you notice any improvement in your condition.

You should consult a doctor if your condition worsens or if you do not improve.

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

Do not take Escitalopram Viso Farmacéutica

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

• If you are taking any other medicine belonging to a group called MAO inhibitors, such as selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), or linezolid (an antibiotic).

• If you were born with, or have experienced an episode of, abnormal heart rhythm (seen on ECG; a test to assess heart function).

• If you are taking medicines for heart rhythm problems or that may affect heart rhythm (see section 2 "Other medicines and Escitalopram Viso Farmacéutica").

Warnings and precautions

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

Tell your doctor if you have any other disorder or illness, as your doctor may need to take this into account. Specifically inform your doctor:

• If you have epilepsy. Treatment with Escitalopram Viso Farmacéutica will be discontinued if you experience seizures for the first time or if there is an increase in their frequency (see also section 4 "Possible side effects").
• If you have liver or kidney impairment. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram Viso Farmacéutica may alter blood glucose control (blood sugar levels). It may be necessary to adjust the dosage of insulin or oral antidiabetic medication.
• If you have low levels of sodium in the blood.
• If you are prone to developing bleeding or bruising easily.
• If you are receiving electroconvulsive therapy (electroshock treatment).
• If you have coronary artery disease.
• If you have or have had heart problems, or have recently had a heart attack.
• If you have a slow resting heart rate and/or you know you may have salt depletion due to prolonged severe diarrhea and vomiting (due to illness) or due to the use of diuretics (water tablets).
• If you experience rapid or irregular heartbeats, fainting, collapse, or dizziness upon standing, which could indicate abnormal heart rhythm.
• If you have or have previously 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 bipolar disorder may enter a manic phase. This is characterized by rapidly changing and unusual thoughts, inappropriate happiness, and excessive physical activity. If you experience this, contact your doctor.

Symptoms such as restlessness or difficulty sitting or standing still may also occur during the first few weeks of treatment. Inform your doctor immediately if you experience these symptoms. Some medicines in the same group as Escitalopram Viso Farmacéutica (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (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 anxiety disorders, you may occasionally have thoughts of harming yourself or committing suicide. This risk may increase when you first start taking antidepressants, as these medicines take time to work—usually about two weeks, but sometimes longer. You are more likely to have such thoughts:

• If you 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 young adults under 25 years of age with psychiatric disorders who were treated with an antidepressant.

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

It may be helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may wish to ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behavior.

Use in children and adolescents

Escitalopram Viso Farmacéutica is not normally used in children and adolescents under 18 years of age. In addition, patients under 18 have a higher risk of side effects such as suicide 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 best for them. If your doctor has prescribed Escitalopram Viso Farmacéutica to a patient under 18 and you wish to discuss it, speak to 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 yet been established.

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 need to take any other medicines.

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

• "Non-selective monoamine oxidase inhibitors (MAOIs)" containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine as active ingredients. If you have taken any of these medicines, you must wait 14 days before starting Escitalopram Viso Farmacéutica. When stopping Escitalopram Viso Farmacéutica, you must wait 7 days before taking any of these medicines.

• "Selective and reversible MAO-A inhibitors" containing moclobemide (used to treat depression).

• "Irreversible MAO-B inhibitors" containing selegiline (used to treat Parkinson's disease). These increase the risk of side effects.

• The antibiotic linezolid.

• Lithium (used to treat bipolar disorder) and tryptophan.

• Imipramine and desipramine (both used to treat depression).

• Sumatriptan and similar medicines (used to treat migraine) and tramadol (used for 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 controlling 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 (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause an increase in escitalopram blood levels.

• St. John's wort (Hypericum perforatum) – a herbal remedy used for depression.

• Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (medicines used for pain relief or to thin the blood, known as anticoagulants). This may increase the tendency to bleed.

• Warfarin, dipiridamole, and phenprocoumon (medicines used to thin the blood, known as anticoagulants).

Your doctor will likely monitor your blood clotting time when starting and stopping Escitalopram to ensure the anticoagulant dose is appropriate.

• 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 (medicines 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). Dose adjustment of Escitalopram Viso Farmacéutica may be necessary.
• Medicines that reduce potassium or magnesium levels in the blood, as this increases the risk of life-threatening heart rhythm disturbances.

DO NOT TAKE Escitalopram Viso Farmacéutica if you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm, such as class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g., sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, halofantrine, particularly in antimalarial treatment), or certain antihistamines (e.g., astemizole, hydroxyzine, mizolastine). If you have further questions about this, 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, combining Escitalopram Viso Farmacéutica with alcohol is not recommended, although an interaction between Escitalopram Viso Farmacéutica and alcohol is not expected.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 occur in your newborn baby: breathing difficulties, bluish skin color, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, exaggerated reflexes, tremors, restlessness, irritability, lethargy, constant crying, drowsiness, and sleep difficulties. If your newborn baby shows any of these symptoms, contact your doctor immediately.

Ensure that your midwife or doctor knows you are taking Escitalopram Viso Farmacéutica. Medicines like Escitalopram Viso Farmacéutica, when taken during pregnancy, especially during the last 3 months, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and turn blue. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife or doctor immediately.

If you take Escitalopram Viso Farmacéutica in the late 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 be aware 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.

Animal studies with the similar medicine citalopram have shown reduced sperm quality. In theory, this could affect fertility, but no impact on human fertility has been observed to date.

Driving and use of machines

You are advised not to drive or operate machinery 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 exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults

Depression

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

Panic disorder

The initial dose is 5 mg once daily 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 daily. 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 your response to the medication.

Generalized anxiety disorder

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

Elderly patients (over 65 years of age):

The initial dose is 5 mg taken once daily. The doctor may increase the dose to 10 mg per day.

Use in children and adolescents

Escitalopram Viso Farmacéutica is normally not given to children or adolescents. For further information, see section 2 “Warnings and precautions”.

Renal impairment

Caution is advised in patients with severely reduced kidney function. Take as prescribed by your doctor.

Hepatic impairment

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

How to take Escitalopram Viso Farmacéutica

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

If necessary, the tablets can be divided by first placing the tablet on a flat surface with the score line facing upwards. The tablets can be split by pressing on each end of the tablet using both index fingers.

Duration of treatment

It may take a couple of weeks before you start to feel 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 medicine without first discussing it with your doctor.

Continue taking Escitalopram Viso Farmacéutica for as long as your doctor advises.

If you stop treatment too early, your symptoms may return. It is recommended to continue treatment for at least 6 months after you start feeling well again.

If you take more Escitalopram Viso Farmacéutica than you should

If you take more Escitalopram Viso Farmacéutica than prescribed, contact your doctor or nearest emergency department immediately. Do this even if you do not feel unwell. Some signs of overdose may include dizziness, tremors, agitation, seizures, coma, nausea, vomiting, changes in heart rate, reduced blood pressure, and disturbances in the body's fluid/salt balance. Take the pack/box of Escitalopram Viso Farmacéutica with you when you go to the doctor or hospital.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 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 during the night or the following day, skip the missed dose and continue as usual.

If you stop taking Escitalopram Viso Farmacéutica

Do not stop taking Escitalopram Viso Farmacéutica until your doctor tells you to do so. When you have completed your course of treatment, it is generally recommended to gradually reduce the dose of Escitalopram Viso Farmacéutica.

When you stop taking Escitalopram Viso Farmacéutica, especially if suddenly, you may experience withdrawal symptoms. These are common when stopping treatment with Escitalopram Viso Farmacéutica. 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 find that symptoms are mild and disappear on their own within about two weeks. However, in some patients, symptoms may be severe or prolonged (2–3 months or longer). If you experience severe withdrawal symptoms when stopping Escitalopram Viso Farmacéutica, contact your doctor. Your doctor may ask you to start taking the tablets again and taper them more slowly.

Withdrawal symptoms include: dizziness (instability or imbalance), feeling of muscle jerks, burning sensation and (less frequently) electric shock-like sensations (including in the head), sleep disturbances (vivid dreams, nightmares, inability to fall asleep), feeling of anxiety, headache, dizziness (nausea), sweating (including night sweats), restlessness or agitation, tremors (shakiness), feeling confused or disoriented, feeling sensitive or irritable, diarrhea (loose stools), visual disturbances, fluttering or strong heartbeats (palpitations).

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

4. Possible adverse effects

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

Adverse effects usually disappear after a few weeks of treatment. Keep in mind that many of these effects may also be symptoms of your illness and will therefore improve as you start to feel better.

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

Uncommon (may affect up to 1 in 100 people):

• Unusual bleeding, such as gastrointestinal bleeding

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

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

Not known (frequency cannot be estimated from the available data):

• Difficulty urinating
• Seizures (fits); see also section “Warnings and precautions”
• Yellowing of the skin or whites of the eyes, which may be signs of liver dysfunction/hepatitis
• Rapid or irregular heartbeat, fainting, which could be symptoms of a life-threatening disorder known as Torsades de Pointes
• Thoughts of self-harm or thoughts of killing yourself (cases of suicidal ideation and suicidal behaviour); see also section “Warnings and precautions”
• Sudden swelling of the skin’s mucous membranes (angioedema)
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); 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 sick (nausea)
• Headache

Common (may affect up to 1 in 10 people):

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

Uncommon (may affect up to 1 in 100 people):

• Hives, eczema, itching (pruritus)
• Teeth grinding, agitation, nervousness, panic attack, state of confusion
• Sleep disorder, altered taste, fainting (syncope)
• Dilated pupils (mydriasis), visual disturbance, ringing in the ears (tinnitus)
• Hair loss
• Excessive menstrual bleeding
• Irregular menstrual periods
• Weight loss
• Rapid heartbeat
• Swelling of arms or legs
• Nosebleeds

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

• Aggression, depersonalisation, hallucinations
• Slow heartbeat

Not known (frequency cannot be estimated from the available data):

• Cases of suicidal ideation and suicidal behaviour; see also section “Warnings and precautions”
• Reduction in blood sodium levels (symptoms include dizziness and malaise with muscle weakness or confusion)
• Dizziness upon standing due to low blood pressure (orthostatic hypotension)
• Abnormalities in liver function tests (increased levels of liver enzymes in the blood)
• Movement disorders (involuntary muscle movements)
• Painful erections (priapism)
• Signs of abnormal bleeding, for example, from the skin or mucous membranes (bruising)
• Increased secretion of a hormone called ADH, causing the body to retain water and dilute the blood, thereby reducing sodium levels (inappropriate ADH secretion)
• Milk production in women who are not breastfeeding
• Mania
• An increased risk of bone fractures has been observed in patients treated with this type of medicine
• Changes in heart rhythm (known as “prolongation of the QT interval”, seen on ECG, the heart’s electrical activity)

In addition, a number of side effects are known to occur with drugs that act similarly to Escitalopram Viso Farmacéutica. These include:

• Motor restlessness (akathisia)
• Loss of appetite

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the national reporting system: Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano Website: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Escitalopram Viso Farmacéutica

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

Do not use this medicine after the expiry date stated on the blister and carton after “EXP”. The expiry date refers to the last day of the month indicated. This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Escitalopram Viso Farmacéutica

The active substance is escitalopram. Each tablet of Escitalopram Viso Farmacéutica contains 15 mg of escitalopram (as oxalate).

The other components are:

Tablet core:

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

Tablet coating:

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

Appearance of the product and contents of the pack

Escitalopram Viso Farmacéutica is available as 15 mg film-coated tablets. The tablets are described as follows:

Oval, biconvex, film-coated tablets, white to off-white in colour, with 'E 3' engraved on one side and scored on the other side. The tablet can be divided into two equal parts.

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

Escitalopram Viso Farmacéutica is available in the following pack sizes:

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

Only certain pack 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Escitalopram Glenmark 15 mg Filmtabletten

Austria: Escitalopram Tillomed 15 mg Filmtabletten

Spain: Escitalopram Viso Farmacéutica 15 mg film-coated tablets EFG

Ireland: Escitalopram Glenmark 15 mg Film-coated tablets

Sweden: Escitalopram Glenmark 15 mg filmdragerade tabletter

Date of the most recent review of this summary: June 2021.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/