ESCITALOPRAM ACCORD 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Escitalopram Accord 10 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.

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

1. What is Escitalopram Accord and what is it used for

Escitalopram Accord contains the active substance escitalopram. Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines work on the serotonin system in the brain by increasing the level of serotonin.

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

It may take a couple of weeks for you to start feeling better. Continue to take Escitalopram Accord, even if it takes some time to start feeling an improvement in your condition.

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before you take Escitalopram Accord

Do not take Escitalopram Accord

• If you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).
• If you are taking other medicines that belong to the group of medicines called MAOIs, including selegiline (used for the treatment of Parkinson's disease), moclobemide (used for the treatment of depression), and linezolid (an antibiotic).
• If you have had episodes of cardiac rhythm abnormalities or have them from birth (observed on an ECG, a test that evaluates heart function).
• If you take medicines for heart rhythm problems or that may affect heart rhythm (see section 2 "Use of Escitalopram Accord with other medicines")

Warnings and precautions

Consult your doctor or pharmacist before starting to take Escitalopram Accord. Please inform your doctor if you have any other disorder or disease, as your doctor may need to take it into account. In particular, inform your doctor:

• If you have epilepsy. Treatment with Escitalopram Accord should be discontinued if seizures occur for the first time or if you observe an increase in the frequency of seizures (see also section 4 "Possible side effects").
• If you have liver or kidney failure. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram Accord may alter glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic.
• If you have a decreased level of sodium in the blood.
• If you tend to easily develop bleeding or bruising, or if you are pregnant (see "Fertility, pregnancy, and lactation").
• If you are receiving electroconvulsive therapy.
• If you have coronary heart disease.
• If you have or have had heart problems or have recently suffered a heart attack.
• If your heart rate is low at rest or if you may have a decrease in salt as a consequence of prolonged intense diarrhea and vomiting (if you have had dizziness) or if you use diuretics.
• If your heartbeats are fast or irregular or if you experience fainting, collapse, or dizziness when standing up, which could indicate abnormalities in your heart rate.
• If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).

Please note:

Some patients with manic-depressive illness may enter a manic phase. This is characterized by a change in ideas that is uncommon and rapid, disproportionate joy, and excessive physical activity. If you experience this, contact your doctor.

Symptoms such as restlessness or difficulty sitting or standing may also occur during the first few weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Medicines like escitalopram (also known as SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may continue after stopping treatment.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may sometimes have thoughts of harming or killing yourself. These may increase when taking antidepressants for the first time, as all these medicines require time to start working, usually around two weeks, although in some cases it may take longer.

You are more likely to have these thoughts:

• If you have previously had thoughts of killing yourself or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who were treated with an antidepressant.

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

It may be helpful for you to tell a relativeor close friendthat you are depressed or have an anxiety disorder and ask them to read this leaflet. You can

ask them if they think your depression or anxiety disorder has worsened. Or if they are concerned about changes in your attitude.

Use in children and adolescents

Escitalopram Accord should not normally be used in the treatment of children and adolescents under 18 years of age. Also, you should know that in patients under 18 years of age, there is a greater risk of adverse effects such as suicidal attempts, suicidal ideas, and hostility (predominantly aggression, confrontational behavior, and irritation) when taking this class of medicines. Nevertheless, your doctor may prescribe Escitalopram Accord to patients under 18 years of age when they decide what is best for the patient. If the doctor who corresponds to you has prescribed Escitalopram Accord to a patient under 18 years of age and you want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms described above progress or if you experience complications when patients under 18 years of age are taking Escitalopram Accord. Also, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Escitalopram Accord in this age group have not yet been demonstrated.

Use of Escitalopram Accord with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• Non-selective monoamine oxidase inhibitors (MAOIs), which contain 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 Accord. After finishing Escitalopram Accord, 7 days must pass before taking any of these medicines.
• Reversible selective MAO-A inhibitors, which contain moclobemide (used in the treatment of depression).
• Irreversible MAO-B inhibitors, which contain selegiline (used in the treatment of Parkinson's disease). These increase the risk of side effects.
• Buprenorphine (a type of opioid medicine). Concomitant use increases the risk of serotonin syndrome, a potentially life-threatening condition. You may experience symptoms such as involuntary and rhythmic muscle contractions, including the muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when you experience any of these symptoms.
• The antibiotic linezolid.
• Lithium (used in the treatment of manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (both used for the treatment of depression).
• Sumatriptan and similar medicines (used for the treatment of migraine) and tramadol and similar medicines (opioids, used for severe pain). These increase the risk of side effects.
• Cimetidine, lansoprazole, and omeprazole (used for the treatment of stomach ulcers), fluconazole (used for the treatment of fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause an increase in blood levels of Escitalopram Accord.
• St. John's Wort (Hypericum perforatum) – a medicinal plant used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or reduce the risk of thrombosis, also called anticoagulants). These may increase the tendency to bleeding.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably monitor the blood coagulation time at the start and end of treatment with Escitalopram Accord to check that the anticoagulant dose is still adequate.
• Mefloquine (used for the treatment of malaria), bupropion (used for the treatment of depression), and tramadol (used for the treatment of severe pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines used for the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the possible risk of lowering 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 Accord.
• Medicines that decrease blood levels of potassium or magnesium, as these conditions increase the risk of life-threatening heart rhythm disorders.

DO NOT TAKE ESCITALOPRAM ACCORDif you take medicines for the treatment of heart rhythm problems or that may affect heart rhythm, such as antiarrhythmics

of Class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, or haloperidol),

tricyclic antidepressants, some antimicrobials (such as sparfloxacin, moxifloxacin,

erythromycin IV, pentamidine, or antimalarials, particularly halofantrine) or some

antihistamines (such as astemizole, hydroxyzine, or mizolastine). Consult your doctor if you have doubts.

Taking Escitalopram Accord with food, drinks, and alcohol

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

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

Fertility, pregnancy, and lactation

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 Accord if you are pregnant or breastfeeding unless you and your doctor have analyzed the risks and benefits involved. If you take Escitalopram Accord during the last 3 months of your pregnancy, be aware that the following effects may be observed in the newborn: breathing difficulties, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, exaggerated reflexes, tremors, restlessness, irritability, lethargy, constant crying, and sleep difficulties. If your newborn has any of these symptoms, please contact your doctor immediately. Make sure your midwife and/or doctor know that you are being treated with escitalopram. During pregnancy, particularly in the last 3 months, medicines like Escitalopram Accord may increase the risk of a serious disease in newborns called persistent pulmonary hypertension (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually start during the first 24 hours after birth. If they appear in your baby, you should contact your midwife and/or doctor immediately.

If you take escitalopram in the final stage of pregnancy, there may be an increased risk of abundant 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.

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

It is expected that escitalopram will be excreted in breast milk.

In animal studies, a reduction in sperm quality has been shown in citalopram, a medicine like escitalopram. Theoretically, this could affect fertility, but the impact on human fertility has not been observed yet.

Driving and using machines

It is advised that you do not drive or use machinery until you know how Escitalopram Accord can affect you.

Escitalopram Accord contains sodium

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

3. How to Take Escitalopram Accord

Follow your doctor's instructions for taking this medication exactly. Consult your doctor or pharmacist if you have any doubts.

Adults

Depression

The normally recommended dose of Escitalopram Accord 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 Accord is 5 mg as a single dose per day for the first week before increasing the dose to 10 mg per day. Your doctor may increase it later up to a maximum of 20 mg per day.

Social Anxiety Disorder

The normally recommended dose of Escitalopram Accord 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.

Generalized Anxiety Disorder

The normally recommended dose of Escitalopram Accord 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.

Obsessive-Compulsive Disorder

The normally recommended dose of Escitalopram Accord is 10 mg taken as a single dose per day. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Elderly Patients (over 65 years)

The initial recommended dose of Escitalopram Accord is 5 mg once a day. Your doctor may increase your dose to 10 mg per day.

Use in Children and Adolescents

Escitalopram Accord should not normally be administered to children and adolescents. For additional information, please see section 2 "Warnings and Precautions".

Renal Insufficiency

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

Hepatic Insufficiency

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

Poor 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 the Tablets

You can take Escitalopram Accord with or without food. Swallow the tablets with water. Do not chew them, as they have a bitter taste.

If necessary, you can split the tablets by placing the tablet on a flat surface with the score line facing up. The tablets can be broken by pressing down on each end of the tablet with your index fingers, as shown in the figure.

Only the 10 mg and 20 mg tablets can be divided into equal doses.

Duration of Treatment

It may take a couple of weeks before you start to feel better. Continue taking Escitalopram Accord even if you start to feel better before the expected time.

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

Continue taking Escitalopram Accord 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 Accord Than You Should

If you take more doses of Escitalopram Accord than prescribed, contact your doctor immediately, go to the emergency department of the nearest hospital, or consult the Toxicology Information Service, phone 915.620.420. Do this even if you do not observe discomfort or signs of intoxication. Some signs of overdose may be dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and changes in body fluid balance. Bring the packaging of Escitalopram Accord if you go to the doctor or hospital.

If You Forget to Take Escitalopram Accord

Do not take a double dose to make up for forgotten doses. If you forgot to take a dose and remember before going to bed, take it immediately. The next day, follow your usual routine. If you remember during the night or the next day, skip the forgotten dose and follow your usual routine.

If You Interrupt Treatment with Escitalopram Accord

Do not interrupt treatment with Escitalopram Accord until your doctor tells you to.

When you finish your treatment course, it is generally recommended that the dose of Escitalopram Accord be gradually reduced over several weeks.

When you stop taking Escitalopram Accord, especially if it is sudden, you may experience withdrawal symptoms. These are common when treatment with Escitalopram Accord is suspended. The risk is greater when Escitalopram Accord has been used for a long time, in high doses, or when the dose is reduced too quickly. Most people find that these symptoms are mild and disappear on their own within two weeks. However, in some patients, they can be intense or prolonged (2-3 months or more). If you experience severe withdrawal symptoms when you stop taking Escitalopram Accord, please contact your doctor. They may ask you to start taking your tablets again and stop them more slowly.

Withdrawal symptoms include: feeling dizzy (unstable or without balance), feeling tingling, feeling itchy, and (less frequently) electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling restless, headache, feeling nauseous, sweating (including night sweats), feeling anxious or agitated, trembling (instability), feeling confused or disoriented, feelings of emotion or irritation, diarrhea, visual disturbances, rapid heartbeat or 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, Escitalopram Accord can have adverse effects, although not everyone experiences them.

Adverse effects usually disappear after a few weeks of treatment.

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

Visit your doctor or go to the nearest hospital if you experience any of the following adverse effects:

Uncommon(may affect up to 1 in 100 people)

• Unusual bleeding, including gastrointestinal bleeding.

Rare(may affect up to 1 in 1000 people)

• Swelling of the skin, tongue, lips, pharynx, or face, hives, or difficulty breathing or swallowing (severe allergic reaction)
• High fever, agitation, confusion, tremors, and sudden muscle contractions can be signs of a rare condition called serotonin syndrome.

Unknown(frequency cannot be estimated from available data):

• Difficulty urinating.
• Rapid and irregular heartbeat or fainting that could be a symptom of a potentially life-threatening condition known as Torsades de Pointes.
• Seizures (attacks), see also section 2 "Warnings and Precautions".
• Yellow skin and eyes, are signs of liver function alteration/hepatitis.
• Thoughts of harming yourself or suicidal thoughts, see also section 2 "Warnings and Precautions".
• Sudden swelling of the skin or mucous membranes (angioedema).

In addition to the above, the following adverse effects have been reported:

Very Common(may affect more than 1 in 10 people)

• Feeling nauseous.
• Headache

Common(may affect up to 1 in 10 people)

• Nasal congestion or runny nose (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty sleeping, feeling sleepy, dizziness, yawning, tremors, itching of the skin.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual disturbances (delayed ejaculation, erection problems, decreased sexual behavior, and women may experience difficulty reaching orgasm).
• Fatigue, fever.
• Weight gain.

Uncommon(may affect up to 1 in 100 people)

• Hives, skin rash, itching (pruritus).
• Teeth grinding, agitation, nervousness, panic attacks, confusion.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbance, ringing in the ears (tinnitus).
• Hair loss.
• Excessive menstrual bleeding
• Irregular menstrual period
• Weight loss.
• Rapid heartbeat.
• Swelling of arms and legs.
• Nosebleeds.

Rare(may affect up to 1 in 1000 people)

• Aggression, depersonalization, hallucinations.
• Slow heartbeat.

Unknown(frequency cannot be determined from available data):

• Decreased sodium levels in the blood (symptoms are feeling dizzy and discomfort with muscle weakness or confusion).
• Alteration of heart rhythm (or "prolongation of the QT interval", observed in the ECG, a tracing of the heart's electrical activity).
• Dizziness when standing up due to low blood pressure (orthostatic hypotension).
• Altered liver function tests (increased liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Signs of unusual bleeding, such as skin and mucous membrane bleeding (ecchymosis)
• Increased secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, reducing the amount of sodium (inadequate ADH secretion).
• Milk flow in men and women who are not breastfeeding.
• Mania.
• An increased risk of bone fractures has been observed in patients treated with this type of medication.
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Fertility, Pregnancy, and Breastfeeding" in section 2 for more information.

Other adverse effects are known to occur with drugs that work similarly to escitalopram (the active ingredient in Escitalopram Accord tablets). These are:

• Motor restlessness (akathisia).
• Lack of appetite

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Escitalopram Accord

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medications should not be disposed of 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 Accord

The active ingredient is escitalopram.

Each Escitalopram Accord 10 mg film-coated tablet contains 10 mg of escitalopram (as oxalate).

The other ingredients are:

Core: microcrystalline cellulose (PH 101) (E 460), sodium croscarmellose (E468), hypromellose E5 (E464), talc (E553b), anhydrous colloidal silica (E551), magnesium stearate (E470b).

Coating: hypromellose E-15 (E464), titanium dioxide (E-171), macrogol 400.

Appearance of the Product and Package Contents

Film-coated tablets, oval, approximately 8.10 mm long, 5.60 mm wide, biconvex, white to almost white, with the inscription "1" and "0" on either side of the score line on one face and smooth on the other face.

The 10 mg and 20 mg tablets can be divided into equal doses.

Escitalopram Accord 10 mg film-coated tablets are available in the following package sizes:

Box with blisters: 14, 28, 56, and 98 tablets.

High-density polyethylene (HDPE) bottles of 100 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6ª planta

08039 Barcelona

Spain

Manufacturer

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

or

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice,

Poland

or

Accord Healthcare Single Member S.A.

64th Km National Road Athens,

Lamia, Schimatari, 32009, Greece

This medication was authorized in the EEA Member States and in the United Kingdom (Northern Ireland) with the following names:

Names:

Austria: Escitalopram Accord 10 mg filmtabletten

Czech Republic: Escitalopram Accord 10 mg potahované tablety

Denmark: Escitalopram Accord Healthcare

Ireland: Escitalopram 10 mg film-coated tablets

Lithuania: Escitalopram Accord 10 mg plevele dengtos tabletes

Portugal: Escitalopram Accord

Spain: Escitalopram Accord 10 mg comprimidos recubiertos con película EFG

Italy: Escitalopram Accord

Netherlands: Escitalopram Accord 10 mg Filmomhulde tabletten

Sweden: Escitalopram Accord 10 mg Filmdragerade tabletter

Slovakia: Escitalopram Accord 10 mg filmom obalené tablet

United Kingdom: Escitalopram 10 mg Film-coated tablets

Date of Last Revision of this Leaflet:May 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.gob.es/