Leaflet: information for the user

Escitalopram Accord 5 mg film-coated tablets EFG

Read this leaflet carefully before you start taking the 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 give it to others,

even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Escitalopram Accord.

3. How to take Escitalopram Accord.

4. Possible side effects.

5. Storage of Escitalopram Accord.

6. Contents of the pack and additional information.

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

This medication 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 to start feeling better. Continue taking Escitalopram, even if it takes some time to notice an improvement in your condition.

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

Do not take Escitalopram Accord

• If you are allergic to escitalopram or any of the other components of this medication (listed in section 6).
• If you are taking other medications that belong to the group called MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).
• If you have had episodes of abnormal heart rhythm or are experiencing them since birth (which are observed on an ECG, a test that allows the heart's functioning to be evaluated).
• If you are taking medications for heart rhythm problems or that could affect heart rhythm (see section 2 “Taking Escitalopram Accord with other medications”)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Escitalopram Accord. Please inform your doctor if you have any other condition 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 interrupted if seizures occur for the first time or if you observe an increase in seizure frequency (see also section 4 “Possible side effects”).
• If you have liver or kidney insufficiency. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram Accord may alter blood sugar control. You may need to adjust your insulin and/or oral hypoglycemic dose.
• If you have low sodium levels in your blood.
• If you are prone to bleeding or bruising easily, or if you are pregnant (see “Fertility, pregnancy, and breastfeeding”).
• If you are receiving electroconvulsive therapy.
• If you have coronary disease.
• If you have or have had heart problems or have recently had a heart attack.
• If your heart rate is low at rest or if you may experience a decrease in sodium due to prolonged diarrhea and vomiting (if you have had dizziness) or if you are taking diuretics.
• If your heartbeats are rapid or irregular or if you experience fainting, collapse, or dizziness when standing up, which may indicate abnormal heart rhythm.
• If you have eye problems, such as certain types of glaucoma (increased eye pressure).

Please note:

Some patients with manic-depressive illness may enter a manic phase.

This is characterized by unusual and rapid changes in ideas, excessive 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 weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Medications such as escitalopram (also known as ISRS/IRSN) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms may persist after stopping treatment.

Thoughts of suicide and worsening of depression or anxiety disorder

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

You would be more prone to having these thoughts:

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

If you ever 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 family member or close friend that 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 be used normally in the treatment of children and adolescents under 18 years old. Also, be aware that in patients under 18 years old, there is a higher risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication. However, your doctor may prescribe Escitalopram Accord to patients under 18 years old when they decide what is best for the patient. If the doctor who is supposed to prescribe Escitalopram Accord to a patient under 18 years old wants 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 old are taking Escitalopram Accord. At the same time, the long-term effects regarding 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 medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

• “Non-selective monoamine oxidase inhibitors (IMAOs)” that contain 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 Accord. After finishing Escitalopram Accord, 7 days must pass before taking any of these medications.
• “Selective reversible 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.
• Buprenorphine (a type of opioid medication). Concomitant use increases the risk of serotonin syndrome, a condition that can be life-threatening. You may experience symptoms such as involuntary and rhythmic muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor if you experience any of these symptoms.
• The antibiotic linezolid.
• Lithium (used to treat manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medications (used to treat migraines) and tramadol and similar medications (opioids, used for severe pain). These increase the risk of side effects.
• 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 Escitalopram Accord blood levels.
• St. John's Wort (Hypericum perforatum) – a medicinal herb used for depression.
• Aspirin and nonsteroidal anti-inflammatory drugs (medications used to relieve pain or reduce the risk of blood clots, also called anticoagulants). These may increase the risk of bleeding.
• Warfarin, dipiridamol, and phenprocoumon (medications used to reduce the risk of blood clots, also called anticoagulants). Your doctor will probably monitor your blood clotting time at the start and end of treatment with Escitalopram Accord to check that the anticoagulant dose is still adequate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medications used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and ISRS) 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). You may need to adjust your Escitalopram Accord dose.

• Medications that lower blood levels of potassium or magnesium, as these conditions increase the risk of life-threatening heart rhythm disorders.

DO NOT TAKE ESCITALOPRAM ACCORDif you are taking medications for heart rhythm problems or that could affect heart rhythm, such as antiarrhythmic 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 any 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 medications, it is not recommended to combine Escitalopram Accord and alcohol, although it is not expected to interact with alcohol.

Fertility, pregnancy, and breastfeeding

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 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: difficulty breathing, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or weakness, intense reflexes, tremors, restlessness, irritability, drowsiness, and difficulty falling asleep. 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, medications like Escitalopram Accord may increase the risk of a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually start within the first 24 hours after birth. If they appear in your baby, contact your midwife and/or doctor immediately.

If you take escitalopram 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 to be able to advise you.

Escitalopram Accord 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 medication similar to escitalopram. Theoretically, this could affect fertility, but the impact on human fertility has not yet been observed.

Driving and operating machinery

It is recommended that you do not drive or operate machinery until you know how Escitalopram Accord may affect you.

Escitalopram Accord 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. 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 further 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.

Older adults (65 years and older)

The recommended initial 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 further information, please see the section 2 “Warnings and precautions”.

Renal impairment

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

Liver 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 the tablets

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

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

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

Treatment duration

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

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

Continue taking Escitalopram Accord for the recommended time by your doctor. If you interrupt the treatment too soon, symptoms may reappear. It is recommended that the 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 nearest hospital emergency room, or consult the Toxicology Information Service, phone 915.620.420. Do this even if you do not observe any discomfort or signs of overdose. Some signs of overdose may include dizziness, tremor, agitation, convulsion, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and changes in the body's electrolyte balance. Bring the Escitalopram Accord packaging with you to the doctor or hospital.

If you forget to take Escitalopram Accord

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

If you interrupt the treatment with Escitalopram Accord

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

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

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

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

Like all medicines, Escitalopram Accord may have side effects, although not everyone will experience them.

Side effects usually disappear after a few weeks of treatment.

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

Visit your doctor or go to the nearest hospital if you experience any of the following side 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, urticaria, or difficulty breathing or swallowing (severe allergic reaction)
• High fever, agitation, confusion, tremors, and sudden muscle contractions, which may be signs of a rare condition called serotonin syndrome.

Unknown(frequency cannot be estimated from available data):

• Difficulty urinating.
• Fast and irregular heartbeat or a fainting spell that could be a symptom of a potentially life-threatening condition known as Torsades de Pointes.
• Seizures (convulsions), see also section 2 “Warnings and precautions”.
• Yellowish skin and whitening of the eyes, which are signs of liver function impairment/hepatitis.
• Thoughts of harming oneself or committing suicide, see also section 2 “Warnings and precautions”
• Sudden swelling of the skin or mucous membranes (angioedemas).

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

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

• Feeling dizzy (nausea).
• Headache

Common(may affect up to 1 in 10 people)

• Blockage or nasal mucus (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty falling asleep, feeling drowsy, dizziness, yawning, tremors, skin itching.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual dysfunction (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)

• Urticaria, skin rash, itching (pruritus).
• Teeth chattering, agitation, nervousness, anxiety attack, confusion.
• Sleep disturbances, taste alterations, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Hair loss.
• Excessive menstrual bleeding
• Irregular menstrual period
• Weight loss.
• Fast heart rate.
• Swelling of arms and legs.
• Nasal bleeding.

Rare(may affect up to 1 in 1000 people)

• Aggression, depersonalization, hallucinations.
• Low heart rate.

Unknown(cannot be determined from available data):

• Decreased sodium levels in the blood (symptoms are feeling dizzy and muscle weakness or confusion).
• Alteration of heart rhythm (or “prolongation of the QT interval”, observed on an ECG, a tracing of the heart's electrical activity).
• Dizziness when standing due to low blood pressure (orthostatic hypotension).
• Abnormal liver function tests (elevated 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)
• Inadequate secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, reducing sodium levels (inadequate ADH secretion).
• Milk leakage in men and women who are not breastfeeding.
• Mania.
• A higher risk of bone fractures has been observed in patients treated with this type of medication.
• Excessive vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Fertility, pregnancy, and lactation” in section 2 for more information.

Other side effects have been reported with medications that work in a similar way to escitalopram (the active ingredient in Escitalopram Accord coated tablets).

• Motor restlessness (akathisia).
• Loss of appetite

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist,

even if it is not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, 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 packaging.

after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and

the medication that you no longer need at the SIGRE collection pointat the pharmacy. In case of doubt

ask your pharmacist how to dispose of the packaging and the medication that you no longer

need. By doing so, you will help protect the environment.

Composition of Escitalopram Accord

The active ingredient is escitalopram.

Each Escitalopram Accord 5 mg film-coated tablet

contains 5 mg of escitalopram (as oxalate).

The other components 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 contents of the package

Film-coated tablets, approximately 5.65 mm in diameter,

round, biconvex, white to almost white, smooth on both sides.

Escitalopram Accord 5 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.

Only some package sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Spain

Responsible for manufacturing

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 medicinal product was authorized in the Member States of the EEA and in the United Kingdom (Northern Ireland) with the following

names:

Austria:Escitalopram Accord 5 mg filmtabletten

Czech Republic:Escitalopram Accord 5 mg potahované tablety

Denmark:Escitalopram Accord Healthcare

Ireland:Escitalopram 5 mg film-coated tablets

Lithuania:Escitalopram Accord 5 mg plevele dengtos tabletes

Portugal:Escitalopram Accord

Spain:Escitalopram Accord 5 mg comprimidos recubiertos con película EFG

Italy:Escitalopram Accord

Netherlands:Escitalopram Accord 5 mg Filmomhulde tabletten

Sweden:Escitalopram Accord 5 mg Filmdragerade tabletter

Slovakia:Escitalopram Accord 5 mg filmom obalené tablet

United Kingdom:Escitalopram 5 mg Film-coated tablets

Last review date of this leaflet:May 2023

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

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