Escitalopram Accord 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Escitalopram Accord 5 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, 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 and must not be given to other people,

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

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are

effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Escitalopram Accord contains the active substance escitalopram. Escitalopram belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). These medicines act 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 before you start to feel better. Continue taking Escitalopram, even if it takes some time before you notice 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 taking 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 belonging to the group called monoamine oxidase inhibitors (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 heart rhythm abnormalities or are born with them (as seen on ECG, a test used to assess heart function).
• If you are taking medicines for heart rhythm problems or that could affect heart rhythm (see section 2 “Use of Escitalopram Accord with other medicines”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Escitalopram Accord. Please inform your doctor if you have any other disorders or medical conditions, as your doctor may need to take them into account. Specifically, inform your doctor:

• If you have epilepsy. Treatment with Escitalopram Accord should be discontinued if you experience seizures for the first time or notice an increase in seizure frequency (see also section 4 “Possible side effects”).
• If you have hepatic or renal impairment. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram Accord may alter glycaemic control. Adjustment of insulin and/or oral hypoglycaemic agent dosage may be necessary.
• If you have low sodium levels in the 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 artery disease.
• If you have heart problems or have recently had a heart attack.
• If your resting heart rate is low, or if you may have low salt levels due to prolonged and severe diarrhoea and vomiting (if you have experienced dizziness), or if you are taking diuretics.
• If your heartbeats are fast or irregular, or if you experience fainting, collapse, or dizziness upon standing, which could indicate heart rhythm abnormalities.
• If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).

Please note:

Some patients with bipolar disorder may enter a manic phase.

This is characterized by unusually rapid and frequent changes in thoughts, excessive 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.

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

Suicidal thoughts and worsening of depression or anxiety disorder

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

You are more likely to have these types of thoughts:

• If you have previously had thoughts of killing or harming yourself.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age 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 help you 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 ask them whether they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your behaviour.

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 an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Escitalopram Accord to patients under 18 years of age if they decide it is in the patient’s best interest. If your doctor has prescribed Escitalopram Accord to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You must inform your doctor if any of the symptoms described above worsen or develop complications while patients under 18 years of age are taking Escitalopram Accord. In addition, the long-term effects on safety, as well as on growth, maturation, and cognitive and behavioural development of Escitalopram Accord in this age group have not yet been established.

Use of Escitalopram Accord with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Inform 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 Accord. After stopping Escitalopram Accord, 7 days must pass before taking any of these medicines.
• “Reversible selective MAO-A inhibitors” containing moclobemide (used for the treatment of depression).
• “Irreversible MAO-B inhibitors” containing selegiline (used for the treatment of Parkinson’s disease). These increase the risk of side effects.
• Buprenorphine (an 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 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 any of these symptoms.
• The antibiotic linezolid.
• Lithium (used for the treatment of bipolar 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 (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause increased blood levels of Escitalopram Accord.
• St. John’s wort (Hypericum perforatum) – a herbal remedy 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 bleed.
• Warfarin, dipiridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will likely monitor your blood clotting time at the beginning and end of treatment with Escitalopram Accord to ensure the anticoagulant dose remains appropriate.
• 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 for cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of Escitalopram Accord may need to be adjusted.
• Medicines that reduce blood potassium or magnesium levels, as these conditions increase the risk of life-threatening heart rhythm disturbances.

DO NOT TAKE ESCITALOPRAM ACCORD if you are taking medicines for heart rhythm problems or that could affect heart rhythm, such as Class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, or haloperidol), tricyclic antidepressants, certain antimicrobials (such as sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, or antimalarials, particularly halofantrine), or certain 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 medicines, combining Escitalopram Accord with alcohol is not recommended, although an interaction between Escitalopram Accord and alcohol is not expected.

Fertility, pregnancy and breastfeeding

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 discussed the risks and benefits involved. If you take Escitalopram Accord during the last 3 months of pregnancy, the following effects may occur in the newborn baby: breathing difficulties, bluish skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, increased reflexes, tremors, restlessness, irritability, lethargy, constant crying, drowsiness, and sleep difficulties. If your newborn baby shows any of these symptoms, please contact your doctor immediately.

Ensure that 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 condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes rapidly and appears blue. These symptoms usually begin within the first 24 hours after birth. If they occur in your baby, contact your midwife and/or doctor immediately.

If you take escitalopram late in 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 so they can advise you appropriately.

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

Escitalopram is expected to be excreted in breast milk.

Animal studies have shown reduced sperm quality with citalopram, a medicine similar to escitalopram. Theoretically, this could affect fertility, but effects on human fertility have not yet been observed.

Driving and using machines

It is advised not to drive or operate machinery until you know how Escitalopram Accord affects you.

Escitalopram Accord contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially “sodium-free”.

3. How to take Escitalopram Accord

Follow exactly your doctor's instructions on how to take this medicine. 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 daily dose. Your doctor may increase it up to a maximum of 20 mg per day.

Panic disorder

The initial dose of Escitalopram Accord is 5 mg as a single daily dose for the first week before increasing the dose to 10 mg per day. Your doctor may subsequently increase it 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 daily dose. Your doctor may reduce your dose to 5 mg per day or increase it 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 daily dose. 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 daily dose. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Elderly patients (over 65 years of age)

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

Use in children and adolescents

Escitalopram Accord should not normally be given to children and adolescents. For further information, please 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 to be 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 may 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 may split the tablets by placing the tablet on a flat surface with the score facing upwards. The tablets can be broken by pressing down on each end of the tablet with the 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 medicine without first speaking to your doctor.

Continue taking Escitalopram Accord for the length of time recommended by your doctor. If you stop treatment too early, symptoms may return. It is recommended that treatment continues for at least 6 months after you feel well again.

If you take more Escitalopram Accord than you should

If you take more Escitalopram Accord than prescribed, contact your doctor immediately, go to the nearest hospital emergency department, or contact the Toxicology Information Service at telephone number 915 620 420. Do so even if you do not notice any discomfort or signs of poisoning. Some of the signs of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and disturbances in the body's fluid and electrolyte balance. Take the Escitalopram Accord packaging with you 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 forget to take a dose and remember before going to bed, take it immediately. The next day, continue as usual. If you remember during the night or the following day, skip the missed dose and continue as usual.

If you stop taking Escitalopram Accord

Do not stop treatment with Escitalopram Accord unless your doctor tells you to. When you have completed your course of treatment, it is generally recommended that the dose of Escitalopram Accord be gradually reduced over several weeks.

When you stop taking Escitalopram Accord, especially if stopped abruptly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram Accord is discontinued. 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 resolve on their own within two weeks. However, in some patients, they may be severe or prolonged (2–3 months or more). If you experience severe withdrawal symptoms when stopping Escitalopram Accord, please contact your doctor. He or she may advise you to restart taking your tablets and then stop more gradually.

Withdrawal symptoms include: dizziness (feeling unsteady or off balance), tingling sensations, burning sensations, and (less frequently) electric shock-like sensations, even in the head; sleep disturbances (excessively vivid dreams, nightmares, inability to sleep); restlessness; headache; dizziness (nausea); sweating (including night sweats); feelings of unease or agitation; tremor (shakiness); feelings of confusion or disorientation; feelings of anxiety or irritability; diarrhoea (loose stools); visual disturbances; rapid pulse or 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, 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 these effects may be symptoms of your illness and will therefore improve as 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, throat or face, hives 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 or irregular heartbeat, or fainting, which could be symptoms of a potentially life-threatening condition known as Torsades de Pointes.
• Seizures (fits), see also section 2 "Warnings and precautions".
• Yellowing of the skin and whites of the eyes, signs of liver dysfunction/hepatitis.
• Thoughts of harming yourself or killing yourself, see also section 2 "Warnings and precautions".
• Sudden swelling of the skin or mucous membranes (angioedema).

In addition to those listed above, the following adverse 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 or mucus (sinusitis).
• Decreased or increased appetite.
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, feeling drowsy, dizziness, yawning, tremors, skin itching.
• Diarrhoea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual disturbances (delayed ejaculation, problems with erection, reduced sexual drive, 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, restlessness, nervousness, panic attacks, confusion.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Hair loss.
• Excessive menstrual bleeding.
• Irregular menstrual periods.
• Weight loss.
• Fast heartbeat.
• Swelling of arms and legs.
• Nosebleeds.

Rare (may affect up to 1 in 1000 people)

• Aggression, depersonalisation, hallucinations.
• Slow heartbeat.

Unknown (frequency cannot be estimated from available data):

• Decreased levels of sodium in the blood (symptoms include dizziness, malaise, muscle weakness or confusion).
• Changes in heart rhythm (or "prolongation of the QT interval", seen on ECG, a tracing of the heart's electrical activity).
• Dizziness upon standing due to low blood pressure (orthostatic hypotension).
• Abnormal liver function tests (increased liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Signs of unusual bleeding, such as on the skin and mucous membranes (ecchymosis).
• Increased secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, reducing sodium levels (inappropriate ADH secretion).
• Milk production 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 medicine.
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage), see "Fertility, pregnancy and breastfeeding" in section 2 for more information.

Other adverse effects are known to occur with drugs that act similarly to escitalopram (the active substance in Escitalopram Accord film-coated tablets). These include:

• Motor restlessness (akathisia).
• Loss of appetite.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Escitalopram Accord

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

Do not use this medicine after the expiry date stated on the packaging

after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

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

6. Contents of the pack and other information

Composition of Escitalopram Accord

The active substance is escitalopram.

Each tablet of Escitalopram Accord 5 mg film-coated tablets contains 5 mg of escitalopram (as oxalate).

The other components are:

Core: microcrystalline cellulose (PH 101) (E 460), sodium croscarmellose (E 468),
hypromellose E5 (E 464), talc (E 553b), colloidal anhydrous silica (E 551), magnesium stearate (E 470b).

Coating: hypromellose E-15 (E 464), titanium dioxide (E-171), macrogol 400.

Appearance of the product and contents of the container

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 pack sizes:

Blister packs in cartons: 14, 28, 56 and 98 tablets.

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

Only certain pack 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

Manufacturer

Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The 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 has been authorised in the EEA Member States and in the United Kingdom (Northern Ireland) under 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 plėvelė dengtos tabletės
Portugal: Escitalopram Accord
Spain: Escitalopram Accord 5 mg comprimidos recubiertos con película EFG
Italy: Escitalopram Accord
The Netherlands: Escitalopram Accord 5 mg Filmomhulde tabletten
Sweden: Escitalopram Accord 5 mg Filmdragerade tabletter
Slovakia: Escitalopram Accord 5 mg filmom obalené tablety
United Kingdom: Escitalopram 5 mg Film-coated tablets

Date of latest review of this leaflet: May 2023

Detailed and up-to-date 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/