Prospecto: Information for the User

Escitalopram MEIJI 10 mg Bucodispersable Tablets EFG

Escitalopram (as oxalate)

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

2. What you need to know before starting to take Escitalopram MEIJI

3. How to take Escitalopram MEIJI

4. Possible adverse effects

5. Storage of Escitalopram MEIJI

6. Contents of the package and additional information

Escitalopram MEIJI contains escitalopram.Escitalopram belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). These medications act on the serotonin system in the brain by increasing the level of serotonin. Alterations in the serotonin system are considered an important factor in the development of depression and related diseases.

Escitalopram MEIJI 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).

You may notice an improvement in a couple of weeks. Continue taking Escitalopram MEIJI even if it takes time to notice any improvement.

You should consult a doctor if you worsen or do not improve.

No take Escitalopram MEIJI

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• If you are taking other medications that belong to the group of monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).
• If you have a history of or have experienced an episode of abnormal heart rhythm (detected on an ECG, a test that evaluates heart function).
• If you are taking medications for heart rhythm problems or that can affect heart rhythm (see section 2 “Other medications and Escitalopram MEIJI”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Escitalopram MEIJI.

Please inform your doctor if you have any other medical condition or disease, as your doctor may need to take it into account. Specifically, inform your doctor:

• If you have epilepsy. Treatment with Escitalopram MEIJI should be discontinued 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 MEIJI may affect blood sugar control. You may need to adjust your insulin and/or oral hypoglycemic medication 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 “Pregnancy, breastfeeding, and fertility”).
• If you are receiving electroconvulsive therapy.
• If you have coronary artery disease.
• If you have or have had heart problems or have recently had a heart attack.
• If your resting heart rate is slow and/or you know you may have low sodium levels due to severe and prolonged diarrhea and vomiting (being ill) or use of diuretics.

• If you experience rapid or irregular heartbeats, dizziness, fainting, or lightheadedness when standing up, which may indicate abnormal heart rhythm.
• If you have or have had eye problems, such as certain types of glaucoma (increased eye pressure).

Some medications in the group to which Escitalopram MEIJI belongs (called ISRS/IRSN) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after discontinuing treatment.

Please note

Some patients with manic-depressive illness may enter a manic phase. This is characterized by unusual and rapid changes in ideas, excessive happiness, and excessive physical activity. If you experience this, contact your doctor.

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

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 yourself or committing suicide. 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.

Youwould be more prone to having these types of thoughts:

• If you have previously had thoughts of harming yourself or committing suicide.
• If you are ayoung adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years old with psychiatric illnesses treated with an antidepressant.

If you ever have thoughts of harming yourself or committing suicide,contact your doctor or go directly to a hospital.

It may be helpful for you to tell a family member or 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.

Children and adolescents

Escitalopram MEIJI should not be used for 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 adverse effects such as suicidal attempts, suicidal thoughts, and hostility (primarily aggression, confrontational behavior, and irritability) when taking this class of medications. However, your doctor may prescribe escitalopram to patients under 18 years old when they decide it is in the best interest of the patient.If the doctor who is responsible for you has prescribed Escitalopram MEIJI to a patient under 18 years old and wants to discuss this decision, please return 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. Additionally, the long-term effects regarding safety and related to growth, maturity, and cognitive and behavioral development of escitalopram in this age group have not yet been demonstrated.

Other medications and Escitalopram MEIJI

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 (MAOIs)”, containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranilcipromine as active ingredients. If you have taken any of these medications, you will need to wait 14 days before starting to take Escitalopram MEIJI. After finishing Escitalopram MEIJI, 7 days must pass before taking any of these medications.

• “Reversible selective 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 adverse effects.
• 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 (used to treat severe pain). These increase the risk of adverse effects.
• 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 medicinal plant used to treat 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 likely monitor your blood clotting time at the start and end of treatment with Escitalopram MEIJI to ensure 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 for the treatment of schizophrenia, psychosis) and antipsychotics (antidepressants) 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 dose.
• Medications that lower potassium or magnesium levels in the blood, as this increases the risk of abnormal heart rhythm, which is life-threatening.

Do not take Escitalopram MEIJI if you are taking medications for heart rhythm problems or that can affect heart rhythm, for example, antiarrhythmic Class IA and III, antipsychotics (for example, phenothiazine derivatives, pimozide, haloperidol), antidepressants, certain antimicrobial agents (for example, sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial treatment particularly halofantrine), some antihistamines (astemizol, mizolastine).

Contact your doctor for any additional consultation

Taking Escitalopram MEIJI with food, drinks, and alcohol

Escitalopram MEIJI can be taken with or without food(see section 3 “How to take Escitalopram MEIJI”).

As with many medications, it is not recommended to combine escitalopram and alcohol, although it is not expected to interact with alcohol.

Pregnancy, breastfeeding, and fertility

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 if you are pregnant or breastfeeding unless you and your doctor have analyzed the risks and benefits involved.

If you take Escitalopram MEIJI during the last months of pregnancy, be aware that you may observe the following effects in the newborn: difficulty breathing, blue skin, seizures, changes in body temperature, difficulty feeding, 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 MEIJI. During pregnancy, particularly in the last months, medications like Escitalopram MEIJI 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 MEIJI in the final 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 know that you are taking Escitalopram MEIJI to be able to advise you.

Escitalopram MEIJI should not be discontinued abruptly.

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

Citalopram, a medication similar to escitalopram, has demonstrated reduced sperm quality in animal models. Theoretically, this effect could affect fertility, but to date, it has not been observed in human fertility.

Driving and operating machinery

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

Escitalopram MEIJI contains aspartame

This medication contains 8 mg of aspartame per tablet. Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Escitalopram MEIJI contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The buccal tablets will be administered in a single daily dose with or without food.

The buccal tablet must be placed on the tongue where it will begin to dissolve with saliva and can be swallowed without water.

The buccal tablet is fragile and must be handled with care.

Adults

Depression

The normally recommended dose of Escitalopram MEIJI is 10 mg taken as a single daily dose. Your doctor may increase it up to a maximum of 20 mg per day.

Anxiety disorder

The initial recommended dose of Escitalopram MEIJI is 5 mg as a single daily dose 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 MEIJI is 10 mg taken as a single daily dose. 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 MEIJI 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 MEIJI 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.

Older adults (over 65 years)

The initial recommended dose of Escitalopram MEIJI is 5 mg taken as a single daily dose. The dose may be increased by your doctor up to 10 mg per day.

Children and adolescents

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

Treatment duration

You may feel better in a couple of weeks. Continue taking Escitalopram MEIJI 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 MEIJI 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 feeling well again.

If you take more Escitalopram MEIJI than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Do it even when you do not observe discomforts or signs of intoxication. Some signs of overdose may be 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 MEIJI packaging if you go to the doctor or hospital.

If you forgot to take Escitalopram MEIJI

Do not take a double dose to compensate for the missed doses. If you forgot to take a dose, and remember before going to bed, 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 treatment with Escitalopram MEIJI

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

When you stop taking Escitalopram MEIJI, especially if it is done abruptly, you may experience withdrawal symptoms. These are common when Escitalopram MEIJI treatment is suspended. The risk is higher when Escitalopram MEIJI 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 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, 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 without balance), feeling of tingling, feeling of prickling, and (less frequently) feeling of 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 (unsteadiness), 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, this medicine can cause side effects, although not everyone will experience them.

The 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 therefore improve when you start to feel better.

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

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

• Unusual bleeding, including gastrointestinal bleeding.

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

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

Unknown (cannot be determined from available data):

• Difficulty urinating.

• Seizures (convulsions), see also the section “Warnings and precautions”.
• Yellowish skin and whitening of the eyes, which are signs of liver function alteration/hepatitis.
• Fast or irregular heartbeats or dizziness, symptoms that may indicate a life-threatening condition known as Torsade de Pointes.
• Thoughts of self-harm or suicidal thoughts, see also the section “Warnings and precautions”.
• Sudden swelling of the skin or mucous membranes (angioedemas).
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy, breastfeeding, and fertility” in section 2 for more information.

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

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

??Dizziness (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.

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

??Urticaria, skin rash, itching (pruritus).

??Tickling of teeth, agitation, nervousness, anxiety crisis, confusion.

??Disorders of sleep, disorders of taste, fainting (syncope).

??Pupil dilation (mydriasis), visual disturbance, buzzing 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 1,000 people):

??Aggression, depersonalization, hallucinations.

??Slow heart rate.

Unknown (cannot be determined from available data):

??Decreased sodium levels in the blood (symptoms are feeling dizzy and feeling unwell with muscle weakness or confusion).

??Dizziness when standing due to low blood pressure (orthostatic hypotension).

??Altered liver function tests (elevated liver enzymes in the blood).

??Movement disorders (involuntary muscle movements).

??Painful erections (priapism).

??Signs of abnormal bleeding, e.g. from the skin or mucous membranes (ecchymosis).

??Increase in the secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, reducing the amount of sodium (inadequate secretion of ADH).

??Milk flow in men and in women who are not breastfeeding.

??Mania.

??An increased risk of bone fractures has been observed in patients treated with this type of medication.

??Alteration of heart rhythm (known as “prolongation of the QT interval”, observed in the ECG, heart electrical activity).

Other side effects that have been reported with medications that act similarly to escitalopram, the active ingredient in Escitalopram MEIJI, are:

• Motor restlessness (akathisia).
• Anorexia.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products 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.

Store below 30°C.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Escitalopram MEIJI 10 mg buccal dispersible tablets

• The active ingredient is escitalopram (as oxalate). Each buccal dispersible tablet contains 10 mg of escitalopram.
• The other components are: talc (E-553b), microcrystalline cellulose silicified (microcrystalline cellulose and anhydrous colloidal silica), sodium croscarmellose (E-468), magnesium stearate (E-572), peppermint aroma, aspartame (E-951) and anhydrous colloidal silica.

Appearance of the product and content of the container

Escitalopram MEIJI 10 mg are white, oblong, and scored tablets on one face.

The score is not intended for splitting the tablet.

Escitalopram MEIJI 10 mg buccal dispersible tablets are available in formats of 28, 56, and 500 tablets.

Other presentations

Escitalopram MEIJI 15 mg buccal dispersible tablets EFG 28, 56, and 500 tablets.

Escitalopram MEIJI 20 mg buccal dispersible tablets EFG 28, 56, and 500 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

Date of the last review of this leaflet: January 2021

Other sources of information

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/