ESCITALOPRAM MEIJI 15 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Escitalopram MEIJI 15 mg Orodispersible Tablets EFG

Escitalopram (as oxalate)

Contents of the pack:

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

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

Escitalopram MEIJI contains escitalopram. Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines work by increasing the levels of serotonin in the brain. Alterations in the serotonin system are considered to be a major factor in the development of depression and related disorders.

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).

It may take a couple of weeks before you start to feel better. Continue to take Escitalopram MEIJI even if it takes time to notice any improvement.

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

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

Do not take Escitalopram MEIJI

• If you are allergic to the active substance or to 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 been born with or have had an episode of alteration of heart rhythm (detected in an ECG, a test that evaluates heart function).
• If you are taking medicines for heart rhythm problems or that may affect heart rhythm (see section 2 "Other medicines 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 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 MEIJI should be discontinued if you experience seizures for the first time or if you notice 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 MEIJI 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 develop bleeding or bruising easily, or if you are pregnant (see "Pregnancy, breastfeeding, and fertility").
• If you are receiving electroconvulsive therapy.
• If you have coronary heart 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 a decrease in salt as a result of severe and prolonged diarrhea and vomiting (being sick) or use of diuretics.
• If you experience rapid or irregular heartbeats, fainting, collapse, or dizziness when standing up, which may be indicative of abnormal heart rhythm.
• If you have or have had eye problems, such as certain types of glaucoma (increased pressure in the eye).

Some medicines in the group to which Escitalopram MEIJI belongs (called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

Please note

Some patients with manic-depressive illness may enter a manic phase. This is characterized by an uncommon and rapid change of ideas, 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.

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 you first start taking antidepressants, as all these medicines require time to start working, usually around two weeks, although in some cases it may be longer.

Youwould be 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 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 relative 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 normally be used in the treatment of children and adolescents under 18 years. Also, you should know that in patients under 18 years, 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 type of medicine. Nevertheless, your doctor may prescribe escitalopram to patients under 18 years when they decide it is most convenient for the patient. If the doctor who corresponds to you has prescribed Escitalopram MEIJI to a patient under 18 years and you wish 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 are taking escitalopram. Also, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of escitalopram in this age group have not yet been demonstrated.

Other medicines and Escitalopram MEIJI

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) that 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 MEIJI. After finishing Escitalopram MEIJI, 7 days must pass before taking any of these medicines.
• Reversible MAO-A inhibitors that contain moclobemide (used in the treatment of depression).
• Irreversible MAO-B inhibitors that contain selegiline (used in the treatment of Parkinson's disease). These increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used for 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 (used for severe pain). These increase the risk of side effects.
• Cimetidine, lansoprazole, and omeprazole (used for the treatment of 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 blood levels of escitalopram.
• St. John's Wort (Hypericum perforatum) - a medicinal plant used for depression.
• Aspirin 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 check the blood coagulation time at the start and end of treatment with Escitalopram MEIJI to check that the dose of anticoagulant 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 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.
• Medicines that decrease potassium or magnesium levels in the blood, as this increases the risk of suffering from heart rhythm disorders, which pose a risk to life.

Do not take Escitalopram MEIJI if you are taking medicines for heart rhythm problems or that may affect heart rhythm, e.g., antiarrhythmics Class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial treatment, particularly halofantrine), some antihistamines (astemizole, mizolastine).

Contact your doctor for any additional queries

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 medicines, it is not recommended to combine escitalopram and alcohol, although it is not expected that escitalopram will interact with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take escitalopram if you are pregnant or breastfeeding unless you and your doctor have discussed the risks and benefits involved.

If you take Escitalopram MEIJI during the last months of pregnancy, be aware that you may observe in the newborn baby the following effects: difficulty breathing, blue skin, seizures, changes in body temperature, difficulties feeding, vomiting, low blood sugar, muscle stiffness or floppiness, intense reflexes, tremors, restlessness, irritability, lethargy, constant crying, and difficulty sleeping. If your newborn baby 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, medicines like Escitalopram MEIJI 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 MEIJI in the final stage 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 so they can advise you.

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

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

Citalopram, a medicine similar to escitalopram, has been shown to reduce sperm quality in animal models. This effect could theoretically affect fertility, but to date, no impact on human fertility has been observed.

Driving and using machines

It is advised that you should not drive or use machinery until you know how Escitalopram MEIJI affects you.

Escitalopram MEIJI contains aspartame

This medicine contains 12 mg of aspartame per tablet. Aspartame is a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

Escitalopram MEIJI contains sodium

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

3. How to take Escitalopram MEIJI

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

The orally disintegrating tablets should be administered in a single daily dose with or without food.

The orally disintegrating tablet should be placed on the tongue where it will start to dissolve with saliva and can be swallowed without water.

The orally disintegrating tablet is fragile and should be handled with care.

Adults

Depression

The normally recommended dose of Escitalopram MEIJI 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 recommended dose of Escitalopram MEIJI 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 MEIJI 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 MEIJI 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 MEIJI 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 MEIJI is 5 mg taken as a single dose per day. 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 section 2 "Warnings and precautions".

Duration of treatment

It may take a couple of weeks before you start to feel better. Continue taking Escitalopram MEIJI 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 MEIJI for the time recommended by your doctor. If you interrupt the treatment too early, the symptoms may reappear. It is recommended that the treatment continue for at least 6 months after you feel better.

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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. 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, decrease in blood pressure, and changes in body hydroelectrolyte balance. Bring the packaging of Escitalopram MEIJI if you go to the doctor or hospital.

If you forget to take Escitalopram MEIJI

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 the usual routine. If you remember during the night or the next day, skip the forgotten dose and follow the usual routine.

If you stop treatment with Escitalopram MEIJI

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

When you stop taking Escitalopram MEIJI, especially if it is sudden, you may feel withdrawal symptoms. These are common when treatment with Escitalopram MEIJI is suspended. The risk is greater 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 within two weeks. However, in some patients, they can be intense or prolonged (2-3 months or more). If you have severe withdrawal symptoms when you stop taking escitalopram, please contact your doctor. He or she may ask you to start taking your tablets again and stop them more slowly.

Withdrawal symptoms include: feeling of dizziness (unstable or without balance), feeling of tingling, feeling of itching, and (less frequently) electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of dizziness (nausea), sweating (including night sweats), feeling of unease or agitation, tremors (instability), feeling of confusion or disorientation, feelings of emotion or irritation, diarrhea (loose stools), visual disturbances, rapid or palpitations heartbeat.

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

4. Possible adverse effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

Adverse effects usually disappear after a few weeks of treatment. Please be aware that many of the effects can be symptoms of your disease and will improve when you start to feel better.

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

Uncommon(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, hives, or difficulty breathing or swallowing (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 determined from available data):

• Difficulty urinating.

• Seizures (attacks), see also the "Warnings and precautions" section.
• Yellow skin and eyes, signs of liver function alteration/hepatitis.
• If you experience rapid or irregular heartbeats or fainting, symptoms that may indicate a life-threatening condition known as Torsade de Pointes.
• Thoughts of harming yourself or thoughts of killing yourself, see also the "Warnings and precautions" section.
• Sudden swelling of the skin or mucous membranes (angioedema).
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

In addition to the above, the following adverse 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):

??Nasal congestion or mucous (sinusitis).

??Decreased or increased appetite.

??Anxiety, agitation, abnormal dreams, difficulty falling asleep, 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, anxiety 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 period.

??Weight loss.

??Rapid heartbeat.

??Swelling of arms and legs.

??Nosebleeds.

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

??Aggression, depersonalization, hallucinations.

??Slow heartbeat.

Unknown (frequency cannot be determined from available data):

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

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

??Altered liver function tests (increase in 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).

??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 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 (called "prolongation of the QT interval", observed in the ECG, electrical activity of the heart).

Other adverse effects that occur with drugs that work similarly to escitalopram, the active ingredient of Escitalopram MEIJI, are known. These are:

• Motor restlessness (akathisia).
• Anorexia.

Reporting of adverse effects

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

5. Conservation of Escitalopram MEIJI

Keep this medication out of 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 thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of 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 MEIJI 15 mg orally disintegrating tablets

• The active ingredient is escitalopram (as oxalate). Each orally disintegrating tablet contains 15 mg of escitalopram.
• The other components are: talc (E-553b), silified microcrystalline cellulose (microcrystalline cellulose and anhydrous colloidal silica), sodium croscarmellose (E-468), magnesium stearate (E-572), peppermint flavor, aspartame (E-951), and anhydrous colloidal silica.

Appearance of the product and package contents

Escitalopram MEIJI 15 mg are white, oblong, and scored on one side.

The score line is not intended for breaking the tablet.

Escitalopram MEIJI 15 mg orally disintegrating tablets are available in packages of 28, 56, and 500 tablets.

Other presentations

Escitalopram MEIJI 10 mg orally disintegrating tablets EFG 28, 56, and 500 tablets.

Escitalopram MEIJI 20 mg orally disintegrating tablets EFG 28, 56, and 500 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

Date of the last revision of this prospectus: January 2021

Other sources of information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/