Package Leaflet: Information for the User

Escitalopram Alter Generics 15 mg Film-Coated Tablets

Read this 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. Do not give it to others even if they have similar symptoms to 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. .

Escitalopram Alter Genéricos contains the active ingredient 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.

Escitalopram 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 Alter Genéricos even if it takes time to notice any improvement.

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

Do not take Escitalopram Alter Genéricos

• 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 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 birth or have experienced an episode of heart rhythm alteration (detected on an ECG, a test that evaluates heart function).
• If you are taking medications for heart rhythm problems or that may affect heart rhythm (see section 2 “Taking Escitalopram Alter Genéricos with other medicines”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Escitalopram Alter Genéricos.

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 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 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 have a history of bleeding disorders or if you develop unusual bleeding or bruising, or if you are pregnant (see “Pregnancy, breastfeeding, and fertility”).
• 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 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 pressure in the eye).

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.

Medicines like Escitalopram Alter Genéricos (also called ISRS/IRSN) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms 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 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.

Youmay 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 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 adverse effects, such as attempts at suicide, suicidal thoughts, and hostility (primarily aggression, confrontational behavior, and irritability) when taking this type of medication. However, your doctor may prescribe escitalopram to patients under 18 years old when they decide it is the best option for the patient. If your doctor has prescribed escitalopram 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. At the same time, 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.

Using Escitalopram Alter Genéricos with other medicines:

Inform your doctor or pharmacist if you are using, or 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 escitalopram. After finishing escitalopram, 7 days should pass before taking any of these medications.
• “Selective reversible 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 side 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 tramadolsimilar 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 blood levels.
• St. John's Wort (Hypericum perforatum) – a medicinal plant used for depression.
• Aspirin and non-steroidal anti-inflammatory drugs (medications used to relieve pain or reduce the risk of thrombosis, also called anticoagulants).These may increase the risk of bleeding.
• Warfarin, dipiridamol, and phenprocoumon (medications used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably monitor your blood clotting time at the start and end of treatment with escitalopram 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) andantidepressants (tricyclic antidepressants and ISRSs) 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 Alter Genéricos if you are taking medications for heart rhythm problems or that may affect heart rhythm, e.g. antiarrhythmic Class IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial treatment particularly halofantrine), some antihistamines (astemizol, hydroxyzine, mizolastine).

Contact your doctor for any additional consultation.

Taking Escitalopram Alter Genéricos with food, drinks, and alcohol

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

As with many medications, it is not recommended to combineescitalopramand alcohol,although it is not expected that Escitalopram Alter Genéricos will 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 Alter Genéricosif you are pregnantor breastfeeding unless you and your doctor have analyzed the risks and benefits involved.

If you take escitalopram 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, difficulty feeding, vomiting, low blood sugar, muscle stiffness or weakness, intense reflexes, tremors, restlessness, irritability, drowsiness, and difficulty sleeping. 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 Alter Genéricos.

During pregnancy, particularly in the last 3 months,medicines like Escitalopram Alter Genéricos 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 startwithin the first 24 hours after birth. Ifthey appear in your baby, contact your midwife and/or doctor immediately.

If you take Escitalopram Alter Genéricos in the final stages of pregnancy, there may be a higher risk of excessive vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking escitalopram to advise you.

Escitalopram should not be stopped abruptly during pregnancy.

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

Citalopram, a similar medication to escitalopram, has been shown to reduce 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 may affect you.

Escitalopram Alter Genéricos contains sodium

This medication contains less than 23 mg of sodium (1mmol) per tablet; that is, 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 doubts.

Adults

Depression

The normally recommended dose of escitalopram 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 is 5 mg as a single dose per day during the first week before increasing the dose to 10 mg per day.

Your doctor may increase it subsequently up to a maximum of 20 mg per day.

Social Anxiety Disorder

The normally recommended dose of escitalopram 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 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 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 is 5 mg taken as a single dose per day. The dose may be increased by your doctor up to 10 mg per day.

Use in Children and Adolescents

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

Renal Insufficiency

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

Liver Insufficiency

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 with or without food. Swallow the tablets with water. Do not chew them, as their taste is bitter. If necessary, you can break the tablets by placing them 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.

Treatment Duration

You may feel better in a couple of weeks. Continue taking escitalopram 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 for the recommended time by your doctor. If you interrupt treatment too soon, symptoms may reappear. It is recommended that treatment continue for at least 6 months after you feel better.

If You Take More Escitalopram Alter Genéricos Than You Should:

If you take more doses of escitalopram 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 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 packaging of this medication with you to the doctor or hospital.

If You Forget to Take Escitalopram Alter Genéricos:

Do not take a double dose to compensate for the missed dose. If you forget 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 Alter Genéricos:

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

When you stop taking escitalopram, especially if it is done abruptly, you may experience withdrawal symptoms. These are common when escitalopram treatment is suspended. The risk is higher when escitalopram 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, 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 itching, and (less frequently) electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of nausea (dizziness), sweating (including night sweats), 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 have side effects, although not everyone will experience them.

The side effects are normally gone 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.

Uncommon(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 (cannot be determined from available data):

• Difficulty urinating.
• Seizures (attacks), see also the "Warnings and precautions" section.
• Yellowing of the skin and the white of the eyes, which are signs of liver function alteration/hepatitis.
• If you experience rapid 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 "Warnings and precautions" section.
• 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 (arthritis and myalgia).
• Sexual difficulties (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 1000 people):

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

Uncommon(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 feeling unwell with muscle weakness or confusion).
• Dizziness when standing due to low blood pressure (orthostatic hypotension).
• Altered liver function tests (increased liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Signs of abnormal bleeding, e.g. from the skin or mucous membranes (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 flow in men and women who are not breastfeeding.
• Mania.
• An increased risk of bone fractures has been observed in patients treated with this type of medication.
• Alteration of heart rhythm (known as "prolongation of the QT interval", observed on the ECG, heart electrical activity).
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

Other side effects have been reported with medications that act similarly to escitalopram (the active ingredient in Escitalopram Alter Genéricos). These are:

• 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 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 website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store above 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 medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Escitalopram Alter Generics

• The active ingredient is escitalopram. Each film-coated tablet contains 15 mg of escitalopram (as escitalopram oxalate).
• The other components are:

Core: microcrystalline cellulose, sodium croscarmellose, talc, anhydrous colloidal silica, and magnesium stearate.

Coating: hypromellose, titanium dioxide (E171), and macrogol.

Appearance of the product and contents of the package

Escitalopram Alter Generics 15 mg tablets are white, elliptical, biconvex, and scored on one face, with lateral grooves and the inscription “E-” engraved on the other face. The tablets can be divided into equal halves.

Escitalopram Alter Generics 15 mg film-coated tablets are available in blister packs of 28 and 56 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Alter, S.A

C/Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036, Madrid

Spain

or

Laboratorios Alter, S.A.

C/ Zeus, 6

Polígono Industrial R2

28880, Meco (Madrid)

Spain

Last review date of this leafletDecember 2024

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