Escitalopram Alter Genericos 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Escitalopram Alter Generics 10 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. 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. It could 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.

Contents of this leaflet

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

1. What Escitalopram Alter Genéricos is and what it is used for

Escitalopram Alter Genéricos contains the active substance escitalopram. Escitalopram belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).

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).

It may take a couple of weeks before you start to feel better. Continue taking Escitalopram Alter Genéricos even if it takes some time to notice improvement.

You should consult a doctor if your condition worsens or if you do not improve.

2. What you need to know before taking Escitalopram Alter Genéricos

Do not take Escitalopram Alter Genéricos

• If you are allergic to escitalopram or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking other medicines belonging to the group known as MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).
• If you have been born with or have experienced an episode of heart rhythm disorder (detected on 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 “Use of Escitalopram Alter Genéricos with other medicines”).

Warnings and precautions

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

Please inform your doctor if you have any other disorders or illnesses, as your doctor may need to take them into account. Specifically, inform your doctor:

• If you have epilepsy. Treatment with escitalopram 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 liver or kidney impairment. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with escitalopram may alter glycaemic control. Adjustment of insulin and/or oral hypoglycaemic agent dosage may be necessary.
• If you have low sodium levels in your blood.
• If you have a history of bleeding disorders or develop unusual bruising, 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 previously 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 levels of salt due to severe and prolonged diarrhoea and vomiting (being unwell) or use of diuretics.
• If you experience rapid or irregular heartbeats, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm.
• If you have or have previously had 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 characterised by unusually rapid and frequent changes of thought, 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 weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Medicines like Escitalopram Alter Genéricos (also called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Suicidal thoughts and worsening of your depression or anxiety disorder

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

You are more likely to have such thoughts:

• If you have previously had thoughts of killing yourself 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 about 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 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.

Children and adolescents

Escitalopram should not normally be used to treat 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, confrontation behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe escitalopram to patients under 18 years of age if they decide it is most appropriate for the patient. If your doctor has prescribed escitalopram to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms described above worsen or complications arise while patients under 18 years of age are taking escitalopram. In addition, the long-term effects on safety and on growth, maturation, and cognitive and behavioural development of escitalopram in this age group have not yet been fully established.

Use of Escitalopram Alter Genéricos with other medicines:

Tell your doctor or pharmacist if you are using, have recently used, or might need to use 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. After stopping escitalopram, 7 days must pass before starting any of these medicines.
• “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 side effects.
• The antibiotic linezolid.
• Lithium (used to treat bipolar disorder) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medicines (used to treat migraine) and tramadol and similar medicines (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 (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause increased blood levels of escitalopram.
• 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, dipyridamole, 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 escitalopram treatment to ensure your anticoagulant dose remains appropriate.
• 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 (medicines used to treat 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 may need to be adjusted.
• Medicines that reduce potassium or magnesium levels in the blood, as this increases the risk of life-threatening heart rhythm disturbances.

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

Contact your doctor for any additional questions.

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 medicines, combining escitalopram with alcohol is not recommended, although no interaction between Escitalopram Alter Genéricos and alcohol is expected.

Pregnancy, breastfeeding and fertility

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

If you take escitalopram during the last 3 months of pregnancy, the newborn baby may experience the following effects: breathing difficulties, bluish skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, strong 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 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 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 Alter Genéricos 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.

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

Escitalopram is expected to be excreted in breast milk.

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

Driving and using machines

You are advised not to drive or operate machinery until you know how escitalopram affects you.

Escitalopram Alter Genéricos contains sodium

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

3. How to take Escitalopram Alter Genéricos

Follow exactly the instructions for using this medicine as given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Adults

Depression

The normally recommended dose of escitalopram 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 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 is 10 mg taken as a single daily dose.

Your doctor may reduce 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 medicine.

Generalized anxiety disorder

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

Use in children and adolescents

Escitalopram 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 renal 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 as poor 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 with or without food. Swallow the tablets with water. Do not chew them, as they have a bitter taste.

If necessary, the 10 mg tablets may be divided by placing the tablet on a flat surface with the score facing upwards. The tablets can be split by pressing down on each end of the tablet with the index fingers.

The 10 mg tablets can be divided into equal doses.

Duration of treatment

It may take a few weeks before you start to feel better. Continue taking escitalopram 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 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 Alter Genéricos than you should:

If you take more escitalopram than prescribed, contact your doctor immediately, go to the nearest hospital emergency department, or call the Toxicology Information Service at telephone number 915 620 420.

Do this 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 rate, decreased blood pressure, and disturbances in the body's fluid and electrolyte balance. Take the medicine's packaging with you if you go to the doctor or hospital.

If you forget to take Escitalopram Alter Genéricos:

Do not take a double dose to make up for the forgotten dose. 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 next day, skip the missed dose and continue as usual.

If you stop taking Escitalopram Alter Genéricos:

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

When you stop taking escitalopram, especially if abruptly, you may experience withdrawal symptoms. These are common when treatment with escitalopram is stopped. 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 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, contact your doctor. He or she may ask you to restart taking your tablets and taper off more slowly.

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 (vivid dreams, nightmares, inability to sleep); restlessness; headache; dizziness (nausea); sweating (including night sweats); feelings of anxiety or agitation; tremor (shakiness); feelings of confusion or disorientation; emotional lability or irritability; diarrhea (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, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects are usually transient and disappear after a few weeks of treatment. Please be aware that many of these effects may in fact be symptoms of your underlying illness and will therefore improve as you start to feel better.

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

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, 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.

Frequency not known (cannot be estimated from available data):

• Difficulty urinating.
• Seizures (fits); see also section “Warnings and precautions”.
• Yellowing of the skin or whites of the eyes, signs of liver dysfunction/hepatitis.
• Fast or irregular heartbeat, or fainting, symptoms which may indicate a life-threatening condition known as Torsade de Pointes.
• Thoughts of harming yourself or thoughts of suicide; see also section “Warnings and precautions”.
• Sudden swelling of the skin or mucous membranes (angioedema).

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

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

• Feeling nauseous.
• Headache.

Common (may affect up to 1 in 10 people):

• Nasal congestion or runny nose (sinusitis).
• Decreased or increased appetite.
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, skin itching.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual disturbances (delayed ejaculation, erectile dysfunction, decreased sexual drive, and women may experience difficulty achieving 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 1,000 people):

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

Frequency not known (cannot be estimated from available data):

• Decreased sodium levels in the blood (symptoms include dizziness, malaise, muscle weakness, or confusion).
• Dizziness upon standing due to low blood pressure (orthostatic hypotension).
• Abnormal liver function tests (elevated liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Signs of abnormal bleeding, e.g., bruising of the skin or mucous membranes (ecchymosis), and low platelet count in the blood (thrombocytopenia).
• Increased secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, leading to low sodium levels (inappropriate ADH secretion).
• Increased levels of prolactin hormone in the blood.
• Milk production in men and in women not breastfeeding.
• Mania.
• An increased risk of bone fractures has been observed in patients treated with this type of medication.
• Changes in heart rhythm (known as “QT interval prolongation,” observed on ECG, the heart’s electrical activity).
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section “Pregnancy, breastfeeding and fertility” in section 2 for more information.

Other adverse effects have been reported with medicines that act similarly to escitalopram (the active substance in Escitalopram Alter Genéricos). These include:

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

Reporting of adverse effects

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

5. Storage of Escitalopram Alter Genéricos

Keep this medicine out of sight and reach of children.

Do not store above 30 ºC.

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.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Package contents and other information

Composition of Escitalopram Alter Genéricos

• The active substance is escitalopram. Each film-coated tablet contains 10 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 pack

Escitalopram Alter Genéricos 10 mg tablets are white, elliptical, biconvex and scored on one side, with lateral notches, and the inscription “E” engraved on the other side. The tablets can be divided into equal doses.

Escitalopram Alter Genéricos 10 mg film-coated tablets are available in blister packs containing 28 and 56 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer

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

Date of the most recent revision of this leaflet: October 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/