Product Information for the User

Escitalopram Aurovitas 20 mg Film-Coated Tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as 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.What is Escitalopram Aurovitas and what it is used for.

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

3.How to take Escitalopram Aurovitas.

4.Possible side effects.

5.Storage of Escitalopram Aurovitas.

6. Contents of the pack and additional information.

Escitalopram Aurovitas contains the active ingredient escitalopram, which 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.

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 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 Aurovitas

-if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).

• if you are taking other medicines that belong to the group called MAO inhibitors, including selegiline (used for the treatment of Parkinson's disease), moclobemide (used for the treatment of depression) and linezolid (an antibiotic).
• if you have a history of or have experienced an abnormal heart rhythm (detected on an ECG, a test that evaluates the heart's function).

If you are taking medicines for heart rhythm problems or that may affect heart rhythm (see section 2 “Other medicines and Escitalopram Aurovitas”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

Please inform your doctor if you have any other condition or disease, as your doctor may need to take this into account. In particular, inform your doctor:

• If you have epilepsy. The treatment with escitalopram should be interrupted if seizures occur for the first time or if you observe an increase in the frequency of seizures (see also section 4 “Possible side effects”).
• If you have liver or kidney problems. Your doctor may need to adjust your dose.
• If you have diabetes. The treatment with escitalopram may affect blood sugar control. You may need to adjust your dose of insulin and/or oral hypoglycaemic.
• If you have a low sodium level in your blood.
• If you are prone to bleeding or bruising easily or if you are pregnant (see “Pregnancy”).
• 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 that you may have a low sodium level as a result of severe and prolonged diarrhoea and vomiting (being sick) or the use of diuretics (medicines to eliminate liquids).
• If you experience rapid or irregular heartbeats, dizziness, fainting, or dizziness 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).
• Some medicines in the group to which escitalopram belongs (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.
• If you are taking medicines that contain buprenorphine. The use of these medicines with escitalopram may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Escitalopram Aurovitas”).

Please note:

Some patients with manic-depressive illness may enter a manic phase. This is characterised 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 also 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 or have an anxiety disorder, you may occasionally have thoughts of harming or killing yourself.These may increase when you first start taking antidepressants, as it takes some time for these medicines to start working, usually around two weeks, although in some cases it may take longer.You are more likely to have these thoughts:

• if you have previously had thoughts of harming or killing yourself.
• if you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults under 25 years with psychiatric illnesses who were treated with an antidepressant.

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

It may be helpful 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 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 higher risk of side effects such as suicidal thoughts, suicidal ideation, and hostility (predominantly aggression, confrontational behaviour, and irritability) when taking this type of medicine.However, your doctor may prescribe escitalopram to patients under 18 years if they decide it is the best option for the patient. If your doctor has prescribed this medicine to a patient under 18 years and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms described above worsen or if you experience complications when patients under 18 years are taking escitalopram. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioural development of escitalopram in this age group have not yet been demonstrated.

Other medicines and Escitalopram Aurovitas

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

Inform your doctor if you are taking any of the following medicines:

• “Non-selective monoamine oxidase inhibitors (IMAOs)”, containing 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. After stopping escitalopram, you should wait 7 days before taking any of these medicines.
• “Selective reversible MAO-A inhibitors”, containing moclobemide (used in the treatment of depression).
• “Irreversible MAO-B inhibitors”, containing selegiline (used in the treatment of Parkinson's disease). These increase the risk of side effects.
• Linezolid (an antibiotic).
• Lithium (used in the treatment of manic-depressive illness) and tryptophan.
• Imipramine and desipramine (both used in the treatment of depression).
• Sumatriptan and similar medicines (used for the treatment of migraine) and tramadol and similar medicines (opioids, used for severe pain). These increase the risk of side effects.
• Cimetidine, lansoprazole, and omeprazole (used for the treatment of stomach ulcers), fluconazole (used 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 herb used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or to reduce the risk of thrombosis, also called anticoagulants). These may increase the risk of bleeding.
• Warfarin, dipiridamol, and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably check your blood clotting time at the start and end of treatment with escitalopram to ensure that the anticoagulant dose 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 used for the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the seizure threshold.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). You may need to adjust your escitalopram dose.
• Medicines that lower potassium or magnesium levels in the blood, as this increases the risk of abnormal heart rhythm, which is life-threatening.

Some medicines may increase the side effects of escitalopram and in some cases may cause severe reactions. Do not take any other medicine while taking escitalopram without first consulting your doctor, especially:

- Medicines that contain buprenorphine. These medicines may interact with escitalopram and you may experience symptoms such as involuntary muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, high body temperature. Contact your doctor if you experience these symptoms.

Do not take escitalopram if you are taking medicines for heart rhythm problems or medicines that affect heart rhythm, such as Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobials (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial treatment, particularly halofantrine) and some antihistamines (astemizole, hydroxyzine, mizolastine). Contact your doctor for any further consultation.

Taking Escitalopram Aurovitas with food, drinks, and alcohol

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

As with many medicines, 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 medicine.

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

If you take escitalopram during the last 3 months of your pregnancy, be aware that the following effects may be observed in the newborn baby: 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 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 this medicine. During pregnancy, particularly in the last 3 months, medicines like escitalopram may increase the risk of a serious condition in newborn babies, 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, please contact your midwife and/or doctor immediately.

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

If you take Escitalopram Aurovitas 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 Aurovitas to be able to advise you.

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

Citalopram, a similar medicine 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 operating machinery

It is recommended that you do not drive or operate machinery until you know how escitalopram affects you.

Escitalopram Aurovitas contains sodium

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

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

.

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 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 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 treatment.

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 slow metabolizers of the CYP2C19 enzyme

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 they have an unpleasant taste.

If necessary, you can break the tablets by placing them on a flat surface with the notch facing up. The tablets can be broken by pressing down on each end of the tablet with your index fingers, as shown in the figure.

Treatment Duration

You may feel better in a couple of weeks. Continue taking escitalopram even if it takes some time before you feel any improvement in your condition.

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 Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or go to the nearest hospital emergency room or consult the Toxicology Information Service, phone 915.620.420 indicating the medication and the amount ingested. Do it 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 Escitalopram Aurovitas packaging if you go to the doctor or hospital.

If you forget to take Escitalopram Aurovitas

Do not take a double dose to compensate for the missed doses. If you forget to take a dose and remember before going to bed, take it immediately. The next day, follow your usual routine. If you remember during the night or the next day, leave the missed dose and follow your usual routine.

If you interrupt treatment with Escitalopram Aurovitas

Do not interrupt treatment with this medication until your doctor tells you to. When you have finished 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, 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 loss of balance), feeling of tingling, feeling of prickling, and (less frequently) 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 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 questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Escitalopram Aurovitas 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 improve as you start to feel better..

Visit your doctor or go to the hospital immediately if you experience any of the following side effects during treatment:

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

• Unusual bleeding, including gastrointestinal bleeding.

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

• Swelling of the skin, tongue, lips, throat, 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.

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

• Difficulty urinating.
• Seizures (convulsions), see also the "Warnings and precautions" section.
• Yellowing of the skin and the white of the eyes, which are signs of liver dysfunction/hepatitis.
• If you experience rapid or irregular heartbeats or dizziness, symptoms that may indicate a life-threatening condition called Torsade de Pointes.
• Thoughts of self-harm or suicidal thoughts, see also section 2 "Warnings and precautions".
• Sudden swelling of the skin or mucous membranes (angioedema).

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 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).
• Teeth chattering, agitation, nervousness, anxiety attacks, confusion.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Hair loss.
• Vaginal bleeding.
• Weight loss.
• Rapid heart rate.
• Swelling of the arms and legs.
• Nasal bleeding.

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

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

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

• Decreased sodium levels in the blood (symptoms are feeling dizzy and experiencing 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).
• Symptoms of abnormal bleeding, e.g. from the skin and mucous membranes (ecchymosis).
• Inadequate secretion of the ADH hormone, causing the body to retain water and dilute blood, reducing sodium levels.
• Milk flow in men and women who are not lactating.
• 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).
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

In addition, other side effects are known to appear with medications that act similarly to escitalopram (the active ingredient in Escitalopram Aurovitas). These 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 Pharmacovigilance of Medicines 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 out of sight and reach of children.

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.

This medication does not require special storage conditions.

Medicines 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 Aurovitas

Each film-coated tablet contains 20 mg of escitalopram (as oxalate).

The other components are:

Tablet core:silicified microcrystalline cellulose, butylhydroxytoluene (E321), butylhydroxyanisole (E320), sodium croscarmellose, microcrystalline cellulose, anhydrous colloidal silica, talc, and magnesium stearate.

Tablet coating:hypromellose, macrogol 400, and titanium dioxide (E171).

Appearance of the product and contents of the packaging

White to off-white, oval-shaped, biconvex film-coated tablets marked with “F” on one face and “56” on the other face with a pronounced groove between “5” and “6”. The size is 11.6 mm x 7.1 mm.

The tablets can be divided into equal doses.

Packaging sizes:

PVC/Alu blisters: 14, 20, 28, 50, 56, 100, and 500 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19,

2700-487 Amadora,

Portugal

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Poland: Escitalopram Aurovitas

Portugal:Escitalopram Aurovitas

Spain:Escitalopram Aurovitas 20 mg film-coated tablets EFG

Last revision date of this leaflet:July 2023

Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)