ESCITALOPRAM AUROVITAS 15 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Escitalopram Aurovitas 15 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 further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Escitalopram Aurovitas contains the active substance escitalopram, which belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain, 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).

It may take a couple of weeks before you start to feel better. Continue to take escitalopram even if it takes some time to notice an 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 Aurovitas

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 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 altered heart rhythm (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 "Other medicines and Escitalopram Aurovitas").

Warnings and precautions

Talk to your doctor or pharmacist before you start taking this medicine.

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 should be discontinued if you experience seizures for the first time or 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. Treatment with escitalopram may alter glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic.
• If you have a low level of sodium in the blood.
• If you tend to develop bleeding or bruising easily or if you are pregnant (see "Pregnancy").
• If you are receiving electroconvulsive treatment.
• 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 (medicines to eliminate fluids).
• If you experience rapid or irregular heartbeats, fainting, collapse, 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) may cause symptoms of sexual dysfunction (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 disease (see "Other medicines and Escitalopram Aurovitas").

Please note:

Some patients with manic-depressive illness may enter a manic phase. This is characterized by a change in ideas that is uncommon and rapid, 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 these medicines take time to start working, usually around two weeks, although in some cases it may be longer. You are 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 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 side effects such as suicidal attempts, suicidal ideas, and hostility (mainly 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 the most convenient for the patient. If your doctor has prescribed this medicine to a patient under 18 years and you want to discuss this decision, please go back 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 related to growth, maturity, and cognitive and behavioral development of escitalopram in this age group have not yet been demonstrated.

Other medicines and Escitalopram Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• Non-selective monoamine oxidase inhibitors (MAOIs), which contain phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substances. If you have taken any of these medicines, you will need to wait 14 days before starting to take escitalopram. After finishing escitalopram, 7 days must pass before taking any of these medicines.
• Reversible MAO-A inhibitors, which contain moclobemide (used in the treatment of depression).
• Irreversible MAO-B inhibitors, which contain selegiline (used in the treatment of Parkinson's disease). These increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used in the treatment of manic-depressive disorder) 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 (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.
• 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 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 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 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). 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 heart rhythm disorders, which can be life-threatening.

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

• Medicines that contain buprenorphine. These medicines can interact with escitalopram, and you may experience symptoms such as involuntary rhythmic muscle contractions, including the muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38 °C. 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, IV erythromycin, pentamidine, antimalarial treatment, particularly halofantrine), and some antihistamines (astemizole, hydroxyzine, mizolastine). Contact your doctor for any additional questions.

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 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 during the last 3 months of your pregnancy, be aware that the following effects may be observed in the newborn: breathing difficulties, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, exaggerated reflexes, tremors, restlessness, irritability, lethargy, constant crying, and sleep disturbances. 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 this medicine. During pregnancy, particularly in the last 3 months, medicines like escitalopram 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 escitalopram is used during pregnancy, it should never be stopped abruptly.

If you take Escitalopram Aurovitas in the final stage of pregnancy, there may be a greater 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 so they can advise you.

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 recommended that you do not drive or use 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; it is essentially "sodium-free".

3. How to Take Escitalopram Aurovitas

Follow the administration instructions for this medication exactly 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 later 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.

Elderly Patients (over 65 years)

The initial recommended 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 section 2 "Warnings and Precautions".

Renal Insufficiency

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

Hepatic 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 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 a bitter taste.

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

Duration of Treatment

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

Do not change the dose of the medication without talking to your doctor first.

Continue taking escitalopram for the recommended time by your doctor. If you interrupt treatment too early, 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 emergency department of the nearest hospital or consult the Toxicology Information Service, phone 915.620.420, indicating the medication and the amount ingested. Do this even if you do not observe discomfort or signs of intoxication. Some signs of overdosing may be dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and changes in body hydro-saline balance. Bring the packaging of Escitalopram Aurovitas if you go to the doctor or hospital.

If You Forget to Take Escitalopram Aurovitas

Do not take a double dose to make up for missed doses. If you forgot 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, skip 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 generally recommended that the dose of escitalopram be gradually reduced over several weeks.

When you stop taking escitalopram, especially if it is sudden, you may feel withdrawal symptoms. These are common when treatment with escitalopram is suspended. The risk is greater when escitalopram 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 dizzy (unstable or without balance), feeling tingling, feeling prickling, and (less frequently) electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling restless, headache, feeling nauseous (nausea), sweating (including night sweats), feeling anxious or agitated, trembling (instability), feeling confused or disoriented, feelings of emotion or irritation, diarrhea (loose stools), visual disturbances, rapid or irregular heartbeat (palpitations).

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

4. Possible Adverse Effects

Like all medications, Escitalopram Aurovitas 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.

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

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 (severe allergic reaction).

• High fever, agitation, confusion, tremors, and sudden muscle contractions, can be signs of a rare condition called serotonin syndrome.

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

• Difficulty urinating.
• Seizures (attacks), see also the section "Warnings and Precautions".
• Yellowing of the skin and whites of the eyes, are 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 committing suicide, see also section 2 "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 (nausea).
• Headache.

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

• Nasal congestion or runny nose (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty sleeping, 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).
• Pupil dilation (mydriasis), visual disturbance, ringing in the ears (tinnitus).
• Hair loss.
• Vaginal bleeding.
• 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.

Frequency not known (cannot be estimated 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 (increased liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Signs of abnormal bleeding, e.g., from skin and mucous membranes (ecchymosis).
• Increased secretion of the ADH hormone, causing the body to retain water and dilute blood, reducing sodium levels (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, heart electrical activity).
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

Additionally, other adverse effects are known to occur with drugs that work similarly to escitalopram (the active ingredient of Escitalopram Aurovitas). 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 leaflet. 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. Storage of Escitalopram Aurovitas

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.

Medications should not be thrown away in drains or 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 Aurovitas

Each film-coated tablet contains 15 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 Package Contents

White to off-white, oval, biconvex film-coated tablets marked with "F" on one side and "55" on the other side with a pronounced score line between "5" and "5". The size is 9.8 mm x 6.3 mm.

The tablets can be divided into equal doses.

Package sizes:

PVC/Aclar-Aluminum blisters: 14, 20, 28, 50, 56, 100, and 500 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19,

2700-487 Amadora,

Portugal

This medication is authorized in the Member States of the European Economic Area with the following names:

Poland: Escitalopram Aurovitas

Portugal: Escitalopram Aurovitas

Spain: Escitalopram Aurovitas 15 mg film-coated tablets EFG

Date of the Last Revision of this Leaflet:July 2023

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)