ESCITALOPRAM AUROVITAS PHARMA 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Escitalopram Aurovitas Pharma 10 mg Orodispersible Tablets EFG

Escitalopram Aurovitas Pharma 15 mg Orodispersible Tablets EFG

Escitalopram Aurovitas Pharma 20 mg Orodispersible 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 get 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 and other information

1. What is Escitalopram Aurovitas Pharma and what is it used for.
2. What you need to know before you take Escitalopram Aurovitas Pharma.
3. How to take Escitalopram Aurovitas Pharma.
4. Possible side effects.
5. Storage of Escitalopram Aurovitas Pharma.

Contents of the pack and further information.

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

Escitalopram Aurovitas Pharma contains the active substance escitalopram. Escitalopram Aurovitas Pharma belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines work by increasing the levels of serotonin in the brain. Changes in the levels of serotonin in the brain are believed to be important in the development of depression and related diseases.

Escitalopram Aurovitas Pharma contains escitalopram and 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 feel better after a few weeks. Continue taking Escitalopram Aurovitas Pharma even if it takes some time before you feel any improvement. You should talk to your doctor if you do not feel better or if you feel worse.

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

Do not take Escitalopram Aurovitas Pharma:

• 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 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 been born with or have had an episode of irregular 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 “Use of Escitalopram Aurovitas Pharma with other medicines”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Escitalopram Aurovitas Pharma.

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 Aurovitas Pharma should be discontinued if seizures occur for the first time or if there is an increase in the frequency of seizures (see also section 4 “Possible side effects”).
• If you have liver or kidney failure. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram Aurovitas Pharma may alter blood sugar control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemics.
• If you have low sodium levels in your blood.
• If you tend to develop 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 you have a low resting heart rate and/or you know you may have a salt depletion as a result of prolonged and intense diarrhea and vomiting (you feel dizzy) or due to the use of diuretics (diuretic pills).
• 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 eye pressure).
• If you are taking medicines that contain buprenorphine. The use of these medicines with escitalopram can cause serotonin syndrome, a potentially life-threatening disease (see “Other medicines and Escitalopram Aurovitas Pharma”).
• Some medicines in the same group as Escitalopram Aurovitas Pharma (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Please note:

Some patients with manic-depressive illness may enter a manic phase. This is characterized by an uncommon and rapid change of ideas, disproportionate joy, and excessive physical activity. If you experience this, contact your doctor.

You may experience symptoms such as agitation or difficulty sitting or standing still during the first few weeks of treatment. If you experience these symptoms, contact your doctor immediately.

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 of harming or killing yourself. These may increase when taking antidepressants for the first time, as all these medicines require time to start working, usually around two weeks, although in some cases it may be longer.

Youwould be more likely to have these thoughts:

• If you have previously had thoughts of killing yourself or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric diseases 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 Aurovitas Pharma should not normally be used in the treatment of children and adolescents under 18 years of age. Also, you should know that in patients under 18 years of age, there is a greater risk of adverse effects such as suicidal attempts, suicidal ideas, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this class of medicines. Nevertheless, your doctor may prescribe Escitalopram Aurovitas Pharma to patients under 18 years of age when they decide it is most convenient for the patient. If the doctor who corresponds to you has prescribed Escitalopram Aurovitas Pharma 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 progress or if you experience complications when patients under 18 years of age are taking Escitalopram Aurovitas Pharma. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Escitalopram Aurovitas Pharma in this age group have not yet been demonstrated.

Other medicines and Escitalopram Aurovitas Pharma

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

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

• "Non-selective monoamine oxidase inhibitors (IMAOs)" that contain phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active ingredients. If you have taken any of these medicines, you will need to wait 14 days before starting to take Escitalopram Aurovitas Pharma. After finishing Escitalopram Aurovitas Pharma, 7 days must pass before taking any of these medicines.
• "Reversible selective MAO-A inhibitors" that contain moclobemide (used in the treatment of depression).
• "Irreversible MAO-B inhibitors" that contain selegiline (used in the treatment of Parkinson's disease). These increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used in the treatment of manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (both used for the treatment of depression).
• Sumatriptan and similar medicines (used for the treatment of migraine) and tramadol (used for severe pain). These increase the risk of side effects.
• Cimetidine, lansoprazole, and omeprazole (used for the treatment of stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause an increase in blood levels of escitalopram.
• St. John's Wort (Hypericum perforatum), a medicinal plant used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain or reduce the risk of thrombosis). 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 Aurovitas Pharma to ensure that the anticoagulant dose remains 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 serotonin reuptake inhibitors (SSRIs)) due to the possible risk of lowering the seizure threshold, and antidepressants.
• 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 Aurovitas Pharma.
• Medicines that decrease potassium and magnesium levels in the blood, as this may increase 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 may 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 Aurovitas Pharma if you are taking medicines for heart rhythm problems or that may affect heart rhythm, such as antiarrhythmics Class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobials (e.g., sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarial treatment, especially halofantrine), and some antihistamines (astemizole, mizolastine). If you have any doubts, you should talk to your doctor.

Taking Escitalopram Aurovitas Pharma with food, drinks, and alcohol

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

As with many medicines, it is not recommended to combine Escitalopram Aurovitas Pharma and alcohol, although it is not expected that Escitalopram Aurovitas Pharma will interact with alcohol.

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 Aurovitas Pharma if you are pregnant or breastfeeding unless you and your doctor have analyzed the risks and benefits involved.

If you take Escitalopram Aurovitas Pharma during the last 3 months of your pregnancy, be aware that the following effects may be observed in the newborn baby: breathing difficulties, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, exaggerated reflexes, tremors, trembles, irritability, lethargy, constant crying, and sleep disturbances. If your newborn baby has any of these symptoms, contact your doctor immediately.

Make sure your midwife and/or doctor know that you are taking Escitalopram Aurovitas Pharma. When taken during pregnancy, particularly in the last 3 months, medicines like Escitalopram Aurovitas Pharma may increase the risk of a serious disease in the newborn baby, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and appear blue. These symptoms usually start 24 hours after the baby's birth. If this happens to your baby, you should contact your midwife and/or doctor immediately.

If Escitalopram Aurovitas Pharma is used during pregnancy, it should never be stopped abruptly. It is expected that Escitalopram Aurovitas Pharma will be excreted in breast milk.

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

Citalopram, a medicine similar to escitalopram, has been shown to reduce sperm quality in animal studies. In theory, this could affect fertility, but so far, 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 Aurovitas Pharma affects you.

Escitalopram Aurovitas Pharma contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Escitalopram Aurovitas Pharma contains sodium

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

3. How to take Escitalopram Aurovitas Pharma

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

Escitalopram Aurovitas Pharma orodispersible tablets are administered every day in a single daily dose. Escitalopram Aurovitas Pharma can be taken with or without food.

Escitalopram Aurovitas Pharma orodispersible tablets break easily, so the tablets should be handled with care. Do not handle the tablets with wet hands, as they may break.

1. Hold the blister strip by the edges and separate one of the blisters from the rest of the strip by carefully tearing it along the perforations that surround it.
2. Gently peel off the adhesive cover.
3. Place the tablet on the tongue. The tablet dissolves quickly and can be swallowed without water.

Adults

Depression

The normally recommended dose of Escitalopram Aurovitas Pharma is 10 mg administered as a single dose per day. Your doctor may increase it to a maximum of 20 mg per day.

Anxiety Disorder

The initial recommended dose is 5 mg of Escitalopram Aurovitas Pharma per day for the first week, then increased to 10 mg per day, and if necessary, up to a maximum of 20 mg per day.

Social Anxiety Disorder

The normally recommended dose of Escitalopram Aurovitas Pharma is 10 mg administered as a single dose per day. Your doctor may decrease your dose to 5 mg per day or increase the dose to a maximum of 20 mg per day, depending on your response to the medication.

Generalized Anxiety Disorder

The normally recommended dose of Escitalopram Aurovitas Pharma is 10 mg administered as a single dose per day. Your doctor may increase it to a maximum of 20 mg per day.

Obsessive-Compulsive Disorder

The normally recommended dose of Escitalopram Aurovitas Pharma is 10 mg administered as a single dose per day. Your doctor may increase it to a maximum of 20 mg per day.

Elderly patients (over 65 years of age)

The recommended dose of Escitalopram Aurovitas Pharma is 5 mg taken as a single dose per day. The dose may be increased by your doctor to 10 mg per day.

Children and adolescents (under 18 years of age)

Escitalopram Aurovitas Pharma should not normally be administered to children and adolescents. For additional information, see section 2 "Before taking Escitalopram Aurovitas Pharma".

Duration of treatment

It may take a couple of weeks before you start to feel better. Continue taking Escitalopram Aurovitas Pharma even if you start to feel better before the expected time.

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

Continue taking Escitalopram Aurovitas Pharma for the time recommended by your doctor. If you interrupt treatment too early, symptoms may reappear. It is recommended that treatment continue for at least 6 months after feeling better again.

If you take more Escitalopram Aurovitas Pharma than you should

If you take more Escitalopram Aurovitas Pharma than prescribed, contact your doctor immediately, go to the emergency department of the nearest hospital, or consult the Toxicology Information Service, phone 915 620 420. Do this even if you do not observe discomfort or signs of intoxication. Some signs of overdose may be dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rate, decrease in blood pressure, and changes in body water balance. Bring the Escitalopram Aurovitas Pharma package if you go to the doctor or hospital.

If you forget to take Escitalopram Aurovitas Pharma

Do not take a double dose to make up for a forgotten dose. If you forgot to take a dose and remember before going to bed, take it immediately. The next day, follow the usual routine. If you remember during the night or the next day, leave the forgotten dose and follow the usual routine.

If you stop treatment with Escitalopram Aurovitas Pharma

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

When you stop taking Escitalopram Aurovitas Pharma, especially if it is sudden, you may feel withdrawal symptoms. These are common when treatment with Escitalopram Aurovitas Pharma is suspended. The risk is greater when Escitalopram Aurovitas Pharma 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 Aurovitas Pharma, please contact your doctor. He or she may ask you to start taking your tablets again and leave them more slowly.

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them.

Side effects usually disappear after a few weeks of treatment. Note that some of the effects may also be symptoms of your disease and will therefore improve when you start to feel better.

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

Uncommon (may affect between 1 and 100 patients):

• Unusual bleeding, including gastrointestinal bleeding.

Rare (may affect between 1 and 1,000 patients):

• Swelling of the skin, tongue, lips, or face, or having difficulty breathing or swallowing (allergic reaction), contact your doctor or go to the hospital immediately.
• High fever, agitation, confusion, tremors, and sudden muscle contractions, these may be signs of a rare disease called serotonin syndrome.

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

• Difficulty urinating.
• Seizures (attacks), see also the "Warnings and precautions" section.
• Yellow color in the skin and the whites of the eyes, sign of altered liver function/hepatitis.
• Rapid and irregular heartbeat, fainting, which could be symptoms of a potentially life-threatening condition known as Torsade de Pointes.
• Thoughts of self-harm or suicide, see also the "Warnings and precautions" section.

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

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

• Feeling nauseous (nausea)
• Headache

Common (may affect between 1 and 10 patients):

• Nasal congestion or runny nose (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty falling asleep, feeling sleepy, dizziness, yawning, tremors, itching of the skin.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual disturbances (delayed ejaculation, erection problems, decreased sexual behavior; women may experience difficulty reaching orgasm).
• Fatigue, fever.
• Weight gain

Uncommon (may affect between 1 and 100 patients):

• Hives, skin rash, itching (pruritus).
• Teeth grinding, agitation, nervousness, anxiety attacks, state of confusion.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbance, ringing in the ears (tinnitus).
• Hair loss.
• Excessive menstrual bleeding.
• Irregular menstrual period.
• Weight loss.
• Rapid heartbeat.
• Swelling of arms and legs.
• Nosebleeds

Rare (may affect between 1 and 1,000 patients):

• Aggression, depersonalization, hallucination
• Slow heartbeat

Not known (frequency cannot be estimated from available data):

• Decrease in sodium levels in the blood, whose symptoms are feeling dizzy and unwell 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 increased bleeding, for example, from skin and mucous membranes (ecchymosis).
• Sudden swelling of the skin or mucous membranes (angioedema).
• Increased urine production (inadequate ADH secretion).
• Milk flow in men and in women who are not breastfeeding.
• Mania
• An increased risk of bone fractures has been observed in patients treated with this type of medication.
• Alteration of heart rhythm (called "prolongation of the QT interval", observed in the ECG, electrical activity of the heart).
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

In addition, other side effects are known to occur with drugs that work similarly to escitalopram (the active ingredient in Escitalopram Aurovitas Pharma). These are:

• Motor restlessness (akathisia)
• Lack of appetite

Reporting of side effects

If you experience any of the side effects, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Escitalopram Aurovitas Pharma

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the blister after CAD.

The expiration date is the last day of the month indicated.

This medication does not require special storage temperature. Store in the original packaging to protect it from moisture and light.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Escitalopram Aurovitas Pharma

The active ingredient is escitalopram.

Escitalopram Aurovitas Pharma 10 mg: Each orodispersible tablet of Escitalopram Aurovitas Pharma contains 10 mg of escitalopram equivalent to 12.775 mg of escitalopram oxalate or

Escitalopram Aurovitas Pharma 15 mg: Each orodispersible tablet of Escitalopram Aurovitas Pharma contains 15 mg of escitalopram equivalent to 19.1625 mg of escitalopram oxalate or

Escitalopram Aurovitas Pharma 20 mg: Each orodispersible tablet of Escitalopram Aurovitas Pharma contains 20 mg of escitalopram equivalent to 25.55 mg of escitalopram oxalate.

• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, potassium polacrilin, acesulfame potassium, neohesperidin dihydrochalcone, magnesium stearate, peppermint flavor [contains maltodextrin (corn), modified cornstarch (E-1450), and peppermint oil (mentha arvensis)], concentrated hydrochloric acid (for pH adjustment).

Appearance of the product and package contents

Escitalopram Aurovitas Pharma 10 mg: White to off-white, circular, biplanar tablets with beveled edges, 9 mm in diameter, with the inscription "10" on one side

Escitalopram Aurovitas Pharma 15 mg: White to off-white, circular, biplanar tablets with beveled edges, 11 mm in diameter, with the inscription "15" on one side

Escitalopram Aurovitas Pharma 20 mg: White to off-white, circular, biplanar tablets with beveled edges, 12 mm in diameter, with the inscription "20" on one side

Blister packs in packages of: 12, 14, 20, 28, 50, 56, 60, 98, 100, and 200 orodispersible tablets.

Not all pack 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

Genepharm S.A

18km Marathon Avenue,

15351 Pallini Attiki,

Greece

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000, Malta

or

Date of the last revision of this leaflet: December 2022

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