Package Insert: Information for the Patient

Escitalopram Aurovitas Pharma 10 mg Bucodispersable Tablets EFG

Escitalopram Aurovitas Pharma 15 mg Bucodispersable Tablets EFG

Escitalopram Aurovitas Pharma 20 mg Bucodispersable Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to otherseven if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information.

Escitalopram Aurovitas Pharma, contains escitalopram as the active substance. Escitalopram Aurovitas Pharmabelongs 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. Alterations in the serotonin system are considered an important factor 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 start feeling better in a couple of weeks. Continue taking Escitalopram Aurovitas Pharma, even if it takes some time before you notice any improvement. You should talk to your doctor if you do not feel better or if you feel worse.

Do not take Escitalopram Aurovitas Pharma:

• If you are allergic to escitalopram or any of the other components of this medication (listed in section 6).
• If you are taking other medications that belong to the group called 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 episode of abnormal heart rhythm (detected on an ECG, a test that evaluates the heart's function).
• If you are taking medications for heart rhythm problems or that may affect heart rhythm (see section 2 “Taking Escitalopram Aurovitas Pharma with other medications.”)

Warnings and precautions

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

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

• If you have epilepsy. Treatment with Escitalopram Aurovitas Pharma should be interrupted if seizures occur for the first time or if an increase in seizure frequency is observed (see also section 4 “Possible side effects”).
• If you have liver or kidney insufficiency. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram Aurovitas Pharma may alter blood sugar control. You may need to adjust your insulin and/or oral hypoglycemic medication dose.
• If you have low sodium levels in your blood.
• If you are prone to bleeding or bruising easily or if you are pregnant (see “Pregnancy”).
• If you are receiving electroconvulsive therapy.
• If you have coronary disease.
• If you have or have had heart problems or have recently had a heart attack.
• If you have a low resting heart rate and/or you know that you may have hyponatremia as a result of prolonged and intense diarrhea and vomiting (you feel dizzy) or due to the use of diuretics (diuretic tablets).
• 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 eye pressure).
• If you are taking medications that contain buprenorphine. The use of these medications with escitalopram may cause serotonin syndrome, a potentially life-threatening condition (see “Other medications and Escitalopram Aurovitas Pharma”).
• Some medications in the group to which Escitalopram Aurovitas Pharma belongs (called ISRS/IRSN) may cause sexual dysfunction symptoms (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 unusual and rapid changes in ideas, excessive joy, and excessive physical activity. If you experience this, contact your doctor.

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

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may occasionally have thoughts of harming yourself or committing suicide. These may increase when you first start taking antidepressants, as all these medications take time to start working, usually around two weeks, although in some cases it may be longer.

Youmay be more likely to have these thoughts:

• If you have previously had thoughts of harming yourself or committing suicide.
• If you are ayoung adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years old with psychiatric disorders who were treated with an antidepressant.

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

It may be helpful 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 behavior.

Children and adolescents

Escitalopram Aurovitas Pharma should not be used normally in the treatment of children and adolescents under 18 years old. Also, be aware that in patients under 18 years old, there is a higher risk of side effects such as suicidal behavior, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication. However, your doctor may prescribe Escitalopram Aurovitas Pharma to patients under 18 years old when they decide it is best for the patient. If the doctor who prescribed Escitalopram Aurovitas Pharma to you is under 18 years old and you want to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms described above progress or if you experience complications when patients under 18 years old are taking Escitalopram 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 medications and Escitalopram Aurovitas Pharma

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

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

• "Non-selective monoamine oxidase inhibitors (IMAO)", containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranilcipromina as active ingredients. If you have taken any of these medications, you will need to wait 14 days before starting to take Escitalopram Aurovitas Pharma. After stopping Escitalopram Aurovitas Pharma, 7 days must pass before taking any of these medications.
• "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.
• 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 medications (used for the treatment of migraines) 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 (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 plant used for depression.
• Aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) (medications used to relieve pain or reduce the risk of thrombosis). These may increase the risk of bleeding.
• Warfarin, dipiridamol, and phenprocoumon (medications used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably check your blood clotting time at the start and end of treatment with Escitalopram Aurovitas Pharma 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 severe pain), due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medications used for the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and selective 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). You may need to adjust your Escitalopram Aurovitas Pharma dose.
• Medications that lower potassium and magnesium levels in the blood, as this may increase the risk of abnormal heart rhythm, which can be life-threatening.

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

• Medications containing buprenorphine. These medications 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, increased muscle tone, high body temperature, etc. Contact your doctor if you experience these symptoms.

Do not take Escitalopram Aurovitas Pharma if you are taking medications for heart rhythm problems or that may affect heart rhythm, such as antiarrhythmic Class IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobials (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial treatment, especially halofantrine) and some antihistamines (astemizol, mizolastine). If you are unsure, you should speak with 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 medications, it is not recommended to combine Escitalopram Aurovitas Pharma 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 medication. Do not take Escitalopram Aurovitas Pharma if you are pregnant or breastfeeding unless you and your doctor have weighed the risks and benefits.

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: difficulty breathing, blue skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, muscle stiffness or weakness, intense reflexes, tremors, twitching, irritability, drowsiness, and difficulty sleeping. 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, especially in the last 3 months, medications like Escitalopram Aurovitas Pharma may increase the risk of a serious condition in the newborn, 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.

Escitalopram Aurovitas Pharma should not be stopped abruptly during pregnancy. It is expected that Escitalopram Aurovitas Pharma will be excreted in breast milk.

If you take Escitalopram Aurovitas Pharma in the final stages of pregnancy, there may be a higher risk of excessive 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 to be able to advise you.

Citalopram, a medication similar to escitalopram, has shown reduced sperm quality in animal studies. In theory, this may affect fertility, but so far, there has been no observed impact on human fertility.

Driving and operating machinery

It is recommended that you do not drive or operate machinery until you know how Escitalopram Aurovitas Pharma may affect you.

Escitalopram Aurovitas Pharma contains lactose

If your doctor has warned you that you are intolerant to some sugars, contact your doctor before taking this medication.

Escitalopram Aurovitas Pharma contains sodium

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

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

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

Escitalopram Aurovitas Pharma buccal tablets are easily broken, 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 blister from the rest of the strip by carefully tearing it along the perforations that surround it.
2. Carefully remove 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 daily dose. 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, to be increased to 10 mg per day and, if necessary, 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 daily dose. Your doctor may reduce 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 daily dose. 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 daily dose. Your doctor may increase it to a maximum of 20 mg per day.

Older adults (65 years of age or older)

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

Children and adolescents (under 18 years)

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

Treatment duration

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

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

Continue taking Escitalopram Aurovitas Pharma 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 Pharma than you should

If you take more Escitalopram Aurovitas Pharma than prescribed, contact your doctor immediately, go to the nearest hospital emergency department, or consult the Toxicology Information Service, phone 915 620 420. Do it even when you do not observe 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 Pharma packaging if you visit your doctor or the hospital.

If you forget to take Escitalopram Aurovitas Pharma

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

If you interrupt treatment with Escitalopram Aurovitas Pharma

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

When you stop taking Escitalopram Aurovitas Pharma, especially if it is done abruptly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram Aurovitas Pharma is suspended. The risk is higher when Escitalopram Aurovitas Pharma 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 Aurovitas Pharma, 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 nocturnal sweating), feeling of anxiety or agitation, tremor (instability), feeling of confusion or disorientation, feelings of emotion or irritability, diarrhea (loose stools), vision disturbances, palpitations.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

Rare (may affect between 1 and 100 patients):

• Unusual bleeding, including gastrointestinal bleeding.

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

• Swelling of the skin, tongue, lips, or face, or difficulty breathing or swallowing (allergic reaction), contact your doctor or go to the hospital immediately.
• High fever, agitation, confusion, tremors, and sudden muscle contractions, which 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 white of the eyes, sign of liver function alteration/hepatitis.
• Fast and irregular heart rhythm, fainting, which could be symptoms of a potentially fatal 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 dizzy (nausea)
• Headache

Common (may affect between 1 and 10 patients):

• Blockage or nasal discharge (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; women may experience difficulty reaching orgasm).
• Fatigue, fever.
• Weight gain

Rare (may affect between 1 and 100 patients):

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

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

• Aggression, depersonalization, hallucination
• Low heart rate

Not known (cannot be estimated from available data):

• Decreased sodium levels in the blood, whose symptoms are feeling dizzy and feeling unwell with muscle weakness or confusion.
• Dizziness when 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 increased bleeding, such as skin and mucous membranes (ecchymosis).
• Sudden swelling of skin or mucous membranes (angioedema).
• Inadequate ADH secretion, resulting in increased urine production.
• 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 (denominated "prolongation of the QT interval", observed in the ECG, heart electrical activity).
• Abundant 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 of Escitalopram Aurovitas Pharma. These are:

• Motor restlessness (akathisia)
• Loss of appetite

Reporting of side effects

Ifyou experience any type of side effect, 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 System for the Pharmacovigilance of Medicines for Human Use, Website: www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

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

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

Medications should not be disposed of through drains or in the trash. Deposit containers and medications you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of containers and medications you no longer need if you are unsure. By doing so, you will help protect the environment.

Composition of Escitalopram Aurovitas Pharma

The active ingredient is escitalopram.

Escitalopram Aurovitas Pharma 10 mg: Each buccal dispersible 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 buccal dispersible 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 buccal dispersible tablet of Escitalopram Aurovitas Pharma contains 20 mg of escitalopram equivalent to 25.55 mg of escitalopram oxalate.

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

Appearance of the product and contents of the package

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

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

Escitalopram Aurovitas Pharma 20 mg: White to off-white, circular, biplanar, beveled-edge tablets, 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 buccal dispersible tablets.

Only some package 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

Genepharm S.A

18km Marathon Avenue,

15351 PalliniAttiki,

Greece

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000, Malta

or

Last review date of this leaflet: December 2022

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