Package Leaflet: Information for the User

Escitalopram Tarbis Farma 10 mg Film-Coated Tablets EFG

Read this 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1. What is Escitalopram Tarbis Farma and what is it used for

2. What you need to know before you start taking Escitalopram Tarbis Farma

3. How to take Escitalopram Tarbis Farma

4. Possible side effects

5. Storage of Escitalopram Tarbis Farma

6. Contents of the pack and additional information

This medication contains the active ingredient escitalopram. Escitalopram 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. Alterations in the serotonin system are considered an important factor in the development of depression and related diseases.

This medication 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 this medication even if it takes time to notice any improvement.

You should consult a doctor if you worsen or do not improve.

Do not take Escitalopram Tarbis Farma

• 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 to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).
• If you have a history of birth or have experienced an episode of heart rhythm alteration (detected in an ECG, a test that evaluates heart function).
• If you are taking medications for heart rhythm problems or that may affect heart rhythm (see section 2 “Other medications and Escitalopram Tarbis Farma ”).

Warnings and precautions

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

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

• If you have epilepsy. Treatment with this medication should be interrupted if seizures occur for the first time or if you observe an increase in seizure frequency (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 may alter blood sugar control. You may need to adjust your insulin and/or oral hypoglycemic dose.
• If you have low sodium levels in your blood.
• If you have a history of bleeding disorders or if you develop unusual bleeding, or if you are pregnant (see “Pregnancy, breastfeeding, and fertility”)
• 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 your resting heart rate is slow and/or you know that you may have low sodium levels as a result of severe and prolonged diarrhea and vomiting (being ill) or use of diuretics.
• 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).

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.

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.

Medications like Escitalopram Tarbis Farma (also called ISRS/IRSN) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

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 taking antidepressants for the first time, as all these medications require time to start working, usually around two weeks, although in some cases it may take longer.Youmay be more prone to having these types of thoughts:

• If you previously had thoughts of harming yourself or committing suicide.
• Ifyouare ayoung adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years old with psychiatric illnesses 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 for you 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

This medication 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 adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication. However, your doctor may prescribe escitalopram to patients under 18 years old when they decide it is best for the patient. If the doctor who prescribed Escitalopram Tarbis Farma to you is under 18 years old and wants 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. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of escitalopram in this age group have not yet been demonstrated.

Other medications and Escitalopram Tarbis Farma

Inform your doctor or pharmacist if you are using, have used recently, or may need to use, any other medication.

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

• “Non-selective monoamine oxidase inhibitors (IMAOs)”, containing phenelzine,iproniazid, isocarboxazid, nialamide, and tranilcipromine as active ingredients. If you have taken any of these medications, you will need to wait 14 days before starting to take this medication. After finishing this medication, 7 days should pass before taking any of these medications.
• “Reversible selective MAO-A inhibitors”, containing moclobemide (used to treat depression).
• “Irreversible MAO-B inhibitors”, containing selegiline (used to treat Parkinson's disease).This increases the risk of side effects.
• The antibiotic linezolid.
• Lithium (used to treat manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medications (used to treat migraines) and tramadol (used to treat severe pain).This increases the risk of side effects.
• Cimetidine, lansoprazole, and omeprazole (used to treat 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 escitalopram blood levels.
• St. John's Wort (Hypericum perforatum) – a medicinal plant used to treat depression.
• Aspirin and non-steroidal anti-inflammatory drugs (medications used to relieve pain or reduce the risk of thrombosis, also called anticoagulants).This 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 monitor your blood clotting time at the start and end of treatment with this medication to check that the anticoagulant dose is still adequate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics(medications used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and ISRSs) 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 dose of this medication.
• Medicationsthat lower potassium or magnesium levels in the blood, as this increases the risk of life-threatening heart rhythm disturbances.

Do not take this medication if you are taking medications for heart rhythm problems or that may affect heart rhythm, e.g. antiarrhythmic Class IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, particular antimalarial treatment halofantrine), some antihistamines (astemizol, hydroxyzine, mizolastine). Contact your doctor for any additional consultation.

Taking Escitalopram Tarbis Farma with food, drinks, and alcohol

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

As with many medications, it is not recommended to combine Escitalopram Tarbis Farma 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 this medication if you are pregnant or breastfeeding unless you and your doctor have analyzed the risks and benefits involved.

If you take this medication 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, restlessness, irritability, drowsiness, and difficulty falling asleep. 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 medication.

During pregnancy, particularly in the last 3 months, medications like this one may increase the risk of a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually start within the first 24 hours after birth. If they appear in your baby, contact your midwife and/or doctor immediately.

If you take this medication 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 to advise you.

This medication should not be stopped abruptly during pregnancy.

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

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

Driving and operating machinery

It is recommended that you do not drive or operate machinery until you know how this medication may affect you.

Escitalopram Tarbis Farma contains Sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Adults

Depression

The usual recommended dose of escitalopram is 10 mg taken as a single daily dose. Your doctor may increase it up to a maximum of 20 mg per day.

Anxiety Disorder

The initial dose of escitalopram is 5 mg as a single daily dose for the first week before increasing the dose to 10 mg per day. Your doctor may increase it further up to a maximum of 20 mg per day.

Social Anxiety Disorder6 of 11

The usual recommended dose of escitalopram is 10 mg taken as a single daily dose. 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 the medication.

Generalized Anxiety Disorder

The usual recommended dose of escitalopram is 10 mg taken as a single daily dose. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Obsessive-Compulsive Disorder

The usual recommended dose of escitalopram is 10 mg taken as a single daily dose. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Older Adults (65 years and older)

The recommended initial dose of escitalopram is 5 mg taken as a single daily dose. 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 as Slow Metabolizers of CYP2C19

Patients with this known genotype should not receive more than 10 mg per day. Take as prescribed by your doctor.

How to Take the Tablets

You can take escitalopram with or without food. Swallow the tablets with water. Do not chew them, as their taste is bitter.

Treatment Duration

You may feel better in a couple of weeks. Continue taking escitalopram even if you start feeling better before the expected time.

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 Tarbis Farma Than You Should

If you take more doses of escitalopram than prescribed, contact your doctor immediately, go to the nearest hospital emergency room, or consult the Toxicological 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 hydro-saline balance. Bring the Escitalopram Tarbis Farma package if you go to the doctor or hospital.

If You Forget to Take Escitalopram Tarbis Farma

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 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 Tarbis Farma

Do not interrupt treatment with escitalopram 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 Tarbis Farma 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 Tarbis Farma, 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 without 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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can have side effects, although not everyone will experience them.

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.

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

Rare (may affect up to 1 in 100 people):

• Unusual bleeding, including gastrointestinal bleeding.

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

• Urticaria or has difficulty breathing or swallowing (severe allergic reaction).
• Fever, agitation, confusion, tremors, and sudden muscle contractions, which may be signs of a rare condition called serotonin syndrome.

Unknown (cannot be determined from available data):

• Difficulty urinating.
• Seizures (attacks), see also the "Warnings and precautions" section.
• Yellowing of the skin and white of the eyes, which are signs of liver function alteration/hepatitis.
• Experiencing rapid or irregular heartbeats or dizziness, symptoms that may indicate a life-threatening condition known as Torsade de Pointes.
• Thoughts of self-harm or suicidal thoughts, see also the "Warnings and precautions" section.
• Sudden swelling of the skin or mucous membranes (angioedemas).

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).
• Coughing.

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

• Runny nose or nasal mucosity (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 crisis, confusion.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Excessive hair loss.
• Excessive menstrual bleeding.
• Irregular menstrual period.
• Weight loss.
• Rapid heart rate.
• Swelling of arms and legs.
• Nasal bleeding.

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

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

Unknown (cannot be determined 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).
• Abnormal liver function tests (elevated liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Signs of abnormal bleeding, e.g. from the skin or mucous membranes (ecchymosis).
• Inadequate secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, reducing sodium levels (inadequate ADH secretion).
• Milk flow in men and 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 (known as "prolongation of the QT interval", observed on the ECG, heart electrical activity).
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

Other side effects that appear with medications that act similarly to escitalopram (the active ingredient in Escitalopram Tarbis Farma) are known:

• Motor restlessness (akathisia).
• Loss of appetite

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 prospectus.You can also report directly through the Spanish System for the Vigilance of Medicines for Human Use website:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the blister after CAD. The expiration date is the last day of the month indicated.

Store below 30 °C.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Escitalopram Tarbis Farma

The active ingredient is escitalopram.

Each Escitalopram Tarbis Farma tablet contains 10 mg of escitalopram (as oxalate).

The other components are:

Core: Microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, talc, and magnesium stearate.

Coating: Titanium dioxide (E171), hypromellose, macrogol 400 (E1521), and polisorbate 80 (E433).

Appearance of the product and contents of the packaging

White to off-white film-coated tablets, oval, scored, biconvex, marked with “J” on one face and “2” on the other face. Approximately 7.90 x 5.40 mm in dimension.

The tablets can be divided into equal doses.

Blister packs: 28 and 56 film-coated tablets.

Marketing authorization holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

Last review date of this leaflet: May 2022

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