ESCITALOPRAM TARBIS FARMA 10 mg FILM-COATED TABLETS

2. What you need to know before you take Escitalopram Tarbis Farma

Do not take Escitalopram Tarbis Farma

• 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 a group called MAOIs (including selegiline, used to treat Parkinson's disease, moclobemide, used to treat depression, and linezolid, an antibiotic).
• If you have been born with or have had an episode of abnormal 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 the heart rhythm (see section 2 "Other medicines and Escitalopram Tarbis Farma").

Warnings and precautions

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

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

• If you have epilepsy. Treatment with this medicine should be discontinued if you experience seizures for the first time or if you notice an increase in the frequency of seizures (see also section 4 "Possible side effects").
• If you have liver or kidney disease. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with escitalopram may alter blood sugar control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic.
• If you have low sodium levels in your blood.
• If you have a history of bleeding disorders or if you develop unusual bruising or bleeding, or if you are pregnant (see "Pregnancy, breastfeeding, and fertility").
• If you are receiving electroconvulsive therapy.
• If you have coronary heart disease.
• If you have or have had heart problems or have recently had a heart attack.
• If your resting heart rate is slow and/or you know you may have low levels of salt as a result of severe and prolonged diarrhea and vomiting (being sick) or use of diuretics.
• 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).

Please note:

Some patients with manic-depressive illness may enter a manic phase. This is characterized by an uncommon and rapid change of 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 few weeks of treatment. Tell your doctor immediately if you experience these symptoms.

Medicines like Escitalopram Tarbis Farma (also called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.

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 all these medicines take time to start working, usually around two weeks, although in some cases it may be longer. Youare more likely to have these thoughts:

• If you have previously had thoughts of killing yourself or harming yourself.
• If you are an adult under 25. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 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 to tell you if they think your depression or anxiety has got worse, or if they are worried about changes in your behavior.

Children and adolescents

This medicine 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 an increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe escitalopram to patients under 18 years when they decide it is the most suitable for the patient. If the doctor who prescribed Escitalopram Tarbis Farma to a patient under 18 years wants to discuss this decision, please go back to your doctor. You should tell your doctor if any of the symptoms described above get worse or if you experience complications when patients under 18 years are taking escitalopram. Also, 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 established.

Other medicines and Escitalopram Tarbis Farma

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 this medicine. After stopping this medicine, 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 for the treatment of depression).
• Sumatriptan and similar medicines (used for the treatment of migraine) and tramadol (used for the treatment of 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 increased blood levels of escitalopram.
• St. John's Wort (Hypericum perforatum) - a herbal remedy 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 your blood clotting time at the start and end of treatment with this medicine to ensure that the dose of anticoagulant is still appropriate.
• 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 this medicine.
• Medicines that lower potassium or magnesium levels in the blood, as this increases the risk of heart rhythm disorders, which can be life-threatening.

Do not take this medicine if you are taking medicines for heart rhythm problems or that may affect the heart rhythm, e.g., 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, particularly halofantrine), some antihistamines (astemizole, hydroxyzine, mizolastine). Contact your doctor for any further questions.

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 medicines, it is not recommended to combine Escitalopram Tarbis Farma and alcohol, although it is not expected that Escitalopram Tarbis Farma 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 this medicine if you are pregnant or breastfeeding unless you and your doctor have discussed the risks and benefits involved.

If you take this medicine during the last 3 months of your pregnancy, be aware that the following effects may be seen in the newborn: difficulty breathing, blue skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, stiffness or floppiness, exaggerated reflexes, tremors, restlessness, irritability, lethargy, constant crying, and difficulty sleeping. If your newborn has any of these symptoms, please contact your doctor immediately.

Make sure your midwife and/or doctor know you are being treated with this medicine.

During pregnancy, particularly in the last 3 months, medicines like this one may increase the risk of a serious condition 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 you take this medicine in the final stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking escitalopram to be able to advise you.

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

It is expected that escitalopram will be excreted into 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 this medicine affects you.

Escitalopram Tarbis Farma contains Sodium

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

3. How to take Escitalopram Tarbis Farma

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 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 Disorder6 of 11

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 the medication.

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 impairment

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

Hepatic impairment

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 they have a bitter taste.

Duration of treatment

It may take a couple of weeks before you start to feel better. Continue taking escitalopram 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 for the time recommended by your doctor. If you interrupt the treatment too early, the symptoms may reappear. It is recommended that the treatment continues 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 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 hydroelectrolyte balance. Bring the packaging of Escitalopram Tarbis Farma if you go to the doctor or hospital.

If you forget to take Escitalopram Tarbis Farma

Do not take a double dose to make up for forgotten doses. If you forget 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, skip the forgotten dose and follow the usual routine.

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 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 Tarbis Farma 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 Tarbis Farma, 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 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), visual disturbances, rapid or palpitations heartbeat.

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

4. Possible adverse effects

Like all medications, this medication can have 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.

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

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

• Unusual bleeding, including gastrointestinal bleeding.

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

• Skin swelling, 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.

Unknown (frequency cannot be determined from available data):

• Difficulty urinating.
• Seizures (attacks), see also the "Warnings and precautions" section.
• Yellowing of the skin and whites of the eyes, 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 killing yourself, see also the "Warnings and precautions" section.
• 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 mucous (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty falling asleep, feeling sleepy, dizziness, yawning, tremors, skin itching.
• 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.
• Excessive menstrual bleeding.
• Irregular menstrual period.
• 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.

Unknown (frequency cannot be determined 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 (increase in 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).
• Increased secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, reducing the amount of sodium (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, breastfeeding, and fertility" in section 2 for more information.

Other adverse effects are known to occur with drugs that work similarly to escitalopram (the active ingredient of Escitalopram Tarbis Farma). These are:

• Motor restlessness (akathisia).
• Lack of appetite.

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

5. Conservation of Escitalopram Tarbis Farma

Keep this medication out of 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 ºC.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE point of the pharmacy. If in 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 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 polysorbate 80 (E433).

Appearance of the product and package contents

White to off-white, oval, scored, biconvex film-coated tablets, marked with "J" on one face and "2" on the other face. With an approximate size of 7.90 x 5.40 mm.

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

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

Date of the last revision of this prospectus: May 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/