ESCITALOPRAM TARBIS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

EscitalopramTarbis 10 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you 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:

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

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

Escitalopram Tarbis is an antidepressant that belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain, increasing the level of serotonin. Alterations in the serotonin system are considered an important factor in the development of depression and related disorders.

Escitalopram Tarbis is used to treat:

• Depressive disorders (major depressive episodes).
• Anxiety disorder with or without agoraphobia (e.g., fear of leaving the house, entering stores, being in crowds and public places).
• Social anxiety disorder (social phobia).
• Obsessive-compulsive disorder.

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

Do not take Escitalopram Tarbis

• if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6),
• if you take other medicines that belong to a group called monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic),
• if you have been born with any type of heart rhythm disorder or have ever had any episode of this type (this is observed with the ECG; a test that serves to evaluate how the heart works),
• if you are taking medicines for heart rhythm problems or that may affect the heart rhythm (see section 2 "Use of other medicines").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Escitalopram Tarbis.

Please inform your doctor if you have any of the following disorders or diseases, as your doctor may need to take it into account. Specifically, inform your doctor:

• If you have epilepsy. Treatment with Escitalopram Tarbis should be discontinued if seizures occur for the first time or if you observe an increase in the frequency of seizures (see section 4 "Possible side effects").
• If you have liver or kidney problems. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram Tarbis may alter glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic.
• If you have a decreased level of sodium in the blood.
• If you have low levels of potassium or magnesium in the blood (hypokalemia/hypomagnesemia).
• If you have a tendency to develop bleeding or bruising, 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 had any heart problems or have recently had a heart attack.
• If you or your family have a heart condition called 'prolonged-QT'.
• If your resting heart rate is slow (this is known as bradycardia) and/or you know you may have a decrease in salt as a result of severe and prolonged diarrhea and vomiting or because you have used diuretics (medicines to urinate).
• If you experience rapid or irregular heartbeats, fainting, collapse, or dizziness when standing up, which may indicate abnormal heart rhythm function.
• If you have narrow-angle glaucoma or a history of glaucoma.

Some medicines in the same group as Escitalopram Tarbis (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment is stopped.

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.

Symptoms such as restlessness or difficulty sitting or standing (akathisia) may also occur during the first few weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may 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 take longer.

You would be more likely to have these types of thoughts:

• If you have previously had suicidal thoughts or thoughts of 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 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 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 (under 18 years)

Escitalopram should not normally be used in the treatment of children and adolescents under 18 years of age. You should also 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 (predominantly aggression, confrontational behavior, and irritation) when taking this class of medicines. Nevertheless, your doctor may prescribe this medicine 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 Tarbis to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You must 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 Tarbis. Also, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Escitalopram Tarbis in this age group have not yet been demonstrated.

Use of Escitalopram Tarbis with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or could use any other medicine.

DO NOT TAKE Escitalopram Tarbisif you are taking medicines for heart rhythm problems or if you are taking medicines that may affect the heart rhythm, such as antiarrhythmics Class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medicines, particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any other doubts, consult your doctor.

Tell 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 Tarbis. After finishing Escitalopram Tarbis, 7 days must pass before taking any of these medicines.
• "Reversible 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 adverse effects.
• The antibiotic linezolid.
• Lithium (used in the treatment of manic-depressive disorder) and tryptophan.
• Sumatriptan and similar medicines (used to treat migraines) and tramadol (used to treat severe pain). These increase the risk of adverse 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 blood levels of escitalopram.
• St. John's Wort (Hypericum perforatum) - a medicinal plant used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory medicines (medicines used to relieve pain or reduce the risk of thrombosis, also called anticoagulants).
• 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 Tarbis to ensure that the dose of anticoagulant is still adequate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression and as an aid to smoking cessation), and tramadol (used to treat severe pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines used to treat schizophrenia, psychosis) due to the possible risk of lowering the seizure threshold and antidepressants.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), desipramine, clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). It may be necessary to adjust the dose of Escitalopram Tarbis.
• Medicines that prolong the so-called 'QT interval' or medicines that reduce blood levels of potassium or magnesium. Consult your doctor regarding these medicines.

Taking Escitalopram Tarbis with food, drinks, and alcohol

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

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

Pregnancy, breastfeeding, and fertility

Pregnancy

If you take escitalopram 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 to advise you.

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.

Make sure your midwife and/or doctor know that you are being treated with escitalopram. During pregnancy, particularly in the last 3 months of pregnancy, medicines like escitalopram may increase the risk of a serious disease 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 the baby is born. If this happens to your baby, you must contact your midwife and/or doctor immediately.

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

If Escitalopram Tarbis is used during pregnancy, it should never be stopped abruptly.

Breastfeeding

Do not take Escitalopram Tarbis if you are breastfeeding unless you and your doctor have analyzed the risks and benefits involved.

Consult your doctor or pharmacist before using any medicine.

Fertility

It has been shown that citalopram, a medicine in the same group as escitalopram, can reduce sperm quality in animal studies. In theory, this could affect fertility, but so far, no effect on human fertility has been observed.

Driving and using machines

This medicine may greatly alter reaction times, even if used as indicated, so as to impair the ability to drive or use machines. Do not drive or use machines until you know how Escitalopram Tarbis may affect you.

Escitalopram Tarbis contains sodium

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

3. How to Take Escitalopram Tarbis

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

Adults

To Treat Depression

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

To Treat Anxiety Disorders with or without Agoraphobia

The initial dose of Escitalopram Tarbis 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.

To Treat Social Anxiety Disorder (Social Phobia)

The recommended dose of Escitalopram Tarbis 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.

To Treat Obsessive-Compulsive Disorders (OCD)

The normally recommended dose of Escitalopram Tarbis 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. In long-term treatments, the benefits of the treatment should be regularly checked.

Elderly Patients (Over 65 Years Old)

The normally recommended initial dose of Escitalopram Tarbis is 5 mg taken as a single dose per day. Your doctor may increase this dose up to 10 mg per day.

The efficacy of Escitalopram Tarbis has not been studied in social anxiety disorder (social phobia) in elderly patients.

Patient with Liver Function Problems

The recommended initial dose of Escitalopram Tarbis for patients with altered liver function should not exceed 5 mg per day for the first 14 days. According to your response, your doctor may increase the daily dose up to 10 mg per day. Caution and special care should be taken when setting the dose in patients with severe liver function alteration.

Patient with Kidney Function Problems

No dose adjustment is necessary in cases of mild or moderate kidney function alteration. Caution should be taken in patients with severe kidney function alteration.

Children and Adolescents (Under 18 Years Old)

Escitalopram Tarbis should not normally be administered to children and adolescents. For additional information, please see section 2 "Before Taking Escitalopram Tarbis".

Take the film-coated tablets once a day, swallowing them whole with a sufficient amount of liquid (preferably a glass of water). Escitalopram Tarbis can be taken with or without food.

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

Duration of Treatment

It may take a couple of weeks before you start to feel better. Continue taking Escitalopram Tarbis 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 Tarbis 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 Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The signs of overdose may be dizziness, tremors, agitation, numbness, loss of consciousness, changes in heart rhythm, seizures, hypoventilation, muscle weakness, pain or sensitivity, and a feeling of discomfort or elevated temperature (rhabdomyolysis), changes in body hydro-saline balance, vomiting, and a feeling of dizziness.

If You Forget to Take Escitalopram Tarbis

Do not take a double dose to make up for forgotten doses. If you forget to take a dose of Escitalopram Tarbis, take the next dose at your usual time.

If You Interrupt Treatment with Escitalopram Tarbis

If you want to interrupt the treatment, discuss it with your doctor first, who will take the appropriate measures. Do not interrupt taking the medication on your own initiative without first discussing it with your doctor. To finish the treatment with Escitalopram Tarbis, your doctor will gradually reduce the dose over several weeks or months. This will help reduce the possibility of withdrawal effects.

When you stop taking Escitalopram Tarbis, 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 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, please contact your doctor. They may ask you to start taking your tablets again and stop them more slowly.

The 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 dizziness (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.

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

4. Possible Adverse Effects

Like all medications, Escitalopram Tarbis may produce adverse effects, although not all people suffer from them.

Adverse effects usually occur in the first or second week of treatment, becoming less frequent and less severe in the continuation of treatment.

Visit your doctor if you have any of the following adverse effects during treatment:

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

• Unusual bleeding, including gastrointestinal bleeding.

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

• If you notice swelling/inflammation of the skin, tongue, lips, or face, or have difficulty breathing or swallowing (allergic reaction), contact your doctor or go to the hospital immediately.
• If you have a high fever, agitation, confusion, tremors, and sudden muscle contractions, they may be signs of a rare condition called serotonin syndrome.

If you experience the following adverse effects, you should contact your doctor or go to the hospital immediately:

• Difficulty urinating.
• Seizures (attacks).
• Yellowish skin and whites of the eyes, signs of liver function alteration/hepatitis.
• Rapid, irregular heartbeats, fainting, symptoms of a life-threatening disorder known as Torsade de Pointes.

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

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

• Feeling dizzy (nausea)
• Headache

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

• Generalized fear, restlessness, abnormal dreams, difficulty falling asleep, feeling drowsy, a sensation on the skin like burning, pinching, itching, or tingling without an apparent physical cause, tremors, yawning.
• Sexual problems (delayed ejaculation, erection problems, reduced sexual desire, and women may experience difficulties in reaching orgasm).
• Diarrhea, constipation, vomiting, dry mouth.
• Stuffy or runny nose (sinusitis).
• Increased sweating.
• Feeling of fatigue, fever.
• Muscle and joint pain.
• Weight gain.
• Increased or decreased appetite.

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

• Involuntary grinding of teeth, agitation, nervousness, anxiety attacks, confusion.
• Alterations in taste, sleep disturbances, fainting.
• Nosebleeds.
• Alteration of vaginal bleeding not associated with menstruation, increased menstrual flow.
• Hives, skin rash, itching (pruritus).
• Hair loss.
• Swelling of arms and legs.
• Pupil dilation (mydriasis), visual disturbance, ringing in the ears (tinnitus).
• Rapid heartbeat (tachycardia).
• Weight loss.

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

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

Some patients have reported with unknown frequency (the frequency cannot be estimated from the available data):

• Thoughts of self-harm or suicidal thoughts, see also the section "Be especially careful with Escitalopram Tarbis.
• Mania-
• Movement disorders (involuntary muscle movements).
• Milk flow in non-lactating women.
• Painful erections.
• Coagulation disorders including skin and mucous membrane bleeding (ecchymosis) and low platelet levels in the blood (thrombocytopenia).
• Dizziness when standing up due to low blood pressure (orthostatic hypotension).
• Decrease in sodium levels in the blood (symptoms are dizziness and discomfort with muscle weakness or confusion).
• Increased urine excretion (inadequate ADH secretion).
• Altered liver function tests (increased liver enzymes in the blood).
• Sudden swelling of the skin or mucous membranes (angioedema).
• Suicidal actions.
• Inability to remain seated or still, feeling of restlessness associated with the need to be constantly moving*
• Anorexia*.
• An increased risk of bone fractures has been observed in patients taking 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.

• These adverse effects have been reported with medications that work similarly to escitalopram (the active ingredient of Escitalopram Tarbis).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Medications: https://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

Keep this medication out of sight and reach of children.

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

Do not store at a temperature above 25°C.

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

6. Package Contents and Additional Information

Composition of Escitalopram Tarbis:

The active ingredient is escitalopram. Each film-coated tablet contains 10 mg of escitalopram (as oxalate).

The other components are: tablet core: microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, talc, magnesium stearate, coating: hypromellose 6cP, titanium dioxide (E 171), macrogol 6000.

Appearance of the Product and Package Contents

Escitalopram Tarbis 10 mg is presented in the form of white, oval (6.4 x 9.25 mm diameter), biconvex film-coated tablets, with a score line on one face and marked with the letter "E" on each side of the score line on the other face. The tablet can be divided into two equal halves.

Escitalopram Tarbis is available in blister packs of 14, 20, 28, 30, 50, 56, 60, 98, 100, and 200 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer

Actavis Ltd.

B16 Bulebel Industrial Estate

ZTN 08 Zejtun

Malta

or

Balkanpharma-Dupnitsa AD,

3 Samokovsko Shosse Str., Dupnitza 2600

Bulgaria.

This medication is authorized in the member states of the European Economic Area with the following names:

Date of the Last Revision of this Prospectus: December 2020

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