Package Insert: Information for the User

EscitalopramTarbis 10 mg Film-Coated Tablets

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 refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even 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.

EscitalopramTarbisis an antidepressant that belongs to the group of drugs 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.

EscitalopramTarbisis used to treat:

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

Do not take EscitalopramTarbis

• if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6),
• if you are taking other medicines that belong to the group 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 a heart rhythm disorder from birth or have ever had an episode of this type (this is observed with an ECG; a test that evaluates how the heart works),
• if you are taking medicines for heart rhythm problems or that can affect the heart rhythm (see section 2 “Use of other medicines”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take EscitalopramTarbis

Please inform your doctor if you have any of the following conditions or diseases, as your doctor may need to take them into account. In particular, inform your doctor:

• If you have epilepsy. Treatment with EscitalopramTarbisshould be interrupted if seizures occur for the first time or if you observe an increase in seizure frequency (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 EscitalopramTarbismay affect blood sugar control. You may need to adjust your dose of insulin and/or oral hypoglycemic.
• If you have low sodium levels in your blood.
• If you have low levels of potassium or magnesium in your blood (hypokalemia/hypomagnesemia)
• If you are prone to 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 or have had any heart problems or have recently had a heart attack.
• If you or your family has a heart condition called “prolongation-QT”.
• If your resting heart rate is slow (this is known as bradycardia) and/or you know that you may have low sodium levels 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, dizziness, fainting, or dizziness when standing up, which may indicate abnormal heart rhythm.
• If you have glaucoma with closed angle or a history of glaucoma.

Some medicines in the group to which Escitalopram Tarbis belongs (called ISRS/IRSN) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Please note:

Some patients with manic-depressive illness may enter a manic phase. This is characterized by 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 (akathisia) may also occur during the first weeks of treatment. Inform your doctor immediately if you experience these symptoms.

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 thoughts 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 take longer.

You are more likely to have these thoughts:

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. Clinical trial information 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 friend that 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 (under 18 years)

Escitalopram should not be used normally in the treatment of children and adolescents under 18 years old. You should also know that in patients under 18 years old, there is a higher risk of adverse effects such as suicidal thoughts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. However, your doctor may prescribe this medicine to patients under 18 years old when they decide it is best for the patient. If the doctor who prescribed EscitalopramTarbisto a patient under 18 years old 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 EscitalopramTarbis. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of EscitalopramTarbisin this age group have not yet been demonstrated.

Use of EscitalopramTarbiswith other medicines

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

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

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

• “Non-selective monoamine oxidase inhibitors (IMAOs)”, containing 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 EscitalopramTarbis. After finishing EscitalopramTarbis, there should be a 7-day wait before taking any of these medicines.
• “Reversible MAO-A inhibitors”, containing moclobemide (used to treat depression).
• “Irreversible MAO-B inhibitors”, containing selegiline (used to treat Parkinson's disease). These increase the risk of adverse effects.
• Linezolid (an antibiotic).
• Lithium (used to treat 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 (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 to treat depression.
• Aspirin and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or to reduce the risk of thrombosis, also called anticoagulants).
• Warfarin, dipiridamol, 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 EscitalopramTarbis, to check that the anticoagulant dose is still adequate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression and as a smoking cessation aid) and tramadol (used to treat severe pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines used to treat schizophrenia and 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). You may need to adjust your dose of EscitalopramTarbis.
• Medicines that prolong the so-called “QT interval” or medicines that reduce blood levels of potassium or magnesium. Consult your doctor about these medicines.

Taking EscitalopramTarbiswith food, drinks, and alcohol

EscitalopramTarbiscan be taken with or without food (see section 3 “How to take EscitalopramTarbis”).

As with many medicines, it is not recommended to combine EscitalopramTarbisand alcohol, although it is not expected to interact with alcohol.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you take escitalopram 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 so they can 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 surethat 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 condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathesrapidlyand turns blue.These symptoms usually start within the first 24 hours after the baby is born. If this happens to your baby, contact your midwife and/or doctor immediately.

If you take EscitalopramTarbisin 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 baby has any of these symptoms, please contact your doctor immediately.

Do not stop taking EscitalopramTarbisbrusquely.

Lactation

Do not take EscitalopramTarbisif 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 operating machinery

This medicine can significantly affect reaction times, even if used as directed, so it may impair your ability to drive or operate machinery. Do not drive or operate machinery until you know how EscitalopramTarbisaffects you.

Escitalopram Tarbis contains sodium

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

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

Adults

For treating 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.

For treating 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 further up to a maximum of 20 mg per day.

For treating 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.

For treating obsessive-compulsive disorder (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 treatment should be regularly checked.

Older patients (over 65 years)

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.

Escitalopram Tarbis has not been studied in patients with social anxiety disorder (social phobia) in older patients.

Patients 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 in setting the dose in patients with severe liver function alteration.

Patients 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)

Escitalopram Tarbis should not normally be administered to children and adolescents. For additional information, please see the 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 break the tablets by placing the tablet on a flat surface with the notch 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.

Treatment duration

You may feel better in a couple of weeks. Continue taking Escitalopram Tarbis 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 Tarbis for the recommended time by your doctor. If you interrupt the 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 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, tremor, agitation, numbness, loss of consciousness, changes in heart rate, seizures, hyperventilation, muscle weakness, pain or sensitivity, and a feeling of discomfort or elevated temperature (rhabdomyolysis), changes in the body's electrolyte balance, vomiting, and a feeling of dizziness.

If you forget to take Escitalopram Tarbis

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

If you interrupt the treatment with Escitalopram Tarbis

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

When you stop taking Escitalopram Tarbis, especially if you stop it abruptly, you may experience withdrawal symptoms. These are common when escitalopram treatment is suspended. The risk is higher when Escitalopram Tarbis 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, please contact your doctor. They may ask you to take your tablets again and taper off them more slowly.

Withdrawal symptoms include: Dizziness (unstable or loss of balance), tingling, prickling, and (less frequently) electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, dizziness (nausea), sweating (including nocturnal sweating), feeling of anxiety or agitation, tremor (instability), feeling of confusion or disorientation, feelings of emotion or irritability, diarrhea (loose stools), visual disturbances, rapid heartbeat or palpitations.

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

Like all medicines, Escitalopram Tarbiscan cause side effects, although not everyone will experience them.

Side effects usually occur in the first or second week of treatment, becoming less frequent and less severe as treatment continues.

Visit your doctor if you experience any of the following side effects during treatment:

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

• Unusual bleeding, including gastrointestinal bleeding

Uncommon (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 high fever, agitation, confusion, tremors, and sudden muscle contractions, they may be signs of a rare condition called serotonin syndrome.

Seek immediate medical attention if you experience the following side effects:

• Difficulty urinating.
• Seizures (convulsions).
• Yellowing of the skin and eyes, which are signs of liver dysfunction/hepatitis.
• Fast, irregular heartbeats, dizziness, symptoms of a life-threatening condition known as Torsade de Pointes.

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 up to 1 in 10 patients):

• Generalized anxiety, restlessness, abnormal dreams, difficulty falling asleep, feeling drowsy, a sensation of burning, itching, or tingling without a physical cause, tremors, yawning.
• Sexual problems (delayed ejaculation, erectile dysfunction, reduced libido, and women may experience difficulty reaching orgasm).
• Diarrhea, constipation, vomiting, dry mouth.
• Blocked nose or nasal discharge (sinusitis).
• Increased sweating.
• Feeling tired (fatigue), fever.
• Muscle and joint pain.
• Weight gain.
• Increased or decreased appetite.

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

• Unintentional grinding of teeth, agitation, nervousness, anxiety attacks, state of confusion.
• Alterations in taste, sleep disturbances, fainting.
• Nasal bleeding.
• Alteration of vaginal bleeding not associated with menstruation, increased menstrual flow.
• Hives, skin rash, itching (pruritus).
• Hair loss.
• Inflammation of arms and legs.
• Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Fast heart rate (tachycardia).
• Weight loss.

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

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

Some patients have reported the following side effects with unknown frequency (frequency cannot be estimated from 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 women who are not breastfeeding.
• Painful erections.
• Blood clotting disorders, including skin and mucous membrane bleeding (ecchymosis) and low platelet count in the blood (thrombocytopenia).
• Dizziness when standing due to low blood pressure (orthostatic hypotension).
• Decreased sodium levels in the blood (symptoms are feeling dizzy and feeling unwell with muscle weakness or confusion).
• Increased urine production (inadequate ADH secretion).
• Abnormal liver function tests (elevated liver enzymes in the blood).
• Sudden swelling of the skin or mucous membranes (angioedema).
• Actions related to suicide.
• Inability to remain seated or still, feeling of restlessness associated with the need to be constantly in motion*
• Anorexia*.
• An increased risk of bone fractures has been observed in patients taking this type of medication.
• Alteration of heart rhythm (known as “prolongation of the QT interval”, observed on the ECG, heart electrical activity).
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy, breastfeeding, and fertility” in section 2 for more information.

* These side effects have been reported with medications that act similarly to escitalopram (the active ingredient in Escitalopram Tarbis).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible 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:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the 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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE 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 EscitalopramTarbis:

The active ingredient isescitalopram. 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,andmagnesium stearate,coating:hypromellose 6cP, titanium dioxide (E 171), macrogol 6000.

Appearance of the product and content of the container

EscitalopramTarbis10 mg is presented in the form of film-coated tablets, white in color, oval (diameter 6.4 x 9.25 mm), biconvex, with a notch on one face and marked with the letter “E” on each side of the notch on the other face. The tablet can be divided into two equal halves.

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

Only some sizes of packaging may be commercially marketed.

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028Barcelona(Spain)

Responsible for Manufacturing

Actavis Ltd.

B16 Bulebel Industrial Estate

ZTN 08 Zejtun

Malta

or

Balkanpharma-Dupnitsa AD,

3 Samokovsko Shosse Str., Dupnitza2600

Bulgaria.

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

Last review date of this leaflet: December 2020

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