Escitalopram Tarbis 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Escitalopram Tarbis 10 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Escitalopram Tarbis is an antidepressant that belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain by increasing the level of serotonin. Disturbances 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).
• Panic disorder with or without agoraphobia (e.g. fear of leaving home, entering shops, being in crowds and public places).
• Social anxiety disorder (social phobia).
• Obsessive-compulsive disorder.

2. What you need to know before taking Escitalopram Tarbis

Do not take Escitalopram Tarbis

• if you are allergic to escitalopram or to any of the other ingredients of this medicine (listed in section 6),
• if you are taking other medicines belonging to the group called monoamine oxidase inhibitors (MAO inhibitors), including selegiline (used for the treatment of Parkinson's disease), moclobemide (used for the treatment of depression), and linezolid (an antibiotic),
• if you have had a congenital heart rhythm disorder or have ever experienced an episode of such a disorder (this is detected by ECG; a test used to assess heart function),
• if you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm (see section 2 “Use with other medicines”).

Warnings and precautions

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

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

• If you have epilepsy. Treatment with Escitalopram Tarbis should be discontinued if you experience seizures for the first time or notice 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 Escitalopram Tarbis may affect blood glucose control. Adjustment of insulin and/or oral hypoglycemic agent dosage may be necessary.
• If you have low sodium levels in the blood.
• If you have low potassium or magnesium levels 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 artery disease.
• If you have or have had heart problems or have recently had a heart attack.
• If you or your family have the heart condition known as ‘QT prolongation’.
• If your resting heart rate is slow (this is known as bradycardia) and/or you know you may have low salt levels due to severe and prolonged diarrhea and vomiting or because you have used diuretics (medicines for urination).
• If you experience rapid or irregular heartbeats, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm.
• If you have narrow-angle glaucoma or a history of glaucoma.

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

Please note:

Some patients with bipolar disorder may enter a manic phase. This is characterized by unusually rapid and frequent changes in thoughts, excessive happiness, and excessive physical activity. If you experience this, contact your doctor.

Symptoms such as restlessness or difficulty sitting or standing still (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 depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may occasionally have thoughts about harming or killing yourself. These thoughts may increase when starting antidepressants, as all such medicines require time to take effect—usually about two weeks, although in some cases it may take longer.

You are more likely to have such thoughts:

• If you have previously had suicidal thoughts or thoughts of self-harm.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in patients under 25 years of age with psychiatric disorders treated with an antidepressant.

If at any time you have thoughts of harming yourself or of suicide, contact your doctor or go directly to a hospital.

It may be helpful for you 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 may ask them whether 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 of age)

Escitalopram should not normally be used to treat children and adolescents under 18 years of age. You should also be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe this medicine to patients under 18 years of age if they decide it is in the patient’s best interest. If your doctor has prescribed Escitalopram Tarbis to a patient under 18 years of age and you wish to discuss this decision, please contact your doctor again. You must inform your doctor if any of the symptoms described above worsen or complications arise while patients under 18 years of age are taking Escitalopram Tarbis. In addition, the long-term effects on safety, as well as on growth, maturation, and cognitive and behavioral development of Escitalopram Tarbis in this age group have not yet been established.

Taking Escitalopram Tarbis with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

DO NOT TAKE Escitalopram Tarbis if you are taking medicines for heart rhythm disorders or medicines that may affect heart rhythm, such as Class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g., sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarials particularly halofantrine), and 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 (MAOIs)” containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine as active ingredients. If you have taken any of these medicines, you must wait 14 days before starting Escitalopram Tarbis. After stopping Escitalopram Tarbis, you must wait 7 days before taking any of these medicines.
• “Reversible selective MAO-A inhibitors” containing moclobemide (used in the treatment of depression).
• “Irreversible MAO-B inhibitors” containing selegiline (used in the treatment of Parkinson’s disease). These increase the risk of adverse effects.
• The antibiotic linezolid.
• Lithium (used in the treatment of bipolar disorder) and tryptophan.
• Sumatriptan and similar medicines (used for the treatment of migraine) and tramadol (used for severe pain). These increase the risk of adverse effects.
• Cimetidine, lansoprazole, and omeprazole (used for the treatment of stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may increase blood concentrations 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).
• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will likely monitor your blood clotting time at the beginning and end of treatment with Escitalopram Tarbis to ensure the anticoagulant dose remains appropriate.
• Mefloquine (used for the treatment of malaria), bupropion (used for the treatment of depression and as an aid to smoking cessation), and tramadol (used for the treatment of 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). The dose of Escitalopram Tarbis may need to be adjusted.
• Medicines that prolong the so-called ‘QT interval’ or medicines that reduce blood potassium or magnesium levels. Consult your doctor about 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, combining Escitalopram Tarbis with alcohol is not recommended, although an interaction between escitalopram and alcohol is not expected.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you take escitalopram in the late 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 be aware 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.

Ensure your midwife and/or doctor know you are being treated with escitalopram. During pregnancy, particularly in the last 3 months, 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 breathes rapidly and turns blue. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

If you take Escitalopram Tarbis during the last 3 months of pregnancy, be aware that the following effects may occur in the newborn baby: breathing difficulties, bluish skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, exaggerated reflexes, tremors, restlessness, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. If your newborn baby shows 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 while breastfeeding unless you and your doctor have discussed the risks and benefits involved.

Consult your doctor or pharmacist before using any medicine.

Fertility

Citalopram, a medicine in the same class as escitalopram, has been shown to reduce sperm quality in animal studies. In theory, this could affect fertility, but no effect on human fertility has been observed so far.

Driving and using machines

This medicine may substantially affect reaction times, even when used as directed, thus impairing your ability to drive or operate machinery. Do not drive or operate machinery until you know how Escitalopram Tarbis affects you.

Escitalopram Tarbis contains sodium

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

3. How to take Escitalopram Tarbis

Follow exactly the instructions for using this medicine as prescribed by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults

To treat depression

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

To treat panic disorders with or without agoraphobia

The initial dose of Escitalopram Tarbis is 5 mg as a single daily dose for the first week before increasing the dose to 10 mg per day. Your doctor may subsequently increase it 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 daily dose. Your doctor may reduce your dose to 5 mg per day or increase it up to a maximum of 20 mg per day, depending on how you respond to the medication.

To treat obsessive-compulsive disorder (OCD)

The normally recommended dose of Escitalopram Tarbis is 10 mg taken as a single daily dose. Your doctor may increase the dose up to a maximum of 20 mg per day. For long-term treatment, the benefits of therapy should be regularly assessed.

Elderly patients (over 65 years of age)

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

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

Patients with liver function impairment

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

Patients with kidney function impairment

Dose adjustment is not necessary in cases of mild or moderate kidney function impairment. Caution should be exercised in patients with severe kidney function impairment.

Children and adolescents (under 18 years of age)

Escitalopram Tarbis should normally not be administered to children and adolescents. For further information, please see section 2 “Before taking Escitalopram Tarbis”.

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

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

Duration of treatment

It may take a few 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 first speaking to your doctor.

Continue taking Escitalopram Tarbis for as long as your doctor recommends. If you stop treatment too early, symptoms may return. It is recommended that treatment continues for at least 6 months after you feel well again.

If you take more Escitalopram Tarbis than you should

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

Signs of overdose may include dizziness, tremor, agitation, drowsiness, loss of consciousness, changes in heart rhythm, seizures, hypoventilation, muscle weakness, pain or tenderness, feeling unwell or elevated body temperature (rhabdomyolysis), disturbances in the body's fluid and electrolyte balance, vomiting, and feeling nauseous.

If you forget to take Escitalopram Tarbis

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

If you stop taking Escitalopram Tarbis

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

When you stop taking Escitalopram Tarbis, especially if abruptly, you may experience withdrawal symptoms. These are common when escitalopram treatment is discontinued. 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 resolve on their own within two weeks. However, in some patients, they may be severe or prolonged (2–3 months or longer). If you experience severe withdrawal symptoms when stopping Escitalopram Tarbis, please contact your doctor. They may ask you to resume taking your tablets and taper them more slowly.

Withdrawal symptoms include: dizziness (feeling unsteady or off balance), tingling sensations, prickling sensations, and (less commonly) electric shock-like sensations, even in the head; sleep disturbances (vivid dreams, nightmares, inability to sleep); restlessness; headache; dizziness (nausea); sweating (including night sweats); feelings of uneasiness or agitation; tremor (shakiness); feelings of confusion or disorientation; emotional or irritable feelings; diarrhea (loose stools); visual disturbances; rapid pulse or palpitations.

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

4. Possible adverse effects

Like all medicines, Escitalopram Tarbis may cause adverse effects, although not everyone experiences them.

Adverse effects usually occur during the first or second week of treatment and then become less frequent and less severe as treatment continues.

Visit your doctor if you experience 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 hospital immediately.
• If you develop high fever, agitation, confusion, tremors, and sudden muscle contractions, these may be signs of a rare condition called serotonin syndrome.

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

• Difficulty urinating.
• Seizures (fits).
• Yellowing of the skin and whites of the eyes, which are signs of liver function impairment/hepatitis.
• Rapid or irregular heartbeat, fainting—symptoms of a potentially life-threatening condition 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 sick (nausea)
• Headache

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

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

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

• Involuntary teeth grinding, agitation, nervousness, panic attacks, state of confusion.
• Taste disturbances, sleep disorders, fainting.
• Nosebleeds.
• Abnormal vaginal bleeding not associated with menstruation, increased menstrual flow.
• Hives, skin rash, itching (pruritus).
• Hair loss.
• Swelling of arms and legs.
• Dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Fast heartbeat (tachycardia).
• Weight loss.

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

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

Some patients have reported the following adverse effects with frequency not known (frequency cannot be estimated from available data):

• Thoughts of harming yourself or suicidal thoughts—see section “Take special care with Escitalopram Tarbis.”

• Mania.

• Movement disorders (involuntary muscle movements).

• Milk production in women who are not breastfeeding.

• Painful erections.

• Bleeding disorders including skin and mucous membrane bleeding (ecchymosis) and low platelet levels in the blood (thrombocytopenia).

• Dizziness upon standing due to low blood pressure (orthostatic hypotension).

• Decreased sodium levels in the blood (symptoms include dizziness and malaise with muscle weakness or confusion).

• Increased urine output (inappropriate ADH secretion).

• Abnormal liver function tests (increased liver enzymes in the blood).

• Sudden swelling of the skin or mucous membranes (angioedema).

• Suicide-related behaviors.

• Inability to remain sitting or still, a feeling of restlessness associated with an urge to keep moving*

• Anorexia*.

• An increased risk of bone fractures has been observed in patients taking this type of medicine.

• Changes in heart rhythm (known as “prolongation of the QT interval,” seen on ECG, electrical activity of the heart).

• Heavy 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 medicines that work in a similar way to escitalopram (the active substance in 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 not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Escitalopram Tarbis

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

Do not use Escitalopram Tarbis after the expiry date stated on the blister strips after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of EscitalopramTarbis:

The active substance 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 contents of the pack

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

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

Only some pack 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 medicinal product is authorized in the European Economic Area member states under the following names:

Date of the latest review of this leaflet: December 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es