Escitalopram Tarbis 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Escitalopram Tarbis 20 mg film-coated tablets EFG

Read the entire 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 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. It could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects 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 called 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 or 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 known as monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic),
• if you have had from birth a certain type of heart rhythm disorder or have ever experienced an episode of this kind (this is observed with ECG; a test used to assess how the heart functions),
• 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. In particular, 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 alter 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 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 artery disease.
• If you have or have had heart problems or have recently suffered 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 reduced salt levels due to severe and prolonged diarrhea and vomiting or due to use of diuretics (medicines for urination).
• If you experience rapid or irregular heartbeats, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm function.
• If you have closed-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 unusual and rapid thought changes, disproportionate 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 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 have an anxiety disorder, you may occasionally have thoughts of harming yourself or taking your own life. These may increase when starting antidepressants, as all such medicines require time to begin working—usually about two weeks, although in some cases it may take longer.

You may be 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 psychiatric patients under 25 years of age 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 close family member or 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 know 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 appropriate. If your doctor 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 should inform your doctor if any of the symptoms described above worsen or become complicated while patients under 18 years of age are taking Escitalopram Tarbis. In addition, the long-term effects on safety, 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

Tell 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), certain antihistamines (astemizole, mizolastine). If you have any further questions, 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 to treat depression).
• “Irreversible MAO-B inhibitors” containing selegiline (used to treat Parkinson’s disease). These increase the risk of adverse effects.
• The antibiotic linezolid.
• Lithium (used to treat bipolar disorder) and tryptophan.
• Sumatriptan and similar medicines (used to treat migraine) and tramadol (used for 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 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 known as anticoagulants).
• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also known as 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 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 for 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 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, combining Escitalopram Tarbis with alcohol is not recommended, although escitalopram is not expected to interact with alcohol.

Pregnancy, breastfeeding, and fertility

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.

Pregnancy

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 knows 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 occurs in 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, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, exaggerated reflexes, tremors, restlessness, irritability, lethargy, constant crying, sleepiness, 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 in animal studies to reduce sperm quality. In theory, this could affect fertility, but no effect on human fertility has been observed so far.

Driving and using machines

This medicine may significantly affect reaction times, even when used as directed, thereby 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; hence, it is essentially “sodium-free”.

3. How to take Escitalopram Tarbis

Follow exactly the instructions for use of this medicine as given 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 your response 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. The dose may be increased by your doctor up to a maximum of 20 mg per day. For long-term treatment, the benefits of therapy should be regularly reviewed.

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 impaired liver function

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 per day. Caution and special care should be taken when determining the dose in patients with severe impairment of liver function.

Patients with impaired kidney function

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

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, you may split the tablets by placing the tablet on a flat surface with the score facing upwards. The tablets can be broken 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 begin to feel better before the expected time. Do not change the dose of the medicine without first speaking to your doctor.

Continue taking Escitalopram Tarbis for the length of time recommended by your doctor. 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, numbness, 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 water 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 medicine 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 likelihood 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 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 more). If you experience severe withdrawal symptoms after stopping Escitalopram Tarbis, please contact your doctor. They may advise you to restart taking your tablets and taper off more slowly.

Withdrawal symptoms include: Dizziness (feeling unsteady or off-balance), tingling sensations, burning sensations, and (less frequently) 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 unease 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 produce 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 the hospital immediately.
• If you have high fever, agitation, confusion, tremors, and sudden muscle contractions, these may be signs of a rare condition called serotonin syndrome.

If you experience the following adverse effects, you must contact your doctor or go to the 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 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 skin sensation such as burning, tingling, itching, or pins and needles without an apparent physical cause, tremors, yawning.
• Sexual problems (delayed ejaculation, erectile difficulties, reduced sexual desire, and women may experience difficulty achieving orgasm).
• Diarrhea, constipation, vomiting, dry mouth.
• Stuffy nose or nasal discharge (sinusitis).
• Increased sweating.
• Feeling of tiredness (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, confusion.
• Taste disturbances, sleep disturbances, fainting.
• Nosebleeds.
• 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 unknown frequency (frequency cannot be estimated from available data):

• Thoughts of self-harm or suicidal thoughts—see also section “Take special care with Escitalopram Tarbis.”

• Mania.

• Movement disorders (involuntary muscle movements).

• Milk discharge in women who are not breastfeeding.

• Painful erections.

• Bleeding disorders including skin and mucosal bleeding (bruising) and low platelet counts in the blood (thrombocytopenia).

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

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

• Increased urine output (inappropriate ADH secretion).

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

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

• Suicide-related behaviors.

• Inability to remain seated or still, feeling restless with an urge to keep moving*.

• Anorexia*.

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

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

• 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 act similarly to escitalopram (the active substance in Escitalopram Tarbis).

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may 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 unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers 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 20 mg of escitalopram (as oxalate).

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

Appearance of the product and pack contents

Escitalopram Tarbis 20 mg is presented as white, oval-shaped (8 x 11.7 mm diameter), biconvex, film-coated tablets, with a score line on one side and marked with the letter “E” on each side of the score 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 certain 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 most recent review of this leaflet: December 2020

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