Escitalopram Tarbis Farma 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Escitalopram Tarbis Farma 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. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

This medicine contains the active substance escitalopram. Escitalopram belongs to a group of antidepressants 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.

This medicine is indicated for the treatment of depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder).

It may take a couple of weeks before you start to feel better. Continue taking this medicine even if it takes some time to notice improvement.

You should consult a doctor if you worsen or do not improve.

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

Do not take Escitalopram Tarbis Farma

• If you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).
• If you are taking other medicines belonging to the group known as 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 were born with or have experienced an episode of heart rhythm disorder (detected on an ECG, a test that evaluates heart function).
• If you are taking medicines for heart rhythm problems or that may affect heart rhythm (see section 2 “Other medicines and Escitalopram Tarbis Farma”).

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

Please inform your doctor if you have any other disorder or illness, as your doctor may need to take this into account. Specifically, inform your doctor:

• If you have epilepsy. Treatment with this medicine should be discontinued if you experience seizures for the first time or notice an increase in seizure frequency (see also section 4 “Possible side effects”).
• If you have hepatic or renal impairment. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with escitalopram 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 a history of bleeding disorders or develop unusual 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 previously had heart problems or have recently suffered a heart attack.
• If your resting heart rate is slow and/or you know you may have low levels of salt due to severe and prolonged diarrhea and vomiting (while ill) or use of diuretics.
• If you experience rapid or irregular heartbeats, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm.
• If you have or have previously had eye problems, such as certain types of glaucoma (increased pressure in the eye).

Please note:

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

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

Medicines like Escitalopram Tarbis Farma (also known as SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

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 of harming yourself or taking your own life. These thoughts may increase when starting antidepressants, as all these medicines require time to begin working—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 thoughts of harming or killing yourself.
• 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 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 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

This medicine should not normally be used to treat children and adolescents under 18 years of age. 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 escitalopram to patients under 18 years of age if they decide it is the most appropriate treatment for the patient. If your doctor has prescribed Escitalopram Tarbis Farma to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You should inform your doctor if any of the symptoms described above worsen or develop complications while patients under 18 years of age are taking escitalopram. In addition, the long-term effects on safety, growth, maturation, and cognitive and behavioral development of escitalopram in this age group have not yet been established.

Other medicines and Escitalopram Tarbis Farma

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

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 this medicine. After stopping this medicine, 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 side effects.
• The antibiotic linezolid.
• Lithium (used in the treatment of bipolar disorder) and tryptophan.
• Imipramine and desipramine (both used for the treatment of depression).
• Sumatriptan and similar medicines (used for the treatment of migraine) and tramadol (used for severe pain). These increase the risk of side effects.
• Cimetidine, lansoprazole, and omeprazole (used for the treatment of stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (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 called anticoagulants). These may increase the tendency to bleed.
• 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 this medicine to ensure the anticoagulant dose remains appropriate.
• Mefloquine (used for the treatment of malaria), bupropion (used for the treatment of depression), and tramadol (used for the treatment of severe pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines used for the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the seizure threshold.
• Flecainide, propafenone, and metoprolol (used for cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of this medicine may need to be adjusted.
• Medicines that reduce potassium or magnesium levels in the blood, as this increases the risk of life-threatening heart rhythm disturbances.

Do not take this medicine if you are taking medicines for heart rhythm problems or that may affect heart rhythm, e.g., Class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g., sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarial treatments particularly halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine). Contact your doctor for any further questions.

Taking Escitalopram Tarbis Farma with food, drinks, and alcohol

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

As with many medicines, combining Escitalopram Tarbis Farma with alcohol is not recommended, although no interaction between Escitalopram Tarbis Farma and alcohol is expected.

Pregnancy, breastfeeding, and fertility

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.

Do not take this medicine if you are pregnant or breastfeeding unless you and your doctor have discussed the risks and benefits involved.

If you take this medicine during the last 3 months of pregnancy, 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 sleep difficulties. If your newborn baby shows any of these symptoms, please contact your doctor immediately.

Ensure that your midwife and/or doctor know that you are being treated with this medicine.

During pregnancy, particularly in the last 3 months, medicines like this one may increase the risk of a serious condition in newborns called persistent pulmonary hypertension 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 they occur in your baby, contact your midwife and/or doctor immediately.

If you take this medicine in late 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 appropriately.

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

Escitalopram is expected to be excreted in breast milk.

Citalopram, a medicine similar to escitalopram, has been shown to reduce sperm quality in animal models. Theoretically, this effect could affect fertility, but to date, no impact on human fertility has been observed.

Driving and using machines

It is advised not to drive or operate machinery until you know how this medicine affects you.

Escitalopram Tarbis Farma contains Sodium

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

3. How to take Escitalopram Tarbis Farma

Follow exactly the instructions for use of this medicine as given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Adults

Depression

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

Panic disorder

The initial dose of escitalopram 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.

Social anxiety disorder 6 of 11

The normally recommended dose of escitalopram is 10 mg taken as a single daily dose. Your doctor may reduce 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 medicine.

Generalized anxiety disorder

The normally recommended dose of escitalopram 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.

Obsessive-compulsive disorder

The normally recommended dose of escitalopram 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.

Elderly patients (over 65 years of age)

The recommended initial dose of escitalopram is 5 mg taken as a single daily dose. The dose may be increased by your doctor up to 10 mg per day.

Use in children and adolescents

Escitalopram should not normally be given to children and adolescents. For further information, please see section 2 “Warnings and precautions”.

Renal impairment

Caution is advised in patients with severely reduced kidney function. Take as prescribed by your doctor.

Hepatic impairment

Patients with liver problems should not receive more than 10 mg per day. Take as

prescribed by your doctor.

Patients considered as poor metabolizers of CYP2C19

Patients with this known genotype should not receive more than 10 mg per day. Take as prescribed by your doctor.

How to take the tablets

You may take escitalopram with or without food. Swallow the tablets with water. Do not chew them, as they have a bitter taste.

Duration of treatment

It may take a few weeks before you start to feel better. Continue taking escitalopram even if you start to feel better before the expected time.

Do not change the dose of the medicine without first talking to your doctor.

Continue taking escitalopram 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 Farma than you should

If you take more escitalopram than prescribed, contact your doctor immediately, go to the nearest hospital emergency department, or call the Toxicology Information Service at 915.620.420. Do this even if you do not notice any discomfort or signs of poisoning.

Some of the signs of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rate, decreased blood pressure, and disturbances in the body's fluid and electrolyte balance. Bring the Escitalopram Tarbis Farma packaging if you go to the doctor or hospital.

If you forget to take Escitalopram Tarbis Farma

Do not take a double dose to make up for missed doses. If you forget to take a dose and remember before going to bed, take it immediately. The next day, continue as usual. If you remember during the night or the following day, skip the missed dose and continue as usual.

If you stop taking Escitalopram Tarbis Farma

Do not stop treatment with escitalopram until your doctor tells you to. When you have completed your course of treatment, it is generally recommended that the dose of escitalopram be gradually reduced over several weeks.

When you stop taking escitalopram, especially if abruptly, you may experience withdrawal symptoms. These are common when treatment with escitalopram is stopped. The risk is greater when Escitalopram Tarbis Farma 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 more). If you have severe withdrawal symptoms when stopping Escitalopram Tarbis Farma, please contact your doctor. He or she may ask you to restart taking your tablets and taper them 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; lightheadedness (nausea); sweating (including night sweats); feelings of unease or agitation; tremor (shakiness); feelings of confusion or disorientation; feelings of emotion or irritability; 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, this medicine can have adverse effects, although not everyone experiences them.

Adverse effects usually disappear after a few weeks of treatment. Please be aware that many of these effects may be symptoms of your illness and will therefore improve as you start to feel better.

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

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

• Unusual bleeding, including gastrointestinal bleeding.

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

• Swelling of the skin, tongue, lips, throat or face, hives, or difficulty breathing or swallowing (severe allergic reaction).
• High fever, agitation, confusion, tremors, and sudden muscle contractions, which may be signs of a rare condition called serotonin syndrome.

Not known (frequency cannot be determined from available data):

• Difficulty urinating.
• Seizures (fits); see also section “Warnings and precautions”.
• Yellowing of the skin and whites of the eyes, signs of liver function impairment / hepatitis.
• If you experience fast or irregular heartbeats or fainting, symptoms which may indicate a life-threatening condition known as Torsade de Pointes.
• Thoughts of harming yourself or thoughts of killing yourself; see also section “Warnings and precautions”.
• Sudden swelling of the skin or mucous membranes (angioedema).

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

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

• Feeling sick (nausea).
• Headache.

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

• Nasal congestion or mucus (sinusitis).
• Decreased or increased appetite.
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, skin itching.
• Diarrhoea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual disturbances (delayed ejaculation, problems with erection, decreased sexual activity, and women may experience difficulty reaching orgasm).
• Fatigue, fever.
• Weight gain.

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

• Hives, skin rash, itching (pruritus).
• Teeth grinding, restlessness, nervousness, panic attacks, confusion.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Hair loss.
• Excessive menstrual bleeding.
• Irregular menstrual periods.
• Weight loss.
• Fast heart rate.
• Swelling of arms and legs.
• Nosebleeds.

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

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

Not known (frequency cannot be determined from available data):

• Decreased levels of sodium in the blood (symptoms include dizziness and malaise with muscle weakness or confusion).
• Dizziness upon standing due to low blood pressure (orthostatic hypotension).
• Abnormal liver function tests (increased liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Signs of abnormal bleeding, e.g. of the skin or mucous membranes (bruising).
• Increased secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, reducing sodium levels (inappropriate ADH secretion).
• Milk flow in men and in women who are not breastfeeding.
• Mania.
• An increased risk of bone fractures has been observed in patients treated with this type of medicine.
• Changes in heart rhythm (called “prolongation of the QT interval”, seen on ECG, the heart's electrical activity).
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for more information.

Other adverse effects are known with medicines that work in a similar way to escitalopram (the active substance in Escitalopram Tarbis Farma). These include:

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, 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 website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Escitalopram Tarbis Farma

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

Do not use this medicine after the expiry date stated on the blister after EXP. The expiry date is the last day of the month indicated.

Store below 30 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Escitalopram Tarbis Farma

The active substance is escitalopram.

Each tablet of Escitalopram Tarbis Farma contains 20 mg of escitalopram (as oxalate).

The other components are:

Core: Microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, talc, and magnesium stearate.

Coating: Titanium dioxide (E171), hypromellose, macrogol 400 (E1521), and polysorbate 80 (E433).

Appearance of the product and contents of the pack

Film-coated tablets, white to off-white, oval-shaped, scored, biconvex, marked with "J" on one side and "4" on the other. Approximate dimensions: 11.40 x 6.90 mm.

The tablets may be divided into equal doses.

Blister packs: 28 and 56 film-coated tablets.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

The Netherlands

Date of the most recent revision of this leaflet: May 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es/