Escitalopram Mabo 15 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Escitalopram Mabo 15mg 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it 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 Mabo is and what it is used for
2. What you need to know before taking Escitalopram Mabo
3. How to take Escitalopram Mabo
4. Possible side effects
5. How to store Escitalopram Mabo
6. Contents of the pack and other information

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

Escitalopram Mabo 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.

Escitalopram 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 Escitalopram Mabo even if it takes some time to notice improvement.

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

2. What you need to know before taking Escitalopram MABO

Do not take Escitalopram Mabo if:

• You are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).

• 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).

• You have been born with or have experienced an episode of heart rhythm disorder (detected on an ECG, a test that evaluates heart function).

• You are taking medicines for heart rhythm problems or that may affect heart rhythm (see section 2 “Use of Escitalopram Mabo with other medicines”).

Warnings and precautions

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

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

• If you have epilepsy. Treatment with Escitalopram Mabo should be discontinued if you experience seizures for the first time or notice an increase in the frequency of seizures (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 Mabo may alter glycaemic control. A dose adjustment of insulin and/or oral hypoglycaemic agents may be necessary.

• If you have low sodium levels in the blood.

• If you are prone to bleeding or bruising easily, 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 your resting heart rate is slow and/or you know you may have low levels of salts due to severe and prolonged diarrhoea and vomiting (being unwell) 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).

Some medicines in the same group as Escitalopram Mabo (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 characterised 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 may also occur during the first few weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Medicines like Escitalopram MABO (also called 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 about harming or killing yourself. These may increase when starting antidepressants, as all such medicines take time to begin working—usually about two weeks, although in some cases longer. You are more likely to have such thoughts:

• If you have previously had thoughts of killing or harming yourself.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour 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 help to inform 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 behaviour.

Children and adolescents

Escitalopram Mabo should not normally be used in the treatment of children and adolescents under 18 years of age. Also, you should 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 behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Escitalopram Mabo to patients under 18 years of age if they decide it is appropriate. If your doctor has prescribed Escitalopram Mabo 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 above-mentioned symptoms worsen or complications arise while patients under 18 years of age are taking Escitalopram Mabo. In addition, the long-term effects on safety, growth, maturation, and cognitive and behavioural development of Escitalopram Mabo in this age group have not yet been fully established.

Use of Escitalopram Mabo with other medicines

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

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

• "Non-selective monoamine oxidase inhibitors (MAOIs)" containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranilcipromine as active ingredients. If you have taken any of these medicines, you must wait 14 days before starting Escitalopram Mabo. After stopping Escitalopram Mabo, 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, dipiridamol, 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 Mabo 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 in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of Escitalopram Mabo may need to be adjusted.
• Medicines that reduce blood potassium or magnesium levels, as this increases the risk of life-threatening heart rhythm disturbances.

Do not take Escitalopram Mabo 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, mizolastine). Contact your doctor for any further questions.

Taking Escitalopram Mabo with food, drinks and alcohol

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

As with many medicines, combining Escitalopram Mabo with alcohol is not recommended, although no interaction between Escitalopram MABO 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 Escitalopram Mabo if you are pregnant or breastfeeding unless you and your doctor have discussed the risks and benefits involved.

If you take Escitalopram Mabo 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 sleep difficulties. If your newborn baby shows any of these symptoms, please contact your doctor immediately.

Ensure that your midwife and/or doctor know you are being treated with Escitalopram Mabo.

During pregnancy, particularly in the last 3 months, medicines like Escitalopram Mabo 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 appears 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 escitalopram late in 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 Escitalopram Mabo is used during pregnancy, it should never be stopped abruptly.

Escitalopram Mabo 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 use of machines

It is advised not to drive or operate machinery until you know how Escitalopram Mabo affects you.

Escitalopram Mabo contains sodium

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

3. How to take Escitalopram Mabo

Follow exactly your doctor's instructions for taking this medicine. 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 starting 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

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 it up to a maximum of 20 mg per day, depending on your response to the medication.

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.

Children and adolescents

Escitalopram should not be given to children and adolescents. For further information, please see section 2, "What you need to know before taking Escitalopram MABO".

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 slow metabolizers of CYP2C19

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

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

If necessary, you may split the tablets in half to help swallow them, placing them on a flat surface with the score line facing upwards. The tablets can be broken by pressing down on each end of the tablet with your index fingers.

Duration of treatment

It may take a couple of weeks before you start to feel better. Continue taking escitalopram even if you start to feel better earlier than expected.

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

Continue taking escitalopram 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 Mabo 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 91 562 04 20. 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, low blood pressure, and disturbances in the body's fluid and electrolyte balance. Take the escitalopram packaging with you if you go to the doctor or hospital.

If you forget to take Escitalopram Mabo

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 Mabo

Do not stop treatment with escitalopram unless 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 stopped abruptly, you may experience withdrawal symptoms. These are common when treatment with escitalopram is discontinued. The risk is higher when escitalopram 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 Mabo, please contact your doctor. He or she may ask you to resume taking your tablets and taper them more slowly.

Withdrawal symptoms include: dizziness (unsteadiness or loss of balance), tingling sensations, burning sensations, and (less frequently) electric shock-like sensations, even in the head; sleep disturbances (overly 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 lability or irritability; diarrhea (loose stools); visual disturbances; rapid pulse or palpitations.

If you have any further questions about using this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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, or face, 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 estimated from available data):

• Difficulty urinating.
• Seizures (fits); see also section “Warnings and precautions”.
• Yellowing of the skin and whites of the eyes (jaundice), signs of liver dysfunction/hepatitis.
• Rapid or irregular heartbeat, or fainting, symptoms that may indicate a life-threatening condition known as Torsade de Pointes.
• Thoughts of harming yourself or thoughts of suicide; 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 nauseous (nausea).
• Headache.

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

• Nasal congestion or runny nose (sinusitis).

• Decreased or increased appetite.

• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, skin itching.

• Diarrhea, constipation, vomiting, dry mouth.

• Increased sweating.

• Muscle and joint pain (arthralgia and myalgia).

• Sexual disturbances (delayed ejaculation, erectile problems, reduced sexual drive; women may experience difficulty achieving 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 heartbeat.
• Swelling of arms and legs.
• Nosebleeds.

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

• Aggression, depersonalization, hallucinations.
• Slow heartbeat.

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

• Decreased levels of sodium in the blood (symptoms include dizziness, malaise, 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 increased bleeding, e.g., bruising of the skin or mucous membranes (ecchymosis).
• Increased secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, leading to reduced sodium levels (inappropriate ADH secretion).
• Milk production 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 (known as “prolongation of the QT interval”, 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.

Other adverse effects are known to occur with drugs that act similarly to escitalopram. These include:

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

Reporting of adverse effects

If you experience any 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 Mabo

Keep out of sight and reach of children.

Store below 30°C. Keep in the original packaging to protect from light and moisture.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Escitalopram Mabo 15 mg film-coated tablets

• The active substance is escitalopram (as oxalate). Each tablet contains 15 mg of escitalopram.
• The other components are: microcrystalline cellulose, colloidal anhydrous silica, sodium croscarmellose, stearic acid, magnesium stearate, hypromellose (E464), titanium dioxide (E171) and macrogol 400.

Appearance of the product and contents of the pack

Escitalopram Mabo 15 mg are biconvex, white, film-coated, scored tablets, marked on one side with an "S" (on the left side of the score) and a "C" (on the right side), and the other side marked with "15".

Escitalopram Mabo 15 mg is available in packs of 28 and 56 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Mabo – Farma S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer:

Teva Operations Poland Sp. Z.o.o.

ul. Mogilska 80, 31-546 Krakow, Poland

or

Medreich PLC

Warwick House, Plane Tree Crescent,

Feltham, TW13 7HF, United Kingdom.

or

Meiji Pharma SPAIN, S.A.

Avd. de Madrid, 94 - Alcala de Henares (Madrid) - 28802 - Spain

Date of the most recent revision of this leaflet: March 2024

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