Escitalopram Almus 15 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Escitalopram Almus 15 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, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See Section 4.

Leaflet Contents:

1. What Escitalopram Almus 15 mg is and what it is used for
2. What you need to know before taking Escitalopram Almus 15 mg
3. How to take Escitalopram Almus 15 mg
4. Possible side effects
5. How to store Escitalopram Almus 15 mg
6. Contents of the pack and other information

1. What Escitalopram Almus 15 mg is and what it is used for

Escitalopram Almus contains escitalopram and is used to treat 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).

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 conditions.

2. What you need to know before taking Escitalopram Almus 15 mg

Do not take Escitalopram Almus

• 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 have a congenital heart rhythm disorder or have ever experienced an episode of this type (this can be detected by an electrocardiogram, a test that evaluates heart function).
• If you are taking medicines for heart rhythm disorders or medicines that may affect heart rhythm (see section 2, "Taking Escitalopram Almus with other medicines").

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Escitalopram Almus.

Please inform your doctor if you have any other disorders or illnesses, as your doctor may need to take them into account. Specifically, tell your doctor:

• If you have epilepsy. Treatment with Escitalopram Almus should be discontinued if seizures occur or if you 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 Almus may alter glycaemic control. An adjustment of insulin and/or oral hypoglycaemic agent dosage may be necessary.
• If you have low levels of sodium in your blood.
• If you tend to bleed easily or develop bruises easily, or if you are pregnant (see "Pregnancy").
• 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 your heart beats slowly at rest and/or you think your body may be losing salts, for example due to severe diarrhoea and vomiting over several days (while ill) or because you have used diuretics (medicines to increase urination).
• If you have noticed rapid or irregular heartbeats, or have experienced fainting or dizziness when standing up from a sitting or lying position. These symptoms could indicate a heart rhythm disorder.
• If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).

Some medicines in the same group as Escitalopram Almus (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may 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 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 suffer from an anxiety disorder, you may occasionally have thoughts about harming yourself or committing suicide. These thoughts may increase when you first start taking 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 these types of 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 behaviour 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 immediately or go directly to a hospital.

It may help 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 whether they are concerned about changes in your behaviour.

Use in children and adolescents under 18 years of age

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

Taking Escitalopram Almus with other medicines

Tell 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, and tranylcypromine as active substances. If you have taken any of these medicines, you will need to wait 14 days before starting Escitalopram Almus. After stopping Escitalopram Almus, 7 days must pass 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.

• Medicines that reduce blood potassium and magnesium levels, as they may increase the risk of serious arrhythmias.

• Cimetidine, esomeprazole, 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 Almus.

• 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 to 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 Almus to ensure that 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) due to the possible risk of lowering the seizure threshold and antidepressants.

• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of Escitalopram Almus may need to be adjusted.

DO NOT TAKE Escitalopram Almus if you are taking medicines for heart rhythm disorders or if you are taking 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 (sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial medicines particularly halofantrine), or certain antihistamines (astemizole, mizolastine).

If you have any doubts about this, consult your doctor.

Taking Escitalopram Almus with food, drinks, and alcohol

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

As with many medicines, combining Escitalopram Almus with alcohol is not recommended, although an interaction between Escitalopram Almus and alcohol is not expected.

Pregnancy, breastfeeding, and fertility

Inform your doctor if you are pregnant or plan to become pregnant. Do not take Escitalopram Almus if you are pregnant or breastfeeding unless you and your doctor have discussed the risks and benefits involved.

Pregnancy¹

If you take Escitalopram Almus 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 Almus so they can advise you.

If you take Escitalopram Almus during the last 3 months of pregnancy, be aware that the following effects may occur in the newborn baby: difficulty breathing, 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.

Ensure that your doctor or midwife knows you are taking Escitalopram Almus. When taken during pregnancy, particularly during the last 3 months, medicines like Escitalopram Almus may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, inform your doctor or midwife immediately.

If Escitalopram Almus is used during pregnancy, it should never be stopped abruptly.

Citalopram, a medicine similar to escitalopram, has been shown to reduce sperm quality in animal studies. Theoretically, this could affect fertility, but an effect on human fertility has not been observed so far.

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

During treatment with Escitalopram, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how treatment with escitalopram affects you.

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

3. How to take Escitalopram Almus 15 mg

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

Adults

Depression

The normally recommended dose of Escitalopram Almus 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 Almus 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 Almus 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 medication.

Generalized anxiety disorder

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

Children and adolescents (under 18 years of age)

Escitalopram Almus should normally not be given to children and adolescents. For further information, please see section 2 “What you need to know before you start taking Escitalopram Almus”.

You may take Escitalopram 15 mg tablets with or without food. Swallow the tablets with water. Do not chew them, as their taste is bitter.

If necessary, you may split the tablets by placing the tablet on a flat surface with the score side facing upwards. The tablets can be broken by pressing down on each end of the tablet with the two index fingers.

Duration of treatment

It may take a couple of weeks before you start to feel better. Continue taking Escitalopram Almus even if you start to feel better before the expected time.

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

Continue taking Escitalopram Almus 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 start feeling well again.

If you take more Escitalopram Almus than you should

If you take more Escitalopram Almus than prescribed, contact your doctor or pharmacist immediately, go to the nearest hospital emergency department, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount taken. Do this even if you do not notice any discomfort. 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.

Take any remaining tablets and the packaging with you when going to the doctor or hospital, even if the packaging is empty.

If you forget to take Escitalopram Almus

Do not take a double dose to make up for a missed dose. 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 normal.

If you stop taking Escitalopram Almus

Do not stop treatment with Escitalopram Almus 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 Almus, especially if abruptly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram Almus is discontinued. The risk is higher when Escitalopram Almus has been used for a long time, at high doses, or when the dose is reduced too quickly. Most people find that these symptoms are mild and disappear on their own within two weeks. However, in some patients, they may be severe or prolonged (2–3 months or more). If you experience severe withdrawal symptoms when stopping Escitalopram Almus, please contact your doctor. They may ask you to restart taking your tablets and then 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 (overly vivid dreams, nightmares, inability to sleep); restlessness; headache; dizziness (nausea); sweating (including night sweats); feelings of anxiety 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 the use of this medicine, ask your doctor, pharmacist, or nurse.

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.

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

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

• Unusual bleeding, including gastrointestinal bleeding

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

• If you notice swelling 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 develop high fever, agitation, confusion, tremors, and sudden muscle contractions, these may be signs of a rare condition called serotonin syndrome. If you experience these symptoms, contact your doctor.

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

• Difficulty urinating
• Seizures (fits), see also section “Warnings and precautions”
• Yellowing of the skin or whites of the eyes, which are signs of liver dysfunction/hepatitis
• If you experience rapid or irregular heartbeat or fainting, symptoms that may indicate a 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 people):

• Headaches
• Feeling dizzy (nausea)

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, feeling drowsy, dizziness, yawning, tremors, and itching or tingling of the skin
• Diarrhea, constipation, vomiting, dry mouth
• Increased sweating
• Muscle and joint pain (arthralgia and myalgia)
• Sexual disturbances (delayed ejaculation, erection problems, decreased sexual activity, and women may experience difficulty achieving orgasm)
• Fatigue, fever
• Weight gain

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

• Persistent itching (urticaria), skin rash, itching (pruritus)
• Involuntary teeth grinding, agitation, nervousness, panic attacks, confusion
• Taste disturbances, sleep disturbances, fainting (syncope)
• Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus)
• Hair loss
• Vaginal bleeding
• Weight loss
• Rapid heartbeat
• Swelling of arms and legs
• Nosebleeds

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

• Aggression, depersonalization, hallucinations
• Slow heartbeat

Some patients have reported (frequency cannot be estimated from available data):

• Thoughts of harming yourself or suicidal thoughts, see also section “Warnings and precautions”
• Decreased sodium levels 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 (elevated liver enzymes in the blood)
• Movement disorders (involuntary muscle movements)
• Painful erections (priapism)
• Bleeding disorders including skin and mucous membrane bleeding (ecchymosis) and low platelet levels in the blood (thrombocytopenia)
• Sudden swelling of the skin or mucous membranes (angioedema)
• Increased urine output (inappropriate ADH secretion)
• Milk production in women who are not breastfeeding
• Mania
• An increased risk of bone fractures has been observed in patients taking this type of medication
• 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 “Pregnancy1” in section 2 for more information.

In addition, other adverse effects are known to occur with drugs that act similarly to escitalopram (the active substance in Escitalopram Almus). These include:

• Increased urine output (inappropriate ADH secretion)
• Milk production in women who are not breastfeeding

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. You may 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 Almus 15 mg

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

Do not use this medicine after the expiry date stated on the carton after “EXP”. The expiry date refers to the last day of the month indicated.

Store below 25 °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 unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package leaflet contents and additional information

Composition of Escitalopram Almus

• The active substance is escitalopram. Each film-coated tablet contains 15 mg of escitalopram (as escitalopram oxalate).
• The other components are:

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

Coating: hypromellose, titanium dioxide (E171), and macrogol.

Appearance of the medicinal product and contents of the pack

Escitalopram Almus 15 mg tablets are oblong, white, biconvex, and scored on one side.

Escitalopram Almus 15 mg film-coated tablets are available in blister packs containing 28 or 56 tablets.

Marketing Authorization Holder

Almus Farmacéutica, S.A.U.
Marie Curie, 54
08840 Viladecans (Barcelona), Spain
Telephone: 93 739 71 80
Email: [email protected]

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra, Portugal

Date of the most recent revision of this leaflet: August 2021

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