Package Leaflet: Information for the User

Escitalopram Almus10 mgfilm-coated tablets

Read this leaflet carefully before you start taking this medicine,because 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. See section 4.

1. What Escitalopram Almus 10 mg is and what it is used for

2. What you need to know before you take Escitalopram Almus 10 mg

3. How to take Escitalopram Almus 10 mg

4. Possible side effects

5. Storage of Escitalopram Almus 10 mg

Escitalopram Almus contains escitalopram and is used for the treatment of depression (major depressive episodes) and anxiety disorders (such as panic disorders with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder).

Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medications act on the serotonin system in the brain by increasing the level of serotonin. Alterations of the serotonin system are considered an important factor in the development of depression and related diseases.

Do not take Escitalopram Almus

• If you are allergic to escitalopram or any of the other ingredients in this medication (listed in section 6).
• If you are taking other medications that belong to the group called MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).
• If you have any type of heart rhythm disorder since birth or have ever experienced an episode of this type (this is observed with an electrocardiogram, a test that evaluates the heart's function).
• If you are taking medications for heart rhythm disorders or that can affect heart rhythm (see section 2 "Use of Escitalopram Almus with other medications").

Warnings and precautions

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

Please inform your doctor if you have any other condition or disease, as your doctor may need to take it into account. In particular, inform your doctor:

• If you have epilepsy. Treatment with Escitalopram Almus should be interrupted if seizures occur or if you observe an increase in seizure frequency (see also section 4 "Possible side effects").
• If you have liver or kidney insufficiency. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram Almus may alter blood sugar control. You may need to adjust your insulin and/or oral hypoglycemic medication dose.
• If you have low sodium levels in your blood.
• If you are prone to bleeding or bruising easily or if you are pregnant (see "Pregnancy 1").
• If you are receiving electroconvulsive therapy.
• If you have coronary artery disease.
• If you have or have had any heart problems or have recently had a heart attack.
• If, when at rest, your heart beats slowly and/or you think your body may be losing salt, for example, because you have had intense diarrhea and vomiting for several days (while ill) or because you have used diuretics (medications to urinate).
• If you have noticed that your heartbeats are rapid or irregular or have experienced dizziness or lightheadedness when getting up from a sitting or lying position. This could indicate that you have a heart rhythm disorder.
• If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).

Some medications in the group to which Escitalopram Almus belongs (called ISRS/IRSN) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Please note:

Some patients with manic-depressive illness may enter a manic phase. This is characterized by unusual and rapid changes in ideas, excessive joy, and excessive physical activity. If you experience this, contact your doctor.

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

Thoughts of suicide 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 committing suicide. These may increase when taking antidepressants for the first time, as all these medications require time to start working, usually around two weeks, although in some cases it may take longer.

You would be more prone to having these types of thoughts:

• If you have previously had thoughts of suicide or self-harm.
• If you are ayoung adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years old with psychiatric illnesses who were treated with an antidepressant.

If you ever have thoughts of harming yourself or committing suicide, contact your doctor or go directly to a hospital.

It may be helpful for you to tell a family member or aclose friendthat you are depressed or have an anxiety disorder and ask them to read this leaflet. You can ask them if they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your attitude.

Use in children and adolescents under 18 years

Escitalopram Almus should not be used normally in the treatment of children and adolescents under 18 years old. Also, be aware that in patients under 18 years old, there is a higher risk of adverse effects such as attempts at suicide, suicidal thoughts, and hostility (primarily aggression, confrontational behavior, and irritability) when taking this type of medication. However, your doctor may prescribe Escitalopram Almus to patients under 18 years old when they decide it is the best option for the patient. If your doctor has prescribed Escitalopram Almus to a patient under 18 years old and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms described above progress or if you experience complications when patients under 18 years old are taking Escitalopram Almus. At the same time, the long-term effects regarding safety and related to growth, maturity, and cognitive and behavioral development of Escitalopram Almus in this age group have not yet been demonstrated.

Use of Escitalopram Almus with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Inform your doctor if you are taking any of the following medications:

• "Non-selective monoamine oxidase inhibitors (MAOIs)", containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active ingredients. If you have taken any of these medications, you will need to wait 14 days before starting to take Escitalopram Almus. After stopping Escitalopram Almus, 7 days must pass before taking any of these medications.

Escitalopram Almus.

Escitalopram Almus.

• "Reversible 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 side effects.
• The antibiotic linezolid.
• Lithium (used to treat manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medications (used to treat migraines) and tramadol

(used to treat severe pain). These increase the risk of side effects.

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

• Cimetidine, esomeprazole, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause an increase in Escitalopram Almus blood levels.
• St. John's Wort (Hypericum perforatum)- medicinal plant used to treat depression.
• Aspirin and nonsteroidal anti-inflammatory drugs (medications used to relieve pain or reduce the risk of blood clots, also called anticoagulants).
• Warfarin, dipiridamol, and phenprocoumon (medications used to reduce the risk of blood clots, also called anticoagulants). Your doctor will likely monitor your blood clotting time at the start and end of treatment with Escitalopram Almus to ensure that your anticoagulant dose is still adequate.

• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medications used to treat schizophrenia, psychosis) due to the possible risk of lowering the seizure threshold and antidepressants.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). You may need to adjust your Escitalopram Almus dose.

DO NOT TAKE Escitalopram Almusif you are taking medications for any heart-related condition or if you are taking medications that may affect heart rhythm, for example, antiarrhythmic class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, medications against malaria, particularly halofantrine), certain antihistamines (astemizole, mizolastine).

If you have 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 medications, it is not recommended to combine Escitalopram Almus and alcohol, although it is not expected to interact with alcohol.

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 analyzed the risks and benefits involved.

Pregnancy1

If you take Escitalopram Almus in the final 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 know that you are taking Escitalopram Almus to be able to advise you.

If you take Escitalopram Almus during the last 3 months of your pregnancy, be aware that the following effects may be observed in the newborn: difficulty breathing, blue skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, muscle stiffness or weakness, intense reflexes, tremors, restlessness, irritability, drowsiness, and difficulty falling asleep. If your newborn baby has any of these symptoms, please contact your doctor immediately.

Make sure your doctor or midwife knows that you are taking Escitalopram Almus. When taken during pregnancy, particularly in the last 3 months of pregnancy, medications like Escitalopram Almus may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and appear blue. These symptoms usually start within the first 24 hours after the baby is born. If this happens to your baby, you should inform your doctor or midwife immediately.

Escitalopram Almus should not be stopped abruptly.

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for Escitalopram Almus as indicated 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 dose per day. 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 dose per day for the first week before increasing the dose to 10 mg per day. Your doctor may increase it further 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 dose per day. Your doctor may decrease 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 dose per day. 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 dose per day. The dose may be increased by your doctor up to a maximum of 20 mg per day..

Older adults (65 years and older)

The normally recommended initial dose of Escitalopram Almus is 5 mg taken as a single dose per day.

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

Children and adolescents (under 18 years)

Escitalopram Almus should not normally be administered to children and adolescents. For additional information, please see the section 2 “What you need to know before starting to take Escitalopram Almus”.

You can take Escitalopram 10 mg tablets with or without food. Swallow the tablets with water. Do not chew them, as their taste is bitter.

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

Treatment duration

You may feel better in a couple of weeks. Continue taking Escitalopram Almus even if you start feeling better before the expected time.

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

Continue taking Escitalopram Almus for the recommended time by your doctor. If you interrupt treatment too soon, symptoms may reappear. It is recommended that treatment continue for at least 6 months after feeling well again.

If you take more Escitalopram Almus than you should

If you take more doses of Escitalopram Almus than prescribed, contact your doctor or pharmacist immediately, go to the nearest hospital emergency department, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.Do so even when you do not observe any discomfort.The signs of overdose may be dizziness, tremor, agitation, convulsion, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and changes in the body's electrolyte balance.

Take the remaining tablets and the packaging with you, even if the packaging is empty, when you visit your doctor or hospital.

If you forget to take Escitalopram Almus

Do not take a double dose to compensate for the missed doses. If you forget to take a dose and remember before going to bed, take it immediately. The next day, follow your usual schedule. If you remember during the night or the next day, leave the missed dose and follow your usual schedule.

If you interrupt treatment with Escitalopram Almus

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

When you stop taking Escitalopram Almus, especially if it is done abruptly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram Almus is suspended. 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 in two weeks. However, in some patients, they can be intense 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 take your tablets again and taper off them more slowly.

Withdrawal symptoms include: Dizziness (unstable or loss of balance), tingling sensation, prickling sensation, and (less frequently) electric shock sensation, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, dizziness (nausea), sweating (including nocturnal sweating), feeling of anxiety or agitation, tremor (instability), feeling of confusion or disorientation, feelings of emotion or irritability, diarrhea (loose stools), visual disturbances, rapid heartbeat or palpitations.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effects usually disappear after a few weeks of treatment. Please be aware that many of the side effects can be symptoms of your illness and will improve when you start to feel better.

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

Rare (can affect up to 1 in 100 people):

• Unusual bleeding, including gastrointestinal bleeding

Uncommon (can 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 have a high fever, agitation, confusion, tremors, and sudden muscle contractions, they may be signs of a rare condition called serotonin syndrome.If you notice these symptoms, contact your doctor.

Seek medical attention immediately if you experience the following side effects:

• Difficulty urinating
• Seizures (convulsions), see also "Warnings and precautions"
• Yellowing of the skin and eyes, which are signs of liver dysfunction/hepatitis
• If you experience rapid or irregular heartbeats or dizziness, symptoms that may indicate a life-threatening condition known as Torsade de Pointes.

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

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

• Headaches

• Feeling dizzy (nausea)

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

• Stuffy nose or nasal mucus (sinusitis)
• Decreased or increased appetite
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, feeling

drowsy, dizziness, yawning, tremors, and itching or tingling in the skin

• Diarrhea, constipation, vomiting, dry mouth
• Increased sweating
• Muscle and joint pain (arthralgia and myalgia)
• Sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased sexual behavior, and women may experience difficulty reaching orgasm)
• Fatigue, fever
• Weight gain

Rare (can affect up to 1 in 100 people):

• Itchy skin (urticaria), skin rash, itching (pruritus)
• Unintentional tooth grinding, agitation, nervousness, anxiety attack, state of confusion
• Changes in taste, sleep disturbances, fainting (syncope)
• Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus)
• Hair loss
• Vaginal bleeding
• Weight loss
• Fast heart rate
• Swelling of arms and legs
• Nasal bleeding

Uncommon (can affect up to 1 in 1,000 people):

• Aggression, depersonalization, hallucinations
• Low heart rate

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

• Thoughts of self-harm or suicidal thoughts, see also "Warnings and precautions"
• Decreased sodium levels in the blood (symptoms are feeling dizzy and experiencing muscle weakness or confusion)
• Dizziness when 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 count in the blood (thrombocytopenia)
• Sudden swelling of the skin or mucous membranes (angioedema)
• Increased urine production (inadequate 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
• Alteration of heart rhythm (known as "prolongation of the QT interval", observed on the ECG, heart electrical activity).
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

In addition, other side effects have been reported with medications that act similarly to escitalopram (the active ingredient in Escitalopram Almus). These are:

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect that does not appear in this leaflet.You can also report them directly through theSSpanish Medicines Adverse Reaction Reporting System. Website:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Escitalopram Almus

- The active ingredient is escitalopram. Each film-coated tablet contains 10 mg of escitalopram (as escitalopram oxalate).

- The other components are:

Core:microcrystalline cellulose, sodium croscarmellose, talc, anhydrous colloidal silica,

and magnesium stearate.

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

Appearance of the product and contents of the pack

Escitalopram Almus 10 mg tablets are elliptical, white, convex, and scored on both sides.

Escitalopram Almus 10 mg film-coated tablets are available in blister packs of 28 or 56 tablets.

Marketing Authorization Holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email:[email protected]

Responsible for manufacturing

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra, Portugal

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares, Rua Outeiro da Armada, 5

Condeixa-a-Nova, 3150-194 Sebal, Portugal

Last revision date of this leaflet: August 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es