ESCITALOPRAM QUALIGEN 10 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Escitalopram Qualigen 10 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine

• 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

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

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

2. What you need to know before you take Escitalopram Qualigen

Do not take Escitalopram Qualigen

• 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 used to treat depression or anxiety, called non-selective monoamine oxidase inhibitors (MAOIs). (See the section “Other medicines and Escitalopram Qualigen”).
• If you have been born with or have had a heart rhythm disorder or have experienced any episode of this type (this is observed with an electrocardiogram, a test used to evaluate how the heart works).
• If you are taking medicines for heart rhythm disorders or that may affect the heart rhythm, (see the section “Other medicines and Escitalopram Qualigen”)

Warnings and precautionsConsult your doctor or pharmacist before starting to take Escitalopram Qualigen. Please inform your doctor if you have any other disorder or disease, as your doctor may need to take it into account. In particular, inform your doctor:

• If you have epilepsy. Treatment with escitalopram should be discontinued if seizures occur or if you observe an increase in the frequency of seizures. (See also section 4 “Possible side effects”).
• If you have liver (hepatic) or kidney (renal) impairment. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with escitalopram may alter glucose control, in which case it may be necessary to adjust the dose of insulin and/or oral hypoglycemic.
• If you have a low sodium level in your blood.
• If you tend to develop bleeding or bruising easily, or if you are pregnant (see “Pregnancy, breastfeeding, and fertility”).
• If you are receiving electroconvulsive therapy.

• If you have or have had heart problems or have recently had a heart attack.
• If your heart beats slowly when you are at rest (this is known as bradycardia) and/or you think your body may be losing salt, for example because you have had intense diarrhea and vomiting for several days or because you have used diuretics (medicines to urinate).
• If you have noticed that your heart beats quickly or irregularly or have fainted or felt dizzy when getting up from a sitting or lying position. This could indicate that you have a heart rhythm disorder.

Some medicines in the same group as Escitalopram Qualigen (called SSRIs) 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 an uncommon and rapid change of ideas, disproportionate 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 few weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may sometimes have thoughts of harming or killing yourself. These may increase when you first start taking antidepressants, as all these medicines take time to start working, usually around two weeks, although in some cases it may be longer. Youwould be more likely to have these thoughts:

• If you have previously had thoughts of killing yourself or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who were 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 relative or close 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.

Bone fractures

An increased risk of bone fractures has been observed in patients treated with this type of medicine.

Children and adolescents (under 18 years of age)

Escitalopram should not normally be used in the treatment of children and adolescents under 18 years of age.

At the same time, you should know that in patients under 18 years of age, there is a greater risk of adverse effects, such as suicidal attempts, suicidal ideas, and hostility (predominantly aggression, confrontational behavior, and irritation) when taking this class of medicines. Nevertheless, the doctor who corresponds to you may prescribe escitalopram to patients under 18 years of age when they decide that it is the most convenient for the patient. If the doctor who corresponds to you has prescribed escitalopram to a patient under 18 years of age and you want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms listed below progress or experience complications when patients under 18 years of age are taking escitalopram. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of escitalopram in this age group have not yet been demonstrated.

Other medicines and Escitalopram Qualigen

Tell your doctor or pharmacist if you are using, or have recently used, other medicines, including those obtained without a prescription.

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

• “Non-selective monoamine oxidase inhibitors (MAOIs)”, which contain phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active ingredients. If you have taken any of these medicines, you will need to wait 14 days before starting to take escitalopram. After finishing escitalopram, 7 days must pass before taking any of these medicines.
• “Reversible MAO-A inhibitors”, which contain moclobemide (used in the treatment of depression).
• “Irreversible MAO-B inhibitors”, which contain selegiline (used in the treatment of Parkinson's disease). These increase the risk of side effects.
• Lithium (used in the treatment of manic-depressive 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 (antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause an increase in blood levels of escitalopram.
• St. John's Wort (Hypericum perforatum) – a medicinal plant used for depression.
• Aspirin and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or 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 probably check the blood coagulation time at the start and end of treatment with escitalopram, to check that the dose of anticoagulant is still adequate.
• Mefloquine (used for the treatment of malaria), bupropion (used for the treatment of depression), and tramadol (used for the treatment of intense pain) due to the possible risk of reducing the seizure threshold.
• Neuroleptics (medicines used for the treatment of schizophrenia, psychosis) due to the possible risk of reducing the seizure threshold and antidepressants.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases) and desipramine, clomipramine, and nortriptyline (antidepressants) and risperidone, thioridazine, and haloperidol (antipsychotics). It may be necessary to adjust the dose of escitalopram.

Do not take Escitalopram Qualigen if you are taking medicines for heart rhythm disorders or if you are taking medicines that may affect the heart rhythm, such as antiarrhythmics class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, medicines against malaria, particularly halofantrine), and certain antihistamines (astemizole, mizolastine).

If you have doubts about this, consult your doctor.

Taking Escitalopram Qualigen with food, drinks, and alcohol

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

As with many medicines, it is not recommended to combine escitalopram and alcohol.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant. Do not take escitalopram if you are pregnant unless you and your doctor have analyzed the risks and benefits involved.

If you take Escitalopram Qualigen in the final stage of pregnancy, there may be a greater risk of abundant 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 Qualigen to advise you.

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

If you take escitalopram during the last 3 months of your pregnancy, be aware that the following effects may be observed in the newborn: breathing difficulties, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, intense reflexes, tremors, restlessness, irritability, lethargy, constant crying, and difficulty sleeping. If your newborn has any of these symptoms, please contact your doctor immediately.

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

Breastfeeding

Do not take escitalopram if you are breastfeeding unless your doctor has analyzed the risks and benefits involved.

Fertility

Citalopram, a medicine like escitalopram, in animal studies has shown that it reduces sperm quality. Theoretically, this could affect fertility, but the impact on human fertility has not been observed yet.

Driving and using machines

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

Escitalopram Qualigen 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 Qualigen

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults

Depression

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

Anxiety Disorder

The initial dose of escitalopram is 5 mg as a single dose per day during the first week before increasing the dose to 10 mg per day.

Your doctor may increase it later up to a maximum of 20 mg per day.

Social Anxiety Disorder

The recommended dose of escitalopram 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.

Obsessive-Compulsive Disorder

The recommended dose of escitalopram 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.

Elderly (over 65 years)

It is recommended to start with a dose of Escitalopram Qualigen of 5 mg per day. If necessary, your doctor may increase this dose up to a maximum of 10 mg per day.

Use in children and adolescents (under 18 years)

Escitalopram should not normally be administered to children and adolescents. For additional information, please see section 2 "What you need to know before taking Escitalopram Qualigen".

You can take Escitalopram Qualigen with or without food. Swallow the tablets with water. Do not chew them. The tablet can be divided into equal doses. If necessary, you can split the tablets by placing the tablet on a flat surface with the score line facing up. The tablets can be broken by pressing down on each end of the tablet with your index fingers.

Treatment Duration

It may take a couple of 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 medication without talking to your doctor first.

Continue taking escitalopram for the time recommended by your doctor. If you interrupt the treatment too early, the symptoms may reappear. It is recommended that the treatment continues for at least 6 months after you feel better again.

If you take more Escitalopram Qualigen than you should

If you have taken more escitalopram tablets than you should, consult your doctor, pharmacist, or go to the nearest hospital or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount taken.

Do this even if you do not observe discomfort or signs of intoxication. Some signs of overdose may be dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rate, decrease in blood pressure, and changes in body hydroelectrolyte balance. Bring the medication packaging if you go to the doctor or hospital.

If you forget to take Escitalopram Qualigen

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, take it as soon as you can. However, if it is almost time for the next dose, wait for the next dose and take it at the usual time.

If you stop taking Escitalopram Qualigen

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

When you stop taking escitalopram, especially if it is sudden, you may feel withdrawal symptoms. These are common when treatment with escitalopram is suspended. The risk is greater when escitalopram has been used for a long time, in 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 can be intense or prolonged (2-3 months or more). If you have severe withdrawal symptoms when you stop taking escitalopram, contact your doctor. Your doctor may ask you to start taking your tablets again and stop them more slowly.

Withdrawal symptoms include: feeling of dizziness (unstable or without balance), feeling of tingling, feeling of itching, and (less frequently) electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of dizziness (nausea), sweating (including night sweats), feeling of unease or agitation, tremors (instability), feeling of confusion or disorientation, feelings of emotion or irritation, diarrhea (loose stools), visual disturbances, rapid or irregular heartbeat.

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people suffer from them. Inform your doctor if you suffer from any of the following adverse effects.

Adverse effects are generally mild and usually disappear after a few weeks of treatment. Consider that many of the effects may be symptoms of your disease and will therefore improve when you start to feel better.

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

Uncommon (at least 1 in 1,000 patients):

• Unusual bleeding, including gastrointestinal bleeding.

Rare (at least 1 in 10,000 patients):

• If you notice skin swelling, tongue, lips, or face swelling, 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 feel this way, contact your doctor.

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

• Difficulty urinating.
• Seizures (attacks), see also the section "Warnings and precautions".
• Yellow skin and eyes, are signs of altered liver function (hepatitis).
• Fast and irregular heartbeats or feeling of fainting, as they could be symptoms of a serious heart problem known as torsades de pointes.

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

Very common (at least 1 in 10 patients):

• Feeling dizzy (nausea).

Common (at least 1 in 100 patients):

• Nasal congestion or mucous (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty sleeping, feeling sleepy, dizziness, yawning, tremors, skin itching.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (myalgia and arthralgia).
• Sexual disturbances (delayed ejaculation, erection problems, decreased sexual behavior, and women may experience difficulty reaching orgasm).
• Fatigue, fever.
• Weight gain.

Uncommon (at least 1 in 1,000 patients):

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

Rare (at least 1 in 10,000 patients):

• Aggression, depersonalization, hallucinations.
• Slow heart rate.
• Suicidal thoughts, see also the section "Use in children and adolescents (under 18 years)".

Frequency not known:

Some patients have reported:

• Decrease in sodium levels in the blood (symptoms are feeling dizzy and discomfort with muscle weakness or confusion).
• Dizziness when standing up due to low blood pressure (orthostatic hypotension).
• Altered liver function tests (increase in liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Coagulation disorders including skin and mucous membrane bleeding (ecchymosis) and low platelet count in blood (thrombocytopenia).
• Sudden swelling of the skin or mucous membranes (angioedema).
• Increased urine output (inadequate secretion of antidiuretic hormone).
• Milk flow in non-lactating women.
• Mania.
• Alteration of heart rhythm (called QT interval prolongation), observed through electrocardiogram.
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, lactation, and fertility" in section 2 for more information.

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

• Motor restlessness (akathisia).
• Anorexia.

If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Escitalopram Qualigen

• Keep this medication out of sight and reach of children. Conservation:
• • PVC/PVDC-Al blister: Do not store above 25°C.
• Do not use Escitalopram Qualigen after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.
• Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Escitalopram Qualigen

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

The other components are: microcrystalline cellulose (E460i), anhydrous colloidal silica, sodium croscarmellose, talc, magnesium stearate (E572), hypromellose (E464), titanium dioxide (E171), macrogol 6000.

Appearance of the product and package contents

Escitalopram Qualigen 10 mg tablets are presented in the form of film-coated tablets, white in color, oval in shape, biconvex, scored on one side, and marked with the letter "E" on the other.

Each package contains 28 or 56 tablets in blisters.

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Actavis Limited

B16 Bulebel Industrial Estate

Zejtun ZTN 08

Malta

Date of the last revision of this prospectus:May 2021

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