PATIENT INFORMATION LEAFLET

Escitalopram Qualigen 10 mg Film-Coated Tablets

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

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

Do not take EscitalopramQualigen

• If you are allergic to escitalopram or any of the other ingredients in this medication.(See section 6).
• If you are taking other medications used to treat depression or anxiety, known as “non-selective monoamine oxidase inhibitors (MAOIs).” (See the section “Other medications and Escitalopram Qualigen”).
• If you have a congenital heart rhythm disorder or have experienced any episodes of this type (this is observed with an electrocardiogram, a test that evaluates how the heart functions).
• If you are taking medications for heart rhythm disorders or that may affect heart rhythm, (See the section “Other medications 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 condition or disease, as your doctor may need to take it into account. In particular, inform your doctor:

• If you have epilepsy. The treatment with escitalopram 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. The treatment with escitalopram may alter blood sugar control, and you may need to adjust your insulin and/or oral hypoglycemic medication dose.
• If you have low sodium levels 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 any heart problems or have recently had a heart attack.
• If, when at rest, your heart beats slowly (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 taken 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 may indicate that you have a heart rhythm disorder.

Some medications in the group to which Escitalopram Qualigen belongs (called SSRIs/SNRIs) may cause sexual dysfunction symptoms. (See section 4).

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

If you are depressed and/or have an anxiety disorder, you may occasionally have thoughts of harming yourself or committing suicide. These thoughts 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.Youmay be more prone to having these types of thoughts:

• If you have previously had thoughts of harming yourself or committing suicide.
• 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 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 has worsened. Or if they are concerned about changes in your attitude.

Fractures

There has been an observed increase in the risk of fractures in patients treated with this type of medication.

Children and adolescents(under 18 years)

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

You should also know that in patients under 18 years old, there is a higher risk of adverse effects, such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability), when taking this type of medication. However, the doctor who prescribes it may decide that it is the best option for the patient. If your doctor has prescribed escitalopram 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 listed below progress or if you experience complications when patients under 18 years old are taking escitalopram. Additionally, the long-term effects of escitalopram on safety, growth, maturity, and cognitive and behavioral development in this age group have not yet been demonstrated.

Other medications and Escitalopram Qualigen

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

Inform your doctor or pharmacist 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 escitalopram. After stopping escitalopram, 7 days should pass before taking any of these medications.
• “Reversible 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.
• Lithium (used in the treatment of manic-depressive illness) 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.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause an increase in escitalopram blood levels.
• St. John's Wort (Hypericum perforatum) – a medicinal plant used to treat depression.
• Aspirin and non-steroidal 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 probably monitor your blood clotting time at the beginning and end of treatment with escitalopram to ensure that the 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) and desipramine, clomipramine, and nortriptyline (antidepressants) and risperidone, thioridazine, and haloperidol (antipsychotics). You may need to adjust your escitalopram dose.

Do not take Escitalopram Qualigen if you are taking medications for any heart rhythm disorder 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 any doubts about this, consult your doctor.

Taking EscitalopramQualigen with food, drinks, and alcohol

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

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

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

Pregnancy

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

If you take Escitalopram Qualigen in the final stages of pregnancy, there may be an increased risk of excessive 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 be able to advise you.

Make sure your midwife and/or doctor know that you are taking Escitalopram Qualigen. When taken during pregnancy, particularly in the last 3 months of pregnancy, medications like Escitalopram Qualigen 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 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: 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.

Escitalopram should not be stopped abruptly during pregnancy.

Breastfeeding

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

Fertility

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

Driving and operating machinery

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

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

The recommended doseis:

Adults

Depression

The usual 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 for 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.

65 years and older

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 the section 2 "What you need to know before starting to take Escitalopram Qualigen".

You can take Escitalopram Qualigenwith or without food. Swallow the tablets with water.Do not chew them.The tablet can be split into equal doses.If necessary, you can split the tablets by placing the tablet on a flat surface with the notch facing up. The tablets can be split 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 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 for the recommended time by your doctor. If you interrupt the treatment too soon, symptoms may reappear. It is recommended that the treatment continue for at least 6 months after you feel well again.

If you take more EscitalopramQualigenthan you should

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

Do it even when you do not observe any discomfort or signs of intoxication. Some 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. Bring the medication packaging if you go to the doctor or hospital.

If you forgot to takeEscitalopramQualigen

Do not take a double dose to compensate for the missed 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 interrupt the treatment withEscitalopramQualigen

Do not interrupt the treatment with escitalopram until your doctor tells you to. When you have finished your treatment course, it is usually recommended to gradually reduce the escitalopram dose over several weeks.

When you stop taking escitalopram, especially if it is suddenly, you may experience withdrawal symptoms. These are common when escitalopram treatment is suspended. 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 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, contact your doctor. Your doctor may ask you to take your tablets again and taper off them more slowly.

Withdrawal symptoms include: feeling of dizziness (unstable or loss of balance), feeling of tingling, feeling of prickling, and (less frequently) electric shock, even in the head, sleep disturbances (too intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of nausea (dizziness), sweating (including night sweats), feeling of anxiety or agitation, tremor (unsteadiness), 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 or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Inform your doctor if you experience any of the following side effects.

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

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

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

• Unusual bleeding, including gastrointestinal bleeding.

Very rare(in at least 1 in 10,000 patients):

• 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 feel this way, contact your doctor.

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

• Difficulty urinating.
• Seizures (convulsions), see also the "Warnings and precautions" section.
• Yellowish skin and whitening of the eyes, which are signs of liver function impairment (hepatitis).
• Fast and irregular heartbeats or a feeling of fainting, as they may be symptoms of a serious heart condition called torsade de pointes.

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

Very common(in at least 1 in 10 patients):

• Feeling dizzy (nausea).

Common(in at least 1 in 100 patients):

• Blockage or nasal mucus (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty falling asleep, feeling drowsy, dizziness, yawning, tremors, skin itching.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (myalgia and arthralgia).
• Sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased sexual behavior, and women may experience difficulty reaching orgasm).
• Fatigue, fever.
• Weight gain.

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

• Hives, skin rash, itching (pruritus).
• Teeth chattering, agitation, nervousness, anxiety attack, state of confusion.
• Changes in sleep, changes in taste, fainting (syncope).
• Pupil dilation (mydriasis), visual impairment, ringing in the ears (tinnitus).
• Hair loss.
• Vaginal bleeding.
• Weight loss.
• Fast heart rate.
• Swelling of arms and legs.
• Nasal bleeding.

Very rare(in at least 1 in 10,000 patients):

• Aggression, depersonalization, hallucinations.
• Low heart rate.
• Events related to suicide, see also the "Use in children and adolescents (under 18 years)" section.

Frequency not known:

Some patients have reported:

• Decreased sodium levels in the blood (symptoms are feeling dizzy and muscle weakness or confusion).
• Dizziness when standing due to low blood pressure (orthostatic hypotension).
• Altered liver function tests (elevated liver enzymes in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erections (priapism).
• Blood clotting disorders, including skin and mucous membrane bleeding (ecchymosis) and low platelet counts in the blood (thrombocytopenia).
• Sudden skin or mucous membrane swelling (angioedema).
• Increased urine production (inadequate secretion of antidiuretic hormone).
• Milk flow in women who are not breastfeeding.
• Mania.
• Alteration of the heart rhythm (called prolongation of the QT interval), observed by electrocardiogram.
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

Other side effects have been reported with medications that act similarly to escitalopram. These are:

• Motor restlessness (akathisia).
• Anorexia.

If you consider that any of the side effects you experience are severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects:

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

• Keep this medication out of the sight and reach of children.Conservation:
• • Blister of PVC/PVDC-Al: Do not store at a temperature above 25?°C.
• Do not useEscitalopramQualigenafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.
• 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 of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Escitalopram Qualigen

The active ingredient is escitalopram.Each tablet contains10mg 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 content of the container

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

Each container contains28or 56 tablets in a blister pack.

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing

Actavis Limited

B16 Bulebel Industrial Estate

Zejtun ZTN 08

Malta

Last review date of this leaflet:May 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.gob.es/