ESCITALOPRAM NORMON 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Escitalopram Normon 10 mg Film-Coated Tablets EFG

Escitalopram Oxalate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not 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 and other information

1. What is Escitalopram Normon and what is it used for
2. What you need to know before you take Escitalopram Normon
3. How to take Escitalopram Normon
4. Possible side effects
5. Storing Escitalopram Normon

1. Contents of the pack and further information

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

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

Escitalopram Normon 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, generalized anxiety disorder, and obsessive-compulsive disorder).

It may take a couple of weeks before you start feeling better. Continue taking Escitalopram Normon even if it takes time to notice any improvement.

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

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

Do not take Escitalopram Normon

• If you are allergic (hypersensitive) to escitalopram or any of the other ingredients of Escitalopram Normon (listed in section 6).
• If you are taking other medicines that belong to the group of 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 been born with or have had an episode of alteration of heart rate (detected in an ECG, a test that evaluates heart function).
• If you are taking medicines for heart rhythm disorders or that may affect heart rhythm (see section 2 "Use of Escitalopram Normon with other medicines").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Escitalopram Normon

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 Normon should be discontinued if you experience seizures for the first time or observe an increase in the frequency of seizures (see also section 4 "Possible side effects").
• If you have liver or kidney failure. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram Normon may alter glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic.
• If you have a decreased sodium level in the 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 coronary artery disease.
• If you have or have had heart problems or have recently had a heart attack.
• If your resting heart rate is slow and/or you know you may have a decrease in salt as a result of severe and prolonged diarrhea and vomiting (being sick) or use of diuretics.
• If you experience rapid or irregular heartbeats, fainting, collapse, or dizziness when standing up, it may be indicative of abnormal heart rhythm.
• If you have or have had eye problems, such as certain types of glaucoma (increased pressure in the eye).

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.

Medicines like Escitalopram Normon (also called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuing treatment.

Suicidal thoughts and worsening of your depression or anxiety disorder

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

• If you have previously had thoughts of harming or killing 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.

Children and adolescents

Escitalopram Normon should not normally be used in the treatment of children and adolescents under 18 years of age. Also, you should know that in patients under 18 years of age, there is 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, your doctor may prescribe Escitalopram Normon to patients under 18 years of age when they decide it is the most convenient for the patient. If the doctor who corresponds to you has prescribed Escitalopram Normon 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 described above progress or if you experience complications when patients under 18 years of age are taking Escitalopram Normon. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Escitalopram Normon in this age group have not yet been demonstrated.

Other medicines and Escitalopram Normon

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• Non-selective monoamine oxidase inhibitors (MAOIs) that 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 Normon. After finishing Escitalopram Normon, 7 days must pass before taking any of these medicines.
• Reversible MAO-A inhibitors that contain moclobemide (used in the treatment of depression).
• Irreversible MAO-B inhibitors that contain 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 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 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 the concentration of escitalopram in the blood.
• St. John's Wort (Hypericum perforatum), a medicinal plant used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or reduce the risk of thrombosis, also called anticoagulants). These may increase the tendency to bleeding.
• 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 Normon 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 lowering the seizure threshold.
• Neuroleptics (medicines used for the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants, SSRIs) 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). It may be necessary to adjust the dose of Escitalopram Normon.
• Medicines that decrease potassium or magnesium levels in the blood, as this increases the risk of suffering from heart rhythm disorders, which pose a risk to life.

Do not take Escitalopram Normon if you are taking medicines for heart rhythm disorders or that may affect heart rhythm, such as antiarrhythmics class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobials (e.g., sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarial treatment, particularly halofantrine), certain antihistamines (astemizole, mizolastine). Contact your doctor for any additional consultation.

Taking Escitalopram Normon with food, drinks, and alcohol

Escitalopram Normon can be taken with or without food (see section 3 "How to take Escitalopram Normon").

As with many medicines, it is not recommended to combine Escitalopram Normon and alcohol, although it is not expected that Escitalopram Normon will interact with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take Escitalopram Normon if you are pregnant or breastfeeding unless you and your doctor have analyzed the risks and benefits involved.

If you take Escitalopram Normon in the final stage of pregnancy, there may be an increased 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 Normon to be able to advise you.

If you take Escitalopram Normon 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.

Make sure your midwife and/or doctor know that you are being treated with Escitalopram Normon. During pregnancy, particularly in the last 3 months, medicines like Escitalopram Normon may increase the risk of a serious disease in newborns called persistent pulmonary hypertension (PPHN), in which the baby breathes faster and turns blue. These symptoms usually start during the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

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

It is expected that escitalopram will be excreted in breast milk.

Citalopram, a medicine similar to escitalopram, has been shown to reduce sperm quality in animal models. This effect could theoretically affect fertility, but to date, it has not been observed in human fertility.

Driving and using machines

It is advised that you do not drive or use machinery until you know how Escitalopram Normon may affect you.

3. How to Take Escitalopram Normon

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults

Depression

The normally recommended dose of Escitalopram Normon 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 Normon 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 subsequently increase it up to a maximum of 20 mg per day.

Social Anxiety Disorder

The normally recommended dose of Escitalopram Normon 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 Normon 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 Normon 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)

The initial recommended dose of Escitalopram Normon 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 Normon should not normally be administered to children and adolescents. For additional information, please see section 2 "Warnings and Precautions".

How to take the tablets

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

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.

Duration of Treatment

It may take a couple of weeks before you start to feel better. Continue taking Escitalopram Normon 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 Normon for the time recommended by your doctor. If you interrupt treatment too early, symptoms may reappear. It is recommended that treatment continues for at least 6 months after you feel better.

If you take more Escitalopram Normon than you should

If you take more doses of Escitalopram Normon than prescribed, contact your doctor immediately, go to the emergency department of the nearest hospital, or consult the Toxicology Information Service, phone 915.620.420. Do this even if you do not observe discomfort or signs of intoxication. Some signs of overdose may include dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rhythm, decrease in blood pressure, and changes in body water balance. Bring the packaging of Escitalopram Normon if you go to the doctor or hospital.

If you forget to take Escitalopram Normon

Do not take a double dose to make up for forgotten doses. If you forgot to take a dose and remember before going to bed, take it immediately. The next day, follow your usual routine. If you remember during the night or the next day, skip the forgotten dose and follow your usual routine.

If you stop treatment with Escitalopram Normon

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

When you stop taking Escitalopram Normon, especially if it is sudden, you may feel withdrawal symptoms. These are common when treatment with Escitalopram Normon is suspended. The risk is greater when Escitalopram Normon 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 Normon, please contact your doctor. He or she 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 nausea (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 palpitations heartbeat.

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

4. Possible Adverse Effects

Like all medications, this medication can have adverse effects, although not all people suffer from them.

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

If you have any of the following symptoms, contact your doctor or go to the hospital immediately:

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

• Unusual bleeding, including gastrointestinal bleeding.

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

• Swelling of the skin, tongue, lips, pharynx, or face, hives, or difficulty breathing or swallowing (severe allergic reaction).
• High fever, agitation, confusion, tremors, and sudden muscle contractions can be signs of a rare condition called serotonin syndrome.

Unknown(frequency cannot be determined from available data):

• Difficulty urinating.
• Seizures (attacks), see also the "Warnings and Precautions" section.

• Yellowish skin and whitening of the eyes are signs of liver function alteration/hepatitis.
• If you experience rapid and irregular heartbeats or fainting, symptoms that may indicate a life-threatening condition known as Torsade de Pointes.
• Thoughts of harming yourself or thoughts of suicide, see also the "Warnings and Precautions" section.
• Sudden swelling of the skin or mucous membranes (angioedema).
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, Breastfeeding, and Fertility" in section 2 for more information.

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

Very Common(may affect more than 1 in 10 people):

• Feeling nauseous (nausea).
• Headache.

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

• Nasal congestion or mucous (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty falling asleep, feeling sleepy, dizziness, yawning, tremors, itching 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 behavior, and women may experience difficulty reaching orgasm).
• Fatigue, fever.
• Weight gain.

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

• 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.
• Excessive menstrual bleeding.
• Irregular menstrual period.
• 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.

Unknown(frequency cannot be determined from available data):

• 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).
• Signs of abnormal bleeding, e.g., from the skin or mucous membranes (ecchymosis).
• Increased secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, reducing the amount of sodium (inadequate ADH secretion).
• Milk flow in men and in women who are not breastfeeding.
• Mania.
• An increased risk of bone fractures has been observed in patients treated with this type of medication.
• Alteration of heart rhythm (called "prolongation of the QT interval", observed by electrocardiogram).

Other adverse effects are known to occur with drugs that work similarly to escitalopram (the active ingredient in Escitalopram Normon). These are:

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

Reporting Adverse Effects:

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

5. Storage of Escitalopram Normon

Keep out of sight and reach of children.

Store below 30 ºC.

Do not use Escitalopram Normon after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in 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. This way, you will help protect the environment.

6. Additional Information

Composition of Escitalopram Normon

The active ingredient is escitalopram.

Each Escitalopram Normon tablet contains 10 mg of escitalopram (as oxalate).

The other ingredients are:

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

Coating: hypromellose, macrogol 6000, titanium dioxide (E-171), and talc.

Appearance of the Product and Packaging Content

Escitalopram Normon 10 mg is presented in the form of film-coated tablets.

Escitalopram Normon 10 mg film-coated tablets are white or almost white, round, biconvex, scored, and engraved tablets that come in packs of 28 and 56 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Spain

OTHER PRESENTATIONS

Escitalopram Normon 15 mg film-coated tablets EFG

Escitalopram Normon 20 mg film-coated tablets EFG

Date of the Last Revision of this Leaflet:January 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/.

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/71417/P_71417.html