Package Leaflet: Information for the User

Escitalopram Normon 10 mg Film-Coated Tablets EFG

Escitalopram oxalate

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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

Escitalopram Normon contains the active ingredient escitalopram. Escitalopram Normon 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 in 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).

You may notice an improvement in a couple of weeks. Continue taking Escitalopram Normon even if it takes time to notice any improvement.

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

Do not take Escitalopram Normon

• If you are allergic (hypersensitive) to escitalopram or to any of the other components of Escitalopram Normon (including those 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 a history of or have experienced an episode of abnormal heart rhythm (detected on an ECG, a test that evaluates the heart's function).
• If you are taking medications for heart rhythm disorders or that may affect heart rhythm (see section 2 "Use of Escitalopram Normon with other medications").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Escitalopram Normon

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

• If you have epilepsy. Treatment with Escitalopram Normon should be discontinued if seizures occur for the first time 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 Normon may affect 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 easilyor if you are pregnant (see "Pregnancy, breastfeeding, and fertility").
• If you are receiving electroconvulsive therapy.
• If you have coronary heart 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 that you may have low sodium levels as a result of severe and prolonged diarrhea and vomiting (being ill) or use of diuretics.
• If you experience rapid or irregular heartbeats, dizziness, fainting, or dizziness when standing up, which may indicate 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 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 few weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Medicines like Escitalopram Normon (also called ISRS/IRSN) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

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.Youmay be more prone to having these 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 of age with psychiatric disorders 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 disorder has worsened, or if they are concerned about changes in your behavior.

Children and adolescents

Escitalopram Normon should not be used normally in the treatment of children and adolescents under 18 years of age. Also, be aware that in patients under 18 years of age, there is a higher risk of adverse effects such as suicidal behavior, suicidal thoughts, and hostility (primarily aggression, confrontational behavior, and irritability) when taking this type of medication. However, your doctor may prescribe Escitalopram Normon to patients under 18 years of age when they decide it is in the best interest of the patient. If the doctor who is responsible for you has prescribed Escitalopram Normon to a patient under 18 years of age 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 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 medications and Escitalopram Normon

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

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

• "Non-selective monoamine oxidase inhibitors (IMAOs)", 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 Normon. After stopping Escitalopram Normon, 7 days should pass before taking any of these medications.
• "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.
• 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). They may cause an increase in the concentration of escitalopram in the blood.
• St. John's Wort (Hypericum perforatum), a medicinal plant used to treat depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medications used to relieve pain or reduce the risk of thrombosis, also called anticoagulants). These may increase the risk of bleeding.
• Warfarin, dipiridamol, and phenprocoumon (medications used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably monitor your blood clotting time at the start and end of treatment with Escitalopram Normon to check 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) and antidepressants (tricyclic antidepressants ISRSs) 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 Normon dose.
• Medications that lower potassium or magnesium levels in the blood, as this increases the risk of abnormal heart rhythm, which is life-threatening.

Do not take Escitalopram Normon if you are taking medications for heart rhythm disorders or that may affect heart rhythm, for example, antiarrhythmic class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (e.g., ciprofloxacin, moxifloxacin, erythromycin IV, 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 medications, it is not recommended to combine Escitalopram Normon and alcohol, although it is not expected to interact with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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 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 Normon so they can 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: 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 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, medications like Escitalopram Normon may increase the risk of a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually start within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

Escitalopram Normon should not be stopped abruptly during pregnancy.

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

Citalopram, a medication similar to escitalopram, has been shown to reduce sperm quality in animal models. Theoretically, this effect could affect fertility, but to date, no effect has been observed in human fertility.

Driving and operating machinery

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of 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 increase it further 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 the 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.

Seniors (65 years and older)

The recommended initial 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 the 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 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 Normon 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 Normon for the recommended time by your doctor. If you interrupt the treatment too soon, the symptoms may reappear. It is recommended that the treatment continue 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 nearest hospital emergency room, or consult the Toxicological Information Service, phone 915.620.420. Do it even when you do not observe 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 Escitalopram Normon packaging if you go to the doctor or hospital.

If you forget to take Escitalopram Normon

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 the treatment with Escitalopram Normon

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

When you stop taking Escitalopram Normon, especially if it is done abruptly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram Normon is suspended. The risk is higher when Escitalopram Normon 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 Normon, please contact your doctor. They 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 have side effects, although not everyone will experience them.

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

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

Rare(may affect up to 1 in 1,000 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, urticaria, or difficulty breathing or swallowing (severe allergic reaction).
• High fever, agitation, confusion, tremors, and sudden muscle contractions, which may be signs of a rare condition called serotonin syndrome.

Unknown(cannot be determined from available data):

• 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.
• Experiencing rapid and irregular heartbeats or dizziness, symptoms that may indicate a life-threatening condition known as Torsade de Pointes.
• Thoughts of self-harm or suicidal thoughts, see also the "Warnings and precautions" section.
• Sudden swelling of the skin or mucous membranes (angioedemas).
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

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

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

• Feeling dizzy (nausea).
• Headache.

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

• 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 (arthritis and myalgia).
• Sexual difficulties (delayed ejaculation, erection problems, decreased sexual behavior, and women may experience difficulty reaching orgasm).
• Fatigue, fever.
• Weight gain.

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

• Urticaria, skin rash, itching (pruritus).
• Teeth chattering, agitation, nervousness, anxiety crisis, state of confusion.
• Sleep disturbances, taste alterations, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Hair loss.
• Excessive menstrual bleeding.
• Irregular menstrual periods.
• Weight loss.
• Rapid heart rate.
• Swelling of arms and legs.
• Nasal bleeding.

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

• Aggression, depersonalization, hallucinations.
• Low heart rate.

Unknown(cannot be determined from available data):

• Decreased sodium levels in the blood (symptoms include feeling dizzy and experiencing 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).
• Signs of abnormal bleeding, e.g. from the skin or mucous membranes (ecchymosis).
• Inadequate secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, reducing sodium levels (inadequate secretion of ADH).
• Milk leakage in men and 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 the heart rhythm (called "prolongation of the QT interval", observed through electrocardiogram).

Other side effects have been reported with medications that act similarly to escitalopram (the active ingredient in Escitalopram Normon). These are:

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

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 Vigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

Store below 30 °C.

Do not use Escitalopram Normon after the expiration date that appears on the packaging after CAD. 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 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 packaging and medicines you no longer need. In this way, you will help protect the environment.

Escitalopram Normon Composition

The active ingredient is escitalopram.

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

The other components are:

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

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

Product Appearance and Packaging Contents

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 printed tablets that are presented in packs of 28 and 56 tablets.

Marketing Authorization Holder and Responsible 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

Last Review Date of this Leaflet: January 2021

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

You can access detailed and updated information about this medicine 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