Package Insert: Information for the User

Escitalopram TecniGen 15 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

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

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

Do not take Escitalopram TecniGen

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

Warnings and precautions

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

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. You may need to adjust your insulin and/or oral hypoglycemic dose.
• If you have low sodium levels in your blood.
• If you are prone to bleeding or bruising easily, or if you are pregnant (see “Pregnancy, breastfeeding, and fertility”).
• If you are receiving electroconvulsive therapy.
• If you have coronary disease.
• If you have or have had any heart problems or have recently had a heart attack.
• If, when at rest, your heart beats slowly and/or you think your body may be losing salt, for example, because you have had intense diarrhea and vomiting for several days (feeling sick) or because you have taken diuretics (medications to urinate).
• If you have noticed that your heartbeats are rapid or irregular or have had fainting or dizziness when getting up from a sitting or lying position. This could indicate that you have a heart rhythm disorder.
• If you have eye problems such as certain types of glaucoma (increased pressure in the eye).

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

Please note:

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

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

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may occasionally have thoughts of harming yourself or committing suicide. These may increase when taking antidepressants for the first time, as all these medications require time to start working, usually around two weeks, although in some cases it may take longer.

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

• If you previously had thoughts of self-harm or 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 illnesses treated with an antidepressant.

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

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

Use in children and adolescents under 18 years

Escitalopram 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 attempts at suicide, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication. However, your doctor may prescribe Escitalopram to patients under 18 years of age when they decide it is the best option for the patient. If your doctor has prescribed Escitalopram 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. 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.

Use of Escitalopram TecniGen with other medications

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

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

• “Non-selective monoamine oxidase inhibitors (IMAOs)”, containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active principles. If you have taken any of these medications, you will need to wait 14 days before starting to take Escitalopram. After finishing Escitalopram, 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.
• Medications that decrease potassium and magnesium levels in the blood, given that it may increase the risk of heart rhythm disorders.
• Cimetidine, esomeprazole, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause an increase in Escitalopram blood levels.
• St. John's Wort (Hypericum perforatum)- medicinal plant used to treat depression.
• Aspirin and nonsteroidal anti-inflammatory drugs (medications used to relieve pain or reduce the risk of thrombosis, also called anticoagulants).
• Warfarin, dipiridamol, and phenprocoumon (medications used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably check 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), clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). You may need to adjust your Escitalopram dose.

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

Taking Escitalopram TecniGen with food, drinks, and alcohol

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

As with many medications, it is not recommended to combine Escitalopram TecniGen and alcohol, although it is not expected to interact with alcohol.

Pregnancy, breastfeeding, and fertility

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

If you take escitalopram in the final stages of pregnancy, there may be a higher 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 to be able to advise you.

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.

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

Escitalopram TecniGen should not be stopped abruptly if it is used during pregnancy.

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.

Consult your doctor or pharmacist before using any medication.

Driving and operating machines

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

Escitalopram TecniGen contains sodium

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

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

Panic Disorder

The initial dose of Escitalopram TecniGen 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 TecniGen 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 TecniGen 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 TecniGen is 10 mg taken as a single dose per day. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Older Adults (65 years and older)

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

Children and Adolescents (under 18 years)

Escitalopram TecniGen 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 TecniGen”.

You can take Escitalopram 15 mg tablets with or without food. Swallow the tablets with water. Do not chew them, as their taste is bitter.

If necessary, you can break the tablets by placing them 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 TecniGen 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 TecniGen 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 better.

If you take more Escitalopram TecniGen than you should

If you take more doses of Escitalopram TecniGen than prescribed, contact your doctor immediately, go to the nearest hospital emergency room. Do it even when you do not observe any discomfort. Signs of overdose may include dizziness, tremor, agitation, convulsion, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and changes in the body's electrolyte balance.

Take the remaining tablets and the packaging with you, even if it is empty when you go to the doctor or hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Escitalopram TecniGen

Do not take a double dose to compensate for the missed doses. If you forgot 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 TecniGen

Do not interrupt the treatment with Escitalopram TecniGen 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 done abruptly, 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, please contact your doctor. They may ask you to take your tablets again and taper off them more slowly.

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

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

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

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

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

• Unusual bleeding, including gastrointestinal bleeding

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

• If you notice swelling of the skin, tongue, lips, or face, or have difficulty breathing or swallowing (allergic reaction), contact your doctor or go to the hospital immediately.
• If you have a high fever, agitation, confusion, tremors, and sudden muscle contractions, they may be signs of a rare condition called serotonin syndrome. If you notice these symptoms, contact your doctor.

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

• Difficulty urinating
• Seizures (convulsions), see also the "Warnings and precautions" section
• Yellowing of the skin and whites of the eyes, which are signs of liver dysfunction/hepatitis
• Fast or irregular heartbeats or a feeling of fainting, symptoms that may indicate a life-threatening condition called Torsade de Pointes.

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

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

• Headache
• Feeling dizzy (nausea)

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

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

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

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

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

• Aggression, depersonalization, hallucinations
• Slow heart rate

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

• Thoughts of self-harm or suicidal thoughts, see also the "Warnings and precautions" section
• 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 count in the blood (thrombocytopenia)
• Sudden swelling of the skin or mucous membranes (angioedema)
• Increased urine production (inadequate ADH secretion)
• Milk production in women who are not breastfeeding
• Mania
• An increased risk of bone fractures has been observed in patients taking this type of medication
• Alteration of the heart rhythm (called QT interval prolongation), observed on the ECG, heart electrical activity.
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, lactation, and fertility" in section 2 for more information.

In addition, other side effects are known to appear with medications that act similarly to escitalopram (the active ingredient in Escitalopram TecniGen). These are:

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

Store below 25 °C.

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

Composition of Escitalopram TecniGen

• The active ingredient is escitalopram. Each film-coated tablet contains 15 mg of escitalopram (as escitalopram oxalate).
• The other components are:

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

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

Appearance of the product and contents of the packaging

Escitalopram TecniGen 15 mg tablets are oblong, white, convex, and scored on one side.

Escitalopram TecniGen 15 mg film-coated tablets are available in blister packs of 28 and 56 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor. Edificio América. Polígono Arroyo de la Vega, 28108 Alcobendas (Madrid) SPAIN

Responsible for manufacturing

Atlantic Pharma – Produções Farmacêuticas, S.A.

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

This leaflet was revised in February 2016

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