ESCITALOPRAM TECNIGEN 15 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Escitalopram TecniGen 15 mg film-coated tablets EFG

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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

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 medicines act on the serotonin system in the brain by increasing the level of serotonin. Alterations of the serotonin system are considered an important factor in the development of depression and related diseases.

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

Do not take Escitalopram TecniGen

• If you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).
• If you are taking other medicines that belong to the group of medicines called MAOIs (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 any heart rhythm disorder or have experienced any episode of this type (this is observed with an electrocardiogram, a test that evaluates how the heart works).
• If you are taking medicines for heart rhythm disorders or that may affect the heart rhythm (see section 2 "Use of Escitalopram TecniGen with other medicines").

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start taking Escitalopram TecniGen.

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

• If you have epilepsy. Treatment with Escitalopram should be discontinued if seizures occur or if you observe an increase in the frequency of seizures (see also section 4 "Possible side effects").
• If you have liver or kidney failure. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram may alter glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic.
• If you have a low sodium level in your blood.
• If you tend to develop bleeding or bruising easily, or if you are pregnant (see "Pregnancy, breastfeeding, and fertility").
• If you are receiving electroconvulsive therapy.
• If you have coronary heart disease.
• If you have or have had any heart problems or have recently had a heart attack.
• If 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 used diuretics (medicines to urinate).
• If you have noticed that your heartbeats are fast or irregular or have fainted or felt dizzy when getting up from a sitting or lying position. This could indicate that you have some heart rhythm disorder.
• If you have eye problems such as certain types of glaucoma (increased pressure in the eye).

Some medicines in the group to which Escitalopram TecniGen belongs (called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment is discontinued.

Please note:

Some patients with manic-depressive illness may enter a manic phase. This is characterized by an uncommon and rapid change of 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.

Suicidal thoughts and worsening of your depression or anxiety disorder

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

You would be more likely to have these thoughts:

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

If at any time you have thoughts of harming yourself or committing suicide, 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 that you havean 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 of age

Escitalopram 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 (mainly aggression, confrontational behavior, and irritation) when taking this class of medicines. Nevertheless, your doctor may prescribe Escitalopram to patients under 18 years of age when they decide it is most convenient for the patient. If your doctor has prescribed Escitalopram to a patient under 18 years of age and you wish 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. 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 medicines

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

Inform 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. After finishing Escitalopram, 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.
• Medicines that decrease potassium and magnesium levels in the blood, as this may increase the risk of heart rhythm disorders.
• Cimetidine, esomeprazole, lansoprazole, and omeprazole (used for the treatment of stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause an increase in Escitalopram blood levels.
• 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).
• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably check the blood coagulation time at the start and end of treatment with Escitalopram to ensure that the anticoagulant dose is still adequate.
• Mefloquine (used for the treatment of malaria), bupropion (used for the treatment of depression), and tramadol (used for the treatment of intense pain) due to the possible risk of reducing the seizure threshold.
• Neuroleptics (medicines used for the treatment of schizophrenia, psychosis) due to the possible risk of reducing the seizure threshold and antidepressants.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). It may be necessary to adjust the dose of Escitalopram.

DO NOT TAKE Escitalopram TecniGenif you are taking medicines for heart rhythm disorders or if you are taking medicines that may affect the heart rhythm, such as antiarrhythmics class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, medicines against malaria, particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have doubts 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 medicines, it is not recommended to combine Escitalopram TecniGen and alcohol, although it is not expected that Escitalopram TecniGen will interact with alcohol.

Pregnancy, breastfeeding, and fertility

Tell 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 stage of pregnancy, there may be a greater risk of abundant vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking escitalopram to advise you.

If you take Escitalopram during the last 3 months of your pregnancy, you should be aware that the following effects may be observed in the newborn baby: breathing difficulties, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or weakness, intense reflexes, tremors, restlessness, irritability, lethargy, constant crying, and difficulty sleeping. 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, medicines like Escitalopram may increase the risk of a serious condition in babies 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, you must inform your doctor or midwife immediately.

If Escitalopram TecniGen is used during pregnancy, it should never be discontinued abruptly.

Citalopram, a medicine like escitalopram, has been shown in animal studies to reduce sperm quality. This could theoretically affect fertility, but the impact on human fertility has not been observed yet.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Escitalopram TecniGen contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

3. How to take Escitalopram TecniGen

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 later 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.

Elderly patients (over 65 years old)

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 old)

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

You can take Escitalopram 15 mg tablets 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 TecniGen 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 TecniGen for the time recommended by your doctor. If you interrupt the treatment too early, the symptoms may reappear. It is recommended that the treatment continues for at least 6 months after you feel better.

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 emergency department of the nearest hospital. Do this even if you do not notice any discomfort. The signs of overdose may be dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rate, decrease in blood pressure, and changes in body fluid balance.

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

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

If you forget to take Escitalopram TecniGen

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 the usual routine.

If you interrupt treatment with Escitalopram TecniGen

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

When you stop taking Escitalopram, especially if it is sudden, you may experience withdrawal symptoms. These are common when treatment with Escitalopram is suspended. The risk is greater when Escitalopram has been used for a long time, in high doses, or when the dose is reduced too quickly. Most people find that these symptoms are mild and disappear on their own within two weeks. However, in some patients, they can be intense or prolonged (2-3 months or more). If you experience severe withdrawal symptoms when you stop taking Escitalopram, please contact your doctor. They may ask you to start taking your tablets again and stop them more slowly.

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

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

4. Possible adverse effects

Like all medications, this medication can produce adverse effects, although not all people experience them.

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

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

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

• Unusual bleeding, including gastrointestinal bleeding

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

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

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

• Difficulty urinating
• Seizures (attacks), see also the section "Warnings and precautions"
• Yellowing of the skin and whites of the eyes, signs of liver function alteration/hepatitis
• Rapid or irregular heartbeats or feeling of fainting, symptoms that may indicate a life-threatening condition known as Torsade de Pointes.

In addition to the above, the following adverse 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):

• Nasal congestion or mucous (sinusitis)
• Decreased or increased appetite
• Anxiety, restlessness, abnormal dreams, difficulty sleeping, feeling sleepy, dizziness, yawning, tremors, and itching or tingling 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):

• Annoying itching (urticaria), skin rash, itching (pruritus)
• Involuntary teeth grinding, agitation, nervousness, anxiety attacks, state of confusion
• Taste disturbances, sleep disturbances, fainting (syncope)
• Pupil dilation (mydriasis), visual disturbance, ringing in the ears (tinnitus)
• Hair loss
• Vaginal bleeding
• 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

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

• Thoughts of self-harm or suicidal thoughts, see also the section "Warnings and precautions"
• Decrease in sodium levels in the blood (symptoms are feeling dizzy and discomfort with muscle weakness or confusion)
• Dizziness when standing up due to low blood pressure (orthostatic hypotension).
• Altered liver function tests (increase in liver enzymes in the blood)
• Movement disorders (involuntary muscle movements)
• Painful erections (priapism)
• Coagulation disorders including skin and mucous membrane bleeding (ecchymosis) and low platelet count in the blood (thrombocytopenia)
• Sudden swelling of the skin or mucous membranes (angioedema)
• Increased urine output (inadequate secretion of ADH)
• Milk flow 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 heart rhythm (called QT interval prolongation), observed in the ECG, heart electrical activity.
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

In addition, other adverse effects are known to occur with drugs that work similarly to escitalopram (the active ingredient of Escitalopram TecniGen). These are:

• Increased urine output (inadequate secretion of ADH)
• Milk flow in women who are not breastfeeding

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Escitalopram TecniGen

Keep this medication out of 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 ºC.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Escitalopram TecniGen

• The active ingredient is escitalopram. Each film-coated tablet contains 15 mg of escitalopram (as escitalopram oxalate).
• The other ingredients 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 package contents

Escitalopram TecniGen 15 mg film-coated 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.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tecnimede España Industria Farmacéutica, S.A.

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

Manufacturer

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

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.es