Escitalopram Tecnigen 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Escitalopram TecniGen 10 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Escitalopram TecniGen contains escitalopram and is used 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).

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

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

Do not take Escitalopram TecniGen

• If you are allergic to escitalopram or any of the other components of this medicine (listed in section 6).
• If you are taking other medicines belonging to the group known as MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), or linezolid (an antibiotic).
• If you have a congenital heart rhythm disorder or have ever experienced episodes of such a disorder (this is detected by electrocardiogram, a test used to assess heart function).
• If you are taking medicines for heart rhythm disorders or medicines that may affect heart rhythm (see section 2 “Use of Escitalopram TecniGen with other medicines”).

Warnings and precautions

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

Please inform your doctor if you have any other disorders or illnesses, as your doctor may need to take them into account. Specifically, inform your doctor:

• If you have epilepsy. Treatment with Escitalopram should be discontinued if seizures occur or if you notice an increase in seizure frequency (see also section 4 “Possible side effects”).
• If you have hepatic or renal impairment. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram may affect blood glucose control. Adjustment of insulin and/or oral hypoglycemic agent dosage may be necessary.
• 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 artery disease.
• If you have or have had heart problems or have recently suffered a heart attack.
• If your heart beats slowly while at rest and/or you suspect your body may be losing salts, for example due to severe diarrhea and vomiting over several days (feeling unwell) or because you are taking diuretics (medicines to increase urine production).
• If you have noticed rapid or irregular heartbeats, or have experienced fainting or dizziness when standing up from a sitting or lying position. This could indicate a heart rhythm disorder.
• If you have eye problems such as certain types of glaucoma (increased pressure in the eye).

Some medicines in the same class as Escitalopram TecniGen (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Please note:

Some patients with bipolar disorder may enter a manic phase. This is characterized by unusually rapid and frequent changes in thoughts, disproportionate happiness, and excessive physical activity. If you experience this, contact your doctor.

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

Suicidal thoughts 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 thoughts may increase when you first start taking antidepressants, as all such medicines require time to begin working—usually about two weeks, although in some cases it may take longer.

You are more likely to have such thoughts:

• If you have previously had suicidal thoughts or thoughts of self-harm.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders treated with antidepressants.

If at any time you have thoughts of self-harm or suicide, contact your doctor or go directly to a hospital.

It may be helpful for you to tell a family member or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them whether they think your depression or anxiety disorder has worsened or if they are concerned about changes in your behavior.

Use in children and adolescents under 18 years of age

Escitalopram should not normally be used to treat children and adolescents under 18 years of age. Also, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Escitalopram to patients under 18 years of age if they decide it is the most appropriate treatment. If your doctor has prescribed Escitalopram to a patient under 18 years of age and you wish to discuss this decision, please contact your doctor again. You must inform your doctor if any of the symptoms described above worsen or become complicated while patients under 18 years of age are taking Escitalopram. In addition, the long-term effects on safety, growth, maturation, and cognitive and behavioral development of Escitalopram in this age group have not yet been fully established.

Use of Escitalopram TecniGen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• "Non-selective monoamine oxidase inhibitors (MAOIs)" containing phenelzine, iproniazid, isocarboxazide, nialamide, or tranylcypromine as active ingredients. If you have taken any of these medicines, you must wait 14 days before starting Escitalopram. After stopping Escitalopram, 7 days must pass before starting any of these medicines.
• "Reversible selective 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 bipolar disorder) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medicines (used to treat migraine) and tramadol (used for severe pain). These increase the risk of side effects.
• Medicines that reduce blood potassium and magnesium levels, as they 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 (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may increase blood levels of Escitalopram.
• St. John's wort (Hypericum perforatum)—a herbal remedy used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or reduce the risk of thrombosis, also known as anticoagulants).
• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also known as anticoagulants). Your doctor will likely monitor your blood clotting time at the beginning and end of treatment with Escitalopram to ensure your anticoagulant dose remains appropriate.
• 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 (medicines used to treat schizophrenia, psychosis), due to the possible risk of lowering the seizure threshold, and other antidepressants.
• Flecainide, propafenone, and metoprolol (used for cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of Escitalopram may need to be adjusted.

DO NOT TAKE Escitalopram TecniGen if you are taking medicines for heart rhythm disorders or medicines that may affect heart rhythm, such as class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarials, particularly halofantrine), or certain antihistamines (astemizole, mizolastine). If you have any doubts about this, consult your doctor.

Taking Escitalopram TecniGen with food, drinks, and alcohol

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

As with many medicines, combining Escitalopram TecniGen with alcohol is not recommended, although no interaction between Escitalopram TecniGen and alcohol is expected.

Pregnancy, breastfeeding, and fertility

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

If you take escitalopram in late pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking escitalopram so they can advise you appropriately.

If you take Escitalopram during the last three months of pregnancy, the following effects may occur in the newborn baby: breathing difficulties, bluish skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, exaggerated reflexes, tremors, restlessness, irritability, lethargy, constant crying, drowsiness, and sleep difficulties. If your newborn baby shows any of these symptoms, please contact your doctor immediately.

Ensure that your doctor or midwife knows you are taking Escitalopram. Medicines like Escitalopram, when taken during pregnancy—particularly during the last three months—may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, inform your doctor or midwife immediately.

If Escitalopram TecniGen is used during pregnancy, it must never be stopped abruptly.

Citalopram, a medicine similar to escitalopram, has shown in animal studies to reduce sperm quality. Theoretically, this could affect fertility, but no impact on human fertility has been observed so far.

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 machinery until you know how Escitalopram affects you.

Escitalopram TecniGen contains sodium

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

3. How to take Escitalopram TecniGen

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults

Depression

The normally recommended dose of Escitalopram TecniGen is 10 mg taken as a single daily dose. Your doctor may increase this dose up to a maximum of 20 mg per day.

Panic disorder

The initial dose of Escitalopram TecniGen is 5 mg as a single daily dose for the first week before increasing the dose to 10 mg per day. Your doctor may subsequently increase the dose 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 daily dose. Your doctor may reduce your dose to 5 mg per day or increase it up to a maximum of 20 mg per day, depending on your response to the medication.

Generalized anxiety disorder

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

Elderly patients (over 65 years of age)

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

Children and adolescents (under 18 years of age)

Escitalopram TecniGen should normally not be given to children and adolescents. For further information, please see section 2 “What you need to know before taking Escitalopram TecniGen”.

You may take Escitalopram 10 mg tablets with or without food. Swallow the tablets with water. Do not chew them, as they have a bitter taste.

If necessary, you may split the tablets by placing the tablet on a flat surface with the score side facing upwards. The tablets can be broken by pressing down on each end with your index fingers.

Duration of treatment

It may take a few weeks before you start to feel better. Continue taking Escitalopram TecniGen even if you begin to feel better before the expected time.

Do not change the dose of the medicine without first speaking to your doctor.

Continue taking Escitalopram TecniGen for as long as your doctor recommends. If you stop treatment too early, symptoms may return. It is recommended that treatment continues for at least 6 months after you feel well again.

If you take more Escitalopram TecniGen than you should

If you take more Escitalopram TecniGen than prescribed, contact your doctor immediately or go to the nearest hospital emergency department. Do this even if you do not notice any discomfort. Signs of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rate, decreased blood pressure, and disturbances in the body's fluid and electrolyte balance.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 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 missed doses. If you forget to take a dose and remember before going to bed, take it immediately. Then continue as usual the next day. If you remember during the night or the following day, skip the missed dose and continue as usual.

If you stop taking Escitalopram TecniGen

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

When you stop taking Escitalopram, especially abruptly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram is discontinued. 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 within two weeks. However, in some patients they may be severe 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 resume taking your tablets and taper them more slowly.

Withdrawal symptoms include: dizziness (feeling unsteady or off balance), tingling sensations, burning sensations, and (less frequently) electric shock-like sensations, even in the head; sleep disturbances (overly vivid dreams, nightmares, inability to sleep); restlessness; headache; dizziness (nausea); sweating (including night sweats); feelings of unease or agitation; tremor (shakiness); feelings of confusion or disorientation; feelings of anxiety or irritability; diarrhea (loose stools); visual disturbances; rapid pulse or palpitations.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects usually disappear after a few weeks of treatment. Please be aware that many of these effects may be symptoms of your illness and will therefore improve as 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 swelling of the skin, tongue, lips, or face, or have difficulty breathing or swallowing (allergic reaction), contact your doctor or go to hospital immediately.
• If you develop high fever, agitation, confusion, tremors, and sudden muscle contractions, these may be signs of a rare condition called serotonin syndrome. If you experience these symptoms, contact your doctor.

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

• Difficulty passing urine
• Seizures (fits), see also section “Warnings and precautions”
• Yellowing of the skin and whites of the eyes, signs of liver dysfunction/hepatitis
• Rapid or irregular heartbeat or feeling faint, symptoms which 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 runny nose (sinusitis)
• Decreased or increased appetite
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, feeling drowsy, dizziness, yawning, tremors, and itching or tingling of the skin
• Diarrhoea, constipation, vomiting, dry mouth
• Increased sweating
• Muscle and joint pain (arthralgia and myalgia)
• Sexual disturbances (delayed ejaculation, problems with erection, decreased sexual activity, and women may experience difficulty achieving orgasm)
• Fatigue, fever
• Weight gain

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

• Itchy rash (urticaria), skin rash, itching (pruritus)
• Involuntary grinding of teeth, agitation, nervousness, panic attacks, confusion
• Taste disturbances, sleep disturbances, fainting (syncope)
• Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus)
• Hair loss
• Vaginal bleeding
• Weight loss
• Fast 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 (frequency cannot be estimated from the available data):

• Thoughts of harming yourself or suicidal thoughts, see also section “Warnings and precautions”
• Decreased sodium levels in the blood (symptoms include dizziness, malaise, muscle weakness, or confusion)
• Dizziness upon standing due to low blood pressure (orthostatic hypotension)
• Abnormal liver function tests (increased liver enzymes in the blood)
• Movement disorders (involuntary muscle movements)
• Painful erections (priapism)
• Bleeding disorders including skin and mucosal bleeding (ecchymosis) and low platelet levels in the blood (thrombocytopenia)
• Sudden swelling of the skin or mucous membranes (angioedema)
• Increased urine output (inappropriate ADH secretion)
• Milk flow in women who are not breastfeeding
• Mania
• An increased risk of bone fractures has been observed in patients taking this type of medicine
• Changes in heart rhythm (known as QT interval prolongation), observed on ECG, electrical activity of the heart
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage), see “Pregnancy, breastfeeding and fertility” in section 2 for more information.

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Escitalopram TecniGen

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Store below 25 ºC.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Escitalopram TecniGen

• The active substance is escitalopram. Each film-coated tablet contains 10 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 pack

Escitalopram TecniGen 10 mg tablets are elliptical, white, biconvex, and scored on both sides.

Escitalopram TecniGen 10 mg film-coated tablets are available in blister packs containing 28, 30, or 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, 2710-228 Sintra, Portugal

or

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro da Armada, 5, Condeixa-a-Nova, 3150-194 Sebal, Portugal

This leaflet has been reviewed in

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es