ESCITALOPRAM TEVA 10 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Escitalopram Teva10mg film-coated tablets EFG

Escitalopram

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Escitalopram Teva 10 mg film-coated tablets and what is it used for
2. What you need to know before you take Escitalopram Teva 10 mg film-coated tablets
3. How to take Escitalopram Teva 10 mg film-coated tablets
4. Possible side effects

5Storage of Escitalopram Teva 10mg film-coated tablets

1. Contents of the pack and other information

1. What is Escitalopram Teva 10 mg film-coated tablets and what is it used for

Escitalopram Teva 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).

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

2. What you need to know before you take Escitalopram Teva 10 mg film-coated tablets

Do not take Escitalopram Teva 10 mg film-coated tablets:

-If you are allergic (hypersensitive) 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 MAO inhibitors, including selegiline (used for the treatment of Parkinson's disease), moclobemide (used for the treatment of depression), and linezolid (an antibiotic)

• If you have been born with any type of heart rhythm disorder or have ever suffered from any episode of this type (this is observed with an electrocardiogram, a test used to evaluate how the heart works).
• If you are taking medicines for heart rhythm disorders or that may affect the heart rhythm (see section 2 "Other medicines and Escitalopram Teva")

Warnings and precautions

Consult your doctor or pharmacist before starting to take Escitalopram Teva. In particular, inform your doctor:

• If you have epilepsy. Your doctor may need to adjust your dose. Treatment with Escitalopram Teva 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 Teva may alter glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic agent.
• If you have a decreased level of sodium in the blood.
• If you tend to develop bleeding or bruising easily or 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 when you are at rest (this is known as bradycardia) and/or you think your body may be losing salt, for example, because you have had intense diarrhea and vomiting for several days or because you have used diuretics (medicines to urinate).
• If you have noticed that your heart beats quickly or irregularly 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.

Please note:

Some patients with manic-depressive illness may enter a manic phase. This is characterized by an uncommon and rapid change of ideas, disproportionate joy, and excessive physical activity. If you experience this, contact your doctor.

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

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

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may occasionally have thoughts of harming or killing yourself. These may increase when 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. Youwould be more likely to have these thoughts:

• If you have previously had thoughts of killing yourself or 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 or killing yourself, contact your doctor or go directly to a hospital.

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

Children and adolescents

Escitalopram should not normally be used in the treatment of children and adolescents under 18 years of age. Also, you should know that in patients under 18 years of age, there is a greater risk of adverse effects such as suicidal attempts, suicidal ideas, and hostility (predominantly aggression, confrontational behavior, and irritation) when taking this class of medicines. Nevertheless, your doctor may prescribe escitalopram 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 want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms described above progress or if you experience complications when patients under 18 years of age are taking escitalopram. Also, the long-term effects on safety, related to growth, maturity, and cognitive and behavioral development of escitalopram in this age group, have not yet been demonstrated.

An increased risk of bone fractures has been observed in patients treated with this type of medicine.

Angle-closure glaucoma

SSRIs, including escitalopram, may have an effect on pupil size, leading to mydriasis (increased pupil size). This mydriatic effect has the potential to reduce the angle of the eye, leading to an increase in intraocular pressure and angle-closure glaucoma, especially in patients who are predisposed. Escitalopram should therefore be used with caution in patients with angle-closure glaucoma or a history of glaucoma.

Other medicines and Escitalopram Teva

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

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

• Non-selective monoamine oxidase inhibitors (MAOIs), which contain phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active ingredients, used for the treatment of depression. 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, which contain moclobemide (used for the treatment of depression).
• Irreversible MAO-B inhibitors, which contain selegiline (used in the treatment of Parkinson's disease). These increase the risk of side effects.
• Tryptophan (dietary supplement that is converted into serotonin during metabolism).
• Other antidepressants, including other SSRIs, such as clomipramine, nortriptyline, desipramine, and imipramine.
• Medicines called triptans, such as sumatriptan, used for the treatment of migraine, and tramadol (used for severe pain). These increase the risk of side effects.
• Medicines such as lithium, risperidone, thioridazine, or haloperidol used in the treatment of psychiatric diseases.
• Acetylsalicylic acid (aspirin), ibuprofen, or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) for pain relief and inflammation.
• Neuroleptics (medicines for the treatment of schizophrenia, psychosis) and other antidepressants, due to the possible risk of reducing the seizure threshold.
• Mefloquine (used for the treatment of malaria), bupropion (used to help quit smoking due to the possible risk of reducing the seizure threshold.
• St. John's Wort (Hypericum perforatum) - a medicinal plant used for depression.
• 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 Teva to check that the anticoagulant dose is still adequate.
• Cimetidine, omeprazol, and lansoprazol (used for the treatment of stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), ticlopidine (used to reduce the risk of stroke). These may cause an increase in blood levels of Escitalopram Teva.
• Flecainide, propafenone, and medicines used for the treatment of irregular heartbeat.
• Medicines that induce hypokalemia/hypomagnesemia

Caution should be exercised with concomitant use of products that induce cardiac problems.

• Serotoninergic medicines, such as buprenorphine, as they may increase the risk of serotonin syndrome.

Do not take Escitalopram Teva if you are taking medicines for any heart rhythm disorder 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 halofantrina), certain antihistamines (astemizole, mizolastine).

If you have doubts about this, consult your doctor.

Taking Escitalopram Teva 10 mg film-coated tablets with food and drinks

Escitalopram tablets can be taken with or without food.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take escitalopram if you are pregnant unless you and your doctor have analyzed the risks and benefits involved.

If you take escitalopram during the last 3 months of pregnancy, consult your doctor, as 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 floppiness, intense reflexes, tremors, restlessness, irritability, lethargy, constant crying, and sleep difficulties. If your newborn baby has any of these symptoms, please contact your doctor immediately.

If you take Escitalopram Teva in the final stages of 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 know that you are taking escitalopram to be able to advise you.

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

Make sure your midwife and/or doctor knows that you are taking Escitalopram Teva.

When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Escitalopram Teva may increase the risk of a serious disease in babies called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start during the first 24 hours after the baby is born. If this happens to your baby, contact your midwife and/or doctor immediately.

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

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

It is recommended not to drive or use machines until you know how the treatment with escitalopram can affect you. This can cause dizziness, fatigue, confusion, or hallucinations (strange visions or sounds). If you have any of these side effects, do not drive or use machines.

Escitalopram Teva 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 Teva 10 mg film-coated tablets

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults

Depression

The normally recommended dose of Escitalopram Teva 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 Teva is 5 mg as a single dose per day during 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 Teva 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 medicine.

Generalized Anxiety Disorders

The normally recommended dose of Escitalopram Teva 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 Teva 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

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

Use in Children and Adolescents

Escitalopram Teva should not be used in the treatment of children and adolescents under 18 years. For additional information, consult section 2 "Before taking Escitalopram Teva".

You can take Escitalopram Teva with or without food. Swallow the tablets with water. Do not chew them.

If necessary, you can break the tablets in half to help swallow them, placing them 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 with the treatment even if you start to feel better before the expected time.

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

If you take more Escitalopram Teva 10 mg tablets than you should

If you take more doses of Escitalopram Teva than prescribed, contact your doctor immediately, go to the emergency department of the nearest hospital, or consult the Toxicology Information Service, phone 91 562 04 20. Do this even if you do not observe discomfort or signs of intoxication. Some signs of overdose may be dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rhythm, decrease in blood pressure, and changes in body hydroelectrolytic balance. Bring the packaging of Escitalopram Teva if you go to the doctor or hospital.

If you forget to take Escitalopram Teva 10 mg tablets

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 stop treatment with Escitalopram Teva 10 mg tablets

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

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

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

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

4. Possible side effects

Like all medicines, Escitalopram Teva 10 mg can cause side effects, although not all people suffer from them.

Side effects are generally mild and 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 have any of the following side effects during treatment:

Uncommon (At least 1 in 1,000 patients):

• Unusual bleeding, including gastrointestinal bleeding.

Rare (At least 1 in 10,000 patients):

• 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, they may be signs of a rare condition called serotonin syndrome. If you feel this way, contact your doctor.

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

• Difficulty urinating.
• Seizures (attacks), see also the section "Special warnings and precautions for use of Escitalopram Teva 10 mg tablets").
• Yellow skin and eyes, are signs of liver function alteration/hepatitis.
• Rapid and irregular heartbeats or feeling of fainting, as they could be symptoms of a serious heart problem known as torsades de pointes.

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

Very common (At least 1 in 10 patients):

• Feeling nauseous (nausea)
• Headache

Common (At least 1 in 100 patients):

• Nasal congestion or mucous (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty sleeping, feeling sleepy, dizziness, yawning, tremors, itching of the skin.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual disturbances (in men, delayed ejaculation, erection problems, decreased sexual behavior, and women may experience difficulty reaching orgasm).
• Fatigue, fever.
• Weight gain

Uncommon (At least 1 in 1,000 patients):

• Hives, skin rash, itching (pruritus).
• Teeth grinding, agitation, nervousness, panic attacks, state of confusion, panic attack.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbance, ringing in the ears (tinnitus).
• Hair loss
• Vaginal bleeding
• Weight loss
• Fast heart rate
• Swelling of arms and legs
• Nosebleeds

Rare (At least 1 in 10,000 patients):

• Aggression, depersonalization, hallucinations.
• Slow heart rate

Frequency not known (cannot be estimated from the available data):

• Thoughts of harming yourself or thoughts of killing yourself, see also the section "Special warnings and precautions for use of escitalopram".
• 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).
• 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 output (inadequate ADH secretion).
• Milk flow in non-lactating women
• Mania
• Alteration of heart rhythm (called QT interval prolongation, observed by electrocardiogram).
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy and lactation" in section 2 for more information.

Other side effects are known to occur with drugs that work similarly to escitalopram. These are:

• Motor restlessness (akathisia).
• Anorexia

If you consider that any of the side effects you suffer is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

.

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 not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Escitalopram Teva 10 mg film-coated tablets

Keep out of sight and reach of children.

Store below 30°C. Store in the original packaging to protect from light and moisture.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and further information

Composition of Escitalopram Teva 10 mg film-coated tablets

• The active ingredient is escitalopram (as oxalate). Each tablet contains 12.78 mg of escitalopram (as oxalate).
• The other ingredients are: microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, stearic acid, magnesium stearate, hypromellose (E464), titanium dioxide (E171), and macrogol 400.

Appearance and packaging of the product

Escitalopram Teva 10 mg are film-coated tablets, round, biconvex, white, marked with a "10" on one side and scored on the other.

Escitalopram Teva 10 mg film-coated tablets are available in packs of 28 and 56 tablets.

Marketing authorization holder and manufacturer

Holder:

Teva Pharma, S.L.U.

Anabel Segura 11. Edificio Albatros B.

28108 Alcobendas. Madrid

Spain

Manufacturer:

Teva Operations Poland Sp. z.o.o.

Ul. Mogilska 80

31-546 Cracovia

Poland

Date of the last revision of this leaflet: November 2021

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