Escitalopram teva 20 mg comprimidos recubiertos con pelicula efg

PROSPECTO: INFORMATION FOR THE USER

Escitalopram Teva20mg film-coated tablets

Escitalopram

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• 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 or pharmacist, even if they are not listed in this prospectus. See section 4.

1.What is Escitalopram Teva 20mg film-coated tablets and for what they are used

2.What you need to know before starting to take Escitalopram Teva 20mg film-coated tablets

3.How to take Escitalopram Teva 20mg film-coated tablets

4.Possible adverse effects

5Storage of Escitalopram Teva 20mg film-coated tablets

6.Contents of the package and additional information

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 known as 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 conditions.

Do not take Escitalopram Teva 20 mg tablets:

-If you are allergic (hypersensitive) to escitalopram or to any of the other ingredients of this medicine (listed in section 6).

-If you are taking other medicines that belong to the group called 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 had any type of heart rhythm disorder since birth or have ever had an episode of this type (this is observed with an electrocardiogram, a test that serves to evaluate how the heart works).
• If you are taking medicines for heart rhythm disorders or that may affect 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 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. Treatment with Escitalopram Teva may alter blood sugar control. You may need to adjust your insulin and/or oral hypoglycemic dose.
• If you have a low sodium level in your blood.
• If you are prone to 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, when at rest, your heart beats slowly (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 heartbeats are rapid or irregular or have had fainting spells or dizziness when getting up from a sitting or lying position. This could indicate that you have a heart rhythm disorder.

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.

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

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may occasionally have thoughts of harming or killing yourself. These may increase when you first start taking antidepressants, as it takes time for them to start working, usually around two weeks, although in some cases it may take longer.Youmay be more likely to have these thoughts:

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

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

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

Children and adolescents

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

A higher risk of bone fractures has been observed in patients treated with this type of medication.

Angle-closure glaucoma

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

Other medicines and Escitalopram Teva

“Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

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

• “Non-selective monoamine oxidase inhibitors (MAOIs)”, containing 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 stopping escitalopram, 7 days should pass before taking any of these medicines (see also the section “Do not take escitalopram”).
• “Reversible MAO-A inhibitors” containing moclobemide (used for the treatment of depression).
• “Irreversible MAO-B inhibitors”, containing selegiline (used in the treatment of Parkinson's disease). These increase the risk of side effects.
• Tryptophan (dietary supplement that is converted to serotonin during metabolism).
• Other antidepressants, including other ISRS such as clomipramine, nortriptyline, desipramine, and imipramine.
• Medicines called triptans, such as sumatriptan, used for the treatment of migraines 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 illnesses.
• 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 lowering the seizure threshold.
• Mefloquine (used for the treatment of malaria), bupropion (used to help quit smoking due to the possible risk of lowering the seizure threshold.
• St. John's Wort (Hypericum perforatum) - medicinal plant used for depression.
• Warfarin, dipiridamol, and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably check your blood clotting time at the start and end of treatment with Escitalopram Teva to ensure that the anticoagulant dose is still adequate.
• Cimetidine, omeprazole, and lansoprazole (used for the treatment of stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), ticlopidine (used to reduce the risk of stroke). They may cause an increase in Escitalopram Teva blood levels.
• Flecainide, propafenone, and medicines used for the treatment of irregular heartbeat.
• Medicines that induce hypopotasemia / hypomagnesemia

Care should be taken with the concomitant use of products that induce cardiac problems.

• Medicines that are serotoninergic, 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 heart rhythm, for example antiarrhythmics class IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, certain antimalarials, particularly halofantrine), certain antihistamines (astemizole, mizolastine).

If you are unsure about this, consult your doctor.

Taking Escitalopram Teva 20 mg 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 to interact with alcohol.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using 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: 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 sleeping. 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 so they can advise you.

Escitalopram should not be stopped abruptly during pregnancy.

Make sure your midwife and/or doctor know 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 illness in newborns, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start within 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.

Escitalopram, a medicine 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 medicine.

Driving and operating machinery

It is recommended not to drive or operate machinery until you know how the treatment with escitalopram affects you. This may cause dizziness, fatigue, confusion, or hallucinations (strange visions or sounds). If you experience any of these side effects, do not drive or operate machinery.

Escitalopram Teva contains sodium

This medicine 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. In case of doubt, consult your doctor or pharmacist again.

Adults

Depression

The usual 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 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 usually 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 medication.

Generalized Anxiety Disorder

The usually 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 usually 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.

Older 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 old. For additional information, see 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 notch facing upwards. The tablets can be broken by pressing down on each end of the tablet with your index fingers.

Treatment Duration

You may feel better in a couple of weeks. Continue with the treatment even if you start feeling better before the expected time.

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

If you take more Escitalopram Teva 20 mg tablets than you should

If you take more doses of Escitalopram Teva than prescribed, contact your doctor immediately, go to the nearest hospital emergency room, or consult the Toxicological Information Service, phone 91 562 04 20. Do this even if you do not observe any symptoms or signs of overdose. Some 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. Bring the Escitalopram Teva packaging with you to the doctor or hospital.

If you forget to take Escitalopram Teva 20 mg tablets

Do not take a double dose to compensate for the missed doses. If you forget to take a dose and remember before going to bed, take it immediately. The next day, follow your usual schedule. If you remember during the night or the next day, leave the missed dose and follow your usual schedule.

If you interrupt the treatment with Escitalopram Teva 20 mg tablets

Do not stop taking Escitalopram Teva until your doctor tells you to. When you have completed your treatment course, it is usually recommended to gradually reduce the Escitalopram Teva dose over several weeks.

When you stop taking Escitalopram Teva, especially if you stop suddenly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram Teva is discontinued. The risk is higher when Escitalopram Teva 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 can be intense or prolonged (2-3 months or more). If you experience severe withdrawal symptoms when stopping Escitalopram Teva, contact your doctor. Your doctor may ask you to take your tablets again and taper off them more slowly.

Withdrawal symptoms include: feeling of dizziness (unstable or loss of balance), feeling of tingling, feeling of prickling, and (less frequently) electric shock, even in the head, sleep disturbances (too intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of nausea (dizziness), sweating (including 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 questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, Escitalopram Teva20mg can cause side effects, although not everyone will experience them.

Side effects are generally mild and 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 as you start to feel better.

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

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

• Unusual bleeding, including gastrointestinal bleeding.

Very rare (at least 1 in 10,000 patients):

• 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 feel this way, contact your doctor.

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

• Difficulty urinating.
• Seizures (convulsions), see also the section “Be especially careful with Escitalopram Teva 20mg tablets”.
• Yellowish skin and whitening of the eyes, which are signs of liver function alteration/hepatitis.
• Fast and irregular heartbeats or a feeling of fainting, as they may be symptoms of a serious heart condition called torsade de pointes.

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

Very common (at least 1 in 10 patients):

• Feeling dizzy (nausea)
• Headache

Common (at least 1 in 100 patients):

• Blockage or nasal mucus (sinusitis).
• Decreased or increased appetite.
• Anxiety, agitation, abnormal dreams, difficulty falling asleep, feeling drowsy, dizziness, yawning, tremors, skin itching.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthritis and myalgia).
• Sexual dysfunction (in men, delayed ejaculation, erection problems, decreased sexual behavior, and women may experience difficulty reaching orgasm).
• Fatigue, fever.
• Weight gain

Rare (at least 1 in 1,000 patients):

• Hives, skin rash, itching (pruritus).
• Teeth chattering, agitation, nervousness, anxiety attack, state of confusion, panic attack.
• Sleep disturbances, taste alterations, fainting (syncope).
• Pupil dilation (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 (at least 1 in 10,000 patients):

• Aggression, depersonalization, hallucinations.
• Low heart rate

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

• Thoughts of self-harm or suicidal thoughts, see also the section “Be especially careful with escitalopram”.
• 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 (increased 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 skin or mucous membrane swelling (angioedema).
• Inadequate ADH secretion, resulting in increased urine output.
• Milk flow in women who are not breastfeeding
• Mania
• Alteration of heart rhythm (called QT interval prolongation, observed by electrocardiogram).
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy and lactation” in section 2 for more information.

Other side effects have been reported with medications that work similarly to escitalopram. These are:

• Motor restlessness (akathisia).
• Anorexia

If you consider any of the side effects you are experiencing to be severe or if you notice any side effects 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 System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

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

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medication at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medication. By doing so, you will help protect the environment.

Composition ofEscitalopram Teva 20mg film-coated tablets

• The active ingredient is escitalopram (as oxalate). Each tablet contains 25.56mg of escitalopram (as oxalate).
• The other components are: microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, stearic acid, magnesium stearate, hypromellose (E464), titanium dioxide (E171), and macrogol 400.

Appearance of the product and contents of the packaging

Escitalopram Teva 20mg are round, biconvex, white, scored on one face, film-coated, marked on one face with a “9” (on the left side of the score) and with a “3” (on the right side) and the other face marked with “7463”.

Escitalopram Teva 20mg film-coated tablets are available in formats of 28 and 56 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Teva Pharma, S.L.U.

Anabel Segura 11. Edificio Albatros B.

28108 Alcobendas. Madrid

Spain

Responsible for manufacturing:

Teva Operations Poland Sp. z.o.o.

Ul. Mogilska 80

31-546 Cracow, Poland

Date of the last review of this leaflet: November 2021

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.gob.es/