ESCITALOPRAM DAVUR 15 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Escitalopram Davur15mg 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 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 Davur and what is it used for
2. What you need to know before you take Escitalopram Davur
3. How to take Escitalopram Davur
4. Possible side effects

5 Conservation of Escitalopram Davur

1. Contents of the pack and additional information

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

Escitalopram Davur contains the active substance escitalopram

Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs).

Escitalopram 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).

It may take a couple of weeks for you to start feeling better. Continue taking escitalopram even if it takes some time to notice an improvement.

You should consult a doctor if you get worse or if you do not improve.

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

Do not take Escitalopram Davur

-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 or have had an episode of altered heart rate (detected on an ECG, a test that evaluates heart function).
• If you are taking medicines for heart rhythm problems or that may affect heart rhythm (see section 2 "Other medicines and Escitalopram Davur")

Warnings and precautions

Consult your doctor or pharmacist before starting to take Escitalopram Davur.

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 for the first time (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 blood sugar control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic.
• If you have a decreased sodium level in the blood.
• If you have a history of bleeding disorders or if you develop unusual bruises, 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 heart problems or have recently had a heart attack.
• If your resting heart rate is slow and/or you know you may have a decrease in salt as a result of severe and prolonged diarrhea and vomiting (being sick) or use of diuretics.

• If you experience rapid or irregular heartbeats, fainting, collapse, or dizziness when standing up, which may indicate abnormal heart rhythm.

• If you have or have had eye problems, such as certain types of glaucoma (increased pressure in the eye).

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.

Medicines like escitalopram (called ISRN/IRSN) 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 sometimes have thoughts of harming or killing yourself. These may increase when you first start taking antidepressants, as all these medicines take 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 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. Also, you should know that in patients under 18 years, there is a greater risk of side effects such as suicidal attempts, suicidal ideas, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this type of medicine. Nevertheless, your doctor may prescribe escitalopram to patients under 18 years when they decide it is most convenient for the patient. If your doctor has prescribed escitalopram to a patient under 18 years 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 worsen or if you experience complications when patients under 18 years 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.

Other medicines and Escitalopram Davur

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 substances. 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 (see the section "Do not take escitalopram").
• 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.
• The antibiotic linezolid.
• Lithium (used in the treatment of manic-depressive disorder) and tryptophan.
• Sumatriptan and similar medicines (used for the treatment of migraine) and tramadol and similar medicines (opioids, used for severe pain). These increase the risk of side effects.
• 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). These may cause an increase in blood levels of escitalopram.
• St. John's Wort (Hypericum perforatum) - a medicinal plant used for depression.
• Aspirin and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or reduce the risk of thrombosis, also called anticoagulants). These may increase the tendency to bleeding.

Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably check your blood coagulation time at the start and end of treatment with escitalopram to check that the dose of anticoagulant is still adequate.

• Mefloquine (used for the treatment of malaria), bupropion (used to help quit smoking due to the possible risk of lowering the seizure threshold), and tramadol (used for the treatment of severe pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines for the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the seizure threshold.
• 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.
• Medicines that decrease potassium or magnesium levels in the blood, as this increases the risk of heart rhythm disorders, which pose a risk to life.
• Serotoninergic medicines, such as buprenorphine, as they may increase the risk of serotonin syndrome.

Do not take Escitalopram Davur if you are taking medicines for heart rhythm problems or if you are taking medicines that may affect 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). Contact your doctor for any additional questions.

Taking Escitalopram Davur with food, drinks, and alcohol

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 plan to become 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 floppiness, intense reflexes, tremors, restlessness, irritability, lethargy, constant crying, and difficulty sleeping. If your newborn has any of these symptoms, please contact your doctor immediately.

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

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

When taken during pregnancy, particularly in the last 3 months, medicines like Escitalopram Davur may increase the risk of a serious disease 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.

If you take Escitalopram Davur in the final stages of pregnancy, there may be a greater 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 is used during pregnancy, it should never be stopped abruptly.

It is expected that escitalopram will be excreted in breast milk.

Citalopram, a medicine similar to escitalopram, has been shown to reduce sperm quality in animal models. This effect could theoretically affect fertility, but to date, no impact on human fertility has been observed. Do not take Escitalopram Davur if you are breastfeeding unless you and your doctor have analyzed the benefits and risks involved.

Driving and using machines

It is advised not to drive or use machines 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 use machines.

Escitalopram Davur contains sodium

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

3. How to take Escitalopram Davur

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 normally recommended dose of escitalopram 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 starting dose of escitalopram 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 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 Disorders

The normally recommended dose of escitalopram 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 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)

The recommended starting dose of escitalopram is 5 mg taken as a single dose per day. The dose may be increased by your doctor up to 10 mg per day.

Use in Children and Adolescents

Escitalopram should not be used in children and adolescents under 18 years. For additional information, consult the section 2 "Warnings and Precautions".

Kidney Failure

Caution is advised in patients with severely decreased renal function. Take as prescribed by your doctor.

Liver Failure

Patients with liver problems should not receive more than 10 mg per day. Take as prescribed by your doctor.

Patients Considered as Slow Metabolizers of CYP2C19

Patients with this known genotype should not receive more than 10 mg per day. Take as prescribed by your doctor.

How to Take the Tablets

You can take escitalopram 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 medication without talking to your doctor first.

Continue taking escitalopram 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 Davur Than You Should

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 water balance. Bring the package of Escitalopram Davur if you go to the doctor or hospital.

If you take more doses of escitalopram 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 poisoning.

If You Forget to Take Escitalopram Davur

Do not take a double dose to make up for forgotten doses. If you forgot to take a dose, and you remember before going to bed, take it immediately. The next day, follow the usual routine.

If You Interrupt Treatment with Escitalopram Davur

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

When you stop taking escitalopram, especially if it is sudden, you may feel withdrawal symptoms. These are common when treatment with this medication 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 have severe withdrawal symptoms when you stop taking this medication, 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 irregular heartbeat.

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

4. Possible Adverse Effects

Like all medications, escitalopram can produce adverse effects, although not all people suffer from them.

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

If you have any of the following symptoms, contact your doctor or go to the hospital immediately.

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

• Unusual bleeding, including gastrointestinal bleeding.

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

• Swelling of the skin, tongue, lips, or face, or has difficulty breathing or swallowing (severe allergic reaction),
• High fever, agitation, confusion, tremors, and sudden muscle contractions, can be signs of a rare condition called serotonin syndrome.

Unknown (cannot be determined from available data):

• Difficulty urinating.
• Seizures (attacks), see also the section "Warnings and Precautions".
• Yellowing of the skin and whites of the eyes, are signs of liver function alteration/hepatitis.
• Experience rapid or irregular heartbeats or fainting, symptoms that may indicate a life-threatening condition known as Torsade de Pointes.
• Thoughts of harming yourself or thoughts of killing yourself, see also the section "Warnings and Precautions".
• Sudden swelling of the skin or mucous membranes (angioedema).

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

Very Common (At least 1 in 10 patients):

• Feeling dizzy (nausea)
• Headache

Common (At least 1 in 100 patients):

• Nasal congestion or mucous (sinusitis).
• Decrease or increase in appetite.
• Anxiety, agitation, abnormal dreams, difficulty falling asleep, 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, anxiety attacks, confusion.
• Sleep disturbances, taste 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 (At least 1 in 10,000 patients):

• Aggression, depersonalization, hallucinations.
• Slow heartbeat

Frequency Not Known (cannot be estimated from available data):

• 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).
• Signs of abnormal bleeding, e.g., from the skin or mucous membranes (ecchymosis) and low platelet count in blood (thrombocytopenia).
• Sudden swelling of the skin or mucous membranes (angioedema).
• Increased secretion of the hormone called ADH, causing water retention in the body and dilution of the blood, reducing the amount of sodium (inadequate ADH secretion).
• Increased levels of the hormone prolactin in the blood.
• Milk flow in women who are not breastfeeding
• Mania
• An increased risk of bone fractures has been observed in patients treated with this type of medication.
• Alteration of heart rhythm (called "prolongation of the QT interval", observed in the ECG, electrical activity of the heart).
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy and Breastfeeding" in section 2 for more information.

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

• Motor restlessness (akathisia).
• Lack of appetite

Reporting of Adverse Effects:

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

5. Conservation of Escitalopram Davur

Keep out of sight and reach of children.

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

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.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications at the SIGRE point of the pharmacy. In case of 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 Davur 15 mg film-coated tablets

• The active ingredient is escitalopram (as oxalate). Each tablet contains 15 mg of escitalopram.
• The other ingredients 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 Package Contents

Escitalopram Davur 15 mg are biconvex, white, scored on one side, film-coated tablets, marked on one side with an "S" (on the left side of the score line) and with a "C" (on the right side) and the other side marked with "15".

They are available in packages of 28 and 56 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

Anabel Segura 11. Edificio Albatros B, 1ª planta.

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:March 2025

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