Leaflet: information for the user

Escitalopram Davur10mg film-coated tablets

Read this leaflet carefully before you start taking this medicine because 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Escitalopram Davur

3.How to take Escitalopram Davur

4.Possible side effects

5Storage of Escitalopram Davur

6. Contents of the pack and additional information

Escitalopram Davur contains the active ingredient escitalopram.

Escitalopram belongs to a group of antidepressants known as 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).

You may notice an improvement in a couple of weeks. Continue taking escitalopram even if it takes time to notice some improvement.

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

Do not take Escitalopram Davur

-If you are allergic to escitalopram or any of the other components of this medication (including those listed in section 6).

-If you are taking other medications that belong to the group called MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).

• If you have a history of birth or have experienced an episode of heart rhythm alteration (detected on an ECG, a test that evaluates heart function).
• If you are taking medications for heart rhythm problems or that may affect heart rhythm, (see section 2 “Other medications 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 condition or disease, as your doctor may need to take it into account. In particular, inform your doctor:

• If you have epilepsy. The treatment with escitalopram should be interrupted if seizures occur or if you observe an increase in seizure frequency for the first time (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. The treatment with escitalopram may alter blood sugar control. You may need to adjust your insulin and/or oral hypoglycemic dose.
• If you have low sodium levels in your blood.
• If you have a history of bleeding disorders or if you develop unusual bleeding, or if you are pregnant (see “Pregnancy, breastfeeding, and fertility”).
• If you are receiving electroconvulsive therapy.
• If you have coronary 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 that you may have a decrease in salt as a result of severe and prolonged diarrhea and vomiting (being ill) or use of diuretics

• If you experience rapid or irregular heartbeats, dizziness, fainting, or dizziness when standing up, which may be indicative of 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 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 few weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Medications such as escitalopram (called ISRN/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 taking antidepressants for the first time, as all these medications require time to start working, usually around two weeks, although in some cases it may take longer.Youmay be more prone to having these types of 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 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 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 attitude.

Children and adolescents

Escitalopram should not be used normally in the treatment of children and adolescents under 18 years old. Also, you should know that in patients under 18 years old, there is a higher risk of adverse effects such as attempts to commit suicide, suicidal thoughts, 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. At the same time, the long-term effects regarding safety and related to growth, maturity, and cognitive and behavioral development of escitalopram in this age group have not yet been demonstrated.

Other medications and Escitalopram Davur

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

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

• “Non-selective monoamine oxidase inhibitors (MAOIs)”, containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active ingredients. If you have taken any of these medications, you will need to wait 14 days before starting to take escitalopram. After finishing escitalopram, 7 days should pass before taking any of these medications (see the section “Do not take escitalopram”).
• “Selective reversible 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 manic-depressive disorder) and tryptophan
• Sumatriptan and similar medications (used to treat migraines) and tramadol and similar medications (opioids, used to treat severe pain). These increase the risk of side effects.
• Cimetidine, omeprazole, and lansoprazole (used to treat 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 blood levels.
• St. John's Wort (Hypericum perforatum) - a medicinal plant used to treat depression.
• Aspirin and nonsteroidal anti-inflammatory drugs (medications used to

relieve pain or to reduce the risk of blood clots, also called anticoagulants). These may increase the risk of bleeding.

• Warfarin, dipiridamol, and phenprocoumon (medications used to reduce the risk of blood clots, also called anticoagulants). Your doctor will probably monitor your blood clotting time at the start and end of treatment with escitalopram to check that the anticoagulant dose is still adequate.
• Mefloquine (used to treat malaria), bupropion (used to help quit smoking due to the possible risk of lowering the seizure threshold and tramadol (used to treat severe pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medications for the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and ISRSs) 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). You may need to adjust your escitalopram dose.
• Medications that lower potassium or magnesium levels in the blood, as this increases the risk of abnormal heart rhythm, which is life-threatening.

• Medications that increase serotonin levels, such as buprenorphine, as they may increase the risk of serotonin syndrome.

Do not take Escitalopram Davur if you are taking medications for any heart rhythm-related disease or if you are taking medications that may affect heart rhythm, for example, antiarrhythmic class IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, medications against malaria, particularly halofantrine), certain antihistamines (astemizole, mizolastine). Contact your doctor for any additional consultation.

Taking Escitalopram Davur with food, drinks, and alcohol

Escitalopram tablets can be taken with or without food.

As with many medications, 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 if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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 falling asleep. If your newborn has any of these symptoms, please contact your doctor immediately.

Escitalopram Davur should not be stopped abruptly.

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

When taken during pregnancy, particularly in the last 3 months of pregnancy, medications like Escitalopram Davur may increase the risk of a serious disease in newborns, called persistent pulmonary hypertension of the newborn (PPHN), which makes the newborn 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 higher risk of excessive vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking escitalopram to advise you.

Escitalopram Davur should not be stopped abruptly.

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

Citalopram, a medication similar to escitalopram, has demonstrated reduced sperm quality in animal models. Theoretically, this effect could affect fertility, but to date, it has not been observed in human fertility.

Driving and operating machines

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

Escitalopram Davur contains sodium

This medication 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 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 further up to a maximum of 20 mg per day.

Social anxiety disorder

The usually 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 disorder

The usually 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 usually 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.

Older patients (65 years and older)

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 old. For additional information, see section 2 "Warnings and precautions".

Renal impairment

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

Hepatic impairment

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 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.

Continue taking escitalopram for the recommended time by your doctor. If you interrupt the treatment too soon, symptoms may reappear. It is recommended that treatment continue for at least 6 months after feeling well again.

If you take more Escitalopram Davur than you should

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 Davur packaging with you to the doctor or hospital.

If you take more doses of escitalopram than prescribed, contact your doctor immediately, go to the nearest hospital emergency room, or consult the Toxicology Information Service, phone 91 562 04 20. Do it even if you do not observe any discomfort or signs of intoxication.

If you forgot to take Escitalopram Davur

Do not take a double dose to compensate for the missed doses. If you forgot 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 Davur

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

When you stop taking escitalopram, especially if it is done abruptly, you may experience withdrawal symptoms. These are common when treatment with this medication is suspended. 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 in 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 this medication, contact your doctor. You can ask them to go back on their tablets and taper them off 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 (nausea), sweating (including night sweats), 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 doubts about the use of this product, ask your doctor or pharmacist.

Like all medications, escitalopram may cause side effects, although not everyone will experience them.

The side effects 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.

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

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

• Unusual bleeding, including gastrointestinal bleeding.

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

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

Unknown (cannot be determined from available data):

• Difficulty urinating.
• Seizures (convulsions), see also the section “Warnings and precautions”.
• Yellowing of the skin and the white of the eyes, which are signs of liver function alteration/hepatitis.
• You experience rapid or irregular heartbeats or dizziness, symptoms that may indicate a life-threatening condition known as Torsade de Pointes.
• Thoughts of self-harm or suicidal thoughts, see also the section “Warnings and precautions”.
• Sudden swelling of the skin or mucous membranes (angioedema).

In addition to the 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, erectile dysfunction, 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.
• Sleep disturbances, taste alterations, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Hair loss
• Vaginal bleeding
• Weight loss
• Rapid heart rate
• Swelling of arms and legs
• Nasal bleeding

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

• Aggression, depersonalization, hallucinations.
• Low heart rate

Unknown frequency (cannot be estimated from available data):

• Decreased sodium levels in the blood (symptoms are dizziness 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).
• Signs of abnormal bleeding, such as skin or mucous membrane bleeding (ecchymosis) and low platelet count in the blood (thrombocytopenia).
• Sudden swelling of the skin or mucous membranes (angioedema).
• Inadequate secretion of the hormone ADH, causing water retention in the body and dilution of the blood, reducing sodium levels (inadequate secretion of ADH).
• Increased levels of prolactin hormone in the blood.
• Milk flow in women who are not lactating
• Mania
• An increased risk of bone fractures has been observed in patients treated with this type of medication.
• Alteration of heart rhythm (known as “prolongation of the QT interval”, observed in the ECG, heart electrical activity).
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy and lactation” in section 2 for more information.

Other side effects that appear with medications similar to escitalopram are known:

• Motor restlessness (akathisia).
• Loss of appetite

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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products 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 below30°C. Store in the original packaging to protect it from light and humidity.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medication at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medication that you no longer need. By doing so, you will help protect the environment.

Composition ofEscitalopram Davur 10 mg coated tablets

• The active ingredient is escitalopram (as oxalate). Each tablet contains 10 mg of escitalopram.
• 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 content of the container

Escitalopram Davur 10mg are coated tablets, round, biconvex, white in color, marked on one face with a “10” and scored on the other.

It is presented in containers of 28 and 56 tablets.

Not all container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Teva Pharma, S.L.U.

Anabel Segura 11. Edificio Albatros B, 1st floor.

28108 Alcobendas. Madrid

Spain

Responsible for manufacturing:

Teva Operations Poland Sp. z.o.o.

Ul. Mogilska 80

31-546 Cracow,

Poland

Revision date of thisleaflet:March 2025

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/