Escitalopram Davur 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Escitalopram Davur 20 mg film-coated tablets EFG

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

Leaflet contents

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

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

Escitalopram Davur contains the active substance 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).

It may take a couple of weeks before you start to feel better. Continue taking escitalopram even if it takes some time to notice any improvement.

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

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

Do not take Escitalopram Davur

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

-If you are taking other medicines belonging to the group known as 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 were born with or have experienced an episode of irregular heart rhythm (detected on an ECG, a test that evaluates heart function).
• If you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm (see section 2 “Other medicines and Escitalopram Davur”)

Warnings and precautions

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

Please inform your doctor if you have any other disorder or illness, as your doctor may need to take this into account. Specifically, tell your doctor:

• If you have epilepsy. Treatment with escitalopram should be discontinued if seizures occur or if you notice an increase in the frequency of seizures for the first time (see also section 4 “Possible side effects”).

• If you have hepatic or renal insufficiency. Your doctor may need to adjust your dose.

• If you have diabetes. Treatment with escitalopram may alter glycaemic control. A dose adjustment of insulin and/or oral hypoglycaemic agents may be necessary.

• If you have low sodium levels in the blood.

• If you have a history of bleeding disorders or if you develop unusual bruising, or if you are pregnant (see “Pregnancy, breastfeeding and fertility”).

• If you are receiving electroconvulsive therapy.

• If you have coronary artery disease.

• If you have or have previously had heart problems or have recently suffered a heart attack.

• If your resting heart rate is slow and/or you know you may have low salt levels due to severe and prolonged diarrhoea and vomiting (being unwell) or use of diuretics.

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

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

Please note:

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

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

Medicines like escitalopram (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may occasionally have thoughts about harming yourself or ending your life. These thoughts may increase when first starting antidepressants, as all these medicines require time to begin working—usually around two weeks, although in some cases it may take longer. You are more likely to have such thoughts:

• If you have previously had thoughts about killing yourself or self-harm.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age treated with an antidepressant.

If at any time you have thoughts about harming yourself or ending your life, contact your doctor or go directly to a hospital.

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

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 an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe escitalopram to patients under 18 years of age if they decide it is the most appropriate treatment. If your doctor has prescribed escitalopram to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You must inform your doctor if any of the symptoms described above worsen or develop complications while patients under 18 years of age are taking escitalopram. In addition, the long-term effects on safety and on growth, maturation, and cognitive and behavioural development of escitalopram in this age group have not yet been established.

Other medicines and Escitalopram Davur

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

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

• “Non-selective monoamine oxidase inhibitors (MAOIs)” containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranilcypramine as active ingredients. If you have taken any of these medicines, you must wait 14 days before starting escitalopram. After stopping escitalopram, 7 days must pass before starting any of these medicines (see section “Do not take escitalopram”).
• “Reversible selective 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.
• The antibiotic linezolid.
• Lithium (used in the treatment of bipolar 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 (an antidepressant), ticlopidine (used to reduce the risk of stroke). These may cause increased blood levels of escitalopram.
• St. John’s wort (Hypericum perforatum)—a herbal remedy used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to

relieve pain or reduce the risk of thrombosis, also called anticoagulants). These may increase the tendency to bleed.

• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will likely monitor your blood clotting time at the beginning and end of escitalopram treatment to ensure the anticoagulant dose remains appropriate.
• Mefloquine (used for the treatment of malaria), bupropion (used to help quit smoking due to possible risk of lowering seizure threshold), and tramadol (used for the treatment of severe pain) due to possible risk of lowering seizure threshold.
• Neuroleptics (medicines for the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to possible risk of lowering seizure threshold.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dose of escitalopram may need to be adjusted.
• Medicines that reduce potassium or magnesium levels in the blood, as this increases the risk of life-threatening heart rhythm disturbances.
• Serotonergic 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 disorders or medicines that may affect heart rhythm, such as class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarials, particularly halofantrine), and certain antihistamines (astemizole, mizolastine). Contact your doctor for any further questions.

Taking Escitalopram Davur with food, drinks, and alcohol

Escitalopram tablets can be taken with or without food.

As with many medicines, combining escitalopram with alcohol is not recommended, although an interaction between escitalopram and alcohol is not expected.

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 discussed the risks and benefits involved.

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

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

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

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

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

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

Escitalopram is expected to be excreted in breast milk.

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

Driving and using machines

You are advised not to drive or operate machinery until you know how escitalopram treatment affects you. Escitalopram 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 machinery.

Escitalopram Davur contains sodium

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

3. How to take Escitalopram Davur

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

Adults

Depression

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

Panic disorder

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

Generalized anxiety disorder

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

Obsessive-compulsive disorder

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

Elderly patients (over 65 years of age)

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

Use in children and adolescents

Escitalopram must not be used in the treatment of children and adolescents under 18 years of age. For additional information, see section 2 "Warnings and precautions".

Renal impairment

Caution is advised in patients with severely reduced kidney 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 may take escitalopram with or without food. Swallow the tablets with water. Do not chew them.

If necessary, you may split the tablets in half to help swallow them, by placing them on a flat surface with the score line facing upwards. 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 few weeks before you start to feel better. Continue treatment even if you start to feel better earlier than expected.

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

Continue taking escitalopram for the length of time recommended by your doctor. If you stop treatment too early, your symptoms may return. It is recommended that treatment continues for at least 6 months after you feel well again.

If you take more Escitalopram Davur than you should

Some signs of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and disturbances in the body's fluid and electrolyte balance. Take the Escitalopram Davur packaging with you if you go to a doctor or hospital.

If you take more escitalopram than prescribed, contact your doctor immediately, go to the nearest hospital emergency department, or contact the Toxicology Information Service at telephone number 91 562 04 20. Do this even if you do not notice any discomfort or signs of poisoning.

If you forget to take Escitalopram Davur

Do not take a double dose to make up for missed doses. If you forget to take a dose and remember before going to bed, take it immediately. The next day, continue as usual. If you remember during the night or the following day, skip the missed dose and continue as usual.

If you stop taking Escitalopram Davur

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

When you stop taking escitalopram, especially if abruptly, you may experience withdrawal symptoms. These are common when treatment with this medicine is stopped. The risk is greater 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 resolve on their own within two weeks. However, in some patients, they may be severe or prolonged (2–3 months or more). If you experience severe withdrawal symptoms when stopping this medicine, contact your doctor. They may advise you to restart your tablets and taper off more slowly.

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

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

4. Possible adverse effects

Like all medicines, escitalopram can cause adverse effects, although not everyone experiences them.

Adverse effects usually disappear after a few weeks of treatment. Please be aware that many of these effects may be symptoms of your illness and will therefore improve as you start to feel better.

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

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 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 frequency (cannot be estimated from available data):

• Difficulty urinating.
• Seizures (fits); see also section “Warnings and precautions”).
• Yellowing of the skin and whites of the eyes, signs of liver function impairment/hepatitis.
• Rapid or irregular heartbeat, 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 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 sick (nausea).
• Headache.

Common (at least 1 in 100 patients):

• Nasal congestion or runny nose (sinusitis).
• Decreased or increased appetite.
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, feeling drowsy, dizziness, yawning, tremors, skin itching.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain (arthralgia and myalgia).
• Sexual disturbances (in men: delayed ejaculation, problems with erection, decreased sexual drive; in women: difficulty achieving orgasm).
• Fatigue, fever.
• Weight gain.

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

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

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

• Aggression, depersonalization, hallucinations.
• Slow heartbeat.

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

• Decreased sodium levels in the blood (symptoms include dizziness, malaise, muscle weakness, or confusion).
• Dizziness upon standing due to low blood pressure (orthostatic hypotension).
• Abnormal liver function tests (elevated 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 (bruising) and low platelet count in the 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, leading to reduced sodium levels (inappropriate antidiuretic hormone secretion, SIADH).
• Increased levels of prolactin hormone in the blood.
• Milk production in women who are not breastfeeding.
• Mania.
• An increased risk of bone fractures has been observed in patients treated with this type of medicine.
• Changes in heart rhythm (known as “QT interval prolongation”, seen on ECG, the electrical activity of the heart).
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy and breastfeeding” in section 2 for more information.

Other adverse effects known to occur with medicines that act similarly to escitalopram include:

• Motor restlessness (akathisia).
• Loss of appetite.

Reporting of adverse effects:

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

5. Storage of Escitalopram Davur

Keep out of sight and reach of children.

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Escitalopram Davur 20 mg film-coated tablets

• The active substance is escitalopram (as oxalate). Each tablet contains 20 mg of escitalopram.
• The other components are: microcrystalline cellulose, colloidal anhydrous silica, sodium croscarmellose, stearic acid, magnesium stearate, hypromellose (E464), titanium dioxide (E171) and macrogol 400.

Appearance of the product and contents of the pack

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

It is available in packs of 28 and 56 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid

Spain

Manufacturer:

Teva Operations Poland Sp. z.o.o.

Ul. Mogilska 80

31-546 Kraków,

Poland

Date of the most recent review of this leaflet: March 2025

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