ESCITALOPRAM KRKA 15 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Escitalopram Krka 15 mg Film-Coated Tablets EFG

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

• Keep this leaflet, as 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.

1. What is Escitalopram Krka and what is it used for.
2. What you need to know before you take Escitalopram Krka.
3. How to take Escitalopram Krka.
4. Possible side effects.
5. Storage of Escitalopram Krka.
6. Pack contents and further information.

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

Escitalopram Krka contains the active substance escitalopram. Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs).

Escitalopram Krka 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 to take Escitalopram Krka 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 Krka

Do not take Escitalopram Krka:

• 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 to treat Parkinson's disease, moclobemide used to treat depression, and linezolid, an antibiotic),
• if you have been born with or have had 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 that may affect heart rhythm (see section 2 “Other medicines and Escitalopram Krka”).

Warnings and precautions

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

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 Krka should be discontinued if seizures occur for the first time or if you observe an increase in the frequency of seizures (see also section 4 “Possible side effects”).
• If you have liver or kidney failure. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram Krka may alter blood sugar control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic.
• If you have a low sodium level in your blood.
• If you tend to develop bleeding or bruising easily, 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 had heart problems or have recently had a heart attack.
• If your resting heart rate is slow and/or you know you may have low salt levels as a result of severe and prolonged diarrhea and vomiting (being sick) or use of diuretics (medicines to remove fluids).
• 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 a certain type 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, disproportionate joy, and excessive physical activity. If you experience this, contact your doctor.

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

Some medicines in the same group as Escitalopram Krka (called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming or killing yourself. These may increase when you start taking antidepressants, as these medicines take time to work, usually a couple of weeks, but sometimes 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 friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You can ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

Children and adolescents

Escitalopram Krka 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 adverse effects such as suicidal attempts, suicidal ideas, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this class of medicines. Nevertheless, your doctor may prescribe Escitalopram Krka to patients under 18 years when they decide it is the most convenient for the patient. If your doctor has prescribed Escitalopram Krka to a patient under 18 years and you wish to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms described above progress or if you experience complications when patients under 18 years are taking Escitalopram Krka. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Escitalopram Krka in this age group have not yet been demonstrated.

Other medicines and Escitalopram Krka

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

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

• “Non-selective monoamine oxidase inhibitors (MAOIs)” (used to treat depression), 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 Krka. After finishing Escitalopram Krka, 7 days must pass before taking any of these medicines.
• “Reversible MAO-A inhibitors”, which contain moclobemide (used in 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 to treat manic-depressive disorder) and tryptophan (used to treat depression).
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medicines (used to treat migraine) and tramadol and other similar medicines (opioids, used to treat severe pain). These increase the risk of side effects.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and 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 herb 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 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 Krka to ensure that the dose of anticoagulant is still adequate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat intense pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines used to treat 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 Krka.
• Medicines that decrease potassium or magnesium levels in the blood, as this increases the risk of life-threatening heart rhythm disorders.

DO NOT TAKE Escitalopram Krkaif you are taking medicines for heart rhythm problems or that may affect heart rhythm, e.g., antiarrhythmics Class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobials (e.g., sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarial treatment, particularly halofantrine), some antihistamines (astemizole, hydroxyzine, mizolastine). Contact your doctor for any additional questions.

Using Escitalopram Krka with food, drinks, and alcohol

Escitalopram Krka can be taken with or without food (see section 3 “How to take Escitalopram Krka”).

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

Pregnancy, breastfeeding, and fertility

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

Do not take Escitalopram Krka if you are pregnant or breastfeeding unless you and your doctor have discussed the risks and benefits involved.

If you take Escitalopram Krka during the last 3 months of your pregnancy, be aware that the following effects may be observed in the newborn: breathing difficulties, blue discoloration of the skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, exaggerated reflexes, tremors, restlessness, irritability, lethargy, constant crying, and sleep difficulties. If your newborn has any of these symptoms, please contact your doctor immediately.

Make sure your midwife and/or doctor know that you are being treated with Escitalopram Krka. During pregnancy, particularly in the last 3 months, medicines like Escitalopram Krka may increase the risk of a serious condition in newborns called persistent pulmonary hypertension (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually start during the first 24 hours after birth. If they appear in your baby, you should contact your midwife and/or doctor immediately.

If you take Escitalopram Krka 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 Krka so they can advise you.

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

It is expected that Escitalopram Krka will be excreted into 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.

Driving and using machines

Do not drive or use machines until you know how Escitalopram Krka affects you.

Escitalopram Krka contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Escitalopram Krka

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

Adults

Depression

The normally recommended dose of Escitalopram Krka 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 Krka is 5 mg as a single dose per day during the first week before increasing the dose to 10 mg per day. Your doctor may increase it later up to a maximum of 20 mg per day.

Social Anxiety Disorder

The normally recommended dose of Escitalopram Krka is 10 mg taken as a single dose per day. Your doctor may decrease your dose to 5 mg per day or increase the dose up to a maximum of 20 mg per day, depending on how you respond to the medicine.

Generalized Anxiety Disorder

The normally recommended dose of Escitalopram Krka 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 Krka 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 (over 65 years)

The initial recommended dose of Escitalopram Krka 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 Krka should not normally be administered to children and adolescents. For additional information, please see section 2 "Warnings and precautions".

Renal insufficiency

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

Hepatic insufficiency

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

Poor metabolizers of CYP2C19

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

Administration route and method

You can take Escitalopram Krka with or without food. Swallow the tablets with water. Do not chew them, as they have a bitter taste.

10 mg and 20 mg tablet: The tablet can be divided into equal doses.

Treatment duration

It may take a couple of weeks before you start to feel better. Continue taking Escitalopram Krka even if you start to feel better before the expected time.

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

Continue taking Escitalopram Krka for the time recommended by your doctor. If you interrupt treatment too early, symptoms may reappear. It is recommended that treatment continues for at least 6 months after you feel better.

If you take more Escitalopram Krka than you should

If you take more doses of Escitalopram Krka than prescribed, contact your doctor immediately, go to the emergency department of the nearest hospital, or consult the Toxicology Information Service, phone 91562 04 20, indicating the medicine and the amount ingested. Do this even if you do not observe discomfort or signs of intoxication. Some signs of overdose may be dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rhythm, decrease in blood pressure, and changes in body water balance. Bring the packaging of Escitalopram Krka if you go to the doctor or hospital.

If you forget to take Escitalopram Krka

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 remember during the night or the next day, leave the forgotten dose and follow the usual routine.

If you stop treatment with Escitalopram Krka

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

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

Withdrawal symptoms include: feeling dizzy (unstable or without balance), feeling tingling, feeling prickling, and (less frequently) electric shock, even in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling restless, headache, feeling nauseous (nausea), sweating (including night sweats), feeling anxious or agitated, trembling (instability), feeling confused or disoriented, 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Escitalopram Krka can cause side effects, although not everyone gets them.

Side effects usually disappear after a few weeks of treatment.

Please be aware that many of the effects can be symptoms of your illness and will improve when you start to feel better.

Visit your doctor or go to the hospital immediately if you have any of the following side effects during treatment:

Uncommon(may affect up to 1 in 100 people):

• Unusual bleeding, including gastrointestinal bleeding.

Rare(may affect up to 1 in 1,000 people):

• Swelling of the skin, tongue, lips, pharynx, or face, hives, or having 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.

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

• Difficulty urinating.
• Seizures (fits), see also the section "Warnings and precautions".
• Yellow skin and whitening of the eyes, are signs of liver function alteration / hepatitis.
• If you 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 mucosa (angioedema).

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

Very common(may affect more than 1 in 10 people):

• Feeling nauseous (nausea).
• Headache

Common(may affect up to 1 in 10 people):

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

Uncommon(may affect up to 1 in 100 people):

• Hives, skin rash, itching (pruritus).
• Teeth grinding, agitation, nervousness, panic attack, confusion.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbance, ringing in the ears (tinnitus).
• Hair loss.
• Excessive menstrual bleeding.
• Irregular menstrual period.
• Weight loss.
• Rapid heartbeat.
• Swelling of arms and legs.
• Nosebleeds

Rare(may affect up to 1 in 1,000 people):

• Aggression, depersonalization, hallucinations.
• Slow heartbeat

Frequency not known (cannot be estimated from the 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 (increased 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 the blood (thrombocytopenia).
• Increased secretion of a hormone called ADH, which causes the body to retain water and dilute the blood, reducing the amount of sodium (inadequate ADH secretion).
• Increased prolactin levels in the blood.
• Milk flow in men and 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, heart electrical activity)
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

Other side effects are known to occur with drugs that work similarly to escitalopram (the active ingredient of Escitalopram Krka). These are:

• Motor restlessness (akathisia).
• Lack of appetite

Reporting of side effects

If you experience any type of side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Escitalopram Krka

Keep this medicine out of sight and reach of children.

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

Store in the original packaging to protect from moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Escitalopram Krka.

• The active ingredient is escitalopram

Each film-coated tablet contains 15 mg of escitalopram, equivalent to 19.170 mg of escitalopram oxalate.

• The other components (excipients) are lactose monohydrate, crospovidone, povidone K30, microcrystalline cellulose, pregelatinized starch (from corn), and magnesium stearate (E470b) in the tablet core, and hypromellose 6cP (E464), titanium dioxide (E171), lactose monohydrate, macrogol 3000, triacetin, and black ink (shellac (E904), iron oxide black (E172), propylene glycol (E1520)) in the coating.

See section 2 "Escitalopram Krka contains lactose".

Appearance of the product and package contents

The film-coated tablets are white, round, biconvex, with beveled edges, and a diameter of 8.5 mm, marked with "15" in black on one side of the tablet.

Escitalopram Krka film-coated tablets are available in packs of 14, 20, 28, 30, 50, 56, 60, 90, and 100 tablets in blisters (OPA/Alu/PVC–Alu), in a carton.

Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

or

TAD Pharma GmbH, Heinz-Lohmann-Straße 6, 27472 Cuxhaven, Germany

or

Krka-farma d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain.

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Date of the last revision of this leaflet: January 2025

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