Package Leaflet: Information for the Patient

Escitalopram Krka 15 mg Film-Coated Tablets EFG

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 their symptoms are the same as yours, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Escitalopram Krka contains the active ingredient 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).

You may feel better in a couple of weeks. Continue taking Escitalopram Krka even if you do not notice any improvement right away.

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

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 called MAO inhibitors, including selegiline (used for the treatment of Parkinson's disease), moclobemide (used for the treatment of depression) and linezolid (an antibiotic),
• if you have a history of or have experienced an episode of abnormal heart rhythm (detected on an ECG, a test that evaluates the heart's 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 condition or disease, as your doctor may need to take this into account.

Specifically, inform your doctor:

• If you have epilepsy. Treatment with Escitalopram Krka should be discontinued if seizures occur for the first time or if there is an increase in seizure frequency (see also section 4 “Possible side effects”).
• If you have liver or kidney insufficiency. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram Krka may affect blood sugar control. You may need to adjust your insulin and/or oral hypoglycaemic dose.
• If you have low sodium levels in your blood.
• If you are prone to bleeding or bruising easily, 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 that you may have a low sodium level as a result of severe and prolonged diarrhoea and vomiting (being ill) or use of diuretics (medicines to eliminate liquids).
• If you experience rapid or irregular heartbeats, dizziness, fainting 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 characterised 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.

Some medicines in the group to which Escitalopram Krka belongs (called ISRS/IRSN) may cause sexual dysfunction (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 anxiety disorders, you may occasionally have thoughts of harming yourself or taking your own life. These may increase when you start taking antidepressants, as these medicines take time to have an effect, usually two weeks, but sometimes longer.

Youwould be more prone to having these types of thoughts:

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

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

It may be helpful for you to tell a close relative or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behaviour.

Children and adolescents

Escitalopram Krka should not normally be used in the treatment of children and adolescents under 18 years. Also, be aware that in patients under 18 years there is a higher risk of side effects such as suicidal thoughts, suicidal ideation and hostility (mainly aggression, confrontational behaviour and irritability) when taking this type of medicine. However, your doctor may prescribe Escitalopram Krka for patients under 18 years if they decide that it is the best option for the patient. If your doctor has prescribed Escitalopram Krka for a patient under 18 years and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms described above worsen or if complications occur 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 behavioural development of Escitalopram Krka in this age group have not yet been demonstrated.

Other medicines and Escitalopram Krka

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

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

• “Non-selective monoamine oxidase inhibitors (IMAOs)” (used for the treatment of depression), containing phenelzine, iproniazid, isocarboxazid, nialamide and tranylcypromine as active ingredients. If you have taken any of these medicines, you will need to wait 14 days before starting to take Escitalopram Krka. After stopping Escitalopram Krka, 7 days must pass before taking any of these medicines.
• “Reversible MAO-A inhibitors”, containing moclobemide (used in 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 manic-depressive illness) and tryptophan (used for the treatment of depression).
• Imipramine and desipramine (both used for the treatment of depression).
• Sumatriptan and similar medicines (used for the treatment of migraine) and tramadol and other similar medicines (opioids, used for severe pain). These increase the risk of side effects.
• St. John's Wort (Hypericum perforatum) – a medicinal plant used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or to reduce the risk of thrombosis, also called anticoagulants). These may increase the risk of bleeding.
• Warfarin, dipiridamol and phenprocoumon (medicines used to reduce the risk of thrombosis, also called anticoagulants). Your doctor will probably check your blood clotting time at the start and end of treatment with Escitalopram Krka to ensure that the dose of anticoagulant is still adequate.
• Mefloquine (used for the treatment of malaria), bupropion (used for the treatment of depression) and tramadol (used for the treatment of severe pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines used 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 dose of Escitalopram Krka.
• Medicines that lower potassium or magnesium levels in the blood, as this increases the risk of abnormal heart rhythm, which is a life-threatening risk.

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

Use of 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, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Do not take Escitalopram Krka if you are pregnant or breastfeeding unless you and your doctor have weighed up 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 baby: difficulty breathing, blue skin, convulsions, changes in body temperature, difficulty feeding, vomiting, low blood sugar, muscle stiffness or weakness, intense reflexes, tremors, restlessness, irritability, drowsiness and difficulty sleeping. If your newborn baby has any of these symptoms, please contact your doctor immediately.

Ensure that 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 newborn babies, called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually start within the first 24 hours after birth. If they appear in your baby, contact your midwife and/or doctor immediately.

If you take Escitalopram in the final stage 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 that they can advise you.

Escitalopram Krka should not be stopped abruptly during pregnancy.

It is expected that Escitalopram Krka will be excreted in breast milk.

Citalopram, a similar medicine 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 operating machines

Do not drive or operate machinery until you know how Escitalopram Krka may affect you.

Escitalopram Krka contains lactose

This medicine contains lactose. If your doctor has told you that you are intolerant to certain sugars, consult with them before taking this medicine.

Follow exactly the administration instructions of this medication as 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 further 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 medication.

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.

Older adults (over 65 years)

The recommended initial 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 the section 2 “Warnings and precautions”.

Renal insufficiency

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

Liver insufficiency

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.

Route and form of administration

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

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

Treatment duration

It may take a couple of weeks before you start feeling better. Continue taking Escitalopram Krka 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 Krka for the recommended time by your doctor. If you interrupt the treatment too soon, symptoms may reappear. It is recommended that the treatment continue 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 nearest hospital emergency room, or consult the Toxicological Information Service, phone 91562 04 20, indicating the medication and the amount ingested. Do it even when you do not observe discomforts or signs of intoxication. Some signs of overdose may be 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 Krka packaging if you go to the doctor or hospital.

If you forgot to take Escitalopram Krka

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 routine. If you remember during the night or the next day, leave the missed dose and follow your usual routine.

If you interrupt the treatment with Escitalopram Krka

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

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

Withdrawal symptoms include: feeling of dizziness (unstable or loss of balance), feeling of tingling, feeling of prickling, and (less frequently) electric shock, even in the head, sleep disturbances (too intense dreams, nightmares, inability to sleep), feeling of restlessness, headache, feeling of nausea (dizziness), sweating (including nocturnal sweating), feeling of anxiety or agitation, tremor (unsteadiness), feeling of confusion or disorientation, feelings of emotion or irritability, diarrhea (loose stools), visual disturbances, rapid heartbeat or palpitations.

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

Like all medicines, Escitalopram Krka may cause side effects, although not everyone will experience them.

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.

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

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

• Unusual bleeding, including gastrointestinal bleeding.

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

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

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

• Difficulty urinating.
• Seizures (fits), see also the section “Warnings and precautions”.
• Yellowish skin and whitening of the eyes, which are signs of liver function impairment/hepatitis.
• Experiencing 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 mucous membranes of the skin (angioedema).

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

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

• Feeling dizzy (nausea).
• Headache

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

• 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 (arthralgia and myalgia).
• Sexual dysfunction (delayed ejaculation, erection problems, decreased sexual behavior, and women may experience difficulty reaching orgasm).
• Fatigue, fever
• Weight gain

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

• Urticaria, skin rash, itching (pruritus).
• Teeth chattering, agitation, nervousness, panic attack, confusion.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Pupil dilation (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Hair loss.
• Excessive menstrual bleeding.
• Irregular menstrual period.
• Weight loss.
• Fast heart rate.
• Swelling of arms and legs.
• Nasal bleeding

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

• Aggression, depersonalization, hallucinations.
• Low heart rate

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

• Decreased sodium levels in the blood (symptoms are feeling dizzy and experiencing muscle weakness or confusion).
• Dizziness when standing due to low blood pressure (orthostatic hypotension).
• Altered liver function tests (elevated 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).
• Inadequate secretion of the ADH hormone, which causes the body to retain water and dilute the blood, reducing sodium levels.
• Increased prolactin levels in the blood.
• Milk flow in men and 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 (known as “prolongation of the QT interval”, observed on the ECG, heart electrical activity)
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see also the section “Pregnancy, breastfeeding, and fertility” in section 2 for more information.

Other side effects have been reported with medications that work similarly to escitalopram (the active ingredient in Escitalopram Krka). These are:

• Motor restlessness (akathisia).
• Loss of appetite

Reporting of side effects

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

Keep this medication out of the sight and reach of children.

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.

Store in the original packaging to protect from moisture.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

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 maize) 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 contents of the pack

White, round, biconvex, bevelled-edged film-coated tablets with 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 pack.

Only some pack sizes may be marketed.

Marketing authorisation holder

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

Responsible for manufacturing

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 obtain further information about this medicinal product by contacting the local representative of the marketing authorisation holder:

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

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Last update of this leaflet: January 2025

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