Escitalopram Krka 15 mg film-coated tablets EFG

Package leaflet: Information for the user

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.

• 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. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Escitalopram Krka contains the active substance escitalopram. Escitalopram belongs to a group of antidepressants known as 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 taking Escitalopram Krka even if it takes some time before you notice any improvement.

You should consult a doctor if your condition worsens or if you do not improve.

2. What you need to know before taking 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 belonging 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 been born with or have experienced an episode of heart rhythm disorder (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

Talk to your doctor or pharmacist before you start taking Escitalopram Krka.

Please inform your doctor if you have any other disorders or illnesses, as your doctor may need to take them into account.

Specifically, tell your doctor:

• If you have epilepsy. Treatment with Escitalopram Krka should be discontinued if you experience seizures for the first time or notice an increase in seizure frequency (see also section 4 “Possible side effects”).
• If you have hepatic or renal impairment. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Escitalopram Krka may alter glycaemic control. A dose adjustment of insulin and/or oral hypoglycaemic agents may be necessary.
• If you have low sodium levels in your blood.
• If you tend to bleed easily or develop bruises 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 previously 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 levels of salts due to severe and prolonged diarrhoea and vomiting (being unwell) or use of diuretics (medicines to remove fluid).
• 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 characterized by unusually rapid and frequent changes in thoughts, excessive 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 weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Some medicines in the same group as Escitalopram Krka (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 have anxiety disorders, you may occasionally have thoughts about harming yourself or ending your life. These thoughts may increase when you first start taking antidepressants, as these medicines take time to work—usually about two weeks, but sometimes longer.

You are more likely to have these types of thoughts:

• If you have previously had thoughts about killing yourself or harming yourself.
• 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 to inform you if they believe your depression or anxiety is worsening, 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 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 Krka to patients under 18 years of age if they decide it is the most appropriate treatment. If your doctor has prescribed Escitalopram Krka 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 complications arise while patients under 18 years of age are taking Escitalopram Krka. In addition, the long-term effects on safety and on growth, maturation, and cognitive and behavioural development of Escitalopram Krka in this age group have not yet been established.

Other medicines and Escitalopram Krka

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

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

• “Non-selective monoamine oxidase inhibitors (MAOIs)” (used for the treatment of depression), containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine as active ingredients. If you have taken any of these medicines, you must wait 14 days before starting Escitalopram Krka. After stopping Escitalopram Krka, you must wait 7 days before taking any of these medicines.
• “Reversible selective MAO-A inhibitors”, containing moclobemide (used for the treatment of depression).
• “Irreversible MAO-B inhibitors”, containing selegiline (used for the treatment of Parkinson’s disease). These increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used for the treatment of bipolar disorder) 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 similar medicines (opioids, used for severe pain). These increase the risk of side effects.
• Cimetidine, lansoprazole, and omeprazole (used for the treatment of stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and 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, dipyradimole, and fenprocoumon (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 treatment with Escitalopram Krka to ensure the anticoagulant dose remains appropriate.
• 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 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). The dose of Escitalopram Krka 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.

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

Taking 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, combining Escitalopram Krka with alcohol is not recommended, although no interaction between escitalopram and alcohol is 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 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 pregnancy, 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 difficulties. If your newborn baby shows 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 newborns called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually begin within the first 24 hours after birth. If they occur in your baby, contact your midwife and/or doctor immediately.

If you take Escitalopram near the end of pregnancy, you may have 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 Krka so they can advise you appropriately.

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

Escitalopram Krka 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

Do not drive or operate machinery 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 certain sugars, consult with them before taking this medicine.

3. How to take Escitalopram Krka

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

Adults

Depression

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

Panic disorder

The initial dose of Escitalopram Krka 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 Krka is 10 mg taken as a single daily dose. Your doctor may reduce your dose to 5 mg per day or increase the dose up to a maximum of 20 mg per day, depending on your response to the medication.

Generalised anxiety disorder

The normally recommended dose of Escitalopram Krka 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 Krka 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 initial dose of Escitalopram Krka is 5 mg taken as a single daily dose. The dose may be increased by your doctor to 10 mg per day.

Use in children and adolescents

Escitalopram Krka should not normally be given to children and adolescents. For further information, please see section 2 “Warnings and precautions”.

Renal impairment

Caution is advised in patients with severely reduced 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 to be poor 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 method of administration

You may 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 tablets: The tablet may be divided into equal doses.

Duration of treatment

It may take a few 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 first talking to your doctor.

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

If you take more Escitalopram Krka than you should

If you take more Escitalopram Krka than prescribed, contact your doctor immediately, go to the nearest hospital emergency department, or contact the Toxicology Information Service at telephone number 91562 04 20, stating the medication and the amount taken. Do this even if you do not notice any discomfort or signs of poisoning. Some signs of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rate, decreased blood pressure, and disturbances in the body's fluid and electrolyte balance. Take the Escitalopram Krka packaging with you 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 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 normal.

If you stop taking Escitalopram Krka

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

When you stop taking Escitalopram Krka, especially if abruptly, you may experience withdrawal symptoms. These are common when treatment with Escitalopram Krka is discontinued. The risk is greater 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 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 Escitalopram Krka, please contact your doctor. He or she may ask you to restart your tablets and taper them more slowly.

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

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

4. Possible adverse effects

Like all medicines, Escitalopram Krka may 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.

Visit your doctor or go to the hospital immediately if you experience any of the following adverse 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, throat, or face, hives, 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 section “Warnings and precautions”.
• Yellowing of the skin and whites of the eyes, signs of liver dysfunction/hepatitis.
• If you experience rapid or irregular heartbeat or fainting, symptoms which may indicate a life-threatening condition known as Torsade de Pointes.
• Thoughts of harming yourself or thoughts of suicide; see also section “Warnings and precautions”.
• Sudden swelling of the skin mucosa (angioedema).

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

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

• Feeling sick (nausea).
• Headache.

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

• 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 (delayed ejaculation, problems with erection, decreased sexual drive, and women may experience difficulty achieving orgasm).
• Fatigue, fever.
• Weight gain.

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

• Hives, skin rash, itching (pruritus).
• Teeth grinding, restlessness, 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 periods.
• Weight loss.
• Fast 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 available data):

• Decreased levels of sodium in the blood (symptoms include dizziness and malaise with muscle weakness or confusion).
• Dizziness upon standing due to low blood pressure (orthostatic hypotension).
• Abnormal 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 (bruising) and low platelet count in the blood (thrombocytopenia).
• Increased secretion of a hormone called ADH, causing the body to retain water and dilute the blood, thereby reducing sodium levels (inappropriate ADH secretion).
• Increased levels of prolactin in the blood.
• Milk discharge in men and in women 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,” observed on ECG, the heart's electrical activity).
• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for more information.

Other adverse effects are known to occur with drugs that act similarly to escitalopram (the active substance in Escitalopram Krka). These include:

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

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Escitalopram Krka

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

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

Store in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, 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 Krka

• The active substance 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”.

Nature of the product and pack sizes

Film-coated white, round, biconvex tablets with bevelled edges, 8.5 mm in diameter, marked with “15” in black on one side of the tablet.

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

Only certain 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

For further information about this medicinal product, contact 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 medicinal product is authorized in the European Economic Area Member States and in the United Kingdom (Northern Ireland) under the following names:

Member State	Medicinal product name
Slovenia	Escitalopram Billev Pharma 15 mg film-coated tablets
Ireland	Escitalopram Krka 15 mg film-coated tablets
Italy	Escitalopram Krka
Finland	Escitalopram Krka
Spain	Escitalopram Krka 15 mg film-coated tablets
Germany	Escitalex 15 mg Filmtabletten
Romania	Elicea 15 mg film-coated tablets
Malta	Escitalopram Krka
France	Escitalopram Krka 15 mg film-coated tablet
United Kingdom (Northern Ireland)	Escitalopram 15 mg film-coated tablets
Denmark	Escitalopram Krka 15 mg film-coated tablets
Sweden	Escitalopram Krka 15 mg film-coated tablet

Date of the most recent review 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/