Elicea Ku-tab, 10 mg 56 pcs

Phobias and panic attacks, Depressed mood, Obsessive compulsive disorder, Depression

– Depressive episodes of any severity.

– Panic disorder with/without agoraphobia.

– Obsessive-compulsive disorder.

Active ingredient

Composition

for 1 tablet 5 mg/10 mg/20 mg

for 1 tablet 5 mg/10 mg/20 mg

Active substance:: justify;”> Active substance:

escitalopram oxalate 6.39 mg/12.78 mg/25.55 mg, equivalent to escitalopram 5.00 mg/10.00 mg/20.00 mg

Associates: polacrylin potassium, lactose monohydrate, microcrystalline cellulose (type 102), croscarmellose sodium, acesulfame potassium, neohesperidin dihydrochalcone, peppermint flavoring1, magnesium stearate

1 Peppermint flavoring contains: maltodextrin (corn), modified starch (corn), field mint leaf oil, pullegon.

How to take, the dosage

Ingestion, once daily. The tablet should not be mixed with food in the mouth.

The tablet is placed on the tongue; after rapid dissolution, it is swallowed without drinking water.

Tablets dispersed in the mouth are not divided.

The oral dispersible tablets are fragile and should be handled with caution.

Extract the tablet as follows:

1. Bend the blister along the tear line.

2. open the blister by gently pulling on the edge of the foil.

3. Carefully remove the tablet.

4 Then immediately place the tablet on your tongue and hold it in your mouth for a few seconds until it dissolves.

The oral dispersible tablets can be used as an alternative to film-coated tablets in patients who have difficulty swallowing the tablet or who do not have liquid to drink.

The drug Elicea® Ku-tab®, oral dispersible tablets, is bioequivalent to escitalopram in film-coated tablets, with similar speed and degree of absorption. The doses and dosing regimen are also consistent.

The drug Elicea® Ku-tab®, oral dispersible tablets, may be used as an alternative to escitalopram in film-coated tablets.

Depressive episodes

Prescribing usually 10 mg once daily. Depending on the patient’s individual response, the dose may be increased to a maximum of 20 mg/day.

The antidepressant effect develops 2-4 weeks after the start of treatment. After symptoms of depression disappear at least 6 months more therapy is necessary to consolidate the effect.

Panic disorder with/without agoraphobia

In the first week, the recommended dose is 5 mg/day, which then increases to 10 mg/day. Depending on the patient’s individual response, the dose may be increased to a maximum of 20 mg/day.

The maximum therapeutic effect is achieved about 3 months after the start of treatment. The therapy lasts for several months.

Obsessive-compulsive disorder

Perhaps 10 mg once daily is usually prescribed. Depending on the patient’s individual response, the dose may be increased to a maximum of 20 mg/day.

Because obsessive-compulsive disorder is a disease with a chronic course, the course of treatment should be long enough to ensure complete relief from symptoms and last at least 6 months. At least 1 year of treatment is recommended to prevent recurrence.

Elderly patients (>65 years)

Half the normally recommended dose (i.e., 5 mg/day) and a lower maximum dose (10 mg/day) are recommended.

Children and adolescents (under 18 years)

The drug Elicea® Ku-tab® should not be used in children and adolescents under 18 years of age (see See “Special Indications”). In addition, there are insufficient long-term safety studies of escitalopram in children and adolescents regarding growth, maturation, and cognitive and behavioral development.

Renal dysfunction

Mild to moderate renal impairment does not require dose adjustments.

In severe renal impairment (CKI less than 30 ml/min), Elicea® Ku-tab® should be prescribed with caution.

Hepatic impairment

The recommended starting dose for the first two weeks of treatment is 5 mg/day. Depending on the individual patient’s reaction, the dose may be increased to 10 mg/day.

Decreased CYP2C19 isoenzyme activity

For patients with poor CYP2C19 isoenzyme activity, the recommended initial dose for the first two weeks of treatment is 5 mg/day. The dose may be increased to 10 mg/day depending on the patient’s individual response.

Cessation of treatment

When treatment with Elicea® Ku-tab is discontinued

sup>®, the dose should be reduced gradually over 1-2 weeks to avoid withdrawal.

Interaction

Pharmacodynamic interactions

Nonselective non-reversible MAOI inhibitors

. Serious adverse reactions have been reported when SSRIs and non-selective non-reversible MAO inhibitors are taken concomitantly, as well as when MAO inhibitors are started in patients who have stopped taking SSRIs shortly before. In some cases, patients have developed serotonin syndrome.

The use of escitalopram concomitantly with non-selective non-reversible MAOI inhibitors is contraindicated. Administration of escitalopram may be started 14 days after discontinuation of non-selective irreversible MAO inhibitors. Before starting non-selective irreversible MAO inhibitors, it should be at least 7 days after the end of escitalopram.

A selective MAO A inhibitor (moclobemide)

Because of the risk of serotonin syndrome, it is not recommended to use escitalopram simultaneously with the MAO A inhibitor moclobemide. If this combination of drugs is clinically necessary, it is recommended to start with the lowest possible dose, and to monitor the patient’s condition clinically on an ongoing basis. The administration of escitalopram may be started at least one day after withdrawal of the reversible MAOA inhibitor moclobemide.

The reversible non-selective MAO inhibitor (linezolid)

The antibiotic linezolid is a reversible non-selective MAO inhibitor and should not be used in patients receiving treatment with escitalopram. When this combination of drugs is deemed clinically necessary, it is recommended to start with the lowest possible dose, and ongoing clinical monitoring of the patient’s condition.

Unreversible selective MAO B inhibitor (selegiline)

Because of the risk of serotonin syndrome, caution should be exercised when taking escitalopram concomitantly with the irreversible MAO B inhibitor selegiline.

Drugs that prolong the interval QT

. Pharmacokinetic and pharmacodynamic studies of the use of escitalopram in combination with other QT interval prolonging drugs have not been performed. Additive effect of escitalopram and these drugs cannot be excluded. Consequently, concomitant use of escitalopram and drugs that prolong the QT interval, such as antiarrhythmic drugs of classes IA and III, neuroleptics (eg, phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants is contraindicated, some antimicrobials (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, drugs to treat malaria, particularly halofantrine), some antihistamines (astemizole, misolastine).

Serotonergic drugs

The concomitant use with serotonergic drugs (e.g., tramadol, sumatriptan and other triptans) may result in serotonin syndrome.

Drugs that lower the seizure threshold

SyOZS may lower the seizure threshold. Caution is required when other drugs that lower the threshold of seizure readiness (tricyclic antidepressants, SSRIs, antipsychotics (neuroleptics) – phenothiazine derivatives, tioxanthene, and butyrophenone, mefloquine, bupropion and tramadol) are used concomitantly with escitalopram.

Lithium, tryptophan

There have been documented cases of enhanced effects when using SSRIs and lithium or tryptophan concomitantly, caution is recommended when using escitalopram with these drugs.

St. John’s Wort

Simultaneous use of SSRIs and drugs containing St. John’s Wort may result in increased side effects.

Anticoagulants and agents that affect blood clotting

Impaired blood clotting may occur with concomitant use of escitalopram with oral anticoagulants and medications that affect blood clotting (e.g., atypical neuroleptics and phenothiazine derivatives, most tricyclic antidepressants, acetylsalicylic acid and nonsteroidal anti-inflammatory drugs, ticlopidine and dipyridamole). In such cases, careful monitoring of blood clotting parameters is necessary at the beginning or end of therapy with escitalopram. Simultaneous use with nonsteroidal anti-inflammatory drugs may lead to increased bleeding.

Ethanol

Escitalopram has no pharmacodynamic or pharmacokinetic interaction with ethanol. However, as with other psychotropic medications, concomitant use of escitalopram and ethanol is not recommended.

Drugs causing hypokalemia/hypomagnesemia

Cautious concomitant use of drugs causing hypokalemia/hypomagnesemia is required because these conditions increase the risk of malignant arrhythmias.

Pharmacokinetic interactions

The effect of other drugs on the pharmacokinetics of escitalopram

Special Instructions

Severe renal insufficiency (creatinine clearance (CK) less than 30 ml/min), mania/hypomania, pharmacologically uncontrolled epilepsy, severe suicidal behavior, diabetes, cirrhosis of liver, tendency to bleeding, concurrent use with MAO B inhibitor (selegiline), serotonergic drugs, drugs that reduce seizure threshold, lithium, tryptophan, Drugs containing St. John’s Wort, oral anticoagulants and drugs that affect blood clotting, drugs that may cause hyponatremia, drugs metabolized with CYP2C19, ethanol, electroconvulsive therapy (ECT), elderly patients, pregnancy, breast-feeding.

The drug Elicea® Ku-tab® should not be used in children and adolescents under 18 years of age.

Kidney function impairment

Dose adjustment is not necessary in mild to moderate renal failure.

In severe renal insufficiency (CKI less than 30 ml/min), Elicea® Ku-tab® should be prescribed with caution.

Hepatic dysfunction

The recommended starting dose for the first two weeks of treatment is 5 mg/day. Depending on the individual patient’s reaction, the dose may be increased to 10 mg/day.

Antidepressants should not be prescribed to children and adolescents under 18 years of age because of the increased risk of suicidal behavior (suicide attempts and suicidal ideation), hostility (with a predominance of aggressive behavior, tendency to confrontation and irritation). If a decision is made based on a clinical assessment to initiate antidepressant therapy, the patient should be closely monitored.

The following should be considered when using drugs belonging to the therapeutic group of SSRIs, including escitalopram

Some patients with panic disorder may have increased anxiety at the start of antidepressant treatment. This paradoxical reaction usually disappears within the first two weeks of treatment. Low initial doses are recommended to reduce the likelihood of anxiogenic effects.

Escitalopram should be discontinued if there is a primary development of seizures or if their frequency increases (in patients with previously diagnosed epilepsy). SSRIs should not be used in patients with unstable epilepsy, and close monitoring is required in controlled seizures.

Escitalopram should be used with caution in patients with a history of mania/hypomania. If a manic state develops, escitalopram should be withdrawn.

In patients with diabetes mellitus, treatment with escitalopram may alter plasma glucose concentrations. Therefore, it may be necessary to adjust the doses of insulin and/or hypoglycemic drugs for oral administration.

Depression is associated with an increased risk of suicidal ideation, self-inflicted injuries, and suicide (suicidal ideation). This risk persists until the onset of significant remission. Because improvement may not be seen for the first few weeks of therapy or even longer, patients should be monitored closely until improvement occurs.

Common clinical practice shows that in the early stages of recovery, there may be an increased risk of suicide.

Other psychiatric conditions for which escitalopram is prescribed may also be associated with an increased risk of suicidal events and phenomena. In addition, these conditions may be co-occurring pathology in relation to the depressive episode. When treating patients with other psychiatric disorders, the same precautions should be followed as when treating patients with a depressive episode.

Patients with a history of suicidal behavior or patients with significant levels of suicidal ideation prior to treatment are at greater risk for suicidal thoughts or suicide attempts, so they should be monitored closely during treatment.

A meta-analysis of placebo-controlled clinical trials of antidepressants involving adult patients with psychiatric disorders found that antidepressant medication administration in patients younger than 25 years old had an increased risk of suicidal behavior compared to placebo administration. Medication treatment of these patients, and in particular those at high risk for suicide, should be accompanied by close monitoring, especially in the early phase of treatment and with dose changes.

Patients (and caregivers) should be warned to monitor for any signs of clinical deterioration, suicidal behavior or thoughts, and unusual behavioral changes, and to seek medical advice immediately if these symptoms occur.

The use of SSRIs/ SSRIs is associated with the development of akathisia, characterized by the development of subjectively unpleasant or depressing restlessness and a need for constant movement, often combined with an inability to sit or stand still. This most often manifests itself during the first few weeks of treatment. In patients with these symptoms, increasing the dose may lead to worsening.

Hyponatremia, possibly associated with impaired ADH secretion, is rare with SSRIs and usually resolves with treatment withdrawal. Caution should be exercised when using escitalopram and other SSRIs in individuals at risk for hyponatremia: elderly patients, patients with cirrhosis of the liver, and patients taking medications that may cause hyponatremia.

When taking SSRIs, there have been cases of skin hemorrhages (ecchymosis and purpura). Caution should be exercised when using escitalopram in patients taking oral anticoagulants and medications that affect blood clotting, as well as in patients who are prone to bleeding.

As clinical experience with concomitant use of SSRIs and ECT is limited, caution should be exercised when concomitantly using escitalopram and ECT.

The concomitant use of escitalopram and MAO A inhibitors is not recommended because of the risk of serotonin syndrome.

Escitalopram should be used with caution concomitantly with drugs with serotonergic effects, such as sumatriptan or other triptans, tramadol and tryptophan. Patients taking escitalopram and other SSRIs concomitantly with serotonergic drugs have rarely developed serotonin syndrome. Its development may be indicated by a combination of symptoms such as agitation, tremor, myoclonus and hyperthermia. If this occurs, concomitant treatment with SSRIs and serotoninergic drugs should be stopped immediately and symptomatic treatment should be initiated.

When treatment is discontinued, “withdrawal” symptoms are common, especially when treatment is stopped abruptly. In clinical studies, discontinuation-related adverse events occurred in approximately 25% of patients treated with escitalopram and 15% of those treated with placebo.

The risk of “withdrawal” symptoms may depend on several factors, including the duration of therapy and the dose of the drug, as well as the rate of dose reduction. The most commonly reported reactions include dizziness, sensory disturbances (including paresthesia and a sensation of electric shock), sleep disturbances (including insomnia and intense dreaming), agitation or anxiety, nausea and/or vomiting, tremor, confusion, increased sweating, headache, diarrhea, palpitations, emotional instability, irritability and visual disturbances. Usually these symptoms are mild to moderate, but they can be severe in some patients.

Symptoms usually occur within the first few days of stopping treatment, but very rarely have these symptoms been reported in patients who have accidentally missed taking the drug.

These symptoms usually go away on their own usually within two weeks, although in some patients they can be prolonged (2-3 months or more). Therefore, gradual dose reduction over several weeks or months is recommended when treatment is discontinued, according to the patient’s condition.

Because of the limited experience of use in patients with coronary heart disease, caution is recommended when using the drug.

Escitalopram has been found to cause dose-dependent prolongation of the QT interval. In the post-registration period, cases of QT interval prolongation and ventricular arrhythmias, including bidirectional ventricular tachycardia, have been reported primarily in female patients, with hypokalemia, or pre-existing QT interval prolongation, or other heart disease.

Cautions are required when using in patients with significant bradycardia or in patients with recent acute myocardial infarction or decompensated heart failure.

Electrolyte disturbances, such as hypokalemia and hypomagnesemia, increase the risk of malignant arrhythmias; these disturbances should be corrected before starting treatment with escitalopram.

In patients with stable coronary heart disease, an ECG should be performed before starting treatment.

If signs of cardiac arrhythmia occur during treatment with escitalopram, therapy should be stopped and an ECG should be performed.

The SSRIs, including escitalopram, may affect pupil size, resulting in mydriasis. This effect of pupil dilation has the potential to narrow the angle of the anterior chamber of the eye, leading to increased intraocular pressure and the development of closed angle glaucoma, especially in patients with a predisposition to this disease. Therefore, caution should be exercised when using escitalopram in patients with closed angle glaucoma or with a history of glaucoma.

Sexual dysfunction

Selective serotonin reuptake inhibitors/serotonin and norepinephrine reuptake inhibitors (SSRIs) can cause symptoms of sexual dysfunction. Long-term sexual dysfunction has been reported, with symptoms persisting after discontinuation of SSRIs/SRIs.

While the drug Elicea® Ku-tab® does not affect intellectual function or psychomotor activity, it is not recommended to drive vehicles or operate machinery during treatment.

Synopsis

5 mg tablets:

Round, flat-cylindrical tablets, white or nearly white, beveled and engraved “5” on one side.

Tablets 10 mg:

Round, flat-cylindrical tablets white or nearly white, beveled and engraved “10” on one side.

Tablets 20 mg:

Round, flat-cylindrical tablets white or nearly white, beveled and engraved “20” on one side.

Contraindications

Side effects

Side effects most often develop during the first or second week of therapy, then usually become less intense and occur less frequently if therapy is continued.

The side effects occurring with drugs belonging to the SSRI class and noted when taking escitalopram are as follows The information is based on data from placebo-controlled clinical trials and spontaneous reports.

Frequency is indicated as: very frequently (≥ 1/10), frequently (≥ 1/100 to < 1/10), infrequently

(≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000), frequency unknown (incidence cannot be estimated from existing data).

Blood and lymphatic system disorders:

frequency unknown: thrombocytopenia.

Disorders of the immune system:

rarely: anaphylactic reactions.

Disorders of the endocrine system:

frequency unknown: insufficient secretion of antidiuretic hormone (ADH).

Disorders in the side of metabolism and nutrition:

often: decreased appetite, increased appetite, increased body weight;

infrequent: decreased body weight;

frequency unknown: hyponatremia, anorexia.

Mental disorders:

often: anxiety, restlessness, unusual dreams, decreased libido, anorgasmia (in women);

infrequent: bruxism, agitation, nervousness, panic attacks, confusion;

rarely: aggression, depersonalization, hallucinations;

frequency unknown: mania, suicidal thoughts, suicidal behavior.

Incidents of suicidal thoughts and behavior have been noted while taking escitalopram and immediately after discontinuation of therapy.

Nervous system disorders:

very often: headache

often: insomnia, drowsiness, dizziness, paresthesia, tremor;

infrequently: taste disturbance, sleep disturbance, syncope;

recommon: serotonin syndrome;

frequent unknown: dyskinesia, movement disorders, seizure disorders, psychomotor agitation/acathisia.

Visual disorders:

frequent: mydriasis (dilation of the pupil), visual disturbances.

Hearing organ and labyrinth disorders:

infrequent: tinnitus (tinnitus).

Cardiovascular disorders:

infrequent: tachycardia;

rarely: bradycardia;

frequent unknown: prolongation of the QT interval on the electrocardiogram (ECG), orthostatic hypotension.

Disorders of the respiratory system, thoracic and mediastinal organs:

often: sinusitis, yawning;

infrequently: nasal bleeding.

Gastrointestinal tract disorders:

very often: nausea;

often: Diarrhea, constipation, vomiting, dry oral mucosa;

infrequently: gastrointestinal bleeding (including bleeding from the rectum).

Disorders of theliver and biliary tract:

frequency unknown: hepatitis, increased activity of “liver” enzymes.

Skin and subcutaneous tissue disorders:

often: increased sweating;

infrequent: urticaria, alopecia, skin rash, skin itching;

frequency unknown: ecchymosis, angioedema.

Musculoskeletal and connective tissue disorders:

often: arthralgia, myalgia.

Repnal and urinary tract disorders:

frequent unknown: urinary retention.

Disorders of the genitals and mammary gland:

often: Impotence, impaired ejaculation;

infrequent: menorrhagia, metrorrhagia;

frequency unknown: galactorrhea, priapism.

General disorders and disorders at the site of administration:

often: weakness, hyperthermia;

infrequently: edema.

There have been cases of QT interval prolongation in the post-registration period, mostly in patients with pre-existing heart disease. In double-blind, placebo-controlled ECG studies in healthy volunteers, the change from baseline QTc value (Friedericia formula correction) was 4.3 msec at 10 mg/day dose and 10.7 msec at 30 mg/day.

Epidemiological studies involving patients aged 50 years and older have shown the existence of an increased risk of bone fracture in patients taking SSRIs and tricyclic antidepressants. The mechanism for this risk has not been established.

Withdrawal of SSRIs/ SSRIs (especially abrupt) often results in “withdrawal” syndrome. The most common effects are dizziness, sensory disturbances (including paresthesia and current sensations), sleep disturbances (including insomnia and intense dreaming), agitation or anxiety, nausea and/or vomiting, tremor, confusion, increased sweating, headache, diarrhea, palpitations, emotional instability, irritability, visual disturbances. These effects are usually mild to moderate and disappear quickly, but in some patients they may be more acute and/or of longer duration. A gradual withdrawal of the drug by reducing the dose is recommended.

Overdose

The data on overdose with escitalopram are limited, in many such cases there was also an overdose with other drugs. In most cases, the symptoms of overdose are mild or absent.

The cases of fatal overdose with escitalopram (without taking other drugs) are rare, in most cases there is also overdose with other drugs. When taking escitalopram in the dosage range of 400-800 mg in monotherapy no clinically significant overdose symptoms have occurred.

Symptoms

In case of overdose with escitalopram mostly symptoms of the central nervous system occur (from dizziness, tremor, and agitation to rare cases of serotonin syndrome, seizure disorders and coma), gastrointestinal tract (nausea/vomiting), cardiovascular system (arterial hypotension, tachycardia, prolongation of QT interval and arrhythmia), and electrolyte disorders (hypokalemia, hyponatremia).

Treatment

There is no specific antidote. The normal airway patency, oxygenation and ventilation of the lungs should be ensured. Gastric lavage should be performed and activated charcoal prescribed. Gastric lavage should be performed as soon as possible after ingestion. It is recommended to monitor the performance of the heart and other vital organs and to carry out symptomatic and supportive therapy.

Pregnancy use

There are limited data on the use of escitalopram during pregnancy.

Escitalopram studies in animals have demonstrated reproductive toxicity.

Escitalopram during pregnancy should only be taken when absolutely necessary and after careful assessment of the benefit/risk ratio.

If administration of escitalopram has continued into late pregnancy, especially in the third trimester, the newborn should be monitored. If administration of escitalopram continued until delivery or was discontinued shortly before delivery, the newborn may develop withdrawal symptoms.

If the mother takes SSRIs/ SSRIs (selective serotonin reuptake inhibitors/selective serotonin and noradrenaline reuptake inhibitors) in late pregnancy, the following side effects may develop in the newborn Respiratory depression, cyanosis, apnea, seizure disorders, temperature spikes, feeding difficulties, vomiting, hypoglycemia, muscle hypertension, muscle hypotonia, hyperreflexia, tremor, increased neuroreflex excitability, irritability, lethargy, constant crying, drowsiness and poor sleep. These symptoms may occur due to the development of withdrawal or serotoninergic syndrome. In most cases, these complications occur within 24 hours of birth.

The data from epidemiological studies suggest that the use of SSRIs during pregnancy, especially in the late term, may increase the risk of sustained pulmonary hypertension (PPHN) in newborns. The observed risk was 5 cases per 1,000 pregnancies. In the general population, there are 1-2 cases of PPHN per 1,000 pregnancies.

Escitalopram is expected to be excreted with breast milk, so breastfeeding is not recommended during treatment with escitalopram.

The data from animal studies have shown that some SSRIs can affect sperm quality. There is no animal research data on this aspect for escitalopram. Reports on the use of some SSRIs in humans have shown that the effects of these medications on semen quality are reversible. So far, the effects of escitalopram on fertility in humans have not been observed.

Similarities