Elicea, 10 mg 56 pcs.

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

– 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

Core:

Active substance:

escitalopram oxalate 6.390 mg/12.780 mg/25.560 mg, equivalent to escitalopram 5.00 mg/10.00 mg/20.00 mg

Auxiliary substances:

Lactose monohydrate, crosspovidone, povidone-K30, microcrystalline cellulose, pregelatinized starch, magnesium stearate

Film shell:

Opadray white 33G287071

1 Opadray White 33G28707: hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol, triacetin

How to take, the dosage

Over the mouth, once daily, regardless of the time of meal.

Depressive episodes

Preferably 10 mg once daily is prescribed. 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 should be continued 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

Preferably 10 mg once daily. 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 (over 65 years)

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

Children and adolescents (under 18 years)

The drug Elicea® should not be used in children and adolescents younger than 18 years (see section “Special Precautions”). In addition, there is insufficient long-term safety research data on the use of escitalopram in children and adolescents regarding growth, maturation, cognitive and behavioral development.

Renal dysfunction

Mild to moderate renal impairment (CK greater than 30 ml/min) does not require dose adjustments.

In severe renal failure (CKD less than 30 ml/min), the drug Elicea® should be administered with caution.

Hepatic impairment

In mild to moderate hepatic impairment (Child-Pugh class A or B), the recommended starting dose for the first 2 weeks of treatment is 5 mg/day. Depending on individual patient’s response, the dose may be increased up to 10 mg/day. In severe hepatic insufficiency (grade C on the Child-Pugh scale), Elicea® is prescribed under close medical supervision.

Decreased CYP2C19 isoenzyme activity

For patients with decreased CYP2C19 isoenzyme activity, the recommended starting dose for the first 2 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 discontinuing treatment with Elicea ®, the dose should be reduced gradually over 1-2 weeks to avoid withdrawal syndrome.

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. Administration of escitalopram may be started at least 1 day after withdrawal of the reversible MAO A 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. 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.

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, the simultaneous 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 and tetracyclic antidepressants (amitriptyline, imipramine, maprotiline, etc.), selective inhibitors of the QT interval, and other drugs is contraindicated.), selective serotonin reuptake inhibitors and similar antidepressants (e.g., fluoxetine, venlafaxine, etc.), and some antimicrobial agents (e.g., methadone).), some antimicrobial drugs (macrolide antibiotics and their analogues such as erythromycin, clarithromycin, quinolone and fluoroquinolone derivatives: sparfloxacin, moxifloxacin, pentamidine), azole antifungal agents (ketoconazole, fluconazole), domperidone, ondansetron, 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

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

Lithium, tryptophan

There have been recorded cases of increasing effect when using SSRIs and lithium or tryptophan concomitantly, it is recommended to be cautious 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 drugs that affect blood clotting (e.g., atypical neuroleptics and phenothiazine derivatives, most tricyclic antidepressants, acetylsalicylic acid and nonsteroidal anti-inflammatory drugs (NSAIDs), ticlopidine and dipyridamole). In such cases, in the beginning or at the end of therapy with escitalopram, close monitoring of blood clotting parameters is necessary. Simultaneous use with NSAIDs 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 (CK less than 30 ml/min), mania/hypomania, pharmacologically uncontrolled epilepsy, evident suicidal behavior, diabetes, cirrhosis of liver, bleeding tendency, concomitant use with MAO B inhibitor (selegiline), serotoninergic drugs, drugs that lower the threshold of seizure readiness, 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.

It is contraindicated in children and adolescents under 18 years of age (effectiveness and safety of use have not been studied).

Elderly patients (over 65 years)

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

Renal dysfunction

Mild to moderate renal impairment (CKR over 30 ml/min) requires no dose adjustment.

In severe renal failure (CKR less than 30 ml/min), Elicea® should be prescribed with caution.

Hepatic impairment

In mild to moderate hepatic impairment (Child-Pugh class A or B), the recommended starting dose for the first 2 weeks of treatment is 5 mg/day. Depending on individual patient’s response, the dose may be increased up to 10 mg/day. In severe hepatic insufficiency (grade C on the Child-Pugh scale), Elicea® is prescribed under close medical supervision.

Reduced CYP2C19 isoenzyme activity

For patients with reduced CYP2C19 isoenzyme activity, the recommended starting dose for the first 2 weeks of treatment is 5 mg/day. Depending on the individual patient’s reaction, the dose can be increased up to 10 mg/day.

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

Application in children and adolescents under the age of 18

Antidepressants should not be prescribed to children and adolescents under 18 years of age due to an increased risk of suicidal behavior (suicide attempts and suicidal ideation), hostility (with predominant aggressive behavior, confrontational and irritant tendencies). If the decision to initiate antidepressant therapy is made on the basis of a clinical evaluation, the patient should be closely monitored. In addition, there are insufficient data on long-term safety in children and adolescents with respect to growth, maturation, and cognitive and behavioral development.

Paradoxical Alarm

In some patients with panic disorder, increased anxiety may be observed at the beginning 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.

Crossroads

Escitalopram should be stopped if seizures develop initially or if their frequency increases (in patients with previously diagnosed epilepsy). SSRIs should not be used in patients with unstable epilepsy and should be closely monitored if seizures are controlled.

Mania

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

Diabetes mellitus

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

Suicidal/suicidal thoughts or clinical deterioration

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

General clinical practice shows that in the early stages of recovery an increased suicide risk is possible.

Other psychiatric conditions for which escitalopram is prescribed may also be associated with an increased risk for 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 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 there is an increased risk of suicidal behavior when taking antidepressants in patients younger than 25 years compared to taking placebo. Medication treatment of these patients, and in particular patients at high risk for suicide, should be accompanied by close monitoring, especially in the early phase of treatment and during 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 appear.

Acathisia/psychomotor agitation

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 quietly. 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

Hyponatremia, possibly associated with impaired ADH secretion, rarely occurs with SSRIs and usually disappears when therapy is withdrawn. Caution should be exercised when using escitalopram and other SSRIs in individuals at risk of hyponatremia: elderly patients, patients with cirrhosis and patients taking medications that may cause hyponatremia.

Bleeding

In cases of cutaneous bleeding (ecchymosis and purpura) have been reported when taking SSRIs. Caution should be exercised when using escitalopram in patients taking oral anticoagulants and medications that affect blood clotting, as well as in patients prone to bleeding.

Electroconvulsive therapy

Because clinical experience with simultaneous use of SSRIs and ECT is limited, care should be taken when using escitalopram and ECT concurrently.

Serotonin syndrome

The concurrent use of escitalopram and MAOA inhibitors is not recommended because of the risk of serotonin syndrome. Caution should be exercised when using escitalopram 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.

Withdrawal syndrome after discontinuation of therapy

“Withdrawal” syndrome is common, especially with abrupt treatment discontinuation. 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 may depend on several factors, including the duration of therapy and the dose of drug and 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 in severity, but in some patients they can be severe.

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

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

Ischemic heart disease (IHD)

Due to limited experience with use in patients with CHD, caution is recommended when using the drug.

Longer QT interval

Escitalopram was found to cause a dose-dependent QT interval prolongation. Cases of QT interval prolongation and ventricular arrhythmias including bidirectional ventricular tachycardia (pirouette type) have been reported during the post-registration period, primarily in female patients, with hypokalemia or pre-existing QT interval prolongation, or other heart disease.

Caution is required when using the drug in patients with significant bradycardia or in patients with recent acute myocardial infarction or decompensated heart failure.

Electrolyte balance disorders such as hypokalemia and hypomagnesemia increase the risk of malignant arrhythmias, it is necessary to correct these disorders before starting treatment with escitalopram.

In patients with stable IBS, an ECG should be performed before starting treatment.

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

Closed angle glaucoma

SSRIs, including escitalopram, can affect pupil size, leading to mydriasis. This effect of pupil dilation has the potential to narrow the anterior chamber angle, 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

SSRIs/ SSRIs can cause symptoms of sexual dysfunction. There have been reports of long-term sexual dysfunction where symptoms continued despite discontinuation of SSRIs/ SSRIs.

Special information on excipients

The drug Elicea® contains lactose; therefore, the following conditions should not be used: lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.

While Elicea® has no effect on intellectual functions and psychomotor activity, it is not recommended to drive vehicles or operate machinery during treatment.

Synopsis

Tablets 5 mg:

“Round, biconvex white film-coated tablets with bevel.

Fracture appearance: a roughened white mass with a white film coating.

Tablets 10 mg and 20 mg:

Oval, biconvex white film-coated tablets with a rib on one side.

Fracture appearance: a rough white mass with a white film coating.

Contraindications

Side effects

Side effects most often develop during the 1st or 2nd 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 listed below. The information is based on data from placebo-controlled clinical trials and spontaneous reports.

Frequency is indicated as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), infrequent (≥ 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, anorexia1.

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 behavior2.

Nervous system disorders:

very common: Headache;

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

infrequently: taste disturbance, sleep disturbance, syncope;

rarely: serotonin syndrome;

frequency unknown: dyskinesia, movement disorders, seizure disorders, psychomotor agitation/acatisia1.

Visual disturbances:

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

Hearing organ and labyrinth disorders:

infrequent: tinnitus (tinnitus).

Cardiac and vascular disorders:

infrequent: tachycardia;

rare: bradycardia;

frequency unknown: QT interval prolongation on electrocardiogram (ECG), ventricular arrhythmia, including pirouette-type ventricular tachycardia, 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 in the blood plasma.

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;

infrequent: edema.

1 Unwanted effects reported with SSRI class drugs.

2 Cases of suicidal thoughts and behavior have been reported while taking escitalopram and immediately after withdrawal of therapy.

Longer interval QT

. There have been cases of QT interval prolongation and ventricular arrhythmias, including pirouette-type ventricular tachycardia, mainly in female patients, with hypokalemia, or in patients with pre-existing QT interval prolongation or other heart disease in the post-registration period.

Class effect

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 determined.

See withdrawal symptoms

Discontinuation of SSRIs/ SSRIs (especially abrupt) often leads to “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. Gradual withdrawal of the drug by reducing the dose is recommended.

Overdose

Toxicity

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

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 a dose range from 400 mg to 800 mg in monotherapy no clinically significant symptoms of overdose have occurred.

Symptoms

In overdose with escitalopram, most of the symptoms are central nervous system (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 balance disorders (hypokalemia, hyponatremia).

Treatment

There is no specific antidote. 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

Pregnancy

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

The studies of escitalopram 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 and norepinephrine 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.

Breastfeeding period

Escitalopram is expected to be excreted with breast milk, so breastfeeding is contraindicated during treatment with escitalopram. Breastfeeding should be discontinued if Elicea® needs to be used.

Fertility

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

Similarities