Elicea, 10 mg 56 pcs.

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.