Index of drugs

Treatment of severe depressive episodes. Treatment of anxiety disorder with anxiety attacks with agoraphobia or without agoraphobia. Treatment of social phobia. Treatment of generalized anxiety disorder. Treatment of obsessive-compulsive disorder.

1 tabl contains 5 mg, 10 mg or 20 mg of escitalopram in the form of oxalate. The preparation contains lactose.

Hypersensitivity to escitalopram or to any of the excipients. Simultaneous treatment with non-selective, irreversible MAO inhibitors is contraindicated due to the risk of serotonin syndrome. Co-administration with escitalopram and reversible MAO-A inhibitors (eg, moclobemide) or a reversible, non-selective MAO-linezolid inhibitor is contraindicated due to the risk of serotonin syndrome. The use of escitalopram is contraindicated in patients with known QT prolongation or congenital long QT syndrome. The use of escitalopram is contra-indicated with drugs that may prolong the QT interval.

Only limited clinical data on the use of escitalopram is available in pregnant women. It should not be used during pregnancy unless clearly necessary and only after careful consideration of the risk / benefit ratio. Newborns should be observed if the woman continued to use the drug later in pregnancy, especially in the third trimester. Avoid sudden withdrawal of the preparation during pregnancy. In neonates whose mothers received SSRI / SRNI medications later in pregnancy, the following symptoms may occur: respiratory disorders, cyanosis, apnea, convulsions, body temperature fluctuations, feeding difficulties, vomiting, hypoglycaemia, hypertonia, hypotension, hyperreflexia, tremor, trembling, irritability, lethargy, constant crying, drowsiness or difficulty falling asleep. These symptoms may be caused by serotonergic effects or may occur as withdrawal symptoms. In most cases, complications appear immediately or soon (<24 h) after delivery. Administration of SSRI during pregnancy, especially in its late life, may increase the risk of persistent neonatal hypertension (PPHN). Escitalopram is presumed to be excreted in human milk. For this reason, breast-feeding is not recommended during treatment. Animal studies have shown that citalopram can affect sperm quality. From the case reports of the use of certain SSRIs in humans, the effect on sperm quality is transient. No effects on human fertility have been observed so far.

Side effects are most common during the first or second week of treatment and usually their severity and incidence decreases with continuation of treatment. Very common: headache, nausea. Common: reduced appetite, increased appetite, weight gain, anxiety, psychomotor anxiety, abnormal dreams, decreased sex drive in men and women, lack of orgasm in women, insomnia, drowsiness, dizziness, paresthesia, tremors, sinusitis, yawning, diarrhea, constipation, vomiting, dry mouth, increased sweating, joint pain, muscle aches, fatigue, fever, men: ejaculation problems, impotence. Uncommon: weight loss, bruxism, agitation, nervousness, panic attacks, confusion, taste disturbances, sleep disorders, syncope, mydriasis, visual disturbances, tinnitus, tachycardia, nosebleeds, gastrointestinal bleeding (including bleeding from the rectum), urticaria, alopecia, rash, pruritus, edema, women: uterine haemorrhage, heavy menstruation. Rarely: anaphylactic reaction, aggression, depersonalization, hallucinations, serotonin syndrome, bradycardia.Not known: thrombocytopenia, abnormal secretion of antidiuretic hormone, hyponatremia, anorexia, mania, suicidal thoughts, suicidal behavior, dyskinesia, movement disorders, convulsions, psychomotor anxiety (akathisia), QT interval prolongation in ECG, ventricular arrhythmia (includingtorsade de pointes), orthostatic hypotension, hepatitis, abnormal liver function tests, bruising, angioneurotic edema, urinary retention, menstruation, men: priapism. There have been post-marketing reports of QT prolongation and ventricular arrhythmia, including type T disorderorsade de pointes, mainly in female patients, in people with hypokalaemia, and in patients with QT prolongation or other heart conditions. Epidemiological studies, mainly in patients aged 50 years and older, show an increased risk of bone fractures in patients receiving SSRIs or tricyclic antidepressants. The mechanism leading to this risk is unknown. Withdrawal of SSRI / SNRIs (especially sudden) often results in withdrawal symptoms. The most frequent reports were: dizziness, sensory disturbances (including paresthesia and the sensation of electric shock), sleep disorders (including insomnia and expressive dreams), anxiety and agitation, nausea and / or vomiting, tremor, confusion, excessive sweating, headaches , diarrhea, palpitations, emotional instability, irritability and blurred vision.

Orally. Adults.Severe depressive episodes. The usual dose is 10 mg once a day. Depending on the patient's individual response, the dose may be increased to a maximum of 20 mg per day. The antidepressant effect is usually obtained after 2-4 weeks of using the drug. After the symptoms have resolved, the treatment should be continued for at least 6 months so that the effect of treatment can be established.Anxiety disorder with panic attacks (panic disorder) with agoraphobia or without agoraphobia. In the first week of treatment, an initial dose of 5 mg is recommended, followed by increasing the dose to 10 mg daily. Depending on the patient's individual response, the dose can then be increased to a maximum of 20 mg per day. The maximum effectiveness is achieved after about 3 months of use of the drug. The treatment lasts several months.Social phobia. The usual dose is 10 mg once a day. In general, the symptoms disappear after 2-4 weeks of treatment. The dose may then be reduced to 5 mg or increased to a maximum dose of 20 mg per day, depending on the patient's individual response. Social phobia is a chronic disorder and it is recommended to continue treatment for 12 weeks in order to obtain a lasting response to treatment. Long-term therapy for people responding to treatment has been analyzed for 6 months, it can be considered individually to prevent the recurrence of the disease; the effects of therapy should be regularly evaluated. Pharmacotherapy is part of a comprehensive therapeutic treatment.Generalized anxiety disorder. The starting dose is 10 mg once a day. Depending on the patient's individual response, the dose may be increased to a maximum of 20 mg per day. Long-term therapy for people responding to treatment has been analyzed for at least 6 months in patients receiving 20 mg daily. The therapeutic benefits and the dose used should be regularly evaluated.Obsessive-compulsive disorder. The starting dose is 10 mg once a day. Depending on the patient's individual response, the dose may be increased to a maximum of 20 mg per day. Obsessive-compulsive disorder is a chronic disease and patients should be treated long enough to ensure the resolution of the disease symptoms. The therapeutic benefits and the dose used should be regularly evaluated. In elderly patients (> 65 years), the starting dose is 5 mg once a day. Depending on the patient's individual response, the dose may be increased to 10 mg a day. The efficacy of using escitalopram in the social phobia of the elderly has not been studied. No dosage adjustment is necessary for patients with mild or moderate renal impairment. Caution is advised in patients with severe renal impairment (creatinine clearance less than 30 ml / min). In patients with mild to moderate hepatic impairment and in patients who are known to be able to metabolise CYP2C19 medication, an initial dose of 5 mg daily is recommended in the first 2 weeks of treatment.Depending on the patient's individual response, the dose may be increased to 10 mg daily. In patients with severe hepatic impairment, extreme caution is recommended when adjusting the dose.
The preparation is given as a single daily dose and can be taken with or without food. The tablet should be placed on the tongue, where it dissolves instantly and can be swallowed without drinking water. Table. disintegrating in the mouth is fragile and should be handled with care. Preparation in the form of tabl. disintegrating in the mouth is bioequivalent to escytalopram in the form of tabl. area, showing a similar rate and extent of absorption (they can be used interchangeably). Table. disintegrating in the mouth is the preferred pharmaceutical form for patients who have problems swallowing conventional tablets or in situations where fluids are not available.