It was found necessary to supplement the instructions for the use of medicinal products with the following information:
1. In the section "Indications for use", the information should be presented in the following edition: "Prevention and treatment of nausea and vomiting caused by cytostatic chemotherapy and radiotherapy in adults, prevention and treatment of nausea and vomiting caused by cytostatic chemotherapy in children, prevention of post-operative nausea and vomiting in adults" .
2. In the section "Contraindications", the information should read as follows: "hypersensitivity to the active substance or any other component included in the preparation, simultaneous application of ondansetron with apomorphine, pregnancy and the period of breastfeeding, children under 3 years of age in the prevention and treatment of nausea and vomiting , caused by cytostatic chemotherapy, children under 18 years of age in the prevention and treatment of nausea and vomiting,caused by radiotherapy, as well as in the prevention of postoperative nausea and vomiting; congenital lengthening syndrome QT".
3. The section "With caution" should be presented in the following edition "In patients with hypersensitivity to other 5HT antagonists3- receptors, with heart rhythm disturbances and conduction; in patients receiving antiarrhythmic drugs and beta-blockers; in patients with significant disturbances in the water-electrolyte balance; In patients with lengthening or the risk of lengthening the interval QTc, including patients with water-electrolyte balance disorders, chronic heart failure, bradyarrhythmia or in patients taking other medications that may cause lengthening of the interval QT or disturbance of the water-electrolyte balance, or a decrease in the heart rate; in patients with subacute intestinal obstruction; in patients with lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome, with simultaneous use with other serotonergic drugs. "
4. Section "Side effect" is recommended to be presented in the following edition "Undesirable reactions, presented below,are listed in accordance with the damage to organs and organ systems and frequency of occurrence. Frequency of occurrence is defined as follows: very often (≥ 1/10), often (≥ 1/100 and <1/10), infrequently (≥ 1/1 000 and <1/100), rarely (≥ 1/10 000 and <1/1 000), very rarely (<1/10 000, including individual cases). Unwanted reactions observed "very often," "often," and "infrequently," were usually determined from clinical trials. The incidence of placebo was also taken into account. Unwanted reactions, observed "rarely" and "very rarely," were determined on the basis of spontaneous reports obtained as part of post-registration surveillance. When the standard recommended doses of ondansetron are taken, the frequency of occurrence is shown below. The profile of adverse reactions in children and adolescents was comparable to the profile observed in adults. Impaired immune system. Rarely: immediate-type hypersensitivity reactions (urticaria, bronchospasm, laryngospasm, angioedema), in a number of severe cases, including anaphylaxis. Violations from the nervous system. Very often: headache.Infrequent: convulsions, motor disorders (including extrapyramidal symptoms such as dystonia, oculogic crisis and dyskinesia) in the absence of persistent clinical consequences. Rarely: dizziness, mainly during rapid intravenous administration. Disorders from the side of the organ of sight. Rarely: transient visual impairment (eg, blurred vision), mainly during intravenous administration. Very rarely: transient blindness, mainly during intravenous administration. Violations from the heart. Infrequent: arrhythmia, pain in the chest, both accompanied, and not accompanied by a decrease in the segment ST, bradycardia. Rarely: interval lengthening QT (including ventricular tachycardia of the "pirouette" type). Violations from the vessels. Often: a feeling of hotness or "hot flashes". Infrequent: lowering blood pressure. Disturbances from the respiratory system, chest and mediastinum. Infrequently: hiccough. Disorders from the gastrointestinal tract. Often: constipation. Disorders from the liver and biliary tract. Infrequently: an asymptomatic increase in the activity of "hepatic" enzymes alanine aminotransferase (ALT), aspartate aminotransferase (ACT) (mainly observed in patients receiving cisplatin chemotherapy).Disturbances from the skin and subcutaneous tissues. Very rarely: toxic skin rash, including toxic epidermal necrolysis. "
In the section "Overdose" information is recommended to be presented in the following edition. "Symptomatology: There is currently insufficient data on overdose with ondansetron." In most cases, the symptoms of an overdose were similar to those reported in patients receiving recommended doses. Ondansetron causes dose-dependent lengthening of the interval QT. It is recommended to monitor the ECG in case of an overdose of the drug. In case of an overdose of the drug, when ingested orally, children reported symptoms indicative of serotonin syndrome. Treatment. There is no specific antidote for ondansetron, so if you suspect an overdose, it is recommended that you take appropriate symptomatic and supportive therapy. Further treatment should be based on the clinical situation. It is not recommended to use ipecacuanas for the treatment of drug overdose, since it is unlikely that patients will respond to treatment with ipecacuanas due to the antiemetic effect of ondansetron. "