The need to supplement the instructions for the use of medicinal products with the following information is revealed:
1. In the section "Contraindications", the information should be presented in the following edition: "Hypersensitivity to aminosalicylic acid (including other salicylates) and other components of the drug, individual salicylate intolerance (history), severe renal and / or liver failure, heart failure in stage decompensation, peptic ulcer of the stomach and duodenum, inflammatory bowel disease in the exacerbation stage, decompensated hypothyroidism, epilepsy, thrombophlebitis, hypocoagulation , the period of breastfeeding, the deficiency of glucose-6-phosphate dehydrogenase, hypertension, swelling,caused by hypernatremia; amyloidosis of internal organs; children's age to 3 years (for this dosage form) ", in addition, information on the excipients included in the preparation is taken into account.
2. In the section "Method of administration and dose" the dosage regimen for children should be stated in the following edition: "For children from 3 to 18 years of age, the drug is prescribed at the rate of 0.15-0.2 g / kg body weight per day in 3-4 doses (daily dose not more than 10 g) ".