1 - NAME OF THE MEDICINAL PRODUCT: Neomycin 500 mg tablets 2 - QUALITATIVE AND QUANTITATIVE COMPOSITION: Each tablet contains: Active ingredient: Neomycin sulphate 500 mg (Equivalent to Neomycin 350000 IU) For a complete list of excipients, see section 6.1. 3 - PHARMACEUTICAL FORM : White to yellowish white flat rounded, scored from one side, uncoated tablet. 4 - CLINICAL PARTICULARS : 4.1 Therapeutic indications ● Aseptic prophylaxis associated with colon surgery. ● Early therapy of hepatic coma. ● Therapy of portal encephalopathy and consequent seizures. 4.2 Dosage and administration • The tablet should be taken as whole without division. • The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Dividing the tablets may not provide an exact "half" dose. Dosage ● Aseptic prophylaxis associated with colon surgery. Adults, including the elderly - 1 g/hour for 4 hours, followed by 1 g every 4 hours for the two or three days prior to the surgical intervention. Children over 12 years old - 1 g every 4 hours for the two or three days prior to the surgical intervention. Children between 6 and 12 years old - 500 mg to 1 g every 4 hours for the two or three days prior to the surgical intervention. It is not recommended to administer oral forms to children under 6 years old, and it may also not be indicated for some older children. ● In hepatic coma: Adults, including the elderly - 4 to 12 g per day, divided in a way to be administered every 6 hours or every 3 hours, for 5 to 7 days. Children - 50 to 100 mg/kg per day, divided into similar intervals.
