Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Schering
PANKREOFLAT TABLETS SCHEDULING STATUS: S1 PROPRIETARY NAME (and dosage form): PANKREOFLAT TABLETS COMPOSITION 1 Pankreoflat coated tablet contains 170 mg pancreatin from porcine pancreas, corresponding to: 6 500 FIP units lipase 5 500 FIP units amylase 400 FIP units protease and 80 mg dimethicone with methyl parahydroxybenzoate 0,035%, propyl parahydroxybenzoate 0,021% and sorbic acid 0,181% as preservatives. PHARMACOLOGICAL CLASSIFICATION A. 11.10 Medicines acting on gastro-intestinal tract. Special combinations. PHARMACOLOGICAL ACTION Pancreatin hydrolyses fats to glycerol and fatty acids, changes protein into proteoses and derived substances, and converts starch into dextrins and sugars. Pankreoflat combats two factors which play a significant role in the occurrence of meteoristic disorders: foam, which is eliminated by the action of the silicone surfactant, dimethicone and fermentative and putrefactive processes, the main cause of pathological formation of gas. INDICATIONS Relief of abdominal distention due to cumulative gas and foam. Meteorism following aerophagia or in digestive disturbances. Flatulence in pancreatic insufficiency, hepatic and biliary dysfunction, and in suitable post-operative situations. Preparation of patients before gastro-intestinal radiological examination. Splenic-flexure syndrome. CONTRA-INDICATIONS Pankreoflat should not be taken in acute pancreatitis and in acute attacks of chronic pancreatitis. DOSAGE AND DIRECTIONS FOR USE A high initial dose is recommended of up to 3 coated tablets at meal times for flatulence. The dose can be decreased in accordance with therapeutic success. In maintenance therapy, 1 to 2 tablets at meal times is recommended. Three tablets 3 times daily on each of the 1 to 2 days prior to radiolo Read the complete document