(and dosage form):
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.
A. 11.10 Medicines acting on gastro-intestinal tract. Special combinations.
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.
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.
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 radiological examination and 2 to 3 tablets on an empty stomach on the morning of the X-ray examination. The tablets should be swallowed unchewed with plenty of liquid.
SIDE EFFECTS AND SPECIAL PRECAUTIONS
Pancreatin may cause buccal and perianal soreness, particularly in infants. Hypersensitivity reactions have been reported; these may be sneezing, lachrymation, or skin rashes. Hyperuricaemia or hyperuricosuria have occurred with high doses.
The preservatives contained in the coated tablets (parabens) can elicit allergic reactions in patients who are hypersensitive to these substances.
The defoaming action of dimeticone can be impaired by the concomitant administration of substances that bind gastric acid (antacids, aluminium hydroxide, magnesium carbonate).
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Overdosage has not yet been reported. See "Side effects and special precautions". Treatment is symptomatic and supportive should it occur.
Oblong white coated tablets.
Cartons containing 25, 50 and 100 tablets.
Store below 25°C in a dry place. Keep out of reach of children.
NAME AND BUSINESS ADDRESS OF THE APPLICANT
Schering (Pty) Ltd
(Reg No: 1964/09072/07)
106 Sixteenth Road
P O Box 5278
Halfway House 1685
DATE OF PUBLICATION OF THIS PACKAGE INSERT
23 April 1996
Updated on this site: December 2000
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