Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PANCREATIN
PCO Manufacturing
150 Milligram
Capsules Gastro-Resistant
2004-06-25
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Creon 10000 Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 150 mg pancreatin, equivalent to: Lipase 10,000 Ph.Eur. units Amylase 8,000 Ph.Eur. units Protease 600 Ph.Eur. units For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard. _Product imported from Greece and Hungary:_ Hard gelatin capsules with opaque brown caps and colourless, transparent bodies filled with gastro-resistant brown granules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pancreatic exocrine insufficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS (INCLUDING THE ELDERLY) AND CHILDREN:_ Initially one to two capsules with meals. Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology. The daily dose of pancreatic enzymes for most patients should remain below 2500 units of lipase per kilogram per meal (10.000 units per kilogram per day). Higher doses should be used with caution and only if quantitative measures demonstrate substantially improved absorption with such treatment. This applies particularly to young children. It is important to ensure adequate hydration of patients at all times whilst dosing Creon. The capsules can be swallowed whole, or for ease of administration they may be opened and the granules taken with fluid or soft food. If the granules are mixed with food, it is important that they are taken immediately, otherwise dissolution of the enteric coating may result. In order to protect the enteric coating, it is important that the granules are not crushed or chewed _(see 4.8 Undesirable Effects)._ Colonic damage has been reported in patients with cystic fibrosis taking high doses of pancreatic e Read the complete document