CREON, 300 MILLIGRAM
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
22-03-2023
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
PANCREATIN
Available from:
G & A Licensing Limited
Dosage:
300 Milligram
Pharmaceutical form:
Capsules Gastro-Resistant
Authorization date:
2009-07-31
Summary of Product characteristics
License
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Creon 25000 300 mg Gastro-Resistant Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 300 mg pancreatin, equivalent to:
-
Lipase 25,000 Ph. Eur. units
-
Amylase 18,000 Ph. Eur. units
-
Protease 1,000 Ph. Eur. Units
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard
Product imported from the United Kingdom:
Hard gelatin capsules with opaque orange caps and colourless transparent bodies filled with gastro-resistant brown
granules.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
For the treatment of pancreatic exocrine deficiency.
4.2 Posology and method of administration
Adults (including the elderly) and children:
Initially one capsule 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), and that higher doses should be used with caution and only if quantitative
measures demonstrate substantially improved absorption with such treatment. This particularly applies to young
children.
It is
Read the complete document
