None stated.
No relevant information additional to that contained elsewhere in the Summary of Product Characteristics.
Absorption
The enzymes are present in the form of pH-sensitive enteric-coated minitablets, which are filled into hard gelatin capsules. The minitablets, which are released from the capsule into the stomach, are enteric coated to resist inactivation at low pH. Once released, the minitablets are distributed into the stomach and pass into the duodenum where the enteric coating begins to dissolve and the enzymes are released when the pH reaches 5.5. Duodenal availability studies in adults indicate that following oral administration of Kreon HL capsules, measurable levels of enzymes are present in the duodenum. Pancreatin is not absorbed from the gastro-intestinal tract in appreciable amounts.
Metabolism
Once they have accomplished their digestive function, the enzymes may be digested in the intestine.
Elimination
The constituents may be partially absorbed and subsequently excreted in the urine. Any undigested enzymes are excreted in the faeces.
Special populations
Paediatrics
The pharmacokinetics of pancreatin in paediatric subjects have not been investigated.
Elderly
The pharmacokinetics of pancreatin in elderly subjects have not been investigated.
Renal impairment
The pharmacokinetics of pancreatin in renally impaired subjects have not been investigated.
Hepatic impairment
The pharmacokinetics of pancreatin in hepatically impaired subjects have not been investigated.
Not applicable.
