POM: Prescription only medicine
This information is intended for use by health professionals
Adults and childrenOne or two capsules during each meal and one capsule with snacks. The inter-individual response to pancreatin supplements is variable and the number of capsules may need to be titrated to the individual based upon parameters of steatorrhoea, the fat content of the diet and symptomatology. Further dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology. Patients should be instructed not to increase the dosage on their own. Changes in dosage may require an adjustment period of several days.Where patients are already in receipt of lower unit dose enteric coated pancreatin supplements, Pancrease HL Capsules may be substituted at one-third of the number of capsules of the previous preparation.Where swallowing of capsules is difficult, they may be opened and the minitablets taken with acidic liquid or soft foods (pH of 4.5 or less such as apple sauce) which do not require chewing. To protect the enteric coating, the minitablets should not be crushed or chewed.Contact of the minitablets with food having a pH higher than 4.5 (e.g., milk, custard, ice cream, and many other dairy products) can dissolve the protective coating and will reduce the efficacy of the product.It is important to ensure adequate hydration of patients at all times whilst dosing Pancrease HL Capsules.Patients who are taking or have been given in excess of 10,000 units of lipase/kg/day are at risk of developing colon damage. The dose of Pancrease HL should usually not exceed this dose. If malabsorption is not controlled at this dosage, further investigation is warranted to rule out other causes of malabsorption.Pancrease HL Capsules are not interchangeable with other pancreatin products.
Potential for irritation to oral mucosaCare must be taken to ensure that no drug is retained in the mouth. Pancrease HL Capsules must not be crushed or chewed or mixed in foods having a pH greater than 4.5. These actions can disrupt the protective enteric coating resulting in early release of enzymes, irritation of oral mucosa, and/or loss of enzyme activity. For patients who are unable to swallow intact capsules, the capsules may be carefully opened and the contents sprinkled on a small amount of acidic soft food with a pH of 4.5 or less.
Potential for risk of hyperuricaemiaCaution should be exercised when prescribing Pancrease HL Capsules to patients with gout, renal impairment, or hyperuricaemia. Porcine-derived pancreatic enzyme products contain purines that may increase blood uric acid levels.
Potential viral exposure from the product sourcePancrease HL Capsules is sourced from pancreatic tissue from swine used for food consumption. Although the risk that Pancrease HL Capsules will transmit an infectious agent to humans has been reduced by testing for and inactivating certain viruses during manufacture, there is a theoretical risk for transmission of viral disease, including diseases caused by novel or unidentified viruses. Therefore, the presence of porcine viruses that might infect humans cannot be definitely excluded. However, no cases of transmission of an infectious illness associated with the use of porcine pancreatic extracts have been reported.
Allergic reactionsCaution should be exercised when administering pancreatin to a patient with a known allergy to proteins of porcine origin. Rarely, severe allergic reactions including anaphylaxis, asthma, hives, and pruritus have been reported with other pancreatic enzyme products with different formulations of the same active ingredient (pancreatin). The risks and benefits of continued Pancrease HL Capsules treatment in patients with severe allergy must be taken into consideration with the overall clinical needs of the patient.
PregnancyNo adequate, well-controlled studies have been conducted in pregnant women. Pancrease HL capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Pancrease HL should not be used in pregnancy unless clearly necessary but if required should be used in doses sufficient to provide adequate nutritional status (see warnings about high dose sections 4.2 & 4.8).
Breast-feedingIt is not known whether pancreatin is excreted in human milk. The possibility of protein constituents appearing in the breast milk cannot be excluded; therefore caution should be exercised when prescribing Pancrease HL capsules to lactating women.
FertilityNo fertility or peri/postnatal studies have been performed in animals.
Table: Adverse Reactions Reported in Postmarketing Experience for Pancrease HL (Pancreatin) Delayed-release Capsules
|System Organ Class||Adverse Reactions|
|Very Common (≥1/10)||Common (≥1/100 to <1/10)||Unknown|
|Gastrointestinal Disorders||Abdominal pain||Abdominal distension, diarrhoea, intestinal obstruction*, nausea, vomiting||Constipation|
|Skin and Subcutaneous Tissue Disorders||Rash|
Symptoms and signsChronic high doses of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures (see Section 4.4). High doses of pancreatic enzyme products have been associated with hyperuricosuria and hyperuricaemia, and should be used with caution in patients with a history of hyperuricaemia, gout or renal impairment. (see Section 4.4).
TreatmentIn the event of overdose, Pancrease HL Capsules should be temporarily discontinued and general supportive treatment given until symptoms resolve.
AbsorptionThe 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 Pancrease HL capsules, measurable levels of enzymes are present in the duodenum. Pancreatin is not absorbed from the gastro-intestinal tract in appreciable amounts.
MetabolismOnce they have accomplished their digestive function, the enzymes may be digested in the intestine.
EliminationThe constituents may be partially absorbed and subsequently excreted in the urine. Any undigested enzymes are excreted in the faeces.
PaediatricsThe pharmacokinetics of pancreatin in paediatric subjects have not been investigated.
ElderlyThe pharmacokinetics of pancreatin in elderly subjects have not been investigated.
Renal impairmentThe pharmacokinetics of pancreatin in renally impaired subjects have not been investigated.
Hepatic impairmentThe pharmacokinetics of pancreatin in hepatically impaired subjects have not been investigated.
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