Triferment

For oral administration.

Patients with pancreatic insufficiency should undergo regular nutritional assessments as a component of routine care and additionally, when dosing of pancreatic enzyme replacement is altered.

Dosage should be individualised to each patient, with therapy being initiated at the lowest possible dose and gradually increase until the desired control of steatorrhoea is obtained.

Adults and children

One 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, Triferment 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 Triferment 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 Triferment 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.

Triferment HL Capsules are not interchangeable with other pancreatin products.

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Children aged 15 or under with cystic fibrosis.

Fibrosing colonopathy has been reported following treatment with different pancreatic enzyme products. Fibrosing colonopathy is a rare serious adverse reaction initially described in association with high-dose pancreatic enzyme use, usually with use over a prolonged period of time and most commonly reported in paediatric patients with cystic fibrosis. The underlying mechanism of fibrosing colonopathy remains unknown.

If symptoms suggestive of gastrointestinal obstruction occur, the possibility of bowel strictures should be considered. In some cases surgery including resection of the bowel is required and the need for this should also be considered.

It is uncertain whether regression of fibrosing colonopathy occurs.

Any change in pancreatic enzyme replacement therapy (e.g., dose or brand of medication) should be made cautiously and only under medical supervision. It is recommended that therapy be initiated at a low dose, followed by titration to an effective dose. The titration schedule should be guided by measured changes in 3-day faecal fat excretion.

Potential for irritation to oral mucosa

Care must be taken to ensure that no drug is retained in the mouth. Triferment 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 hyperuricaemia

Caution should be exercised when prescribing Triferment 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 source

Triferment HL Capsules is sourced from pancreatic tissue from swine used for food consumption. Although the risk that Triferment 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 reactions

Caution 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 Triferment HL Capsules treatment in patients with severe allergy must be taken into consideration with the overall clinical needs of the patient.

It is not known if Triferment HL Capsules has an effect on motor skills; however, there is no evidence that Triferment HL Capsules alters a patient's ability to drive and use machines.