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Tryplase

Travellers familiar with Tryplase from Western Europe are unlikely to encounter the same brand elsewhere — it is registered in only five countries. The marketing footprint covers France, Ireland, Italy, the Netherlands, and the United Kingdom, and outside this small cluster the brand is rarely seen on pharmacy shelves.

The active ingredient in Tryplase is pancreatin, a preparation of digestive enzymes classified within the enzyme-replacement category, with combined amylolytic, lipolytic, and proteolytic activity. Pancreatin-based products are used to replenish a deficiency of pancreatic enzymes, and Tryplase is prescribed in the management of conditions associated with that deficiency — including chronic pancreatitis, pancreatitis, and cystic fibrosis, as well as in certain surgical contexts. The structured indication block below this introduction lists the registered uses as recognised by the relevant national authorities.

Although the Tryplase brand itself is regionally limited, pancreatin and equivalent pancreatic enzyme replacement therapies are available in many other countries around the world under different brand names. A patient who has been using Tryplase and is now travelling or relocating will usually find equivalent therapy at the destination, but it will likely be a different brand — and possibly a different enzyme unit specification — rather than the same product. Enzyme content and coating characteristics can vary meaningfully between preparations within this class.

A local pharmacist familiar with the regional formulary is well placed to identify the appropriate equivalent product, and any substitution in long-term enzyme replacement therapy is a matter for the prescribing healthcare provider rather than a decision to be made at the counter alone.

Countries
France Ireland Italy Netherlands United Kingdom
Diseases
Surgery Cystic fibrosis Pancreatitis Chronic pancreatitis
Ingredients
Pancreatin
Drug Actions
Enzymes Amylolytic Lipolytic Proteolytic Replenishing deficiency of pancreatic enzymes

Drugs with the same active ingredients

Créon Creon (pancreatin) Pankreoflat Pankreoflat (pancreatin) Panzytrat Helopanflat Kreon Kreon micro Pancrin A-zyme Crezyme Enzitrol (+dimethicone) Enzitrol (dimethicone,pancreatin) Gasflat Gastenorm forte Gastenorm forte 10000 Gaszym Gesdyp Hazmolin Helopan

Overdose

Symptoms and signs

Chronic high doses of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures. 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..

Treatment

In the event of overdose, Tryplase HL Capsules should be temporarily discontinued and general supportive treatment given until symptoms resolve.

Contraindications

.

Children aged 15 or under with cystic fibrosis.

Incompatibilities

None stated.

Undesirable effects

The following table displays adverse reactions that have been reported with the use of pancreatin from postmarketing experience. The displayed frequency categories use the following convention:

Very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available clinical trial data).

Table: Adverse Reactions Reported in Postmarketing Experience for Tryplase HL (Pancreatin) Delayed-release Capsules

System Organ Class

Adverse Reactions

Frequency Category

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

* Mainly cases of fibrosing colonopathy in paediatric subjects with cystic fibrosis.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Preclinical safety data

No relevant information additional to that contained elsewhere in the Summary of Product Characteristics.

Pharmacotherapeutic group

Enzyme preparations, ATC code: A09AA02.

Pharmacodynamic properties

Pharmacotherapeutic group: Enzyme preparations, ATC code: A09AA02.

Mechanism of action

The porcine-derived pancreatic enzymes (lipases, proteases, and amylases) catalyse the hydrolysis of fats to monoglyceride, glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars such as maltose and maltriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas..

Pharmacokinetic properties

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 Tryplase 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.

Special warnings and precautions for use

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. Tryplase 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 Tryplase 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

Tryplase HL Capsules is sourced from pancreatic tissue from swine used for food consumption. Although the risk that Tryplase 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 Tryplase HL Capsules treatment in patients with severe allergy must be taken into consideration with the overall clinical needs of the patient.

Effects on ability to drive and use machines

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

Dosage (Posology) and method of administration

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, Tryplase 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 Tryplase 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 Tryplase 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.

Tryplase HL Capsules are not interchangeable with other pancreatin products.

Special precautions for disposal and other handling

Not applicable.

Frequently asked questions

What conditions does Tryplase treat?

Tryplase is used in the management of conditions associated with insufficient pancreatic enzyme activity, including chronic pancreatitis, pancreatitis, and cystic fibrosis, as well as in certain post-surgical contexts where digestive enzyme support is needed. Pancreatin replenishes amylolytic, lipolytic, and proteolytic activity that the pancreas would normally provide. The structured indication section further down this page lists the registered uses recognised in the markets where Tryplase is sold.

Which active substance is in Tryplase?

Tryplase contains pancreatin, a preparation of digestive enzymes with combined amylolytic, lipolytic, and proteolytic activity used to replenish a deficiency of pancreatic enzymes. Pancreatin is the same active ingredient whether sold under the Tryplase brand or under other commercial names; internationally, the same enzyme preparation circulates under several brand names, with formulations and enzyme unit specifications that vary between manufacturers.

In how many countries is Tryplase available?

Tryplase is registered in five countries, all within Western Europe: France, Ireland, Italy, the Netherlands, and the United Kingdom. Outside this small cluster the brand is rarely encountered, although pancreatin-based enzyme replacement therapy is available in many other markets under different brand names. If your country is not on this list, a local pharmacist can confirm whether a comparable pancreatin product is registered locally.

Are there alternatives to Tryplase?

Pancreatin is sold under several brand names worldwide, particularly in markets where pancreatic enzyme replacement therapy is part of standard care for cystic fibrosis or chronic pancreatitis. Products within this enzyme-replacement category are not freely interchangeable — enzyme unit content, coating, and release profiles can differ meaningfully between preparations. To identify a regional equivalent, search the active ingredient pancreatin on Pill2Trip or ask a pharmacist about locally available options.

Is Tryplase a prescription medication?

Tryplase is generally a prescription medication, and pancreatic enzyme replacement therapy is calibrated to the individual patient's underlying condition, nutritional needs, and clinical context. Prescription requirements and available formulations differ between countries, which is particularly relevant for travellers and people relocating across borders. Any decision to start, stop, switch, or substitute a pancreatin product should involve a healthcare provider familiar with the patient's history.

Tryplase

Available in 5 countries