Monograph: Pancreatic Enzymes

Date: 2019-04-29

NHPID name

• Pancreatic Enzymes ( Integrated Taxonomic Information System )
• Pancreatic Extract ( Integrated Taxonomic Information System )
• Pancrelipase ( Integrated Taxonomic Information System )
• Pancreatin ( Integrated Taxonomic Information System )

Proper name(s)

Common name(s)

Pancreatic Enzymes

Source material

Route Of administration

Oral

Dosage form(s)

• The dosage form must be qualified with an additional term to describe the delayed release (e.g. enteric-coated capsules, gastro-resistant tablets, microencapsulated pancreatic enzymes) (WHO 2011).
• The only acceptable pharmaceutical dosage forms are delayed-release capsules, tablets, or granules (e.g. enteric-coated tablets, capsules containing enteric-coated granules/(mini)microspheres) (Friess et al. 1999; Suarez et al. 1999; Sharpé et al. 1997).
• This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or purpose(s)

Statement(s) to the effect of:

• Digestive aid.  (Cichoke 2006)
• Digestive enzyme.
• Helps to decrease bloating after high caloric, high fat meals.  (Suarez et al. 1999)
• Digestive aid to help decrease bloating after high caloric, high fat meals.  (Suarez et al. 1999)

Dose(s)

Duration of use

Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 4 weeks.  (Friess et al. 1998)

Risk information

Statement(s) to the effect of:

Caution(s) and Warning(s):

• Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
• Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are pregnant, breastfeeding, have diabetes, pancreatitis, pancreatic exocrine insufficiency or cystic fibrosis.

Contraindication(s):

• Do not use this product if you are sensitive to pancreatic enzymes.
• Do not use this product if you are sensitive to pork proteins.

Known Adverse Reaction(s): Stop use and consult a health care practitioner/health care provider/health care professional/ doctor/physician if nausea, vomiting, abdominal pain/epigastric pain and/or heartburn occur.

Non-medicinal ingredients

Must be chosen from the current Natural health products ingredients database and must meet the limitations outlined in the database.

Specifications

• The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of natural health products guide.
• The medicinal ingredient must comply with the requirements outlined in the Natural health products ingredient database (NHPID).