PANCREASE MT

). 2 Geriatrics It is recommended that enzyme doses, expressed as lipase units/kg/meal, be decreased in older patients since they weigh more but tend to ingest less fat per kilogram (see 4 DOSAGE AND ADMINISTRATION) 2 CONTRAINDICATIONS Pancrease MT is contraindicated in: • patients who have known hypersensitivity to porcine protein, pancreatic enzymes, or any excipients (see

1 Adverse Reaction Overview The most common adverse reactions are abdominal discomfort, constipation and dermatitis. Other gastrointestinal reactions are less common and include abnormal stool and diarrhea. Nausea and vomiting have been reported, but these are not common.

With high doses, perianal irritation and inflammation have been reported (see 7 WARNINGS AND PRECAUTIONS). At extremely high doses, hyperuricosuria and hyperuricemia have been reported. Allergic or hypersensitivity reactions of the skin have been reported (see 7 WARNINGS AND PRECAUTIONS, General).

5 Post-Market Adverse Reactions The following adverse reactions have been reported during post-marketing experience (Table ).

The frequencies are provided according to the following convention:

Very common  1/10 Common  1/100 and < 1/10 Uncommon  1/1,000 and < 1/100 Rare  1/10,000 and < 1/1000 Very rare < 1/10,000 Table 2: Adverse Drug Reactions Identified During Post-Marketing Experience with Pancrease MT by Frequency Category Estimated from Spontaneous Reporting Rates Gastrointestinal Disorders Very rare Abdominal distention, abdominal pain, diarrhea, intestinal obstruction*, nausea, vomiting Skin and Subcutaneous Tissue Disorders Very rare Rash * Mainly cases of fibrosing colonopathy in pediatric subjects with cystic fibrosis (see 7 WARNINGS AND PRECAUTIONS).

). Usually, half the mealtime dose is given with a snack. The total daily dose should reflect approximately three meals and two snacks per day. Instruct the patient to take the medication immediately and not store it to be taken later.

2 Recommended Dose and Dosage Adjustment If doses greater than 2,500 lipase units/kg/meal (4,000 lipase units/g fat/day) are required to control malabsorption, further investigation is warranted to rule out other causes of malabsorption.

Doses greater than 2,500 units/kg/meal should be used with caution and only if they are documented to be effective by 3-day fecal fat studies. Doses greater than 6,000 lipase units/kg/meal have been associated with colonic strictures, particularly in children with cystic fibrosis less than 12 years of age.

Patients currently on higher doses than 6,000 lipase units/kg/meal should be re-evaluated and the dosage either immediately decreased or titrated downward to the lowest effective clinical dose as assessed by 3-day fecal fat excretion (see 7 WARNINGS AND PRECAUTIONS, Gastrointestinal).

Pancrease MT (pancrelipase) Page 6 of 18 Infants (up to 12 months):

Fat Consumption Scheme • 2,000-4,000 USP lipase units per 120 mL of formula or per breast-feeding. 5 grams of fat per 120 mL standard cow’s milk-based formula). Higher doses are used in infants because, on average, infants ingest 5 grams of fat per kilogram of body weight per day, whereas adults tend to ingest about 2 grams of fat per kilogram per day.

Contents of the capsule should not be mixed directly into formula or breast milk as this may diminish efficacy.

Children (over 12 months) and Adults:

Weight-based Scheme • Less than 4 years: Begin with 1,000 USP lipase units/kg/meal to a maximum of 2,500 lipase units/kg/meal. • Over 4 years and Adults: Begin with 500 USP lipase units/kg/meal to a maximum of 2,500 lipase units/kg/meal.

Geriatrics (≥ 65 years of age): • Enzyme doses, expressed as lipase units/kg/meal, should be decreased in older patients, since they weigh more but tend to ingest less fat per kilogram. 4 Administration The capsules should not be chewed or crushed because the coating (that is formulated to deliver the enzymes to the correct place in the intestines) will be destroyed.

, milk, custard, ice cream, other dairy products) because the enteric coating will dissolve prematurely and limit absorption (see 4 DOSAGE AND ADMINISTRATION). 5 Missed Dose If the patient misses a dose, instruct him/her to wait until their next meal and take their usual number of capsules at their usual time.

Inform patients not to make up for missed doses. 5 OVERDOSAGE Chronic high doses of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures (see 7 WARNINGS AND PRECAUTIONS, Gastrointestinal).

Extremely high dosages of pancreatic enzymes have been reported to cause hyperuricosuria and hyperuricemia and should be used with caution in patients with a history of hyperuricemia, gout, or renal impairment (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).

Most cases responded to supportive measures, including discontinuation of the enzyme therapy and ensuring adequate hydration. For management of a suspected drug overdose, contact your regional poison control centre. Pancrease MT (pancrelipase) Page 7 of 18 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Pancrease MT capsules contain enteric-coated microtablets of pure porcine pancreatic enzyme concentrate — predominantly steapsin (pancreatic lipase), amylase, and protease — isolated by a proprietary process that ensures high enzyme purity and activity.

850 USP units and protease 6,200 USP units. Capsules are filled with white-grey microtablets. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients oral Capsule/ Pancrease® MT 2 colloidal anhydrous silica, crospovidone, magnesium stearate, methacrylic acid ethyl oralacrylate copolymer, microcrystalline celloralulose, montan glycol wax, simethicone emulsion, talc and triethyl citrate.

The capsule shell contains hypromellose, titanium dioxide and iron oxide. oral Capsule/ Pancrease® MT 4 colloidal anhydrous silica, crospovidone, magnesium stearate, methacrylic acid ethyl acrylate copolymer, microcrystalline cellulose, montan glycol wax, simethicone emulsion, talc and triethyl citrate.

The capsule shell contains hypromellose, titanium dioxide and iron oxide. oral Capsule/ Pancrease® MT 10 colloidal anhydrous silica, crospovidone, magnesium stearate, methacrylic acid ethyl acrylate copolymer, microcrystalline cellulose, montan glycol wax, simethicone emulsion, talc and triethyl citrate.

The capsule shell contains hypromellose, titanium dioxide and iron oxide. oral Capsule/ Pancrease® MT 16 colloidal anhydrous silica, crospovidone, magnesium stearate, methacrylic acid ethyl acrylate copolymer, microcrystalline cellulose, montan glycol wax, simethicone emulsion, talc, and triethyl citrate.

The capsule shell contains hypromellose, titanium dioxide and iron oxide. oral Capsule/ Pancrease® MT 20 colloidal anhydrous silica, crospovidone, magnesium stearate, methacrylic acid ethyl acrylate copolymer, microcrystalline cellulose, montan glycol wax, simethicone emulsion, talc, and triethyl citrate.

The capsule shell contains hypromellose, and titanium dioxide. Pancrease MT (pancrelipase) Page 8 of 18 Pancrease® MT 4 capsules, yellow opaque body and clear cap, imprinted "MT 4" on clear cap, and "VIVUS" on body, containing: lipase 4,200 USP units, amylase 17,500 USP units and protease […]

Pancrease MT is contraindicated in: • patients who have known hypersensitivity to porcine protein, pancreatic enzymes, or any excipients (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). • patients experiencing an episode of acute pancreatitis or the acute exacerbation of chronic pancreatitis excipients (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).