PANCREASE MT 10 CAPSULE (DELAYED RELEASE)

Canada - English - Health Canada

Buy It Now

Active ingredient:
AMYLASE; PROTEASE; LIPASE
Available from:
VIVUS INC.
ATC code:
A09AA02
INN (International Name):
MULTIENZYMES (LIPASE, PROTEASE ETC)
Dosage:
43750UNIT; 25000UNIT; 10500UNIT
Pharmaceutical form:
CAPSULE (DELAYED RELEASE)
Composition:
AMYLASE 43750UNIT; PROTEASE 25000UNIT; LIPASE 10500UNIT
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
DIGESTANTS
Product summary:
Active ingredient group (AIG) number: 0302964029; AHFS: 56:16.00
Authorization status:
APPROVED
Authorization number:
00789437
Authorization date:
1999-05-03

Documents in other languages

PH-10-003-00

Page 1 of 17

PRODUCT MONOGRAPH

Pr

PANCREASE

®

MT 4

4,200 USP Units Lipase/17,500 USP Units Amylase/10,000 USP Units Protease/Capsule

Pr

PANCREASE

®

MT 10

10,500 USP Units Lipase/43,750 USP Units Amylase/25,000 USP Units Protease /Capsule

Pr

PANCREASE

®

MT 16

16,800 USP Units Lipase/70,000 USP Units Amylase/40,000 USP Units Protease /Capsule

Pancrelipase

Delayed-Release Capsules

Digestant

VIVUS, Inc.

900 East Hamilton Avenue, Suite #550,

Campbell, California, USA 95008

Date of Preparation:

February 9, 1996

Date of Revision:

May 17, 2019

www.vivuspharma.ca

Distributed in Canada by:

Innomar Strategies Inc.

Oakville, Ontario

L6L 0C4

Submission Control No: 226277

All trademarks used under license.

PH-10-003-00

Page 2 of 17

© 2017 VIVUS, Inc.

PH-10-003-00

Page 3 of 17

Table of Contents

PART I: HEALTH PROFESSIONAL INFORMATION .........................................................4

SUMMARY PRODUCT INFORMATION ........................................................................4

INDICATIONS AND CLINICAL USE ..............................................................................5

CONTRAINDICATIONS ...................................................................................................5

WARNINGS AND PRECAUTIONS ..................................................................................5

ADVERSE REACTIONS ....................................................................................................7

DRUG INTERACTIONS ....................................................................................................8

DOSAGE AND ADMINISTRATION ................................................................................8

OVERDOSAGE ................................................................................................................10

ACTION AND CLINICAL PHARMACOLOGY ............................................................10

STORAGE AND STABILITY ..........................................................................................11

DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................11

PART II: SCIENTIFIC INFORMATION ...............................................................................12

PHARMACEUTICAL INFORMATION ..........................................................................12

REFERENCES ..................................................................................................................14

PART III: CONSUMER INFORMATION..............................................................................15

PH-10-003-00

Page 4 of 17

Pr

PANCREASE

®

MT 4

Pr

PANCREASE

MT 10

Pr

PANCREASE

MT 16

Pancrelipase Delayed-Release Capsules

Digestant

PART I: HEALTH PROFESSIONAL INFORMATION

SUMMARY PRODUCT INFORMATION

Route of

Administration

Dosage Form / Strength

Nonmedicinal Ingredients

oral

Capsules/

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

gelatin, titanium dioxide, sodium lauryl sulfate,

sorbitan monolaurate, and iron oxide.

Capsules/

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

gelatin, titanium dioxide, sodium lauryl sulfate,

sorbitan monolaurate, and iron oxide.

Capsules/

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

gelatin, titanium dioxide, sodium lauryl sulfate,

sorbitan monolaurate, and iron oxide.

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.

PH-10-003-00

Page 5 of 17

INDICATIONS AND CLINICAL USE

PANCREASE

MT (pancrelipase) capsules are indicated for the treatment of pancreatic

insufficiency attributed to cystic fibrosis, chronic pancreatitis, or any other medically defined

pancreatic disease that might require pancreatic enzyme therapy.

Geriatrics (≥ 65 years of age):

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 DOSAGE AND

ADMINISTRATION).

Pediatrics (< 18 years of age):

PANCREASE

MT is approved for use in pediatrics for the treatment of pancreatic insufficiency

attributed to cystic fibrosis, chronic pancreatitis, or any other medically defined pancreatic

disease that might require pancreatic enzyme therapy (see DOSAGE AND

ADMINISTRATION).

CONTRAINDICATIONS

Patients who have known hypersensitivity to porcine protein, pancreatic enzymes or any

excipients; and

During acute pancreatitis or the acute exacerbation of chronic pancreatitis.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Pancreatic

enzyme

products,

including

PANCREASE

®

MT

(pancrelipase)

have

been

associated with fibrosing colonopathy (strictures of the ileo-caecum and large intestine) if

given at high doses chronically to patients with cystic fibrosis. It is not clear whether this

complication is caused by high dosages of pancreatic enzymes, or whether the underlying

disease is responsible. Unusual abdominal symptoms should be reviewed to exclude the

possibility of colonic damage, especially if the patient is taking in excess of 6,000 lipase

units/kg/meal.

PANCREASE

®

MT cannot be substituted (unit for unit) with other pancreatic enzyme

products because they are biological products and, therefore, differ in their manufacturing

processes, formulations, exact composition, enzymatic activities, stability and bioactivity in

the small intestine, so the response of the patient to the estimated dose must be monitored

and adjusted as necessary. Special attention to the response of the patient is required

during any change in treatment from one pancreatic enzyme product to another.

>

PH-10-003-00

Page 6 of 17

General

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 (pancrelipase). Should hypersensitivity occur, discontinue medication and treat the

patient symptomatically.

It is important to ensure adequate hydration in patients at all times during therapy with pancreatic

enzymes.

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. If the capsules are opened

and the contents shaken onto soft food, it should not have an alkaline pH (e.g., milk, custard, ice

cream, other dairy products) because the enteric coating will dissolve prematurely and limit

absorption (see DOSAGE AND ADMINISTRATION).

To avoid irritation of the mouth, lips, and tongue, opened PANCREASE

MT capsules should

be swallowed immediately before regular feedings or meals to minimize the likelihood that the

microtablets are retained in the mouth. Proteolytic enzymes present in PANCREASE

MT, when

retained in the mouth, may begin to digest the mucous membranes and cause ulcerations.

Any change in pancreatic enzyme replacement therapy (e.g., dose or brand of medication) should

be made cautiously and only under medical supervision. Pancreatic extracts can form insoluble

complexes with folic acid, resulting in folic acid deficiency.

Pancreatic enzyme replacement therapy, in patients in whom both the exocrine and endocrine

pancreas are not functioning, may interact with insulin therapy of diabetes. High-dose pancreatin

mini-microspheres improve but do not fully normalize fat absorption, possibly because of the

residual influence of diabetes and malnutrition on absorptive function. Since control of blood

glucose may be brittle in malnourished, insulin-dependent patients, enzyme adjustment should be

carefully supervised in-hospital to avoid exacerbation of pancreatic dysfunction.

Gastrointestinal

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 pediatric patients with cystic fibrosis. The underlying

mechanism of fibrosing colonopathy remains unknown. Doses of pancreatic enzyme products

exceeding 6,000 lipase units/kg/meal have been associated with colonic strictures in children less

than 12 years of age. Close monitoring of patients with fibrosing colonopathy is recommended

because some patients may be at risk of progressing to stricture formation. It is uncertain whether

regression of fibrosing colonopathy occurs. It is generally recommended, unless clinically

indicated, that enzyme doses be less than 2,500 lipase units/kg/meal (corresponding to less than

10,000 lipase units/kg/day or 4,000 lipase units/g fat ingested/day).

Doses greater than 2,500 lipase units/kg/meal must be used with caution and only if they are

documented to be effective by 3-day fecal fat measures that indicate a significantly improved

coefficient of fat absorption. It is recommended that patients receiving higher doses than 6,000

PH-10-003-00

Page 7 of 17

lipase units/kg/meal be examined and the dosage either immediately decreased or titrated

downward to a lower range, if possible.

Hepatic/Biliary/Pancreatic

PANCREASE

MT or other pancreatic enzyme products may cause hyperuricosuria and

hyperuricemia with very high doses. Also at very high doses, perianal irritation and

inflammation may occur.

Caution should be exercised when prescribing PANCREASE

MT to patients with gout, renal

impairment, or hyperuricemia. Porcine-derived pancreatic enzyme products contain purines that

may increase blood uric acid levels.

Potential Viral Exposure from the Product Source

PANCREASE

MT is sourced from pancreatic tissue from swine used for food consumption.

Although the risk that PANCREASE

MT will transmit an infectious agent to humans has been

reduced by testing for certain viruses during manufacturing and by inactivating certain viruses

during manufacturing, there is a theoretical risk for transmission of viral disease, including

diseases caused by novel or unidentified viruses. Thus, 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.

Special Populations

Pregnant Women:

There is insufficient data from the use of drug pancrelipase in pregnant women. Although some

animal studies have been conducted, no adequate, well-controlled studies have been conducted in

pregnant women. PANCREASE

MT should only be used during pregnancy if, in the opinion of

the healthcare practitioner, the potential benefits outweigh the potential risks.

Nursing Women:

There is insufficient data to assess the risks. Pancreatic enzymes act locally in the gastrointestinal

tract, and cannot be absorbed in their intact state systemically. Some of the constituent amino

acids and nucleic acids are probably absorbed with dietary protein. However, the possibility of

protein constituents being secreted into breast milk cannot be excluded. PANCREASE

should be used only if, in the opinion of the healthcare practitioner, the potential benefits

outweigh the potential risks.

ADVERSE REACTIONS

Adverse Drug 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 WARNINGS AND PRECAUTIONS).

At extremely high doses, hyperuricosuria and hyperuricemia have been reported.

PH-10-003-00

Page 8 of 17

Allergic or hypersensitivity reactions of the skin have been reported (see WARNINGS AND

PRECAUTIONS, General).

Post-Market Adverse Drug Reactions

The following adverse reactions have been reported during post-marketing experience (Table

1.1). 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 1.1:

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 WARNINGS AND PRECAUTIONS).

DRUG INTERACTIONS

No drug interactions have been identified.

DOSAGE AND ADMINISTRATION

General Guidelines

Patients with pancreatic insufficiency should consume a high-calorie, unrestricted fat diet

appropriate for their age and clinical status. A nutritional assessment should be performed

regularly as a component of routine care, and additionally when the dosage of pancreatic enzyme

replacement is made.

Dosage should be adjusted according to the severity of the exocrine pancreatic enzyme

deficiency. The number of capsules or capsule strength given with meals and/or snacks should

be estimated by assessing at which dose steatorrhea is minimized and good nutritional status is

maintained. In some patients with pancreatic enzyme deficiency, satisfactory responses have

been achieved with dosages (expressed in USP units of lipase) similar to the ones stated below.

However, dosages should be adjusted according to the response of the patients. Dosage should be

adjusted based on 3-day fecal fat studies.

Dose increases, if required, should be made slowly, with careful monitoring of response and

symptomatology. It is important to ensure adequate hydration of patients at all times while

administering PANCREASE

MT capsules.

There is considerable variation among individuals in response to enzymes with respect to control

of steatorrhea; therefore, a range of doses is suggested.

PH-10-003-00

Page 9 of 17

If the patient cannot swallow whole capsules, they may be opened and the contents shaken onto a

small quantity of soft food that does not require chewing e.g., applesauce, dessert gelatin, etc.,

but not milk, ice cream, other dairy products or custard because the pH is too high (see

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.

Dosing Considerations

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 WARNINGS AND PRECAUTIONS, Gastrointestinal).

Recommended Dose and Dosage Adjustment

Infants (up to 12 months):

Fat Consumption Scheme

2,000-4,000 USP lipase units per 120 mL of formula or per breast-feeding. This provides

approximately 450-900 lipase units per gram of fat ingested (based on 4.5 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.

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.

PH-10-003-00

Page 10 of 17

OVERDOSAGE

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Chronic high doses of pancreatic enzyme products have been associated with fibrosing

colonopathy and colonic strictures (see 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 WARNINGS AND PRECAUTIONS,

Hepatic/Biliary/Pancreatic).

Most cases responded to supportive measures, including discontinuation of the enzyme therapy

and ensuring adequate hydration.

ACTION AND CLINICAL PHARMACOLOGY

Mechanism of Action

PANCREASE

MT microtablets resist gastric inactivation and deliver predictable, high levels of

biologically active pancreatic enzymes (lipase, amylase, and protease) into the duodenum. The

enzymes catalyze the hydrolysis of fats into glycerol and fatty acids, proteins into proteoses and

derived substances, and starch into dextrins and sugars.

Pharmacokinetics

Absorption:

The intestinal bioavailability of PANCREASE

MT 16 capsules

I

was determined, in vitro, under

simulated physiological conditions

1

. PANCREASE

MT capsules were placed into a test tube

containing an incubation medium consisting of 2.0 g NaCl, 9.2 g NaH

and distilled water

(total volume: 1 litre). Employing a disintegration tester, the contents of the test tube were

shaken at a constant speed of 30 rpm at an incubation temperature of 37

C. The pH of the

mixture was adjusted by adding 4N HCl or 4N NaOH.

To simulate the acidic conditions of the stomach during a meal, a pH of 4.0 was initially

established and gradually reduced in increments of 0.5 at 30-minute intervals to a pH of 2.5. To

simulate the relative alkalinity of the intestine, the preparation was then transferred to a buffer

where a pH of 6.6 was maintained. While the preparation was exposed to the buffer, release of

pancreatic lipase, the marker enzyme, was measured as a function of time. The lipase content of

the incubation medium was determined every 15 minutes for 120 minutes. More than 90% of

the enzyme activity of the PANCREASE

MT capsules was released at 15 minutes with peak

levels (97%) occurring at 30 minutes. The results demonstrate that PANCREASE

MT capsules

are nearly 100% bioavailable and rapidly release high levels of pancreatic enzymes.

This study, conducted in West Germany, used Panzytrat

20000 (Nordmark Arzneimittel GmbH, Uetersen, West Germany) which contains

microtablets that are the same formulation as those of PANCREASE

MT 16.

PH-10-003-00

Page 11 of 17

Excretion:

Unused enzymes in PANCREASE

MT capsules are excreted in the feces. Digested enzymes

are absorbed and are subsequently excreted in the urine.

STORAGE AND STABILITY

Keep bottle tightly closed. Store between 10

C-25

C in a dry place. Dispense in a tight

container. Do not refrigerate.

The PANCREASE

MT 4 bottle contains a desiccant canister. DO NOT eat or throw away the

canister (desiccant) in the bottle. The packet will protect the medicine from moisture.

DOSAGE FORMS, COMPOSITION AND PACKAGING

PANCREASE

MT 4 capsules, yellow opaque, clear hard gelatin capsule, imprinted "MT 4" on

clear cap, and "VIVUS" on body, containing: lipase 4,200 USP units, amylase 17,500 USP units

and protease 10,000 USP units. Capsules are filled with white-grey microtablets.

PANCREASE

MT 10 capsules, pink opaque, clear hard gelatin capsule, imprinted "MT 10" on

clear cap, and "VIVUS" on body, containing: lipase 10,500 USP units, amylase 43,750 USP

units and protease 25,000 USP units. Capsules are filled with white-grey microtablets.

PANCREASE

MT 16 capsules, salmon opaque, clear hard gelatin capsule, imprinted "MT 16"

on clear cap, and "VIVUS" on body, containing: lipase 16,800 USP units, amylase 70,000 USP

units and protease 40,000 USP units. Capsules are filled with white-grey microtablets.

Composition

PANCREASE

MT capsules contain the following inactive ingredients: 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 gelatin, titanium dioxide, sodium lauryl sulfate, sorbitan monolaurate,

and iron oxide.

Packaging

Bottles of 100 capsules are available for each strength.

PH-10-003-00

Page 12 of 17

PART II: SCIENTIFIC INFORMATION

PHARMACEUTICAL INFORMATION

Drug Substance

Proper name: Pancrelipase

Chemical name: Pancrelipase drug substance is a complex biological non-recombinant material

comprising various enzymes of lipolytic, amylolytic, and proteolytic activities (including trypsin,

chymotrypsin, kallikrein, amylase, lipase, colipase and some isoforms).

Molecular formula and molecular mass: Not applicable

Structural formula: Not applicable

Physicochemical properties: Pancreatic enzymes, especially lipase, are acid-sensitive in that

they are increasingly and irreversibly inactivated with further decreasing pH values below pH 4.

Product Characteristics

Macroscopic Appearance

Pancrelipase, the enzyme component of PANCREASE

MT capsules, is a white-grey granulate.

Similarity to Other Compounds

PANCREASE

MT capsules closely relate to other lipase-enriched pancrelipase preparations

and to pancreatin. PANCREASE

MT capsules differ from conventional pancreatic enzyme

preparations in that the pancreatic enzymes are prepared as small enteric-coated microtablets (2

mm diameter). The pH-sensitive coating reduces or prevents inactivation of the enzymes by the

acidic environment of the stomach. The extremely small size of the microtablets promotes rapid

and uniform dispersion with food in the stomach and emptying into the duodenum with the

chyme. In addition, a proprietary pancrelipase extraction process ensures that the microtablets

contain high-potency, biologically active pancreatic enzymes, including activated proteases.

Physical and Chemical Compatibilities

To protect the enteric coating, the microtablets should not be crushed or chewed. Diminished

clinical effectiveness could result if the microtablets are crushed.

5

If patients have difficulty

swallowing capsules, the PANCREASE

MT capsules may be opened and the microtablets may

be shaken onto a small quantity of a soft food which does not require chewing (e.g., applesauce,

dessert gelatin, etc.), and swallowed immediately. Contact of the microtablets with foods having

a pH greater than 7.3 (e.g., milk, custard, ice cream, and many other dairy products) can dissolve

the protective enteric coating.

The pancrelipase powder is partly soluble in water and practically insoluble in alcohol or ether.

General Stability

PH-10-003-00

Page 13 of 17

Temperature

The enteric coating and the potency of the pancreatic enzymes may be adversely affected by high

temperature.

Moisture

The enteric coating and the potency of the pancreatic enzymes may be adversely affected by high

humidity.

pH Stability

The enteric-coated microtablets are completely resistant to gastric acid, as indicated by testing

for 2 hours in 0.1 N HCl (simulated gastric fluid). In vitro, the microtablets begin to dissolve

above a pH of 5.5, with nearly 100% dissolution occurring within 30 minutes at a pH of 6.0.

Exposing the microtablets to simulated intestinal fluid (pH 6.6) results in a 93% enzyme release

within 15 minutes.

1

PH-10-003-00

Page 14 of 17

REFERENCES

Otte M, Ridder P, Dageforde J: In vitro tests of pancreatic enzyme preparations. Deutsche

Medizinische Wochenschrift 1987; 112(39):1498-1502.

Stapleton FB, Kennedy J, Nousia-Arvanitakas S, Linshaw MA: Hyperuricosuria due to high-dose

pancreatic extract therapy in cystic fibrosis. New England Journal of Medicine 1976; 295:246-

248.

Davidson GP, Hassel FM, Crozier D, et al: Iatrogenic hyperuricemia in children with cystic

fibrosis. The Journal of Pediatrics 1978; 93:976-978.

Martindale:

Extra

Pharmacopoeia

30th

Edition,

Reynolds,

ed.,

London:

Pharmaceutical Press, 1993; p. 1397, 1398.

Weber AM, de Gheldere B, Roy CC, et al: Effectiveness of enteric coated pancrease in cystic

fibrosis (CF) children under 4 years old. Cystic Fibrosis Club Abstracts; May 1979; 18.

Stern M, Plettner C, Gruttner R: Pancreatic-enzyme replacement therapy in cystic fibrosis (CF):

Clinical trial of a gastric-acid resistant pancreatin preparation in encapsulated microtablet form.

Klinische Padiatrie 1988; 200:36-39.

Gottschalk B, Wiesemann HG, Stephan U: Comparison of two pancreatic enzyme preparations

for the treatment of digestive insufficiency in cystic fibrosis. Monatsschrift Kinderheilkunde.

1988; 136(9):626-629..

Lankisch PG, Lembcke B, Kirchhoff S, et al: Therapy of pancreatogenic steatorrhea: Comparison

of two acid-protected enzyme preparations. Deutsche Medizinische Wochenschrift 1988; 113:15-

Meyer J, Sulkowski U, Preusser P: Results of replacement therapy in insufficiency of the

exocrine pancrease. Medizinische Welt 1987; 38:516-518.

Borowtiz DS, Grand RJ, Durie PR, and the Consensus Committee: Use of Pancreatic Enzyme

Supplements for Patients with Cystic Fibrosis in the Context of Fibrosing Colonopathy. The

Journal of Pediatrics 1995; 127:681-683.

Pancreatic Enzymes - Evaluation of Current Practice in a Large Clinic. CF Conference 1995, 309.

Borowitz D, Baker RD, Stallings V. Consensus report on nutrition for pediatric patients with

cystic fibrosis. J Pediatr Gastroenterol Nutr. 2002;35:246-259.

Stallings VA, Start LJ, Robinson KA, Feranchak AP, Quinton H, Clinical Practice Guidelines on

Growth

Nutrition

Subcommittee;

Working

Group.

Evidence-based

practice

recommendations for nutrition-related management of children and adults with cystic fibrosis and

pancreatic insufficiency: results of a systematic review. J Am Diet Assoc. 2008;108:832-839.

IMPORTANT: PLEASE READ

PH-10-003-00

Page 15 of 17

PART III: CONSUMER INFORMATION

Pr

PANCREASE

®

MT 4

Pr

PANCREASE

®

MT 10

Pr

PANCREASE

®

MT 16

Pancrelipase Delayed-Release Capsules

This leaflet is Part III of a three-part "Product Monograph"

published when PANCREASE

MT was approved for sale in

Canada and is designed specifically for Consumers. This leaflet is

a summary and will not tell you everything about PANCREASE

MT. Contact your doctor or pharmacist if you have any questions

about the drug.

ABOUT THIS MEDICATION

What the medication is used for:

PANCREASE

MT is for the treatment of pancreatic insufficiency

attributed to cystic fibrosis, chronic pancreatitis, or any other

medically defined pancreatic disease that might require pancreatic

enzyme therapy, as determined by your doctor.

What it does:

PANCREASE

MT is classified as a digestant. This means that

PANCREASE

MT capsules contain enzymes that help in the

digestion of food. These enzymes – called lipase, amylase and

protease – break down the fats, proteins and starches in food and

convert them into substances that can be easily used by the body.

The tiny microtablets inside each capsule of PANCREASE

contain a certain amount of each of these enzymes. Because these

microtablets are enteric coated, they are not digested by the

stomach but work directly in the lower gastrointestinal tract. Once

they have done their work, any undigested enzymes are simply

passed out of the body in the feces (bowel movements).

When it should not be used:

PANCREASE

MT should not be used if you have known

hypersensitivity to porcine protein, pancreatic enzymes or any

excipients; and/or during acute pancreatitis or the acute

exacerbation of chronic pancreatitis.

What the medicinal ingredient is:

Each capsule of enteric-coated porcine pancreatic enzyme

concentrate microtablets contains:

PANCREASE

MT 4

Lipase

4,200 USP Units

Amylase

17,500 USP Units

Protease

10,000 USP Units

PANCREASE

MT 10

Lipase

10,500 USP Units

Amylase

43,750 USP Units

Protease

25,000 USP Units

PANCREASE

MT 16

Lipase

16,800 USP Units

Amylase

70,000 USP Units

Protease

40,000 USP Units

What the nonmedicinal ingredients are:

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 gelatin, titanium

dioxide, sodium lauryl sulfate, sorbitan monolaurate, and iron

oxide.

What dosage forms it comes in:

PANCREASE

MT 4 Capsules

PANCREASE

MT 10 Capsules

PANCREASE

MT 16 Capsules

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Pancreatic enzyme products, including PANCREASE

®

MT,

have been associated with strictures of the ileo-caecum and

large intestine if given at high doses chronically to patients

with cystic fibrosis.

PANCREASE

®

MT cannot be substituted (unit for unit) with

other pancreatic enzyme products because they are

biological products and, therefore, differ in their

manufacturing processes, formulations, exact composition,

enzymatic activities, stability and bioactivity in the small

intestine, so the response of the patient to the estimated dose

must be monitored and adjusted as necessary.

BEFORE you use PANCREASE

®

MT talk to your doctor or

pharmacist if you:

are allergic to pork (pig) products

have a history of blockage of your intestines, or scarring

or thickening of your bowel wall (fibrosing colonopathy)

have gout, kidney disease or high blood uric acid

(hyperuricemia)

have trouble swallowing capsules

have any other medical condition

are pregnant or plan to become pregnant. It is not known

if PANCREASE

MT will harm your unborn baby

are breast-feeding or plan to breast-feed. It is not known

if PANCREASE

MT passes into your breast milk. You

and your doctor should decide if you will take

PANCREASE

MT or breast-feed.

Tell your doctor about all the medicines you take, including

prescription and nonprescription drugs, natural health products,

vitamins, or herbal supplements.

PROPER USE OF THIS MEDICATION

PANCREASE

MT capsules and capsule contents should not be

crushed or chewed. Capsules should be swallowed whole. If

there is a problem with taking capsules whole (younger children

may sometimes have a problem swallowing the capsules) the

capsules may be opened up and the microtablets mixed with soft

food

which does not require chewing e.g., applesauce, dessert

gelatin, etc., but not milk, ice cream, other dairy products or

custard because the pH is too high. If you sprinkle

IMPORTANT: PLEASE READ

PH-10-003-00

Page 16 of 17

PANCREASE

MT on food, give the PANCREASE

MT and

food mixture to your child right away. Do not store

PANCREASE

MT that is mixed with food.

Your doctor will do special tests periodically and, if necessary,

will adjust the number of capsules you or your child take. Do not

change the number of capsules unless your doctor tells you to.

Taking too many capsules over a long period of time may lead

to complications.

You should always drink plenty of fluids to maintain your body’s

fluid balance.

Usual dose

Adults and Children:

Because PANCREASE

MT acts as a digestant, the capsules

should be taken with, and only with, meals and snacks. Your

doctor will tell you how many capsules to take with each meal and

with snacks. The doctor may instruct you to start with a small

number of capsules and gradually increase the number until the

best effect is achieved. Follow your doctor’s instructions

carefully. The number of capsules you should take is calculated

according to age, weight and the results of special tests. Usually, a

certain number of capsules are taken with each meal and half that

number are taken with each snack. The total number of capsules

per day usually reflects 3 meals and 2 snacks per day.

Infants < 12 months:

Give PANCREASE

MT right before each feeding of formula or

breast milk. Do not mix PANCREASE

MT capsule contents

directly into formula or breast milk. Do not store PANCREASE

MT that is mixed with food. Follow your doctor’s instructions

carefully.

Overdose:

In case of drug overdose, contact a health care practitioner,

hospital emergency department or regional Poison Control

Centre immediately, even if there are no symptoms.

Missed Dose:

If you forget to take PANCREASE

MT, call your healthcare

provider or wait until your next meal and take your usual number

of capsules. Take your next dose at your usual time. Do not make

up for missed doses.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

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 are not common. With high

doses, perianal irritation and inflammation have been reported.

Allergic or hypersensitivity reactions of the skin have been

reported.

Increase in blood uric acid levels. This may cause worsening of

swollen, painful joints (gout) caused by an increase in your blood

uric acid levels.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY

HAPPEN AND WHAT TO DO ABOUT THEM

Symptom / effect

Talk with your

doctor

Stop taking

drug and call

your doctor

immediately

Only if

severe

In all

cases

Very rare

abdominal pain,

bloating, nausea,

vomiting, diarrhea

and/or constipation

Rare

Allergic reactions :

trouble breathing

skin rash

swollen lips

This is not a complete list of side effects. For any unexpected

effects while taking PANCREASE

®

MT, contact your doctor or

pharmacist.

HOW TO STORE IT

You should keep the capsules in the bottle with the lid tightly

closed. Store the bottle in a dry place with a temperature of 10ºC-

25ºC (room temperature). Do not refrigerate.

The PANCREASE

MT 4 bottle contains a desiccant canister.

DO NOT eat or throw away the canister (desiccant) in your

medicine bottle. This packet will protect your medicine from

moisture.

Keep out of the sight and reach of children.

If you have any questions that have not been answered in this

leaflet, please consult your doctor, pharmacist or other health care

professional.

IMPORTANT: PLEASE READ

PH-10-003-00

Page 17 of 17

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with

the use of health products to the Canada Vigilance Program by

one of the following 3 ways:

--------------------------------------------------------------------------

Report online at www.canada.ca/en/health-

canada/services/drugs-health-products/medeffect-

canada/adverse-reaction-reporting

Call toll-free at 1-866-234-2345

Complete a Canada Vigilance Reporting Form and:

- Fax toll-free to 1-866-678-6789, or

- Mail to:

Canada Vigilance Program

Health Canada

Postal Locator 1908C

Ottawa, Ontario

K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the

adverse reaction reporting guidelines are available on the

MedEffect

®

Canada Web site at www.canada.ca/en/health-

canada/services/drugs-health-products/medeffect-canada/adverse-

reaction-reporting

NOTE: Should you require information related to the management

of side effects, contact your health professional. The Canada

Vigilance Program does not provide medical advice.

MORE INFORMATION

For questions, concerns, or the full product monograph go to:

www.vivuspharma.ca

or contact the manufacturer, VIVUS, Inc., at:

1-888-998-4887.

This leaflet was prepared by

VIVUS, Inc.

Campbell, California, USA 95008

Last revised:

All trademarks used under license.

Similar products

Search alerts related to this product

Share this information