Mezym® forte 20000

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MEZYMâ FORTE 20000 (MEZYMâ FORTE 20000)

Composition:

Active substance: pancreatic powder (from pigs);

One enteric-coated tablet contains 160–222.22 mg of pancreatic powder from pigs, having a minimum lipolytic activity of 20,000 IU EP (European Pharmacopoeia units), minimum amylolytic activity of 12,000 IU EP, and minimum proteolytic activity of 900 IU EP;

Excipients: lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silicon dioxide, crospovidone, magnesium stearate, hypromellose, methacrylate copolymer (type A), triethyl citrate, titanium dioxide (E 171), talc, simethicone, polyethylene glycol, polysorbate, sodium carmellose, vanilla flavor, bergamot flavor, sodium hydroxide.

Pharmaceutical form. Enteric-coated tablets.

Main physicochemical properties:

Slightly biconvex film-coated tablets, white to slightly grey in color, with a smooth surface.

Pharmaco-therapeutic group.

Digestive enzymes. Pancreatic enzyme preparations.

ATC code A09AA02.

Pharmacological Properties.

Pharmacodynamics.

The active substance of the medicinal product Mezymâ forte 20000 is pancreatic powder from mammals, usually pigs, which, in addition to excretory pancreatic enzymes (lipase, alpha-amylase, trypsin, and chymotrypsin), contains other enzymes. Pancreatin also includes other accompanying substances that do not possess enzymatic activity.

Pharmacokinetics.

Absorption

Pancreatic powder is not absorbed in the gastrointestinal tract and is excreted in feces. The majority of it is destroyed or denatured by digestive juices or with bacterial involvement.

Bioavailability

The enteric coating of the tablets, resistant to gastric juice, protects acid-sensitive enzymes from inactivation during passage through the stomach. Only upon reaching the neutral or slightly alkaline environment of the small intestine are the enzymes released following dissolution of the coating. Since pancreatic powder is not absorbed in the gastrointestinal tract, data regarding its pharmacokinetics and bioavailability are lacking.

The efficacy of pancreatic powder is determined by the extent and rate of enzyme release from the dosage form.

Clinical characteristics.

Indications.

Pancreatic exocrine insufficiency associated with maldigestion.

Contraindications.

Hypersensitivity to the active substance, pork meat (pork allergy), or to any of the excipients of the medicinal product.

Acute pancreatitis or chronic pancreatitis in the acute phase (however, occasional use may be possible during the resolving phase of exacerbation when diet is being expanded, in the presence of pancreatic insufficiency). The product should not be used in patients with obstructive intestinal obstruction.

Interaction with other medicinal products and other forms of interaction.

Folic acid.

When using medicinal products containing pancreatin, absorption of folic acid may be reduced, which may necessitate additional folic acid supplementation.

Acarbose, miglitol.

The blood glucose-lowering effect of oral antidiabetic agents acarbose and miglitol may be reduced when used concomitantly with the medicinal product Mezymâ forte 20000.

Special precautions for use.

As a precautionary measure, if unusual abdominal discomfort or changes in symptoms occur, patients should undergo an examination to rule out intestinal damage, especially if the patient is taking a dose exceeding 20,000 IU PE lipase per kilogram of body weight per day.

The medicine contains active enzymes which, if released in the oral cavity (e.g. due to chewing), may damage the mucosa, potentially leading to ulceration. Therefore, Mezymâ forte 20000 should be swallowed whole.

Mezymâ forte 20000 should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

Use during pregnancy or breastfeeding.

There are insufficient data on the use of Mezymâ forte 20000 in pregnant women. There is also inadequate information from animal studies regarding its effects on pregnancy, embryonic/fetal development, labor, or postnatal development; therefore, the potential risk to humans is unknown. Consequently, Mezymâ forte 20000 should not be used during pregnancy or lactation, except when its use is absolutely necessary.

Ability to affect reaction speed when driving or operating machinery.

The effect of Mezymâ forte 20000 on the ability to drive or operate machinery is absent or negligible.

Method of Administration and Dosage.

Dosage.

Recommended dose per meal: 1–2 tablets (corresponds to 20000–40000 IU PE of lipase).

The dose of Mezymâ forte 20000 is determined according to the severity of pancreatic insufficiency. The usual recommended dose is 20000–40000 IU PE of lipase per meal, but it may be higher.

The goal of treatment with Mezymâ forte 20000 is to achieve or maintain normal body weight and normalize stool frequency or consistency. Dose increases should be performed only under medical supervision and aimed at alleviating symptoms (e.g., steatorrhea, stomach pain).

The daily dose of enzymes should not exceed 15000–20000 IU of lipase per kilogram of body weight.

Method of Administration.

Mezymâ forte 20000 tablets should be swallowed whole with a large amount of liquid during meals, as the effectiveness of Mezymâ forte 20000 may be reduced if chewed. Enzymes released in the oral cavity may damage the mucous membrane.

Duration of Administration.

The duration of treatment depends on the course of the disease and is determined by the physician.

Children.

The medicinal product Mezymâ forte 20000 is used for the treatment of children aged 3 years and older. Dosage and duration of treatment are determined by a physician.

Overdose.

Administration of very high doses of pancreatic enzymes may be accompanied by hyperuricosuria and hyperuricemia. Treatment is symptomatic.

Side effects

The following classification is used to assess the frequency of adverse reactions:

Very common: ≥ 1/10;
Common: ≥ 1/100 to < 1/10;
Uncommon: ≥ 1/1000 to < 1/100;
Rare: ≥ 1/10000 to < 1/1000;
Very rare: < 1/10000;
Frequency not known (cannot be estimated from the available data).

Immune system disorders. Very rare: immediate-type allergic reactions (skin rash, urticaria, sneezing, lacrimation, bronchospasm, dyspnea), hypersensitivity reactions localized in the gastrointestinal tract.

Gastrointestinal disorders. Very rare: diarrhea, abdominal discomfort, abdominal pain, nausea, vomiting. Formation of strictures in the ileocecal region and ascending colon has been reported after administration of pancreatic enzyme powder at high doses.

Reporting suspected adverse reactions.

Reporting of suspected adverse reactions after marketing authorization of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions.

Shelf life. 3 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 30 °C. Keep out of reach and sight of children.

Packaging.

10 tablets in a blister; 2 or 5 blisters in a cardboard box.

Pharmaceutical classification.

Over-the-counter (without prescription).

Manufacturer.

BERLIN-CHEMIE AG

Manufacturer's address and place of business.

Glienicker Weg 125, 12489 Berlin, Germany.