Expiration date: 01/2025

Composition

Tablets covered with an intestinal-soluble shell.

Active substance:

Pancreatin-220-293. 34 mg with minimal activity:

lipases 20000 UNITS

amylase 12000 UNITS

proteases 900 UNITS

excipients: lactose monohydrate-83.34 mg; MCC-72.66 mg; silicon dioxide colloidal-1.6 mg; crospovidone (type A) - 10.4 mg; magnesium stearate-2 mg

intestinal shell: hypromellose — 6.25 mg; methacrylic acid and ethylacrylate copolymer (1:1), 30% dispersion (dry weight) — 15.89 mg; triethylcitrate — 5.07 mg, talc — 9.6 mg; titanium dioxide (E171) — 6.58 mg; simetikon emulsion 30% (dry weight) — 0.43 mg; macrogol 6000 — 0.25 mg; sodium carmellose — 0.55 mg; Polysorbate 80 — 0.88 mg; vanilla flavoring — 0.34 mg, bergamot flavoring — 0.16 mg

Description of the dosage form

Round, biconvex tablets, covered with a film of intestinal-soluble shell, from white to white with a grayish tinge of color with a smooth surface, with a specific smell, brown inclusions are possible on the fracture.

Pharmacological action

Pharmacological action-compensating for the deficiency of pancreatic enzymes.

Pharmacodynamics

Pancreatin is a powder from the pancreas of pigs. Pancreatic enzymes, which are part of Pancreatin, have proteolytic, amylolytic and lipolytic effects and contribute to the breakdown of proteins, fats, carbohydrates, improve the functional state of the gastrointestinal tract, normalize the digestive processes.

Pharmacokinetics

Mezym ® 20000 tablets are coated with an acid-resistant shell that does not dissolve under the action of hydrochloric acid of the stomach and thus protects the enzymes contained in the drug from inactivation. The dissolution of the shell and the release of enzymes occurs at pH values close to neutral or slightly alkaline.

Indications of the drug Mezym ® 20000

• insufficiency of external secretory function of the pancreas, (chronic pancreatitis, cystic fibrosis);
• chronic inflammatory and dystrophic diseases of the stomach, intestines, liver, and gallbladder;
• conditions after resection or irradiation of these organs, accompanied by disorders of digestion, flatulence, diarrhea (as part of combined therapy);
• to improve the digestion of food in patients with normal gastrointestinal function in the case of errors in nutrition;
• preparation for x-ray examination and ultrasound of the abdominal cavity;
• functional disorders of the gastrointestinal tract (with intestinal infectious diseases, irritable bowel syndrome).

Contraindications

• hypersensitivity to the components of the drug;
• acute pancreatitis or chronic pancreatitis in the acute stage (however, the appointment is acceptable in the phase of fading exacerbation with the expansion of the diet, if there are signs of digestive disorders);
• hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome;
• children under 3 years of age (for this dosage form).

Use during pregnancy and lactation

There are no data on the use of digestive enzyme preparations during pregnancy and during breastfeeding.

During pregnancy and breast-feeding, you can take the drug Mezym ® 20000 as prescribed by a doctor.

Side effect

Allergic reactions are possible, with prolonged use in high doses, hyperuricosuria may develop. In cystic fibrosis in case of exceeding the necessary dose of Pancreatin may develop strictures (fibrous kolonopatii) in the Department of the ileocecal and ascending colon.

Interaction

When taking drugs containing Pancreatin, it is possible to reduce the absorption of folic acid.

Action of hypoglycemic agents for oral use (acarbose, miglitol) it may decrease when used simultaneously with the drug Mezym ® 20000.

With simultaneous use of the drug Mezym ® 20000 with iron preparations, it is possible to reduce the absorption of the latter. Simultaneous use of antacids containing calcium carbonate and / or magnesium hydroxide may reduce the effectiveness of the drug.

Dosage and administration

Inside, during meals, without chewing and drinking a sufficient amount of liquid (for example, a glass of water).

The dose of Mezym ® 20000 is set individually depending on the composition and severity of the disease.

If there are no other instructions, adults should take 1-2 tablets of the drug Mezym ® 20000. It is possible to increase the dose, which should be carried out only under the supervision of a doctor, while focusing on the weakening of symptoms (for example, steatorrhea, abdominal pain).

It is not recommended to exceed the daily dose of enzymes, which is 15000-20000 UNITS of lipase/kg.

Children dosage regimen and duration of treatment is set by the doctor depending on the severity of the disease and the composition of food at the rate of 1000 UNITS of lipase/kg for each meal.

The duration of treatment can vary from a few days (for digestive disorders, errors in the diet) to several months or even years (if permanent replacement therapy is necessary).

Overdose

There are no data on cases of overdose and intoxication with the drug.

Special instruction

In acute pancreatitis or exacerbation of chronic pancreatitis (at the stage of attenuation of exacerbation), during a restorative diet, it is advisable to prescribe the drug Mezym ® 20000 against the background of existing or remaining in the future insufficiency of pancreatic function.

The effect of the drug on the ability to drive vehicles and manage mechanisms. Mezym ® 20000 does not affect the speed of psychomotor reactions and the ability to perceive or assess the situation.

Form release

Tablets coated with an intestinal membrane, 20000 UNITS. 10 tables, covered with an intestinal-soluble shell, in a blister made of aluminum foil or aluminum foil. 1, 2 or 5 blisters are placed in a cardboard pack.

Manufacturer

Berlin-Chemie AG. Tempelhofer Weg, 83 12347, Berlin, Germany.

Storage conditions of the drug Mezym ® 20000

At a temperature no higher than 30 °C.

Keep out of reach of children.

Shelf life of the drug Mezym ® 20000

3 years.

Do not use after the expiration date indicated on the package.