Mezim NEO 10000 50 caps (Mezym neo)

Description

Dosage form

opaque hard gelatin capsules of a cylindrical shape with hemispherical ends No. 2: the capsule body is light orange, the capsule cap is yellowish green.
Capsule contents: enteric-coated cylindrical mini-tablets, light beige in color with a shiny surface.

Compound

Active ingredient: Pancreatin – 153.5 mg
with minimal activity:
lipase 10,000 units
amylase 9000 units
protease 500 U
Excipients: croscarmellose sodium – 5.12 mg, microcrystalline cellulose – 8.52 mg, hydrogenated castor oil – 1.709 mg, colloidal anhydrous silicon dioxide – 0.849 mg, magnesium stearate – 0.849 mg.
Shell: methacrylic acid and ethyl acrylate copolymer (1: 1), 30% dispersion – 25.0 mg, triethyl citrate – 2.51 mg, simethicone emulsion 30% (dry weight) – 0.015 mg; talc – 5.01 mg;
Capsule: body: gelatin – 36.20 mg, titanium dioxide (E 171) – 0.20 mg; iron dye yellow oxide (E 172) – 0.20 mg; iron dye red oxide (E 172) – 0.01 mg;
cap: gelatin – 23,800 mg; titanium dioxide (E 171) – 0.400 mg; quinoline yellow dye (E 104) – 0.200 mg; indigo carmine (E 132) – 0.002 mg

Special conditions

In patients with cystic fibrosis who received high doses of pancreatin preparations, strictures of the ileum, cecum, and colon (fibrosing colonopathy) have been described. As a precautionary measure, when unusual symptoms appear or the nature of the symptoms of the underlying disease changes, a medical examination is necessary to exclude lesions of the colon, especially if the drug is used at a dose of more than 10,000 lipase units per kg of body weight per day.
The effect of the drug on the ability to drive vehicles and other mechanisms
Mezim® neo 10000 does not affect the performance of potentially hazardous activities that require special attention and quick response.

Drug interactions

Interaction studies have not been conducted.

Pharmacodynamics

The active ingredient of Mezim® neo 10000 is pancreatin, which is a powder from the pancreas of pigs. The enzymes that make up pancreatin contribute to the breakdown of fats, carbohydrates and proteins from food. Pancreatin, having a proteolytic, amylolytic and lipolytic effect, compensates for the enzymatic insufficiency of the pancreas, improves the functional state of the gastrointestinal tract (GIT), and normalizes digestion processes.

Pharmacokinetics

Gelatin capsules of Mezim® neo 10000 dissolve quickly in the stomach, releasing enteric-coated mini-tablets. Thus, the enzymes remain protected from inactivation in the acidic environment of the stomach. The release form of the drug provides mixing of mini-tablets with intestinal contents and uniform distribution of enzymes. Dissolution of the mini-tablet shell and activation of enzymes occurs at neutral or slightly alkaline pH in the small intestine. Pancreatin is not absorbed in the gastrointestinal tract, excreted in feces.

Indications

Replacement therapy for insufficiency of exocrine pancreatic function in adults and children under the following conditions:
• chronic pancreatitis;
• cystic fibrosis;
• pancreas cancer;
• conditions after surgical interventions on the pancreas and stomach (complete or partial resection of the organ);
• after irradiation of the digestive tract, accompanied by impaired digestion, flatulence, diarrhea (as part of combination therapy);
• narrowing of the pancreatic duct, for example, due to a tumor or gallstones;
• Schwachman-Diamond syndrome;
• subacute pancreatitis;
• other diseases accompanied by exocrine pancreatic insufficiency.
Relative enzyme deficiency in the following conditions and situations:
• gastrointestinal disorders of a functional nature, with acute intestinal infections, irritable bowel syndrome;
• the use of indigestible plant or fatty foods;
Preparation for X-ray and ultrasound examinations of the abdominal organs.

Contraindications

Contraindications
• acute pancreatitis;
• exacerbation of chronic pancreatitis;
• hypersensitivity to porcine pancreatin or other components of the drug.
Application during pregnancy and during breastfeeding
Pregnancy
There are no clinical data on the treatment of pregnant women with preparations containing pancreatic enzymes. In the course of studies on animals, absorption of pancreatic enzymes of porcine origin was not detected, therefore, toxic effects on reproductive function and fetal development are not expected.
The use of the drug Mezim® neo 10000 during pregnancy is possible if the expected benefit to the mother outweighs the possible risk to the fetus.