Mezim Neo 25000,25000 units 50 pcs

Pharmacotherapeutic group: digestive enzyme drug

ATX code: A09AA02

Pharmacological properties

Pharmacodynamics

The active ingredient of the drug Mesim® neo 25000 is pancreatin, which is powder from pig pancreas glands. Enzymes contained in pancreatin help to break down fats, carbohydrates and proteins from food. Pancreatin having proteolytic, amylolytic and lipolytic action compensates enzymatic insufficiency of the pancreas, improves functional condition of the gastrointestinal tract (GIT) and normalizes digestive processes.

Pharmacokinetics

The gelatin capsules of the drug Mesim® neo 25000 quickly dissolve in the stomach, releasing mini-tablets covered with an enteric-soluble (acid-resistant) coating. This way, the enzymes remain protected from inactivation in the acidic environment of the stomach. The form of the drug ensures that the mini-tablets are mixed with the intestinal contents and that the enzymes are evenly distributed. Dissolution of the shell of the mini-tablets and enzyme activation occurs at neutral or slightly alkaline pH in the small intestine. Pancreatin is not absorbed in the gastrointestinal tract and is excreted with the feces.

Indications

Replacement therapy for exocrine pancreatic insufficiency in adults and children in the following conditions:

chronic pancreatitis;
cystic fibrosis;
pancreatic cancer;
conditions after surgical interventions on the pancreas and stomach (complete or partial resection of the organ);
after irradiation of the gastrointestinal tract, accompanied by impaired digestion of food, flatulence, diarrhea (as part of combination therapy);
narrowing of the pancreatic duct, for example due to a tumor or gallstones;
Shwachman-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;
consumption of indigestible plant or fatty foods;

Preparation for x-ray and ultrasound examinations of the abdominal organs.

Pharmacological effect

Pharmacotherapeutic group: digestive enzyme agent

ATX code: A09AA02

Pharmacological properties

Pharmacodynamics

The active ingredient of Mezim® neo 25000 is pancreatin, which is a powder from the pancreas of pigs. The enzymes that make up pancreatin help break down fats, carbohydrates and proteins coming from food. Pancreatin, having proteolytic, amylolytic and lipolytic effects, compensates for enzymatic insufficiency of the pancreas, improves the functional state of the gastrointestinal tract (GIT), and normalizes digestive processes.

Pharmacokinetics

Gelatin capsules of the drug Mezim® neo 25000 quickly dissolve in the stomach, releasing mini-tablets coated with an enteric (acid-resistant) coating. Thus, the enzymes remain protected from inactivation in the acidic environment of the stomach. The release form of the drug ensures mixing of mini-tablets with intestinal contents and uniform distribution of enzymes. Dissolution of the mini-tablet shell and activation of enzymes occurs at a neutral or slightly alkaline pH in the small intestine. Pancreatin is not absorbed from the gastrointestinal tract and is excreted in the feces.

Special instructions

In patients suffering from 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, if unusual symptoms appear or changes in the nature of the symptoms of the underlying disease, a medical examination is necessary to exclude damage to 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.

Effect of the drug on the ability to drive vehicles and other mechanisms

Mezim® neo 25000 does not affect the performance of potentially hazardous activities that require special attention and speed of reaction.

Active ingredient

Pancreatin

Composition

For one capsule:

Capsule contents (enteric-coated mini-tablets):

Core:

Active ingredient:

Pancreatin – 356.10 mg
with minimal activity:
lipase 25000 units
amylase 22500 units
protease 1250 units

Excipients: croscarmellose sodium – 11.87 mg, microcrystalline cellulose – 19.77 mg, hydrogenated castor oil – 3.96 mg, colloidal anhydrous silicon dioxide – 1.97 mg, magnesium stearate – 1.97 mg;

Shell: methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion – 57.9 mg, triethyl citrate – 5.82 mg, simethicone emulsion 30% (dry weight) – 0.036 mg; talc – 11.63 mg;

Capsule:
Body: gelatin – 65.40 mg, titanium dioxide (E 171) – 0.30 mg; iron dye yellow oxide (E 172) – 0.30 mg; red iron oxide dye (E 172) – 0.02 mg;
Cap: gelatin – 42,900 mg; titanium dioxide (E 171) – 0.800 mg; quinoline yellow dye (E 104) – 0.300 mg; indigo carmine (E 132) – 0.003 mg.

Description: opaque hard gelatin capsules of a cylindrical shape with hemispherical ends No. 0: the capsule body is light orange, the capsule cap is yellowish-green.

Capsule contents: cylindrical mini-tablets, enteric-coated, light beige in color with a shiny surface.

Pregnancy

Pregnancy

There are no clinical data on the treatment of pregnant women with drugs containing pancreatic enzymes. Animal studies have not revealed the absorption of pancreatic enzymes of porcine origin, therefore toxic effects on reproductive function and fetal development are not expected.

The use of Mezim® neo 25000 during pregnancy is possible if the expected benefit to the mother outweighs the possible risk to the fetus.

Breastfeeding period

Based on animal studies in which no negative effects of pancreatic enzymes were detected, no harmful effects of the drug on the child through breast milk are expected. You can take pancreatic enzymes while breastfeeding.

Contraindications

acute pancreatitis;
exacerbation of chronic pancreatitis;
hypersensitivity to porcine pancreatin or other components of the drug.

Side Effects

Possible side effects are listed below in descending frequency of occurrence: often (> 1/100, 1/1000, 1/10000, <1/1000), very rare (<1/10000), including isolated messages.

Gastrointestinal disorders:
Common: nausea, vomiting and bloating.
Gastrointestinal disorders are mainly associated with the underlying disease. The incidence of the following adverse reactions was lower or similar to that observed with placebo:
Very common: pain in the abdominal area;
Common: diarrhea.

Skin and subcutaneous tissue disorders:
Rarely: rash;
Itching, urticaria – there is insufficient data to estimate the frequency of cases.

Overdose

Symptoms: The use of large doses of pancreatic enzymes may be accompanied by hyperuricosuria and hyperuricemia in patients with cystic fibrosis.

Treatment: drug withdrawal, symptomatic therapy.

Storage conditions

Store at a temperature not exceeding 25°C.

Keep the medicine out of the reach of children!

Shelf life

2 years.

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

Organization receiving complaints from consumers:

LLC “Berlin-Chemie/A. Menarini”, Russia

123112, Moscow, Presnenskaya embankment, building 10, Business Center “Tower on the Embankment”, Block B, tel. (495) 785-01-00, fax (495) 785-01-01.

Manufacturer

Adair Pharmaceuticals S.r.l., Italy