Mezym Neo 25000 enteric-soluble capsules 25000 units, 20pcs

Composition

Per capsule:

Capsule contents (mini-tablets coated with enteric coating):

Core:

Active ingredient:

Pancreatin – 356.10 mg with minimal activity: lipases 25,000 edamylases 22,500 edproteases 1250 ED

Auxiliary substances:  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 30% emulsion (dry weight) – 0.036 mg; talc-11.63 mg;

Capsule: Body:  gelatin-65.40 mg, titanium dioxide (E 171) – 0.30 mg; iron oxide yellow dye (E 172) – 0.30 mg; iron oxide red 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 solid gelatin capsules of cylindrical shape with hemispherical ends No. 0: the capsule body is light orange in color, the capsule cap is yellowish-green in color.

Capsule contents:  mini-tablets of cylindrical shape, covered with an enteric coating, light beige color with a shiny surface.

Pharmacological action

Pharmacotherapy group:  digestive enzyme remedy

ATX code:  A 09 AA 02

Pharmacological properties

Pharmacodynamics

The Active ingredient of the drug Mezym® NEO 25000 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 that come from food. Pancreatin, having proteolytic, amylolytic and lipolytic effects, compensates for the enzymatic insufficiency of the pancreas, improves the functional state of the gastrointestinal tract (GIT), normalizes digestive processes.

Pharmacokinetics

Gelatin capsules of Mezym® neo 25000 quickly dissolves 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 Form of production of the drug provides mixing of mini-tablets with intestinal contents and uniform distribution of enzymes. The dissolution of the shell of mini-tablets and the activation of enzymes occurs at a neutral or slightly alkaline pH in the small intestine. Pancreatin is not absorbed in the gastrointestinal tract, it is excreted in the feces.

Indications

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

• chronic pancreatitis;
• cystic fibrosis;
• pancreatic cancer;
• condition after surgery on the pancreas and stomach (full or partial organ resection);
• after irradiation of the digestive tract, associated with impaired digestion, flatulence, diarrhea (in combination therapy);
• the narrowing of the pancreatic duct, for example, because of a tumor or gallstones;
• syndrome Shwachman-diamond;
• acute pancreatitis;
• other diseases, accompanied by exocrine pancreatic insufficiency.

Relative enzyme deficiency in the following conditions and situations:

• disorders of the gastrointestinal tract of a functional nature, with acute intestinal infections, irritable bowel syndrome;
• consumption of hard-to-digest vegetable or fatty foods;

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

Use during pregnancy and lactation

Pregnancy

There are no clinical data on the treatment of pregnant women with drugs containing pancreatic enzymes. No absorption of porcine pancreatic enzymes has been detected in animal studies, so toxic effects on reproductive function and fetal development are not expected.

Application of the drug Mezym® neo 25000 during pregnancy is possible if the expected benefit to the mother exceeds the possible risk to the fetus.

Breast-feeding period

Based on animal studies that did not reveal a negative effect of pancreatic enzymes, no harmful effects of the drug on the child through breast milk are expected. During breast-feeding, you can take pancreatic enzymes.

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 by descending frequency: common (> 1/100, >< 1/10), infrequent (> 1/1000, < 1/10), infrequent (>< 1/100), rare (> 1/10000, < 1/100), rare (>< 1/1000), very rare (

Disorders of the gastrointestinal tract: Often:  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 of placebo: : Very often:  abdominal pain; Often:  diarrhea.

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

How to take, course of use and dosage

Dosage of the drug Mezym® neo 25000 is selected individually depending on the severity of the disease, as well as the volume and composition of the food taken.

If there are no other instructions, adults should take 1-2 capsules of the drug Mezym® neo25000 during each meal, swallowing whole (do not chew), washed down with a sufficient amount of liquid (for example, a glass of water).

If taking a whole capsule is difficult for the patient (for example, in young children or elderly patients), you can pour its contents, for example, into a glass, open the capsule by separating the lid from the body, and then take the contents (mini-tablets) with a certain amount of liquid or add to liquid food that does not require chewing (for example, applesauce or fruit juice). A mixture of mini-tablets with food or liquid should not be stored (take immediately after preparation).

Increasing the dose of the drug should be carried out only under the supervision of a doctor, while focusing on the dynamics of symptoms (for example, a decrease in steatorrhea, relief of abdominal pain).

It is not recommended to exceed the daily enzyme dose of 15000-20000 lipase units/kg of body weight.

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

For children, the 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 500-1000 lipase units/kg of the child’s body weight for each meal.

Use in cystic fibrosis

Dosage of the drug Mezym® neo25000 depends on body weight and should be 1000 lipase units / kg at the beginning of treatment for each meal for children under 4 years of age, and 500 lipase units/kg at each meal for children over 4 years of age.

The dose of the drug should be selected individually, depending on the severity of the disease, under the control of steatorrhea and the support of an optimal diet. In most patients, the dose should not exceed 10,000 lipase units / kg of body weight per day or 4,000 lipase units/g of fat consumed.

Overdose

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

Treatment:  drug withdrawal, symptomatic therapy.

Special instructions

In patients with cystic fibrosis treated with high doses of pancreatin preparations, strictures of the ileum, cecum and colon (fibrosing colonopathy) are described. As a precautionary measure, if unusual symptoms appear or the nature of symptoms of the underlying disease changes, a medical examination is necessary to exclude colon damage, 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

Mezym® neo 25000 does not affect the performance of potentially dangerous activities that require special attention and quick response.

Storage conditions

Store at a temperature not exceeding 25 ° C.

Keep the medicine out of the reach of children!

Shelf

life is 2 years.

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

Active ingredient

Pancreatin

Dosage form

Capsules