Mezym Pro intestinal-Soluble tablets, 20pcs

Composition

Core

Active ingredient:

Pancreatin * 100,000 -138,889 mg with minimal activity:

lipases 10000 edamylases 7500 edproteases 375 ED

Excipients: lactose monohydrate, microcrystalline cellulose (type 12), colloidal silicon dioxide, crospovidone, magnesium stearate;

Shell: hypromellose (~5 MPa * s), methacrylic acid and ethyl acrylate copolymer (1: 1) dispersion 30% (dry weight), triethyl citrate, titanium dioxide (E 171), talc, simethicone emulsion 30% (dry weight), macrogol 6000, carmellose sodium, polysorbate 80, azorubin varnish (E 122), sodium hydroxide.

* obtained from porcine pancreas

Pharmacological action

Pharmacotherapeutic group:  Digestive enzyme remedy

ATX code: A 09 AA 02.

Pharmacological properties

Pharmacodynamics .

An enzyme preparation that improves digestion. Pancreatin is a powder from porcine pancreas, which contains other enzymes along with external secretory pancreatic enzymes – lipase, amylase, protease, trypsin and chymotrypsin.

Pancreatic enzymes included in the preparation facilitate the breakdown of proteins, fats and carbohydrates, which leads to their more complete absorption in the small intestine. Trypsin suppresses the stimulated secretion of the pancreas, having an analgesic effect. The maximum enzymatic activity of the drug is noted in 30-45 minutes after oral use.

Pharmacokinetics.

Mezym ® Pro tablets are coated with an acid-resistant coating that does not dissolve under the action of gastric hydrochloric acid and thus protects the enzymes contained in the preparation from inactivation. The shell dissolves and the enzymes are released at a pH close to neutral or slightly alkaline.

Indications

• replacement therapy in exocrine insufficiency of the pancreas (including chronic pancreatitis, cystic fibrosis);
• chronic inflammatory-dystrophic diseases of the stomach, intestines, liver, gallbladder;
• status after resection or irradiation of the digestive tract, associated with impaired digestion, flatulence, diarrhea (in combination therapy);
• gastrointestinal disorders functional nature (for intestinal infectious diseases, irritable bowel syndrome, etc. );
• to improve food digestion in patients with normal function of the digestive tract in the case of errors in the diet;
• preparation for x-ray and ultrasound studies of the abdomen.

Contraindications

• acute pancreatitis;
• exacerbation of chronic pancreatitis;
• hypersensitivity to pancreatin or other components of the drug;
• hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;
• children under 3 years of age (undivided dosage form).

Side effects

No side effects or complications were observed even with prolonged and regular use of Mezym ® Pro in patients with impaired pancreatic function.

In some cases, after taking pancreatin, allergic reactions may develop, rarely-diarrhea or constipation, nausea, discomfort in the epigastric region. In isolated cases, patients suffering from cystic fibrosis, with prolonged use of high doses of the drug, may develop hyperuricosuria (increased uric acid levels in blood plasma), the formation of strictures in the ileocecal region and the ascending colon is possible.

Interaction

When taking drugs containing pancreatin, it is possible to reduce the absorption of folic acid. The effect of hypoglycemic drugs (acarbose, miglitol) may decrease when taken simultaneously with pancreatin.

Concomitant use of pancreatin with iron preparations may reduce the absorption of the latter. Concomitant use of antacids containing calcium carbonate and / or magnesium hydroxide may reduce the effectiveness of the drug.

How to take, course of use and dosage

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

Unless otherwise indicated, the average single adult dose is 2-4 tablets of Mezym ® Pro per meal. It is recommended to take half or a third of a single dose at the beginning of a meal, and the rest during it. The drug is taken orally without chewing and washed down with a sufficient amount of liquid.

It is possible to increase the dose, which should only be carried out under the supervision of a doctor, while focusing on reducing symptoms (for example, steatorrhea, abdominal pain). The maximum daily dose is 15000-20000 units of lipase/kg of body weight.

It is possible to increase the dose, which should only be carried out under the supervision of a doctor, while focusing on reducing symptoms (for example, steatorrhea, abdominal pain). The maximum daily dose is 15000-20000 units of lipase/kg of body weight.

For children, the dosage regimen is set by the doctor depending on the severity of the disease and the composition of food at the rate of 500-1000 units of lipase/kg of body weight of the child for each meal.

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

Overdose

There are no data on cases of overdose or intoxication with the drug. Possible: hyperuricosuria, hyperuricemia, constipation in children. Treatment: drug withdrawal, symptomatic therapy.

Description

Pink flat-cylindrical tablets, coated with a shell, with almost plane-parallel surfaces and beveled edges, brown inclusions are possible on the fracture.

Special instructions

In case of 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 ® Pro against the background of existing or remaining in the future insufficiency of pancreatic function.

The drug Mezym ® Pro, taking into account the solid indivisible dosage form, is contraindicated in children under 3 years of age.

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

The drug Mezym ® Pro does not affect the speed of psychomotor reactions and the ability to perceive or evaluate the situation.

Form of production

Enteric-soluble coated tablets,10000 units.

10 tablets each in a contour cell package (blister) made of foil (oriented polyamide / aluminum / PVC (OPA/ALU/PVC)) and aluminum foil.

1 or 2 blisters with instructions for use of the drug in a cardboard box.

Storage conditions

At a temperature not exceeding 25 ° C. Keep the medicine out of the reach of children!

Shelf

life is 3 years. Do not use after the expiration date.

Active ingredient

Pancreatin

Dosage form

Tablets