Mezim 20000,20000 units 20 pcs

Pharmacotherapeutic group: Digestive enzyme agent

ATX code: A09AA02

Pharmacological properties

Pharmacodynamics. Pancreatin is a powder from the pancreatic glands of pigs. Pancreatic enzymes contained in pancreatin have proteolytic, amylolytic and lipolytic effects and contribute to the breakdown of proteins, fats and carbohydrates, improving the functional state of the gastrointestinal tract (GIT), thus normalizing digestive processes.

Pharmacokinetics. The tablets of Mesim^® 20000 are coated with an acid-resistant coating, which is resistant to stomach hydrochloric acid and thus protects the pancreatic enzymes contained in the drug from inactivation. Dissolution of the enteric coating and release of the enzymes occurs at neutral or slightly alkaline pH values.

Indications

Insufficiency of exocrine pancreatic function (chronic pancreatitis, cystic fibrosis, etc.);
Chronic inflammatory-dystrophic diseases of the stomach, intestines, liver, gall bladder;
Conditions after resection or irradiation of the gastrointestinal tract, accompanied by impaired digestion of food, flatulence, diarrhea (as part of combination therapy);
To improve food digestion in patients with normal gastrointestinal function in case of dietary errors;
Preparation for x-ray and ultrasound examination of the abdominal organs;
Gastrointestinal disorders of a functional nature (acute intestinal infections, irritable bowel syndrome, etc.).

Pharmacological effect

Pharmacotherapeutic group: Digestive enzyme agent

ATX code: A09AA02

Pharmacological properties

Pharmacodynamics. Pancreatin is a powder made from porcine pancreas. Pancreatic enzymes, which are part of pancreatin, have a proteolytic, amylolytic and lipolytic effect and promote the breakdown of proteins, fats and carbohydrates, improve the functional state of the gastrointestinal tract (GIT), thus normalizing digestive processes.

Pharmacokinetics. Mezim® 20000 tablets are coated with an acid-resistant coating, which is resistant to the effects of gastric hydrochloric acid and, thereby, protects the pancreatic enzymes contained in the drug from inactivation. Dissolution of the enteric coating and release of enzymes occurs at neutral or slightly alkaline pH values.

Special instructions

In case of acute pancreatitis or exacerbation of chronic pancreatitis (at the stage of attenuation of exacerbation), during the period of restorative dietary nutrition, it is advisable to take the drug Mezim® 20000 against the background of existing and/or remaining exocrine pancreatic insufficiency.

In patients with cystic fibrosis, especially when taking high doses of pancreatin, hyperuricosuria may occur, so the concentration of uric acid in the urine should be monitored in this group of patients.

In the above group of patients, strictures in the ileocecal and ascending colon are described.

As a precautionary measure, if unusual abdominal discomfort occurs or changes in the nature of complaints, especially when taking more than 10,000 IU of lipase/kg body weight per day, a medical examination is necessary.

The drug Mezim® 20000 contains active enzymes that, when released in the oral cavity, for example during chewing, can damage the oral mucosa (up to the formation of ulcers). Therefore, the tablet must be swallowed whole.

The drug contains lactose, so it is contraindicated in patients with hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

Impact on the ability to drive vehicles and machinery

The drug Mezim® 20000 does not affect or has an insignificant effect on the ability to drive vehicles and other mechanisms.

Active ingredient

Pancreatin

Composition

Core:

Active ingredient: Pancreatin* with minimal activity:

amylase 12000 units

lipase 20000 units

protease 900 units

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

Shell: hypromellose, methacrylic acid and ethyl acrylate copolymer (1:1), dispersion 30% (dry weight), triethyl citrate, titanium dioxide, E 171, talc, simethicone emulsion 30% (dry weight), vanilla flavor, bergamot flavor, macrogol 6000, carmellose sodium, polysorbate 80, hydroxide.

*obtained from pork pancreas

Pregnancy

Before using Mezim® 20000, if you are pregnant, or think you might be pregnant, or are planning a pregnancy, you should consult your doctor.

During breastfeeding, before using Mezim® 20000, you should consult your doctor.

There are no data on the use of pancreatin during pregnancy and breastfeeding.

During pregnancy and breastfeeding, the prescription of pancreatin by the attending physician is possible only if the expected benefit to the mother outweighs the possible risk to the fetus or child.

Contraindications

Hypersensitivity to any of the components of the drug;
Acute pancreatitis or chronic pancreatitis in the acute stage. However, it is possible to use it in the phase of a fading exacerbation when expanding the diet, if there are signs of digestive disorders;
Hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;
Children up to 3 years of age (for this dosage form).

Side Effects

Possible side effects are listed below in descending frequency of occurrence: very common (≥ 1/10), common (> 1/100, < 1/10), uncommon (> 1/1000, < 1/100), rare (> 1/10000, < 1/1000), very rare (< 1/10000), frequency not established (cannot be estimated based on available data).

Immune system disorders

Very rare: immediate allergic reactions (such as skin rash, urticaria, sneezing, lacrimation, bronchospasm, dyspnea), gastrointestinal hypersensitivity.

Gastrointestinal disorders

Very rare: diarrhea, abdominal discomfort, abdominal pain, nausea, vomiting; formation of strictures in the ileocecal and ascending colon in patients with cystic fibrosis when using high doses of pancreatin.

Disorders of the genitourinary system

Frequency unknown: hyperuricosuria (see section “Special instructions”).

If you experience side effects listed in the instructions or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

It is possible to reduce the absorption of folic acid when used simultaneously with pancreatin preparations. The effect of oral hypoglycemic agents (such as acarbose, miglitol) may be reduced when used simultaneously with digestive enzyme preparations containing enzymes that break down carbohydrates (for example, amylase).

If you are using the above or other medications (including over-the-counter medications), consult your doctor before using Mezim® 20000.

Overdose

Symptoms: hyperuricosuria and hyperuricemia (especially in patients with cystic fibrosis taking high doses of enzyme preparations).

Treatment: symptomatic therapy, drug withdrawal.

Storage conditions

At a temperature not higher than 30 oC.
Keep out of the reach of children!

Shelf life

3 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

Berlin-Chemie AG, Germany