Mezym forte 10000 enteric-coated tablets 20 pieces

Pharmacodynamics. The active substance of the drug Mezym forte is a powder from the pancreas (pancreatin) of mammals, usually pigs, which, in addition to excretory pancreatic enzymes (lipase, alpha-amylase, trypsin and chymotrypsin), contains other enzymes. Pancreatin also contains other accompanying substances that do not have enzymatic activity.

Pharmacokinetics. Absorption. Pancreatic powder is not absorbed in the gastrointestinal tract and is excreted in the feces. Most of it is broken down or denatured by digestive juices or bacteria.

Bioavailability. The enteric coating of the tablets, resistant to the action of gastric juice, protects the acid-sensitive enzymes from inactivation during passage through the stomach. Only after reaching a neutral or slightly alkaline environment in the small intestine are the enzymes released after dissolution of the coating. Due to the fact that the pancreatic powder is not absorbed in the gastrointestinal tract, there is no information on its pharmacokinetics and bioavailability.

The effectiveness of pancreatic powder is determined by the degree and rate of enzyme release from the dosage form.

Impairment of the exocrine function of the pancreas, accompanied by digestive disorders.

Recommended dose per meal: 2-4 tablets of Mezym Forte 10,000 or 1-2 tablets of Mezym Forte 20,000 (corresponding to 20,000-40,000 units of lipase).

The dose of Mezym forte is determined according to the severity of the existing pancreatic insufficiency. Usually the recommended dose is a dose of lipase 20,000-40,000 U. F. per 1 meal, but it may be higher.

The goal of treatment with Mezym forte is to achieve or maintain normal body weight and normalize the frequency of defecation or stool consistency. Increasing the dose should only be done under the supervision of a physician and in order to alleviate symptoms (e.g. steatorrhea, stomach pain).

The daily dose of enzymes should not be exceeded, which is 15,000-20,000 U of lipase per kilogram of body weight.

Mezym Forte tablets should be swallowed whole, with plenty of liquid, during meals, since the effectiveness of the drug Mezym Forte may decrease when chewed, and the enzymes contained in the drug, when released in the oral cavity, may damage its mucous membrane.

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

Hypersensitivity to the active substance, pig meat (pork allergy) or any of the excipients of the drug.

Acute pancreatitis or chronic pancreatitis in the exacerbation stage (but episodic use is possible in the phase of fading exacerbation when expanding the diet in the presence of pancreatic dysfunction). The drug should not be used in patients with obstructive intestinal obstruction.

The following classification is used to assess the frequency of side effects: very common (≥1/10), common (≥1/100 and 1/10), uncommon (≥1/1000 and 1/100), rare (≥1/10,000 and 1/1000), very rare (1/10,000), frequency unknown (cannot be estimated from the available data).

Immune system disorders: Very rare: immediate allergic reactions (skin rash, sneezing, lacrimation, bronchospasm, dyspnoea), hypersensitivity reactions localized in the gastrointestinal tract.

Gastrointestinal: Very rare: diarrhoea, abdominal discomfort, abdominal pain, nausea, vomiting. Formation of strictures in the ileocecal region and in the ascending colon has been described after administration of a preparation containing pancreatic powder in high doses.

Reporting of suspected adverse reactions. Reporting of suspected adverse reactions after the registration of a medicinal product plays an important role. This allows for continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions.

If unusual abdominal discomfort or changes in symptoms occur, it is recommended to undergo an examination to exclude intestinal damage as a precautionary measure, especially when the patient is taking a dose of 20,000 units of lipase per 1 kg of body weight per day.

The drug contains active enzymes that can damage the oral mucosa, up to the formation of ulcers, so the tablets should be swallowed whole, without chewing.

Mezym forte should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

Pregnancy and breast-feeding. There are no adequate data on the use of Mezym forte in pregnant women. There is insufficient data on the effects on pregnancy, embryonal/fetal development, childbirth or postnatal development obtained in animal experiments, so the potential risk to humans is unknown. In this regard, Mezym forte should not be taken during pregnancy and breast-feeding, except in cases where its use is absolutely necessary.

Children. The drug Mezym forte is used in children over the age of 3. The dose and duration of use are determined by the doctor.

Ability to influence the reaction rate when driving vehicles or working with other mechanisms. The effect of Mezym forte on the ability to drive vehicles or work with other mechanisms is absent or insignificant.

When using drugs containing pancreatic powder, it is possible to reduce the absorption of folic acid, which may require its additional intake into the body. The hypoglycemic effect of acarbose and miglitol may be reduced with simultaneous use of the drug Mezym Forte 10,000 and Mezym Forte 20,000.

The use of pancreatic enzymes in very high doses may be accompanied by hyperuricemia and hyperuricosuria. Treatment is symptomatic.

At a temperature not exceeding 30 °C.