Mezym forte 10000 pills, 20pcs

Composition

Active ingredients:  

pancreatin 137.5 mg with minimal enzymatic activity: lipases 10,000 units Ph. Eur, amylases 7,500 UNITS Ph. Eur, proteases 375 UNITS Ph. Eur.

Auxiliary substances:  

lactose monohydrate,

microcrystalline cellulose,

colloidal silicon dioxide,

crospovidone,

magnesium stearate.

Shell composition:

hypromellose,

copolymer of methacrylic acid and ethyl acrylate (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.

Pharmacological action

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 ® forte 10000 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.

Use during pregnancy and lactation

Due to the lack of sufficient data on the use of pancreatic enzymes in humans during pregnancy and lactation, the use of Mezym® forte 10000 is possible only if the expected benefit to the mother exceeds the possible risk to the fetus or child.

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 ® forte 10000 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 ® forte 10000 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 ® forte 10000 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 Ph. Eur. 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 Ph. Eur. 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.

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 Mezym ® forte 10000 against the background of existing or remaining pancreatic insufficiency.

Mezym ® forte 10000, taking into account the solid indivisible dosage form, is contraindicated in children under 3 years of age.

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

Mezym ® forte 10000 does not affect the speed of psychomotor reactions and the ability to perceive or evaluate the situation.

Composition

Tablet Form of production

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Pancreatin

Dosage form

Tablets

Description

Children over 3 years of age, Pregnant women as prescribed by a doctor, For adults, Nursing mothers as prescribed by a doctor, Children as prescribed by a doctor

Indications

Flatulence, Diet errors, Chronic pancreatitis, Diarrhea, Overeating, Preparation for ultrasound and abdominal X-ray