Mezim forte 10000ed pills coated №20

Trade name: Mezim ^® forte 10,000

International non-proprietary name or grouping name: Pancreatin

Dosage Form: enteric coated tablets

The composition of one tablet

Core:
Active substance:
Pancreatin powder –137.5 mg with minimal enzymatic activity:

Crospovidone, Magnesium stearate; shell: hypromellose (~ 5 MPa • s), methacrylic acid and copolymer ethyl acrylate (1: 1) dispersion 30% (dry weight), triethyl citrate, titanium dioxide (E 171), talc, simethicone emulsion 30% (dry weight), macrogol 6000, carmellose sodium (~ 30 mPa • s), polysorbate 80, azorubic varnish (E 122), sodium hydroxide.

Description: pink round pills covered with an enteric shell, with biconvex surfaces, with chamfers, brown blotches are possible on a break.

Pharmacotherapeutic group: digestive enzyme agent

Pharmacological properties:

Pharmacodynamics. Enzymatic drug that improves digestion. Pancreatin is a powder of porcine pancreas glands, in which, along with exocrine pancreatic enzymes — lipase, amylase, protease, trypsin, and chymotrypsin — contain other enzymes.The pancreatic enzymes that make up the drug facilitate the breakdown of proteins, fats and carbohydrates, which leads to their more complete absorption in the small intestine. Trypsin inhibits stimulated secretion of the pancreas, providing an analgesic effect. The maximum enzymatic activity of the drug is noted in 30-45 minutes after oral administration.

Pharmacokinetics. pills mezim^® Forte 10000 is covered with an acid-resistant casing, which does not dissolve under the action of the hydrochloric acid of the stomach and thus protects the enzymes contained in the preparation from inactivation. The dissolution of the shell and the release of enzymes occurs at pH values ​​close to neutral or slightly alkaline.

Indications for use

- replacement therapy in case of exocrine insufficiency of pancreatic functions (including chronic pancreatitis, cystic fibrosis);
- chronic inflammatory-dystrophic diseases of the stomach, intestines, liver, gallbladder;
- conditions after resection or irradiation of the digestive tract organs, accompanied by a violation of food digestion, flatulence, diarrhea (as part of combination therapy);
- disorder of the gastrointestinal tract of a functional nature (in intestinal infectious

diseases, irritable bowel syndrome, etc.);
- to improve the digestion of food in patients with normal function of the gastrointestinal tract in case of errors in nutrition;
- preparation for radiological and ultrasound studies of the abdominal cavity organs.

Contraindications

- acute pancreatitis;
- exacerbation of chronic pancreatitis;
- hypersensitivity to Pancreatin or other components of the drug;
- hereditary intolerance to galactose, lack of lactase or glucose-galactose malabsorption syndrome;
- children's age up to 3 years (indivisible dosage form).

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 the drug Mezim^® Forte 10000 is only possible if the expected benefit to the mother outweighs the possible risk to the fetus or child.

Dosage and administration

Dose of the drug Mezim^® Forte 10000 is set individually depending on the severity of the disease and the composition of food.
Unless otherwise indicated, the average single dose for adults is 2-4 Mezim tablets.^® Forte 10,000 to eat. 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 drinking plenty of fluids.
You may increase the dose, which should be carried out only under the supervision of a physician, focusing on the weakening of symptoms (for example, steatorrhea, abdominal pain). The maximum daily dose - 15000-20000 IU Ph. Eur. lipase / kg body weight.
Children dosing regimen sets the doctor, depending on the severity of the disease and the composition of food at the rate of 500-1000 IU Ph. Eur. lipase / kg body weight of the child for each meal.
The duration of treatment can vary from several days (in case of digestive disorders, errors in diet) to several months and even years (if necessary, constant replacement therapy).

Adverse effects

There was no development of side effects or complications even with prolonged and regular use of the drug Mezim^® Forte 10,000 in patients with impaired pancreatic function.
In some cases, after taking pancreatin, allergic reactions may develop, rarely diarrhea or constipation, nausea, epigastric discomfort. In isolated cases in patients suffering from cystic fibrosis, with prolonged use of high doses of the drug may develop hyperuricosuria (increased uric acid levels in the blood plasma), the formation of strictures in the ileocecal region and the ascending colon.

Overdosage

Data on cases of overdose and intoxication drug no.
Possible: hyperuricuria, hyperuricemia, in children - constipation.
Treatment: drug withdrawal, symptomatic therapy.

Interaction with other drugs

When taking drugs containing pancreatin, may decrease the absorption of folic acid. The effect of glucose-lowering drugs (acarbose, miglitol) may decrease while taking it with pancreatin.
With simultaneous use of pancreatin with iron preparations may decrease the absorption of the latter.The simultaneous use of antacids containing Calcium carbonate and / or magnesium hydroxide, can lead to a decrease in the effectiveness of the drug.

Special notes

In acute pancreatitis or exacerbation of chronic pancreatitis (at the stage of attenuation of exacerbation), during a restorative diet, it is advisable to prescribe Mezim^® Forte 10000 against the existing or remaining inadequate pancreatic function.
Mezim^® Forte 10000, taking into account the solid indivisible dosage form, is contraindicated in children under 3 years

The influence of the drug on the ability to drive vehicles and control mechanisms
Mezim^® Forte 10000 does not affect the speed of psychomotor reactions and the ability to perceive or assess the situation.

Storage conditions

At a temperature not higher than 30 ° C.
Keep the medicine out of the reach of children!