Mezim forte 10000 - instructions for use, dose, side effects, contraindications

Excipients: lactose monohydrate - 89,100 mg, microcrystalline cellulose - 52,000 mg, silicon dioxide colloid - 1,533 mg, crospovidone - 18,000 mg, magnesium stearate - 1.867 mg;

Sheath: hypromellose (~ 5 mPa - from) - 4,800 mg, methacrylic acid and ethyl acrylate copolymer (1: 1) dispersion 30% (dry weight) - 12,200 mg, triethyl citrate - 3,900 mg, titanium dioxide (E171) 5,050 mg, talc 6,780 mg, simethicone emulsion 30% (dry weight) 0.049 mg, macrogol 6000 0.210 mg, carmellose sodium (~ 30 mPa-s) 0.440 mg, polysorbate 80 - 0,690 mg, azorubin varnish (E 122) - 0.232 mg, sodium hydroxide - 0.035 mg.

Description:

Pink planocylindrical tablets, coated with a shell, with almost plane-parallel surfaces and bevelled edges, brown inclusions are possible at the break.

Pharmacotherapeutic group:Digestive enzyme agent

ATX: & nbsp

A.09.A.A Enzyme preparations

A.09.A.A.02 Pancreatin

Pharmacodynamics:

Enzyme preparation that improves digestion.

Pancreatin is a powder from porcine pancreas, in which, along with exocrine pancreatic enzymes - lipase, amylase, protease, trypsin and chymotrypsin, there are other enzymes.

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

Pharmacokinetics:

Mezim® forte 10000 tablets are covered with an acid-resistant coating that does not dissolve under the action of hydrochloric acid in the stomach and thereby protects the enzymes contained in the preparation from inactivation. Dissolution of the membrane and the release of enzymes occur at a pH close to neutral or slightly alkaline.

Indications:

- Substitution therapy with exocrine insufficiency of pancreatic functions (including chronic pancreatitis, cystic fibrosis);

- chronic inflammatory-dystrophic diseases of the stomach, intestines, liver, gall bladder;

- condition after resection or irradiation of the gastrointestinal tract, accompanied by a violation of digestion of food, flatulence, diarrhea (as part of combination therapy);

- GI disorder of a functional nature (with intestinal infectious diseases, irritable bowel syndrome, etc.);

- to improve the digestion of food in patients with normal gastrointestinal function in the event of errors in nutrition;

- Preparation for X-ray and ultrasound examination 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, a lack of lactase or a syndrome of glucose-galactose malabsorption;

- children under 3 years (indivisible dosage form).

Pregnancy and lactation:In view of the lack of sufficient data on the use of pancreatic enzymes in humans during pregnancyand during lactation, the use of Mezim® forte 10000 is only possible if the expected benefit to the mother exceeds the possible risk to the fetus or child.

Dosing and Administration:

The dose of Mezim® forte 10000 is determined individually, depending on the severity of the disease and the composition of the food.

Unless otherwise indicated, the average single dose for of adults is 2-4 tablets Mezim® forte 10000 for food intake. It is recommended to take half or a third of a single dose at the beginning of the meal, and the rest during it. The drug is taken orally, without chewing and squeezed with enough liquid. It is possible to increase the dose, which should be carried out only under the supervision of a doctor, while focusing on reducing symptoms (for example, steatorrhea, abdominal pain). The maximum daily dose is 15,000-20,000 units Ph. Eur. lipase / kg body weight.

Children the dosage regimen is set by the doctor depending on the degree of severity of the disease and food composition at the rate of 500-1000 units Ph. Eur. lipase / kg body weight of the baby for each meal.

Duration of treatment can vary from several days (with digestion disorders, inaccuracies in the diet) to several months and even years (if necessary, permanent replacement therapy).

Side effects:

There was no development of side effects or complications even with prolonged and regular use of Mezim® forte 10000 in patients with impaired pancreatic function.

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

Overdose:

There are no data on cases of overdose and intoxication with the drug.

Possible: hyperuricosuria, hyperuricemia, in children - constipation.

Treatment: withdrawal of the drug, symptomatic therapy.

Interaction:

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

With the simultaneous use of pancreatin with iron preparations, it is possible to reduce absorption of the latter.The simultaneous use of antacid agents containing calcium carbonate and / or magnesium hydroxide, can lead to a decrease in the effectiveness of the drug.

Special instructions:

In case of acute pancreatitis or exacerbation of chronic pancreatitis (at the stage of exacerbation of exacerbation), during rehabilitative dietary nutrition, it is advisable to prescribe Mezim® forte 10000 against the background of pancreatic function that is or remains inadequate. Mezim® forte 10000, given a solid, indivisible dosage form, is contraindicated in children under 3 years of age.

Effect on the ability to drive transp. cf. and fur:

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

Form release / dosage:

Tablets, covered with enteric coating.

Packaging:

For 10 tablets in a planar cell package (blister) [aluminum / PVC / polyamide]. For 1 or 2 blisters together with instructions for use in a cardboard bundle.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep the medicine out of the reach of children!

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N014681 / 01

Date of registration:24.03.2009 / 15.12.2016

Expiration Date:Unlimited

The owner of the registration certificate:BERLIN-PHARMA, CJSC BERLIN-PHARMA, CJSC Russia

Manufacturer: & nbsp

BERLIN-CHEMIE, AG Germany

Information update date: & nbsp26.04.2018

Illustrated instructions

Instructions

Mezim® forte 10000 (Mezym® forte 10000)