Mezim forte 10000,0,3 mg 20 pcs

Pharmacodynamics

A digestive-improving enzyme drug. Pancreatin is a powder from porcine pancreatic glands which contains along with external pancreatic enzymes – lipase, amylase, protease, trypsin and chymotrypsin.

The pancreatic enzymes in the drug facilitate the breakdown of proteins, fats and carbohydrates, which leads to their more complete absorption in the small intestine. Trypsin suppresses stimulated pancreatic secretion with analgesic effect. Maximum enzymatic activity of the drug is observed 30-45 minutes after oral administration.

Pharmacokinetics

The tablets Mezim® forte 10000 are covered with an acid-resistant coating that does not dissolve under the influence of gastric hydrochloric acid and thus protects the enzymes contained in the drug from inactivation. Dissolution of the coating and enzyme release occur at pH values close to neutral or slightly alkaline.

Indications

Active ingredient

Composition

Active ingredient:

Pancreatin 137.5 mg with minimal enzymatic activity: lipase 10,000 units Ph.Eur, amylase 7500 units Ph.Eur, proteases 375 units Ph.Eur.

Auxiliary substances:

Lactose monohydrate,

Microcrystalline cellulose,

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colloidal silicon dioxide,

crospovidone,

magnesium stearate.

Shell composition:

Hypromellose,

Methacrylic acid and ethyl acrylate copolymer (1:1) 30% dispersion (dry weight),

triethylcitrate,

titanium dioxide (E171),

talk,

simethicone emulsion 30% (dry weight),

macrogol 6000,

sodium carmellose,

polysorbate 80,

azorubin varnish (E122),

sodium hydroxide.

How to take, the dosage

The dose of the drug Mezim® forte 10000 is set individually depending on the severity of the disease and the food composition. If there are no other indications, the average single dose for adults is 2-4 tablets of the drug Mezim® forte 10000 per meal.

It is recommended that half or one third of the single dose be taken at the beginning of a meal and the rest during the meal. The drug is taken orally without chewing and with plenty of fluid. It is possible to increase the dosage, which should only be done under the supervision of a physician, focusing on the easing of symptoms (e.g. steatorrhea, abdominal pain).

The maximum daily dose is 15000-20000 IU of Ph.Eur. lipase/kg body weight.

In children the dosing regimen is determined by the physician depending on the severity of the disease and the food composition at the rate of 500-1000 IU of Ph.Eur. lipase/kg of body weight for each meal of the child.

The duration of treatment can vary from a few days (for digestive disorders and poor diet) to several months or even years (if permanent replacement therapy is necessary).

Interaction

When taking drugs containing pancreatin, folic acid absorption may be reduced.

The effect of antidiabetic drugs (acarbose, miglitol) may be decreased when taking pancreatin at the same time.

Concomitant use of pancreatin with iron preparations may decrease absorption of the latter.

Simultaneous use of antacids containing calcium carbonate and/or magnesium hydroxide may decrease the effectiveness of the drug.

Special Instructions

In acute pancreatitis or exacerbations of chronic pancreatitis (during the stage of waning exacerbation), during restorative dietary feeding, it is advisable to prescribe Mesim® forte 10000 against the background of existing or remaining pancreatic function insufficiency.

Mesim® Forte 10000, in solid indivisible dosage form, is contraindicated in children less than 3 years of age.

Impact on the ability to drive vehicles and other mechanisms requiring high concentration

Mesim® Forte 10000 has no effect on the speed of psychomotor reactions and the ability to perceive or assess the situation.

Contraindications

Side effects

No side effects or complications have been found even with long-term and regular use of the drug Mezim®forte 10000 in patients with impaired pancreatic function.

In single cases allergic reactions may occur after pancreatin administration; rarely – diarrhea or constipation, nausea, discomfort in epigastric region.

In single cases in patients with cystic fibrosis, prolonged use of high doses of the drug may cause hyperuricosuria (increase in plasma levels of uric acid); stricture formation in the ileocecal region and ascending colon may occur.

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.

Pregnancy use

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 possible only if the expected benefits to the mother exceed the possible risk to the fetus or child.

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