Pancreatin - instructions for use, dose, side effects, contraindications

amylolytic activity - not less than 2800 ED FIP, proteolytic activity - not less than 180 units FIP, lipolytic activity - not less than 3000 units FIP) [including: active substance: pancreatin; Excipients: lactose monohydrate, sucrose, sodium chloride, microcrystalline cellulose and macrogol-4000 (polyethylene glycol-4000)].

Excipients: core lactose monohydrate - 138.5 mg, starch potato - 3.0 mg, magnesium stearate - 2.8 mg, povidone-K25 (medium-molecular weight polyvinylpyrrolidone) -10.7 mg; sheath - acrylic yellow 93O32874 28.0 mg of [methacrylic acid and ethyl acrylate copolymer [1: 1] (copolymer methacrylic acid, type C) - 11,20 mg], talc - 10.43 mg, titanium dioxide (E 171) - 2.83 mg, triethyl citrate - 1.34 mg, dye quinoline yellow aluminum lacquer (E 104) - 0.67 mg, iron dye oxide yellow (E 172) - 0.53 mg, silicon dioxide 0.35 mg, sodium hydrogen carbonate (sodium bicarbonate) 0.34 mg, solar sunset dye yellow aluminum lacquer (E 110) -0.17 mg, sodium lauryl sulfate 0.14 mg.

Description:Tablets are round, coated with a light yellow to orange-yellow color, biconvex form. A specific odor is allowed.

Pharmacotherapeutic group:digestive enzyme.

ATX: & nbsp

A.09.A.A Enzyme preparations

A.09.A.A.02 Pancreatin

Pharmacodynamics:

Compensates the insufficiency of the exocrine function of the pancreas, has a proteolytic, amylolytic and lipolytic effect.

The enzymes included in the pancreatin (lipase, amylase, trypsin, chymotrypsin) promote the breakdown of proteins to amino acids, fats to glycerol and fatty acids, starch to dextrins and monosaccharides. Improves the functional state of the gastrointestinal tract, normalizes the digestive process.

Trypsin inhibits the stimulated secretion of the pancreas, providing analgesic effect.

Pancreatic enzymes are released from the dosage form in alkaline medium of the small intestine; protected from gastric juice shell.

Indications:

Substitution therapy with exocrine pancreatic insufficiency: chronic pancreatitis, pancreatectomy, condition after irradiation, dyspepsia, cystic fibrosis.

Flatulence, diarrhea of non-infectious genesis, Remkheld's syndrome (gastrocardial syndrome).

Disturbance of the assimilation of food (state after resection of the stomach and small intestine); to improve the digestion of food in people with normal gastrointestinal function in the event of errors in nutrition (eating fatty foods, a large amount of food, irregular meals) and in cases of malfunctioning, sedentary lifestyle, prolonged immobilization.

Preparation for X-ray and ultrasound examination of the abdominal organs.

Contraindications:

Hypersensitivity to the components of the drug, acute pancreatitis, exacerbation of chronic pancreatitis, children under 6 years.

Pregnancy and lactation:

The safety of pancreatin in pregnancy is not well understood.The application is possible in cases where the expected benefit for the mother exceeds the potential risk to the fetus. During the lactation period, the use of pancreatin is not contraindicated.

Dosing and Administration:

Inside. The drug is taken during or after meals, without chewing and washing with non-alkaline liquid (water, fruit juices).

The dose is determined individually depending on the degree of digestion disorders. Adults usually - 2-4 tablets 3-6 times a day. The maximum daily dose is 16 tablets.

In children older than 6 years, the drug is used as directed by a doctor. The dose is determined individually. Usually appoint 1 tablet 3 times a day. The duration of treatment can vary from several days (if the digestive process is disturbed due to inaccuracies in the diet) to several months or years (if necessary, permanent replacement therapy).

Side effects:

Allergic reactions. Rarely - diarrhea, constipation, a feeling of discomfort in the stomach, nausea (the cause-and-effect relationship of the development of these reactions with the action of pancreatin is not established, because these phenomena refer to symptoms of exocrine pancreatic insufficiency).With prolonged use in high doses, the development of hyperuricosuria is possible. hyperuricemia. In case of cystic fibrosis in case of exceeding the necessary dose of pancreatin, development of strictures (fibrous colonopathy) in the ileocecal region in the ascending colon can be possible.

When using pancreatin in high doses, children may experience perianal irritation and irritation of the mucous membrane of the oral cavity.

Overdose:

Symptoms: hyperuricosuria, hyperuricemia. Children have constipation.

Treatment: withdrawal of the drug, symptomatic therapy.

Interaction:

When using pancreatin, it is possible to reduce the absorption of iron and folic acid. The simultaneous use of antacid agents containing calcium carbonate and / or magnesium hydroxide, can lead to a decrease in the effectiveness of pancreatin.

Special instructions:

Cystic fibrosis does not recommend the use of pancreatin in high doses due to an increased risk of stricture (fibrous colonopathy). The dose should be adequate to the number of enzymes that is necessary for the absorption of fats, taking into account the quality and quantity of food consumed.

Form release / dosage:

The tablets are covered with an enteric coating of 125 mg.

Packaging:

10 tablets per contour cell pack.

1, 2, 3 or 5 packages with instructions for use in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 15 ° C.

Keep out of the reach of children.

Shelf life:2 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:P N000253 / 01

Date of registration:02.06.2010

The owner of the registration certificate:PHARMSTANDART-FORESTRY, OJSC PHARMSTANDART-FORESTRY, OJSC Russia

Manufacturer: & nbsp

PHARMSTANDART-FORESTRY, OJSC Russia

Information update date: & nbsp19.08.2015

Illustrated instructions

Instructions

Pancreatin (Pancreatinum)