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

lactose monohydrate - 196.4 mg, microcrystalline cellulose - 64.0 mg, croscarus-mallose sodium - 3.2 mg, silicon dioxide colloid (aerosil) - 3.2 mg, calcium stearate - 3.2 mg;

composition of the shell:

methacrylic acid and ethyl acrylate copolymer [1: 1] (Collikut MAE 100 P) 13.73 mg, macrogol 4000 to 2.03 mg, titanium dioxide 0.60 mg, talc 3.59 mg, dye azorubin (carmoazine , an acid red dye 2 C) - 0.05 mg

Description:Round biconvex tablets, covered with a film coating of dark-colored color with impregnations,with a weak characteristic odor; On the cross-section, two layers are visible: a shell of dark pink color and a white core with a yellowish tinge colors with impregnations.

Pharmacotherapeutic group:digestive enzyme.

ATX: & nbsp

A.09.A.A Enzyme preparations

A.09.A.A.02 Pancreatin

Pharmacodynamics:

Digestive enzyme, compensates for the lack of exocrine function of the pancreas, has a proteolytic, amylolytic and lipolytic effect.

The enzymes included in the pancreatin (lipase, alpha-amylase, trypsin, chymotrypsin) promote the cleavage of proteins to peptides and polypeptides, triglycerides to monoglycerides and fatty acids, starch to dextrins, maltose, maltotriose and glucose.

Improves the functional state of the gastrointestinal tract, normalizes the digestive process.

Trypsin inhibits stimulated pancreatic secretion.

Pancreatic enzymes "are released from the dosage form in the alkaline medium of the small intestine, since they are protected from the action of gastric juice by an enteric-soluble membrane.

The maximum enzymatic activity is observed 30-45 minutes after oral administration.

Pharmacokinetics:Pancreatin is not absorbed from the gastrointestinal tract, it is excreted through the intestine.

Indications:

Substitution therapy with exocrine pancreatic insufficiency: chronic pancreatitis (outside exacerbation), pancreatectomy, obstruction of the pancreatic duct or common bile duct due to neoplasm, after irradiation of the pancreas, dyspepsia, Remkheld syndrome (gastrocardial syndrome), cystic fibrosis; feeling of overflow of the stomach or flatulence, caused by fatty or unusual food, overeating; diarrhea of non-infectious genesis.

Disturbance of food assimilation (condition after resection of stomach and small intestine); in the case of errors in nutrition (eating excessively fatty foods, a large amount of food, irregular meals) and in violation of the masticatory function.

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

Contraindications:

Hypersensitivity to the components of the drug, acute pancreatitis, exacerbation of chronic pancreatitis,lactose intolerance, lack of sucrase / isomaltase, lactase, fructose intolerance, glucose-galactose malabsorption, children under 6 years.

Pregnancy and lactation:

The application is possible in cases where the expected benefit for the mother exceeds the potential risk to the fetus and the baby.

Dosing and Administration:

The drug is taken orally, without chewing, squeezed large amounts of liquid (water, fruit juices), during or after a meal.

Adults and children over 14 years: 2-4 tablets 3-4 times a day.

Children - as prescribed by the doctor. Single doses for children: 6-7 years - 1 tablet, 8-9 years - 1-2 tablets, 10-14 years - 2 tablets. 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. In some cases - diarrhea, constipation, discomfort in the stomach, nausea (the causal relationship of these reactions to the action of pancreatin is not set because these phenomena are the symptoms of exocrine insufficiency of the pancreas).With prolonged use in high doses, it is possible to develop hyperuricosuria, an increase in the concentration of uric acid in the blood plasma. When using pancreatin in high doses, children may experience perianal irritation and irritation of the mucous membrane of the oral cavity. Patients with cystic fibrosis may develop strictures in the ileocecal region and in the ascending colon.

Overdose:

Symptoms: hyperuricosuria, hyperuricemia. Children have constipation.

Treatment: withdrawal of the drug, symptomatic therapy.

Interaction:

With the simultaneous use of pancreatin with iron preparations, it is possible to reduce the absorption of iron.

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 are needed to absorb fat, taking into account the quality and quantity of food consumed. With prolonged use, iron preparations are simultaneously prescribed.

Effect on the ability to drive transp. cf. and fur:The drug does not affect the performance of potentially hazardous activities requiring special attention and quick reactions (driving and other vehicles, working with moving mechanisms, dispatcher and operator work, etc.).

Form release / dosage:

Tablets, covered with enteric coating.

Packaging:

For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

6 contour packs together with instructions for use are placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 20 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LS-001109

Date of registration:06.07.2010

The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Manufacturer: & nbsp

VALENTA PHARMACEUTICS, JSC Russia

Information update date: & nbsp19.08.2015

Illustrated instructions

Instructions

Pancreatin (Pancreatin)