Active substancePancreatinPancreatin
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  • Dosage form: & nbspIntestinal-coated tablets
    Composition:

    Composition per 1 tablet:

    Active substance: Pancreatin - 100 mg.

    The amount of pancreatin is indicated for a substance with amylolytic activity of not less than 1700 units.FIP; lipolytic activity of at least 3000 units.FIP; total proteolytic activity of at least 130 U-FIP.

    Excipients: calcium stearate - 3.2 mg, potato starch - 7.4 mg, croscarmellose sodium - 1.2 mg, lactose monohydrate - until a tablet without an envelope weighing 320 mg.

    Auxiliary of the shell material to a tablet with a coating weight of 335 mg: titanium dioxide 0.933 mg, dye azorubin (dye acid red 2C) 0.025 mg, methacrylic acid and ethyl acrylate copolymer (1: 1) 6.948 mg, macrogol 4000 1.044 mg, talcum powder - 4.184 mg, povidone - 1.866 mg.

    Description:Tablets, covered with a pink or dark pink color with interspersed, with a specific odor, biconvex form, two layers are visible on the transverse section.
    Pharmacotherapeutic group:digestive enzyme.
    ATX: & nbsp

    A.09.A.A   Enzyme preparations

    A.09.A.A.02   Pancreatin

    Pharmacodynamics:

    Pancreatin compensates for the deficiency of the exocrine function of the pancreas, has a proteolytic, amylolytic and lipolytic effect. The enzymes included in the pancreatin (lipase, alpha-amylase, trypsin, chymotrypsin) promotes 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, has an analgesic effect.

    Pancreatic enzymes are released from the dosage form in the alkaline environment of the small intestine, since they are protected from the action of gastric juice by the membrane.
    Maximum enzymatic activity preparation is observed 30-45 minutes after oral administration.
    Indications:

    Substitution therapy for exocrine pancreatic insufficiency: chronic pancreatitis, pancreatectomy, condition after irradiation, dyspepsia, Remkheld syndrome (gastrocardial syndrome), cystic fibrosis, flatulence, diarrhea of ​​noninfectious genesis.

    Disturbance of the assimilation of food (state after resection of the stomach and small intestine); to improve the digestion of food in individuals 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 examination and ultrasound of the abdominal cavity organs.

    Contraindications:

    Hypersensitivity to the components of the drug, acute pancreatitis, exacerbation of chronic pancreatitis, children under 3 years (for this dosage form).

    Dosing and Administration:

    The drug is taken orally, without chewing, during or after a meal.

    Adults: 2-4 tablets 3-4 times a day.

    Children - individually, as prescribed by the doctor.

    Duration of treatment can vary from several days (if the digestive process is disturbeddue to inaccuracies in the diet) up to several months or years (if necessary permanent replacement therapy).

    Side effects:

    Allergic reactions. In some cases - 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, since these phenomena refer to symptoms of exocrine pancreatic insufficiency). With prolonged use in high doses, perianal irritation and irritation of the mucous membrane of the oral cavity may occur. 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 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 pancreatin.

    Special instructions:

    The safety of the use of pancreatin during 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.

    Cystic fibrosis does not recommend the use of pancreatin in high doses due to increased risk of strictures (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 adversely affect the ability to drive vehicles and / or other mechanisms.
    Form release / dosage:Intestine-soluble tablets shell.

    Packaging:

    For 10 or 15 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered. For 2 or 6 out-of-round cell packs of 10 tablets, 4 contour packs of 15 tablets together with the instructions for use are placed in a pack of cardboard.

    Storage conditions:

    In a place protected from moisture and light, at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use the drug after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-009899/08
    Date of registration:11.12.2008
    The owner of the registration certificate:AVVA RUS, OJSC AVVA RUS, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp19.08.2015
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