Active substancePancreatinPancreatin
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  • Dosage form: & nbspenteric coated tablets
    Composition:

    Active substance: pancreatin - 90 mg with activities, not less than:

    Proteolytic activity 200 units of FIP

    Amylolytic activity 3500 ED FIP

    Lipolytic activity 3500 ED FIPS

    Auxiliary substances: lactose monohydrate (milk sugar) - 106 mg, lactose (lactopress) - 16 mg, povidone (polyvinylpyrrolidone low molecular weight) - 4.8 mg, microcrystalline cellulose MCC - 100 mg, calcium stearate - 3.2 mg, methacrylic acid copolymer with ethyl acrylate 12.3 mg, azorubin (acid red 2C) dye 0.12 mg, titanium dioxide (titanium dioxide pigment grade A) 0.37 mg, polysorbate (tween 80) 0.4 mg, macrogol ( polyethylene glycol 6000) - 1.5 mg, talc - 0.31 mg.

    Description:

    Tablets, covered with enteric-coated shell of pink or dark pink color, with a specific odor, biconvex form.On the cross-section, two layers are visible, without any risks.

    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. Enzymes included in Pancreatin (lipase, alpha-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 stimulated secretion of the pancreas, providing analgesic effect.

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

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

    Indications:

    Substitution therapy with exocrine pancreatic insufficiency: chronic pancreatitis, pancreatectomy,state after irradiation, dyspepsia, Remkheld's syndrome (gastrocardial syndrome), cystic fibrosis, flatulence, diarrhea of ​​non-infectious genesis.

    Disturbance of food intake (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 violation of masticatory function, 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.

    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. In experimental studies it was established that pancreatin does not have a teratogenic effect.
    Dosing and Administration:

    The drug is used inside, not liquid, during or after a meal.

    Adults: 1-3 tablets per reception 3-4 times a day.

    Children - as directed by a doctor. Dosage for children is selected individually by the treating pediatrician.

    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, 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, it is possible to develop hyperuricosuria, an increase in the level of uric acid in the blood plasma. When using Pancreatin in high doses, children may experience perianal irritation and irritation of the oral mucosa. 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, simtomaticheskaya 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:

    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 have a negative effect on the ability to drive vehicles and potentially dangerous mechanisms.
    Form release / dosage:

    Tablets, covered with enteric coating.

    Packaging:

    For 10, 15, 20 tablets in a contour mesh package. For 60 tablets in cans of orange glass type BDS or cans of orange glass type BV, or in cans of polymer type BP.For 6, 4, 3 contour squares or each jar, together with the instruction for use, is placed in a pack of cardboard box.

    Storage conditions:Store in a dark place at a temperature of no higher than 20 ° C. Keep out of the reach of children.
    Shelf life:2 years. Do not use after expiry date.
    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-006070/08
    Date of registration:31.07.2008
    The owner of the registration certificate:Tyumen Chemical - Pharmaceutical Plant, OJSC Tyumen Chemical - Pharmaceutical Plant, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp19.08.2015
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