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

    Composition per 1 tablet:

    Pancreatin

    corresponding to the enzymatic activity:

    - amylases - not less than 4620 units

    - lipases - not less than 3850 units

    - proteases - (275-500) ED

    Excipients:

    carboxymethyl starch sodium (primogel) 21.5 mg

    Pregelatinized starch (starch 1500) - 16.5 mg

    polyvinylpyrrolidone low molecular weight medical (povidone) - 5 mg

    magnesium stearate 3.3 mg

    aerosil (silicon dioxide colloidal) 3.3 mg

    cellulose microcrystalline - to obtain a tablet without an envelope with a mass of 330 mg

    Shell composition:

    cellase (acetylphthalic cellulose) - 2.847 mg

    Tween-80 (polysorbate) - 0.85 mg

    paraffin liquid (Vaseline oil) - 0.5 mg

    iron oxide brown (sikovig 70 E172) - 0.803 mg

    Description:The tablets are round biconvex, covered with a brown or dark brown shell, with a specific odor.
    Pharmacotherapeutic group:digestive enzyme
    ATX: & nbsp

    A.09.A.A   Enzyme preparations

    A.09.A.A.02   Pancreatin

    Pharmacodynamics:

    Digestive enzyme, compensates for the deficiency of secretory function of the pancreas, improves the digestion of food, has proteolytic, amylolytic and lipolytic effects.

    Included in the composition of pancreatic enzymes (lipase, alpha-amylase, trypsin, chymotrypsin) promote the breakdown of proteins to amino acids, fats to glycerol and fatty acids, starch to dextrins and monosaccharides.

    Trypsin suppresses stimulated secretion pzhezhelof the breast, rendering analgesing action.

    Enzyme hemicellulase promotes the cleavage of plant fiber, which also improves digestive processes, reduces the formation of gases in the intestine.

    Pharmacokinetics:

    Pancreatic enzymes are released from the form in the alkaline medium of the small intestine. protected from the action of gastric juice with an enteric-soluble coat.

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

    Indications:

    Substitution therapy with exocrine pancreatic insufficiency: chronic pancreatitis, pancreatectomy, condition after irradiation, dyspepsia, cystic fibrosis; flatulence, diarrhea of ​​non-infectious 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, large amounts of food, irregular meals) and in cases of malfunctioning, sedentary lifestyle, prolonged immobilization. Remkheld's syndrome (gastrocardial syndrome).

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

    Contraindications:

    Hypersensitivity to the components of the drug, acute pancreatitis, exacerbation of chronic pancreatitis.

    Children's age (up to 3 years).

    Pregnancy and lactation:

    During pregnancy and lactation, the drug is prescribed only if the expected benefit to the mother exceeds the potential risk to the fetus or child.

    Dosing and Administration:

    Inside, swallowing whole (without chewing), during or immediately after eating. with a large amount of liquid (if possible alkaline: water, fruit juices).

    The dose of the drug is set individually (in terms of lipase) depends on the age and degree of pancreatic insufficiency.

    Do not exceed the maximum recommended daily dosage of the enzymes lipase component of 15,000-20,000 IU / kg, especially in patients with cystic fibrosis.

    The average dose for adults is 150,000 units / day; full insufficiency exocrine pancreatic function - to 400 thousand units / day, which corresponds to a daily, an adult needs lipase..

    The duration of treatment may vary from single dose or several days (at disturbance due to the digestion process errors in the diet) to several months or even years (permanent replacement therapy, if necessary). Adults - 3-4 tablets 3 times a day. Higher doses are prescribed by the doctor.

    2 tablets 2-3 times a day for 2-3 days before x-ray or ultrasound.
    Children older than 3 years - 100 thousand units / day (lipase), divided into 3-4 reception.
    Side effects:

    Allergic reactions, rarely diarrhea or constipation, nausea, discomfort in the epigastric region, abdominal pain, decreased endogenous synthesis of bile acids. With long-term use in high doses, hyperuricosuria, when high doses are used in patients with cystic fibrosis, strictures in the ileocecal region and in the ascending colon appear as symptoms of intestinal obstruction.

    Overdose:

    Symptoms: With prolonged use in high doses - hyperuricosuria, when using high doses in patients with cystic fibrosis - strictures in the ileocecal region and in the ascending colon. Hyperuricemia. Children have constipation.

    Treatment: withdrawal of the drug, symptomatic therapy.

    Interaction:

    With simultaneous use with pancreatin, the absorption of para-aminosalicylic acid, sulfonamides, antibiotics is enhanced.

    Reduces absorption of iron (especially with prolonged use). Antacid agents containing calcium carbonate and / or magnesium hydroxide, can lower the effectiveness of pancreatin.

    Special instructions:

    In cystic fibrosis, the drug should be administered with caution. The dose should be adequate to the quantity and quality of the food consumed.

    With prolonged use in cases of digestive disorders (with normal pancreas function), iron preparations should be prescribed simultaneously.

    Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive vehicles and mechanisms.
    Form release / dosage:

    Tablets, covered with enteric coating.

    Packaging:

    60 tablets in a dark glass can of BPS type, sealed with a lid of a stretchable with sealing element or in a can of polymer type BP.

    A label is attached to each jar.

    10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered or paper with a polymer coating.

    Each jar or 2, 3, 6 contour squares with instructions for the use of the drug is placed in a pack of cardboard.

    Storage conditions:

    In a dry place, at a temperature not exceeding 20 ° С.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:PL-000586
    Date of registration:21.09.2011
    The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp17.08.2015
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