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

    Active substance: Pancreatin with minimal enzymatic activity: amylase 4 200 units FIP *, lipase 3 500 units FIP, proteases 250 IU FIP

    Excipients: Povidone K-30, sodium chloride, microcrystalline cellulose, lactose monohydrate, sodium glycolate, silicon dioxide colloid, talc, magnesium stearate, opadrai white OY-IN-58903 (cellacate, triacetin, titanium dioxide, sorbitan oleate).

    * Units of the International Federation of Pharmaceuticals.

    Description:

    White or almost white, round, biconvex tablets covered with enteric coating. A slightly rough surface may be observed.

    Pharmacotherapeutic group:Digestive enzyme agent
    ATX: & nbsp

    A.09.A.A   Enzyme preparations

    A.09.A.A.02   Pancreatin

    Pharmacodynamics:

    The drug compensates for the lack of exocrine function of the pancreas.

    The pancreatin enzymes of lipase, amylase and protease facilitate the digestion of fats, carbohydrates and proteins, which contributes to their fuller absorption in the small intestine.

    Indications:

    Insufficiency of the exocrine function of the pancreas (chronic pancreatitis, cystic fibrosis, etc.).

    Chronic inflammatory-dystrophic diseases of the stomach, intestines, liver, gall bladder. Conditions after resection or irradiation of these organs, accompanied by disruption of food digestion, flatulence, diarrhea (as part of combination therapy).

    To improve the digestion of food in patients with normal function of the gastrointestinal tract in the case of errors in nutrition, as well as violations of the masticatory function, long-term immobilization, a sedentary lifestyle.

    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 3 years.

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

    Dosing and Administration:

    The dose is determined individually depending on the degree of digestion disorders. Adults (in the absence of other prescriptions): 1 to 4 tablets at meal time, without chewing and washing down with a sufficient amount of liquid. Do not exceed the daily dose of enzymes, which is 15,000 units FIP lipase per kg of body weight.

    In children, the drug is used as directed by a doctor. Usually it is prescribed 1 tablet 3 times a day during meals.

    Duration of treatment can vary from a single intake or 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 (sneezing, lacrimation, skin rash). Rarely - diarrhea or constipation, nausea, discomfort in the epigastric region.With prolonged use in high doses, it is possible to develop hyperuricosuria, an increase in the level of uric acid in the blood plasma. In case of cystic fibrosis, in case of exceeding the necessary dose of pancreatin, development of strictures (fibrous colonopathy) in the ileocecal region and 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:

    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:With prolonged use, iron preparations are simultaneously prescribed.
    Form release / dosage:Tablets, covered with enteric coating.
    Packaging:

    For 10 tablets in PVC / aluminum blister. For 2 or 5 blisters together with the instructions for use are placed in a pack of cardboard.

    Storage conditions:

    In a dry, protected from light place at a temperature of no higher than 25 ° 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:LSR-003129/08
    Date of registration:25.04.2008 / 29.12.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:Roushan Pharma Co., Ltd.Roushan Pharma Co., Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspRoushan Pharma Co., Ltd.Roushan Pharma Co., Ltd.
    Information update date: & nbsp15.03.2017
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