Festal enteric tablets p / o No. 10×2

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Festal dragee in blister pack No. 10×2
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White, glossy, round dragees with a slight smell of vanilla. The main active ingredient Pancreatin Release form Dragee Special instructions Studies on the safety of pancreatin have not been conducted in pregnant and lactating women. In this regard, the use of the drug during pregnancy and lactation should be avoided. During pregnancy and lactation, the drug is prescribed only if absolutely necessary. In experimental studies, it has been established that pancreatin does not cause a teratogenic effect. In cystic fibrosis, the drug should be administered with caution, since the dose should be adequate to the quantity and quality of the food consumed. Pharmacological action The drug compensates for the insufficiency of the secretory function of the pancreas and the biliary function of the liver. The enzymes that make up pancreatin: amylase, lipase and protease facilitate the digestion of carbohydrates, fats and proteins, which contributes to their more complete absorption in the small intestine. The drug also stimulates the secretion of its own enzymes of the pancreas, stomach and small intestine, as well as bile. The enzyme hemicellulase promotes the breakdown of plant fiber, which also improves digestive processes, reduces the formation of gases in the intestines. Bile extract has a choleretic effect, promotes the emulsification of fats, facilitating their absorption and absorption of fat-soluble vitamins, promotes the release of lipase by the pancreas. The use of the drug leads to an improvement in the functional state of the gastrointestinal tract, normalization of the digestive process. Pharmacokinetics The action of the drug Festal is the cumulative effect of its components, so it is not possible to conduct kinetic observations; all together the components cannot be traced using markers or bioassays. For the same reason, it is impossible to detect drug metabolites. Indications for use Insufficiency of the exocrine function of the pancreas (with chronic pancreatitis). Chronic inflammatory-dystrophic diseases of the stomach, intestines, liver, gallbladder; conditions after resection or irradiation of these organs, accompanied by disorders of food digestion, flatulence, diarrhea (as part of combination therapy). To improve the digestion of food in people with normal function of the gastrointestinal tract in case of impaired chewing function, as well as forced prolonged immobilization. Preparation for x-ray and ultrasound examination of the abdominal organs. Dosage and administration The drug is taken orally, without chewing, during or immediately after a meal, with a small amount of non-alkaline liquid (juice, warm tea or water). Adults: 1-2 tablets 3 times a day. Higher doses are prescribed by a doctor. Children – as prescribed by a doctor. The duration of treatment can vary from a few days (if the digestive process is disturbed due to changes in diet) to several months or years (if permanent replacement therapy is necessary). Before x-ray or ultrasound examination: 2 tablets 2-3 times a day for 2-3 days before the examination. A single dose is possible. Precautions With caution, the drug is prescribed to patients with a history of chronic pancreatitis. The drug can be used as prescribed by a doctor during the recovery period or changes in diet after an exacerbation of chronic pancreatitis. It is possible to use Festal to increase the absorption of certain drugs (PASK, sulfonamides, antibiotics). It should be borne in mind that with a high activity of lipase contained in pancreatin, the likelihood of developing severe constipation in children increases. In clinical practice, there have been cases of fibrosing colonopathy, constipation and intestinal obstruction in children with cystic fibrosis who received drugs containing pancreatin in high doses daily. It is recommended to consult a doctor if complaints persist or the patient’s condition worsens, as well as if additional symptoms appear. Digestive disorders may occur in patients with hypersensitivity to pancreatin, or in patients with meconium ileus or a history of bowel resection. When using pancreatin in high doses, perianal irritation may occur in some cases. Due to the need to swallow the pills whole, the drug is not recommended for use in infants and young children (under 6 years of age), who may not have completed the maturation of the function of swallowing. Taking Festal dragees by a child over 6 years of age is recommended in the presence of an adult. Tablets should not be chewed or crushed, as this may lead to premature release of enzymes and, as a result, irritation of the oral mucosa and / or a decrease in enzyme activity. The drug contains purines and should be used with caution in patients with the following diseases: – gout – hyperuricemia – renal failure Interaction with other drugs Pancreatin may reduce the effectiveness of acarbose, which is why they should not be used simultaneously. With simultaneous use with Festal, the absorption of PAS, sulfonamides, antibiotics increases; may reduce the absorption of iron and folic acid. Cimetidine may enhance the effect of pancreatin. The simultaneous use of antacids containing calcium carbonate and / or magnesium hydroxide may lead to a decrease in the effectiveness of Festal. Contraindications Hypersensitivity to the components of the drug, acute pancreatitis, exacerbation of chronic pancreatitis, liver failure, hepatitis, obstructive jaundice, cholelithiasis, gallbladder empyema, intestinal obstruction. The drug is contraindicated in children under the age of 3 years. Composition 1 dragee contains: active substances: pancreatin – 192.00 mg, which is equivalent (in units of the International Pharmaceutical Federation – FIP): lipase – 6000 a-amylase – 4500 protease – 300; hemicellulase – 50.00 mg of bile components – 25.00 mg; excipients: sodium chloride, cellulose acetate phthalate, ethylvanillin, castor oil (E15OZ), sucrose, gelatin, liquid glucose, talc (E553), calcium carbonate (E170), acacia extract, glycerin (E422), polyethylene glycol 6000 (E1521), titanium dioxide (E171). OverdoseSymptoms: increased levels of uric acid in plasma and urine. Treatment: drug withdrawal, symptomatic therapy. Side effects Anaphylactic reactions, including urticaria and Quincke’s edema, nausea, diarrhea, abdominal pain, perianal irritation, anal itching, constipation, stenosis of the large intestine, fibrosing colonopathy, vomiting, irritation of the oral mucosa, increased levels of uric acid in blood plasma, decreased endogenous synthesis of bile acids. When using pancreatin in high doses, hyperuricosuria may develop. In children, when using high doses, it is possible to develop perianal irritation and irritation of the oral mucosa. In children with cystic fibrosis, cases of intestinal obstruction and constipation have been reported with high doses of pancreatin. If any of the listed adverse reactions or a reaction not mentioned in the package leaflet occurs, you should consult a doctor! Storage conditionsStore at a temperature not exceeding +25°C. Store in a place protected from moisture. Keep out of the reach of children. 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