Festal dragee, є40
Expiration Date: 05/2027
Russian Pharmacy name:
Фестал драже, №40
insufficiency of exocrine pancreatic function in chronic pancreatitis in combination with biliary insufficiency due to various pathological conditions, clinically manifested by impaired digestion of food, flatulence, tendency to constipation, as part of combination therapy with:
- diffuse liver diseases - alcoholic and toxic liver damage, liver cirrhosis;
- large losses of bile acids (in patients after cholecystectomy);
- violation of the circulation of bile acids, observed with biliary dyskinesia, dysbacteriosis, malabsorption;
- violation of neurohumoral regulation of the processes of bile formation and bile secretion in chronic diseases of the gastrointestinal tract - chronic gastritis, chronic duodenitis, chronic cholecystitis;
to improve the digestion of food in patients with normal gastrointestinal tract function in case of errors in nutrition, as well as in violation of chewing function, forced prolonged immobilization, a sedentary lifestyle;
preparation for X-ray and ultrasound examination of the abdominal organs.
Inside, without chewing, during or immediately after a meal, with a small amount of liquid.
Assign 1-2 pills 3 times a day. Higher doses are prescribed only by a physician.
Before X-ray or ultrasound examination - 2 tablets 2-3 times a day 2-3 days before the study.
The dosage regimen in children is determined by the doctor.
The duration of treatment can vary from several days (if the digestive process is disturbed due to dietary errors) to several months or years (if constant replacement therapy is necessary).
Dragee enteric | 1 tablet |
core | |
active substances: | |
pancreatin | 192 mg |
(equivalent to amylase - 4500 FIP U; lipase - 6000 FIP U; protease - 300 FIP U) | |
hemicellulase | 50 mg |
bile components | 25 mg |
excipients: sodium chloride | |
shell: cellacephate (cellulose acetate phthalate); ethyl vanillin; Castor oil; sucrose; methyl parahydroxybenzoate (methylparaben); propyl parahydroxybenzoate (propylparaben); gelatin; liquid dextrose (liquid glucose); talc; calcium carbonate; acacia gum; glycerol (glycerin); macrogol (polyethylene glycol 6000); titanium dioxide |
hypersensitivity to drug components;
acute pancreatitis, exacerbation of chronic pancreatitis;
liver failure, hepatic coma or precoma;
hepatitis;
hyperbilirubinemia;
obstructive jaundice, cholelithiasis;
empyema of the gallbladder, intestinal obstruction;
a tendency to diarrhea;
children under 3 years of age (for this dosage form).
With care: cystic fibrosis, pregnancy.
pharmachologic effect
The drug compensates for the insufficiency of the exocrine function of the pancreas due to pancreatin and the biliary function of the liver due to the bile component. FestalЃ has proteolytic, amylolytic and lipolytic effects. The enzymes in 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 presence of bile acids in the composition of the FestalЃ preparation provides additional opportunities for the correction of biliary insufficiency, which often accompanies chronic pancreatitis. Bile extract has a choleretic effect, facilitates the absorption of fats and fat-soluble vitamins A, E and K, promotes the release of lipase by the pancreas. The enzyme hemicellulase promotes the breakdown of plant fiber,which also improves digestive processes, reduces the formation of gases in the intestines.
Side effect
According to the WHO, adverse reactions are distributed by systemic organ classes, indicating the frequency of their occurrence as follows: very often (? 1/10), often (? 1/100, <1/10), infrequently (? 1/1000, <1 / 100), rarely (? 1/10 000, <1/1000) and very rarely (<1/10 000), the frequency is unknown (the frequency of occurrence of events cannot be determined from the available data). From the immune system: the frequency is unknown - anaphylactic reactions, including urticaria and angioedema. From the side of the kidneys and urinary tract: the frequency is unknown - there are reports of cases of hyperuricosuria with prolonged use of high doses of pancreatin. From the gastrointestinal tract: the frequency is unknown - abdominal pain, diarrhea, vomiting, irritation of the oral mucosa (see the section 'Special instructions'), anal itching.In patients with cystic fibrosis while taking large doses of pancreatin (significantly higher than those recommended for the drug FestalЃ), in a number of cases, the development of constipation, stenosis of the large intestine, intestinal obstruction, fibrosing colonopathy was observed. From the side of metabolism and nutrition: the frequency is unknown - hyperuricemia (while taking ultra-high doses of pancreatin).
Application during pregnancy and lactation
The safety of using pancreatin during pregnancy and during breastfeeding has not been established. FestalЃ is contraindicated for use during pregnancy and lactation.
Application for violations of liver function
The use of the drug is contraindicated in liver failure, hepatitis, jaundice of mechanical origin, cholelithiasis.
Application for impaired renal function
The drug should be used with caution in case of renal failure.
Application in children
The use of the drug in children under 3 years of age is contraindicated.
special instructions
The use of the drug FestalЃ is contraindicated during attacks of acute pancreatitis, as well as during an exacerbation of chronic pancreatitis. The use of the drug is possible after consulting a doctor during the recovery period and during diet correction. Cases of narrowing of the colon (fibrosing colonopathy), intestinal obstruction and constipation have been reported in children with cystic fibrosis who take pancreatin in high doses (significantly higher than those recommended for FestalЃ) or for a long period of time. Therefore, if the complaints persist or intensify or if any additional symptoms occur, the patient is advised to consult with the attending physician. The tablet should not be chewed or crushed, because this can lead to premature release of enzymes,which can cause irritation of the oral mucosa and / or lead to a decrease in enzyme activity. FestalЃ contains purines, so it should be used with caution in patients with gout, hyperuricemia, renal failure. Influence on the ability to drive vehicles and control mechanisms There is no effect of FestalЃ on the ability to drive vehicles and operate mechanisms.
Overdose
Symptoms: hyperuricemia and hyperuricosuria. Treatment: drug withdrawal and symptomatic therapy.
Drug interactions
With simultaneous use with the drug FestalЃ, the absorption of PASK, sulfonamides, antibiotics is enhanced. A decrease in the absorption of iron preparations is possible. Long-term use of pancreatin can reduce the absorption of iron preparations. The simultaneous use of antacids containing calcium carbonate and / or magnesium hydroxide can lead to a decrease in the effectiveness of pancreatin. Cimetidine can enhance the action of pancreatin. Pancreatin can reduce the effect of acarbose, therefore, FestalЃ and acarbose should not be used at the same time. Pancreatin can reduce the absorption of folic acid.