Festal, 40 pcs.

Pharmacological group: digestive enzyme agent.

ATX code: A09AA02

Pharmacological action

The drug compensates insufficiency of external pancreatic secretory function due to pancreatin, and biliary function of the liver due to the bile component. Festal has proteolytic, amylolytic and lipolytic action. As part of pancreatin enzymes: amylase, lipase and protease facilitate the digestion of carbohydrates, fats and proteins, which contributes to their more complete absorption in the small intestine. And in this respect Festal is practically no different from other enzyme preparations.

The presence in Festal of bile acids gives the drug additional possibilities for the correction of biliary insufficiency, which often accompanies chronic pancreatitis. Bile extract has a choleretic effect, facilitates absorption of fats and fat-soluble vitamins A, E, and K, and promotes secretion of lipase by the pancreas.

Indications

Insufficiency of the exocrine function of the pancreas in chronic pancreatitis in combination with biliary insufficiency due to various pathological conditions, clinically manifested by impaired digestion of food, flatulence, a tendency to constipation, as part of combination therapy for:
– diffuse liver diseases – alcoholic and toxic liver damage, liver cirrhosis;
– large losses of bile acids (in patients after cholecystectomy);
– disruption of the circulation of bile acids, observed with biliary dyskinesia, dysbacteriosis, malabsorption;
– violation of the 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 function of the gastrointestinal tract in case of errors in nutrition, as well as in cases of disorders of chewing function, forced long-term immobilization, and a sedentary lifestyle.
Preparation for x-ray and ultrasound examination of the abdominal organs.

Pharmacological effect

Pharmacological group: digestive enzyme agent.

ATX code: A09AA02

Pharmacological action

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. Festal has proteolytic, amylolytic and lipolytic effects. The enzymes included 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. And in this respect, Festal is practically no different from other enzyme preparations.

The presence of bile acids in Festal gives the drug additional opportunities for correcting 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, and promotes the secretion of lipase by the pancreas

The enzyme hemicellulase promotes the breakdown of plant fiber, which also improves digestive processes and reduces the formation of gases in the intestines.

Special instructions

The use of Festal® is contraindicated during attacks of acute pancreatitis, as well as during exacerbation of chronic pancreatitis (see “Contraindications”). The use of the drug is possible after consultation with 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 taking pancreatin in high doses (much higher than those recommended for Festal®) or for a long period of time. Therefore, if complaints persist or worsen, or if any additional symptoms occur, the patient is advised to consult with his or her doctor.

The tablet should not be chewed or crushed as this may cause the enzymes to be released prematurely, which may cause

cause irritation of the oral mucosa and/or lead to a decrease in enzyme activity.

The drug Festal® contains purines, so it should be used with caution in patients with gout, hyperuricemia, and renal failure.

Impact on the ability to drive vehicles and machinery

The drug does not affect the ability to perform potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions (including driving vehicles, working with moving mechanisms).

Active ingredient

Hemicellulase, Bile components, Pancreatin

Composition

Kernel composition

Active ingredients:

Pancreatin – 192.00 mg equivalent (lipase – 6000 FIP units, amylase – 4500 FIP units, protease – 300 FIP units);

Hemicellulase – 50.00 mg;

Bile components – 25.00 mg.

Excipients: sodium chloride. Shell composition

Excipients: cellacephate (cellulose acetate phthalate), ethyl vanillin, castor oil, sucrose, gelatin, liquid dextrose [dextrose, oligo- and polysaccharides] or liquid glucose, talc, calcium carbonate, acacia gum, glycerol (glycerin), macrogol (polyethylene glycol 6000), titanium dioxide

Pregnancy

The safety of using pancreatin during pregnancy and breastfeeding has not been established. The drug Festal® is contraindicated for use during pregnancy and breastfeeding.

Contraindications

Hypersensitivity to the components of the drug, acute pancreatitis, exacerbation of chronic pancreatitis, liver failure, hepatic coma or precoma, hepatitis, hyperbilirubinemia, obstructive jaundice, cholelithiasis, gallbladder empyema, intestinal obstruction, tendency to diarrhea, children under 3 years of age, pregnancy and breastfeeding. With caution
The drug should be used with caution in patients with cystic fibrosis, gout, hyperuricemia, and renal failure.

Side Effects

According to the World Health Organization (WHO), adverse reactions are distributed according to systemic organ classes, indicating the frequency of their occurrence as follows: very often (≥ 1/10), often (≥1/100,

<1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000) and very rare (<1/10000); frequency unknown (the frequency of events cannot be determined from the available data).

Immune system disorders: frequency unknown – anaphylactic reactions, including urticaria and angioedema.

Renal and urinary tract disorders: frequency unknown – there have been reports of cases of hyperuricosuria with prolonged use of high doses of pancreatin.

Gastrointestinal disorders: frequency unknown – abdominal pain, diarrhea, vomiting, irritation of the oral mucosa (see.

“Special instructions”), anal itching. In patients with cystic fibrosis, while taking large doses of pancreatin (significantly exceeding those recommended for the drug Festal®), in some cases, the development of constipation, colon stenosis, intestinal obstruction, fibrosing colonopathy,

Metabolic and nutritional disorders: frequency unknown – hyperuricemia (while taking ultra-high doses of pancreatin).

Interaction

When used simultaneously with the drug Festal®, the absorption of PAS (p-aminosalicylic acid), sulfonamides, and antibiotics is enhanced.

Long-term use of pancreatin may reduce the absorption of iron supplements.

The simultaneous use of antacids containing calcium carbonate and/or magnesium hydroxide may reduce the effect of pancreatin.

Cimetidine may enhance the effect of pancreatin.

Pancreatin may reduce the effect of acarbose, so Festal® and acarbose should not be used simultaneously.

Pancreatin may reduce the absorption of folic acid.

Overdose

Symptoms of overdose are hyperuricemia and hyperuricosuria. If symptoms of overdose appear, the drug should be discontinued and symptomatic therapy should be carried out.

Storage conditions

Store at a temperature not exceeding 25 ºС. Keep out of the reach of children.

Shelf life

3 years.
Do not use after expiration date.

Manufacturer

Lactose (India) Limited, India