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

Active ingredient

Composition

Core Composition

The active ingredients:

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

Hemicellulase – 50.00 mg;

Bile components – 25.00 mg.

Excipients: sodium chloride. The composition of the shell

Auxiliary substances: Cellacephate (cellulose acetate phthalate), ethylvanillin, 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.

How to take, the dosage

Ingestion.

The drug is taken orally, without chewing, during or immediately after a meal, with a small amount of fluid.

Prescribe 1-2 tablets 3 times a day. Higher doses should only be prescribed by a doctor.

The dosage and dosage regimen in children is determined by the doctor.

The duration of treatment can vary from a few days (if digestive problems are caused by poor diet) to a few months or years (if continued replacement therapy is necessary).

Before an X-ray or ultrasound examination, 2 tablets 2-3 times a day 2-3 days before the examination.

Interaction

Simultaneous use with the drug Festal® increases absorption of PASC (p-aminosalicylic acid), sulfonamides, antibiotics.

Long-term use of pancreatin may decrease absorption of iron preparations.

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

Cimetidine may increase the effect of pancreatin.

Pancreatin may decrease the effect of acarbose, therefore the drug Festal® and acarbose should not be used simultaneously.

Pancreatin may decrease absorption of folic acid.

Special Instructions

The use of the drug 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 the doctor during the recovery period and during the correction of the diet.

In children with cystic fibrosis who take pancreatin in high doses (significantly higher than those recommended for the drug Festal®) or for a long period of time there have been reported cases of constriction of the colon (fibrosing colonopathy), intestinal obstruction and constipation. Therefore, if complaints persist or increase, or if any additional symptoms occur, the patient is advised to consult his or her physician.

The tablet should not be chewed or crushed as this may cause premature release of the enzymes, which may irritate the oral mucosa and/or cause decreased enzyme activity.

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

Impact on ability to drive vehicles, operating machinery

The drug does not influence the ability to perform potentially hazardous activities requiring increased concentration and quick psychomotor reactions (including driving vehicles and operating moving machinery).

Synopsis

Contraindications

Side effects

According to the World Health Organization (WHO), adverse reactions are categorized into system-organ classes with the frequency of occurrence as follows: Very common (≥1/10), common (≥1/100,

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

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

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

Gastrointestinal disorders: frequency is unknown – abdominal pain, diarrhea, vomiting, irritation of the mucous membrane of the mouth (see

“Special indications”), anal itching. In patients with cystic fibrosis when taking high doses of pancreatin (significantly higher than those recommended for the drug Festal®) in some cases the development of constipation, colonic stenosis, intestinal obstruction, fibrosing colonopathy,

Mechanism and nutrition disorders: frequency unknown – hyperuricemia (in overdose of pancreatin).

Overdose

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

In case of overdose, the drug should be discontinued and symptomatic therapy should be carried out.

Pregnancy use

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

Similarities