Universal reference book for medicines
Product name: FESTAL ® (FESTAL ® )

Active substance: non-appropriated, pancreatin

Type: Enzyme preparation

Manufacturer: SANOFI INDIA (India) manufactured by SANOFI INDIA (India), issuing quality control SANOFI INDIA (India), issuing quality control BIOKOM (Russia)
Composition, form of production and packaging

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The dragees are enteric in white, glossy, round, with a faint smell of vanilla.
1 dragee

pancreatin 192 mg

with enzymatic activity:

lipase 6000 units FIP

amylase 4500 units FIP

protease 300 units FIP

hemicellulase 50 mg

bile components 25 mg

Excipients: sodium chloride.

Composition of the coating: cellacephate (cellulose acetate phthalate), ethylvaniline, castor oil, sucrose, methyl parahydroxybenzoate (methylparaben), propyl parahydroxybenzoate (propylparaben), gelatin, dextrose liquid (glucose liquid), talc, calcium carbonate, acacia gum, glycerol (glycerin), macrogol polyethylene glycol 6000), titanium dioxide.

10 pieces.
- strips of aluminum foil (2) - packs of cardboard.
10 pieces.
- strips of aluminum foil (4) - packs of cardboard.
10 pieces.
- Strips of aluminum foil (6) - packs of cardboard.
10 pieces.
- strips of aluminum foil (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

Enzyme preparation.
Compensates the insufficiency of the exocrine function of the pancreas due to pancreatin and bile excretory function of the liver due to the bile component. Festal ® has a proteolytic, amylolytic and lipolytic effect. Enzymes included in pancreatin: amylase, lipase and protease facilitate digestion of carbohydrates, fats and proteins, which contributes to their full absorption in the small intestine.
The presence of bile acids in the preparation of Festal ® gives additional possibilities for 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 cleavage of plant fiber, which also improves digestive processes, reduces the formation of gases in the intestine.

PHARMACOKINETICS

Data on the pharmacokinetics of the drug are not available.

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 digestive disorders, flatulence, propensity to constipation.

In the combination therapy with:

- diffuse liver diseases - alcohol and toxic liver damage, liver cirrhosis;

- large losses of bile acids (in patients after cholecystectomy);

- violation of bile acid circulation, observed with dyskinesia of bile ducts, dysbiosis, malabsorption;

- Violation of the neurohumoral regulation of the processes of bile formation and bile secretion in chronic gastrointestinal diseases - chronic gastritis, chronic duodenitis, chronic cholecystitis.

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

Preparation for X-ray and ultrasound of the abdominal organs.

DOSING MODE

The drug should be taken orally, without chewing, during or immediately after eating, with a small amount of liquid.

Adults appoint 1-2 tablets 3 times / day.
A higher dose is prescribed by the doctor.
Use of the drug in children as directed by a doctor.

The duration of treatment can vary from several days (if the digestive process is disturbed due to inaccuracies in the diet) to several months or years (if necessary, permanent replacement therapy).

Before x-ray or ultrasound examination - 2 dragees 2-3 times / day for 2-3 days before the study.

SIDE EFFECT

Allergic reactions: flushing of the skin, sneezing, lacrimation.

From the digestive system: nausea, diarrhea, abdominal pain (including intestinal colic).

With prolonged use in high doses: possibly - hyperuricemia, hyperuricosuria.

When used in high doses in children: it is possible - perianal irritation, irritation of the oral mucosa.

CONTRAINDICATIONS

- hypersensitivity to the components of the drug;

acute pancreatitis;

- exacerbation of chronic pancreatitis;

- liver failure;

- hepatic coma or precoma;

- Hepatitis;

- Hyperbilirubinemia;

- mechanical jaundice;

- cholelithiasis;

- Empyema of the gallbladder;

- intestinal obstruction;

- predisposition to diarrhea;

- Children's age under 3 years (for this dosage form).

With caution: cystic fibrosis, pregnancy.

PREGNANCY AND LACTATION

Caution should be used during pregnancy.

Data on the safety of the drug during lactation (breastfeeding) are not provided.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated use of the drug in liver failure, hepatitis, jaundice of mechanical genesis, cholelithiasis.

APPLICATION FOR CHILDREN

Use of the drug in children as directed by a doctor.

SPECIAL INSTRUCTIONS

Caution should be used in patients with cystic fibrosis.

OVERDOSE

Symptoms: hyperuricemia and hyperuricosuria.

Treatment: withdrawal of the drug and symptomatic therapy.

DRUG INTERACTION

At simultaneous application with preparation Festal ® the absorption of PASK, sulfonamides, antibiotics is strengthened.
It is possible to reduce the absorption of iron preparations.
Simultaneous use of antacid agents containing calcium carbonate and / or magnesium hydroxide can lead to a decrease in the effectiveness of the drug Festal ® .

Cimetidine enhances the effect of the drug.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
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