Festal^® (Tablets) Instructions for Use

Marketing Authorization Holder

Sanofi Consumer Healthcare India, Limited (India)

Manufactured By

Lactose (India), Limited (India)

Packaging and Quality Control Release

LACTOSE (INDIA), Limited (India)

Or

ORTAT, JSC (Russia)

Contact Information

OPELLA HEALTHCARE LLC (Russia)

ATC Code

A09AA02 (Polyenzyme preparations (incl. Lipase, Protease))

Active Substances

Pancreatin (BAN)

Hemicellulase (Group)

Bile (Group)

Dosage Form

Festal®

Enteric-coated tablets 192 mg+25 mg+50 mg: 10, 20, 40, or 100 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated tablets.
Glossy, round tablets, coated white, with a faint vanilla odor.

Excipients : sodium chloride.

Shell composition cellacephate (cellulose acetate phthalate), ethylvanillin, castor oil, sucrose – 128.123 mg, gelatin, liquid dextrose [dextrose, oligo- and polysaccharides] or liquid glucose – 3.17 mg, talc, calcium carbonate, acacia gum, glycerol (glycerin), macrogol (polyethylene glycol 6000), titanium dioxide.

10 pcs. – aluminum strips (1) – cardboard packs.
10 pcs. – aluminum strips (2) – cardboard packs.
10 pcs. – aluminum strips (4) – cardboard packs.
10 pcs. – aluminum strips (10) – cardboard packs.

Clinical-Pharmacological Group

Digestive enzyme preparation

Pharmacotherapeutic Group

Drugs aiding digestion, including enzyme preparations; enzyme preparations

Pharmacological Action

The drug compensates for the insufficiency of the exocrine function of the pancreas due to pancreatin and the bile excretory function of the liver due to the bile component.

The drug Festal^® has a proteolytic, amylolytic and lipolytic effect. 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.

Replenishment of enzyme deficiency and normalization of food digestion processes helps to reduce the symptoms of dyspepsia, such as bloating, heaviness, rumbling. And in this respect, the drug Festal^® is practically no different from other enzyme preparations.

The presence of bile acids in the drug Festal^® gives it additional opportunities for correcting biliary insufficiency, which often accompanies chronic pancreatitis. Bile extract acts choleretically, facilitates the absorption of fats and fat-soluble vitamins A, E and K, and promotes the release of lipase by the pancreas.

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

Indications

For adults and children aged 3 years and older as a digestive enzyme agent for

• Insufficiency of the exocrine function of the pancreas in chronic pancreatitis combined with biliary insufficiency due to various pathological conditions, clinically manifested by digestive disorders, flatulence, 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);
• Impaired circulation of bile acids, observed in biliary dyskinesia, dysbacteriosis, malabsorption;
• Impaired neurohumoral regulation of bile formation and bile secretion processes in chronic gastrointestinal diseases – chronic gastritis, chronic duodenitis, chronic cholecystitis.

To improve food digestion in patients with normal gastrointestinal function in case of dietary errors, as well as in case of chewing disorders, forced long-term immobilization, sedentary lifestyle.

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

ICD codes

Dosage Regimen

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

Adults are prescribed 1-2 tablets 3 times/day. Higher doses are prescribed only by a doctor.

The dosage regimen for children from 3 to 18 years does not differ from the dosage regimen for adults.

The safety and efficacy of the drug Festal^® in children from 0 to 3 years have not been established.

The duration of treatment can vary from several days (in case of digestive disorders due to dietary errors) to several months or years (if constant replacement therapy is necessary).

Before X-ray or ultrasound examination – 2 tablets 2-3 times/day for 2-3 days before the examination.

Adverse Reactions

According to WHO, adverse reactions are classified according to their frequency of occurrence as follows: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000) and very rare (<1/10000), frequency unknown (frequency of occurrence cannot be determined from the available data).

From the immune system: frequency unknown – anaphylactic reactions, including urticaria and angioedema.

From metabolism and nutrition: frequency unknown – hyperuricemia (against the background of taking ultra-high doses of pancreatin).

From the gastrointestinal tract: frequency unknown – abdominal pain, diarrhea, vomiting, irritation of the oral mucosa (see section “Special Precautions”), anal itching. In patients with cystic fibrosis against the background of taking large doses of pancreatin (significantly exceeding those recommended for the drug Festal^®), in some cases, constipation, colon stenosis, intestinal obstruction, fibrosing colonopathy were observed.

From the kidneys and urinary tract: frequency unknown – cases of hyperuricosuria with prolonged use of high doses of pancreatin.

Contraindications

• Hypersensitivity to the components of the drug;
• Acute pancreatitis;
• Exacerbation of chronic pancreatitis;
• Hepatic insufficiency;
• Hepatic coma or precoma;
• Hepatitis;
• Hyperbilirubinemia;
• Mechanical jaundice;
• Cholelithiasis;
• Empyema of the gallbladder;
• Intestinal obstruction;
• Tendency to diarrhea;
• Children under 3 years of age;
• Pregnancy;
• Breastfeeding period.

With caution

Cystic fibrosis, gout, hyperuricemia, renal failure.

Use in Pregnancy and Lactation

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

Use in Hepatic Impairment

The use of the drug is contraindicated in hepatic insufficiency, hepatitis, jaundice of mechanical origin, cholelithiasis.

Use in Renal Impairment

The drug should be used with caution in renal failure.

Pediatric Use

The use of the drug is contraindicated in children under 3 years of age.

Special Precautions

The use of the drug Festal^® is contraindicated during attacks of acute pancreatitis, as well as during exacerbation of chronic pancreatitis (see section “Contraindications”). The use of the drug is possible after consultation with a doctor during the recovery period and during dietary correction.

In children with cystic fibrosis taking Pancreatin in high doses (significantly exceeding those recommended for the drug Festal^®) or for a long period of time, cases of narrowing of the colon (fibrosing colonopathy), intestinal obstruction and constipation have been reported. Therefore, if complaints persist or intensify, or if any additional symptoms occur, the patient is recommended to consult the attending physician.

The tablet should not be chewed or crushed, as this may lead to premature release of enzymes, which may 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, renal failure.

Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take this drug.

Patients with rare glucose-galactose malabsorption should not take this drug.

Effect on the ability to drive vehicles and mechanisms

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

Overdose

Symptoms hyperuricemia and hyperuricosuria.

Treatment the drug should be discontinued and symptomatic therapy should be carried out.

Drug Interactions

With simultaneous use 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 preparations.

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 the drug Festal^® and acarbose should not be used simultaneously.

Pancreatin may reduce the absorption of folic acid.

Storage Conditions

The drug should be stored out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.