Festal® neo 10 000

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FESTAL® NEO 10,000 (Festal® NEO 10,000)

Composition:

Active substance: pancreatin;

One tablet contains pancreatin corresponding to a minimum enzymatic activity of:

10,000 lipolytic units, 7,500 amylolytic units, 375 proteolytic units;

Excipients: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, crospovidone, hypromellose, colloidal anhydrous silicon dioxide, magnesium stearate;

Coating: polyethylene glycol, dry mixture "Acryl-eze white" containing talc, titanium dioxide (E 171), methacrylate copolymer, sodium lauryl sulfate, sodium carbonate, colloidal anhydrous silicon dioxide.

Pharmaceutical form. Enteric-coated tablets.

Main physicochemical properties: enteric-coated, round-shaped, biconvex tablets of white or almost white color, with a slight specific odor. Two layers are visible upon cross-section.

Pharmacotherapeutic group.

Digestive enzymes and other agents improving digestion. Pancreatic enzyme preparations.

ATC code A09AA02.

Pharmacological properties.

Pharmacodynamics.

Pancreatin is a pancreatic enzyme that aids digestion. The drug contains the main pancreatic digestive enzymes: lipase, α-amylase, and proteases (trypsin and chymotrypsin), which exert lipolytic, amylolytic, and proteolytic actions, enhancing the breakdown of proteins, carbohydrates, and fats in the duodenum and proximal part of the small intestine, thereby promoting their more complete absorption. The decisive factors are the enzymatic activity of lipase and the content of trypsin.

Pharmacokinetics.

The coating covering the tablets does not dissolve under the action of gastric juice and protects the enzymes from inactivation by gastric acid. The coating dissolves only under the influence of the neutral or slightly alkaline environment of the small intestine, resulting in the release of enzymes.

Clinical characteristics.

Indications.

Diseases associated with impaired digestion due to insufficient secretion of pancreatic digestive enzymes, such as chronic pancreatitis.

Conditions following simultaneous resection of the stomach and small intestine, conditions after pancreatectomy.

Functional acceleration of food passage through the intestine.

Meteorism, dyspepsia, intestinal disorders.

Preparation for radiological or ultrasound diagnostic examinations of abdominal organs (intestinal degassing).

To improve digestion in individuals with normal gastrointestinal tract function in cases of masticatory dysfunction, consumption of hard-to-digest plant-based, fatty or unfamiliar food, or overeating.

Contraindications.

Hypersensitivity to porcine-derived pancreatin or to excipients of the drug. Acute pancreatitis or acute exacerbation of chronic pancreatitis, acute hepatitis, mechanical jaundice. The drug should not be used in patients with obstructive intestinal obstruction.

Interaction with other medicinal products and other forms of interaction.

When using preparations containing pancreatin, absorption of folic acid may be reduced, which may require additional supplementation. Prolonged use of pancreatin may reduce iron absorption.

Cimetidine may enhance the effect of the drug.

Pancreatin may reduce the effect of the oral hypoglycemic antidiabetic drugs acarbose and miglitol; therefore, they should not be used simultaneously.

Concomitant use with antacids containing calcium carbonate and/or magnesium hydroxide, tannins, or alcohol-containing preparations reduces the effectiveness of pancreatin.

Special precautions for use

The drug is contraindicated in acute pancreatitis or acute exacerbation of chronic pancreatitis. During recovery period or diet expansion, the drug may be used only as prescribed by a physician.

If unusual abdominal discomfort or changes in symptoms occur, as a precautionary measure, patients should undergo examination to exclude intestinal damage, especially if the patient is receiving a dose exceeding 10,000 IU EPI lipase per kilogram of body weight per day.

To prevent formation of uric acid stones, urinary uric acid levels should be monitored.

In patients receiving high-dose or long-term pancreatin therapy, cases of fibrosing colonopathy with narrowing of the colon, intestinal obstruction, and constipation have been observed. Therefore, patients should consult their physician if symptoms persist, worsen, or if any new symptoms develop.

Tablets should not be chewed or crushed, as this may cause premature release of enzymes, potentially leading to irritation of the oral mucosa and/or reduced enzymatic activity. The drug should not be administered to patients with rare hereditary disorders of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

Use with caution in patients with renal impairment, hyperuricemia, or allergy to porcine proteins.

The drug contains purines in its composition; therefore, it should be used cautiously in patients with the following conditions:

• Gout;
• Hyperuricemia;
• Renal impairment.

Use during pregnancy or breastfeeding

The safety of pancreatin use in pregnant women has not been established. Therefore, use of Festal® NEO 10,000 during pregnancy should be avoided.

The safety of pancreatin use in breastfeeding women has not been established; therefore, use of the drug should be avoided during breastfeeding.

Ability to influence reaction rate while driving or operating machinery
No precautions are necessary.

Method of Administration and Dosage.

The dose of Festal® NEO 10,000 depends on the deficiency of pancreatic enzymes in the duodenum and is determined individually. In the absence of other recommendations and when consuming hard-to-digest plant-based food, fatty or unusual food, take 1–2 tablets as a single dose. In other cases, when digestive disturbances occur, the recommended single dose is 2–4 tablets. If necessary, the dose may be increased. Dose escalation aimed at reducing disease symptoms, such as steatorrhea or symptoms of chronic pancreatitis, should be performed only under physician supervision. The daily dose of lipase should not exceed 15,000–20,000 IU Ph.Eur. per 1 kg of body weight.

Take tablets during meals, swallowing them whole with a sufficient amount of liquid, for example, a glass of water.

The duration of treatment depends on the course of the disease and is determined by the physician individually.

Children.

Festal® can be used in children aged 3 years and older. The physician determines the dosage and duration of treatment for children. The drug should be administered in a daily dose necessary to normalize bowel movements, with each main meal, but not exceeding 1,500 IU of lipase per 1 kg of body weight in children under 12 years of age. For children aged 12 years and older, the daily enzyme dose should not exceed 15,000–20,000 IU Ph.Eur. of lipase per 1 kg of body weight.

Overdose.

Overdose may lead to an increase in adverse effects. When extremely high doses of other pancreatic enzyme powder preparations were taken, hyperuricemia and hyperuricosuria have been observed; in children – constipation. Treatment is symptomatic: discontinuation of the drug and adequate hydration.

Side effects.

The following classification is used to assess the frequency of adverse reactions: very common: ≥ 1/10; common: ≥ 1/100 and < 1/10; uncommon: ≥ 1/1000 and < 1/100; rare: ≥ 1/10000 and < 1/1000; very rare: < 1/10000; frequency not known (cannot be estimated from the available data).

Cardiovascular system.

Frequency not known: tachycardia.

Immune system.

Very rare: immediate-type allergic reactions (skin rash, urticaria, sneezing, lacrimation, bronchospasm, dyspnea).

Frequency not known: anaphylactic reactions, including urticaria and angioneurotic edema.

Gastrointestinal system.

Very rare: gastrointestinal allergic reactions (diarrhea, abdominal pain, nausea, changes in stool characteristics). Possible occurrence of epigastric discomfort, flatulence, intestinal colic, intestinal obstruction.

Frequency not known: cases of intestinal obstruction and constipation have been reported, especially with high doses of pancreatin enzymes. Formation of strictures in the ileocecal region and ascending colon has been described after administration of pancreatic powder in high doses. Vomiting, irritation of the oral mucosa. Abdominal pain, diarrhea, perianal irritation, constipation, extensive intestinal stenosis, fibrosing colonopathy.

Metabolism and nutrition disorders.

Frequency not known: hyperuricemia.

The use of very high doses of the drug may lead to increased blood uric acid levels.

Skin.

Frequency not known: hyperemia, pruritus.

Urinary and reproductive system.

Frequency not known: hyperuricosuria, especially when high doses of the drug are used. Increased excretion of uric acid in urine is possible, especially with high-dose therapy. To prevent the formation of uric acid stones in such patients, urinary uric acid levels should be monitored.

General disorders.

Frequency not known: sensation of heat, general weakness.

Reporting of suspected adverse reactions

It is very important to report suspected adverse reactions that occur after the drug has been marketed, as this allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are encouraged to report any suspected adverse reactions via the national pharmacovigilance system.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging. No. 20 (20 × 1): 20 tablets in a blister, 1 blister per cardboard box.

Prescription status. Over-the-counter.

Manufacturer.

LLC "Farmeks Group".

Manufacturer's address.

100 Shevchenka Street, Boryspil, Kyiv region, 08301, Ukraine.

Marketing Authorization Holder.

LLC "Opella HealthCare Ukraine", Ukraine.

Address of the Marketing Authorization Holder.

48-50A Zhylianska Street, Kyiv, 01033, Ukraine.