Kreon^® 10000 (Capsules) Instructions for Use

Marketing Authorization Holder

Abbott Laboratories, GmbH (Germany)

Manufactured By

Abbott Laboratories, GmbH (Germany)

Or

Veropharm, JSC (Russia)

Packaging and Quality Control Release

ABBOTT LABORATORIES, GmbH (Germany)

Or

VEROPHARM, JSC (Russia)

ATC Code

A09AA02 (Polyenzyme preparations (incl. lipase, protease))

Active Substance

Pancreatin

Dosage Form

Kreon® 10000

Enteric-coated capsules 150 mg (10000 IU Eur.Ph.): 20, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated capsules hard gelatin, size No. 2, consisting of a brown opaque cap and a transparent colorless body; the capsule contents are light brown granules.

Excipients: macrogol 4000 – 37.5 mg.

Coating of Kreon Minimicrospheres^® granules: hypromellose phthalate – 56.34 mg, dimethicone 1000 – 1.35 mg, cetyl alcohol – 1.18 mg, triethyl citrate – 3.13 mg.

Composition of the hard gelatin capsule: gelatin – 60.44 mg, iron oxide red (E172) – 0.23 mg, iron oxide yellow (E172) – 0.05 mg, iron oxide black (E172) – 0.09 mg, titanium dioxide (E171) – 0.07 mg, sodium lauryl sulfate – 0.12 mg.

20 pcs. – white high-density polyethylene bottles (1) – cardboard packs.
50 pcs. – white high-density polyethylene bottles (1) – cardboard packs.
100 pcs. – white high-density polyethylene bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Enzyme preparation

Pharmacotherapeutic Group

Digestive enzyme agent

Pharmacological Action

Enzyme medicinal product. It improves digestion processes in adults and children, thereby significantly reducing the symptoms of pancreatic enzyme deficiency, including abdominal pain, flatulence, changes in stool frequency and consistency.

The pancreatic enzymes included in this product facilitate the breakdown of proteins, fats, and carbohydrates, leading to their complete absorption in the small intestine.

Pharmacokinetics

Animal studies have demonstrated the absence of absorption of undigested enzymes, therefore classical pharmacokinetic studies have not been conducted.

Medicinal products containing pancreatic enzymes do not require absorption to exert their effects.

On the contrary, the full therapeutic activity of these products is realized in the lumen of the gastrointestinal tract.

By their chemical structure, they are proteins and, therefore, when passing through the gastrointestinal tract, enzyme preparations are broken down until they are absorbed as peptides and amino acids.

Indications

Replacement therapy for exocrine pancreatic insufficiency in children and adults caused by various gastrointestinal diseases, and most commonly occurring in

• Cystic fibrosis;
• Chronic pancreatitis;
• After pancreatic surgery;
• After gastrectomy;
• Pancreatic cancer;
• Partial gastric resection (e.g., Billroth II);
• Obstruction of pancreatic ducts or common bile duct (e.g., due to neoplasm);
• Shwachman-Diamond syndrome;
• Condition after an attack of acute pancreatitis and resumption of enteral or oral nutrition.

To improve food digestion in patients with normal gastrointestinal function in cases of dietary errors (consumption of fatty foods, overeating, irregular meals, etc.).

ICD codes

Dosage Regimen

Take orally during or immediately after each meal (including a light snack).

The dose is selected individually, depending on the severity of the disease and the composition of the diet.

It is important to ensure adequate constant fluid intake by the patient, especially with increased fluid loss.

Inadequate fluid intake can lead to or worsen constipation.

Cystic fibrosis

The dose for adults and children depends on body weight and should be at the beginning of treatment 1000 lipase units/kg for each meal for children under 4 years of age, and 500 lipase units/kg during a meal for children over 4 years of age and adults.

The dose should be determined depending on the severity of the disease symptoms, the results of steatorrhea control and the maintenance of an adequate nutritional status.

For most patients, the dose should remain less than or not exceed 10,000 lipase units/kg of body weight per day or 4,000 lipase units/gram of fat consumed.

Administration via gastrostomy tube

If medically indicated, this product can be administered through a gastrostomy tube.

Other conditions accompanied by exocrine pancreatic insufficiency

The dose should be established taking into account the individual characteristics of the patient, which include the degree of digestive insufficiency and the fat content in the food.

The dose required by the patient with a main meal varies from 25,000 to 80,000 lipase units, and during a light snack – half of the individual dose.

The dose to improve food digestion in patients with normal gastrointestinal function in cases of dietary errors depends on body weight and fat content in food, varies from 10,000 to 20,000 lipase units per dose.

In children, this product should be used as prescribed by a doctor.

Adverse Reactions

Gastrointestinal disorders very common (≥1/10) – abdominal pain*; common (≥1/100, <1/10) – nausea, vomiting, constipation, flatulence, diarrhea*; frequency unknown – ileal, cecal and colonic strictures (fibrosing colonopathy).

* Gastrointestinal disorders are mainly associated with the underlying disease. The frequency of such adverse reactions as abdominal pain and diarrhea was lower or similar to that when using placebo.

Strictures of the ileum, cecum and colon (fibrosing colonopathy) have been observed in patients with cystic fibrosis receiving high doses of pancreatin preparations.

Skin and subcutaneous tissue disorders uncommon (≥1/1000, <1/100) – rash; frequency unknown – pruritus, urticaria.

Immune system disorders frequency unknown – hypersensitivity (anaphylactic reactions).

Allergic reactions were observed mainly from the skin, but other manifestations of allergy were also noted.

Reports of these side effects were received during post-marketing use and were spontaneous.

For an accurate assessment of the frequency of cases, the available data are insufficient.

No specific adverse reactions were noted when used in children. The frequency, type and severity of adverse reactions in children with cystic fibrosis were similar to those in adults.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients included in the dosage form.

Use in Pregnancy and Lactation

Pregnancy

There are no clinical data on the treatment of pregnant women with preparations containing pancreatic enzymes.

Animal studies have not revealed absorption of pancreatic enzymes of porcine origin, so toxic effects on reproductive function and fetal development are not expected.

This product should be prescribed to pregnant women with caution if the intended benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding period

Based on animal studies, during which no systemic negative effects of pancreatic enzymes were identified, no harmful effects of the drug on the breastfed infant are expected.

Pancreatic enzymes can be taken during breastfeeding.

If it is necessary to take during pregnancy or during breastfeeding, this product should be taken in doses sufficient to maintain an adequate nutritional status.

Pediatric Use

In children, this product should be used as prescribed by a doctor.

Special Precautions

Strictures of the ileum, cecum and colon (fibrosing colonopathy) have been described in patients with cystic fibrosis receiving high doses of pancreatin preparations.

As a precaution, if unusual symptoms or changes in the abdominal cavity appear, a medical examination is necessary to exclude fibrosing colonopathy, especially in patients who are taking the drug at a dose of more than 10,000 lipase units/kg of body weight/day.

To avoid complications, this product should be used only after consultation with a doctor.

Effect on the ability to drive vehicles and mechanisms

The use of this product does not affect or has an insignificant effect on the ability to drive vehicles and mechanisms.

Drug Interactions

No studies on interaction with other medicinal products have been conducted.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.