Product Overview

Structure

1 capsule contains:

active substance:

pancreatin 150 mg;

Excipients:

macrogol 4000,

liquid paraffin

hypromellose phthalate,

Dimethicone 1000

dibutyl phthalate;

capsule shell composition:

iron oxide red (E172),

iron oxide yellow (E172),

iron oxide black (E172),

titanium dioxide (E171),

sodium lauryl sulfate,

gelatin

Indications

Substitution therapy for exocrine pancreatic insufficiency in children and adults, due to a variety of diseases of the gastrointestinal tract and most common with:

cystic fibrosis
chronic pancreatitis
after pancreatic surgery
after gastrectomy
pancreatic cancer
partial gastrectomy (e.g., Billroth II)
obstruction of the ducts of the pancreas or common bile duct (for example, due to neoplasm)
Schwachman – Diamond syndrome
condition after an attack of acute pancreatitis and the resumption of nutrition

To avoid complications, use only after consulting a doctor.

Recommendations for use

Capsules are taken orally, washed down with water. Take half a dose or a third of it at the beginning of the meal, the rest - during.

If swallowing is difficult, the capsule is carefully opened, and the contents are consumed with liquid or liquid food (the mixture cannot be stored). Crushing or chewing the contents of the capsule, or taking it with food with a pH above 5.5, is prohibited.

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

It is recommended to prescribe at the beginning of treatment 1st-2 capsules during each main meal, one capsule during each snack. An effective daily dose is approximately 4 to 15 capsules.

In cases of cystic fibrosis in children under 4 years of age, the dose for each meal should not exceed 500 PIECES of Ph. Eur./kg, and for older children - 1000 PIECES Ph. Eur./kg

During the course of taking the drug, it is necessary to ensure a constant sufficient intake of fluids.

Contraindications

Hypersensitivity (including pork intolerance), acute pancreatitis, exacerbation of chronic pancreatitis.

Side effects

Gastrointestinal Disorders

Very often (≥1 / 10): pain in the abdomen. Often (≥1 / 100, less than 1/10): nausea, vomiting, constipation, bloating, diarrhea. Frequency is unknown: strictures of the ileum, cecum, and colon (fibrosing colonopathy).

Gastrointestinal disorders are mainly associated with the underlying disease. The incidence of adverse reactions such as abdominal pain and diarrhea was lower or similar to that with placebo. Iliac, cecum, and colon strictures (fibrosing colonopathy) were observed in patients with cystic fibrosis who received high doses of pancreatin.

Disorders of the skin and subcutaneous tissue: Infrequently (≥1 / 1000, less than 1/100): rash. Frequency unknown: pruritus, urticaria.

Disorders from the immune system: Frequency unknown: hypersensitivity (anaphylactic reactions).

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

Messages about these side effects were received during post-marketing use and were spontaneous. There is insufficient data to accurately assess the frequency of cases.

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

Interaction

Studies on the interaction of the drug Kreon® 10 000 with other drugs have not been conducted.

Overdose

Symptoms: hyperuricosuria and hyperuricemia.

Treatment: drug withdrawal, symptomatic therapy.

Description

Creon is an enzyme preparation that improves digestion. Pancreatic enzymes, which are part of the drug, facilitate the breakdown of proteins, fats and carbohydrates, which leads to their complete absorption in the small intestine.

Creon® 10000 contains pork pancreatin in the form of minimicrospheres, enteric coated (acid resistant), in gelatin capsules. Capsules dissolve quickly in the stomach, releasing hundreds of minimicrospheres.

This principle was developed with the aim of thoroughly mixing minimicrospheres with intestinal contents, and, ultimately, better distribution of enzymes after they are released inside the intestinal contents. When the minimicrospheres reach the small intestine, the enteric membrane rapidly collapses (at pH> 5.5), and enzymes are released with lipolytic, amylolytic and proteolytic activity, which leads to the breakdown of fats, carbohydrates and proteins.

The substances obtained as a result of cleavage are then either absorbed directly or undergo further hydrolysis by intestinal enzymes.

Functional Features

In animal studies, a lack of absorption of intact (non-split) enzymes was demonstrated, as a result of which classical pharmacokinetic studies were not conducted.

Drugs containing pancreatic enzymes do not require absorption to manifest their effects. On the contrary, the therapeutic activity of these drugs is fully realized in the lumen of the gastrointestinal tract.

According to their chemical structure, they are proteins and, therefore, when passing through the gastrointestinal tract, they undergo proteolytic cleavage until they are absorbed in the form of peptides and amino acids.

Special instructions

In patients with cystic fibrosis who received high doses of pancreatin preparations, strictures of the ileum, cecum, and colon (fibrosing colonopathy) are described.

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

Like all currently used preparations of pork pancreatin, Creon® 10 000 is made from the pancreatic tissue of pigs specially grown for human consumption.

Although the probability of transmission of an infectious agent to humans has been minimized by checking and inactivating certain viruses during production, there is a theoretical risk of transmission of a viral disease, including diseases caused by new or unknown viruses.

The presence of swine viruses that can infect humans cannot be completely ruled out. However, over a long period of time using pig pancreatic extracts, not a single case of transmission of an infectious disease has been reported.