Kreon 25000 capsules are enteric-soluble 25000 units, 50pcs

Composition

1 capsule contains:

Active ingredient:  

pancreatin — 300 mg, which corresponds to:

• 25000 UNITS of Heb. F. lipase,
• 18000 UNITS of Heb. F. amylase,
• 1000 UNITS of Heb. F. protease.

Auxiliary substances:

macrogol 4000-75.00 mg,

hypromellose phthalate-112.68 mg,

dimethicone 1000-2.69 mg,

cetyl alcohol-2.37 mg,

triethyl citrate-6.26 mg.

Solid Gelatin Capsule:

gelatin — 95,08 mg,

dye iron oxide red (E 172) — 0,46 mg,

dye iron oxide yellow (E 172) — 0.08 mg,

titanium dioxide (E 171) and 0.19 mg,

sodium lauryl sulfate and 0.19 mg

Pharmacological action

Pharmacodynamics

Enzyme preparation that improves the process of digestion in adults and children, and thereby significantly reduce the symptoms of enzyme deficiency of the pancreas, including pain in the abdomen, flatulence, changes in the frequency and stool consistency.

Pancreatic enzymes, which are part of the drug, facilitate the breakdown of proteins, fats, carbohydrates, which leads to their complete absorption in the small intestine. Kreon ® 25000 contains porcine pancreatin in the form of minimicrospheres coated with an enteric (acid-resistant) coating, in gelatin capsules. The capsules quickly dissolve in the stomach, releasing hundreds of minimicrospheres.

This principle is designed for simultaneous passage (entry) of minimicrospheres with food from the stomach to the intestines and thorough mixing of minimicrospheres with intestinal contents, and, ultimately, better distribution of enzymes after their release inside the intestinal contents.

When the minimicrospheres reach the small intestine, the intestinal membrane is rapidly destroyed (at pH > 5.5), and enzymes with lipolytic, amylolytic, and proteolytic activity are released, which leads to the breakdown of fats, carbohydrates, and proteins. The resulting substances are then either absorbed directly or further broken down by intestinal enzymes.

Pharmacokinetics

In animal studies, the lack of absorption of non-cleaved enzymes was demonstrated, so that 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.

By their chemical structure, they are proteins and, therefore, when passing through the gastrointestinal tract, enzyme preparations are broken down until absorption occurs in the form of peptides and amino acids.

Indications

Substitution therapy for exocrine (enzyme) pancreatic insufficiency in children and adults, caused by a decrease in the enzymatic activity of the pancreas due to a violation of the production, regulation of secretion, delivery of pancreatic enzymes or increased their destruction in the intestinal lumen, which is caused by various diseases of the gastrointestinal tract, and is most often found in:

cystic fibrosis;

chronic pancreatitis;

after pancreatic surgery;

after gastrectomy;

pancreatic cancer;

partial resection of the stomach (for example, Billroth II);

obstruction of the pancreatic ducts or common bile duct (for example, due to a neoplasm);

Schwachman-Diamond syndrome;

condition after an attack of acute pancreatitis and resumption of nutrition.

To avoid complications, use only after consulting a doctor.

Use during pregnancy and lactation

Pregnancy

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

No absorption of porcine pancreatic enzymes has been detected in animal studies, so toxic effects on reproductive function and fetal development are not expected. Prescribe the drug to pregnant women with caution if the intended benefit to the mother exceeds the potential risk to the fetus.

Breast-feeding period

Based on animal studies that did not reveal a systematic negative effect of pancreatic enzymes, no harmful effects of the drug on an children through breast milk are expected.

During breast-feeding, you can take pancreatic enzymes. If it is necessary to take it during pregnancy or lactation, the drug should be taken in doses sufficient to maintain an adequate nutritional status.

Contraindications

Hypersensitivity to any of the components of the drug.

Side effects

Disorders of the gastrointestinal tract

Very common (≥1/10): abdominal pain.

Often (≥1/100,

Frequency unknown: strictures of the ileum, caecum 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 experienced with placebo.

Strictures of the ileum, caecum and colon (fibrosing colonopathy) have been observed in patients with cystic fibrosis who received high doses of pancreatin preparations (see section “Special instructions”).

Skin and subcutaneous tissue disorders

Infrequently (≥1/1000,

Frequency unknown: pruritus, urticaria.

Immune system disorders

Frequency unknown: hypersensitivity (anaphylactic reactions).

Allergic reactions were observed mainly from the skin, but other manifestations of allergies were also noted. Reports of these side effects were received during the post-marketing period and were spontaneous. The available data are not sufficient to accurately estimate the frequency of cases.

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

Interaction

No interaction studies have been conducted.

How to take, course of use and dosage

Inside

Doses of the drug are selected individually, depending on the severity of the disease and the composition of the diet.

Capsules should be taken during or immediately after each meal (including a light snack), swallowed whole, not broken or chewed, with a sufficient amount of liquid.

If swallowing is difficult (for example, in young children or elderly patients) capsules are carefully opened, and minimicrospheres are added to soft food that does not require chewing and has a sour taste (pH < 5.5), or taken with a liquid that also has a sour taste (pH 

For example, minimicrospheres can be added to applesauce, yogurt, or fruit juice (apple, orange, or pineapple) with a pH of less than 5.5. It is not recommended to add the contents of capsules to hot food. Any mixture of minimicrospheres with food or liquid should not be stored and should be taken immediately after preparation.

Crushing or chewing the minimicrospheres, or mixing them with food or liquids with a pH greater than 5.5, can destroy their protective intestinal membrane. This can lead to an early release of enzymes in the oral cavity, reduced effectiveness, and irritation of the mucous membranes. It is necessary to make sure that there are no minimicrospheres left in the mouth.

It is important to ensure that the patient’s fluid intake is sufficient at all times, especially in cases of increased fluid loss. Inadequate fluid intake can cause constipation to occur or worsen.

Dosage for adults and children with cystic fibrosis

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

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

In 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/g of fat consumed.

Dosage for other conditions accompanied by exocrine pancreatic insufficiency

The dose should be adjusted according to the individual characteristics of the patient, which include the degree of digestive insufficiency and the fat content in the food. The dose that the patient requires along with the main meal varies from 25,000 to 80,000 units of lipase, and during a light snack — half of the individual dose.

In children, the drug should be used in accordance with the doctor’s prescription.

Overdose

Symptoms:  hyperuricosuria and hyperuricemia.

Treatment:  drug withdrawal, symptomatic therapy.

Special instructions

In patients with cystic fibrosis treated with high doses of pancreatin preparations, strictures of the ileum, cecum and colon (fibrosing colonopathy) are described. As a precautionary measure, if unusual symptoms or changes in the abdominal cavity occur, a medical examination is necessary to rule out fibrosing colonopathy, especially in patients who take the drug at a dose of more than 10,000 lipase units/kg per day.

Influence on the ability to drive a car and other mechanisms

The use of Kreon ® 25000 does not affect or has a slight effect on the ability to drive a car and mechanisms.

Storage conditions

Store at a temperature not exceeding 25 °C in tightly closed packaging. Keep out of reach of children!

Shelf

life is 3 years. Shelf life after the first opening of the bottle is 3 months. Do not use after the expiration date indicated on the package.

Active ingredient

Pancreatin

Dosage form

Capsules