Creon capsules 10000ED, No. 50

Replacement therapy for insufficiency of exocrine pancreatic function in children and adults, caused by a decrease in the enzymatic activity of the pancreas due to impaired production, regulation of secretion, delivery of pancreatic enzymes or their increased destruction in the intestinal lumen, which is caused by various diseases of the gastrointestinal tract, and is most common in:

• cystic fibrosis;

• chronic pancreatitis;

• after surgery on the pancreas;

• after gastrectomy;

• pancreatic cancer;

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

• obstruction of the pancreatic duct 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 improve the digestion of food in patients with normal gastrointestinal tract function in cases of nutritional errors (eating fatty foods, overeating, irregular eating, etc.).

The drug is taken orally. The dose is 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 snacks), swallowed whole, do not crush or chew, and drink plenty of liquid.

If swallowing is difficult (for example, in young children or elderly patients), the capsules are carefully opened, and the minimicrospheres are added to soft foods that do not require chewing and have a sour taste (pH <5.5), or taken with a liquid that also has a sour taste (pH < 5.5). 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 the capsules to hot food. Any mixture of minimicrospheres with food or liquid should not be stored and should be taken immediately after preparation.

Grinding or chewing minimicrospheres, as well as mixing them with food or liquid with a pH of more than 5.5, can destroy their protective enteric coating. This can lead to early release of enzymes in the mouth, decreased efficiency and irritation of the mucous membranes. Make sure that no microspheres remain in the mouth.

It is important to ensure that the patient is receiving adequate and consistent fluid intake, especially when fluid loss is increased. Inadequate fluid intake can lead to or worsen constipation.

Cystic fibrosis

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

The dose should be determined depending on the severity of the symptoms of the disease, 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 / g of fat consumed.

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 indigestion and the fat content of the food. The dose required by the patient along with the main meal varies from 25,000 to 80,000 U of lipase, and during the intake of a light snack, half of the individual dose.

The dose for improving food digestion in patients with normal gastrointestinal tract function in cases of inaccuracies in nutrition depends on body weight and fat content in food, varies from 10,000 to 20,000 U of lipase per dose.

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

Enteric-soluble hard gelatin capsules, size No. 2, with a colorless transparent body and a brown opaque lid; the contents of the capsules are light brown minimicrospheres.

1 caps. pancreatin 150 mg,

which corresponds to the content: lipase 10,000 U Ph.Eur., amylase 8,000 U Ph.Eur., protease 600 U Ph.Eur.

Excipients : macrogol 4000 - 37.5 mg, hypromellose phthalate - 56.34 mg, dimethicone 1000 - 1.35 mg, cetyl alcohol - 1.18 mg, triethyl citrate - 3.13 mg.

The composition of a hard gelatin capsule: gelatin - 60.44 mg, iron dye red oxide (E172) - 0.23 mg, iron dye yellow oxide (E172) - 0.05 mg, iron dye black oxide (E172) - 0.09 mg, titanium dioxide (E171) - 0.07 mg, sodium lauryl sulfate - 0.12 mg.

• Acute pancreatitis.

• Hypersensitivity to pancreatin.

pharmachologic effect

An enzyme preparation that improves the digestive processes in adults and children, and thereby significantly reduces the symptoms of pancreatic enzyme insufficiency, including abdominal pain, flatulence, changes in the frequency and consistency of stools. Pancreatic enzymes that make up the drug facilitate the breakdown of proteins, fats, carbohydrates, which leads to their complete absorption in the small intestine.

CreonЃ 10000 contains pork pancreatin in the form of enteric-coated (acid-resistant) coated mini-microspheres in gelatin capsules. The capsules dissolve quickly in the stomach, releasing hundreds of minimicrospheres. This principle was developed with the aim of simultaneous passage (entry) of minimicrospheres with food from the stomach into the intestine and thorough mixing of minimicrospheres with intestinal contents, and, ultimately, better distribution of enzymes after their release within the intestinal contents.

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

Pharmacokinetics

In animal studies, the lack of absorption of uncleaved enzymes has been demonstrated and, as a result, classical pharmacokinetic studies have not been carried out. Preparations 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, in this regard, when passing through the gastrointestinal tract, enzyme preparations are cleaved until absorption occurs in the form of peptides and amino acids.

Side effect

When used in moderate therapeutic doses, side effects are observed in less than 1%. From the digestive system: in some cases - diarrhea, constipation, discomfort in the stomach, nausea. The causal relationship between the development of these reactions and the action of pancreatin has not been established. these phenomena refer to the symptoms of exocrine pancreatic insufficiency. Allergic reactions: in some cases - skin manifestations. From the side of metabolism: with prolonged use in high doses, hyperuricosuria may develop, in excessively high doses - an increase in the level of uric acid in the blood plasma.

Others: when using pancreatin in high doses in children, perianal irritation may occur.

Application during pregnancy and lactation

There are no clinical data on the treatment of pregnant women with preparations containing pancreatic enzymes. In the course of studies on animals, absorption of enzymes of the pancreas of porcine origin was not detected, therefore, toxic effects on reproductive function and fetal development are not expected.

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

Based on animal studies, during which no systemic negative effect of pancreatic enzymes was detected, no harmful effect of the drug on an infant when breastfeeding is expected.

Pancreatic enzymes can be taken while breastfeeding.

If necessary, during pregnancy or lactation, the drug should be taken in doses sufficient to maintain adequate nutritional status.

Application in children

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

special instructions

In patients with cystic fibrosis who received high-dose pancreatin preparations, strictures of the ileum and cecum and colon (fibrosing colonopathy) have been described. As a precautionary measure, if unusual symptoms or changes in the abdominal cavity appear, a medical examination is necessary to exclude fibrosing colonopathy, especially in patients taking the drug at a dose of more than 10,000 lipase units / kg body weight / day.

To avoid complications, the drug should be used only after consulting a doctor.

Influence on the ability to drive vehicles and mechanisms

The use of the drug CreonЃ 10000 does not affect or has a slight effect on the ability to drive a car and mechanisms.

Overdose

Symptoms: hyperuricosuria and hyperuricemia.

Treatment: drug withdrawal, symptomatic therapy.

Drug interactions

Interaction studies with other drugs have not been conducted.

Storage conditions of the drug CreonЃ 10000

The drug should be stored in a tightly closed container out of the reach of children at a temperature not exceeding 25 ? C.

Shelf life of the drug CreonЃ 10000

Shelf life is 2 years. Do not use after the expiration date printed on the package.

After the first opening of the bottle, the shelf life is 3 months.