CREON 40,000 capsules №50

Dosage Form:

enteric capsules

Composition:

1 capsule contains:

Active substance: Pancreatin - 400 mg, which corresponds to:

40,000 IU Heb. lipase

25000 IU Heb. amylase, 1600 IU Heb. proteases. Excipients: macrogol 4000 - 100.00 mg, hypromellose phthalate - 150.24 mg, dimethicone 1000 - 3.59 mg, cetyl alcohol - 3.16 mg, triethyl citrate - 8.34 mg. Hard gelatin capsule: gelatin - 116.92 mg, iron dye red oxide (E 172) - 0.44 mg, iron dye yellow oxide (E 172) - 0.10 mg, iron dye black oxide (E 172) - 0.17 mg, titanium dioxide (E 171) - 0.13 mg, sodium lauryl sulfate - 0.24 mg.

Description: hard gelatin capsules number 00, consisting of brown opaque

lid and transparent colorless case.

The contents of the capsules are minimicrospheres of a light brown color.

pharmachologic effect

Pharmacotherapeutic group:

digestive enzyme agent

Pharmacodynamics

Enzyme preparation that improves the processes of digestion. Pancreatic enzymes that are part of the drug, facilitate the digestion of proteins, fats, carbohydrates, which leads to their complete absorption in the small intestine.

Creon^® 40000 contains pork Pancreatin in the form of minimicrospheres, covered with an enteric (acid-resistant) shell, in gelatin capsules. Capsules quickly dissolve in the stomach, releasing hundreds of minimicrospheres. This principle is designed to thoroughly mix minimicrospheres with intestinal contents, and, ultimately, to better distribute enzymes after they are released inside the intestinal contents. When the minimicrospheres reach the small intestine, the enteric membrane quickly collapses (at pH> 5.5), the release of enzymes with lipolytic, amylolytic and proteolytic activity occurs, which leads to the breakdown of fats, carbohydrates and proteins. The substances resulting from the cleavage are then either absorbed directly or undergo further hydrolysis by intestinal enzymes.

Pharmacokinetics

In animal studies, the absence of absorption of whole (not cleaved) enzymes was demonstrated and, as a result, classical pharmacokinetic studies were not performed.Preparations containing pancreatic enzymes do not require absorption to manifest their effects. On the contrary, the fully therapeutic activity of these drugs is realized in the lumen of the gastrointestinal tract. Moreover, in their chemical structure, they are proteins and, therefore, when passing through the gastrointestinal tract, they undergo proteolytic cleavage until they are absorbed as peptides and amino acids.

Indications for use

Replacement therapy for exocrine pancreatic insufficiency in children and adults. The insufficiency of the exocrine function of the pancreas is associated with various diseases of the gastrointestinal tract and is most often found in:

• cystic fibrosis,
• chronic pancreatitis,
• after pancreas surgery,
• after gastrectomy,
• pancreatic cancer,
• partial resection of the stomach (eg, Billroth II),
• obstruction of the pancreatic ducts or common bile duct (for example, due to neoplasm),
• Schwachman-Diamond Syndrome.

To avoid complications, use only after consulting a doctor.

Contraindications

Hypersensitivity to pancreatin of porcine origin or to any of the excipients.

Use during pregnancy and during breastfeeding

Pregnancy

Clinical data on the treatment of pregnant women with preparations containing pancreatic enzymes are not available. Animal studies have not revealed absorption of pancreatic enzymes of porcine origin; therefore, no toxic effects on reproductive function and fetal development are expected. Prescribing the drug to pregnant women should be with caution. Breastfeeding period

In animal studies, no systemic adverse effect of pancreatic enzymes during lactation was detected, therefore no adverse effect of the drug on the infant is expected. During lactation, pancreatic enzymes can be taken.

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

Dosage and administration

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 snacks), swallow whole, do not break and do not chew, drinking plenty of liquids.

If swallowing is difficult (for example, in young children or elderly patients), the capsules are gently opened, and minimicrospheres are added to soft foods (pH <5.5) that do not require chewing and have a sour taste, for example, apple sauce, or take with liquid ( pH <5.5), for example, with fruit juice. It is not recommended to add the contents of the capsules to hot food. Any mixture of minimicrospheres with food or liquid cannot be stored and should be taken immediately after preparation.

It is important to ensure that the patient receives sufficient fluid intake continuously, especially with increased fluid loss. Inadequate fluid intake can lead to or increase constipation. Dose for adults and children with cystic fibrosis

• The dose depends on body weight and should be at the beginning of treatment 1000 lipase units / kg for each meal for children under four years, and 500 lipase units / kg for meals for children older than four years.
• The dose should be determined depending on the severity of symptoms of the disease, the results of monitoring steatorrhea and maintaining adequate nutritional status.
• In most patients, the dose should remain less than or not more than 10,000 lipase units / kg body weight per day or 4000 lipase units / g of fat consumed. Dose in other conditions involving exocrine pancreatic insufficiency

The dose is selected individually depending on the degree of deficiency of digestion and the fat content in food. The dose that is required by the patient along with the main meal varies from 25,000 to 80,000 IUE Ev.F. lipase, and while taking a snack, half the individual dose.

Side effects

Disorders of the gastrointestinal tract

Often (> 1/100, <1/10): nausea, vomiting, constipation, and bloating.

Gastrointestinal disorders are mainly associated with the underlying disease. The incidence of the following adverse reactions was lower or similar to that with placebo: diarrhea (often,> 1/100, <1/10), pain in the abdomen (very often,> 1/10).

Violations of the skin and subcutaneous tissues
Infrequently (> 1/1000, <1/100): rash.
Frequency is unknown: itching, urticaria.

Immune system disorders

Frequency unknown: hypersensitivity (anaphylactic reactions). Allergic reactions were observed mainly on the part of the skin, but other manifestations of allergy were also noted. Reports of these side effects were received during post-marketing use and were spontaneous. There is not enough data available to accurately estimate the frequency of cases.

Overdose

Symptoms when taking extremely high doses: hyperuricuria and hyperuricemia. Treatment: drug withdrawal, symptomatic therapy.

Cautions

Do not use the drug inside in the early stages of acute pancreatitis.

Interaction with other drugs

Interaction studies were not conducted.

special instructions

In patients with cystic fibrosis who received high doses of pancreatin preparations, strictures of the ileum, cecum and colon (fibrosing colonopathy) have been described. In studies conducted using the case-control method, no data were obtained indicating the relationship between the occurrence of fibrosing colonopathy and the use of Creon 40,000. As a precautionary measure, unusual symptoms or changes in the abdominal cavity require a medical examination to exclude fibrosing colonopathy. , especially in patients who take the drug in a dose of more than 10,000 lipase units / kg per day.

Like all currently used preparations of porcine pancreatin, CREON 40,000 is made from pancreatic tissue of pigs, specially grown for human consumption. Although the risk of transferring an infectious agent to humans has been minimized by testing and inactivating certain viruses during production, there is a theoretical risk of transferring a viral disease, including diseases caused by new or unknown viruses. The presence of swine viruses that can infect humans cannot be completely excluded. However, for a long period of time using porcine pancreatic extracts, no cases of infectious disease transmission have been registered.

Influence on ability to drive a car and other mechanisms

The use of the drug CREON 40,000 does not affect or has a minor effect on the ability to drive a car and machinery.

Release form

Enteric capsules 40,000 IU. On 20, 50 or 100 capsules in a bottle from polyethylene of high density of white color with the screw-on cover from polypropylene with control of the first opening. Label on the bottle. On 1 bottle together with the application instruction in a pack cardboard.

Storage conditions

Store at a temperature not higher than 25 ° С, in tightly closed package. Keep out of the reach of children!