Description
Pharmacological action
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 is designed to thoroughly mix 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 enteric membrane collapses rapidly (at pH> 5.5), enzymes with lipolytic, amylolytic and proteolytic activity are released, which leads to the breakdown of fats, carbohydrates and proteins.
The resulting cleavage of the substance is then either directly absorbed or further hydrolyzed by intestinal enzymes.
Indications
Replacement therapy for exocrine pancreatic insufficiency in children and adults due to various diseases of the gastrointestinal tract and most common in: cystic fibrosis after pancreatic surgery after pancreatic cancer of the pancreas (for example, pancreatic cancer of the pancreas, e.g. ) obstruction of the ducts of the pancreas or common bile duct (for example, due to neoplasm) Schwachman Dai syndrome Monda condition after an attack of acute pancreatitis and the resumption of nutrition
In order to avoid complications, use onlyafter consultation with a doctor.
Contraindications
Hypersensitivity (including pork intolerance), acute pancreatitis, exacerbation of chronic pancreatitis.
Directions for use
Capsules are taken orally, washed down with water.
Take half the 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 1 to 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.
Specific instructions
Icritic, ileum, and colon strictures (fibrosing colonopathy) have been described in patients with cystic fibrosis who received high doses of pancreatin preparations.
As a precaution, if unusual symptoms or abdominal changes 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.
Like all currently used preparations of pork pancreatin, Creon ® 10,000 is made from the pancreatic tissue of pigs specially grown for food.
Although the likelihood of transferring 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.
Side effects
Disorders of the gastrointestinal tract Very often ( 1/10): pain in the abdomen. Often ( 1/100, less than 1/10): nausea, vomiting, constipation, bloating, diarrhea. Frequency is unknown: ileum, cecum, and colon strictures (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.
Structures of the ileum, cecum, and colon (fibrosing colonopathy) were observed in patients with cystic fibrosis who received high doses of pancreatin preparations.
Disorders of the skin and subcutaneous tissue: Infrequently ( 1/1000, less than 1/100): rash. Frequency unknown: pruritus, urticaria.
Immune System Disorders: Unknown frequency: Hypersensitivity (anaphylactic reactions).
Allergic reactions were observed mainly from the skin, but there were also other manifestations of allergies.
Messages about these side effects were received during post-marketing use and were spontaneous. There is insufficient data to accurately assess the incidence 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.
Overdose
Symptoms: hyperuricosuria and hyperuricemia. Treatment: drug withdrawal, symptomatic therapy.
Storage conditions
Store at a temperature not exceeding 25 ° C in tightly closed packaging.
Keep out of the reach of children!
Conditions for dispensing from pharmacies
Without a prescription
dosage form
kapsul
