Expiration date: 06/2025
Release form and composition:
Capsules containing enteric coated microspheres. Hard gelatin capsules No. 00, two-tone, the case is clear, colorless with brown opaque cap contents of capsules - microspheres beige.
Excipients: macrogol 4000, liquid paraffin, these phthalate, Dimethicone 1000, dibutyl phthalate.The composition of the shell capsules: iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172), titanium dioxide (E171), sodium lauryl sulfate, gelatin.20 PCs. - vials made of HDPE (1) - packs of cardboard.
50 PCs. - bottles from HDPE (1) - packs of cardboard.
100 PCs. - vials made of HDPE (1) - packs of cardboard.
Pharmacological action: Enzyme preparation that improves the process of digestion. Included in the preparation of pancreatic enzymes provide an enzymatic digestion, which leads to a significant increase in the absorption of the products of hydrolysis of proteins, fats, carbohydrates from the small intestine.The drug has a specially designed dosage form is a gelatin capsule containing enteric coated microspheres. Capsules dissolve quickly in the stomach, releasing hundreds of minimicrospheres. The purpose of the principle mnogodetnoj dose is mixing minimicrospheres with intestinal contents, and ultimately the best distribution of enzymes after their release in the intestinal content. When the microspheres reach the small intestine, the enteric coating breaks down, is released enzymes with lipolytic, amylolytic and proteolytic activity, leading to the disintegration of fats, starch and lipids.
Pharmacokinetics: In studies on animals have demonstrated the absence of absorption of whole (not split) enzymes and therefore classical pharmacokinetic studies have not been performed. Since the therapeutic activity of preparations containing pancreatic enzymes, is implemented in the lumen of the intestine, absorption is not required for the manifestation of their effects. Moreover, according to its chemical structure enzymes are proteins and, therefore, when passing through the digestive tract are subjected to proteolytic cleavage as long as they are not absorbed in the form of peptides and amino acids.
Indications: replacement therapy of exocrine insufficiency of the pancreas under the following conditions:- cystic fibrosis - chronic pancreatitis - pancreatectomy - pancreatic cancer - ductal obstruction due to neoplasm (for example, obstruction of the ducts of the pancreas or common bile duct) syndrome Shwachman-diamond - fermentopathia decrease GI function in elderly patients.For the symptomatic therapy of disorders of digestion in the following cases:- the status after cholecystectomy and partial gastrectomy (Billroth-I/II)- total gastrectomy- duodeno and gastrosis - biliary obstruction - cholestatic hepatitis - cirrhosis - pathology of the terminal part of the small intestine - excessive bacterial growth in the small intestine.
Dosing regimen: the Drug is taken orally, it is recommended to take a single dose during a meal. Dose determined individually, depending on the severity of the disease and diet. During the meal, or light snacks capsules and microspheres should be swallowed whole, without breaking them, and not liquid, squeezed enough water.When difficulty swallowing (for example, young children or elderly patients) capsules carefully opened and the microspheres added to liquid foods (pHt5.0) that does not require projivania, or take in liquid (pHt5.0). Any mixture of minimicrospheres with food or liquid to be stored and shall be used immediately after preparation.To prevent amplification of constipation it is important to ensure permanent adequate fluid intake by the patient, particularly at extreme loss of fluids.In cystic fibrosis, the initial dose of lipase to children under 4 years of age is 1000 IU Ph. Eur./kg per meal for children 4 years and older - 500 U Ph. Eur./kg for each meal.The dose should be determined depending on the severity of symptoms, the results of the control of steatorrhea and maintain good nutritional status. In most patients, the dose of lipase should not exceed 10 000 IU Ph. Eur./kg/day.To achieve adequate individual dose in addition to capsules CREON 40 000 it is possible to use drugs CREON 10,000 or CREON 25 000.At other States, accompanied by exocrine pancreatic insufficiency, the dose is set based on the degree of insufficiency of digestion and fat content in food.The patient requires the dose of lipase coming during a main meal (Breakfast, lunch or dinner) ranges from 20 000 to 75 000 UNITS of Ph. Eur., and during the light meal approximately from 5 000 to 25 000 IU Ph. Eur.In drug treatment, CREON 40 000, the average initial dose of lipase is 10 000-25 000 IU Ph. Eur. during the main meal. However, there may require higher doses to achieve a therapeutic effect. According to routine clinical practice the patient should receive with food at least 20 000-50 000 IU Ph. Eur. lipase.For dose selection should be applied Kreon 40 000 and CREON 10,000 or CREON 25 000.
Side effects: the assessment data obtained in clinical studies the overall incidence of adverse reactions associated with the use of Pancreatin was similar to that when using a placebo.From the digestive system: often - pain in the abdomen and in some cases - diarrhea, constipation, changes in stool, nausea, vomiting.Allergic reaction: in some cases, - skin reactions or hypersensitivity reactions.
Contraindications: hypersensitivity to Pancreatin of porcine origin or to other components of the drug.You should not use the drug in the early stages of acute pancreatitis.
Pregnancy and lactation: the Use of CREON 40 000 in pregnancy and lactation (breastfeeding) is possible only if the expected benefit of therapy for the mother outweighs the potential risk to the fetus or child, in connection with the lack of reliable clinical data, confirming the safety of use of pancreatic enzymes in this category of patients.
Special instructions: patients with cystic fibrosis who have received preparations of Pancreatin in high doses, described stricture ileum, cecum and colon (fibrosarcoma kolonopatii), and also colitis. The research method case-control were not shown evidence of a relationship between occurrence of fibrosarcoma kolonopatii with drug CREON 40 000.As a precaution to exclude lesions of the colon should monitor any unusual symptoms or changes in abdominal cavity, especially if the patient is taking (based on lipase) more 10 000 U Ph. Eur./kg of body weight/day.Usage of CREON 40 000 allowed patients who profess Islam and Judaism.Effects on ability to drive vehicles and management mechanismerror has no effect on the ability to drive the vehicle and to the control of machines and mechanisms.
Overdose: Symptoms: hyperuricosuria and hyperuricemia (while taking the drug in very high doses).Treatment: cancel the drug, symptomatic therapy.
Drug interactions: reports of clinically significant drug interaction Kreon 40 000 with other drugs currently available.
Terms and conditions of storage: the Drug should be stored out of reach of children at temperature not above 30°C in tightly closed container. Shelf life - 3 years.After first opening bottle shelf life - 6 months.
1 capsule contains:
Pancreatin 400 mg
with a minimum of enzymatic activity:
mrlopez 40 000 IU Ph.Eur.
mramirez 25 000 IU Ph.Eur.
embraces 1 600 IU Ph.Eur.
