Kreazim 20000 hard enteric-coated capsules 20 pcs.

Composition

active ingredient: 1 capsule contains pancreatin in enteric-coated granules with enzymatic activities of not less than: 20,000 lipolytic U Ph. Eur., 16,000 amylolytic U Ph. Eur., 1200 proteolytic U Ph. Eur.;

excipients: polyethylene glycol 4000 (macrogol 4000), methacrylate copolymer dispersion, simethicone, talc, triethyl citrate;

capsule composition: titanium dioxide (E 171), sunset yellow FCF (E 110), carmoisine (E 122), diamond black BN (E 151), iron oxide (E 172), gelatin.

Release form

The capsules are hard, enteric-coated.

Pharmacodynamics. Kreazim is an enzyme preparation of animal origin. Improves digestive processes. The therapeutic effect of the drug is based on the activity of pancreatic enzymes lipase, amylase and protease, which are part of pancreatin and ensure the digestion of fats, carbohydrates and proteins, contributing to a more complete absorption of nutrients in the small intestine.

The special dosage form of the drug avoids a decrease in enzyme activity due to inactivation by gastric juice.

Pharmacokinetics. The drug granules contained in the capsule have an acid-resistant coating, mix evenly with the contents of the stomach and enter the duodenum. Rapid release and activation of enzymes begins in the small intestine (at pH 5.5), where the coating of the granules disintegrates.

Replacement therapy for pancreatic exocrine insufficiency in the following conditions: chronic pancreatitis, pancreatectomy, pancreatic cancer, obstruction of the pancreatic or common bile duct (e.g. by a tumor), Shwachman-Diamond syndrome, other diseases accompanied by exocrine pancreatic insufficiency.

Hypersensitivity to pancreatin of animal origin or any other component of the drug; acute inflammation of the pancreas in the early stages, exacerbation of chronic pancreatitis.

The dosage of the drug is based on the individual needs of the patient and depends on the degree of digestive disorders and the composition of the food.

If the single dose is more than one capsule, it is recommended to take half or a third of the total number of capsules at the beginning of a meal and the rest during the meal. If the single dose is 1 capsule, it should be taken during a meal.

Capsules with granules are swallowed without chewing and washed down with a sufficient amount of liquid (about 100 ml). If the capsule cannot be swallowed whole (children and the elderly), it can be opened and the granules added to liquid food that does not require chewing, or to a liquid with a pH of 5.0 (for example, grated apple, yogurt). This mixture should be taken immediately and not stored.

During treatment with Kreazim 10,000 and 20,000, it is very important to drink enough fluids, especially during periods of increased fluid loss. Fluid deficiency can worsen constipation.

Dosage in other types of exocrine pancreatic insufficiency. The dose should be selected individually, depending on the degree of digestive disorders and the fat content of the food.

The usual starting dose is 10,000-20,000 IU of lipase with each main meal. However, it is possible that some patients may require higher doses to eliminate steatorrhea and maintain adequate nutritional status. Therefore, the dose for administration during main meals (breakfast, lunch or dinner) may be 20,000-70,000 IU of lipase, and with additional light meals between main meals – 5,000-20,000 IU of lipase.

If the dose per dose is a multiple of 20,000 U of lipase, it is more convenient to use the drug Kreazim 20,000, which contains 20,000 U of lipase in one capsule.

The duration of treatment can vary from several days (in case of nutritional disorders due to errors in the diet) to several months and even years (if permanent replacement therapy is necessary).

Use during pregnancy and breastfeeding. Due to the lack of clinical data on the effect of pancreatic enzymes on the course of pregnancy, the drug should be prescribed with caution during pregnancy. Animal studies have shown no signs of absorption of pancreatic enzymes. Thus, the possibility of toxic effects on reproductive function and fetal development is excluded.

Use during pregnancy and breastfeeding is possible if, in the opinion of the doctor, the expected positive effect for the mother outweighs the potential risk to the fetus or child.

Children. The drug is not used in children.

Ability to influence the reaction speed when driving vehicles or working with other mechanisms. There is no data on the negative impact of Kreazim on the ability to drive vehicles or work with other mechanisms.

When taking other pancreatin preparations in very high doses, hyperuricemia and hyperuricuria were noted.

Gastrointestinal: abdominal pain, constipation, change in stool pattern, diarrhea, vomiting and nausea.

In order to exclude colonic involvement, all unusual symptoms or changes in the abdominal cavity should be monitored, especially when the patient is taking the drug at a dose of 10,000 U of lipase / kg / day.

Skin and subcutaneous tissue disorders: Allergic skin reactions may occur, including rash, itching, urticaria, and skin hyperemia.

Immune system disorders: hypersensitivity reactions, including bronchospasm.

General disorders: asthenia.

With simultaneous use of pancreatin with iron preparations, a decrease in the absorption of the latter is possible.

There are no reports of interactions with other drugs or other types of interactions.

At a temperature not exceeding 25 °C.