Kreon 25000, enteric soluble capsules 25000 units 20pcs

Composition

One capsule contains:

Active ingredient:

pancreatin 300 mg,

Auxiliary substances:

macrogol 4000-75 mg,

hypromellose phthalate-112.68 mg,

dimethicone 1000-2.69 mg,

cetyl alcohol-2.37 mg,

triethyl citrate-6.26 mg.

Composition of the shell of a hard gelatin capsule:

gelatin-95.08 mg,

iron oxide red dye (E 172) – 0.46 mg,

iron oxide yellow dye(E 172) – 0.08 mg,

titanium dioxide (E 171) – 0.19 mg,

sodium lauryl sulfate-0.19 mg

Pharmacological action

An enzyme preparation that improves digestion. Pancreatic enzymes, which are part of the drug, facilitate the digestion of proteins, fats, carbohydrates, which leads to their complete absorption.

The drug has a specially developed dosage form-a gelatin capsule containing enteric-soluble minimicrospheres. The capsules quickly dissolve in the stomach, releasing hundreds of minimicrospheres.

The goal of the multi-unit dose principle, which is implemented in this case, is to mix the minimicrospheres with the intestinal contents and ultimately better distribute the enzymes inside the intestinal contents after their release.

When the minimicrospheres reach the small intestine, their intestinal membrane is destroyed, which leads to the release of pancreatic enzymes with lipolytic, amylolytic and proteolytic activity, leading to the disintegration of fat, starch and lipid molecules.

Indications

Replacement therapy for pancreatic exocrine insufficiency in the following conditions: cystic fibrosis, chronic pancreatitis, pancreatectomy, pancreatic cancer, ductal obstruction due to neoplasms (for example, obstruction of the pancreatic ducts or common bile duct), Schwachman-Diamond syndrome, senile age.

For symptomatic treatment of digestive disorders in the following cases: conditions after cholecystectomy, partial gastric resection (Billrot-1/P), total gastrectomy, duodenal and gastrostasis, biliary obstruction, cholestatic hepatitis, cirrhosis of the liver, pathology of the terminal small intestine, excessive bacterial growth in the small intestine.

To avoid complications, use only after consulting a doctor.

Use during pregnancy and lactation

The use of Kreon® during pregnancy and lactation (breastfeeding) is possible only if the expected positive effect of therapy for the mother exceeds the possible risk to the fetus or child, due to the lack of reliable clinical data confirming the safety of the use of pancreatic enzymes in this category of patients.

Contraindications

• acute pancreatitis;
• exacerbation of chronic pancreatitis;
• hypersensitivity to porcine pancreatin and other components of the drug.

Side effects

When evaluating data obtained in clinical trials, the overall incidence of adverse reactions associated with the use of pancreatin was similar to that with placebo.

From the digestive system: often-abdominal pain; in some cases – constipation, changes in stool, diarrhea, nausea, vomiting.

Allergic reactions: in some cases – skin manifestations, hypersensitivity reactions.

Interaction

No studies were conducted

How to take, course of use and dosage

The drug is taken orally, it is recommended to take 1/2 or 1/3 of a single dose at the beginning of a meal, and the rest – during meals. The dose is determined individually, depending on the severity of the disease and the composition of the diet. Capsules or minimicrospheres should be swallowed whole, without breaking them or chewing them, with a sufficient amount of water.

If swallowing is difficult (for example, in young children or senile patients) capsules are carefully opened, and minimicrospheres are added to liquid food (pH<5) that does not require chewing, or taken with liquid (pH Any mixture of minimicrospheres with food or liquid should not be stored and should be taken immediately after preparation. It is important to ensure a sufficient constant intake of fluids, especially with increased fluid loss.

Inadequate fluid intake can lead to increased constipation. Crushing or chewing minimicrospheres, as well as adding them to food with a pH >5.5 leads to the destruction of their shell, which protects against the action of gastric juice.

In cystic fibrosis, the initial dose of lipase for children under 4 years of age is 1000 units Ph. Eur. / kg for each meal, for children over 4 years of age – 500 UNITS Ph. Eur. / kg for each meal.

The dose should be determined depending on the severity of the symptoms of the disease, the results of steatorrhea control and the maintenance of a good nutritional status.

In most patients, the lipase dose should not exceed 10,000 units Ph. Eur. / kg / day.

In other conditions accompanied by exocrine pancreatic insufficiency, the dose is set taking into account the degree of digestive insufficiency and the fat content in food.

The dose of lipase that the patient requires together with the main meal (breakfast, lunch or dinner) varies from 20,000 to 75,000 units Ph. Eur., during a light meal – from approximately 5,000 to 25,000 units Ph. Eur.

Overdose

Symptoms: hyperuricosuria and hyperuricemia.

Treatment: drug withdrawal, symptomatic therapy.

Description

Enteric-soluble solid gelatin capsules, size No. 0, with a colorless transparent body and an orange-brown opaque lid; the contents of the capsules are light brown minimicrospheres.

Special instructions

Do not use the drug inside in the early stages of acute pancreatitis. Children with cystic fibrosis who have been taking Kreon ® 25 000 for a long time should be regularly monitored by a specialist.

Ileal and caecal strictures and colitis have been reported in patients with cystic fibrosis treated with high-dose pancreatin preparations. In case-control studies, no data were obtained indicating a relationship between the occurrence of fibrosing colonopathy and the use of Kreon®.

As a precautionary measure, all unusual symptoms or changes in the abdominal cavity should be monitored to avoid damage to the colon, especially if the patient takes (based on lipase) more than 10,000 units of Ph. Eur. / kg of body weight/day.

The use of Kreon® is allowed for patients who profess Islam and Judaism. Influence on the ability to drive motor vehicles and manage mechanisms The drug does not affect the ability to drive a car and manage machines and mechanisms.

Form of production

Enteric capsules, solid gelatin

Storage conditions

At a temperature not exceeding 25 °C, in tightly closed packaging

Shelf life

1 year

Active ingredient

Pancreatin

Dosage form

Capsules