Creon 10000,10000 units 50 pcs

digestive enzyme agent

ATX code:

A09AA02

Pharmacological properties

Pharmacodynamics
. An enzyme preparation, which improves digestion processes in adults and children, and thus significantly reduces symptoms of pancreatic enzymatic insufficiency, including abdominal pain, flatulence, changes in frequency and consistency of stools. Pancreatic enzymes contained in the drug facilitate digestion of proteins, fats, carbohydrates, which leads to their complete absorption in small intestine.

Creon® 10000 contains porcine pancreatin in the form of minimicrospheres coated with an enteric-soluble (acid-resistant) coating in gelatin capsules. The capsules dissolve rapidly in the stomach, releasing hundreds of minicrospheres. This principle is designed to thoroughly mix the minicrospheres with the chyme, to allow the minicrospheres and chyme from the stomach to enter the intestine at the same time, and ultimately to better distribute the enzymes once they are released within the intestinal contents.

When the minimicrospheres reach the small intestine, the enteric membrane is rapidly degraded (at pH > 5.5) and enzymes with lipolytic, amylolytic and proteolytic activity are released, leading to the breakdown of fats, carbohydrates and proteins. The resulting substances are then either directly absorbed or further broken down by intestinal enzymes.

Pharmacokinetics

In animal studies, the absence of absorption of non-cracked enzymes has been demonstrated, due to which classical pharmacokinetic studies were not conducted. Drugs containing pancreatic enzymes do not require absorption to manifest their effects. On the contrary, the therapeutic activity of the indicated drugs is fully realized in the lumen of the gastrointestinal tract.

In their chemical structure they are proteins and therefore the enzyme preparations are broken down during passage through the gastrointestinal tract until they are absorbed as peptides and amino acids.

Indications

The replacement therapy of pancreatic exocrine function insufficiency in children and adults due to a variety of gastrointestinal diseases, and most commonly found in:

Active ingredient

Composition

1 capsule contains:

The active ingredient: pancreatin – 150 mg, which corresponds to:

10000 IU of Eur.F. lipase,
8000 IU of Eur.F. amylase,
600 IU of Eur.F. protease.

Auxiliary substances: macrogol 4000 – 37.50 mg, hypromellose phthalate – 56.34 mg, dimethicone 1000 – 1.35 mg, cetyl alcohol -1.18 mg, triethyl citrate – 3.13 mg.

The solid gelatin capsule contains: gelatin 60.44 mg, iron oxide red dye (E 172) – 0.23 mg, iron oxide yellow dye (E 172) – 0.05 mg, iron oxide black dye (E 172) – 0.09 mg, titanium dioxide (E 171) – 0.07 mg, sodium lauryl sulfate 0.12 mg.

How to take, the dosage

Interaction

Special Instructions

Strictures of the ileum, cecum, and colon (fibrosing colonopathy) have been described in patients with cystic fibrosis who have received high doses of pancreatin preparations. As a precautionary measure, medical evaluation to rule out fibrosing colonopathy should be performed if unusual symptoms or abdominal changes occur, especially in patients who take the drug at doses greater than 10,000 lipase units/kg per day.

To avoid complications, use only after consulting a physician.

Injection of Creon® 10000 through a gastrostomy tube
Before using Creon® 10000 through a gastrostomy tube it is important to ensure that the syringe and tube are correctly selected for the size of the microspheres.

The administration of Creon® 10000 has no or negligible effect on the ability to drive vehicles and operate machinery.

Synopsis

Creon® is an innovative product for better digestion

Creon® contains a complex of enzymes that helps in the digestion of proteins, fats and carbohydrates. The enzymes in Creon® are identical to those produced by the human body. Creon ® supplements its own digestion, and therefore when taking the drug, the body does not stop digesting its own food.

If you have difficulty swallowing, the Creon® capsule can be opened and the minimicrospheres mixed with warm soft food. This is also convenient for adjusting the individual dose for babies.

Contraindications

Side effects

In clinical trials, more than 1000 patients were treated with the drug.

The most common adverse reactions were gastrointestinal disorders, which were mostly mild to moderate in severity.

The following adverse reactions were reported in clinical trials with the indicated frequency:

Strictures of the ileum, cecum or colon (fibrosing colonopathy) have been observed in patients with cystic fibrosis receiving high doses of pancreatin (see section “Special Precautions”).

Allergic reactions were observed predominantly on the skin, but other manifestations of allergy were also observed. These side effects have been reported in the post-marketing period and were spontaneous. There are insufficient data to give an accurate estimate of the incidence.

No specific adverse reactions have been reported in children. The frequency, type and severity of adverse reactions in children with cystic fibrosis were similar to those in adults.

Overdose

Pregnancy use

Pregnancy

There are no clinical data on the treatment of pregnant women with preparations containing pancreatic enzymes. Animal studies have shown no absorption of porcine pancreatic enzymes, so toxic effects on reproductive function and fetal development are not expected.

The drug should be administered to pregnant women with caution if the anticipated benefit to the mother exceeds the potential risk to the fetus.

Breastfeeding

Based on animal studies in which no systemic adverse effects of pancreatic enzymes have been identified, no harmful effects of the drug on the breastfed infant through breast milk are expected.

Pancreatic enzymes can be taken during breastfeeding.
If administration during pregnancy or while breastfeeding is necessary, the drug should be taken in doses sufficient to maintain adequate nutritional status.

Similarities