Creon 40000,40000 units 50 pcs

Creon is an enzyme preparation which improves the digestive processes. The pancreatic enzymes contained in the drug facilitate the breakdown of proteins, fats and carbohydrates, which leads to their complete absorption in the 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 quickly in the stomach, releasing hundreds of minicrospheres.

This principle is designed to thoroughly mix the minimicrospheres with the intestinal contents and, ultimately, to better distribute the enzymes once they are released inside the intestinal contents. When the mini-microspheres reach the small intestine, the enteric coating is rapidly degraded (at pH > 5.5) and enzymes with lipolytic, amylolytic and proteolytic activities are released, leading to a breakdown of fats, carbohydrates and proteins. The resulting substances are then either absorbed directly or further hydrolyzed by intestinal enzymes.

Pharmacokinetics:

In animal studies it has been demonstrated that there is no absorption of intact (non-cracked) enzymes, so classical pharmacokinetic studies were not conducted. Drugs containing pancreatic enzymes do not require absorption to show their effects.

On the contrary, the therapeutic activity of the indicated drugs is fully realized in the lumen of the gastrointestinal tract. By their chemical structure they are proteins and, therefore, when passing through the gastrointestinal tract they undergo proteolytic cleavage until they are absorbed as peptides and amino acids.

Indications

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

• mucoviscidosis
• chronic pancreatitis
• after pancreatic surgery
• pancreatic cancer
• partial gastric resection (e.g., Bilroth II)
• Schwachman-Daimond syndrome
state after an attack of acute pancreatitis and resumption of nutrition

To avoid complications, use only after consulting a physician.

Active ingredient

Pancreatin

Composition

1 capsule contains:

Active ingredients:

pancreatin 400 mg, which corresponds to the content of: lipase 40 000 ED Ph.Eur, amylase 25 000 ED Ph.Eur, proteases 1600 ED Ph.Eur.

Excipients:

Macrogol 4000 – 100 mg,

Hypromellose phthalate – 150.24 mg,

dimethicone 1000 – 3.59 mg,

cetyl alcohol – 3.16 mg,

triethyl citrate – 8.34 mg.

Contents of hard gelatin capsules: gelatin – 116.92 mg, iron oxide red dye (E172) – 0.44 mg, iron oxide yellow dye (E172) – 0.1 mg, iron oxide black dye (E172) – 0.17 mg, titanium dioxide (E171) – 0.13 mg, sodium lauryl sulfate – 0.24 mg.

How to take, the dosage

Creon is taken orally, before meals, without chewing, with plenty of liquid, preferably alkaline: water, fruit juices. The dose is set individually, depending on the severity of the digestive disorder.

In usual dosage – 0.25-0.5 g 3-6 times a day immediately before or with a meal.

The duration of treatment varies from several days (in case of digestive disorders due to errors in the diet) up to several months or even years (if substitution therapy is required).

Interaction

No interaction studies have been conducted.

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, if unusual symptoms or abdominal changes occur, a medical evaluation should be performed to rule out fibrosing colonopathy, especially in patients who take the drug at doses greater than 10,000 lipase units/kg per day. Like all currently used porcine pancreatin preparations, Creon^® 10,000 is made from pancreatic tissue from pigs specially bred for consumption.

While the likelihood of transferring an infectious agent to humans has been minimized by screening and inactivating certain viruses during production, there is a theoretical risk of viral disease transfer, including diseases caused by new or unknown viruses. The presence of porcine viruses that can infect humans cannot be completely ruled out.

But in the long period of time in which pig pancreatic extracts have been used, not a single case of transmission of an infectious disease has been reported.

Synopsis

Capsules are enteric soluble solid gelatin, with a colorless transparent body and a brown opaque cap; the contents of the capsules are minimicrospheres of light brown color.

Contraindications

Hypersensitivity (including pork intolerance), acute pancreatitis, exacerbation of chronic pancreatitis.

Side effects

Gastrointestinal disorders:

Very common (≥1/10): abdominal pain. Frequent (≥1/100, less than 1/10): nausea, vomiting, constipation, abdominal bloating, diarrhea. Frequency unknown: strictures of the ileum, cecum and colon (fibrosing colonopathy). Gastrointestinal disorders are mainly related to the underlying disease. The incidence of adverse reactions such as abdominal pain and diarrhea was lower or similar to that of placebo. Strictures of the ileum, cecum and colon (fibrosing colonopathy) were observed in patients with cystic fibrosis who received high-dose pancreatin preparations.

Skin and subcutaneous tissue disorders:

Infrequent (≥1/1000, less than 1/100): rash. Frequency unknown: itching, urticaria.

Immune system disorders:

Frequency unknown: hypersensitivity (anaphylactic reactions). Allergic reactions have been observed mainly on the skin, but other manifestations of allergy have also been noted. These side effects have been reported during post-marketing use and were spontaneous. The available data are insufficient for an accurate estimation 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

Symptoms: hyperuricosuria and hyperuricemia.

Treatment: drug withdrawal, symptomatic therapy.

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 no toxic effects on reproductive function and fetal development are expected. The drug should be administered to pregnant women with caution if the estimated benefit to the mother exceeds the potential risk to the fetus.

The period of breastfeeding:

Based on animal studies in which no systemic adverse effects of pancreatic enzymes have been found, no harmful effects of the drug on the infant through breast milk are expected. Pancreatic enzymes can be taken during breastfeeding. If administration during pregnancy or lactation is necessary, the drug should be taken in doses sufficient to maintain adequate nutritional status.

Similarities

Mezim forte, Pancreatin, Creon 25000, Micrazyme, Hermital, Panzinorm forte 20000, Penzital, Pancreatin Forte, Creon 10000, Creon 25000, Mezim 20000, Enzival-P, Mezim