Creon Micro - instructions for use, dose, side effects, contraindications

Excipients: macrogol 4000 - 15.03 mg, hypromellose phthalate - 22.58 mg, cetyl alcohol - 0.48 mg, triethyl citrate - 1.25 mg, dimethicone 1000 - 0.54 mg.

Description:The granules are light brown in color from spherical to cylindrical.

Pharmacotherapeutic group:Digestive enzyme agent

ATX: & nbsp

A.09.A.A Enzyme preparations

A.09.A.A.02 Pancreatin

Pharmacodynamics:

Enzyme preparation that improves digestion. Pancreatic enzymes included in the preparation facilitate the cleavage of proteins, fats, carbohydrates, which leads to their complete absorption in the small intestine.

Creon® Micro contains pork pancreatin in the form of granules coated with an enteric-insoluble (acid-fast) coat, the principle of dosing is designed to thoroughly mix the granules with intestinal contents, and ultimately better distribution of enzymes after their release inside the intestinal contents. When the granules reach the small intestine, the enteric membrane rapidly breaks down (at pH> 5.5), the enzymes release with lipolytic, amylolytic and proteolytic activity, which leads to the breakdown of fats, carbohydrates and proteins. The resulting substances are then either absorbed directly or subjected to further hydrolysis by intestinal enzymes.

Pharmacokinetics:

In animal studies, the absence of absorption of intact (uncleaved) enzymes was demonstrated, as a result of which classical pharmacokinetic studies were not performed. Preparations containing pancreatic enzymes do not require absorption to manifest their effects. On the contrary, the therapeutic activity of these drugs is fully realized in the lumen of the gastrointestinal tract.According to their chemical structure, they are proteins and, therefore, are subjected to proteolytic digestion when passing through the gastrointestinal tract until they are absorbed in the form of peptides and amino acids.

Indications:

Substitution therapy of insufficiency of exocrine pancreatic function in children and adults, caused by various diseases of the gastrointestinal tract and most common in:

- cystic fibrosis;

- chronic pancreatitis;

- after surgery on the pancreas;

- after gastrectomy;

- pancreatic cancer;

- partial resection of the stomach (eg, Billroth II);

- obstruction of the ducts of the pancreas or common bile duct (eg, due to neoplasm);

- Shvakhman-Diamond syndrome;

- state after an attack of acute pancreatitis and renewal of nutrition.

To avoid complications, use only after consulting a doctor.

Contraindications:

Hypersensitivity to the active component of the drug or to any of the excipients.

Pregnancy and lactation:

Pregnancy

Clinical data on the treatment of pregnant women with drugs containing pancreatic enzymes are absent. In the course of studies on animals, no absorption of pancreatic enzymes of porcine origin has been detected, therefore, toxic effects on reproductive function and fetal development are not expected. Prescribe the drug to pregnant women with caution. Breastfeeding period

In studies on animals, no systemic negative effects of pancreatic enzymes during lactation have been revealed, so no harmful effect of the drug on the infant is expected. During breastfeeding, you can take pancreatic enzymes.

If you need to take during pregnancy or breast-feeding, the drug should be taken in doses sufficient to maintain adequate nutritional status.

Dosing and Administration:

Inside.

Doses of the drug are selected individually, depending on the severity of the disease and the composition of the diet.

Enzyme preparations should be taken during or immediately after each meal.

A special dosage form of the Creon® Micro preparation with a smaller granule size is specially designed for use in children, since it is difficult for them to swallow the capsule whole. This dosage form allows you to more accurately choose an individual dose with a lower lipase activity, which is necessary for adequate treatment of children. Granules can be added to a small amount of soft food that does not require chewing and has an acidic taste (pH <5.5), or may be taken with a liquid that also has an acidic taste (pH <5.5). For example, granules can be added to apple puree, yoghurt or fruit juice (apple, orange or pineapple) with a pH of less than 5.5. It is not recommended to add granules to hot food. Any mixture of granules with food or liquid is not to be stored, and it should be taken immediately after preparation, without chewing, squeezed with enough liquid (water or juice).

Grinding or chewing granules, as well as mixing them with food or liquid with a pH of more than 5.5, can destroy their protective enteric coating. This can lead to early release of enzymes in the oral cavity, reduced efficiency and irritation of the mucous membranes.It is necessary to make sure that there are no granules left in the mouth.

It is important to ensure sufficient constant fluid intake by the patient, especially with increased loss of fluid. Inadequate fluid intake can lead to constipation or constipation.

Dose for adults and children with cystic fibrosis

- The initial dose for infants should be from 2000 to 5000 lipase units per each feeding (usually 120 ml), then the dose should be adjusted, and not exceed 2500 lipase units / kg for feeding at a maximum daily dose of 10,000 lipase units / kg.

- The dose depends on body weight and should be at the beginning of treatment 1000 lipase units / kg for each meal for children under four years old, and 500 lipase units / kg during meals for children over the age of four and adults.

- The dose should be determined depending on the severity of the symptoms of the disease, the results of monitoring the steatorrhea and maintaining adequate nutritional status.

- The daily dose for most patients should not exceed 10,000 lipase units / kg of body weight or 4000 lipase units / g of consumed fat.

Dose for other conditions,accompanied by exocrine pancreatic insufficiency

The dose is selected individually, depending on the degree of insufficiency of digestion and the content of fat in food. The dose that is required for the patient along with the main meal varies from 25,000 to 80,000 units of lipase, and half of the individual dose is needed during a light snack. In children, the drug should be used in accordance with the appointment of a doctor.

Side effects:

Disorders from the gastrointestinal tract

Very often (≥1 / 10): pain in the abdomen.

Often (≥1 / 100, <1/10): nausea, vomiting, constipation, bloating, diarrhea.

Frequency unknown: stricture of the iliac, blind and colon (fibrosing colonopathy).

Gastrointestinal disorders are mainly associated with the underlying disease. The incidence of such adverse reactions as abdominal pain and diarrhea was lower or similar to that of placebo.

Structures of the ileum, the blind and the large intestine (fibrosing colonopathy) were observed in patients with cystic fibrosis. who received high doses of pancreatin preparations (see section "Special instructions").

Disturbances from the skin and subcutaneous tissues

Infrequent (≥1 / 1000, <1/100): skin rash.

The frequency is unknown: itching, hives.

Immune system disorders

The frequency is unknown: hypersensitivity (anaphylactic reactions).

Allergic reactions were observed mainly from the skin, but other manifestations of allergy were also noted. These side effects were reported during the postmarketing period and were spontaneous. To accurately assess the frequency of the cases of available data is not enough.

When used in children, no specific adverse reactions were noted. The frequency, type and severity of adverse reactions in children with cystic fibrosis were similar to those in adults.

Overdose:

Symptoms when taking extremely high doses: hyperuricosuria and hyperuricemia. Treatment: withdrawal of the drug, symptomatic therapy.

Interaction:

There were no studies on the interaction.

Special instructions:

In patients with cystic fibrosis who received high doses of pancreatin preparations, strictures of the iliac, the blind and the large intestine (fibrosing colonopathy) are described.As a precaution, when unusual symptoms or changes in the abdominal cavity appear, a medical examination is necessary to exclude fibrosing colonopathy, especially in patients who take the drug at a dose of more than 10,000 lipase units / kg per day.

Effect on the ability to drive transp. cf. and fur:

The use of Creon® Micro is not affected or has little effect on the ability to drive and machines.

Form release / dosage:Granules intestine soluble 5000 U.

Packaging:

To 20 g in a bottle of colorless glass, sealed with a lid of low density polyethylene with control of the first opening. A label is attached to the vial. For 1 bottle complete with a measuring spoon in a pack of cardboard along with instructions for use.

Storage conditions:

Store at a temperature of no higher than 25 ° C in a tightly closed container. Keep out of the reach of children!

Shelf life:

3 years.

Shelf life after the first opening of the bottle is 3 months.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-004189

Date of registration:15.03.2017

Expiration Date:15.03.2022

The owner of the registration certificate:Abbott Laboratories, GmbHAbbott Laboratories, GmbH Germany

Manufacturer: & nbsp

ABBOTT LABORATORIES, GmbH Germany

Representation: & nbspABBOTT LABORATORIES LLC ABBOTT LABORATORIES LLC Russia

Information update date: & nbsp04.04.2017

Illustrated instructions

Instructions

Creon® Micro (Kreon® Micro)