Creon 40000 - instructions for use, dose, side effects, contraindications

Excipients: macrogol 4000 - 100.00 mg, hypromellose phthalate - 150.24 mg, dimethicone 1000 - 3.59 mg, cetyl alcohol - 3.16 mg, triethyl citrate - 8.34 mg.

Hard gelatin capsule: gelatin - 116.92 mg, iron dye red oxide (E 172) - 0.44 mg, iron dye oxide yellow (E 172) - 0.10 mg, ferric oxide black oxide (E 172) - 0.17 mg, titanium dioxide (E 171) - 0.13 mg, sodium lauryl sulfate - 0.24 mg.

Description:

Hard gelatin capsules №00, consisting of a brown opaque lid and a transparent, colorless body.

The contents of the capsules are a minimacrosphere of light brown color.

Pharmacotherapeutic group:Digestive enzyme agent.

ATX: & nbsp

A.09.A.A Enzyme preparations

A.09.A.A.02 Pancreatin

Pharmacodynamics:

An enzyme preparation that improves digestion processes in adults and children, and thereby significantly reduces the symptoms of pancreatic enzyme insufficiency, including abdominal pain, flatulence, changes in stool frequency and consistency. Pancreatic enzymes included in the preparation facilitate the cleavage of proteins, fats, carbohydrates, which leads to their complete absorption in the small intestine. Creon® 40000 contains pork pancreatin in the form of minimocrosses, coated with enteric-acid (acid-fast) coating, in gelatin capsules. Capsules quickly dissolve in the stomach, releasing hundreds of minimocrosses. This principle is designed for the simultaneous passage of microcircuits with food from the stomach to the intestine and careful mixing of the minimosphere with intestinal contents, and ultimately better distribution of enzymes after their release inside the intestinal contents.

When the minimosphere reaches 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 digestion by intestinal enzymes.

Pharmacokinetics:

In animal studies, the lack of absorption of uncleaved enzymes was demonstrated, as a result of which classical pharmacokinetic studies were not performed. Preparations containing enzymes of the pancreas 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. By their chemical structure, they are proteins and, in this connection, when passing through the gastrointestinal tract, enzyme preparations are cleaved until absorption occurs in the form of peptides and amino acids.

Indications:

Substitution therapy of exocrine (enzymatic) pancreatic insufficiency in children and adults caused by a decrease in the enzymatic activity of the pancreas due to impaired production, regulation of secretion, delivery of pancreatic enzymes or increased destruction in the lumen of the intestine,which is caused by a variety of diseases of the gastrointestinal tract, and is most common when:

- cystic fibrosis;

- chronic pancreatitis;

- after surgery on the pancreas;

- after gastrectomy;

- pancreatic cancer;

- partial gastrectomy (for example, 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 any of the components of the drug.

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.

Capsules should be taken during or immediately after each meal (in the part of a light snack), swallowed whole, do not break and do not chew, squeezed with enough liquid.

If swallowing is difficult (for example, in young children or elderly patients), capsules are gently opened, and minimocrosses are added to soft foods that do not require chewing and have an acidic taste (pH <5.5) or are taken with a liquid that also has an acidic taste pH <5.5). For example, minimocrosses 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 the contents of the capsules to hot food.Any mixture of minimocrosses with food or liquid is not subject to storage, and it should be taken immediately after preparation.

Grinding or chewing the minimocrosses, 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 the mouth does not have a minimosphere.

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

Dose for adults and children with cystic fibrosis

- 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 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.

- In most patients, the dose should remain less or less than 10,000 lipase units / kg of body weight per day or 4000 lipase units / g of consumed fat.

Dose for others Conditions accompanied by exocrine pancreatic insufficiency

The dose should be set taking into account the individual characteristics of the patient, which include the degree of inadequate digestion and fat content 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 at the time of light snack intake, half of the individual dose.

In children, the drug should be used in accordance with the appointment of a doctor.

Side effects:

Disorders from the gastrointestinal tract

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

Infrequently (≥1/1000, <1/100): a 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 fibrotic 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® 40000 does not affect or has a negligible effect on the ability to drive and operate machinery.

Form release / dosage:Intestinal insoluble capsules 40000 units.

Packaging:

For 20, 50 or 100 capsules in a bottle of high density polyethylene of white color with a screw cap of polypropylene with control of the first opening. A label is attached to the vial.

1 bottle with instructions for use in a pack of cardboard.

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 expiration date indicated on the package,

Terms of leave from pharmacies:On prescription

Registration number:LSR-000832/08

Date of registration:18.02.2008 / 08.09.2015

Expiration Date:Unlimited

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

Manufacturer: & nbsp

ABBOTT PRODUCTS, GmbH Germany

Representation: & nbspABBOTT LABORATORIES LLC ABBOTT LABORATORIES LLC Russia

Information update date: & nbsp22.01.2018

Illustrated instructions

Instructions

Creon® 40000 (Kreon® 40000)