Creon 10 thousand instructions for use. Creon for children: application features

The composition of the preparation Creon 10000, 25000 and 40000 includes the main component:.

Additional components: , liquid paraffin, methylhydroxypropyl cellulose phthalate, dibutyl phthalate, dimethicone 1000 , iron oxide red, black and yellow, gelatin and titanium dioxide.

Release form

Creon 10000, 25000 and 40000 are available in the form of capsules. In this case, the capsules are packaged in blisters of 10 or 25 pieces or in vials of 20 or 50 pieces. The blisters can be packed in packs of 2 or 4 in each.

pharmachologic effect

This drug is able to compensate for the deficiency in the pancreas.

Pharmacodynamics

This enzyme preparation, as Wikipedia points out, is designed to improve digestive processes. The pancreatic enzymes included in it contribute to the breakdown of proteins, fats and carbohydrates, leading to complete absorption in small intestine. The main substance pancreatin is also the INN of the drug.

According to the abstract, the capsule shell dissolves easily in the stomach, resulting in the release of many mini-microspheres. Thus, mini-microspheres are mixed with the intestinal contents, improving the distribution of enzymes within the intestine.

Indications for the use of Creon

The main indications for use are:

substitution treatment for insufficient exocrine function pancreas accompanying diseases - cystic fibrosis, pancreatectomy, pancreatic cancer, obstruction of the ducts of the gastrointestinal tract in neoplasms, Shwachman-Diamond syndrome, as well as in elderly patients;
symptomatic treatment of digestive disorders in case of partial resection of the stomach, total gastrectomy, biliary obstruction, cholestatic hepatitis , pathologies of the terminal section and excessive bacterial growth in the small intestine.

Contraindications

The drug Kreon is not prescribed for:

acute form;
high sensitivity to the drug;
exacerbations of chronic pancreatitis.

Side effects

The use of the drug causes side effects only in rare cases. This may show up: , gastrointestinal discomfort, nausea .

Creon capsules, instructions for use (Method and dosage)

Instructions for use Creon 10000 recommends prescribing them to small patients. In general, this drug of any number of units is taken orally. The selection of the dosage is carried out individually and depends on the age, severity of the disease and type. It is usually recommended to take the medicine partly before meals and the rest with food.

At the beginning of treatment, tablets are prescribed at a dosage of 10,000–25,000 IU. When it is necessary to reduce steatorrhea and maintain the optimal condition of the patient, the dose may be increased. In medical practice, patients can receive an average of 20,000–50,000 units of lipase EF.

During the treatment of cystic fibrosis, the dosage is set depending on the weight. For example, in the treatment of young patients up to 4 years of age, 1000 lipase units per kg of body weight are prescribed, and over 4 years of age, 500 lipase units per kg of body weight are prescribed with each meal. For many patients, the daily dosage should not exceed 10,000 IU per 1 kg of body weight.

Instructions for use Creon 25000 recommends taking it in the treatment of other conditions that may be accompanied by exocrine insufficiency pancreas. In this case, the dose is set, taking into account the individual characteristics of the patient, for example, how much digestion is disturbed, how much fat is contained in food, and so on.

Instructions for the use of Creon for children contain detailed description how to give to children with difficulty swallowing. To use this drug for children, the capsules are carefully opened. The internal contents are mixed with liquid or food that does not require chewing. It must be remembered that such mixtures cannot be stored, therefore they are taken immediately after they are prepared. It is forbidden to crush or chew mini-microspheres and add them to acidic foods - this can destroy their shell, which protects against the effects of gastric juice.

Instructions for use Creon 40000 recommends taking this drug for adult patients. Its dosage also depends on the severity of the disease and the personal characteristics of the patient. The duration of use must be determined by the attending physician.

Overdose

In cases of overdose develops hyperuricuria or hyperuricemia.

Eliminate their manifestation allows the abolition of the drug and symptomatic therapy.

Interaction

Drug interactions with other drugs have not been established.

special instructions

There have been cases when patients in the treatment of cystic fibrosis received pancreatin in high dosages, which caused colitis, strictures of the caecum and ileum.

For this reason, it is necessary to control the dose, especially when Creon 40000 is prescribed. It is also necessary to monitor the appearance of any symptoms and changes that occur in the abdominal cavity. In addition, you should immediately find out how to take Creon 10,000 adult patients and not exceed its dosage.

Terms of sale

Without recipe.

Storage conditions

Capsules can be stored at room temperature, out of the reach of children.

Best before date

Creon during pregnancy and lactation

Data on how safe it is to take Creon with and , missing. This applies in general to any pancreatic enzymes. Therefore, the use of the drug is permissible only when the expected benefit of treatment for the mother significantly outweighs the likely danger to the fetus or baby.

Creon for children

An enzyme preparation is prescribed for children when it is necessary to improve digestion. The recommended daily dosage of Creon 10000 for children is divided into several parts and taken with each meal.

When prescribing it, parents should immediately find out from the doctor how to take Creon for children, since the dose is prescribed taking into account the weight of the baby.

It should be noted that the reviews for the child are very ambiguous. Some mothers report the effectiveness of capsules, but there are also reviews about the uselessness of this medicine.

Creon for babies

When this drug is prescribed to babies, many parents immediately have questions: what is Creon and why is it taken? It is known that the organs of the gastrointestinal tract of newborns are formed over a certain period of time. Therefore, even small deviations in the diet for infants can cause a violation.

Also mothers start to worry how to give baby medicine in capsules? In fact, the pediatrician explains all this in detail and describes the instructions for the drug. It should be noted that Creon 10000 is usually prescribed for newborns, indicating the dosage, regimen and duration of therapy.

Reasons to prescribe capsules for newborns are:

constant colic;
or diarrhea with particles of undigested products;

By the way, parents' reviews show that the question of how to give this medicine to a baby is not a problem at all. Many mothers are confused by the effect of the drug, since its effectiveness is not always manifested.

Creon's analogs

Coincidence in the ATX code of the 4th level:

The main analogues of Creon 10000 and other units: , Gastenorm, PanziKam, . However, this does not mean that each of them is an equivalent substitute.

It should be noted that the price of analogues can be very different and cannot incline towards the purchase of a particular medicine. The question of what can replace the treatment should be clarified with the doctor. Especially when the medicine is selected for children whose age is less than one year.

Creon or Pancreatin - which is better?

Despite many similarities, each of these drugs has significant differences. But if you know what the difference is, then you can make the right choice when buying. medicinal product.

If we compare how Creon differs from, then the first is the form of release. Pancreatin is available in tablets. The second difference is the concentration of the active substance, which is presented in Pancreatin in an arbitrary content.

The effect of drugs is also not the same - Pancreatin already acts in the stomach and therefore does not fulfill its function completely, and therefore is considered less effective. Although the cost is much lower.

Thus, based on these data, each patient will be able to decide which drug to choose.

Ermital or Creon - which is better?

The compositions of these drugs are quite similar, but have less effectiveness due to the type active substance. Creon mini-microgranules are easily mixed with the contents of the stomach, significantly improving physiological digestion, while other agents have a somewhat delayed effect.

Which is better - Creon or Micrasim?

These funds are almost identical in everything, but they differ in the dosages of their components.

For example, it contains 320 mg of pancreatin. In addition, it is a domestically produced medicine and is cheaper.

Therefore, when prescribing this drug, it is important to take into account the high content of the enzyme, since such a difference is noticeable and can lead to complications in the digestive tract.

Creon or Panzinorm - which is better?

Another absolute analogue is . It is produced by the KRKA brand from Slovenia. This medicine is also used in the treatment of enzyme deficiency.

It is believed that each of them has the same effectiveness, and which drug is suitable for treatment, you need to choose for yourself, but still on the recommendation of a doctor.

Reviews about Creon

This drug is quite popular and is discussed in various forums. Especially often there are reviews of Creon 10000, which is prescribed for young children suffering from digestive disorders. Although many mothers do not understand what Creon tablets are for, they try to treat their baby with them.

It is interesting that the reviews on Creon 10000 for babies are markedly ambiguous - if some mothers report that the treatment helped them quickly get rid of problems, others call it the most useless medicine. However, it does not harm the child.

Also, patients are actively discussing Creon 25000, which is prescribed to patients with disorders digestive system. Numerous reviews about Creon 25000 on the forums are also very ambiguous. If some take it for complex disorders of the digestive system, then most in cases where there are problems with the digestion of "heavy" food. One way or another, this allows you to improve the condition with insufficiency of the exocrine function of the pancreas and other disorders.

By the way, there are reports that some adult patients refuse to use this drug due to the fact that it is produced from porcine pancreas. In rare cases, you can find stories about the undesirable effect of this drug, in the form of heaviness and discomfort in the stomach, pain in the gallbladder.

Undoubtedly, patients for whom this drug brought the desired effect and helped to reduce the manifestations serious illnesses digestive system, they are not going to refuse to take it. An important point The therapeutic course is to follow a diet with the use of healthy foods and nutrition in a normal amount. With this approach, it is possible to maintain one's own health and prevent the development of complications.

Creon price, where to buy

The price of Creon depends on the number of units and the quantity in the package.

The price of Creon 10000 in Ukraine is 113-118 UAH. You can buy tablets in Moscow at a cost of 230-300 rubles, in St. Petersburg a similar cost. This is the drug of choice for children.

The price of Creon 25000 capsules for 20 pieces is approximately 590 rubles.

The price of Creon 40,000 for 50 pieces starts from 1300 rubles.

When you need to find out how much this or that form of the drug costs, you should contact the help desk of the nearest pharmacy.

Internet pharmacies in Russia Russia
Internet pharmacies in Ukraine Ukraine
Internet pharmacies of Kazakhstan Kazakhstan

ZdravCity

Creon 25000 caps. ksh/sol 300mg n20 Abbott GmbH

Creon 40000 caps. ksh/sol n50 Abbott GmbH

Creon 10000 caps. ksh/sol 150mg n20 Abbott Laboratories GmbH

Creon 10 000- an enzyme preparation that improves the processes of digestion.
Pancreatic enzymes, which are part of the drug, facilitate the digestion of proteins, fats, carbohydrates, which leads to their complete absorption in the small intestine.
Creon 10,000 capsules, containing pancreatin in the form of enteric-coated minimicrospheres, quickly dissolve in the stomach, releasing hundreds of minimicrospheres. The aim of this principle is to mix the mini-microspheres with the intestinal contents and ultimately to better distribute the enzymes after their release within the intestinal contents.
When the minimicrospheres reach the small intestine, the enteric coating is destroyed (at pH>5.5), pancreatic enzymes are released with lipolytic, amylolytic and proteolytic activity, resulting in the breakdown of fats, carbohydrates and proteins.
The substances obtained as a result of splitting are then either absorbed directly or subjected to further hydrolysis by intestinal enzymes.

Pharmacokinetics

In animal studies, no absorption of whole (non-digested) enzymes has been demonstrated and, as a result, classical pharmacokinetic studies have not been performed. Preparations containing pancreatic enzymes do not require absorption to exert their effects. On the contrary, the therapeutic activity of these drugs is fully realized in the lumen of the gastrointestinal tract. Moreover, they are proteins in their chemical structure and, therefore, during the passage through the gastrointestinal tract, they undergo proteolytic cleavage until they are absorbed in the form of peptides and amino acids.

Indications for use

A drug Creon 10 000 applied in replacement therapy insufficiency of the exocrine function of the pancreas in children and adults, which is most often found in the following conditions: cystic fibrosis; chronic pancreatitis; condition after surgery on the pancreas; after gastrectomy; pancreas cancer; partial resection of the stomach (for example, Billroth II); obstruction of the ducts of the pancreas or common bile duct (for example, due to a neoplasm); Shwachman-Diamond syndrome.

Mode of application

A drug Creon 10 000 take inside.
The dose is determined individually, depending on the severity of the disease and the composition of the diet.
Capsules should be taken during or immediately after each meal (including snacks), swallowed whole, not broken or chewed, with plenty of liquid.
When swallowing is difficult (for example, in young children or elderly patients), the capsules are carefully opened, and the mini-microspheres are added to a liquid food that does not require chewing and has a sour taste, such as applesauce or fruit juice (pH< 5.5). Не рекомендуется добавлять содержимое капсул в горячую пищу. Любая смесь минимикросфер с пищей или жидкостью не подлежит хранению, и ее следует принимать сразу же после приготовления.
It is important to ensure sufficient continuous fluid intake by the patient, especially with increased fluid loss. Inadequate fluid intake can lead to or worsen constipation.
In cystic fibrosis, the initial dose of lipase for children under 4 years of age is 1000 IU / kg of body weight for each meal, for children over the age of 4 years and adults - 500 IU / kg of body weight for each meal. The dose should be determined depending on the severity of the symptoms of the disease, the results of the control of steatorrhea and the maintenance of good nutritional status. In most patients, the dose of lipase should not exceed 10,000 U/kg body weight/day or 4,000 U/g fat intake.
In other conditions accompanied by exocrine pancreatic insufficiency, the dose is set taking into account the degree of insufficiency of digestion and the fat content in food. The dose of lipase required by the patient along with the main meal varies from 25,000 to 80,000 IU Ph. Eur., while taking a light snack - half of the individual dose.

Side effects

From the digestive system: often (≥1 / 100,<1/10) - тошнота, рвота, запор и вздутие живота. Желудочно-кишечные расстройства связаны главным образом с основным заболеванием. Частота возникновения следующих неблагоприятных реакций была ниже или схожей с таковой при применении плацебо: диарея - часто (≥ 1/100, <1/10), боли в области живота - очень часто (≥1/10).
Allergic reactions: rarely (≥ 1/1000,<1/100) - сыпь; недостаточно данных для оценки частоты случаев - зуд, крапивница.

Contraindications

Contraindications to the use of the drug Creon 10 000 are: acute pancreatitis; exacerbation of chronic pancreatitis; hypersensitivity to pancreatin of porcine origin and other components of the drug.

Pregnancy

Clinical Application Data Creon 10 000 during pregnancy, drugs containing pancreatic enzymes are absent. Prescribe Creon 10,000 during pregnancy with caution if the intended benefit to the mother outweighs the potential risk to the fetus.
In the course of experimental studies, no absorption of pancreatic enzymes of porcine origin was detected, therefore, toxic effects on reproductive function and fetal development are not expected.
During lactation (breastfeeding), you can take pancreatic enzymes, incl. Creon 10000.
In the course of experimental studies, no systemic negative effect of pancreatic enzymes was detected, therefore, no harmful effect of the drug on a nursing baby is expected when breastfeeding.
If necessary, during pregnancy or during lactation, the drug should be taken in doses sufficient to maintain an adequate nutritional status.

Interaction with other drugs

Drug interaction studies Creon 10 000 not tested with other drugs.

Overdose

Symptoms of drug overdose Creon 10 000: hyperuricuria and hyperuricemia.
Treatment: drug withdrawal, symptomatic therapy.

Storage conditions

A drug Creon 10 000 should be stored out of the reach of children at a temperature not exceeding 25 ° C in a tightly closed package. Shelf life - 2 years.
After the first opening of the vial, the shelf life is 3 months.

Release form

Enteric-soluble hard gelatin capsules, size No. 2, with a colorless transparent body and a brown opaque cap; the contents of the capsules are minimicrospheres of light brown color.
20 pcs. - high-density polyethylene bottles (1) - cardboard packs.
50 pcs. - high-density polyethylene bottles (1) - cardboard packs.
100 pieces. - high-density polyethylene bottles (1) - cardboard packs.

Composition

1 capsule Creon 10 000 contains: pancreatin 150 mg, which corresponds to the content of: lipases 10,000 IU Ph.Eur., amylase 8,000 IU Ph.Eur., proteases 600 IU Ph.Eur.
Excipients: macrogol 4000, hypromellose phthalate, dimethicone 1000, cetyl alcohol, triethyl citrate.
The composition of the capsule shell: gelatin, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), titanium dioxide (E171), sodium lauryl sulfate.

Additionally

In patients with cystic fibrosis treated with high doses of pancreatin preparations, strictures of the ileum and caecum and large intestine (fibrosing colonopathy) have been described. In studies conducted using the case-control method, no data were obtained indicating a relationship between the occurrence of fibrosing colonopathy and the use of the drug Creon 10 000. As a precautionary measure, if 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 (calculated as lipase) of more than 10,000 IU / kg body weight / day.
Influence on the ability to drive vehicles and control mechanisms
The use of the drug Creon® 10,000 does not affect or has a slight effect on the ability to drive a car and mechanisms.

main parameters

Name:	CREON 10 000
ATX code:	A09AA02 -

Against the backdrop of unhealthy nutrition and bad ecology, digestive problems occur even in children. Against the background of complementary foods, the imperfect digestive system of infants can fail due to a lack of enzymatic activity.

Diarrhea, pain, constipation, heartburn, increased gas formation and flatulence - such symptoms are considered the most characteristic of gastrointestinal disorders. In such a situation, to normalize digestion and eliminate pathological symptoms, gastroenterologists recommend taking.

Can a child take this drug?

Digestive problems occur in patients of any age, both adults and very young children.

, gastritis, cystic fibrosis and, pancreatic pathologies are often found even in patients of very young age. It is for such patients that it is recommended to take Creon capsules, which are safe even for newborns and infants.
Creon is one of the most modern enzymatic preparations of the latest generation. It was developed to normalize digestion by filling insufficiency of enzymatic pancreatic activity.
The drug has many advantages, because its main active ingredient is placed in microgranules coated with a shell that is resistant to gastric acid.
The microspheres are placed in a gelatin-based capsule. When the capsule reaches the stomach, it dissolves there, releasing hundreds of small microspheres. They are evenly mixed with food masses and penetrate with a lump of food into the intestinal cavity, where the shell of the microsphere dissolves, releasing pancreatic enzymes that will help the food to be better broken down and assimilated.

The composition of the drug

As part of the drug, the main active ingredient is pancreatin, obtained by extracting from the pancreas in pigs. Each Creon capsule contains the amount of enzymes - amylase, protease and lipase, recommended and safe for children.

In fact, Creon is not a medicine in the generally accepted concept, because it does not force the body of children to produce the missing enzymes, but simply supplies them to the body in a ready-made form.

That is, in fact, Creon is prescribed for enzyme replacement therapy. When the child stops taking the drug, the lack of enzymes may reappear.

Indications and contraindications

Babies need to be given only half the contents of the capsule at a time before each full meal.
Children from one year old are prescribed one capsule also before a full meal.

Child over 3 years old

Children over 3 years of age can usually swallow the capsule on their own, but if it causes vomiting or difficulty in swallowing, then the medicine should be given by analogy with children under the age of 3, i.e. mixing microgranules with food or drink.

It is better to mix the microspheres from the capsule with something acidic that does not need to be chewed. For children, it can be yogurt, applesauce or juice.

Before each full meal, the child is given 1-2 capsules of Creon. Typically, such children are prescribed the drug up to 3-5 times a day.

Parents also need to know that pancreatin from Creon impairs iron absorption, so iron deficiency anemia may occur with long-term treatment. Against the background of treatment with Creon, you need to give the child more drink to avoid constipation.

Side effects

In case of non-compliance with the dosage, unreasonably long-term use of Creon, or the presence of intolerance in a child, adverse reactions may occur, such as:

stool problems, such as diarrhea or constipation;
Allergic reaction to the drug in the form of rashes, vomiting, etc.;
Painful discomfort in the epigastric region.

To exclude the possibility of developing adverse reactions, you must first familiarize yourself with the attached annotation, having studied the contraindications and possible reactions to the drug.

You should be especially careful when treating children under one year of age. It is allowed to take the drug by children who eat only breast milk, but only on medical prescription.

Composition and form of release of the drug

◊ Enteric capsules hard gelatin, size No. 2, with a colorless transparent body and a brown opaque cap; the contents of the capsules are minimicrospheres of light brown color.

Excipients: macrogol 4000 - 37.5 mg, hypromellose phthalate - 56.34 mg, dimethicone 1000 - 1.35 mg, cetyl alcohol - 1.18 mg, triethyl citrate - 3.13 mg.

Composition of hard gelatin capsule: gelatin - 60.44 mg, iron dye red oxide (E172) - 0.23 mg, iron dye yellow oxide (E172) - 0.05 mg, iron dye black oxide (E172) - 0.09 mg, titanium dioxide (E171) - 0.07 mg, sodium lauryl sulfate - 0.12 mg.

20 pcs. - white high-density polyethylene bottles with a polypropylene screw cap (1) - cardboard packs.
50 pcs. - white high-density polyethylene bottles with a polypropylene screw cap (1) - cardboard packs.
100 pieces. - white high-density polyethylene bottles with a polypropylene screw cap (1) - cardboard packs.

pharmachologic effect

Enzyme agent. Contains pancreatic enzymes - amylase, lipase and protease, which facilitate the digestion of carbohydrates, fats and proteins, which contributes to their more complete absorption in the small intestine. In diseases of the pancreas, it compensates for the insufficiency of its exocrine secretory function and improves the digestion process.

Pharmacokinetics

The pharmacokinetics of pancreatin has not been studied.

Indications

Insufficiency of the exocrine function of the pancreas (including in chronic, cystic fibrosis).

Chronic inflammatory-dystrophic diseases of the stomach, intestines, liver, gallbladder; conditions after resection or irradiation of these organs, accompanied by disorders of food digestion, diarrhea (as part of combination therapy).

To improve the digestion of food in patients with normal gastrointestinal function in case of nutritional errors, as well as in violation of chewing function, forced long-term immobilization, sedentary lifestyle.

Preparation for x-ray and ultrasound examination of the abdominal organs.

Contraindications

Acute pancreatitis. Hypersensitivity to pancreatin.

Dosage

The dose (in terms of lipase) depends on the age and degree of pancreatic insufficiency. The average dose for adults is 150,000 IU / day. With complete insufficiency of the exocrine function of the pancreas - 400,000 IU / day, which corresponds to the daily requirement of an adult in lipase.

Maximum daily dose is 15,000 U/kg.

Children under the age of 1.5 years - 50,000 IU / day; older than 1.5 years - 100,000 IU / day.

The duration of treatment can vary from several days (in violation of the digestive process due to errors in the diet) to several months and even years (if necessary, constant replacement therapy).

Side effects

When used in average therapeutic doses, side effects are observed in less than 1%.

From the digestive system: in some cases - constipation, discomfort in the stomach, nausea. A causal relationship between the development of these reactions and the action of pancreatin has not been established; these phenomena are symptoms of exocrine pancreatic insufficiency.

Allergic reactions: in some cases - skin manifestations.

From the side of metabolism: with prolonged use in high doses, the development of hyperuricosuria is possible, in excessively high doses - an increase in the level of uric acid in the blood.

Others: when using pancreatin in high doses in children, perianal irritation may occur.

drug interaction

With simultaneous use with antacids containing calcium carbonate and / or magnesium hydroxide, it is possible to reduce the effectiveness of pancreatin.

With simultaneous use, it is theoretically possible to reduce the clinical efficacy of acarbose.

With simultaneous use with iron preparations, a decrease in the absorption of iron is possible.

special instructions

When the dose should be adequate to the amount of enzymes that is necessary for the absorption of fats, taking into account the quality and quantity of food consumed.

In cystic fibrosis, the use of pancreatin in doses of more than 10,000 units / kg / day (in terms of lipase) is not recommended due to an increased risk of developing strictures (fibrous colonopathy) in the ileocecal region and in the ascending colon.

With a high activity of lipase contained in pancreatin, the likelihood of developing constipation in children increases. Increasing the dose of pancreatin in this category of patients should be carried out gradually.

Gastrointestinal disorders may occur in patients with hypersensitivity to pancreatin, or in patients with meconium ileus or a history of bowel resection.

Pregnancy and lactation

The safety of pancreatin use has not been sufficiently studied. Application is possible in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

In experimental studies it was found that pancreatin does not have a teratogenic effect.

Application in childhood

Application is possible according to the dosing regimen. With a high activity of lipase contained in pancreatin, the likelihood of developing constipation in children increases.

Creon 10000: instructions for use and reviews

Creon 10000 is a digestive enzyme.

Release form and composition

Dosage form Creon 10000 - enteric capsules: size No. 2, gelatinous, hard, with a brown opaque cap and a colorless transparent body; contents - minimicrospheres of light brown color (20, 50 and 100 pieces in polyethylene bottles with a screw cap and first opening control, 1 bottle in a carton box).

The active substance of the drug: pancreatin, in 1 capsule - 150 mg, which corresponds to the content:

lipase - 10,000 units of the European Pharmacopoeia (ED Evr. F.);
amylase - 8000 IU Euro. F.;
protease - 600 IU Euro. F.

Additional components (their content in 1 capsule):

excipients: hypromellose phthalate (56.34 mg), macrogol 4000 (37.5 mg), triethyl citrate (3.13 mg), dimethicone 1000 (1.35 mg), cetyl alcohol (1.18 mg);
composition of the capsule shell: gelatin (60.44 mg), sodium lauryl sulfate (0.12 mg), titanium dioxide (E 171) (0.07 mg), as well as iron dyes yellow oxide (E 172) (0.05 mg) , iron oxide red (E 172) (0.23 mg) and iron oxide black (E 172) (0.09 mg).

Pharmacological properties

Pharmacodynamics

Pancreatin is an enzyme substance that improves the digestion of food, which significantly reduces the symptoms of pancreatic enzyme deficiency, such as flatulence, abdominal pain, changes in stool consistency and frequency. Pancreatic enzymes facilitate the digestion of fats, carbohydrates and proteins, so that they are completely absorbed in the small intestine.

Creon 10000 contains porcine pancreatin in the form of minimicrospheres coated with an enteric (that is, acid-resistant) shell, in gelatin capsules. Once in the stomach, the capsules quickly dissolve, releasing hundreds of minimicrospheres. This dosage form is designed specifically to ensure that the minimicrospheres are simultaneously thoroughly mixed with the intestinal contents and delivered with food from the stomach to the intestines, i.e., so that the enzymes are better distributed after release.

As soon as the mini-microspheres reach the small intestine, the capsular membrane is rapidly destroyed (at pH more than 5.5), enzymes with proteolytic, lipolytic and amylolytic activity are released, resulting in the breakdown of proteins, fats and carbohydrates. Substances obtained as a result of splitting are absorbed directly or undergo further splitting by intestinal enzymes.

Pharmacokinetics

In animal studies, it was found that there is no absorption of undigested enzymes, so classical pharmacokinetic studies have not been performed.

Preparations containing pancreatic enzymes do not require absorption to exert their effects. On the contrary, their therapeutic activity is fully realized in the lumen of the gastrointestinal tract.

By chemical structure, enzymes are proteins, and therefore, when passing through the gastrointestinal tract, they are broken down until they are absorbed in the form of amino acids and peptides.

Indications for use

Creon 10000 is used for replacement therapy of enzyme (exocrine) pancreatic insufficiency due to a decrease in its enzyme activity due to impaired production, regulation of secretion and delivery of pancreatic enzymes or due to their increased destruction in the intestinal lumen caused by various diseases of the gastrointestinal tract (GIT) .

Most often, Creon 10000 is prescribed in the following cases:

conditions after an attack of acute pancreatitis;
chronic pancreatitis;
cystic fibrosis;
Shwachman-Diamond syndrome;
partial resection of the stomach (for example, Billroth II);
obstruction of the ducts of the pancreas or common bile duct (for example, due to a neoplasm);
pancreas cancer;
conditions after surgery on the pancreas;
conditions after extirpation (gastrectomy) of the stomach;
preparation for ultrasound or x-ray examination of the abdominal organs.

For patients with normal gastrointestinal function, the drug is recommended for nutritional errors, chewing disorders, a sedentary lifestyle, or forced prolonged immobilization.

Contraindications

The use of Creon 10000 is contraindicated in case of hypersensitivity to its components.

Do not take the drug during an acute attack of pancreatitis.

Instructions for use Creon 10000: method and dosage

Capsules are taken orally during meals or immediately after each meal, including light snacks. They must be swallowed whole and washed down with a sufficient amount of liquid. For patients who have difficulty swallowing and children, the capsules can be carefully opened and the minimicrospheres contained therein can be added to a soft food that does not require chewing and has a sour taste, or taken with a sour tasting liquid. Foods that can be mixed include: applesauce, yogurt, fruit juices (apple, pineapple and orange) with pH< 5,5. Такие смеси не подлежат хранению, поэтому должны быть использованы сразу же после приготовления. Не стоит смешивать содержимое капсул с горячей пищей.

The dose of Creon 10,000 (in terms of lipase) is selected individually, taking into account the type of disorder, the severity of the course of the disease, the composition of the diet and the patient's body weight.

In cystic fibrosis, at the beginning of treatment, adults and children from 4 years old are prescribed 500 IU / kg, children under 4 years old - 1000 IU / kg with each meal. Depending on the severity of the symptoms of the disease, the results of the control of steatorrhea and individual sensitivity, the dose can be adjusted. For most patients, the daily dose does not exceed 10,000 U/kg of body weight or 4,000 U/g of fat consumed.

In other conditions accompanied by pancreatic enzyme deficiency, the dose is determined depending on the individual characteristics of the patient, including the degree of indigestion and the fat content in the diet. With the main meal, a dose of 25,000–80,000 IU of lipase is usually required, with light snacks - ½ of the therapeutic dose.

For children, Creon 10000 is used only in accordance with the doctor's instructions.

Side effects

on the part of the digestive system *: very often (≥ 1/10) - pain in the abdomen; often (from ≥ 1/100 to< 1/10) – вздутие живота, запор или диарея, тошнота, рвота; частота неизвестна – стриктуры слепой, толстой и подвздошной кишки (фиброзирующая колонопатия);
on the part of the skin and subcutaneous tissues: infrequently (from ≥ 1/1000 to< 1/100) – сыпь; частота неизвестна – крапивница, зуд;
on the part of the immune system **: the frequency is unknown - hypersensitivity reactions (anaphylactic reactions);
on the part of metabolism: with prolonged use of the drug in high doses - hyperuricosuria, in excessively high doses - an increase in the level of uric acid in the blood plasma;
others: in children when using the drug in high doses - perianal irritation.

* Gastrointestinal disorders are predominantly associated with the underlying disease. The incidence of diarrhea and abdominal pain is similar or lower than placebo. Fibrosing colonopathy has been observed in patients with cystic fibrosis taking high doses of pancreatin.

** Allergic reactions occurred more often on the part of the skin, but other manifestations of allergy were also observed.

Overdose

An overdose of pancreatin can manifest as hyperuricosuria and hyperuricemia. In this case, the drug is canceled and symptomatic therapy is carried out.

special instructions

Due to chewing and crushing minimicrospheres or mixing them with food / drinks with a pH greater than 5.5, their protective enteric coating may be destroyed and, as a result, early release of enzymes in the oral cavity, irritation of the mucous membranes and a decrease in the effectiveness of pancreatin. Therefore, when using non-capsular minimicrospheres, it is necessary to ensure that they are all swallowed and that nothing remains in the mouth.

During treatment, it is important to ensure that adequate fluid intake is maintained, especially with increased fluid loss. Due to inadequate fluid intake, constipation may occur or worsen.

Patients with cystic fibrosis receiving high doses of pancreatin are at risk of developing fibrosing colonopathy. Therefore, the dose should be adequate to the amount of enzymes necessary for the absorption of fats, taking into account the quantity and quality of food in the diet, and, if possible, should not exceed 10,000 IU / kg per day (in terms of lipase). If unusual symptoms or changes in the abdominal cavity appear, a medical examination is indicated, especially in patients taking Creon 10,000 in daily doses greater than 10,000 IU / kg.

Gastrointestinal disorders may occur in patients with individual hypersensitivity to pancreatin, patients with meconium ileus and a history of bowel resection.

Influence on the ability to drive vehicles and complex mechanisms

According to the instructions, Creon 10000 does not have a significant negative effect on the ability to work with complex mechanisms, drive a car and perform work that requires attention and speed of reactions.

Use during pregnancy and lactation

In animal studies, no toxic effects on reproductive function and fetal development have been identified, however, there are no clinical data on the treatment of pregnant women with preparations containing porcine pancreatic enzymes, so the drug is prescribed to them with caution if the expected benefit outweighs the potential risks.

Given the results of animal studies, in which the negative effects of pancreatic enzymes have not been identified, the harmful effects of Creon 1000 on an infant through mother's milk are also not expected. In this regard, the drug can be taken during lactation.

Both pregnant and breastfeeding women are advised to take the drug in moderate doses sufficient to maintain an adequate nutritional status.

Application in childhood

The use of Creon 10000 in childhood is possible according to the recommended dosing regimen.

In children, the risk of constipation increases with a high activity of the lipase contained in pancreatin, so increasing the dose should be carried out gradually.

drug interaction

Pancreatin interaction studies have not been conducted.

Pancreatin may reduce the absorption of concomitantly used iron preparations. Theoretically, it may reduce the clinical efficacy of acarbose.

Analogues

The analogues of Creon 10000 are: Gastenorm forte, Gastenorm forte 10000, Creon 25000, Creon 40000, Creon Micro, Mezim 20000, Mezim forte, Mezim forte 10000, Mikrazim, Pangrol 25000, PanziKam, Panzim forte, Pancreasim, Pancreatin, Pancreatin, Pancreatin forte LekT, Penzital, Enzistal-P, Ermital.

Terms and conditions of storage

Store in a tightly closed vial, out of the reach of children with temperatures up to 25 ° C.

Shelf life - 2 years, after the first opening of the bottle - 3 months.