Creon 1000 instructions for use for children. Creon - an expert solution to digestive problems

- all these phenomena that occur in the life of every person. Almost always we do not pay any attention to it. However, this is wrong. If these troubles began to "visit you" quite often, then they already pose a certain threat to you. In order not to become a "hostage" of digestive problems, it is best to consult a specialist doctor. To date, there are a huge variety of different enzyme preparations that will definitely be able to help you. In this article, the medical board of the site will tell you about Creon, one of the best enzyme preparations of modern pharmacology.

How does Creon work?

Indications for use

Let's dwell a little on the dosing regimen of this drug.

Side effects and contraindications

Each of you who takes or will take Creon should clarify one truth for himself - during the course of treatment with this drug, you should see your doctor as often as possible. It is very important.

I would like to draw your attention to the fact that today there are a large number of different dietary supplements (biologically active additives), the action of which is also directed towards the gastrointestinal tract. But in spite of everything, Creon 10,000 still remains one of the best enzyme preparations of our time!

Reviews

I read here that some people drink without a shell, pouring it into a spoon. It's like not drinking at all. The shell is needed so that Creon (other enzyme preparations are also made with a special shell) is not absorbed in the stomach !!! The drugs must act in the intestines, otherwise it's like drinking chalk - everything will dissolve in the stomach. People, do you think? that pharmacists are dumber than you, that they came up with a shell for such pills ???

Appointed by a doctor, with a problem with the pancreas Creon. I drank 1 capsule. The throat was swollen from the inside, wheezing began in the lungs, it was very difficult to breathe. Two days later she removed the effects of diazolin and drank thyme for a week, he helped to remove spasms. I don't drink Creon anymore.

Dibutyl phthalate is a primitive industrial plasticizer of bisphenols and dianes,
in general, it is believed that when bound, it evaporates very slowly, but this is only in theory, in fact, in its pure form, LUTO is harmful, and human contact with it is not desirable,
although it is not water soluble, it can be harmful in the form of vapors. For life, it is a cumulative carcinogen with a high degree of toxicity.
Therefore, the slightest violation of technology, well, you understand ... but in general it is used because it costs a penny.
By the way, the circle is like this, and not specific particulars,
the production of capsule shells is a standard process, not the achievements of a particular company.

Invented some more dibutyl phthalate!!! I didn't find anything like this in Creon's instructions. The drug has been on the market for a long time, the manufacturer is a proven company. I don’t think that for so many years they haven’t revealed the harm allegedly caused by this drug! The drug does not contain almost anything at all except enzymes, which are not even absorbed into the blood, and here about some kind of kidney depletion. In my opinion, you need to drink less soda and all that!

It's been one year since I never ate everything, only the custom and gradually lost weight. I have a disease of chronic pancreatitis and inflammation of the pancreas. Does Creon treat well. Please write what you can eat.

Five minutes after taking the cocoon, it throws me into a fever, my husband says that my face either turns white or reddens.
Today I took half a capsule without a shell, just poured the borders into a spoon and screamed with water. There was no such reaction.

Still, Creon is synthetic, and in order to avoid side effects, you need to take natural plant enzymes. I take enzymes (Canada), there is a mixture of 10 enzymes, it helps, and there are no unpleasant sensations.

Girls, how often can you take Creon. Child 1.5, stopped drinking 2 weeks ago, but poops often and thinly, the doctor prescribed Creon again

Nastya,
Sonya
what are you talking about?? Why wishful thinking, engage in misinformation and mislead people?? Creon was prescribed to my child by a very good and familiar doctor with 30 years of experience as a pediatrician, who immediately reassured us about these "terrible" phthalates, simply explaining that it really contains an insignificant amount, which does not affect the health of the body at all, and eat out in a timely manner. way! And the fact that you had problems with your kidneys there, there may be 1000 and 1 reason, to which Creon will have absolutely nothing to do. You know, I’m somehow more inclined to believe this person than anonymous reviews on the Internet, written by no one knows who and for what purpose ....

Tradename: Creon ® 10000

International non-proprietary name or grouping name:

pancreatin

Dosage form:

Compound:

1 capsule contains:

Active substance: pancreatin - 150 mg, which corresponds to: 10000 IU Evr.F. lipases, 8000 IU Evr.F. amylase, 600 IU Evr.F. proteases. Excipients: 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. Hard gelatin capsule: gelatin - 60.44 mg, iron dye red oxide (E 172) - 0.23 mg, iron dye yellow oxide (E 172) - 0.05 mg, iron dye black oxide (E 172) - 0.09 mg, titanium dioxide (E 171) - 0.07 mg, sodium lauryl sulfate - 0.12 mg.

Description: No. 2 hard gelatin capsules, consisting of brown opaque

caps and transparent colorless body.

The contents of the capsules are light brown minimicrospheres.

Pharmacotherapeutic group:

ATX code: A09AA02

Pharmacological properties

Pharmacodynamics

An enzyme preparation that improves digestion. Pancreatic enzymes, which are part of the drug, facilitate the breakdown of proteins, fats, carbohydrates, which leads to their complete absorption in the small intestine.

Creon ® 10000 contains porcine pancreatin in the form of mini-microspheres coated with an enteric (acid-resistant) shell in gelatin capsules. Capsules quickly dissolve in the stomach, releasing hundreds of mini-microspheres. This principle is designed to thoroughly mix the mini-microspheres with the intestinal contents, and ultimately to better distribute the enzymes after they are released within the intestinal contents. When the minimicrospheres reach the small intestine, the enteric coating is rapidly degraded (at pH > 5.5), enzymes with lipolytic, amylolytic and proteolytic activity are released, leading to 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, the absence of absorption of intact (non-digested) enzymes has been demonstrated, as a result of which classical pharmacokinetic studies have not been conducted. 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. They are proteins in their chemical structure and therefore undergo proteolytic cleavage as they pass through the gastrointestinal tract until they are absorbed as peptides and amino acids.

Indications for use

Replacement therapy for exocrine pancreatic insufficiency in children and adults. Exocrine pancreatic insufficiency is associated with a variety of diseases of the gastrointestinal tract and is most common in:

cystic fibrosis,

chronic pancreatitis,

After pancreatic surgery,

After gastrectomy,

pancreatic 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.

To avoid complications, use only after consulting a doctor.

Contraindications

Hypersensitivity to pancreatin of porcine origin or to one of the excipients,

acute pancreatitis,

Exacerbation of chronic pancreatitis.

Use during pregnancy and during breastfeeding

Pregnancy

Clinical data on the treatment of pregnant women with drugs containing pancreatic enzymes are not available. In animal studies, no absorption of porcine pancreatic enzymes has been detected, so toxic effects on reproductive function and fetal development are not expected.

The drug should be prescribed to pregnant women with caution if the intended benefit to the mother outweighs the potential risk to the fetus. breastfeeding period

Based on animal studies, during which there was no systematic negative effect of pancreatic enzymes, no harmful effect of the drug on the nursing child through breast milk is expected.

You can take pancreatic enzymes while breastfeeding.

If necessary, during pregnancy or lactation, the drug should be taken in doses sufficient to maintain an adequate nutritional status.

Dosage and administration

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 (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 liquid foods that do not require chewing and have an acidic 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.

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 at each meal for children under four years of age, and 500 lipase units / kg at mealtime for children over four years of age.

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 an adequate nutritional status.

In most patients, the dose should remain less than or not exceed 10,000 lipase units/kg body weight per day or 4,000 lipase units/g fat intake.

Dose for other conditions associated with exocrine pancreatic insufficiency

The dose should be determined taking into account the individual characteristics of the patient, which include the degree of indigestion and the fat content of the food. The dose required by the patient along with the main meal varies from 25,000 to 80,000 IU of lipase, and while taking a light snack, half the individual dose.

Side effects

Gastrointestinal disorders

Often (> 1/100,<1/10): тошнота, рвота, запор и вздутие живота.

Gastrointestinal disorders are associated mainly with the underlying disease. The incidence of the following adverse reactions was lower or similar to placebo: diarrhea (often, >1/100,<1/10), боли в области живота (очень часто, >1/10).

Skin and subcutaneous tissue disorders Uncommon (>1/1000,<1/100): сыпь. Частота неизвестна: зуд, крапивница. Immune System Disorders

Frequency unknown: hypersensitivity (anaphylactic reactions). Allergic reactions were observed mainly from the skin, but other manifestations of allergy were also noted. Reports of these side effects were received during the period of post-marketing use and were of a spontaneous nature. The available data are insufficient to accurately estimate the incidence of cases.

Overdose

Symptoms: hyperuricosuria and hyperuricemia. Treatment: drug withdrawal, symptomatic therapy.

Interaction with other drugs

Interaction studies have not been conducted.

special instructions

In patients with cystic fibrosis who received high doses of pancreatin preparations, strictures of the ileum, 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® 10000. As a precautionary measure, if unusual symptoms or changes in the abdominal cavity appear, a medical examination is necessary to rule out fibrosing colonopathy, especially in patients who take the drug at a dose of more than 10,000 lipase units / kg per day.

Like all currently used preparations of porcine pancreatin, Creon® 10000 is produced from the pancreatic tissue of pigs specially bred for human consumption. Although the risk of transmission of an infectious agent to humans has been minimized by screening and inactivation of certain viruses during the manufacturing process, there is a theoretical risk of transmission of a viral disease, including diseases caused by new or unknown viruses. The presence of swine viruses that can infect humans cannot be completely ruled out. However, over a long period of time using porcine pancreatic extracts, not a single case of transmission of an infectious disease has been registered.

Influence on the ability to drive a car and other mechanisms

The use of the drug Creon® 10000 does not affect or has a slight effect on the ability to drive a car and mechanisms.

Release form

Enteric capsules 10000 IU. 20, 50 or 100 capsules in a white high-density polyethylene bottle with a tamper-evident polypropylene screw cap. A label is attached to the bottle. 1 bottle with instructions for use in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25 ° C in a tightly closed container. Keep out of the reach of children!

Best before date

Shelf life after the first opening of the vial - 3 months.

Do not use after the expiry date stated on the packaging.

Terms of dispensing from pharmacies

Without recipe.

Name and legal address of the manufacturer

Abbott Products GmbH Hans-Bockler-Allee 20, 30173 Hannover, Germany.

Name and actual address of the manufacturer

Abbott Products GmbH Justus von Liebig Strasse 33, 31535 Neustadt, Germany.

Quality claims should be sent to:

LLC "Abbott Products" 119334, Russia, Moscow, st. Vavilov, d. 24.

Release form, composition and pack

Creon® 10 000

• 
  
• 
  Capsules hard gelatinous, two-color, transparent colorless body with brown opaque cap; the contents of the capsules are beige mini-microspheres. 1 caps. 150 mg with minimal enzymatic activity: lipases 10,000 IU Ph.Eur. amylase 8000 IU Ph.Eur. protease 600 U Ph.Eur. Excipients: macrogol, liquid paraffin, methylhydroxypropyl cellulose phthalate, dimethicone 1000, dibutyl phthalate. The composition of the capsule shell: red oxide (E172), black iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), gelatin.

Creon® 25 000

• 
  Capsules containing enteric microspheres.
• 
  Capsules hard gelatinous, two-color, transparent colorless body with brown opaque cap; the contents of the capsules are beige mini-microspheres. 1 caps. pancreatin 300 mg with minimal enzymatic activity: lipases 25,000 IU Ph.Eur. amylase 18,000 IU Ph.Eur. proteases 1000 U Ph.Eur. Excipients: macrogol 4000, liquid paraffin, methylhydroxypropyl cellulose phthalate, dimethicone, dibutyl phthalate. The composition of the capsule shell: iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), gelatin.

Clinico-pharmacological group: Enzyme product.

pharmachologic effect

An enzyme product that improves digestion. Pancreatic enzymes, which are part of the product, facilitate the digestion of proteins, fats, carbohydrates, which leads to their complete absorption. The drug has a specially designed dosage form - a gelatin capsule containing enteric-soluble minimicrospheres. Capsules quickly dissolve in the stomach, releasing hundreds of mini-microspheres. The purpose of the multi-unit dose principle, which is carried out in this case, is the mixing of the mini-microspheres with the intestinal contents and, ultimately, a better distribution of enzymes within the intestinal contents after their release. When minimicrospheres reach the small intestine, their enteric coating is destroyed, which entails the release of pancreatic enzymes with lipolytic, amylolytic and proteolytic activity, leading to the disintegration of fat, starch and lipid molecules.

Pharmacokinetics

Data on the pharmacokinetics of the Creon product are not provided.

Indications

Replacement therapy for exocrine pancreatic insufficiency in the following conditions:

• 
  pancreatectomy;
• 
  ductal obstruction due to neoplasm (for example, obstruction of the pancreatic ducts or common bile duct);
• 
  Shwachman-Diamond syndrome;
• 
  a decrease in the enzyme-forming function of the gastrointestinal tract in elderly patients.

For symptomatic therapy of digestive disorders in the following cases: conditions after cholecystectomy;

• 
  partial resection of the stomach (Billroth-I/II);
• 
  total gastrectomy;
• 
  duodeno- and gastrostasis;
• 
  biliary obstruction;
• 
  cholestatic hepatitis;
• 
  pathology of the terminal part of the small intestine;
• 
  overgrowth of bacteria in the small intestine.

Dosing regimen

The drug is taken orally, it is recommended to take 1/2 or 1/3 of a single dose at the beginning of a meal, and the rest with meals. The dose is determined individually, depending on the severity of the disease and the composition of the diet. Capsules or minimicrospheres should be swallowed whole, without breaking them or chewing them, drinking plenty of water.

• 
  When swallowing is difficult (for example, in young children or in senile patients), the capsules are carefully opened, and the minimicrospheres are added to liquid food that does not require chewing, or taken with liquid. Any mixture of minimicrospheres with food or liquid should not be stored and should be taken immediately after preparation. Crushing or chewing minimicrospheres, as well as adding them to food with a pH >5.5, leads to the destruction of their shell, which protects against the action of gastric juice.
• 
  In cystic fibrosis, the initial dose of lipase for babies under the age of 4 years is 1000 IU Ph. Eur. / kg for each meal, for babies over the age of 4 years - 500 IU Ph. Eur./kg 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 IU Ph. Eur./kg/day
• 
  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 (breakfast, lunch or dinner) varies from 20,000 to 75,000 IU Ph. Eur., during a light meal, about 5,000 to 25,000 IU Ph. Eur.
• 
  When treated with Creon, the average initial dose of lipase is 10,000-25,000 IU Ph. Eur. during the main meal. However, higher doses may be required to minimize steatorrhea and maintain good nutritional status. According to the usual clinical practice, the patient should receive at least 20,000 - 50,000 units of Ph with food. Eur. lipases.

To select the dose, Creon 10,000, Creon 25,000, Creon 40,000 should be used.

Side effect

On the part of the digestive system: infrequently - diarrhea, discomfort in the stomach, nausea. Other: allergic reactions.

Contraindications

• 
  high susceptibility to product components.

Pregnancy and lactation

The use of Creon during pregnancy and lactation (breastfeeding) is possible only if the expected positive effect of therapy for the mother outweighs the possible risk to the fetus or baby, due to the lack of reliable clinical data confirming the safety of the use of pancreatic enzymes in this category sick.

special instructions

Children with cystic fibrosis and taking Creon 25,000 for a long time should be under regular medical supervision.

In patients with cystic fibrosis who received high doses of pancreatin products, strictures of the ileum and caecum and colitis have been described. In studies by the "case-control" method, no data were obtained indicating the relationship between the occurrence of fibrosing colonopathy and the use of Creon.

As a precautionary measure to rule out colonic damage in patients with cystic fibrosis, it is recommended that any unusual symptoms or changes in the abdominal cavity be monitored, especially if the patient takes (calculated as lipase) more than 10,000 IU Ph. Eur./kg body weight/day The drug should be used only after consulting a doctor to prevent complications. Reception of Creon is allowed for patients who profess Islam and Judaism.

Influence on the ability to drive vehicles and control mechanisms

Creon 10000 is one of the most popular representatives of modern enzyme products. It is used for enzyme replacement therapy for pancreatic enzyme deficiency. To ensure maximum effect, it is important to consider how to take Creon 10000 correctly. It must necessarily enter the intestines at the same time as meals. Only in this case will the reproduction of the natural process of digestion be ensured, when enzymes are released in response to food entering the intestines.

Pancreatin in the preparation is contained in the form of granules or minimicrospheres with an enteric coating, which are enclosed in a gelatin capsule. After entering the stomach, the capsule disintegrates, and the minimicrospheres are mixed with chyme. A large number of granules and their small (0.7-1.25 mm) dimensions ensure uniform mixing of pancreatin with the contents of the stomach and unhindered evacuation into the intestine. There, the shell of the granules dissolves and the effect of the drug begins to appear.

Features of taking Creon 10,000 by adult patients

Creon 10000 is dispensed from pharmacies without a prescription. However, you should not self-medicate and make a decision to start taking this drug without consulting a doctor.

• Of course, if digestive problems arose due to nutritional errors or overeating, then medication is allowed to improve the condition.
• But if the violation of food digestion is physiological in nature, then the examination and prescription of a medicine by a doctor is a prerequisite.

The instructions for use indicate that the use of the drug for medicinal purposes should be carried out during meals or immediately after it. This also applies to snacks. The dose of Creon 10000 is selected by the doctor, taking into account the type of disease, the severity of its course, the composition of the food intake and the individual characteristics of the patient. The dosage of the drug is calculated by lipase. Recommended doses for adults:

• in case of insufficiency of pancreatic enzymes caused by diseases or malnutrition - 25,000-80,000 IU of lipase during each full meal and 10,000-40,000 with a snack;
• in cystic fibrosis, the dose is calculated taking into account the weight of the patient - 500 IU of lipase per 1 kg of body weight simultaneously with each meal.

Thus, single doses vary from 1 to 8 capsules, and their intake is not limited to the morning or evening and is required throughout the day during each meal.

• For example, a person with a body weight of 50 kg with cystic fibrosis needs to consume 25,000 lipid units during all meals. This corresponds to 2.5 capsules of the drug. In such cases, it may be more convenient to take a stronger form of release of the drug - Creon 25000, since 1 of its capsules will be enough.
• And a person with a body weight of 80 kg will need 4 capsules of Creon 10,000 under the same conditions, which corresponds to 40,000 IU of lipase. In such cases, it is more convenient to take Creon 40000, which will be enough to take 1 capsule with meals.

Sometimes patients, for convenience and accurate dosing, immediately purchase Creon with different contents of pancreatin. Then there is no need to separate the capsules.

If you have been prescribed Creon 10000 and you have difficulty swallowing gelatin capsules, then there is a simple way out of the situation. It is enough to pour the minimicrospheres from the capsule and take them mixed with soft liquid food that does not need to be chewed. Required condition:

• food should be acidic (pH< 5,5), например фруктовое пюре;
• suitable for these purposes and sour fruit juice (from apples, oranges, cherries).

The prepared mixture of Creon granules and food or drink should be drunk immediately. If there are no problems with swallowing the capsules, then they are swallowed whole with water.

It is forbidden to chew the medicine or mix minimicrospheres with liquids and food, the pH of which exceeds 5.5. This can cause destruction of the shell, resistant to acids, resulting in a decrease in the effectiveness of the drug and may cause irritation of the oral mucosa.

During treatment with the drug, it is necessary to drink water in sufficient quantities, since in other cases, constipation may develop.

• It is allowed to take the medicine for pregnant and breastfeeding women, if necessary, in the minimum effective doses.
• For children, the drug can be prescribed from birth in carefully selected individual doses.
• Patients suffering from cystic fibrosis who take high doses of the drug require special attention. They may develop a stricture of the colon, caecum, and ileum called fibrosing colonopathy. Such patients should monitor their well-being and, if abdominal pain or changes in the abdominal cavity occur, immediately consult a doctor for diagnosis.

In some cases, Creon 10000 may cause side effects:

• allergic reactions;
• epigastric pain;
• nausea;
• flatulence;
• stool disorder.

Often, digestive system disorders are associated with the underlying disease, and not with the use of Creon.

Overdose symptoms

When using the drug Creon 10000 in doses exceeding the recommended ones, an overdose may develop. This condition is characterized by hyperuricemia and hyperuricosuria, which are manifested by an increase in the content of uric acid, determined during a biochemical blood test. The symptoms of these conditions are:

• pain in the joints and muscles;
• increased sweating;
• headache;
• dizziness;
• abdominal pain;
• nervous tics.

To eliminate hyperuricemia and hyperuricosuria, symptomatic treatment is carried out and an appropriate diet is prescribed.

Contraindications for taking Creon 10000

The drug is characterized by good tolerance. Normalizing digestion, the remedy does not affect the motility of the gastrointestinal tract, the work of the biliary tract or the secretion of bile.

KNF (drug is included in the Kazakhstan National Formulary of Medicines)

ALO (Included in the Free Outpatient Drug Supply List)

Manufacturer: Abbott Laboratories GmbH

Anatomical-therapeutic-chemical classification: Multienzymes (lipase, protease etc.)

Registration number: No. RK-LS-5 No. 010897

Date of registration: 18.01.2018 - 18.01.2023

Limit price: 76.87 KZT

Instruction

• Russian

Tradename

Creon® 10000

International non-proprietary name

Dosage form

Compound

One capsule contains

active substance - pancreatin 150 mg, with minimal enzymatic activity: amylases - 8000 units Eur. F., lipases - 10000 Eur. F., proteases - 600 units Eur. F.,

Excipients

pellet core: macrogol 4000,

pellet shell: hypromellose phthalate, cetyl alcohol, triethyl citrate, dimethicone 1000,

capsule shell: gelatin, iron oxide anhydrousIII(E 172) , f iron oxide hydratedIII(E 172), iron oxide II, III(E 172), titanium dioxide (E 171), sodium lauryl sulfate.

Description

Hard, gelatin capsules, size No. 2, with a dark brown cap and a colorless body, filled with brown mini-microspheres (pellets)

Pharmacotherapeutic group

Digestive aids (including enzyme preparations). Digestive enzyme preparations. Pancreatin

ATX code А09AA 02

Pharmacological properties

Pharmacokinetics

It is known that intact enzymes are not absorbed, so classical studies on the pharmacokinetics of Creon® 10000 have not been conducted. For the implementation of the action of pancreatic enzymes, their absorption is not required. On the contrary, the full therapeutic effect is carried out in the lumen of the gastrointestinal tract. Since they are protein molecules, the enzymes are further proteolytically digested as they move through the gastrointestinal tract until they are absorbed as peptides or amino acids.

Pharmacodynamics

Creon® 10000 capsules contain pancreatin of porcine origin in the form of minimicrospheres coated with an enteric (acid-resistant) coating. The capsule shell quickly dissolves in the stomach, releasing hundreds of mini-microspheres. At the same time, minimicrospheres are mixed with chyme already in the stomach, which significantly increases the contact area of ​​the food bolus and pancreatic enzymes. When the minimicrospheres reach the small intestine, their enteric coating rapidly breaks down (at pH > 5.5), followed by the release of enzymes with lipolytic, amylolytic, and proteolytic activities, resulting in the disintegration of fat, starch, and protein molecules. The products of pancreatic digestion then undergo absorption or subsequent hydrolysis by intestinal enzymes.

Results of clinical studies

A total of 30 clinical studies of the effectiveness of Creon® in patients with exocrine pancreatic insufficiency were conducted. At the same time, 10 of them were placebo-controlled or studies that evaluated the effectiveness of treatment relative to the initial state, in patients with cystic fibrosis, chronic pancreatitis, or after surgical interventions. In all randomized, placebo-controlled trials, the primary endpoint was the superiority of Creon® over placebo in the primary efficacy parameter, the fat absorption coefficient (FAT). The KLL is calculated as a percentage of the amount of fat absorbed to the amount of fat excreted from the body with faeces. In placebo-controlled studies involving patients with exocrine pancreatic insufficiency (EPI), the mean KLL (%) with Creon® was higher (83.0%) than with placebo (62.6%). In other studies, regardless of design, the mean KPI at the end of treatment with Creon was the same as in placebo-controlled studies.

In all studies, regardless of the etiology of the disease, an improvement in specific symptoms (frequency and consistency of stools, flatulence) was shown.

Children

The effectiveness of the drug Creon® in patients with cystic fibrosis was demonstrated in 288 patients aged from newborns to adolescents. In all studies, the average QVZh in children by the end of treatment with Creon® exceeded 80%, regardless of age.

Indications for use

Replacement therapy for exocrine pancreatic insufficiency in children and adults associated with, but not limited to, the following conditions:

cystic fibrosis

chronic pancreatitis

condition after pancreatectomy

condition after complete or partial resection of the stomach (gastroenterostomy according to Billroth-II)

obstruction of the pancreatic ducts or common bile duct (including due to neoplasm)

Shwachman-Diamond syndrome

condition after an attack of acute pancreatitis during the recovery of enteral nutrition

Dosage and administration

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

Creon® 10000 capsules are taken orally during a meal or immediately after it. If it is necessary to take more than 1 capsule of Creon® 10000, 1 capsule is taken before, the rest - during a meal. The capsules should be swallowed whole, without breaking or chewing, with a sufficient amount of liquid. When swallowing is difficult (for example, in children or elderly patients), the capsules are carefully opened, and the minimicrospheres are added to soft food that does not require chewing, or taken with a drink. At the same time, the food or drink with which the mini-microspheres are mixed should be with a sour taste so that there is no premature release and destruction of enzymes (pH< 5.5). Это может быть яблочное пюре, йогурт или фруктовый сок, например, ананасовый, яблочный или апельсиновый. Любая смесь минимикросфер с пищей или с жидкостью не подлежит хранению и ее следует принимать сразу же после приготовления. Разжевывание или повреждение минимикросфер может нарушить защитную кишечнорастворимую оболочку, в результате чего преждевременное высвобождение энзимов может вызвать раздражение слизистой полости рта и/или снизить терапевтический эффект препарата. Также необходимо следить, чтобы минимикросферы не оставались в полости рта после приема пищи.

It is important to constantly take a sufficient amount of fluid, especially with increased fluid loss. Insufficient fluid intake can cause constipation.

If the patient has forgotten to take Creon® on time, the missed dose can be taken immediately after a meal. A much later reception is not advisable. During the next meal, you must take the usual dose of the drug. Do not take a double dose to make up for a missed dose.

Dose Selection for Children and Adults in Cystic Fibrosis

In cystic fibrosis, the dosage of the drug is selected by the attending physician.

Dosing should be based on body weight and calculated as 1000 units of lipase per 1 kg of body weight per meal for children under 4 years of age and 500 units of lipase per 1 kg of body weight per meal for the age category over 4 years .

The dosage and duration of treatment is determined depending on the severity of the disease, the results of the control of steatorrhea and the maintenance of a good nutritional status.

In most patients, the dose should not exceed 10,000 units of lipase/kg of body weight per day, or 4,000 units of lipase per gram of dietary fat.

Dosage for other conditions associated with exocrine pancreatic insufficiency.

Dosage and duration of treatment should be determined taking into account the individual characteristics of the patient, which include the degree of indigestion and the fat content of food. The dose required by the patient along with the main meals (lunch, breakfast or dinner) can vary from 25,000 to 80,000 units. lipase (Heb. F.), which is from 3 to 8 capsules of Creon® 10000, and when taking a snack between main meals, the dose is approximately half the individual dosage, or 1-4 capsules.

Side effects

Often

Abdominal pain*

Often

nausea, vomiting, flatulence, diarrhea, constipation*

Infrequently

Frequency unknown

hypersensitivity reactions (anaphylactic reactions), allergic skin reactions: urticaria, pruritus, fibrosing colonopathy**

*Gastrointestinal disorders are associated with the underlying disease. The incidence of abdominal pain and diarrhea was similar or lower than in the placebo group.

** Fibrosing colonopathy has been described in patients with cystic fibrosis taking high doses of drugs containing pancreatin (see "Special Instructions").

In clinical studies involving pediatric patients, no additional adverse reactions have been identified.

Contraindications

increased individual sensitivity to pancreatin of porcine origin or any other component of the drug

Drug Interactions

There are no reports of interaction with other drugs or other forms of interaction.

special instructions

Strictures of the ileocecal angle and large intestine (fibrosing colonopathy) have been described in patients with cystic fibrosis taking high doses of pancreatin. As a precautionary measure, it is recommended that all unusual symptoms or changes in the gastrointestinal tract be subjected to a thorough medical evaluation to rule out damage to the colon. Especially if the patient takes more than 10,000 units of lipase / kg of body weight per day.

Pregnancy and lactation

Creon® 10000 during pregnancy is prescribed with caution.

Due to the lack of systemic absorption of pancreatic enzymes, during breastfeeding, Creon® 10000 is prescribed in doses necessary to ensure adequate nutritional status.

Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Creon® 10000 does not affect the ability to drive a car and control machines and mechanisms.

Overdose

Symptoms: doses of Creon® 10000, much higher than therapeutic, can cause hyperuricosuria and hyperuricemia.

Treatment: drug withdrawal, adequate fluid intake, supportive measures.

Release form and packaging

20, 50, 100 capsules in white high-density polyethylene bottles, sealed with a screw cap with a tamper evident device. The bottles are labeled with self-adhesive paper. Each vial, together with instructions for medical use in the state and Russian languages, is placed in a pack of cardboard boxes.

For packing 20 capsules (alternative packaging).

10 capsules in a blister pack made of PVC film and aluminum foil.

2 blisters, together with instructions for medical use in the state and Russian languages, are placed in a cardboard box.

Storage conditions

Store below 25°C in a tightly closed container.

Keep out of the reach of children!

Shelf life

Do not use after the expiration date.

Do not use after 6 months after opening the vial.

Terms of dispensing from pharmacies

Without recipe

Name and country of the manufacturing organization

Abbott Laboratories GmbH, Germany.

Name and country of ownerregistration certificate

Name and country of the packaging organization

Abbott Laboratories GmbH, Germany

31535 Neustadt am Rübenberge, Justus-von Liebig Strasse 33.

Address of the organization accepting claims from consumers on the quality of products in the territory of the Republic of Kazakhstan:

Representative office of Abbott Laboratories S.A. in the Republic of Kazakhstan, Dostyk Ave. 117/6, Business Center "Khan Tengri-2", 050059, Almaty, Republic of Kazakhstan. Tel.: +77272447544, fax: +77272447644.

e-mail: [email protected]

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