What does Creon help with? Instructions for use. Creon - an expert solution to digestive problems

Improper digestion occurs in every second person. This is due to the fact that we do not take care of our stomach at all. After all, any food contains fat, protein and carbohydrates, but a person does not control their consumption. Consequently, digestion becomes difficult and we feel heaviness. To facilitate this process, it is necessary to take a pancreatic drug. One of the drugs that can provide the desired effect according to the instructions for use is Creon. Let's look at its composition and dosage for children and adults in more detail.

Composition of Creon

In Latin the medicine is called Kreon 1000, INN pancreatin. Release form: capsules. The active substance is pancreatin 150 mg, this corresponds to 1000 units of lipase, 8000 amylase and 600 units of protease. The capsule has a gelatin shell, its contents are a light brown minimicrosphere. Photos of the packaging and capsule are on the manufacturer’s website. Manufacturer: Germany; in Russia, claims must be sent to Abbott Products LLC.

What is the price?

The cost of the drug depends on the number of capsules in the package. Creon in a package of 20 capsules costs 270 rubles.

What does Creon help with - indications for use in children and adults

Treatment of insufficiency of exocrine pancreatic function is the most important indication for the use of Creon according to the instructions. So the enzyme preparation is prescribed:

with pancreatitis,
after pancreatic surgery,
during gastrectomy,
for pancreatic cancer.

Also significant indications for use are steatorrhea and intestinal flu. Another medicine according to the instructions may be included in the treatment of atopic dermatitis.

Analogues of Creon

If the cost of this drug does not suit you, then with the permission of your doctor you can replace it with a cheaper analogue, the composition of which is identical. Cheap analogues. The medications prescribed in the prescription are most often suggested to be replaced with the following:

1. Micrasim
2. Mezim Forte tablets
3. Festal
4. Pangrol
5. Panzinorm
6. Hermital

If you understand what the difference is, then each of them differs in dosage form, these are tablets or capsules, which can cover both hard and soft shells, and in the content of the main substance. One is to replace the Russian one, the other is imported.

Creon or Pancreatin, which is better?

These two drugs are essentially the same medicine. But they have minimal differences. So Pancreatin (in Latin Pancreatinum) begins to work in the stomach, and Creon in the intestines. The first is available in tablets and is much cheaper, so replacement is often carried out. What is best is often determined by the patient himself after treatment according to the instructions for use and his own feelings. Doctors have divided opinions on both drugs.

Creon 1000 instructions for use

The method of taking the medicine according to the instructions is internal. The capsules do not need to be chewed. It is enough to wash them down with water at the time specified according to the instructions for use of Creon 1000. The annotation states that the dose should be taken during or immediately after meals.

The enzyme preparation is also taken after small snacks. The dosage is selected individually and depends on the complexity of the disease and the diet. Since it is impossible to give a capsule to an infant, its contents (small granules) are added to liquid food, or better yet, to sour food. Don't expect the granules to dissolve, they won't.

Dosage Creon 1000 adults

The dose is calculated based on body weight. The initial phase should be 500 units/kg with meals. However, the dose should not exceed 1000 units/kg per day or 4000 units/g of fat eaten. For insufficient digestion, the dose can vary from 25,000 to 8,000 IU of lipase.

Instructions for use Creon 25000

The initial stage of treatment with Creon 25000 should be 500 units/kg with meals, but the dose should not exceed 1000 units/kg per day or 4000 units/g of fat eaten. Also taken with food.

Creon 10000 instructions for use for children

For children under 4 years of age, the dose cannot be more than 1000 units/kg for each meal. The dose for a newborn and infant is calculated by the pediatrician; there are no universal instructions for calculating the dosage. This can be either ¼ capsule in one dose three times a day, or ½ part for children over one year old.

Duration of taking the drug

Treatment usually lasts 14 days, but it may be prescribed for a longer period, and the therapy will last a month.

For atopic dermatitis, how to drink Creon?

If you are allergic to undigested food, then this enzyme will become an effective medicine. For babies under 6 months, the use of the product should correspond to the number of meals. That is, the capsule is divided by the number of feedings per day. According to doctors, in this case, give the granules along with water.

For gastritis

For gastritis, the dosage is 500 units/kg with meals. Here the prescription is prescribed based on the patient's diet.

During pregnancy and breastfeeding, instructions for use of Creon

During pregnancy and lactation this remedy is not prohibited. Even in the early stages, a dosage of 500 units/kg does not harm the fetus. During breastfeeding, it is recommended to drink Creon in such an amount that will maintain adequate nutritional status.

Creon is a drug that is often used for various digestive disorders. This drug consists only of natural ingredients, and due to its safety, it can be used to treat people of any age, including small children.

Description

The drug contains enzymes that are vital for our digestive tract. As you know, the food we eat, no matter whether it is of plant or animal origin, consists of three main components - carbohydrates, proteins and fats. However, in order for these compounds to be absorbed by the body, they must be processed with special enzymes. In humans, these enzymes are produced in one of the sections of the pancreas and are called amylase, lipase and protease. Amylase is responsible for the breakdown of carbohydrates, or, more precisely, starch, lipase is responsible for the breakdown of fats, and protease is responsible for the breakdown of proteins.

In a healthy person, the pancreas produces a sufficient amount of these enzymes. But if the activity of the pancreas is impaired for some reason, then there will be too few enzymes and food will not be properly digested. And this will lead not only to indigestion, but also to a lack of certain nutrients in the body.

Drugs such as Creon are designed to compensate for the lack of enzymes secreted by the pancreas. Creon contains all three necessary enzymes - lipase, amylase and protease. These substances are obtained from the pancreas of pigs. Together, all these enzymes are called pancreatin. This is also the international nonproprietary name of the drug.

The enzymes that make up the drug are packaged in special microscopic spherical capsules that are resistant to acidic environments. This is done specifically so that the enzymes can easily pass through the stomach and reach the small intestine. After all, the process of breaking down food should occur precisely in this section of the gastrointestinal tract. These secondary microscopic capsules dissolve only at pH levels greater than 5.5.

After entering the stomach, the outer gelatin capsule dissolves and the microspheres end up in the stomach cavity. In this case, the acid contained in the gastric juice is not able to dissolve the spherical capsules. However, upon reaching the intestines, the acidic environment changes to an alkaline one, as a result of which the microcapsule shells are destroyed and their contents come out.

The drug exerts its effect in the intestinal lumen. There is no absorption of the drug, as has been proven in animal experiments. This is easily explained, because enzymes, by their structure, themselves belong to proteins and are subsequently broken down into amino acids and peptides.

Indications for use of Creon

The drug is prescribed for various diseases and conditions associated with insufficient enzyme activity of the pancreas, as well as for other diseases of the gastrointestinal tract accompanied by digestive disorders. It could be:

in chronic form;
pancreatic tumors;
surgeries for resection of the stomach or intestines;
removal of the gallbladder or pancreas;
cholestatic hepatitis;
biliary obstruction;
Shwachman-Diamond syndrome;
digestive disorders of various ethologies;
cirrhosis;
duodenostasis and gastrostasis;
pathologies of the terminal part of the small intestine;
recovery from intestinal infections and diarrhea;
decreased enzyme activity of the pancreas caused by old age;
obstruction of the pancreatic or bile ducts;
bacterial overgrowth in the small intestine;
recovery from acute diarrhea in children.

First of all, the drug is used for chronic inflammation of the pancreas (pancreatitis). It is well known that pancreatitis leads to insufficient production of enzymes, resulting in pieces of undigested food in the intestines. This can cause fermentation and putrefactive processes in the intestines, leading to intoxication of the body and deterioration of well-being. In most cases, Creon is not the only remedy prescribed for pancreatitis and other diseases, but is one of the components of complex therapy.

Use of the drug in newborns

In newborns, the organs of the gastrointestinal tract are just forming, so they may experience various digestive disorders. The most common symptoms for which pediatricians prescribe Creon include:

constipation,
diarrhea,
indigestion of food,
bloating.

Release form

The drug is a gastrosoluble gelatin capsule, in turn, filled with microscopic spherical capsules with enzymes (pancreatin). The dosage of enzymes in capsules can be 10,000, 25,000 and 40,000 special units, indicating the activity of the main enzyme - lipase. There are no other forms of the drug.

Creon 10000 contains 150 mg of pancreatin, Creon 25000 - 300 mg, Creon 40000 - 400 mg.

In addition to lipase, Creon also contains protease and amylase. The table below shows the content of these enzymes in specific units for each type of tablet.

In addition to enzymes, the capsules contain the following substances:

macrogol,
hypromellose phthalate,
cetyl alcohol,
triethyl citrate,
dimethicone,
gelatin,
iron oxide,
sodium lauryl sulfate,
paraffin.

The composition of excipients is the same for all dosages of the drug.

The price of Creon depends on the dosage and number of capsules in the package. The approximate price for Creon 10000 20 capsules is about 300 rubles, Creon 25000 - 600 rubles, Creon 40000 - 1200 rubles.

Possible number of capsules per package for different dosages:

Creon 10000 – 10, 20, 25, 50;
Creon 25000 – 10, 20, 25, 50, 100;
Creon 40000 – 20, 50, 100.

Analogues of the drug

Analogs of the drug include Mezim, Mezim forte, Gastenorm forte, Pancreatin, Pangrol, Panzikam, Panzim forte, Ermital, Panzinorm and some other drugs. But before replacing Creon with these drugs, you should familiarize yourself with their composition and instructions. After all, it may well turn out that they are not suitable at all, either in composition or in indications. But even if the Creon analogue is structural, that is, it contains the same enzymes, it can be presented in a different dosage form, for example, in the form of tablets rather than capsules. And this can affect the effect of the drug, because the tablets dissolve in the stomach, and Creon is designed in such a way that the enzymes begin to act only in the intestines, which increases their effectiveness. Also, for some structural analogues, the dosage may not coincide with the dosage of Creon.

Varieties of the drug Creon 10000 and Creon 25000 are available in pharmacies without a prescription, and in order to receive Creon 40000, a doctor’s prescription is required. The shelf life of the drug is 2 years. The drug must be stored at a temperature not exceeding +20 ° C, in a dry place inaccessible to children.

Contraindications

In some cases the drug cannot be taken. According to the instructions for use of Creon, this applies primarily to cases of exacerbation of chronic diseases of the pancreas (for example, pancreatitis). You should not take the drug not only for acute pancreatitis, but even at the beginning of the recovery period after recently suffering acute pancreatitis. The drug should be taken with caution during pregnancy. In this case, it is better to ask your doctor for advice. Although cases of negative effects of the drug on the developing fetus are unknown. Also, the drug should not be used if the patient has a history of intolerance to pork pancreatin.

Children, including infants and newborns, are allowed to take the drug. However, treatment should be carried out under the close supervision of a specialist. The same applies to the use of the drug in older people. In both cases, regular examination of biochemical blood parameters is necessary.

Capsules with a dosage of 40,000 units can only be taken by adult patients. The preparations Creon 10000 and Creon 25000 are intended for children.

Interaction with other drugs

In general, due to its natural composition, Creon has a minimum of unwanted interactions. Thus, it can be used in conjunction with other medications intended to treat diseases of the gastrointestinal tract.

Concomitant use with antacid drugs containing calcium carbonate and magnesium hydroxide may lead to a decrease in pancreatin activity. When taken together with iron supplements, iron absorption may be reduced. It is not recommended to use the drug simultaneously with acarbose.

Side effects

Side effects when taking Creon are quite rare. It is no coincidence that Creon is approved for use in childhood. However, occasionally, phenomena such as allergic reactions (Quincke's edema, urticaria, dermatitis), nausea, diarrhea, constipation, and abdominal pain may occur. If you stop taking the drug, the above symptoms should disappear.

In case of an overdose of the drug in patients with cystic fibrosis, narrowing of the cecum and ileum is possible. Also, in case of an overdose, an increase in the level of uric acid in the blood or urine, nausea and vomiting, excessive salivation, and severe abdominal pain may occur. Treatment of overdose is symptomatic.

Preparations Creon 10000, 25000 and 40000 do not affect the reaction rate and can be used by people driving vehicles and other complex mechanisms. Is it possible to become infected with some kind of zoogenic infection, such as swine flu, when using the drug, given that its components are obtained from pigs? Such cases are excluded and have never been observed in practice, because the components undergo thorough processing, cleaning and testing.

Creon, instructions for use

The drug can be used only with the permission of a doctor. In addition, only a doctor can determine what dosage is necessary in each specific case. Creon can be administered into the body only orally, that is, by swallowing Creon 10,000, 25,000 or 40,000 tablets.

According to the instructions for use, Creon is recommended to be taken half an hour before meals, in some cases during meals. Or some part of a single dose can be taken before meals, and part after. The portion taken before meals can be half or one third, depending on the doctor’s prescription.

It is not advisable to take the drug after meals, but if the patient forgot to take the capsules during or before meals, then it is better to take the capsules after meals than to skip a dose.

According to the instructions for use, Creon must be taken in a single dose of 5,000 to 75,000 units, depending on the disease and the severity of the condition. Also, a lot depends on the diet that the patient adheres to, how dense the meal is, how much fat is contained in the diet. In general, most patients should keep in mind that the daily dose per kilogram of body weight should not exceed 10,000 units.

When compensating for pancreatic insufficiency, in the case of a normal meal (breakfast, lunch and dinner), a single dose of 25,000-75,000 units is used, in the case of a light snack - 5,000-25,000 units

Treatment of cystic fibrosis in children - children under 4 years of age take 1000 lipase units per kilogram of weight during meals, children over 4 years of age - 500 units.

According to the instructions for use, Creon must be swallowed whole. Under no circumstances should the capsule be chewed to avoid damaging the microspheres.

If a capsule is difficult for a patient (for example, a small child) to swallow, it can be opened and the microcapsules mixed with food or liquid. However, in no case should the liquid have an alkaline reaction, since the shell of the microcapsules may be damaged in this case. That is, the acidity of food or liquid must be less than pH 5.5. Therefore, you cannot drink the contents of the capsules with mineral water; it is better to take, for example, tea with lemon. Also, this mixture should not be stored for a long time.

The duration of treatment is determined by the doctor depending on the severity of the disease. It should be borne in mind that long-term use of the drug in large doses can lead to damage to the large intestine. In addition, during therapy with Creon, it is necessary to take a sufficient amount of fluid. This will help prevent constipation.

Creon is a medicinal drug that contains digestive enzymes of the pancreas. It is prepared from the pancreas of pigs, produced by the international pharmaceutical company Abbott.

Creon helps both patients with digestive disorders and healthy people with dietary errors (eating large amounts of fatty, starchy and fried foods, which accompany large feasts during festivals).

The substance extracted from the pancreas of slaughtered pigs is purified from various biological impurities, various microorganisms that are carried by pigs, dried and formed into a medicine in the form of granules or tablets. Various substances are added to the dried pancreatin, and a special shell is applied on top, which is resistant to the effects of gastric juice, thereby allowing the drug to reach the patient’s duodenum.

The drug Creon normalizes the digestion process, because it contains those enzymes that take an active part in it. The balanced enzyme composition of the drug Creon helps to digest proteins, carbohydrates and fats supplied with food, ensuring the complete breakdown and absorption of these substances.

Creon capsules stimulate the production of enzymes by the pancreas.

Used for gastrointestinal diseases, pancreatitis, gastrectomy, Shwachman-Diamond syndrome, to restore oral or enteral nutrition.

Release forms

Capsules 10,000, 25,000 and 40,000 (sometimes mistakenly called tablets).

Creon 10000 contains:
10000 IU lipase, 8000 IU amylase, 600 IU protease

Creon 25000 contains:
25,000 IU lipase, 18,000 IU amylase, 1000 IU protease.

Creon ® 40000:
1 capsule contains 400 mg of pancreatin in gastro-resistant granules (minimicrospheres™), which have enzymatic activity: lipase 40,000 units. EF, amylase 25000 units. EF, protease 1600 units. EF.

When the mini-microspheres reach the small intestine, the enteric coating is destroyed, releasing enzymes with lipolytic, amylolytic and proteolytic activity, which ensure the breakdown of fats, starches and proteins.

Indications for use Creon

The drug Creon is used for insufficiency of exocrine pancreatic function in children and adults caused by:

Pancreatectomy;
Cystic fibrosis;
Gastrectomy;
Chronic pancreatitis;
Pancreatic cancer.

Inside the package there must be instructions, following which you will be able to:

- improve food digestion;
— beneficial nutrients are fully absorbed in the body;
- activate the process of breaking down fats and starch.

In pediatric practice, this drug is prescribed to children in cases of severe syndrome of functional impairment of the pancreas as a result of its lag behind physiological development.

In addition, Creon is indicated for use as an adjuvant for intestinal dysbiosis, accompanied by excessive proliferation of pathogenic bacteria in the small and large intestines and a decrease in the activity of beneficial microflora.

Instructions for use of Creon, dosage

The dosage of the drug is based on the individual needs of the patient and depends on the severity of the disease and the composition of the food.

If swallowing is difficult (for example, in small children or elderly patients), Creon capsules are carefully opened, and minimicrospheres are added to liquid food that does not require chewing, or taken with liquid (such opened granules cannot be stored).

The dose of Creon is selected individually, depending on the nosology, the degree of digestive disorders and other factors. In most cases, the initial dosage is from 10 thousand to 25 thousand units of lipase during each meal.

The maintenance dosage is calculated depending on the nature of the food, the degree of exocrine pancreatic insufficiency and on average ranges from 20 thousand to 75 thousand units of lipase during each main meal and from 5 thousand to 25 thousand units of lipase during additional meals .

The standard dosage of Creon for adults is from 25,000 to 80,000 units, that is, 1-3 capsules of Creon 25,000 per meal and half this dose for a snack.

In case of insufficiency of pancreatic function for various nosologies, the dose is determined depending on the results of control of steatorrhea and the severity of symptoms of the disease to maintain 10,000 IU of lipase per 1 kg per day.

Pregnant and breastfeeding women are allowed to use Creon only under the supervision of a physician, even at a dosage of 10,000 units. The reason for this lies in the fact that the tablets have not been properly tested in these cases.

Features of application

The use of Creon® 10000 does not affect or has an insignificant effect on the ability to drive a car and operate machinery.

It should be remembered that ethanol worsens the digestive processes and adversely affects the breakdown of food, and also places a tremendous burden on the pancreas, therefore, when treating this organ, including through taking Creon, the consumption of alcohol-containing liquids is contraindicated.

During treatment with Creon 10000, Creon 25000, Creon 40000, it is very important to drink enough fluid, especially during periods of increased loss. A lack of fluid can cause constipation.

No undesirable interactions of Creon with other drugs have been identified.

It must be remembered that if there is a need to use several drugs, the interval between their use should not be less than 5 minutes. This applies to both children and adults.

It is important to use the drug with every meal, be it a full lunch or a light snack before dinner: then the absorption of nutrients from the food you eat during the day will be at the level of your body's needs.

Side effects and contraindications Creon

Side effects of Creon:

pain in the epigastric region;
constipation;
changes in stool;
diarrhea;
nausea,
vomit;
skin manifestations;
hypersensitivity reactions.

In addition, as with any other drug, you may be allergic to Creon. Most often it manifests itself in the form of an allergic rash.

Overdose

When taking extremely large doses of Creon, hyperuricemia and hyperuricosuria may occur. In case of an overdose of Creon, a large amount of uric acid salts may appear in the patient’s blood and urine.

Most cases of drug overdose occur in patients with cystic fibrosis. If a doctor makes this diagnosis, then the dosage of the drug used should not exceed 10,000 units. Otherwise, narrowing of the cecum and ileum may occur.

Contraindications Creon

Creon is not recommended for use if the patient is hypersensitive to the drug or its components. In addition, the main contraindications to the use of the drug Creon are acute pancreatitis, as well as chronic pancreatitis in the acute stage.

Also, Creon should not be used in the early stages of pancreatitis. When using Creon by children for a long time, it is necessary to undergo regular monitoring by a specialist.

The use of the drug 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 child, due to the lack of reliable clinical data confirming the safety of the use of pancreatic enzymes in this categories of patients.

Analogues of Creon, list of drugs

You should discuss the duration, dose and frequency of taking Creon for pancreatitis with your doctor. Creon can be used once, as a course or continuously. It all depends on the severity of the disease and its course. Sometimes it is necessary to take it constantly, but adjust the dose. During remission - decrease, during relapse - increase. Sometimes it can be combined or replaced with other drugs.

Based on the active component, analogues of Creon include medications in the form of capsules and tablet forms:

Mezim forte,
Vestal,
Biozyme,
Gastenorm forte,
Micrasim,
Pancreatin,
Panzim forte,
PanziCam,
Pancitrate,
Uni-Festal,
Hermital.

Pancreazim;
Penzital;
Panzinorm 10000;
Panzinorm forte 20000;
Pancreatin for children.

Important - instructions for use of Creon, price and reviews do not apply to analogues and cannot be used as a guide to the use of drugs of similar composition or action. All therapeutic prescriptions must be made by a doctor. When replacing Creon with an analogue, it is important to consult a specialist; you may need to change the course of therapy, dosages, etc.

Don't self-medicate!

Creon is an enzyme medicine used to improve digestion for adults and children.

The mechanism of action of the drug is the mixing of pancreatin mini-microspheres with intestinal contents. After the minimicrospheres reach the small intestine, at a pH level greater than 5.5, the enteric membrane is destroyed.

Due to the release of pancreatic enzymes with amylolytic, lipolytic and proteolytic activity, a more complete breakdown of food components (fats, carbohydrates and proteins) occurs.

Clinical and pharmacological group

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

Conditions for dispensing from pharmacies

Dispensed without a doctor's prescription.

Prices

How much does Creon 10000 cost? The average price in pharmacies is 300 rubles.

Release form and composition

The medication is produced in the form of enteric hard capsules containing light brown mini-microspheres - pancreatin (active component):

Creon 10000 – containing 150 mg of pancreatin (which corresponds to 10,000 units of Ph.Eur. lipase);
Creon 25000 – containing 300 mg of pancreatin (which corresponds to 25,000 units of Ph.Eur. lipase);
Creon 40000 – containing 400 mg of pancreatin (which corresponds to 40,000 units of Ph.Eur. lipase).

When using the medication for children, it should be taken into account that Creon 1000 is not produced, and in pediatrics they use Creon 10000, the dose of which is calculated by the doctor based on the age and body weight of the child.

The medicine is produced in bottles of 20, 50 and 100 pieces.

Pharmacological effect

Creon contains porcine pancreatin in the form of enteric-coated minimicrospheres. The contents of the capsule are resistant to acidic environments and quickly dissolve, releasing granules. This ensures excellent mixing of the drug with the contents of the stomach, transportation to the intestines and good distribution of enzymes in it.

When the microspheres enter the small intestine, the shell dissolves, releasing lipolytic, amylolytic and proteolytic enzymes. They ensure the breakdown of fats, carbohydrates and proteins. After pancreatic digestion, products are absorbed immediately or after hydrolysis by intestinal enzymes of the intestinal contents. According to research, the effect of the drug is manifested in the lumen of the gastrointestinal tract.

According to the scientists who conducted the experiments, the drug does not exhibit toxicity in the small intestine and other parts of the intestine.

Indications for use

The drug Creon 10000 is used in replacement therapy for exocrine pancreatic insufficiency due to impaired production of enzymes or their excessive destruction in the intestinal lumen against the background of gastrointestinal pathologies.

As a rule, Creon is prescribed for pathological conditions such as:

Cystic fibrosis;
After surgery on the pancreas;
Obstruction of the pancreas or bile ducts;
After gastric gastrectomy;
Partial removal of the stomach;
Chronic pancreatitis;
After a recent attack of acute pancreatitis;
Shwachman-Diamond syndrome;
Pancreatic oncology;
In preparation for x-ray or ultrasound diagnostics of the abdominal organs.

Contraindications

Creon's list of contraindications is modest. Even infants who are breastfed can take it, but sometimes they have to refrain from taking the medicine due to contraindications.

It is not allowed to take the drug if you have an individual intolerance to one of the components included in Creon-10000. If a child swallows a capsule and has an allergic reaction, you must immediately stop taking the medication. You cannot start treatment on your own without a thorough examination by a doctor. Hyperfunction of the pancreas is a direct contraindication to taking enzymes.

Use during pregnancy and lactation

There is no data on how safe it is to take Creon during pregnancy and lactation. This applies to any pancreatic enzymes in general. Therefore, the use of the drug is permissible only when the expected benefit from treatment for the mother significantly exceeds the likely danger to the fetus or baby.

Dosage and method of administration

The instructions for use indicate: Creon 10000 capsules are taken orally during meals or immediately after each meal, including light snacks. They must be swallowed whole and washed down with sufficient liquid.

For patients who have difficulty swallowing and children, the capsules may be carefully opened and the minimicrospheres contained in them may be added to soft, sour-tasting, non-chewable foods or taken with sour-tasting liquids. Foods acceptable for mixing 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 disease, the composition of the diet and the patient’s body weight.
For cystic fibrosis, at the beginning of treatment, adults and children over 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 control of steatorrhea and individual sensitivity, the dose can be adjusted. For most patients, the daily dose does not exceed 10,000 units/kg of body weight or 4,000 units/g of fat consumed.
For other conditions accompanied by pancreatic enzyme deficiency, the dose is determined depending on the individual characteristics of the patient, including the degree of digestive insufficiency 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 as prescribed by a doctor.

Side effects

The drug is well tolerated by patients. In some cases, with increased individual sensitivity to enzymes, the following side effects may develop in patients during therapy with Creon:

Allergic reactions - skin rash, hyperemia, severe itching, urticaria;
From the digestive canal - pain in the epigastric region, nausea, increased salivation, vomiting, constipation, bloating, increased appetite;

In rare cases, angioedema or anaphylaxis may develop.

Overdose

Salivation;
Severe abdominal pain;
Nausea and vomiting.

The development of hyperuricosuria and hyperuricemia is possible. If the patient develops signs of overdose, symptomatic treatment is carried out.

Special instructions

Before you start using the drug, read the special instructions:

Chewing, crushing or adding minimicrospheres to food with a pH greater than 5.5 leads to the destruction of their shell, which protects against the action of gastric juice.
During treatment, it is important to ensure adequate fluid intake, because lack of fluid can lead to increased constipation.
To exclude colon lesions, it is recommended as a precaution in patients with cystic fibrosis to monitor any unusual symptoms or changes in the abdominal cavity, especially in patients taking more than 10,000 IU lipase/kg per day.
Children with cystic fibrosis taking Creon 25000 for a long time should be under constant medical supervision.
The drug Creon can be taken by patients who profess Judaism and Islam.

The drug does not have a negative effect on the speed of reactions and the ability to concentrate.

Drug interactions

Clinical studies on the interaction of the drug with other medications have not been conducted.

If a person, in addition to Creon-10000, is forced to take other medications, it is better not to take risks and leave a gap of at least 2 hours between taking medications and taking enzymes.

P N 015581/01

Trade name: Creon ® 10000

International nonproprietary name or generic name:

pancreatin

Dosage form:

enteric capsules

Compound:

1 capsule contains:

Active substance: pancreatin - 150 mg, which corresponds to: 10,000 units EUR.F. lipase, 8000 units Eur.F. amylase, 600 units Eur.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, red iron oxide dye (E 172) - 0.23 mg, yellow iron oxide dye (E 172) - 0.05 mg, black iron oxide dye (E 172) - 0.09 mg, titanium dioxide (E 171) - 0.07 mg, sodium lauryl sulfate -0.12 mg.

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

cap and transparent colorless body.

The contents of the capsules are minimicrospheres of light brown color.

Pharmacotherapeutic group:

digestive enzyme agent

ATX code: A09AA02

Pharmacological properties

Pharmacodynamics

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

Creon ® 10000 contains porcine pancreatin in the form of minimicrospheres, enteric-coated (acid-resistant) in gelatin capsules. The capsules quickly dissolve in the stomach, releasing hundreds of minimicrospheres. This principle is designed to thoroughly mix the minimicrospheres 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 rapidly destroyed (at pH > 5.5), releasing enzymes with lipolytic, amylolytic and proteolytic activity, resulting in the breakdown of fats, carbohydrates and proteins. The resulting substances are then either absorbed directly or undergo further hydrolysis by intestinal enzymes.

Pharmacokinetics

Animal studies have demonstrated a lack of absorption of intact (uncleaved) enzymes and, as a result, classical pharmacokinetic studies have not been performed. Drugs containing pancreatic enzymes do not require absorption to produce 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, therefore, when passing through the gastrointestinal tract, they undergo proteolytic cleavage until they are absorbed in the form of peptides and amino acids.

Indications for use

Replacement therapy for exocrine pancreatic insufficiency in children and adults. Insufficiency of exocrine pancreatic function is associated with a variety of diseases of the gastrointestinal tract and most often occurs with:

Cystic fibrosis,

Chronic pancreatitis,

After pancreatic surgery,

After gastrectomy,

pancreatic cancer,

Partial gastrectomy (for example, Billroth II),

Obstruction of the pancreatic duct 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 porcine pancreatin or to one of the excipients,

Acute pancreatitis,

Exacerbation of chronic pancreatitis.

Use during pregnancy and breastfeeding

Pregnancy

There are no clinical data on the treatment of pregnant women with drugs containing pancreatic enzymes. Animal studies have not revealed the absorption of pancreatic enzymes of porcine origin, therefore toxic effects on reproductive function and fetal development are not expected.

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

Based on animal studies in which no systematic negative effects of pancreatic enzymes were detected, no harmful effects of the drug on the nursing infant through breast milk are expected.

You can take pancreatic enzymes while breastfeeding.

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

Directions for use and doses

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, without breaking or chewing, and with sufficient liquid.

If swallowing is difficult (for example, in young children or elderly patients), the capsules are carefully opened and the minimicrospheres are added to liquid foods that do not require chewing and have 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 that the patient maintains sufficient fluid intake at all times, especially if there is increased fluid loss. Inadequate fluid intake can cause or worsen constipation.

Dose for adults and children with cystic fibrosis

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

The dose should be determined depending on the severity of symptoms of the disease, the results of control of steatorrhea and the maintenance of 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 accompanied by exocrine pancreatic insufficiency

The dose should be set taking into account the individual characteristics of the patient, which include the degree of digestive insufficiency and the fat content of food. The dose required by the patient with the main meal varies from 25,000 to 80,000 units of lipase, and half the individual dose when taking a snack.

Side effects

Gastrointestinal disorders

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

Gastrointestinal disorders are mainly associated with the underlying disease. The incidence of the following adverse reactions was lower or similar to that observed with placebo: diarrhea (common, >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 on the skin, but other manifestations of allergies were also noted. Reports of these side effects were received during post-marketing use and were spontaneous. There are insufficient data to accurately estimate the incidence of cases.

Overdose

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

Interaction with other drugs

No interaction studies have been conducted.

Special instructions

In patients with cystic fibrosis who received high doses of pancreatin preparations, strictures of the ileum, cecum and colon (fibrosing colonopathy) have been described. In case-control studies, there was no evidence of a relationship between the occurrence of fibrosing colonopathy and the use of Creon® 10000. As a precaution, if unusual symptoms or changes in the abdominal cavity occur, a medical examination is necessary to exclude fibrosing colonopathy. 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 porcine pancreatin preparations, Creon® 10000 is produced from pancreatic tissue from pigs specially raised for human consumption. Although the risk of transmission of an infectious agent to humans has been minimized by testing and inactivation of certain viruses during the manufacturing process, there is a theoretical risk of transmission of viral disease, including diseases caused by new or unknown viruses. The presence of swine viruses that can infect humans cannot be completely excluded. However, over a long period of time using porcine pancreas extracts, not a single case of infectious disease transmission has been recorded.

Effect on the ability to drive a car and other mechanisms

The use of Creon® 10000 does not affect or has an insignificant effect on the ability to drive a car and operate machinery.

Release form

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

Storage conditions

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

Best before date

Shelf life after first opening the bottle is 3 months.

Do not use after the expiration date stated on the package.

Conditions for dispensing from pharmacies

Over the counter.

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 complaints should be sent to: