Creon for children: indications, method of application, reviews. Creon for children: application features Reviews of Creon

SOLVAY PHARMA Bofur Ipsen Industry Solway Pharmaceuticals GmbH Abbott Laboratories GmbH Abbott Products GmbH

Country of origin

Germany Netherlands France

Product group

Digestive tract and metabolism

Enzyme preparation

Release forms

capsules - 20 pcs.

Description of the dosage form

Capsules hard gelatin, two-color (colorless transparent body and brown opaque cap); the contents of the capsules are enteric microspheres of beige color

pharmachologic effect

An enzyme preparation that improves digestion. Pancreatic enzymes, which are part of the drug, facilitate the digestion of proteins, fats, carbohydrates, which leads to their complete absorption. Creon capsules containing enteric-coated minimicrospheres quickly dissolve in the stomach, releasing hundreds of minimicrospheres. The aim of the multi-unit dose 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 breaks down (at pH>5.5), pancreatic enzymes are released with lipolytic, amylolytic and proteolytic activity, leading to the disintegration of fat, starch and lipid molecules.

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, in their chemical structure they are proteins and, in this regard, when passing through gastrointestinal tract undergo proteolytic cleavage until they are absorbed as peptides and amino acids.

Special conditions

The drug should not be taken orally for early stages acute pancreatitis. Children with cystic fibrosis and taking Creon® 25,000 for a long time should be under regular medical supervision. In patients with cystic fibrosis treated with high doses of pancreatin, strictures of the ileum and caecum and colitis have been described. In studies by the "case-control" method, no data were obtained indicating a relationship between the occurrence of fibrosing colonopathy and the use of Creon®. As a precautionary measure to rule out colonic involvement, any unusual symptoms or changes in the abdominal cavity should be monitored - especially if the patient is taking (as lipase) more than 10,000 IU Ph. Eur./kg body weight/ Creon® is allowed for patients who profess Islam and Judaism. Influence on the ability to drive vehicles and control mechanisms The drug does not affect the ability to drive a car and to control machines and mechanisms.

Composition

pancreatin 150 mg with minimal enzymatic activity: lipases 10,000 IU Ph.Eur. amylase 8000 IU Ph.Eur. protease 600 U Ph.Eur. Excipients: macrogol 4000, liquid paraffin, methylhydroxypropyl cellulose phthalate, dimethicone 1000, dibutyl phthalate. The composition of the capsule shell: gelatin, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172), titanium dioxide (E171).

Creon 10000 indications for use

Replacement therapy insufficiency exocrine function pancreas in the following conditions: - cystic fibrosis; - chronic pancreatitis; - pancreatectomy; - pancreas cancer; - duct obstruction due to neoplasm (for example, obstruction of the pancreatic ducts or common bile duct); - Shwachman-Diamond syndrome; - Decreased enzyme-forming function of the gastrointestinal tract in elderly patients. For symptomatic therapy violations of the digestive processes in the following cases: - conditions after cholecystectomy; - partial resection of the stomach (Billroth-I/II); - total gastrectomy; - duodeno- and gastrostasis; - biliary obstruction; - cholestatic hepatitis; - cirrhosis of the liver; - pathology of the terminal part of the small intestine; - bacterial overgrowth in the small intestine.

◊ caps. enteric 150 mg: 20, 50 or 100 pcs. Reg. No.: P N015581/01

Clinico-pharmacological group:

Enzyme preparation

Release form, composition and packaging

◊ 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.

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

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.

Description of the active ingredients of the drug Creon ® 10 000»

pharmachologic effect

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, which leads 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.

Indications

Replacement therapy of exocrine pancreatic insufficiency in children and adults, caused by a variety of diseases of the gastrointestinal tract and most common in:

- cystic fibrosis;

— chronic pancreatitis;

- after surgery on the pancreas;

- after gastrectomy;

- pancreatic cancer;

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

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

- Shwachman-Diamond syndrome;

- condition after an attack of acute pancreatitis and resumption of nutrition.

Dosing regimen

The drug is taken orally. 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 minimicrospheres are added to soft food that does not require chewing and has a sour taste (pH<5.5), или принимают с жидкостью, также имеющей кислый вкус (рН<5.5). Например, минимикросферы можно добавлять к
applesauce, yogurt, or fruit juice (apple, orange, or pineapple) with a pH less than 5.5. Not
it is recommended to add the contents of the capsules to hot food. Any mixture of minimicrospheres with food or liquid is not
must be stored and should be taken immediately after preparation.

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

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 cystic fibrosis depends on body weight and should be at the beginning of treatment 1000 lipase units / kg for each meal for children under 4 years old, and 500 lipase units/kg at mealtime for children over 4 years old and adults. 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. For 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.

At 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 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. In children, the drug should be used in accordance with the doctor's prescription.

Side effect

From the digestive system: very often (≥1 / 10) - pain in the abdomen; often (≥1/100,<1/10) - тошнота, рвота, запор, вздутие живота, диарея; частота неизвестна - стриктуры подвздошной, слепой и толстой кишки (фиброзирующая колонопатия). Желудочно-кишечные расстройства связаны главным образом с основным заболеванием. Частота возникновения таких нежелательных реакций как боль в области живота и диарея была ниже или схожей с таковой при применении плацебо. Стриктуры подвздошной, слепой и толстой кишки (фиброзирующая колонопатия) наблюдались у пациентов с муковисцидозом, получавших высокие дозы препаратов панкреатина.

From the skin and subcutaneous tissues: infrequently (≥1/1000,<1/100) - сыпь; частота неизвестна - зуд, крапивница.

From the immune system: 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.

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

Contraindications

- hypersensitivity to any of the components of the drug.

Pregnancy and lactation

There are no clinical data on the use of drugs containing pancreatic enzymes during pregnancy. Prescribe the drug Creon ® 10,000 during pregnancy with caution if the intended benefit to the mother outweighs the potential risk to the fetus.

During 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. preparation Creon ® 10 000.

During experimental studies no systemic negative effects of pancreatic enzymes have been identified, therefore, no harmful effects of the drug on an infant are expected when breastfeeding.

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

special instructions

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. 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 taking the drug at a dose of more than 10,000 lipase units / kg body weight / day.

Like all currently used preparations of porcine pancreatin, Creon ® 10000 is produced from the pancreatic tissue of pigs specially grown for human consumption. While the potential for transmission of an infectious agent to humans has been minimized by testing and inactivating 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 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.

Overdose

Symptoms: hyperuricosuria and hyperuricemia.

Treatment: drug withdrawal, symptomatic therapy.

drug interaction

Terms of dispensing from pharmacies

The drug is approved for use as a means of OTC.

Terms and conditions of storage

The drug 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.

drug interaction

Studies on the interaction of the drug Creon ® 10,000 with other drugs have not been conducted.

ABBOTT PRODUCTS GmbH (Germany)

ATX: A09AA02 (Multienzymes (lipase, protease etc.))

Enzyme preparation

ICD: C25 Pancreatic malignancy E84 Cystic fibrosis K83.1 Bile duct obstruction K85 Acute pancreatitis K86.1 Other chronic pancreatitis K86.8 Other specified diseases of the pancreas (atrophy, stones, cirrhosis, pancreatic fibrosis) K90.3 Pancreatic steatorrhea K91 .1 Syndromes of the operated stomach K91.2 Malabsorption after surgery, not elsewhere classified

An enzyme preparation that improves 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, which leads 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.

Indications

Contraindications

- hypersensitivity to any of the components of the drug.

Dosage

The drug is taken orally. 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...

Overdose

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

drug interaction

Studies on the interaction of the drug Creon 10,000 with other drugs have not been conducted.

Side effect

From the digestive system: very often (≥1 / 10) - pain in the abdomen; often (≥1/100, see full

During pregnancy and lactation

There are no clinical data on the use of drugs containing pancreatic enzymes during pregnancy. Prescribe Creon 10,000 during pregnancy with caution if the expected benefit to the mother outweighs the potential ...

Use in children

Application is possible according to the dosing regimen.

special instructions

Special admission conditions

use with caution during pregnancy, may be used while breastfeeding, may be used for children

Pharmacokinetics

Terms of dispensing from pharmacies

The drug is approved for use as a means of OTC.

Storage conditions

The drug 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.
1 caps.
pancreatin
150 mg
which matches...

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Such manifestations in children have certain reasons. This is the imperfection of the secretory function of the digestive glands, and the underdevelopment of the smooth muscles of the children's intestines, which is responsible for, as well as the absence or lack of enzymes involved in the digestion of food. Creon helps improve this process , but to prescribe a dose for each individual child, as well as to determine how many days to drink the drug, you should consult a specialist.

The composition of the drug

The composition of the drug includes pancreatin, which is obtained by extracting from the pancreas in pigs. The therapeutic effect of the use of this drug is achieved when it enters the stomach.

One capsule of Creon, consisting of digestive enzymes, contains the dose recommended for children:

lipase – 5000 units;
protease - 200 units;
amylase - 3600 units.

Creon 10,000 is not a medicine as such, because it does not contribute to the development of a child, but simply supplies them in finished form. This therapy is called replacement therapy. As soon as the drug is stopped, the problem can reappear, therefore, Creon capsules are usually given to children as part of complex therapy.

The active compound Creon 10,000 is a microsphere placed in a special gelatin capsule, which dissolves upon contact with the internal environment of the gastrointestinal tract. After release, the microspheres are mixed with gastric contents and then pass into the small intestine, where the final dissolution of the drug occurs and its active enzymatic action begins, due to which the breakdown and absorption of proteins, carbohydrates and fats occurs.

Is it possible to give Creon to a child?

The drug is suitable for the treatment of disorders in the digestive tract, not only in adults, but also in children. Naturally, for a one-year-old baby and older patients, the doctor can prescribe how many days to drink this remedy and in what quantity, only after a preliminary diagnosis. The use of Creon capsules helps to improve digestion in case of insufficiency of the enzymatic activity of substances secreted by cells.

Creon for a child up to a year

The first year of a baby's life is often accompanied by such an unpleasant condition as colic. In some situations, doctors recommend that young children drink Creon. The active compounds contained in it help the absorption of food, but the drug does not affect the production of pancreatic enzymes, so after stopping use, it may happen that unpleasant symptoms resume.

There are some features of the appointment of Creon and its dosage for children up to a year . If the baby eats only mother's milk, then it is necessary to offer him clean water to drink in order to provide protection against the appearance.

How to give Creon to a one-year-old child? The method of using the drug in this case will differ from that in an adult patient. The Creon 10000 capsule must be carefully opened, mixed with liquid or baby puree, only half of the total number of microspheres and given to the baby without delay, since the drug may be inactivated, being unprotected by a gelatin capsule.

Indications and contraindications

According to the information specified in the instructions for use of the drug, Creon can be given to 10,000 children with the following diseases and conditions of the digestive system:

Chronic inflammation of the pancreas ().
Congenital hereditary disease cystic fibrosis.
Functional insufficiency of pancreatic enzymes, in which the use of Creon allows a 1-year-old child to fully eat and develop.
Symptoms associated with diarrhea . At the same time, a complex therapy is prescribed for a small patient, and doctors also recommend drinking plenty of water, especially in summer , to prevent dehydration.
The use of Creon is indicated for colic in children under one year old.

The therapeutic dose of the drug, the regimen and duration of treatment with Creon in childhood should comply with the recommendations specified in the instructions for use. It is not necessary to exceed the allowable period of drug use in infants and toddlers up to a year, this may adversely affect the synthesis of pancreatic enzymatic substances.

Among the contraindications to the use of Creon, the following diseases can be distinguished, which must be excluded before taking medicine for children:

and exacerbation of its chronic course.
Individual intolerance to the constituent components of the drug.

Instructions for use

Self-medication with Creon can lead to various side effects in children; only a doctor should prescribe therapy after diagnostic measures. Starting Creon therapy for children, you should carefully read the instructions for use.

The dose of the drug is determined by the doctor depending on the severity of the disease, the characteristics of its course and the age of the child. Exceeding the recommended amount of Creon 10,000 for the treatment of children may cause an overdose.

Before starting therapy with Creon, it should be noted that the instructions for use have special instructions on how to give the drug to children under the age of three. The child must necessarily fully eat and eat enough food per day so that the enzymatic substances can act and not harm the mucous membranes of the stomach and intestines. It is also required to ensure that the baby drinks plenty of water, which is necessary to prevent constipation. The daily dosage of Creon for children should be divided into three equal parts and allowed to drink capsules before meals.

The main issue that worries parents when a pediatrician prescribed Creon to a child under the age of one year is how to give medicine. For babies who are not yet able to swallow gelatin capsules, or this causes them to gag, it is allowed to open the shell and mix the contents of the pill with water or food. This has already been said above.

What are the features of the use of Creon and how many capsules should children take? The dosage depends on age. Babies are prescribed Creon with a content of pancreatin 10,000 IU . It is necessary to consume 1-2 capsules before each full meal. Babies should only mix half the contents of the pill with food.

Side effects

The use of the drug in children in some cases may be accompanied by the occurrence of side effects:

Allergy to Creon not previously manifested in a child;
problems with bowel movements, such as constipation or diarrhea;
pain and discomfort in the epigastric region.

In order to avoid the occurrence of an overdose of the Creon drug in a child, it is necessary before taking it , carefully read the information leaflet, which indicates possible complications and contraindications. With extreme caution, it is necessary to approach the treatment of a child up to a year with Creon. Children who are exclusively breastfed can take children's Creon, but strictly following all the doctor's recommendations.

Analogues

Creon is suitable for children of different ages, however, when individual intolerance occurs, they give analogue drugs that have a similar composition and mechanism of action. Their prices are often lower.

The most famous analogues are:

They contain pancreatic enzymes that perform the same functions as Creon components, but generics are not always suitable for a child who is not yet 2 years old, as they are tablet forms. This makes it difficult to swallow the medication at such an early age.

It is necessary to transfer the baby to an analogue of Creon with severe diarrhea or vomiting , arising from the use of this medication, as well as due to individual intolerance. However, the appointment of another drug is carried out only by a doctor, an independent transition to cheaper analogues may not bring the desired therapeutic effect.

Creon is prescribed by the attending pediatrician in the presence of various digestive disorders provoked by insufficient enzymatic activity of the pancreas, for example, with diarrhea, colic, and dysbacteriosis in a child. The drug is suitable for children of any age, the difference will only be in the dosage of the drug. Before you give Creon a drink to an infant, you should consult a pediatrician, as well as establish an adequate drinking regimen.

Useful video about pancreatic diseases in children

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 10000 (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 intake.

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.