Pharmacodynamics. Polyenzyme preparation. pancreatic enzymes (lipase, amylase and protease), which are part of it, promote the breakdown of fats, proteins and carbohydrates, which leads to their complete absorption in the small intestine. in diseases of the pancreas, the preparation compensates for the insufficiency of its exocrine function and helps to improve the digestion process.
Pharmacokinetics. The tablets are coated with a protective coating, insoluble in the acidic environment of the stomach, which protects the digestive enzymes from destruction in the stomach. Only under the action of a neutral or slightly alkaline medium of the small intestine dissolution of the membrane and the release of enzymes occurs.
Diseases accompanied by impaired digestion of food due to insufficient secretion of digestive enzymes by the pancreas, such as chronic pancreatitis.
Conditions after simultaneous resection of the stomach and small intestine, functional acceleration of the passage of food through the intestines, intestinal disorders, the simultaneous use of indigestible vegetable, fatty and unusual food.
Bloating and preparation for diagnostic x-rays or ultrasound examinations.
The dose of the preparation depends on the deficiency of pancreatic enzymes in the duodenum and is set individually. in the absence of other recommendations, as well as in cases of the use of difficult-to-digest plant, fatty or unusual food, use 1-2 tablets. in the other cases mentioned above, in the event of digestive disorders, the recommended dose is 2–4 tablets. the dose can be increased if necessary. increasing the dose in order to reduce the severity of symptoms of the disease, such as steatorrhea or abdominal pain, should be carried out only under the supervision of a physician. the daily dose of lipase should not exceed 15,000–20,000 ph. eur. per 1 kg of body weight.
Take the tablets with meals, swallowing whole with plenty of liquid, such as 1 glass of water.
The duration of treatment depends on the course of the disease and is determined by the doctor on an individual basis.
The doctor decides on the dose of the preparation and the duration of treatment for children.
The preparation is prescribed in a daily dose necessary to normalize the stool, but not more than 1500 U Ph. Eur. lipase per 1 kg of body weight of a child under 12 years of age. For children over the age of 12, the daily dose of enzymes should not exceed 15,000–20,000 Ph. Eur. lipase per 1 kg of body weight.
Children. For use in children aged 3 years and older.
Hypersensitivity to the components of the preparation. acute pancreatitis, exacerbation of chronic pancreatitis, intestinal obstruction.
To assess the incidence of adverse reactions, the following classification is used: very often (≥1 / 10); often (≥1 / 100 and 1/10); infrequently (≥1 / 1000 and 1/100); rarely (≥1 / 10,000 and 1/1000); very rare (1 / 10,000), frequency unknown (cannot be estimated from available data).
From the side of the cardiovascular system: the frequency is unknown - tachycardia.
From the immune system: very rarely - immediate allergic reactions (skin rash, itching, sneezing, urticaria, lacrimation, bronchospasm), anaphylactic reactions; the frequency is unknown - the dye carmoisin (E122) can cause allergic reactions.
From the gastrointestinal tract: very rarely - when using high doses of pancreatin (more than 10,000 IU Ph. Eur. Lipase / kg / day), narrowings may form in the ileocecal region and in the ascending part of the colon; diarrhea, abdominal pain, nausea, vomiting, changes in the nature of the stool; possible development of intestinal obstruction, constipation.
On the part of the skin and subcutaneous tissues: the frequency is unknown - urticaria, hyperemia, itching, angioedema.
From the genitourinary system: the frequency is unknown - an increased excretion of uric acid in the urine is possible, especially when using high doses of pancreatin. In order to avoid the formation of uric acid calculi in such patients, its content in the urine should be monitored.
General disorders: the frequency is unknown - a feeling of heat, general weakness.
In the presence of symptoms similar to the state of intestinal obstruction, it is necessary to remember about the possibility of intestinal strictures. it is recommended that any unusual symptoms be controlled, especially when taking more than 10,000 ph. eur. lipase / kg / day
The preparation contains active enzymes that can damage the oral mucosa, so the tablets must be swallowed whole without chewing.
Use during pregnancy and lactation. There are no data on the safety of lipase, amylase and protease during pregnancy.
During animal studies, no direct or indirect negative effects on pregnancy, embryo development, childbirth or postnatal development have been identified. Should be used with caution in pregnant women. Enzymes are not absorbed from the gastrointestinal tract, but the risk cannot be excluded. The preparation should be used by pregnant women and women who are breastfeeding only if the expected benefit to the mother outweighs the potential risk to the child.
The ability to influence the reaction rate when driving or working with other mechanisms. No effect on the ability to drive a car or other mechanical means was observed.
The preparation reduces the absorption of iron with prolonged use, therefore, if necessary, iron supplements should be prescribed at the same time. the simultaneous use of antacids containing calcium carbonate and / or magnesium hydroxide can lead to a decrease in the effectiveness of pancreatin.
Simultaneous use with tannin, alcohol-containing agents can lead to a decrease in the effectiveness of pancreatin.
Pancreatic enzymes inhibit the absorption of folic acid. With the simultaneous administration of bicarbonates and cimetidine with high doses of pancreatic enzymes, it is recommended to periodically analyze the concentration of folic acid salts in the blood serum and provide additional intake of folic acid, if necessary.
Pancreatic enzymes can reduce the effectiveness of acarbose and miglitol.
Symptoms possible increased side effects. while taking other preparations from pancreatic powder in extremely high doses, hyperuricemia and hyperuricosuria were observed, in children - constipation.
Treatment. Discontinuation of the preparation, adequate hydration and symptomatic treatment.
In original packaging at temperatures up to 25 ° C.
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