Micrasim capsules 10000ED, No. 20

• replacement therapy for exocrine pancreatic insufficiency: chronic pancreatitis, pancreatectomy, condition after irradiation, dyspepsia, cystic fibrosis, flatulence, non-infectious diarrhea;

• violation of food assimilation (condition after resection of the stomach and small intestine);

• to improve the digestion of food in persons with normal gastrointestinal tract function in case of errors in nutrition (consumption of fatty foods, large amounts of food, irregular nutrition) and in case of impaired chewing function, sedentary lifestyle, prolonged immobilization;

• Remheld syndrome (gastrocardiac syndrome);

• preparation for X-ray examination and ultrasound of the abdominal organs.

The dose of the drug is selected individually depending on the age, the severity of symptoms and the composition of the diet. Dose selection is carried out using registered drugs MicrasimЃ 10,000 U and MicrasimЃ 25,000 U.

The capsules are taken orally with a sufficient amount of non-alkaline liquid (water, fruit juices). If a single dose of the drug is more than 1 capsule, you should take half of the total number of capsules immediately before meals, and the other half during meals. If a single dose is 1 capsule, it should be taken with meals.

In case of difficulty swallowing (for example, in children or the elderly), the capsule can be opened and the drug can be taken directly in pellets, after mixing them with liquid or liquid food (pH <5.0) that does not require chewing (applesauce, yogurt). Grinding or chewing pellets, as well as adding them to food with a pH above 5.5, leads to the destruction of their shell, which protects against the action of gastric juice. Any mixture of pellets with food or liquid should be taken immediately after preparation.

The permissible dose for children under the age of 1.5 years is 50,000 U / day, over 1.5 years - 100,000 U / day.

The duration of taking pancreatin can vary from a few days (indigestion) to several months or years (long-term substitute therapy).

Replacement therapy for various types of exocrine pancreatic insufficiency

The dose is selected individually and depends on the severity of exocrine insufficiency, individual dietary habits and the patient's age.

Steatorrhea (more than 15 g of fat in feces per day)

In the presence of diarrhea, weight loss and the lack of effect from diet therapy, 25,000 units of lipase are prescribed at each meal. If necessary and well tolerated, the dose is increased to 30,000-35,000 IU of lipase per dose. A further increase in the dose, in most cases, does not improve the results of treatment and requires a revision of the diagnosis, a decrease in the fat content in the diet and / or additional prescription of drugs - proton pump inhibitors.

With mild steatorrhea, not accompanied by diarrhea and a decrease in body weight, from 10,000 U to 25,000 U of lipase is prescribed per dose.

Cystic fibrosis

The initial calculated dose for children under the age of 4 years is 1000 U of lipase / kg of body weight at each feeding, for children over the age of 4 years - 500 U of lipase / kg of body weight at each meal. The dose should be selected individually, depending on the severity of the disease, the severity of steatorrhea and nutritional status. The maintenance dose for most patients should not exceed 10,000 IU of lipase / kg of body weight / day.

Active substance:

pancreatin - 168 mg * (10,000 units), incl. pancreatin powder - 125 mg

which corresponds to the activity:

? protease - 520 units

? amylase - 7500 U

? lipase - 10,000 units

* in the form of enteric pellets.

** in terms of nominal lipolytic activity.

Excipients of the enteric pellet shell: copolymer of methacrylic acid and ethyl acrylate (1: 1) (in the form of a 30% dispersion, additionally containing polysorbate 80, sodium lauryl sulfate) - 25.3 mg, triethyl citrate - 5.1 mg, simethicone emulsion 30% (dry weight 32.6%) - 0.1 mg, including: dimethicone - 27.8%, colloidal precipitated silicon - 1.3%, colloidal suspended silicon - 0.9%, methylcellulose - 2.5%, sorbic acid - 0.1%, water - 67.4%, talc - 12.6 mg.

The composition of the capsule body: gelatin - up to 100%, water - 13-16%.

The composition of the capsule cap: gelatin - up to 100%, water - 13-16%, crimson dye (ponceau 4R) - 0.6666%, quinoline yellow dye - 0.1000%, patented blue dye - 0.0200%, titanium dioxide - 1.2999%.

• acute pancreatitis;

• exacerbation of chronic pancreatitis;

• individual intolerance to pancreatin or individual components of the drug.

Hard gelatin capsules, size No. 2, with a transparent body and a brown lid; contents of capsules - enteric pellets of cylindrical or spherical, or irregular shape from light brown to brown color, with a characteristic odor; non-uniformity of color is allowed.

Clinical and pharmacological group: Enzyme preparation

Pharmaco-therapeutic group: Digestive enzyme agent

pharmachologic effect

MicrasimЃ - pancreatin pellets in capsules. The preparation contains natural enzymes from the pancreas of animals - protease, lipase and amylase, which ensure the digestion of proteins, fats and carbohydrates from food.

After taking MicrasimЃ, the capsule dissolves quickly in the stomach, releasing enteric-coated pancreatin pellets. Due to their small size, the pellets are quickly and evenly mixed with food and, simultaneously with the food lump, easily penetrate into the duodenum, and then into the small intestine, where pancreatic enzymes are released and begin to actively act, contributing to the rapid and complete digestion of proteins, fats and carbohydrates from food.

Rapid mixing of pancreatin pellets with the contents of the stomach, their uniform distribution in it, simultaneous passage with chyme, as well as the preservation of enzymes before they start to work in the intestine (due to the presence of an enteric pellet shell), provide a higher digestive activity and the maximum approximation of the action of the drug to the natural process digestion.

The enzymatic activity of MicrasimЃ is manifested within a maximum of 30 minutes after ingestion, which ensures the rapid onset of the effect.

After interacting with substrates, protease, lipase and amylase in the lower intestine lose activity and, together with the intestinal contents, are excreted from the body.

Pharmacokinetics

MicrasimЃ is not absorbed in the gastrointestinal tract and acts only in the intestinal lumen.

Indications

• replacement therapy for exocrine pancreatic insufficiency: chronic pancreatitis, pancreatectomy, condition after irradiation, dyspepsia, cystic fibrosis, flatulence, non-infectious diarrhea;

• violation of food assimilation (condition after resection of the stomach and small intestine);

• to improve the digestion of food in persons with normal gastrointestinal tract function in case of errors in nutrition (consumption of fatty foods, large amounts of food, irregular nutrition) and in case of impaired chewing function, sedentary lifestyle, prolonged immobilization;

• Remheld syndrome (gastrocardiac syndrome);

• preparation for X-ray examination and ultrasound of the abdominal organs.

Dosage regimen

The dose of the drug is selected individually depending on the age, the severity of symptoms and the composition of the diet. Dose selection is carried out using registered drugs MicrasimЃ 10,000 U and MicrasimЃ 25,000 U.

The capsules are taken orally with a sufficient amount of non-alkaline liquid (water, fruit juices). If a single dose of the drug is more than 1 capsule, you should take half of the total number of capsules immediately before meals, and the other half during meals. If a single dose is 1 capsule, it should be taken with meals.

In case of difficulty swallowing (for example, in children or the elderly), the capsule can be opened and the drug can be taken directly in pellets, after mixing them with liquid or liquid food (pH <5.0) that does not require chewing (applesauce, yogurt). Grinding or chewing pellets, as well as adding them to food with a pH above 5.5, leads to the destruction of their shell, which protects against the action of gastric juice. Any mixture of pellets with food or liquid should be taken immediately after preparation.

The permissible dose for children under the age of 1.5 years is 50,000 U / day, over 1.5 years - 100,000 U / day.

The duration of taking pancreatin can vary from a few days (indigestion) to several months or years (long-term substitute therapy).

Replacement therapy for various types of exocrine pancreatic insufficiency

The dose is selected individually and depends on the severity of exocrine insufficiency, individual dietary habits and the patient's age.

Steatorrhea (more than 15 g of fat in feces per day)

In the presence of diarrhea, weight loss and the lack of effect from diet therapy, 25,000 units of lipase are prescribed at each meal. If necessary and well tolerated, the dose is increased to 30,000-35,000 IU of lipase per dose. A further increase in the dose, in most cases, does not improve the results of treatment and requires a revision of the diagnosis, a decrease in the fat content in the diet and / or additional prescription of drugs - proton pump inhibitors.

With mild steatorrhea, not accompanied by diarrhea and a decrease in body weight, from 10,000 U to 25,000 U of lipase is prescribed per dose.

Cystic fibrosis

The initial calculated dose for children under the age of 4 years is 1000 U of lipase / kg of body weight at each feeding, for children over the age of 4 years - 500 U of lipase / kg of body weight at each meal. The dose should be selected individually, depending on the severity of the disease, the severity of steatorrhea and nutritional status. The maintenance dose for most patients should not exceed 10,000 IU of lipase / kg of body weight / day.

Side effect

Possibly: allergic reactions.

Rarely: when using the drug in high doses, diarrhea, nausea, constipation, discomfort in the epigastric region are observed.

With prolonged use in high doses, the development of hyperuricosuria, hyperuricemia is possible.

Contraindications for use

• acute pancreatitis;

• exacerbation of chronic pancreatitis;

• individual intolerance to pancreatin or individual components of the drug.

Application during pregnancy and lactation

There are no data on the potential risks of using pancreatin during pregnancy and lactation, so the drug should be prescribed to pregnant women and nursing mothers only if the expected effect of therapy outweighs the possible risk.

special instructions

Children and adults who have been receiving high-dose pancreatin therapy for a long time should be monitored by a specialist.

The main reasons for the ineffectiveness of enzyme therapy are inactivation of enzymes in the duodenum as a result of acidification of its contents, concomitant diseases of the small intestine (helminthic invasions, dysbiosis), patients' failure to comply with the recommended treatment regimen, and the use of enzymes that have lost their activity.

Influence on the ability to drive vehicles and use mechanisms

There are no data on the effect of the drug on the ability to drive vehicles and perform work requiring increased concentration of attention and speed of psychomotor reactions.

Overdose

Symptoms: increased uric acid content in urine (hyperuricuria) and blood (hyperuricemia); in children - constipation.

Treatment: drug withdrawal, symptomatic therapy.

Drug interactions

With the simultaneous use of pancreatin with iron preparations, it is possible to reduce the absorption of the latter.

Storage conditions

The drug should be stored in a place protected from moisture and light, out of reach of children, at a temperature not exceeding 25 ? C.

Shelf life

Shelf life is 2 years. Do not use after the expiration date.

Terms of sale

The drug is dispensed without a prescription.

Contacts for inquiries

OTISIPHARM PJSC (Russia)