Ermytal, capsules 25 units, 50pcs

Composition

Dosage 25,000 UNITS: One capsule with microtablettes resistant to gastric juice contains 218.2-282.4 mg of pancreatin from the pig pancreas, which corresponds to the activity of lipase 25,000 units, amylase 22,500 UNITS, proteases 1,250 units (according to the European Pharmacopoeia). Auxiliary substances: Microcrystalline cellulose, Crospovidone, Colloidal anhydrous silicon dioxide, Magnesium stearate; Microtablet film coating: Copolymer of methacrylic acid and ethyl acrylate (1: 1), Triethyl citrate, Talc, Simethicone; Polishing agent: Montane-glycol wax. Capsule cap: Gelatin, Red Iron Oxide (E 172), Black Iron Oxide (E 172), Titanium dioxide (E 171), Sodium Lauryl Sulfate; Capsule body: Gelatin, Sodium Lauryl sulfate.

Pharmacological action

Ermytal contains standard highly active pancreatin derived from the pig pancreas in the form of microtubules that are resistant to the effects of gastric juice.

Digestive enzyme agent, replenishes the deficiency of pancreatic enzymes, has proteolytic, amylolytic and lipolytic effects.

The enzymes included in the composition (lipase, alpha-amylase, trypsin, chymotrypsin), promotes the breakdown of proteins to amino acids, fats to glycerol and fatty acids, starch to dextrins and monosaccharides, improves the functional state of the gastrointestinal tract, normalizes digestive processes.

Pharmacodynamics

The Form of production of the drug provides complete release of microtablettes resistant to the action of gastric juice from the capsule in the stomach, followed by fine mixing of microtablettes with

intestinal contents and chyme and rapid release of enzymes from microtablettes in the duodenum at pH>5.

Products of cleavage by pancreatic enzymes are absorbed in the intestine either directly or after cleavage by intestinal enzymes.

Pharmacokinetics

The pancreatic enzymes contained in Ermytal are not absorbed into the blood. Enzymes are inactivated and digested in the gut like proteins by autolysis and proteolysis.

Residual enzymatic activity can be determined in the stool.

Indications

• To improve food digestion in patients with normal gastrointestinal function in the event of nutritional errors.
• Replacement therapy for external secretory pancreatic insufficiency:
  • cystic fibrosis;
  • chronic pancreatitis;
  • pancreatectomy;
  • pancreatic cancer;
  • ductal obstruction due to neoplasms (including obstruction of the pancreatic ducts, common bile duct);
  • Schwachman-Diamond syndrome;
  • senile age;
• Symptomatic treatment of digestive disorders:
  • condition after cholecystectomy;
  • partial resection of the stomach (Billroth-I/II);
  • total gastrectomy;
  • feeling of fullness of the stomach when overeating, eating fatty or unusual food;
  • duodeno-and gastrostasis;
  • biliary obstruction;
  • cholestatic hepatitis;
  • cirrhosis of the liver;
  • Crohn
  • ‘s disease dysbiosis.

Use during pregnancy and lactation

The use of the drug during lactation (breastfeeding) is possible only if the intended benefit of therapy for the mother exceeds the potential risk for the infant.

Contraindicated for children.

Contraindications

• hypersensitivity to pancreatic enzymes;
• exacerbation of chronic pancreatitis;
• acute pancreatitis.

Side effects

Gastrointestinal disorders Very common (≥1/10): abdominal pain. Often (≥1/100, Frequency unknown: strictures of the ileum, caecum and colon (fibrosing colonopathy). Gastrointestinal disorders are mainly associated with the underlying disease. The incidence of adverse reactions such as abdominal pain and diarrhea was lower or similar to that experienced with placebo. Strictures of the ileum, cecum, and colon (fibrosing colonopathy) have been observed in patients with cystic fibrosis treated with high doses of pancreatin preparations (see section “Special instructions”). Skin and subcutaneous tissue disorders often (≥1/1000, Frequency unknown: pruritus, urticaria. Immune system disorders Frequency unknown: hypersensitivity (anaphylactic reactions). Allergic reactions were observed mainly from the skin, but other manifestations of allergies were also noted. No specific adverse reactions were observed with CoWhen used in children. The frequency, type, and severity of adverse reactions in children with cystic fibrosis were similar to those in adults.

Interaction

When taking Ermytal®, folic acid absorption may decrease.

The effect of oral hypoglycemic drugs acarbose and miglitol may be reduced during treatment with Ermytal®.

How to take, course of use and dosage

Inside, doses are selected individually depending on the severity of the disease and diet. The dose is calculated in terms of lipase activity units. Capsules should be swallowed whole during a meal, washed down with a large amount of liquid (water, juices); if swallowing is difficult, the capsules can be opened and their contents added to liquid food that has an acidic taste (pHCrushing, chewing microtablettes or adding them to food with pH>5.5 leads to the destruction of their shell, which protects against the action of gastric juice. This can lead to an early release of enzymes in the oral cavity, reduced effectiveness, and irritation of the mucous membranes. Make sure that there are no microtubules left in your mouth. Cystic fibrosis depends on body weight and should be 1000 lipase units / kg at the beginning of treatment for each meal for children under four years of age and 500 lipase units / kg during meals for children over four years of age and adults. The dose should be determined depending on the severity of the symptoms of the disease, the results of monitoring steatorrhea and maintaining an adequate nutritional status. In most patients, the dose should remain less than or not exceed 10,000 lipase units / kg of body weight per day or 4,000 lipase units/g of fat consumed. Other conditions associated with exocrine pancreatic insufficiency The recommended dose is 2-4 capsules of Ermytal ® 10,000 units, or 1-2 capsules of Ermytal® 25,000 units, or 1 capsule of Ermytal® 36,000 UNITS during each meal. If necessary, the dose can be increased. Increasing the dose should be under the supervision of a doctor. Do not exceed the daily dose of enzymes in the range of 15-20 thousand lipase units per kg of body weight. Therapy should be carried out against the background of copious fluid intake. In children, the drug should be used in accordance with the doctor’s prescription.

Overdose

Symptoms:  hyperuricosuria, hyperuricemia.

Treatment:  drug withdrawal, symptomatic therapy.

Special instructions

With prolonged use of pancreatin in high doses in patients with cystic fibrosis, constipation, strictures of the ileum and cecum (fibrosing colonopathy), colitis may develop. When taking the drug in high doses (more than 10,000 lipase units/kg of body weight per day), unusual symptoms and side effects from the gastrointestinal tract should be carefully monitored and, if necessary, a medical examination should be carried out to exclude fibrosing colonopathy. Ermytal® contains active enzymes that, when released in the oral cavity (for example, when chewed), can cause irritation and ulceration of the mucous membrane. Therefore, microtablets should be swallowed without chewing. The drug does not affect the ability to drive vehicles and mechanisms.

Form of production

Capsules 10,000 units,25,000 UNITS,36,000 UNITS. 20 or 50 capsules in a dark glass bottle with a plastic lid. 1 bottle of 20 or 50 capsules is placed in a cardboard box together with the instructions for use.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Pancreatin

Dosage form

Capsules

Description

Nursing mothers as prescribed by a doctor, For adults, Pregnant women as prescribed by a doctor, Children as prescribed by a doctor

Indications

Chronic pancreatitis, Overeating, Flatulence, Gastritis, Cirrhosis of the liver, Irritable bowel syndrome, Crohn’s disease, Hepatitis, Dysbiosis, Preparation for ultrasound and X-ray of the abdominal cavity, Diet error, Diarrhea