Ermytal, capsules 36 units, 50pcs

Composition

Dosage 36,000 UNITS: One capsule with gastric juice-resistant microtablettes contains 272.02-316.68 mg of pancreatin from the pig pancreas, which corresponds to the activity of lipase 36,000 units, amylase 18,000 UNITS, proteases 1,200 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 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) contribute to the breakdown of proteins to amino acids, fats to glycerol and fatty acids, starch to dextrins and monosaccharides, improve the functional state of the gastrointestinal tract, normalize digestive processes. Products of cleavage by pancreatic enzymes are absorbed in the intestine either directly or after cleavage by intestinal enzymes. Pharmacokinetics The Form of production of the drug provides complete release of microtablettes resistant to 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. Pancreatic enzymes are not absorbed into the blood. Enzymes are inactivated and digested in the gut as proteins by autolysis and proteolysis.

Indications

It is used for adults and children:

• to improve food digestion in patients with normal function of the gastrointestinal tract in the case of errors in the diet;
• replacement therapy in exocrine insufficiency of the pancreas: cystic fibrosis, chronic pancreatitis, pancreatectomy, pancreatic cancer, ductal obstruction due to neoplasm (including obstruction of the ducts of the pancreas, the common bile duct), the syndrome of Shwachman-diamond, condition after an attack of acute pancreatitis and the resumption of power, old age;
• symptomatic treatment of digestive disorders: status after cholecystectomy, partial gastric resection (Billroth-I/II), total gastrectomy, duodeno and gastrosis, biliary obstruction, cholestatic hepatitis, liver cirrhosis, Crohn’s disease, dysbiosis.

Use during pregnancy and lactation

Application of the drug Ermytal® during pregnancy and lactation is possible only after careful assessment of the ratio of benefit to the mother and risk to the fetus or infant.

Due to the low systemic absorption of pancreatin, a negative effect on the mother’s body, as well as the fetus and baby, is not expected.

Contraindications

Known hypersensitivity to any of the components of the drug.

Side effects

Disorders of the gastrointestinal tract

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

Infrequently (≥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.

Reports of these side effects were received during the post-marketing period and were spontaneous. The available data are not sufficient to accurately estimate the frequency of cases.

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

Interaction

When taking the drug Ermytal® may reduce the absorption of folic acid.

During drug treatment Ermytal® may reduce the effect of oral hypoglycemic drugs acarbose and miglitol.

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

a sour taste (pH 

Crushing, 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

The dose 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 the drug Ermytal® 10 000 units, or 1-2 capsules of the drug Ermytal®25,000 units, or 1 capsule of the drug Ermytal® 36,000 UNITS at 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

When taking pancreatin in high doses, hyperuricosuria and hyperuricemia may develop, especially in patients with cystic fibrosis.

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.

Medication 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

Solid oblong gelatin capsule, size No. 0 el, opaque brown lid, colorless transparent body.

Capsule contents: whitish-gray convex film-coated microtablettes; the presence of a characteristic smell in microtablettes is allowed.

Storage conditions

At a temperature not exceeding 25 C. Keep out of reach of children!

Shelf life

3 years

Active ingredient

Pancreatin

Dosage form

Capsules

Purpose

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

Indications

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