Description
Latin name
Ermytal
Release form
Capsules 10,000 units, 25,000 units, 36,000 units. 20 or 50 capsules in a glass bottle of dark glass with a plastic cap. 1 vial of 20 or 50 capsules is placed in a cardboard box along with instructions for use.
Packing
50 pcs
Pharmacological action of
Hermitage ® contains standard highly active pancreatin obtained from porcine pancreas in the form of microtablets resistant to gastric juice. Digestive enzyme remedy, compensates for the deficiency of pancreatic enzymes, has a proteolytic, amylolytic and lipolytic action. 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 digestion processes. Digestion products by pancreatic enzymes are absorbed in the intestine either directly or after digestion by intestinal enzymes.
Pharmacokinetics
The release form of the drug provides the complete release of gastric juice-resistant microtablets from the capsule in the stomach, followed by finely mixed microtablets with intestinal contents and chyme and the rapid release of enzymes from microtablets in the duodenum.
Pancreatic enzymes are not absorbed into the blood. Enzymes are inactivated and digested in the intestines as proteins by autolysis and proteolysis.
Indications
In adults and children it is used:
to improve food digestion in patients with normal gastrointestinal function in case of nutritional errors
replacement therapy for exocrine pancreatic insufficiency: cystic fibrosis, chronic pancreatitis, pancreatic pancreatitis obstruction due to neoplasm (including obstruction of the ducts of the pancreas, common bile duct), Schwachmann-Diamond syndrome, conditions after an attack of th pancreatitis and the resumption of power, old age
symptomatic treatment of digestive disorders: condition after cholecystectomy, partial gastric resection (Billroth-I / II), total gastrectomy, and duodeno- gastrostasis, biliary obstruction, cholestatic hepatitis, cirrhosis, Crohn ² ¢s disease, dysbiosis.
Contraindications
Known hypersensitivity to any of the components of the drug.
Use during pregnancy and lactation
The use of the drug Hermital ® during pregnancy and lactation is possible only after a careful assessment of the ratio of benefits for the mother and the risk to the fetus or baby. Due to the slight systemic absorption of pancreatin, a negative effect on the mother’s body, as well as the fetus and baby, is not expected.
Composition
Dosage 25,000 PIECES: One capsule with gastric juice-resistant microtablets contains 218.2 – 282.4 mg of pancreatic pancreatin from pigs, which corresponds to lipase activity of 25,000 units,
amylase 22,500 units, protease 1,250 units (according to the European Pharmacopoeia).
Excipients: microcrystalline cellulose, crospovidone, colloidal anhydrous silicon dioxide, magnesium stearate film coating microtablets: copolymer of methacrylic acid and ethyl acrylate (1: 1), triethyl citrate, talc, simethicone polishing agent: montan-glycol wax. Capsule cover: gelatin, red iron oxide (E 172), black iron oxide (E 172), titanium dioxide (E 171), sodium lauryl sulfate capsule body: gelatin, sodium lauryl sulfate.
Dosage and Administration
Inside, doses are selected individually depending on the severity of the disease and diet.
Dose calculation is based on units of lipase activity. Capsules should be swallowed whole during meals, washed down with large quantities of liquid (water, juices), if it is difficult to swallow, the capsules can be opened and their contents added to liquid foods that have an acidic taste (pH <5.5), or pour the contents of the capsules into the mouth and swallow them without chewing and drinking plenty of fluids (about a glass of water). Crushing, chewing microtablets or adding them to food with a pH> 5.5 leads to the destruction of their membrane, which protects against the action of gastric juice. This can lead to early release of enzymes in the oral cavity, decreased effectiveness and irritation of the mucous membranes. Make sure that there are no microtablets left in the mouth.
Cystic fibrosis
The dose is dependent on body weight and should be 1000 lipase units / kg per meal for children under four years of age and 500 lipase units / kg for meals for children over four years of age and adults at the beginning of treatment.
The dose should be determined depending on the severity of the symptoms of the disease, the results of monitoring for steatorrhea and maintaining an adequate nutritional status. In 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 consumed fat.
Other conditions accompanied by exocrine pancreatic insufficiency
The recommended dose is 2-4 capsules of the drug Hermital ® 10 000 units, or 1-2 capsules of the drug Hermital ® 25 000 units or 1 capsule of the drug Hermital ® 36,000 units during each meal. If necessary, the dose may be increased. Increasing the dose should be under the supervision of a physician. 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 heavy fluid intake.
In children, the drug should be used as directed by a doctor.
Side effects
Disorders of the gastrointestinal tract
Very often ( 1/10): pain in the abdomen.
Often ( 1/100, <1/10): nausea, vomiting, constipation, bloating, diarrhea. Frequency unknown: ileal stricture, cecum 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 with placebo. Strictures of the ileum, cecum, and colon (fibrosing colonopathy) were observed in patients with cystic fibrosis who received high doses of pancreatin preparations (see the section Special Instructions ). Disorders of the skin and subcutaneous tissue Infrequently ( 1/1000, <1/100): rash. Frequency unknown: pruritus, urticaria. Immune system disorders Frequency unknown: hypersensitivity (anaphylactic reactions). Allergic reactions were observed mainly from the skin, but other allergies have also been noted. Co 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. Drug Interaction Fertile acid absorption may be decreased when administered with Hermital ®. The effect of oral hypoglycemic drugs acarbose and miglitol may be diminished against treatment with Hermital ®. Overdose Symptoms: hyperuricosuria, hyperuricemia. Treatment: withdrawal of the drug, symptomatic therapy. Storage conditions At a temperature not above 25 ° C. Keep out of the reach of children! Expiration 3 years. Do not use after the expiry date stated on the packaging. Deystvuyuschee substances Pancreatin dosage form dosage form capsules Nordmark Arzneimittel, Germany
