Hermital capsules 25000ED, No. 50

In adults and children:

- to improve the digestion of food in patients with normal function of the gastrointestinal tract in case of inaccuracies in nutrition;

- replacement therapy for exocrine pancreatic insufficiency: cystic fibrosis, chronic pancreatitis, pancreatectomy, pancreatic cancer, ductal obstruction due to neoplasm (including obstruction of the pancreatic ducts, common bile duct), Schwachman-Diamond syndrome, conditions after an attack and re-feeding;

- symptomatic therapy of digestive disorders: condition after cholecystectomy, partial gastrectomy (Billroth-I / II), total gastrectomy, duodeno- and gastrostasis, biliary obstruction, cholestatic hepatitis, liver cirrhosis, Crohn's disease, dysbiosis.

Inside, doses are selected individually, depending on the severity of the disease and diet. The dose is calculated in terms of units of lipase activity.

The capsules should be swallowed whole during meals with plenty of fluids (water, juices); if swallowing is difficult, the capsules can be opened and their contents added to liquid food that has a sour taste (pH <5.5), or the contents of the capsules can be poured into the mouth and swallowed without chewing and drinking plenty of liquid (about a glass of water).

Crushing, chewing microtablets or adding them to food with a pH> 5.5 leads to the destruction of their shell, which protects against the action of gastric juice. This can lead to early release of enzymes in the mouth, decreased efficiency and irritation of the mucous membranes.

Make sure there are no microtablets left in your mouth.

Cystic fibrosis

The dose depends on body weight and should be at the beginning of treatment 1000 lipase units / kg for each meal for children under four years of age and 500 lipase units / kg at 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 steatorrhea control and the maintenance of 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 accompanied by exocrine pancreatic insufficiency

The recommended dose is 2-4 capsules of ErmitalЃ 10,000 IU, or 1-2 capsules of ErmitalЃ 25,000 IU, or 1 capsule of ErmitalЃ 36,000 IU during each meal. The dose can be increased if necessary. Dose escalation should be supervised by 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 abundant fluid intake.

In children, the drug should be used in accordance with the doctor's prescription.

Dosage 25,000 U: One capsule with gastric-resistant microtablets contains 218.2 - 282.4 mg of pancreatin from the pancreas of a pig, which corresponds to the activity of lipase 25,000 U, amylase 22,500 U, protease 1,250 U (according to the European Pharmacopoeia) ...

- Known hypersensitivity to any component of the drug.

Carefully

The use of the drug ErmitalЃ during pregnancy and lactation is possible only after a careful assessment of the ratio of benefits to the mother and risks to the fetus or baby. Due to the insignificant systemic absorption of pancreatin, a negative effect on the body of the mother, as well as the fetus and infant, is not expected.

Active substance

Pancreatin

Dosage form

capsules

Composition

Dosage 10,000 U: One capsule with resistant to gastric juice microtablets contains 87.28 - 112.96 mg of pancreatin from the pancreas of a pig, which corresponds to the activity of lipase 10,000 U, amylase 9,000 U. proteases 500 U (according to the European Pharmacopoeia).

Dosage 25,000 U: One capsule with gastric-resistant microtablets contains 218.2 - 282.4 mg of pancreatin from the pancreas of a pig, which corresponds to the activity of lipase 25,000 U, amylase 22,500 U, protease 1,250 U (according to the European Pharmacopoeia) ...

Dosage 36,000 U: One capsule with gastric-resistant microtablets contains 272.02 - 316.68 mg of pancreatin from the pancreas of a pig, which corresponds to the activity of lipase 36,000 U, amylase 18,000 U, protease 1,200 U (according to the European Pharmacopoeia) ...

Excipients: microcrystalline cellulose, crospovidone, colloidal anhydrous silicon dioxide, magnesium stearate; film coating of microtablets: copolymer of methacrylic acid and ethyl acrylate (1: 1), tri ethyl citrate, talc, simethicone; polishing agent: montan glycol wax. Cap of the capsule: gelatin, red iron oxide (E 172), black iron oxide (E 172), titanium dioxide (E 171), sodium lauryl sulfate; capsule body: gelatin, sodium lauryl sulfate.

Description

Dosage 10,000 IU:

Solid oblong gelatin capsule size 2, brown opaque cap, colorless transparent body. Capsule contents: whitish-gray convex film-coated microtablets; the presence of a characteristic odor in microtablets is allowed.

Dosage 25,000 IU:

Hard, oblong gelatin capsule, size no. 0 el, brown opaque cap, colorless transparent body. Capsule contents: whitish-gray convex film-coated microtablets; the presence of a characteristic odor in microtablets is allowed.

Dosage 36,000 IU:

Hard, elongated gelatin capsule, size No. 00, brown opaque cap, colorless transparent body. Capsule contents: whitish-gray convex film-coated microtablets; the presence of a characteristic odor in microtablets is allowed.

Pharmacotherapeutic group

digestive enzyme agent.

Pharmacodynamics

ErmitalЃ contains standard highly active
pancreatin obtained from the pancreas of a pig in the form of microtablets 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) promote 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, and normalize digestion processes. The cleavage products by pancreatic enzymes are absorbed in the intestine either directly or after digestion by intestinal enzymes.

Pharmacokinetics

The release form of the drug ensures the complete release of microtablets resistant to the action of gastric juice from the capsule in the stomach, followed by fine mixing of the microtablets with intestinal contents and chyme and the rapid release of enzymes from the microtablets in the duodenum.

Pancreatic enzymes are not absorbed into the bloodstream. Enzymes are inactivated and digested in the intestine as proteins by autolysis and proteolysis.

Indications for use

In adults and children:

- to improve the digestion of food in patients with normal function of the gastrointestinal tract in case of inaccuracies in nutrition;

- replacement therapy for exocrine pancreatic insufficiency: cystic fibrosis, chronic pancreatitis, pancreatectomy, pancreatic cancer, ductal obstruction due to neoplasm (including obstruction of the pancreatic ducts, common bile duct), Schwachman-Diamond syndrome, conditions after an attack and re-feeding;

- symptomatic therapy of digestive disorders: condition after cholecystectomy, partial gastrectomy (Billroth-I / II), total gastrectomy, duodeno- and gastrostasis, biliary obstruction, cholestatic hepatitis, liver cirrhosis, Crohn's disease, dysbiosis.

Contraindications

- Known hypersensitivity to any component of the drug.

Carefully

The use of the drug ErmitalЃ during pregnancy and lactation is possible only after a careful assessment of the ratio of benefits to the mother and risks to the fetus or baby. Due to the insignificant systemic absorption of pancreatin, a negative effect on the body of the mother, as well as the fetus and infant, is not expected.

Method of administration and dosage

Inside, doses are selected individually, depending on the severity of the disease and diet. The dose is calculated in terms of units of lipase activity. The capsules should be swallowed whole with food with plenty 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 <5.5), or the contents of the capsules can be poured into the mouth and swallowed without chewing and drinking plenty of liquid (about a glass of water). Crushing, chewing microtablets or adding them to food with a pH> 5.5 leads to the destruction of their shell, which protects against the action of gastric juice. This can lead to early release of enzymes in the mouth, decreased efficiency and irritation of the mucous membranes. Make sure there are no microtablets left in your mouth.

Cystic fibrosis

The dose depends on body weight and should be at the beginning of treatment 1000 lipase units / kg for each meal for children under four years of age and 500 lipase units / kg at 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 steatorrhea control and the maintenance of 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 accompanied by exocrine pancreatic insufficiency

The recommended dose is 2-4 capsules of ErmitalЃ 10,000 IU, or 1-2 capsules of ErmitalЃ 25,000 IU, or 1 capsule of ErmitalЃ 36,000 IU during each meal. The dose can be increased if necessary. Dose escalation should be supervised by 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 abundant fluid intake.

In children, the drug should be used in accordance with the doctor's prescription.

Side effect

Gastrointestinal disorders

Very common (1/10): abdominal pain.

Often (1/100, <1/10): nausea, vomiting, constipation, bloating, diarrhea.

Frequency unknown: strictures of the ileum, caecum and colon (fibrosing colonopathy).

Gastrointestinal disorders are mainly associated with an underlying medical condition. 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) have been observed in patients with cystic fibrosis who received high doses of pancreatin preparations (see section 'Special instructions').

Rut and subcutaneous tissue disorders

Uncommon (1/1000, <1/100): rash.

Frequency not known: pruritus, urticaria.

Immune system disorders

Frequency unknown: hypersensitivity (anaphylactic reactions).

Allergic reactions were observed mainly on the part of the skin, but other manifestations of allergy were also noted. These side effects were reported during post-marketing use and were spontaneous. The available data are insufficient to accurately estimate the incidence.

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.

Overdose

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

Treatment: drug withdrawal, symptomatic therapy.

Interaction

When taking ErmitalЃ, the absorption of folic acid may decrease.

Against the background of treatment with ErmitalЃ, the effect of oral hypoglycemic drugs acarbose and miglitol may decrease.

special instructions

With prolonged use of high doses of pancreatin in patients with cystic fibrosis, it is possible to develop constipation, strictures of the ileum and cecum (fibrosing colonopathy), colitis.

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.

HermitalЃ contains active enzymes that, when released in the oral cavity (for example, when chewing), can cause irritation and ulceration of the mucous membrane. Therefore, microtablets should be swallowed without chewing.

Impact on the ability to drive a vehicle

The drug does not affect the ability to drive vehicles, mechanisms.

Release form

Capsules 10,000 IU, 25,000 IU, 36,000 IU.

Packaging
20 or 50 capsules in a dark glass bottle with a plastic cap. 1 bottle of 20 or 50 capsules is placed in a cardboard box along with instructions for use.

Storage conditions

At a temperature not higher than 25 ? C.

Keep out of the reach of children!

Shelf life

3 years.

Do not use after the expiration date printed on the package.

Conditions of dispensing from pharmacies

Without recipe.