Hermitage - instructions for use, dose, side effects, contraindications

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

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

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

Excipients: microcrystalline cellulose, crospovidone, colloidal anhydrous silicon dioxide, magnesium stearate; film coating of the microtablet: a copolymer of methacrylic acid and ethyl acrylate (1: 1), three ethyl citrate, talc, simethicone; polishing substance: montane-glycolic wax. Capsule cap: gelatin, red iron oxide (E 172), ferric iron oxide (E 172), titanium dioxide (E 171), sodium lauryl sulfate; capsule body: gelatin, sodium lauryl sulfate.

Description:

Dosage of 10,000 units:

Solid, elongated gelatin capsule size no. 2, cap of brown color opaque, the body is colorless transparent. Contents of the capsule: whitish-gray convex covered film shell microtablets; allowed Availability characteristic smell of microtablets.

Dosage of 25,000 units:

Hard, oblong gelatin capsule, size No. 0 el, The cap of brown color is opaque, the case is colorless transparent. Contents of the capsule: whitish-gray convex film-coated micro-tablets; the availability of characteristic smell of microtablets.

Dosage of 36,000 units:

Solid, elongated gelatin capsule, size 00, brownish opaque cap, colorless transparent body.Contents of the capsule: whitish-gray convex film-coated micro-tablets; the availability of characteristic smell of microtablets.

Pharmacotherapeutic group:digestive enzyme.

ATX: & nbsp

A.09.A.A Enzyme preparations

A.09.A.A.02 Pancreatin

Pharmacodynamics:

Hermitage® contains a 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. Included in the enzymes (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, normalize the digestive process. The products of cleavage by pancreatic enzymes are absorbed in the intestine either directly or after digestion by intestinal enzymes.

Pharmacokinetics:

Release form of the drug provides complete release resistant to gastric juice microtablets of capsules in the stomach, followed by stirring microtablets particulate with intestinal contents and chyme and rapid release of enzymes from the micro-tablets in the duodenum.

Enzymes of the pancreas are not absorbed into the blood. Enzymes are inactivated and digested in the intestine as proteins by autolysis and proteolysis.

Indications:

In adults and children:

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

- replacement therapy in exocrine pancreatic insufficiency: cystic fibrosis, chronic pancreatitis, pancreatectomy, pancreatic cancer, ductal obstruction from neoplasm (including obstruction of the pancreatic duct, common bile duct), Shvahmana-Diamond syndrome, conditions after an attack of acute pancreatitis and renewal of nutrition;

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

Contraindications:

Known hypersensitivity to any of the components of the drug.

Pregnancy and lactation:

The use of Hermitage® during pregnancy and lactation is possible only after a careful evaluation of the relationship between use for the mother and the risk to the fetus or baby. Due to the insignificant systemic absorption of pancreatin, the negative impact on the mother's body, as well as the fetus and infant, is not expected.

Dosing and Administration:Inside, the doses are selected individually, depending on the severity of the disease and diet. Calculation of the dose is carried out in terms of units of lipase activity. Capsules should be swallowed whole while eating, squeezed with a large amount of liquid (water, juices); with difficulty swallowing capsules can be opened and the contents added to a liquid food having a sour taste (pH <5.5), or pour the contents of the capsules in their mouth and swallow them without chewing and with a large amount of liquid (about a glass of water).Grinding, chewing microtables or adding them to food with a pH> 5.5 leads to the destruction of their shell, which protects against action of gastric juice. This can lead to early release of enzymes in the oral cavity, reduced efficiency and irritation of the mucous membranes. It is necessary to make sure that there are no microtablets left in the 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 and 500 lipase units / kg during meals for children over the age of four and adults.

The dose should be determined depending on the severity of the symptoms of the disease, the results of monitoring the steatorrhea and maintaining adequate nutritional status. In most patients, the dose should remain less or less than 10,000 lipase units / kg of body weight per day or 4,000 lipase units / g of consumed fat.

Other conditions accompanied by exocrine pancreatic insufficiency

The recommended dose is 2-4 capsules of the Hermitage® 10,000 ED, or 1-2 capsules of the Hermitage® 25,000 ED, or 1 capsule of the Hermitage® 36,000 ED at each meal.If necessary, the dose may be increased. The dose should be increased 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 performed against a background of copious fluid intake.

In children, the drug should be used in accordance with the appointment of a doctor.

Side effects:

Violations from the side ofgastrointestinal tract

Often (≥1/10): pain in the abdomen.

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

Frequency unknown: stricture of the iliac, blind and colon (fibrosing colonopathy).

Gastrointestinal disorders are mainly associated with the underlying disease. The incidence of such adverse reactions as abdominal pain and diarrhea was lower or similar to that of placebo. Structures of the ileum, the blind and the large intestine (fibrosing colonopathy) were observed in patients with cystic fibrosis who received high doses of pancreatin preparations (see section "Special instructions").

Disorders from the rut and subcutaneous tissues

Infrequently (≥1/1000, <1/100): a rash.

The frequency is unknown: itching, hives.

Immune system disorders

The frequency is unknown: hypersensitivity (anaphylactic reactions).

Allergic reactions were observed mainly from the skin, but other manifestations of allergy were also noted. These side effects were reported during the postmarketing period and were spontaneous. To accurately assess the frequency of the cases of available data is not enough.

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, it is possible to develop hyperuricosuria and hyperuricemia, especially in patients with cystic fibrosis.

Treatment: withdrawal of the drug, symptomatic therapy.

Interaction:

When taking the drug Hermitage®, absorption of folic acid may decrease.

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

Special instructions:

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

When taking the drug at high doses (more than 10,000 lipase units / kg of body weight per day), unusual symptoms and side effects on the part of the gastrointestinal organs should be carefully monitored and, if necessary, a medical examination to exclude fibrosing colonopathy.

The preparation Hermitage contains active enzymes, which when released in the mouth (for example, when chewing) can cause irritation and ulceration of the mucosa. Therefore, the microtablets should be swallowed without chewing.

Effect on the ability to drive transp. cf. and fur:

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

Form release / dosage:Capsules 10 000 units, 25 000 units, 36 000 units.

Packaging:For 20 or 50 capsules in a glass bottle of dark glass with a plastic lid. For 1 bottle of 20 or 50 capsules are placed in a cardboard pack together with instructions for use.

Storage conditions:

At a temperature of no 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.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-002032/08

Date of registration:21.03.2008

The owner of the registration certificate:Nordix Pharma Fertrib GmbHNordix Pharma Fertrib GmbH Germany

Manufacturer: & nbsp

NORDIX PHARMA VERTRIEB, GmbH Germany

Representation: & nbspSTADA CISASTADA CISARussia

Information update date: & nbsp19.08.2015

Illustrated instructions

Instructions

Hermitage® (Ermytal®)