Description

Dosage form

Hard oblong gelatin capsule, size No. 00, brown opaque cap, colorless transparent body.

Capsule contents: whitish-gray convex film-coated microtablets microtablets may have a characteristic odor.

Structure

One capsule with resistant to gastric juice 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, anhydrous colloidal silicon dioxide, magnesium stearate.

The composition of the film shell of the microtablet: copolymer of methacrylic acid and ethyl acrylate (1: 1), triethyl citrate, talc, simethicone

polishing agent - montan glycol wax.

The composition of the capsule cap: gelatin, red iron oxide (E172), black iron oxide (E172), titanium dioxide (E171), sodium lauryl sulfate.

The composition of the capsule body: gelatin, sodium lauryl sulfate.

general description

Digestive Enzyme Remedy

Special conditions

Long-term use of pancreatin in high doses in patients with cystic fibrosis may 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.

Hermital® 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.

Influence on the ability to drive vehicles, mechanisms

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

Drug interactions

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

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

Pharmacodynamics

Enzyme preparation.

Hermital contains a standard highly active pancreatin obtained from the pancreas of a pig in the form of microtablets resistant to gastric juice.

The drug compensates for the deficiency of pancreatic enzymes, has proteolytic, amylolytic and lipolytic effects.

The enzymes included in its 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, improves the functional state of the gastrointestinal tract, and normalizes digestion processes.

The form of release of the drug provides complete release of microtablets resistant to the action of gastric juice from the capsule in the stomach, followed by fine mixing of microtablets with intestinal contents and chyme and rapid release of enzymes from microtablets in the duodenum at pH> 5.

The cleavage products by pancreatic enzymes are absorbed in the intestine either directly or after digestion by intestinal enzymes.

Pharmokinetics

The form of release 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 microtablets with intestinal contents and chyme and rapid release of enzymes from microtablets in the duodenum.

Pancreatic enzymes are not absorbed into the bloodstream.

Enzymes are inactivated and digested in the intestine like proteins by autolysis and proteolysis.

Indications

In adults and children:

- to improve the digestion of food in patients with normal gastrointestinal tract function 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 duct, 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

Contraindications for use

- hypersensitivity to any component of the drug.

Application during pregnancy and lactation

The use of the drug Ermital® 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 mother's body, as well as the fetus and infant, is not expected.

Application in children

For children under 4 years of age with cystic fibrosis, the dose depends on body weight and should be at the beginning of treatment 1000 lipase units / kg for each meal and 500 lipase units / kg during meals for children over 4 years old.

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

Overdose

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

Treatment: drug withdrawal, symptomatic therapy.

Side effects

From the side of the gastrointestinal tract: very often (? 1/10) - pain in the abdomen

often (? 1/100, < 1/10) - nausea, vomiting, constipation, bloating, diarrhea

frequency unknown - strictures of the ileum, cecum and colon (fibrosing colonopathy).

Gastrointestinal disorders are associated mainly 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 receiving high doses of pancreatin preparations (see section Special instructions").

On the part of the skin and subcutaneous tissues: infrequently (? 1/1000, < 1/100) - rash

frequency unknown - itching, urticaria.

From the immune system: frequency is unknown - hypersensitivity (anaphylactic reactions).

Allergic reactions were observed mainly on the part of the skin, but other manifestations of allergy were also noted.

Reports of these side effects were received 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.

Dosage

36000ED

Indications

In adults and children: - to improve the digestion of food in patients with normal gastrointestinal tract function 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 duct, 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.

INN / Active ingredient

pancreatin

Storage conditions and periods

At a temperature not higher than 25 degrees.

Specifications