Hermital, Capsules 10000 units 50 pcs

Ermital contains standard highly active pancreatin derived from the pancreas of pigs in the form of micro tablets resistant to gastric juice.

A digestive enzyme, replenishes pancreatic enzyme deficiencies, has proteolytic, amylolytic and lipolytic action.

Included enzymes (lipase, alpha-amylase, trypsin, chymotrypsin) help to breakdown proteins into amino acids, fats into glycerol and fatty acids, starch into dextrins and monosaccharides, improves the functional state of the gastrointestinal tract and normalizes digestive processes.

Pharmacodynamics

The form of the drug ensures complete release of the gastric juice-resistant microtablets from the capsule in the stomach, followed by fine mixing of the microtablets with

intestinal contents and chyme and rapid release of enzymes from the microtablets in the duodenum at pH>5.

Pancreatic enzyme breakdown products are absorbed in the intestine either directly or after breakdown by intestinal enzymes.

Pharmacokinetics

The pancreatic enzymes contained in Hermital are not absorbed into the blood. The enzymes are inactivated and digested in the intestine as proteins by autolysis and proteolysis. Residual enzymatic activity can be determined in the stool.

Indications

For adults and children it is used:
to improve food digestion in patients with normal gastrointestinal function in case of dietary errors;
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), Shwachman-Diamond syndrome, conditions after an attack of acute pancreatitis and resumption of nutrition, old age;
symptomatic treatment 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, dysbacteriosis.

Pharmacological effect

Ermital contains standard highly active pancreatin obtained from the pig pancreas in the form of microtablets 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) promote the breakdown of proteins into amino acids, fats into glycerol and fatty acids, starch into dextrins and monosaccharides, improves the functional state of the gastrointestinal tract, normalizes digestive processes.

Pharmacodynamics

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 rapid release of enzymes from microtablets in the duodenum at pH>5.

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

Pharmacokinetics

Pancreatic enzymes contained in Ermital are not absorbed into the blood. Enzymes are inactivated and digested in the intestine, like proteins, through autolysis and proteolysis. Residual enzymatic activity can be determined in stool.

Special instructions

With long-term use of pancreatin in high doses in patients with cystic fibrosis, constipation, strictures of the ileum and cecum (fibrosing colonopathy), and colitis may develop.

When taking the drug in high doses (more than 10,000 lipase units/kg 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 performed to exclude fibrosing colonopathy.

Ermital® contains active enzymes that, when released in the oral cavity (for example, during chewing), 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 or machinery.

Active ingredient

Pancreatin

Composition

Dosage 10,000 units:

One capsule with gastric acid-resistant microtablets contains 87.28 – 112.96 mg of pancreatin from the pig pancreas, which corresponds to the activity of lipase 10,000 units, amylase
9,000 units, protease 500 units (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),

Triethyl citrate,

Talc,

Simethicone;

Polishing agent:

Montan 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.

Pregnancy

Should not be used during pregnancy.

During breastfeeding, the risk/benefit ratio must be taken into account.

Contraindications

Known hypersensitivity to pancreatic enzymes;
acute pancreatitis;
exacerbation of chronic pancreatitis;
pregnancy.

Side Effects

Gastrointestinal disorders

Very common (≥1/10): pain in the abdominal area.

Common (≥1/100, <1/10): nausea, vomiting, constipation, bloating, diarrhea.Not known: strictures of the ileum, 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 observed 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”).Disorders of the skin and subcutaneous tissuesUncommon (≥1/1000, <1/100): rash.Frequency unknown: itching, urticaria.Immune system disordersNot known: hypersensitivity (anaphylactic reactions).Allergic reactions were observed mainly from the skin, but other manifestations of allergies were also noted. CoWhen 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 Ermital®, the absorption of folic acid may be reduced.

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

Overdose

Symptoms: hyperuricosuria, hyperuricemia.

Treatment: drug withdrawal, symptomatic therapy.

Storage conditions

At a temperature not higher than 25 ˚С.

Keep out of the reach of children!

Shelf life

3 years.

Manufacturer

Nordmark Pharma GmbH, Germany