Ermytal^® (Capsules) Instructions for Use

Marketing Authorization Holder

Nordix Pharma Vertrieb, GmbH (Germany)

Manufactured By

NORDMARK ARZNEIMITTEL, GmbH & Co.KG (Germany)

Quality Control Release

NORDIX PHARMA VERTRIEB, GmbH (Germany)

Contact Information

NIZHPHARM group of companies (Russia)

ATC Code

A09AA02 (Polyenzyme preparations (incl. lipase, protease))

Active Substance

Pancreatin (BAN)

Dosage Forms

	Ermytal®	Enteric-coated capsules 10000 U: 20 or 50 pcs.
		Enteric-coated capsules 25000 U: 20 or 50 pcs.
		Enteric-coated capsules 36000 U: 20 or 50 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated capsules hard gelatin, size No. 2, oblong; cap brown opaque, body colorless transparent; capsule contents – microtablets, film-coated whitish-gray, convex; a characteristic odor of the microtablets may be present.

Excipients: microcrystalline cellulose, crospovidone, colloidal anhydrous silicon dioxide, magnesium stearate.

Microtablet film coating composition methacrylic acid and ethyl acrylate copolymer (1:1), triethyl citrate, talc, simethicone; polishing agent – montan glycol wax.

Cap composition gelatin, iron oxide red (E172), iron oxide black (E172), titanium dioxide (E171), sodium lauryl sulfate.
Body composition gelatin, sodium lauryl sulfate.

20 pcs. – dark glass bottles^× (1) – cardboard packs.
50 pcs. – dark glass bottles^× (1) – cardboard packs.

^× the bottle is equipped with a sealing disk consisting of two parts fastened with wax dots.

Enteric-coated capsules hard gelatin, size No. 0 el, oblong; cap brown opaque, body colorless transparent; capsule contents – microtablets, film-coated whitish-gray, convex; a characteristic odor of the microtablets may be present.

Excipients: microcrystalline cellulose, crospovidone, colloidal anhydrous silicon dioxide, magnesium stearate.

Microtablet film coating composition methacrylic acid and ethyl acrylate copolymer (1:1), triethyl citrate, talc, simethicone; polishing agent – montan glycol wax.

Cap composition gelatin, iron oxide red (E172), iron oxide black (E172), titanium dioxide (E171), sodium lauryl sulfate.
Body composition gelatin, sodium lauryl sulfate.

20 pcs. – dark glass bottles (1) – cardboard packs.
50 pcs. – dark glass bottles (1) – cardboard packs.

Enteric-coated capsules hard gelatin, size No. 00, oblong; cap brown opaque, body colorless transparent; capsule contents – microtablets, film-coated whitish-gray, convex; a characteristic odor of the microtablets may be present.

Excipients: microcrystalline cellulose, crospovidone, colloidal anhydrous silicon dioxide, magnesium stearate.

Microtablet film coating composition methacrylic acid and ethyl acrylate copolymer [1:1], triethyl citrate, talc, simethicone*; polishing agent – montan glycol wax.

Cap composition gelatin, colorant iron oxide red (E172), iron oxide black (E172), titanium dioxide (E171), sodium lauryl sulfate.
Body composition gelatin, sodium lauryl sulfate.

20 pcs. – dark glass bottles (1) – cardboard packs.
50 pcs. – dark glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Enzyme preparation

Pharmacotherapeutic Group

Digestive enzyme agent

Pharmacological Action

Enzyme agent. Contains standardized highly active Pancreatin, obtained from porcine pancreas in the form of microtablets resistant to gastric juice. Compensates for the deficiency of pancreatic enzymes, has proteolytic, amylolytic, and lipolytic action.

The enzymes included in its 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 digestion processes.

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

Pharmacokinetics

Pancreatic enzymes are not absorbed into the blood. Enzymes are inactivated and digested in the intestine, like proteins, by autolysis and proteolysis.

Indications

In adults and children

• 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 pancreatic ducts, common bile duct), Shwachman-Diamond syndrome, conditions after an acute pancreatitis attack and resumption of nutrition;
• Symptomatic therapy of digestive disorders: condition after cholecystectomy, partial gastrectomy (Billroth-I/II), total gastrectomy, duodenal and gastric stasis, biliary obstruction, cholestatic hepatitis, liver cirrhosis, Crohn’s disease, dysbiosis.

ICD codes

Dosage Regimen

Orally, doses are selected individually depending on the severity of the disease and diet.

The dose calculation is based on lipase activity units.

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 4 years and 500 lipase units/kg during meals for children over 4 years and adults.

The dose should be determined depending on the severity of disease symptoms, results of steatorrhea control and maintenance of adequate nutritional status. For most patients, the dose should remain less than or not exceed 10,000 lipase units/kg of body weight per day or 4000 lipase units/g of fat consumed.

Other conditions accompanied by exocrine pancreatic insufficiency

The recommended single dose is 20,000-50,000 U during each meal. If necessary, the dose can be increased. Dose increase should be under medical supervision. The daily dose of enzymes should not exceed 15-20 thousand lipase units per kg of body weight. Therapy should be carried out with abundant fluid intake.

Adverse Reactions

Gastrointestinal disorders very common (≥1/10) – abdominal pain; common (≥1/100, <1/10) – nausea, vomiting, constipation, flatulence, diarrhea; frequency unknown – ileal, cecal and colonic strictures (fibrosing colonopathy).

Gastrointestinal disorders are mainly associated with the underlying disease. The frequency of such adverse reactions as abdominal pain and diarrhea was lower or similar to that with placebo. Ileal, cecal and colonic strictures (fibrosing colonopathy) were observed in patients with cystic fibrosis receiving high doses of pancreatin preparations (see section “Special Precautions”).

Skin and subcutaneous tissue disorders uncommon (≥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 manifestations of allergy were also noted. Reports of these side effects were received during post-marketing use and were spontaneous. For an accurate assessment of frequency, available data are insufficient.

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.

Contraindications

• Hypersensitivity to any component of the used preparation.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is possible only after careful assessment of the benefit to the mother versus the risk to the fetus or infant. Due to negligible systemic absorption of pancreatin, negative effects on the mother’s body, as well as the fetus and infant, are not expected.

Pediatric Use

In children, Pancreatin should be used in accordance with the doctor’s prescription.

Special Precautions

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

When taking pancreatin 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 performed to exclude fibrosing colonopathy.

Drug Interactions

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

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

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.