Panzytrat^® (Capsules) Instructions for Use

Marketing Authorization Holder

NORDMARK ARZNEIMITTEL, GmbH & Co.KG (Germany)

ATC Code

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

Active Substance

Pancreatin (BAN)

Dosage Forms

	Panzytrat®	Capsules 10 thousand units: fl. 10, 20, 50 or 100 pcs.
		Capsules 25 thousand units: fl. 10, 20, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 2, oblong, with a brown cap and a colorless transparent body; the contents of the capsules are convex microtablets coated with a whitish-gray film coat.

Excipients: microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid – ethyl acrylate copolymer, triethyl citrate, talc, simethicone 23% emulsion, montan glycol wax, gelatin, titanium dioxide, iron oxide red, iron oxide black.

20 pcs. – bottles (1) – cardboard packs.
50 pcs. – bottles (1) – cardboard packs.
100 pcs. – bottles (1) – cardboard packs.

Capsules hard gelatin, size No. 0, oblong, with a brown cap and a colorless transparent body; the contents of the capsules are convex microtablets coated with a whitish-gray film coat.

Excipients: microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid – ethyl acrylate copolymer, triethyl citrate, talc, simethicone 23% emulsion, montan glycol wax, gelatin, titanium dioxide, iron oxide red, iron oxide black.

20 pcs. – bottles (1) – cardboard packs.
50 pcs. – bottles (1) – cardboard packs.
100 pcs. – bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Enzyme preparation

Pharmacotherapeutic Group

Digestive enzyme agent

Pharmacological Action

Enzyme preparation. Compensates for the insufficiency of the exocrine function of the pancreas, has a proteolytic, amylolytic and lipolytic effect. Improves the functional state of the gastrointestinal tract, normalizes digestion processes.

The pancreatic 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. Trypsin inhibits stimulated secretion of the pancreas, providing an analgesic effect.

The capsules contain microtablets coated with an enteric coating. Pancreatic enzymes are released from the dosage form in the alkaline environment of the small intestine, as they are protected from the action of gastric juice by the coating.

Pharmacokinetics

Data on the pharmacokinetics of the drug Panzytrat^® are not provided.

Indications

• Replacement therapy for exocrine pancreatic insufficiency (including chronic pancreatitis, post-radiation condition, dyspepsia, Roemheld’s syndrome, cystic fibrosis, flatulence, diarrhea of non-infectious origin, after pancreatectomy);
• In case of malabsorption of food after resection of the stomach and/or small intestine;
• To improve food digestion in persons with normal gastrointestinal function in case of dietary errors (including irregular meals, consumption of large amounts of food, consumption of fatty foods, chewing disorders, sedentary lifestyle, prolonged immobilization);
• Preparation for X-ray and ultrasound examination of the abdominal organs.

ICD codes

Dosage Regimen

The drug is taken orally during or after meals, without chewing and washed down with a non-alkaline liquid (water, fruit juices).

The dose is determined depending on the degree of digestive impairment. Adults are prescribed 1-2 caps. (10,000 units) or 1 caps. (25,000 units) 3 times/day. In children over 6 years old, the drug is used as prescribed by a doctor, the dose is determined individually.

The duration of treatment can vary from several days (in case of digestive disorders due to dietary errors) to several months or years (if constant replacement therapy is necessary).

Adverse Reactions

From the digestive system rarely – diarrhea, constipation, feeling of discomfort in the stomach, nausea (the cause-and-effect relationship of the development of these reactions with the action of pancreatin has not been established, since these phenomena are symptoms of exocrine pancreatic insufficiency).

With long-term use in high doses possible – hyperuricosuria, hyperuricemia.

In cystic fibrosis in case of exceeding the required dose of pancreatin possible – strictures (fibrosing colonopathy) in the ileocecal section of the ascending colon.

When used in high doses in children possible – perianal irritation, irritation of the oral mucosa.

Other allergic reactions.

Contraindications

• Acute pancreatitis;
• Exacerbation of chronic pancreatitis;
• Children under 6 years of age;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The use of pancreatin during pregnancy and during lactation (breastfeeding) is not contraindicated.

Pediatric Use

In children over 6 years old, the drug is used as prescribed by a doctor, the dose is determined individually.

Children under 6 years old the drug is contraindicated.

Special Precautions

In cystic fibrosis, the use of pancreatin in high doses is not recommended due to an increased risk of developing strictures (fibrosing colonopathy).

The dose should be adequate to the amount of enzymes necessary for the absorption of fats, taking into account the quality and quantity of food consumed.

Use in pediatrics

The use of the drug is contraindicated in children under 6 years of age.

Overdose

Symptoms hyperuricosuria, hyperuricemia; in children – constipation.

Treatment drug withdrawal, symptomatic therapy.

Drug Interactions

When using pancreatin, a decrease in the absorption of iron and folic acid is possible.

Simultaneous use of antacids containing calcium carbonate and/or magnesium hydroxide may lead to a decrease in the effectiveness of pancreatin.

Storage Conditions

The drug should be stored out of the reach of children, in a dry place at a temperature not exceeding 20°C (68°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.