Pangrol 10000 (Capsules) Instructions for Use

Marketing Authorization Holder

Berlin-Chemie/Menarini Pharma, GmbH (Germany)

Manufactured By

Aptalis Pharma S.r.l. (Italy)

ATC Code

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

Active Substance

Pancreatin

Dosage Form

Pangrol 10000

Enteric-coated capsules 10,000 units: 20, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated capsules opaque, hard gelatin cylindrical with hemispherical ends size No. 2: capsule body light orange, capsule cap greenish-yellow. Capsule contents: cylindrical mini-tablets coated with an enteric coating, light beige in color with a shiny surface.

Excipients: croscarmellose sodium 5.12 mg, microcrystalline cellulose 8.52 mg, hydrogenated castor oil 1.709 mg, colloidal anhydrous silicon dioxide 0.849 mg, magnesium stearate 0.849 mg.

Coating composition: methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion – 25 mg, triethyl citrate – 2.51 mg, simethicone emulsion 30% (dry mass) – 0.015 mg; talc – 5.01 mg; capsule body composition: gelatin – 36.20 mg, titanium dioxide (E 171) – 0.20 mg; iron oxide yellow (E 172) – 0.20 mg; iron oxide red (E 172) – 0.01 mg; capsule cap composition: gelatin – 23.8 mg; titanium dioxide (E 171) – 0.4 mg; quinoline yellow (E 104) – 0.2 mg; indigo carmine (E 132) – 0.002 mg.

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

Clinical-Pharmacological Group

Enzyme preparation

Pharmacotherapeutic Group

Digestive enzyme agent

Pharmacological Action

Enzyme agent. Contains pancreatic enzymes – amylase, lipase, and proteases, which facilitate the digestion of carbohydrates, fats, and proteins, promoting their more complete absorption in the small intestine. In pancreatic diseases, it compensates for the insufficiency of its exocrine function and helps improve the digestive process.

Pharmacokinetics

Pancreatic enzymes are not absorbed from the gastrointestinal tract, therefore classical pharmacokinetic studies have not been conducted.

Indications

Exocrine pancreatic insufficiency (including in chronic pancreatitis, cystic fibrosis).

Chronic inflammatory-dystrophic diseases of the stomach, intestines, liver, gallbladder; conditions after resection or irradiation of these organs, accompanied by digestive disorders, flatulence, diarrhea (as part of combination therapy).

To improve food digestion in patients with normal gastrointestinal function in case of dietary errors, as well as in cases of impaired chewing function, forced prolonged immobilization, sedentary lifestyle.

Preparation for X-ray and ultrasound examination of the abdominal organs.

ICD codes

Dosage Regimen

Orally. The dose, regimen, and duration of use are determined individually, depending on the indications, clinical situation, patient’s age, and the dosage form used.

The average dose for adults is 150,000 units/day.

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

Adverse Reactions

From the digestive system very rarely – diarrhea, abdominal discomfort, abdominal pain, nausea, vomiting; formation of strictures in the ileocecal and ascending parts of the colon in patients with cystic fibrosis when using high doses of pancreatin.

From the immune system: very rarely – immediate-type allergic reactions (skin rash, urticaria, sneezing, lacrimation, bronchospasm, dyspnea), gastrointestinal hypersensitivity.

From metabolism with long-term use in high doses, the development of hyperuricosuria is possible; in excessively high doses – an increase in the level of uric acid in the blood plasma.

Other when using pancreatin in high doses in children, perianal irritation may occur.

Contraindications

Hypersensitivity to pancreatin; acute pancreatitis; childhood – depending on the dosage form.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, use is possible according to indications in cases where the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Pediatric Use

Use in children is possible according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the pancreatin drug leaflets regarding contraindications for the use of specific pancreatin dosage forms in children of different ages.

Special Precautions

Use is not recommended in the exacerbation phase of chronic pancreatitis. Use is possible in the phase of subsiding exacerbation when expanding the diet, if there are signs of digestive disorders.

In cystic fibrosis, the dose should be adequate to the amount of enzymes required for fat absorption, taking into account the quality and quantity of food consumed.

In cystic fibrosis, the use of pancreatin in doses exceeding 10,000 units/kg/day (calculated as lipase) is not recommended due to an increased risk of developing strictures (fibrosing colonopathy) in the ileocecal region and ascending colon.

In patients with cystic fibrosis, especially when taking high doses of pancreatin, hyperuricosuria may be observed, so in this group of patients it is necessary to monitor the concentration of uric acid in the urine.

As a precaution, if unusual abdominal discomfort occurs or if the nature of complaints changes during pancreatin use, especially when taking doses exceeding 10,000 units of lipase/kg/day, a medical examination is necessary.

Due to the high activity of lipase contained in pancreatin, the likelihood of constipation in children increases. Increasing the dose of pancreatin in this category of patients should be done gradually.

Digestive system disorders may occur in patients with hypersensitivity to pancreatin, or in patients with a history of meconium ileus or intestinal resection.

Drug Interactions

With simultaneous use with antacids containing calcium carbonate and/or magnesium hydroxide, a decrease in the effectiveness of pancreatin is possible.

With simultaneous use with iron preparations, a decrease in iron absorption is possible.

A decrease in the absorption of folic acid is possible with simultaneous use with pancreatin preparations.

The effect of oral hypoglycemic agents (such as acarbose, miglitol) may decrease with simultaneous use with digestive enzyme preparations containing carbohydrate-splitting enzymes.

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.