Panzim^® forte (Tablets) Instructions for Use

Marketing Authorization Holder

Bryntsalov-A, JSC (Russia)

ATC Code

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

Active Substance

Pancreatin

Dosage Form

Panzim® forte

Film-coated tablets: 10, 20, 30, 40, 50, 80, 100, 160, 200, 800 pcs.

Dosage Form, Packaging, and Composition

20 pcs. – dark glass jars (1) – cardboard packs.
10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (8) – cardboard packs.
20 pcs. – blisters (1) – cardboard packs.
20 pcs. – blisters (2) – cardboard packs.
20 pcs. – blisters (5) – cardboard packs.
20 pcs. – blisters (8) – cardboard packs.
20 pcs. – blisters (10) – cardboard packs.
20 pcs. – blisters (40) – cardboard packs.
20 pcs. – blisters (4) – cardboard packs.
40 pcs. – dark glass jars (1) – cardboard packs.
80 pcs. – dark glass jars (1) – cardboard packs.
100 pcs. – dark glass jars (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 diseases of the pancreas, 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

Insufficiency of the exocrine function of the pancreas (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 U/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 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-recommended doses and dosage forms. It is necessary to strictly follow the instructions in the prescribing information for pancreatin preparations regarding contraindications for the use of specific dosage forms of pancreatin 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 U/kg/day (in terms of 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 the nature of complaints changes during the use of pancreatin, especially when taking doses exceeding 10,000 U of lipase/kg/day, a medical examination is necessary.

With high lipase activity contained in pancreatin, the likelihood of developing 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 30°C (86°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.