Pancreatin® forte 20 000

INSTRUCTIONS for medical use of the medicinal product Panzynorm® forte 20 000 (Panzynorm forte 20 000)

Composition:

Active substance: 1 tablet contains 269.12–279.44 mg of porcine pancreatin with enzymatic activity of lipase – 20,000 IU, amylase – 12,000 IU, protease – 900 IU;

Excipients: lactose monohydrate, microcrystalline cellulose, crospovidone, colloidal anhydrous silicon dioxide, magnesium stearate, hypromellose, methacrylate copolymer (type A), triethyl citrate, titanium dioxide (E 171), talc, simethicone emulsion, vanilla flavor, bergamot flavor, macrogol 6000, sodium carmellose, polysorbate 80.

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: white to light grey, smooth, round, convex, aromatic film-coated tablets.

Pharmacotherapeutic group. Digestive enzymes. Pancreatic enzyme preparations. ATC code A09AA02.

Pharmacological properties.

Pharmacodynamics.

Pancreatin is a powder derived from porcine pancreatic glands, containing enzymes such as lipase, amylase, trypsin, and chymotrypsin, which aid in the digestion of proteins, fats, and carbohydrates in the gastrointestinal tract. The key components are the enzymatic activity of lipase and the presence of trypsin, since even with significantly reduced pancreatic secretory activity, amylase still demonstrates sufficient activity.

Pharmacokinetics.

The acid-resistant coating protects the active enzymes from the action of gastric juice. The coating dissolves and releases the enzymes only under the influence of the neutral or slightly alkaline environment of the small intestine.

Clinical characteristics.

Indications.

Chronic pancreatitis.

Conditions following simultaneous resection of the stomach and small intestine, functional acceleration of food passage through the intestine.

Intestinal disorders, concurrent intake of poorly digestible plant-based, fatty and unusual food.

PanzyNorm® forte 20 000 is also used for intestinal bloating and in preparation for X-ray or ultrasound diagnostic examinations.

Contraindications.

PanzyNorm**®** forte 20000 is contraindicated:

• in patients with hypersensitivity to pork or other components of the drug;
• in acute pancreatitis or acute exacerbation of chronic pancreatitis;
• obstructive intestinal obstruction.

Interaction with other medicinal products and other forms of interaction.

Pancreatic enzymes inhibit the absorption of folic acid, which may lead to the need for additional folic acid supplementation.

Pancreatic enzymes may reduce iron absorption, but the clinical significance of this interaction is unknown.

The acid-resistant film coating of PanzyNorm**®** forte 20 000 tablets dissolves in the duodenum. If the duodenal contents are too acidic, the enzymes will be released untimely. Reduction of gastric acid secretion achieved by using H2-receptor antagonists or proton pump inhibitors improves the efficacy of enzyme administration in some patients and allows for a reduction in the dose of PanzyNorm**®** forte 20 000.

Acarbose, miglitol.

The blood glucose-lowering effect of the oral antidiabetic agents acarbose and miglitol may be reduced when used concomitantly with PanzyNorm® forte 20 000.

Special precautions for use

The drug contains active enzymes that may damage the oral mucosa; therefore, the tablets should be swallowed whole, without chewing, and taken with sufficient fluid.

If unusual abdominal discomfort or changes in symptoms occur, as a precautionary measure, patients should undergo an examination to rule out intestinal damage, especially if the patient is receiving a dose exceeding 10,000 IU of lipase per kilogram of body weight per day.

PanzyNorm**®** Forte 20,000 contains lactose. The drug should not be used in patients with rare hereditary disorders such as galactose intolerance, congenital lactase deficiency, or glucose-galactose malabsorption syndrome.

Use during pregnancy or breastfeeding

PanzyNorm**®** Forte 20,000 is recommended for use only under a physician's prescription when the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to affect reaction rate while driving or operating machinery

No effects on the ability to drive or operate machinery have been observed.

Dosage and Administration

The dose of Pancreatin**®** forte 20 000 is determined individually depending on the severity of pancreatic insufficiency. The usual initial dose is 1–2 tablets per meal. The tablet must not be chewed and should be taken with an adequate amount of liquid (a glassful). Depending on the type of food and the severity of digestive disturbances, the dose may be gradually increased. Dose escalation should be performed under medical supervision, guided by improvement of disease symptoms, such as steatorrhea or pain syndrome. The maximum daily dose for adults and children aged 15 years and older is 9 tablets. The decision regarding dose adjustment and duration of treatment is made by the physician on an individual basis.

Children.

Not recommended for children under 15 years of age, since Pancreatin® forte 20 000 tablets are film-coated and cannot be divided.

Overdose.

There is no data on systemic intoxication due to overdose. Overdose may cause nausea, vomiting, diarrhea, hyperuricemia, hyperuricosuria, and uricosuria, perianal irritation, and very rarely, fibrosing colonopathy. In case of overdose, administration of the tablets should be discontinued; hydration and symptomatic treatment are recommended.

Side effects.

When using high doses of the drug, increased excretion of uric acid with urine may be observed; therefore, to prevent the formation of uric acid concretions in such patients, the level of uric acid in urine should be monitored.

Immune system side effects. In isolated cases, immediate-type allergic reactions (skin rash, urticaria, sneezing, lacrimation, bronchospasm, dyspnea) and hypersensitivity reactions localized in the gastrointestinal tract have been observed after pancreatin intake.

Gastrointestinal side effects. Diarrhea, abdominal discomfort, abdominal pain, nausea, and vomiting have been observed very rarely.

When very high doses of pancreatin are used, formation of strictures in the ileocecal region and ascending colon may occur.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging.

Keep out of reach of children.

Packaging.

10 film-coated tablets in a blister; 1, 3, or 10 blisters in a box.

Prescription status.

Over-the-counter (without prescription).

Manufacturer.

KRKA, d.d., Novo mesto, Slovenia / KRKA, d.d., Novo mesto, Slovenia.

Manufacturer's address and place of business.

Smarjeska cesta 6, 8501 Novo mesto, Slovenia / Smarjeska cesta 6, 8501 Novo mesto, Slovenia.