Pancreatin forte

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PANCREATIN FORTE

Composition:

Active substance: pancreatin;

One tablet contains pancreatin corresponding to a minimum enzymatic activity: 4500 Ph. Eur. amylolytic units; 6000 Ph. Eur. lipolytic units; 300 Ph. Eur. proteolytic units;

Excipients: lactose monohydrate; sodium chloride; calcium stearate; sodium croscarmellose; povidone; colloidal anhydrous silicon dioxide; triethyl citrate; Acryl-I white 93A18597 (a mixture of dry substances: methacrylate copolymer (type C); talc; titanium dioxide (E 171); colloidal anhydrous silicon dioxide; sodium bicarbonate; sodium lauryl sulfate).

Pharmaceutical form. Enteric-coated tablets.

Main physicochemical properties: white, coated, round-shaped tablets with a smooth, biconvex surface, a characteristic odor may be present. When broken and examined under a magnifying glass, a core surrounded by a single continuous layer is visible.

Pharmacotherapeutic group. Digestive enzymes and enzyme preparations. Polyzyme preparations. ATC code A09AA02.

Pharmacological Properties.

Pharmacodynamics.

An enzyme preparation derived from the pancreases of cattle and pigs. Pancreatic enzymes contained in the preparation – lipase, amylase, and protease – facilitate the digestion of proteins, carbohydrates, and fats in food, promoting more complete absorption of nutrients in the small intestine. In pancreatic disorders, the preparation compensates for exocrine insufficiency and improves the digestive process.

Pharmacokinetics.

Due to the acid-resistant coating, the enzymes are not inactivated by gastric hydrochloric acid. The coating dissolves and enzymes are released in the duodenum. The enzymes are poorly absorbed in the gastrointestinal tract and exert their action within the intestinal lumen.

Clinical characteristics.

Indications.

• Diseases associated with impaired digestion due to insufficient secretion of pancreatic digestive enzymes, such as chronic pancreatitis.
• Conditions following simultaneous resection of the stomach and small intestine; functional acceleration of food passage through the intestine, intestinal disorders, consumption of poorly digestible plant-based, fatty, and unusual foods.
• Intestinal bloating.
• Preparation for radiological or ultrasound diagnostic examinations.

Contraindications.

Hypersensitivity to pancreatin or to any of the other components of the medicinal product. Acute pancreatitis, chronic pancreatitis in the phase of exacerbation, acute hepatitis, mechanical jaundice, obstructive intestinal obstruction.

Interaction with other medicinal products and other types of interactions.

When administered concomitantly with antithrombotic agents, vitamin K antagonists, and acetylsalicylic acid, the effect of these drugs is reduced. The efficacy of non-selective inhibitors of neuronal monoamine reuptake is also reduced when used simultaneously with pancreatin.

Concomitant use with M-cholinoblockers enhances the anticholinergic effect.

Concomitant use of the medicinal product Pancreatin forte with iron preparations and folic acid may lead to reduced absorption and diminished hypoglycemic effect of acarbose.

Concomitant use of antacid agents containing calcium carbonate and/or magnesium hydroxide, tannins, or alcohol-containing agents may result in reduced effectiveness of pancreatin.

Special precautions.

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

To prevent the formation of uric acid stones in intestinal obstruction, urine uric acid levels should be monitored.

The drug reduces iron absorption; therefore, iron supplements should be administered concomitantly during prolonged use. Gastrointestinal disturbances may occur in patients with increased sensitivity to pancreatin or in patients with a history of intestinal resection.

Administration of pancreatin-containing drugs may reduce folic acid absorption, which may necessitate additional folic acid supplementation.

The drug contains lactose; therefore, if a patient has been diagnosed with intolerance to certain sugars, medical advice should be sought before taking this drug.

The drug contains sodium croscarmellose.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, the drug should be taken only as prescribed by a physician, if the expected benefit to the mother outweighs the potential risk to the fetus/infant.

Ability to affect reaction rate when driving or operating machinery.

Does not affect.

Method of Administration and Dosage

The dose of Pancreatin forte depends on the deficiency of pancreatic enzymes in the duodenum and is determined individually by a physician.

In the absence of other recommendations, and in cases of consuming poorly digestible plant-based food, fatty or unusual food, take 1–2 tablets. In other cases of digestive disturbances, the recommended dose is 2–4 tablets. If necessary, the dose may be increased. Dose escalation aimed at reducing symptoms of disease (e.g., steatorrhea or abdominal pain) should be performed only under medical supervision. The daily dose of lipase should not exceed 15000–20000 lipolytic IU Ph. Eur. per 1 kg of body weight.

Tablets should be swallowed whole, without chewing, with a large amount of liquid, for example, one glass of water.

The duration of treatment is determined by the nature of the disease and is established individually by a physician.

Questions regarding dosage and duration of treatment in children are decided by a physician.

The drug should be prescribed at a daily dose necessary to normalize bowel movements, but not exceeding 1500 lipolytic IU Ph. Eur. per 1 kg of body weight in children under 12 years of age. For children aged 12 years and older, the daily dose of enzymes should not exceed 15000–20000 lipolytic IU Ph. Eur. per 1 kg of body weight.

Children.

The medicinal product is recommended for use in children aged 6 years and older.

Overdose.

Symptoms. With intake of extremely high doses of pancreatin, hyperuricemia and hyperuricosuria, as well as elevated levels of uric acid in blood plasma, have been observed.

Treatment. Discontinuation of the drug, symptomatic therapy, adequate hydration.

Side effects.

Gastrointestinal system: diarrhea, abdominal pain, bloating, vomiting, nausea, changes in bowel habits, possible development of intestinal obstruction, constipation, epigastric discomfort.

In patients taking high doses of pancreatin, narrowing of the ileocecal region and colon (fibrosing colonopathy), as well as colitis, have been observed. If unusual abdominal symptoms occur or if there is a change in the clinical presentation of the underlying disease, involvement of the colon should be ruled out, especially in patients receiving more than 10,000 Ph.Eur. units of lipase/kg/day.

Immune system: allergic reactions, including itching, skin rash, rhinitis, urticaria, sneezing, lacrimation, bronchospasm, anaphylactic reactions, angioneurotic edema.

Reporting of adverse reactions after drug registration is highly important. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmacy professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life.

2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 10 tablets per blister, pack containing 10×2, or 10×4, or 10×5, or 10×6 blisters in a cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer.

JSC "VITAMINS".

Manufacturer's address and place of business.

31 Uspenska St., Uman, Cherkasy region, 20300, Ukraine.

Marketing Authorization Holder.

JSC "VITAMINS".

Address of the Marketing Authorization Holder.

31 Uspenska St., Uman, Cherkasy region, 20300, Ukraine.