Pancreatin-zdorovya forte 14000

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PANKREATYN-ZDOROVIYA FORTE 14000

Composition:

Active ingredient: pancreatin;

1 tablet contains 384 mg of pancreatin with activity not less than 10,000 amylolytic units (Ph. Eur. U.), 14,000 lipolytic units, and 800 proteolytic units;

Excipients: lactose monohydrate; microcrystalline cellulose, sodium croscarmellose, crospovidone, povidone, colloidal anhydrous silicon dioxide, magnesium stearate, polyethylene glycol, azorubine (E 122); dry mixture "Acryl-eze white" containing talc, titanium dioxide (E 171), methacrylate copolymer, sodium lauryl sulfate, sodium bicarbonate, silicon dioxide.

Pharmaceutical form. Enteric-coated tablets.

Main physicochemical properties: enteric-coated tablets, round-shaped with a biconvex surface, light pink in color, with a slight specific odor. Two layers are visible in cross-section.

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

Pharmacological properties.

Pharmacodynamics. A polyenzyme preparation that aids digestion. The preparation contains the main pancreatic digestive enzymes: lipase, α-amylase, and proteases (trypsin and chymotrypsin), which exert lipolytic, amylolytic, and proteolytic actions, enhancing the breakdown of proteins, carbohydrates, and fats in the duodenum and proximal part of the small intestine, thereby promoting their more complete absorption. Improves gastrointestinal tract function and normalizes digestive processes.

The tablets have a protective coating insoluble in the acidic environment of the stomach, which prevents the destruction of pancreatic enzymes by gastric juice. The pancreatic enzymes are active only in an alkaline environment and are released from the dosage form in the alkaline environment of the small intestine, acting within the intestinal lumen.

Pharmacokinetics. The enzymes contained in the preparation are not absorbed in the gastrointestinal tract and therefore are not detected in systemic circulation; they are inactivated through hydrolysis and digested. A small portion of enzymes that resist hydrolysis is excreted unchanged in the feces.

Clinical characteristics.

Indications.

• Replacement therapy in exocrine insufficiency of the pancreas: chronic pancreatitis, post-pancreatectomy states, pancreatic cancer, radiation, dyspepsia.
• Meteorism, non-infectious diarrhea.
• Impaired digestion (post-gastrectomy and post-resection of the small intestine).
• To improve digestion in individuals with normal gastrointestinal tract function in cases of impaired mastication, consumption of hard-to-digest, plant-based, fatty or unusual food; overeating.
• Preparation for radiological examination and ultrasound diagnostic procedures of abdominal organs (intestinal degassing).

Contraindications. Hypersensitivity to porcine pancreatin or other components of the drug, lactose intolerance, acute pancreatitis, acute exacerbation of chronic pancreatitis, intestinal obstruction.

Interaction with other medicinal products and other forms of interaction. When using the drug, reduced absorption of iron and folic acid may occur, as well as reduced hypoglycemic effect of acarbose. Concurrent use with antacids containing calcium carbonate and/or magnesium hydroxide, tannins, or alcohol-containing agents reduces the effectiveness of pancreatin.

Special precautions for use.

During prolonged use, simultaneous administration of iron supplements is recommended.

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

Azo-rubine (E 122) may cause allergic reactions.

Use during pregnancy or breastfeeding. The safety of using pancreatin during pregnancy has not been sufficiently studied.

This preparation should be used during pregnancy or breastfeeding only if clearly needed and under medical supervision, when the expected benefit to the mother outweighs the potential risk to the fetus/infant.

Effect on ability to drive and use machines. Has no effect.

Dosage and Administration.

Take orally during or immediately after a meal. The tablets should be swallowed whole, without chewing, with a large amount of liquid (water, fruit juices). Dosage is individual and depends on the patient's age, degree of digestive impairment, and dietary composition.

It is recommended to take 1–2 tablets (14,000–28,000 IU of lipase) with each meal. However, some patients may require an increase in dosage by 1.5–2 times or even more to control steatorrhea and maintain adequate nutritional status. The dose should not exceed 15,000–20,000 IU of lipase/kg body weight/day.

Duration of treatment may vary from several days (in cases of digestive disturbances due to excessive food intake) to several months or even years (in cases requiring long-term replacement therapy).

Children. The drug is recommended for use in children aged 4 years and older.

Overdose.
Symptoms: hyperuricosuria, hyperuricemia; in children – constipation.

Treatment: discontinue the drug, ensure adequate hydration, symptomatic therapy.

Side effects.

Gastrointestinal system: very rare – nausea, vomiting, flatulence, diarrhea, epigastric discomfort, changes in bowel habits.

Possible hypersensitivity reactions (including rash, itching, sneezing, lacrimation, bronchospasm, urticaria, anaphylactic reactions), perianal irritation.

Shelf life. 3 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging. Tablets in blisters: № 10, № 10×2, № 10×5 in a box.

Availability. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVYA".

Limited Liability Company "FARMEKS GROUP".

Manufacturer's address and place of business. Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenka Street, building 22.

(LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVYA")

Ukraine, 08301, Kyiv region, city of Boryspil, Shevchenka Street, building 100.

(Limited Liability Company "FARMEKS GROUP")