Properties
What is it?
LIPHOFER FORTÉ Composition: Each enteric-coated tablet contains: Pancreatin USP (Contains Amylase activity 15,000 USP units Lipase activity 4,000 USP units Protease activity 15,000 USP units) Sodium Tauroglycocholate BPC 54.65 mg, Sugar coating containing essential carminative oils. Clinical Pharmacology: Digestive disorders are most often caused by improper diet and overeating. Discomfort, meteorism, and abdominal colic can develop when the body's own pancreatic enzymes cannot cope with the large amount of food consumed. In such cases, the enzymes contained in LIPHOFERTM FORTÉ naturally improve the digestive process and, consequently, reduce the amount of undigested food where fermentation and putrefaction processes occur. LIPHOFER FORTÉ improves the digestive process as it contains a balanced formula that enhances the body's digestive factors. It contains the enzyme amylase, which helps the body process starch, lipase, which is involved in lipid processing, and protease, which is necessary for protein processing. Small molecules formed by the action of lipase on fats are absorbed if they are soluble in water. Glycerol is soluble in water, but fats and fatty acids are not. This problem is solved by bile salts, specifically sodium tauroglycocholate contained in LIPHOFER FORTÉ. Bile salt binds to insoluble glycerides and fatty acids, emulsifying fats, thereby creating better conditions for enzyme action, which helps the body adequately and fully digest lipids. They also enhance lipase activity. Bile salts also aid in the absorption of iron, calcium, and fat-soluble vitamins, including vitamins A, D, E, and K. This increases the peristalsis of the small and large intestines, giving it a laxative effect. Therefore, in addition to ensuring the digestion of carbohydrates, fats, and proteins, LIPHOFER FORTÉ has a laxative effect and improves the absorption of fats and fat-soluble vitamins. Pharmacokinetics: Pharmacokinetic data of oral enzymes in humans have not been studied. A portion of the enzymes is absorbed in the small intestine via enterohepatic circulation. Indications: LIPHOFERTM FORTÉ is used for the treatment of pancreatic enzyme insufficiency in chronic pancreatitis, cystic fibrosis, after pancreatectomy, and in pancreatic carcinoma. Chronic inflammatory and degenerative diseases of the intestines, stomach, liver, and gallbladder that develop after resection or irradiation of these organs and are accompanied by meteorism, diarrhea, and digestive disorders. Post-gastrectomy period; Functional disorders of the gastrointestinal tract, such as intestinal infections, irritable bowel syndrome. Relief of symptoms caused by digestive disorders, including bloating, dyspepsia, meteorism, abdominal distension, diarrhea associated with digestive disorders. Additionally, LIPHOFERTM FORTÉ is used before ultrasound or radiographic, radiological examination of the digestive tract. Dosage and Administration: Dosage is individual and determined by steatorrhea and fat content in the diet. Therapy should be initiated at the lowest dose, and the dose should be gradually increased until adequate control of steatorrhea is achieved. Each tablet should be allowed to dissolve in the mouth for a few seconds and then swallowed. Tablets should not be chewed. Infants (up to 12 months): Fat intake regimen: 2,000 - 4,000 USP lipase units per 120 ml of infant formula or with breast milk. This provides 450-900 lipase units per 1 g of absorbed fat (calculated for 4.5 g of fat in 120 ml of standard infant formula using cow's milk). Higher doses are used in infants because children absorb an average of 5 g of fat per kg of body weight per day, while adults absorb only 2 g of fat per kg of body weight per day. Children (over 12 months) and adults: Weight-based regimen: «4 years: The initial dose is 1000 USP lipase units/kg of food, the maximum dose is 2500 USP lipase units/kg of food.» 4 years: The initial dose is 400 USP lipase units/kg of food, the maximum dose is 2500 USP lipase units/kg of food. If more than 2500 lipase units/kg/food (4000 lipase units per 1 g of fat per day) is required for malabsorption control, further investigation is needed to rule out other causes of malabsorption. Doses exceeding 2500 lipase units/kg/food are used with extreme caution and only if adequate effect is confirmed by a three-day determination of fat in the stool. Colonic strictures, especially in children, are associated with the use of doses higher than recommended. When using the preparation to supplement pancreatic enzymes, the dose should not exceed 10,000 units of lipase activity per 1 kg of body weight. LIPHOFER TM FORTÉ tablets are taken only during meals or snacks. LIPHOFER TM FORTÉ tablets should be taken whole (uncrushed) with a sufficient amount of water. It is preferable to choose foods that do not require prolonged chewing and have a pH less than 7.3. Such foods include baby food made from apricots, bananas, and sweet potatoes, applesauce, instant pudding, and gelatin-based foods. Contact of the tablets with products whose pH exceeds 7.3 may cause the enteric coating of the tablets to dissolve and the enzymes contained in the preparation to be destroyed. If the tablets are held in the mouth, the proteolytic enzymes contained in the preparation can damage the mucous membrane and cause ulcer formation in the oral cavity. Contraindications: Hypersensitivity to the components of the preparation. Hypersensitivity to preparations of porcine origin. Side Effects: The most common side effects are gastrointestinal disorders, including nausea, vomiting, epigastric discomfort, meteorism, diarrhea, or constipation. Oral lesions are associated with incorrect use. Itching, urticaria, and rash are relatively rare. Prolonged use of high doses may cause hyperuricemia and hyperuricosuria. In patients with cystic fibrosis, fibrosing colonopathy may develop. Folic acid should be monitored and supplemented if necessary. Pregnancy and Lactation: During pregnancy and lactation, LIPHOFERTM FORTÉ is used under medical supervision when the potential benefit outweighs the risks. Teratogenic effects: Not known. Overdose: There are data on the association of hyperuricemia and hyperuricosuria with the use of extremely high doses of pancreatin. Treatment is symptomatic. Interactions with other drugs: Concomitant administration of antacids containing aluminum may reduce the effectiveness of LIPHOFER TM FORTÉ. Antacids containing calcium carbonate or magnesium hydroxide should not be taken simultaneously. This combination can lead to the formation of precipitates of glycin-conjugated bile acids and the formation of calcium and magnesium fatty acid soaps, which reduces fat absorption and increases steatorrhea. Storage: Store at a temperature not exceeding 25°C. Protect from light and moisture. Keep out of reach of children.