ENZAR FORTE TABLETS. (derived from Pancreatin USP) Sodium tauroglycocholate BPC 65mg (with sugar coating containing essential carminative oils)

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1 ENZAR FORTE TABLETS COMPOSITION Each enteric-coated tablet contains: Amylase activity -15,000 USP units Lipase activity -4,000 USP units Protease activity -15,000 USP units of (derived from Pancreatin USP) Sodium tauroglycocholate BPC 65mg (with sugar coating containing essential carminative oils) DESCRIPTION Innermost Pancreatin with a balanced formula of Amylase, Lipase & Protease activity for complete digestion of Carbohydrates, Fats & Proteins. The advantage of bile salt i.e. sodium tauroglycocholate for improving absorption of fat & fat-soluble vitamins. Middle shellac coat for preventing destruction of enzymes in stomach. Outermost sugar layer with essential carminative flavours like cardamom, ginger, clove & cinnamon present in it. Carminative flavours are released before swallowing for improved patient compliance.

2 HIGHLIGHTS (USPs) Only enzyme with the advantage of bile salt i.e. sodium tauroglychocholate for improving absorption of fat & fat-soluble vitamins. Middle shellac coat for preventing destruction of enzymes in stomach. Carminative flavours are released before swallowing for improved patient compliance. ENZAR FORTE is the only ALL IN ONE DIGESTANT. CLINICAL PHARMACOLOGY Digestive upsets are more often caused by dietary indiscretion and excess food. Discomfort and flatulence and abdominal colic may result when the bodies own pancreatic enzymes cannot cope with excessive quantities of food consumed. In such cases the enzymes present in ENZAR FORTE enhance the digestive processes in a natural way, thereby reducing the amount of undigested food available for fermentation & putrefaction. Thus, ENZAR FORTE aids digestion naturally as it contains a balanced formula, which reinforces body s own supply of digestive factors. It contains Amylase enzyme, which helps in the digestion of starch, lipase, which is involved in the digestion of lipids, and protease, which is required for digestion of proteins. The smaller molecules produced by the action of lipases on fats can only be absorbed provided they are dissolved in water. Glycerol is soluble in water, but fats & fatty acids are not. This problem is overcome by action of bile salts i.e. Sodium tauroglycocholate present in ENZAR FORTE. Bile salt combines with insoluble glycerides and fatty acids, emulsifies fats rendering larger surface area for enzymes to act which aids in adequate and complete digestion of lipids. They also enhance the activity of Lipases.

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4 Bile salts also help in absorption of iron, calcium & fat soluble vitamins like A, D, E & K. It increases peristalsis of both small & large intestine & thus acts as a laxative. Thus, besides digestion of carbohydrates, fats and proteins, ENZAR FORTE also has mild laxative action and enhances absorption of fats and fat-soluble vitamins. INDICATIONS AND USAGE Indigestion /Dyspepsia Flatulence Bloating Fullness after eating Heartburn Anorexia Hepatic and pancreatic insufficiency Post operative digestive upsets and convalescence CONTRAINDICATIONS Jaundice Acute and Chronic Cholecystitis Acute Pancreatitis PRECAUTIONS General The excessive consumption of pancreatic extracts has been reported to cause perianal soreness & to interfere with the absorption of Iron.

5 Information for Patients Each tablet should be sucked for few seconds & then swallowed. Tablets should NOT be chewed. Drug Interactions Simultaneous administration of antacids containing alluminium may diminish the effectiveness of ENZAR FORTE. Antacids containing calcium carbonate or magnesium hydroxide should not be taken concurrently. The combination may precipitate glycineconjugated bile acids & may form calcium and magnesium fatty acid soaps, causing a decrease in fat absorption & thus an increase in steatorrhoea. Pregnancy Animal reproduction studies have not been conducted with ENZAR FORTE tablets. It is not known whether it can harm the fetus harm when administered to a pregnant woman or can affect reproduction capacity. Hence should be used in pregnancy only if potential benefit outweighs the potential risks. Nursing Mothers It is not known whether it is excreted in human milk. Caution should be exercised. Teratogenic Effects None known.

6 ADVERSE REACTIONS Digestive Tract Few gastrointestinal side effects like diarrhoea may be seen. DOSAGE AND ADMINISTRATION Dosage As a digestive enzyme: 1 tablet to be sucked (not chewed) for few seconds and then swallowed with every meal. In pancreatic insufficiency: Upto 2 tablets 2-3 times a day can also be given. But dosage is individualized depending on patient s pancreatic function. PRESENTATION ENZAR FORTE is presented as a biconvex, sugarcoated tablet. Inside the tablet enzymes and sodium tauroglycocholate (bile salt) are contained within the enteric-coated core. An external sugar coating containing carminatives completes the tablet. Available in a strip of 15 tablets.