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Primary Hypercholesterolemia or Mixed Dyslipidemia Fenofibrate Tablets is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia. Severe Hypertriglyceridemia Fenofibrate Tablets is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. Important Limitations of Use Fenofibrate at a dose equivalent to 145 mg of Fenofibrate Tablets was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus. How to use The recommended dose is one tablet each day. The tablet can be taken with or without food. Warnings and precautions Mortality and Coronary Heart Disease Morbidity The effect of Fenofibrate Tablets on coronary heart disease morbidity and mortality and non- cardiovascular mortality has not been established. Side Effects The following adverse reactions have been identified during post approval use of fenofibrate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: myalgia, rhabdomyolysis, pancreatitis, acute renal failure, muscle spasm, hepatitis, cirrhosis, anemia, arthralgia, decreases in hemoglobin, decreases in haematocrit, white blood cell decreases, asthenia, severely depressed HDL-cholesterol levels, and interstitial lung disease. Photosensitivity reactions have occurred days to months after initiation; in some of these cases, patients reported a prior photosensitivity reaction to ketoprofen Storage Information Store below 30°C. Drug Interactions Coumarin Anticoagulants Immunosuppressants such as cyclosporine and tacrolimus Ingredients The active substance is Fenofibrate. Each film coated tablet contains Fenofibrate Ph.Eur 145mg.
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