Loodil Suprap 160 mg (Fenofibrate)

Adult dose

Fenofibrate should be taken orally at a dose of 160 mg once a day immediately after meals. Fenofibrate must be administered along with dietary measures. This drug should be taken immediately after meals to ensure optimal absorption, as fasting may reduce absorption.

Child dose

There is currently no clinical data regarding the use of this drug in children.

This drug should not be used in patients with liver dysfunction. Impaired liver function can lead to severe side effects due to interference with drug metabolism. Patients with moderate to severe renal impairment should also avoid this drug, as it poses a high risk of rhabdomyolysis due to muscle tissue damage. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this drug due to potential harm to the fetus or infant. Patients with allergies to this drug or its components should not use it, as allergic reactions can be severe. Patients with gallbladder disease or gallstones should exercise caution, as this drug may increase the likelihood of developing gallstones. Patients with a history of photosensitivity or phototoxic reactions related to this drug should avoid it. Severe reactions may occur with sun exposure or artificial ultraviolet light. This drug is not used in pediatric patients due to insufficient evidence of safety and efficacy. Patients with biliary cirrhosis or pancreatitis should also refrain from this medication, especially except in cases of acute pancreatitis due to severe hypertriglyceridemia. Patients with lactose intolerance or specific genetic metabolic disorders should not take this drug, as it contains lactose which may worsen symptoms. Patients with allergies to soybean oil, soy, or peanuts should be cautious due to potential allergic reactions from the ingredients in this drug. Patients with mild renal impairment must reduce the dose or extend the interval between doses to minimize the risk of rhabdomyolysis. Patients with liver dysfunction or past liver issues should regularly undergo liver function tests, and if abnormalities are found, dosage adjustment or discontinuation may be necessary. Patients with hypoalbuminemia, a history of gallstones, those on anticoagulants, those on HMG-CoA reductase inhibitors, the elderly, and individuals with lipid metabolic disorders should be administered this drug cautiously. This drug may affect the liver and biliary system, leading to elevated liver enzyme levels, hepatitis, gallstones, and cholestasis. Skin rashes, itching, and photosensitivity reactions may occur frequently and, rarely, hair loss may happen. Neurological symptoms such as dizziness, headaches, and fatigue can arise, and vascular abnormalities, such as thrombosis, may rarely occur. Muscle pain, muscle cramps, and elevated creatine kinase levels may occur, and consultation with a doctor is necessary if these symptoms arise; severe cases may require stopping the medication. Gastrointestinal symptoms, such as abdominal pain, nausea, vomiting, and diarrhea, may occur, and pancreatitis may occur rarely. Regular liver function tests and blood lipid level checks should be conducted during this drug therapy to monitor for abnormalities. This drug can interact with other medications, particularly when taken with anticoagulants, hypoglycemic agents, or cholesterol-lowering drugs, hence caution is required. Pregnant or nursing women should not take this drug, and women who may become pregnant must confirm their pregnancy status prior to use. The elderly may have reduced liver and kidney function, necessitating closer observation and care when taking this drug. No specific antidote exists for overdose, so strict adherence to the dosing regimen is required, and it should be stored out of reach of children.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, oral/eye mucosal pain, shortness of breath or breathing difficulties, asthma attacks, cough with fever accompanied respiratory issues, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headaches, seizures, disorientation, vision changes, paralysis, urination.

Mild side effects

Elevated serum aminotransferase levels, liver enlargement, cholestatic hepatitis, gallstones, rashes, itching, photosensitivity, hair loss, fatigue, elevated body temperature, dizziness, headaches, peripheral neuropathy, thrombosis (pulmonary embolism, deep vein thrombosis), increased creatine kinase (CK), muscle pain, muscle cramps, joint pain, gastrointestinal disturbances (abdominal pain, nausea, vomiting, diarrhea, abdominal bloating), seizures, decreased hemoglobin, leukopenia, eosinophilia.

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best stored at room temperature, between 1 to 30 degrees Celsius.

Appearance

White oblong film-coated tablet

Package unit

100 tablets/box [10 tablets/PTP x 10], 30 tablets/bottle, 100 tablets/bottle