Fenofibrate Tablets 160 mg

Adult dose

Fenofibrate: Administer 160 mg orally once daily immediately after a meal. Fenofibrate should always be administered in conjunction with a dietary regimen. This medication should be taken immediately after meals as absorption may be less when taken on an empty stomach.

This drug should not be used in patients with impaired liver function. It should not be administered to patients with moderate to severe kidney impairment due to the risk of rhabdomyolysis, a serious muscle damage condition. Pregnant or potentially pregnant women, as well as breastfeeding women, should not use this drug. Patients with an allergy to this drug or its components should also avoid taking it. Patients with gallbladder issues or a history of gallstones should be cautious as there is a risk of gallstone formation when taking this drug. It should not be administered to patients who have experienced photosensitivity reactions while taking fibrate-class medications or ketoprofen. This drug is not intended for use in children. Patients with biliary sclerosis or pancreatitis should not take this drug, except in cases of acute pancreatitis due to severe hypertriglyceridemia. Patients with genetic disorders that prevent lactose breakdown should not take this drug. Patients who are allergic to soybean oil, soybeans, peanuts, or similar allergens should avoid using this medication. Patients with mild kidney impairment or a history of decreased kidney function should use this drug cautiously with dose adjustment or increased dosing intervals. Caution is also necessary for patients with liver dysfunction or a history of liver problems. Caution is advised for patients with hypoalbuminemia, gallstone history, on anticoagulants, the elderly, and those with dyslipidemia or diabetic dyslipidemia. This drug can affect liver function, so regular liver function tests are required, and if abnormal findings occur, dosage adjustment or discontinuation may be necessary. Muscle pain, muscle cramps, elevated creatine kinase levels, and other musculoskeletal adverse reactions may occur, so the doctor should be notified immediately if symptoms appear. Skin-related side effects such as rashes, itching, and photosensitivity reactions may also occur. Neurological symptoms such as dizziness, headache, and weakness have been reported. There may be an increased risk of thromboembolism, so caution is advised. Gastrointestinal side effects including abdominal pain, nausea, vomiting, and diarrhea may occur, and pancreatitis may occur rarely. This medication can cause a decrease in blood hemoglobin and leukocyte counts, therefore regular blood tests are necessary. This drug may interact with other medications, and caution is especially needed if taken with anticoagulants, statins, and antihyperglycemic agents. Pregnant or breastfeeding women should not use this drug as it may harm the fetus or newborn. Elderly patients may have decreased liver and kidney function, requiring extra caution when using this drug. In case of overdose, there is no specific antidote, so it is essential to follow the prescribed dosage and keep it out of reach of children.

Serious side effects

Urticaria, severe swelling (edema), cold sweats, severe allergic reactions, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, severe skin adverse reactions, difficulty breathing, asthma attacks, respiratory distress accompanied by cough and fever, jaundice, extreme drowsiness, liver abnormalities, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, severe neurological symptoms, decreased urine output

Mild side effects

Elevated serum aminotransferase levels, hepatomegaly, cholestatic hepatitis, gallstones, rashes, itching, photosensitivity reactions, hair loss, weakness, high fever, dizziness, headache, peripheral neuropathy, thromboembolism, elevated creatine kinase (CK), muscle pain, muscle cramps, joint pain, gastrointestinal disorders (abdominal pain, nausea, vomiting, diarrhea, abdominal bloating), seizures, decreased hemoglobin, leukopenia, eosinophilia, serum creatinine and urea increases

This medication should be stored in a tightly closed container to protect it from air and moisture, and the storage temperature should be maintained between 1 to 30 degrees Celsius at room temperature. Keeping the medication at the appropriate temperature will help safely maintain its effectiveness.

Appearance

White oval film-coated tablets

Package unit

100 tablets/box [(10 tablets/PTP) X 10]