Phenofibrate Tablets (Fenofibrate)

Adult dose

Fenofibrate is taken orally at a dose of 160 mg once daily immediately after a meal. Fenofibrate must be administered in conjunction with dietary measures. This medication is less absorbed on an empty stomach, therefore it is administered immediately after meals.

Child dose

There is currently no clinical data on the use of this medication in children.

This medication should not be used in patients with poor liver function. It should also be used cautiously in patients with moderate to severe renal impairment, as it may lead to severe muscle damage known as rhabdomyolysis. Women who are pregnant or may become pregnant, and nursing mothers should not take this medication. Patients who are allergic to this medication or any of its ingredients should also avoid it. It is advisable that patients with gallbladder issues or a history of gallstone formation, as well as those who have previously experienced photoallergic or phototoxic reactions, refrain from using this medication. This medication is not intended for children. Since this medication contains lactose, patients with genetic conditions such as lactose intolerance, lactose enzyme deficiency, or glucose-galactose malabsorption should not take it. Patients with slight renal impairment or a past history of kidney issues should use this medication carefully, possibly with reduced dosage or prolonged intervals, and must be closely monitored due to the risk of rhabdomyolysis. Patients with abnormal liver function or a history of liver problems should regularly conduct liver function tests while on this medication. Patients on anticoagulants, the elderly, and those with a history of gallstones need careful management when taking this medication. This medication can affect the liver or bile ducts, potentially causing elevated liver enzyme levels or leading to gallstones, hepatitis, and cirrhosis, necessitating regular liver function tests. Skin reactions like rashes or itching, sensitivity to sunlight, and occasionally hair loss may occur. Neurological symptoms such as dizziness, headache, weakness, and peripheral neuropathy may also present. There is a risk of thromboembolism, and there may be elevations in muscle pain, muscle cramps, and related test values, so patients should consult their doctor immediately if symptoms arise. Gastrointestinal issues such as abdominal pain, nausea, vomiting, diarrhea, and bloating may occur, and in some cases, pancreatitis may arise. Respiratory problems, decreased blood cell counts, and renal function deterioration are also rarely reported. This medication may interact with other drugs, especially with statins, anticoagulants, and hypoglycemic agents, so patients should consult their physician or pharmacist when taking these medications together. Pregnant or nursing women are advised not to take this medication. The elderly are at a higher risk of decreased liver and kidney function, so caution is necessary. In cases of overdose, there is no specific antidote, making it important to adhere strictly to the prescribed dosage, keeping it out of reach of children.

Serious side effects

Hives, severe swelling (edema), skin and mucous membrane syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), chest tightness, difficulty breathing, cold sweat, paleness. Severe skin adverse reactions: Severe rash, blisters, skin peeling, pain in the mouth/eyes mucosa. Liver abnormalities (jaundice): Yellowing of the skin or eyes (jaundice), generalized malaise. Serious neurological symptoms: Sudden and severe headache, thunderclap headache, seizures.

Mild side effects

Hepatobiliary adverse reactions: Elevated serum aminotransferases, liver enlargement, cholestatic hepatitis, gallstones. Skin adverse reactions: Rash, itching, photosensitivity reactions, hair loss. Neurological adverse reactions: Weakness, fever, dizziness, headache, peripheral neuropathy. Musculoskeletal adverse reactions: Elevated creatine kinase, muscle pain, muscle cramps, joint pain. Gastrointestinal adverse reactions: Gastrointestinal disturbances (abdominal pain, nausea, vomiting, diarrhea, bloating), pancreatitis. Respiratory adverse reactions.

This medication should be stored in a tightly sealed container to protect it from air and moisture, ideally at room temperature between 1°C and 30°C. Proper storage can help maintain the medication’s effectiveness.

Appearance

White oblong film-coated tablet

Package unit

100 tablets/PTP[(10 tablets/PTP)×10]