Fenofibrate Tablets (Fenofibrate)

Adult dose

As Fenofibrate, 160 mg should be taken orally once daily immediately after meals. It must be taken in conjunction with dietary changes, and should be taken right after meals rather than on an empty stomach.

This medication should not be used in patients with impaired liver function. Patients with moderate to severe renal impairment should also not take this medication. It is safest for pregnant women or those who may become pregnant, as well as nursing mothers, to avoid this medication. Patients who have had allergic reactions to this drug or its components should avoid taking it. Individuals with gallbladder disease or a history of gallstone formation should also refrain from using this medication. Care is needed for patients who have experienced photosensitivity when using fibrate drugs or ketoprofen. This medication is not to be administered to children. It is advisable for patients with biliary cirrhosis or pancreatitis to avoid this drug as well. Patients with genetic disorders affecting lactose breakdown, as well as those allergic to soybean oil, soy, or peanuts, should avoid taking this drug. Patients with mild renal impairment should use this medication cautiously by reducing the dose or extending the dosing interval. Patients with abnormal liver function tests or a history of liver issues should use this medication cautiously. Patients with hypoalbuminemia or a history of gallstones should be observed closely while taking this medication. There is an increased risk of adverse reactions for those taking this medication alongside anticoagulants or certain hyperlipidemic agents, especially in the elderly. This drug may affect liver function, so regular liver function tests should be conducted, and if abnormal findings occur, dose adjustment or discontinuation may be necessary. Immediate consultation with a physician is required if symptoms of gallstones or pancreatitis appear. Skin rashes, itching, and photosensitivity reactions may occur, so attention should be given to UV protection when outdoors. If muscle pain, fatigue, or dizziness occur, notify medical staff immediately, and discontinuation may be necessary in severe cases. As this medication regulates blood lipid levels, regular blood tests are necessary to confirm treatment efficacy. There may be interactions with other medications; thus, consultation with a physician is essential, especially when taking anticoagulants, diabetes medications, or certain hyperlipidemic agents. During pregnancy or breastfeeding, this medication should not be used to ensure the safety of the fetus and infant. Children and the elderly should be dosed with frequent monitoring of kidney and liver function status. There are no specific detoxifying agents for overdose, so prescribed dosages must be adhered to and stored out of reach of children.

Serious side effects

• Hives, severe swelling (edema)
• Cold sweats
• Severe allergic reactions
• Severe skin adverse reactions: severe rash, blisters, skin peeling, pain in mucous membranes of mouth/eyes
• Respiratory issues: shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever
• Liver abnormalities (jaundice): yellowing of the skin or eyes, extreme lethargy
• Severe neurological symptoms: sudden and very severe headache, lightning headache, seizures, altered consciousness.

Mild side effects

• Hepatobiliary: Elevated serum aminotransferase levels, hepatomegaly, cholestatic hepatitis, gallstones
• Skin: Rash, itching, photosensitivity reactions, hair loss
• Nervous system: Fatigue, hyperthermia, dizziness, headache, peripheral neuropathy
• Vascular system: Thromboembolism (pulmonary embolism, deep vein thrombosis)
• Musculoskeletal system: Elevated creatine kinase, muscle pain, muscle cramps, joint pain
• Gastrointestinal: Gastrointestinal disturbances (abdominal pain, nausea, vomiting, diarrhea, abdominal bloating), pancreatitis
• Respiratory system

This medication should be kept in a tightly sealed container to prevent exposure to air or moisture, and it is recommended to store it at room temperature between 1 degree Celsius and 30 degrees Celsius. This helps maintain the drug’s effectiveness and ensures safe usage.

Appearance

White rectangular film-coated tablet

Package unit

100 tablets (10 tablets/PTP x 10)