Phenobate Capsule (Phenofibrate Granules (Unmodified))

Adult dose

○ Adults: Administer 200 mg of fenofibrate orally once daily immediately after a meal. Fenofibrate must be administered in conjunction with dietary therapy. This medicine may be less well absorbed on an empty stomach, so administer it immediately after a meal (except for the 145 mg formulation). ○ Elderly patients: Dose reduction is generally not required if renal function is not reduced. ○ Patients with renal impairment: Do not administer this medicine to patients with moderate to severe renal impairment (serum creatinine level of 2.5 mg/dL or higher).

Child dose

○ Children: Clinical data on the use of this medicine in children are not yet available.

This drug should not be used in patients with liver dysfunction. Patients with moderate to severe kidney dysfunction should avoid this medication as it can cause muscle tissue damage, leading to rhabdomyolysis. Pregnant women or women who may become pregnant, as well as nursing mothers, should not use this drug. Patients who have had allergic reactions to this medication or its ingredients should not take it. Patients with gallbladder issues or a history of gallstones are also advised to avoid this medication. Those who experienced photosensitivity while taking fibrate drugs or ketoprofen should use this drug cautiously. This medication is not intended for use in children. Patients with pancreatitis should be cautious when taking this medication, especially if it is not due to severe hypertriglyceridemia. Patients with mild kidney dysfunction or a history of kidney issues should reduce the dosage or increase the intervals between doses and should undergo regular kidney function tests. Patients with liver dysfunction or a history of liver issues must have frequent liver function tests; if abnormalities are found, dosage adjustment or discontinuation may be necessary. Patients with hypoalbuminemia or a history of gallstones, those taking anticoagulants, and elderly patients should use this drug with caution. This medication may affect the liver and bile ducts, leading to elevated liver enzyme levels or, rarely, hepatitis or gallstones. Skin reactions such as rashes, itching, or photosensitivity may occur, and rare cases of hair loss may happen. Neurological symptoms like dizziness, headache, or weakness can occur. There is a risk of thromboembolism due to vascular issues, requiring caution. If muscle pain, cramps, or elevated creatine kinase levels arise, consult a physician; in severe cases, discontinue use of the drug. Gastrointestinal side effects may include abdominal pain, nausea, vomiting, and diarrhea, with rare occurrences of pancreatitis. Respiratory issues or decreased blood cell counts are also reported rarely. As this drug can affect kidney function, regular monitoring is essential. Allergic reactions such as urticaria or phototoxic dermatitis may occur; notify a physician immediately if symptoms arise. This medication may interact with other drugs, so special caution should be observed when combined with hyperlipidemia medications, anticoagulants, and antidiabetic agents. It should not be used during pregnancy due to potential harm to the fetus, and nursing mothers are also advised to avoid it. Elderly patients may have decreased liver and kidney function, necessitating dosage adjustments and regular monitoring. In case of overdose, there is no specific antidote, so contact a healthcare provider immediately, as it cannot be removed by dialysis. Store this medication in a tightly sealed container to prevent exposure to air or moisture, and maintain it at room temperature between 1 to 30 degrees Celsius to retain its efficacy.

• Elevated serum aminotransferases
• liver enlargement
• cholestatic hepatitis
• gallstones
• rash
• itching
• photosensitivity reactions
• hair loss
• fatigue
• hyperthermia

This drug should be stored in a tightly sealed container to prevent air or moisture exposure, and it is recommended to store it at room temperature between 1 to 30 degrees Celsius. This storage method will help maintain the drug's effectiveness over time.

Appearance

An orange capsule containing white spherical fine granules

Package unit

30 capsules/bottle, 100 capsules/bottle