Ridos Capsules (Fenofibrate Granules (Micronized))

Adult dose

○ Adults: Administer 200 mg of fenofibrate orally once daily immediately after a meal. Fenofibrate must be taken in conjunction with dietary therapy. This medicine may be less well absorbed on an empty stomach; therefore, take it immediately after a meal (except for the 145 mg formulation). ○ Elderly patients: Dose reduction is generally not necessary if renal function is not decreased. ○ 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 medication should not be used in patients with impaired liver function. It can be harmful to patients with severe liver impairment. It is also safer for patients with moderate to severe kidney impairment to avoid this medication, as poor kidney function can increase the risk of muscle damage such as rhabdomyolysis. Women who are pregnant, may become pregnant, or are nursing should not take this medication as it may be harmful to the fetus or newborn. Patients with allergies to this medication or its components should not use it. Patients with gallbladder issues or those who have formed gallstones need to be cautious when taking this medication as gallstone formation may occur. Patients who experienced sensitivity to sunlight or allergic reactions while taking fibrates or ketoprofen should also use this medication with caution. This medication is not used in children. It is advisable for patients with pancreatitis not to take this medication, except for cases of acute pancreatitis induced by severe hypertriglyceridemia. Patients with mild kidney function impairment or a history of it should use this medication carefully, potentially reducing the dose or increasing the dosing interval. Patients with liver dysfunction or a history of liver issues should undergo frequent functional tests while using this medication. Patients with hypoalbuminemia, a history of gallstones, those taking anticoagulants, and the elderly should also take precautions when using this medication. This medication contains the pigment Yellow No. 5; those with allergies to this component should exercise caution. Regular liver function tests should be conducted during treatment with this medication, as liver and biliary issues may arise. Symptoms may include elevated liver enzyme levels, hepatitis, and cholestatic liver disease. Skin rash or itching may occur, and photosensitivity can develop upon exposure to sunlight. Rarely, hair loss may also occur. Neurological symptoms such as dizziness, headache, or weakness may appear, so consult a physician if any unusual symptoms develop. Be observant for vascular symptoms as there is a risk of thrombosis. If muscle pain, muscle cramps, or signs of muscle damage occur, immediate notification is necessary, and if muscle enzyme levels increase, the medication should be discontinued or the dosage adjusted. Gastrointestinal symptoms may include abdominal pain, nausea, vomiting, diarrhea, and rarely pancreatitis. This medication can interact with other drugs, particularly anticoagulants and cholesterol medications, so caution is warranted when co-administering. It should not be taken during pregnancy or lactation, nor should it be used in children. Elderly patients often have diminished liver and kidney function, making them more susceptible to adverse reactions; thus, regular testing is necessary. There is no specific antidote for overdose, so it is essential to adhere strictly to the prescribed dosage and keep it out of reach of children. Long-term use of this medication has been associated with the risk of liver tumors, so caution is advised for extended treatment.

• Elevated serum aminotransferases
• hepatomegaly
• cholestatic hepatitis
• gallstones
• rash
• pruritus
• photosensitivity reactions
• alopecia
• malaise
• hyperthermia

This medication should be stored in a tightly sealed container to protect it from air and moisture. The recommended storage temperature is between 1 degree and 30 degrees Celsius to safely maintain the medication's efficacy.

Appearance

Orange capsule containing white spherical fine granules

Package unit

[For domestic use] 30 capsules/bottle, 300 capsules/bottle, [For export] 30 capsules (10 capsules/PTP×3)