Fenoren Capsules (Fenofibrate Granules (Micronized))

Adult dose

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

This medication should not be used by patients with poor liver function. Taking this medication in a compromised liver state may pose health risks. Patients with moderate to severe kidney impairment should also refrain from taking this medication. High creatinine levels can lead to muscle tissue damage, so caution is needed. It is safest for pregnant women or those who may become pregnant, as well as nursing mothers, to avoid this medication due to potential harm to the fetus or baby. Those who have had allergic reactions to this medication or its ingredients should avoid taking it. Patients with gallbladder disease or gallstones should also avoid using this medication due to the risk of gallstone formation. Those who have previously experienced photosensitivity while using fibrate class drugs or ketoprofen should exercise caution when taking this medication. This medication is not administered to children. Patients with biliary cirrhosis or pancreatitis should also avoid using this medication. Patients with mild renal impairment or a history of it should reduce the dosage or increase the dosing interval, and kidney function should be monitored regularly. Those with liver function abnormalities or a history of liver disease should have frequent liver function tests conducted while on this medication, and if abnormalities are discovered, dosage adjustment or discontinuation of use may be necessary. Patients with hypoalbuminemia, a history of gallstones, those on anticoagulants, and the elderly should take special precautions when using this medication. Particularly, this medication contains Yellow No. 5 dye, and those allergic to this component should be cautious. Symptoms such as liver function abnormalities, skin rashes, itching, dizziness, muscle pain, and digestive disorders may appear while taking this medication. If any of these symptoms occur, medical consultation should be sought immediately. If muscle pain or weakness occurs, it may indicate a serious adverse effect known as rhabdomyolysis, and the physician should be notified immediately. Regular blood tests are necessary as the liver enzyme levels may rise or blood coagulation function may become abnormal. This medication may interact with other medications, so especially if taking anticoagulants, cholesterol-lowering agents, and antihyperglycemic agents, consultation with a physician is mandatory. During pregnancy, it should be avoided as it may harm the fetus and should also not be used while breastfeeding. The elderly may be at higher risk of side effects due to potentially decreased kidney and liver function, so caution is needed in their use. There is no specific antidote in case of overdose; therefore, following the prescribed dosage accurately is essential, and if an overdose is suspected, a medical facility should be visited immediately. This medication should be kept out of children's reach and should not be transferred to other containers. There have been reports of the risk of tumors in the liver with prolonged use, thus regular check-ups and adherence to physician’s instructions are necessary.

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

This medication should be stored in a tightly closed container to prevent air and moisture exposure, ideally at a temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness over time.

Appearance

A capsule containing spherical white microgranules with a light brown upper part and a white lower part.

Package unit

For domestic use: 30 capsules/bottle, 300 capsules/bottle For export: 30 capsules (10 capsules/PTPx3)