Refill Pen Capsule 160 mg (Micronized Fenofibrate)

Adult dose

○ Adults: Administer 160 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; therefore, administer it immediately after a meal (except 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: There are no clinical data available on the use of this medicine in children.

This medication should not be used in patients with poor liver function. Caution is also advised for patients with moderate to severe impaired renal function as serious adverse effects such as muscle damage may occur. It is safer for women who are pregnant or may become pregnant and those who are breastfeeding to avoid using this medication. Patients with allergic reactions to this medication or its components should avoid taking it. Patients with gallbladder disease or gallstones should also refrain from using this medication as it may worsen symptoms. Patients who have experienced photosensitivity or allergic reactions while taking fibrate drugs or ketoprofen should avoid this medication. This medication is not intended for use in children. Patients with biliary cirrhosis or pancreatitis should be cautious when taking this medication. Patients with slightly impaired renal function should use it carefully by reducing the dosage or increasing the interval between doses. Patients with abnormal liver function or a history of liver problems should be monitored closely with regular liver function tests. Patients on anticoagulants are at increased risk for bleeding, so they should consult a specialist when taking this medication. Older patients may need extra caution due to potentially decreased liver and kidney function. This medication may affect the liver or bile ducts, so regular liver function tests and gallbladder assessments are advised. There can be skin rashes or itching, and phototoxic reactions may occur when exposed to sunlight, hence it's advisable to avoid sun exposure. If muscle pain or cramps occur, contact a doctor immediately, as dosage adjustments or discontinuation may be necessary. Gastrointestinal symptoms such as abdominal pain, nausea, vomiting, and diarrhea may occur, and medical advice should be sought if symptoms are severe. Since this medication can interact with other drugs, disclose any other medications being taken. Particularly, the risk of muscle damage increases when taken with statins, so caution is warranted. The bleeding risk may increase when taken with anticoagulants, thus regular blood tests are required. It should not be used by women who are pregnant or planning to become pregnant as it may harm the fetus. Breastfeeding women should also avoid taking this medication. This medication is not intended for use in children. Older adults may be more susceptible to side effects such as hypoglycemia, thus regular monitoring of blood glucose and renal function is necessary. There are no specific antidotes for overdose, so adherence to prescribed dosage and method is crucial; seek medical advice immediately for any unusual symptoms. This medication should be stored out of reach of children and not transferred to other containers.

• Elevation of serum aminotransferases
• liver enlargement
• cholestatic hepatitis
• gallstones
• rash
• itching
• photosensitivity reactions
• hair loss
• weakness
• high fever

This medication must be stored in a tightly closed container to protect it from air and moisture. Additionally, it is recommended to store the medication at room temperature between 1°C and 30°C, away from excessively hot or cold places.

Appearance

Opaque orange upper half and transparent lower half hard capsule filled with white spherical microgranules

Package unit

30 capsules/box [10 capsules/PTP x 3], 30 capsules/bottle