Farmgen Fenofibrate Tablet 160 mg

Adult dose

As fenofibrate, it is administered orally immediately after meals at a dosage of 160 mg once daily. Fenofibrate must be taken in conjunction with dietary measures. This medication may be absorbed less effectively on an empty stomach, so it should be taken immediately after meals.

Child dose

There are no clinical data regarding the use of this medication in children.

This drug should not be used in patients with impaired liver function. Patients with moderate to severe renal impairment may experience muscle damage leading to rhabdomyolysis upon taking this medication, thus it should not be administered. Women who are pregnant or may become pregnant, as well as nursing mothers, should not use this drug. Patients who have had allergic reactions to this drug or its components should refrain from using it. Patients with gallbladder disease or a history of gallstones should also avoid this medication. Patients who have experienced photosensitivity reactions while taking fibrate-class medications or ketoprofen should not use this drug. This medication should not be administered to children. Patients with biliary cirrhosis or pancreatitis should avoid this drug. Additionally, this medication contains lactose and is not suitable for patients with lactose intolerance or specific genetic metabolic disorders. Patients with mild renal impairment or a history of it should reduce the dosage or extend the dosing interval while carefully monitoring renal function. Patients with liver function abnormalities or a history of liver issues should undergo frequent liver function tests. Patients with hypoalbuminemia or a history of gallstones should exercise caution. Patients taking anticoagulant medications or concurrently using statins may have an increased risk of side effects and should use this drug with caution. The elderly are more likely to have decreased hepatic and renal function, thus should use this medication with increased caution. This drug can affect the liver and biliary system, leading to elevated liver enzyme levels or the occurrence of gallstones and cholestatic hepatitis. Skin reactions such as rashes, itching, and photosensitivity may occur, and, rarely, hair loss can happen. Neurological symptoms such as dizziness, headaches, and fatigue may be reported. There is a risk of thrombus formation, and if muscle pain, cramps, or elevated muscle enzyme levels occur, medical consultation should be sought immediately. Gastrointestinal symptoms may include abdominal pain, nausea, vomiting, and diarrhea, and pancreatitis can occur rarely. Respiratory and hematological abnormalities may also happen occasionally, requiring immediate medical attention for any unusual symptoms. Regular blood tests and liver function tests should be conducted while taking this medication, and treatment can be discontinued if there is no therapeutic effect. If gallstones are suspected, gallbladder examination should be performed, and if stones are found, medication use should be halted. This drug may interact with other medications, particularly statins, anticoagulants, antidiabetic drugs, uric acid treatments, oral contraceptives, and hepatotoxic drugs, and caution is advised when used concurrently with these. Particularly with statins, the risk of muscle damage is heightened, so co-administration is generally not recommended. Women who are pregnant or may become pregnant and nursing mothers should refrain from taking this drug, as should those who are breastfeeding. This drug is not for use in children, and the elderly should take it with caution while regularly monitoring liver and kidney function. In cases of overdose, there is no specific antidote, so prescribed dosages should always be adhered to, and it is not removed by hemodialysis. This drug should be kept out of reach of children and not transferred to other containers.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral or eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, and urination changes.

Mild side effects

Elevated serum aminotransferase levels, hepatomegaly, cholestatic hepatitis, gallstones, rash, itching, photosensitivity reactions, hair loss, fatigue, fever, dizziness, headache, peripheral neuropathy, thromboembolism, elevated creatine kinase, myalgia, muscle cramps, arthralgia, gastrointestinal disturbances (abdominal pain, nausea, vomiting, diarrhea, abdominal bloating), seizures, decreased hemoglobin, leukopenia, eosinophilia, elevated serum creatinine and urea.

This medication should be stored in a sealed container to prevent exposure to air or moisture. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature, avoiding excessively hot or cold places.

Appearance

White, rectangular film-coated tablet

Package unit

100 tablets/box [(10 tablets/PTP X 10)]