Medication info

Fenot tablets 160 mg (Fenofibrate)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Fenofibrate›160mg / 1 tablet
Manufacturer / importer
코스맥스파마(주)
Appearance
White, oblong film-coated tablet
Packaging
100 tablets/PTP [(10 tablets/PTP) x 10]
Approval status
Approval withdrawn

MFDS item code 201907592 · Approved 2019.10.31

This product's status changed to Approval withdrawn on 2024.01.10. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of primary hyperlipidemia (hypercholesterolemia, hypertriglyceridemia)
Who takes it
Adults · Children
Adult dose
As Fenofibrate, take 160 mg orally once a day immediately after a meal. Fenofibrate must be administered in conjunction with dietary therapy. This medication should be taken immediately after a meal as absorption may be reduced on an empty stomach.
Child dose
There are no clinical data on the use of this medication in children.

Ingredients

Manufacturer
코스맥스파마(주)

Efficacy & effects

Improvement of primary hyperlipidemia (hypercholesterolemia, hypertriglyceridemia)

  • Primary hyperlipidemia
  • hypercholesterolemia
  • hypertriglyceridemia
View approved original text

This medicine is used for primary hyperlipidemia and various types of hypercholesterolemia and hypertriglyceridemia. Specifically, it is effective in treating hypercholesterolemia (type IIa), combined hypercholesterolemia and hypertriglyceridemia (type IIb, III), and hypertriglyceridemia (type IV). It helps normalize blood lipid levels by improving these dyslipidemic conditions.

How to take

Adult dose

As Fenofibrate, take 160 mg orally once a day immediately after a meal. Fenofibrate must be administered in conjunction with dietary therapy. This medication should be taken immediately after a meal as absorption may be reduced on an empty stomach.

Child dose

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

Precautions

This medication should not be used in patients with poor liver function, as it may worsen liver damage if administered to individuals with impaired liver function. Patients with moderate to severe renal impairment are at high risk of developing rhabdomyolysis if they take this medication, and thus it should not be used. Women who are pregnant or may become pregnant, as well as breastfeeding mothers, should not take this medication due to the potential harm to the fetus or infant. Patients who have allergies to this medication or its components should avoid taking it, and those who have experienced hypersensitivity reactions related to this medication in the past should not take it. Patients with gallbladder issues or gallstones should be cautious as this medication may worsen gallstone conditions. Patients with a history of photosensitivity reactions while taking fibrate drugs or ketoprofen may experience skin photosensitivity reactions with this medication and should exercise caution. Children should not take this medication since its safety and efficacy in pediatric patients have not been established. Patients with biliary cirrhosis or pancreatitis should avoid this medication, as it may worsen their condition. Patients with lactose intolerance or specific genetic metabolic issues should not take this medication due to the presence of lactose. Patients with mild renal impairment, liver function abnormalities, and hypoalbuminemia should use this medication with caution by adjusting the dose or increasing the dosing interval. Patients on anticoagulants or simultaneously taking cholesterol-lowering medications should use this medication with caution and follow their doctor’s advice due to possible interactions. During treatment, regular liver function tests and blood lipid level checks should be conducted, and if abnormalities are found, the treatment should be adjusted or discontinued. Skin rash, itching, hair loss, dizziness, muscle pain, gastrointestinal disturbances, and other symptoms may occur; if these occur, consult a doctor. If muscle pain, weakness, or increased creatine kinase levels are observed, it may indicate a risk of rhabdomyolysis, and immediate medical attention should be sought. This medication may increase the risk of thrombosis, so patients with a history of thrombosis or risk factors should take caution. Interactions may occur when this medication is used alongside other drugs, so especially consult a doctor when taking anticoagulants, antidiabetic drugs, or cholesterol-lowering agents. Women who are pregnant or breastfeeding should avoid using this medication due to potential harm to the fetus or infant. Elderly patients may have reduced kidney and liver functions, thus extra caution is required when using this medication, and regular checks are recommended. No specific antidote exists for overdose, so it is important to adhere to prescribed dosages and inform medical staff immediately in case of suspected overdose. This medication should be stored in a safe place out of reach of children, and transferring it to another container may degrade its quality, so care must be taken.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), hepatic impairment, cholestatic hepatitis, acute pancreatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), anaphylaxis, angioedema, DRESS syndrome, severe skin reactions (SCAR), thromboembolism (pulmonary embolism, deep vein thrombosis), rhabdomyolysis, rapid deterioration of kidney function, jaundice, liver cirrhosis, severe neurological symptoms (seizures, confusion, visual disturbances)

Mild side effects

Skin rash, itching, hair loss, weakness, high temperature, dizziness, headache, peripheral neuropathy, increased serum aminotransferases, liver enlargement, cholestatic hepatitis, gallstones, muscle pain, muscle cramps, joint pain, gastrointestinal disturbances (abdominal pain, nausea, vomiting, diarrhea, abdominal bloating), hematological changes (reduction in hemoglobin, leukopenia, eosinophilia), increased serum creatinine, fatigue, sexual dysfunction, weight gain, ventricular arrhythmia

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is best to maintain the storage temperature between 1 and 30 degrees Celsius. This helps to preserve the medication’s efficacy and safety.

Appearance and packaging

Appearance

White, oblong film-coated tablet

Package unit

100 tablets/PTP [(10 tablets/PTP) x 10]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.