Medication info
Phenofin Tablets (Fenofibrate)

Phenofin Tablets (Fenofibrate)

Prescription medicationTablet경구
Ingredient · strength
Fenofibrate›160mg / 1 tablet
Manufacturer / importer
(주)메디카코리아
Appearance
White oblong film-coated tablets
Packaging
100 tablets per box [10 tablets/PTP × 10]
Approval status
Active

MFDS item code 202003920 · Approved 2020.05.27 · Insurance code 646005170

Summary

Main use
Improvement of primary hyperlipidemia (hypercholesterolemia, hypertriglyceridemia)
Who takes it
Adults · Children
Adult dose
As fenofibrate, take 160 mg orally once daily immediately after meals. Fenofibrate must be administered in conjunction with dietary therapy. This medication may have reduced absorption on an empty stomach, so take it immediately after meals.
Child dose
Clinical data regarding the use of this medication in children is still lacking.

Ingredients

Manufacturer
(주)메디카코리아

Efficacy & effects

Improvement of primary hyperlipidemia (hypercholesterolemia, hypertriglyceridemia)

  • Primary hyperlipidemia
  • hypercholesterolemia
  • hypertriglyceridemia
View approved original text

This medication is used for the treatment of primary hyperlipidemia including hypercholesterolemia (Type IIa), combined hypercholesterolemia and hypertriglyceridemia (Type IIb, III), and hypertriglyceridemia (Type IV).

How to take

Adult dose

As fenofibrate, take 160 mg orally once daily immediately after meals. Fenofibrate must be administered in conjunction with dietary therapy. This medication may have reduced absorption on an empty stomach, so take it immediately after meals.

Child dose

Clinical data regarding the use of this medication in children is still lacking.

Precautions

This medication should not be used in patients with poor liver function. Patients with moderate to severe renal dysfunction should also not take this medication. Women who are pregnant or may become pregnant, and those who are breastfeeding should not take this medication. Individuals with allergies to this medication or its ingredients should avoid use. Patients with gallbladder issues or gallstones should also not take this medication. Care should be taken for those who have experienced phototoxicity while using fibrate class medications or ketoprofen. This medication is not to be administered to children. Patients with sclerosing cholangitis or pancreatitis should also avoid using this medication. Patients with lactose intolerance or specific genetic metabolic disorders should not take this medication. Persons allergic to soybean oil, soy, peanuts, etc., should also exercise caution. Patients with mild renal impairment or liver abnormalities, those with hypoalbuminemia, and those with a history of gallstones should use this medication cautiously. Patients on anticoagulants or the elderly, and those with diabetic dyslipidemia should also take care. While taking this medication, liver and biliary issues may arise, so regular liver function tests should be conducted. Skin rashes or itching, as well as phototoxic reactions may occur, so precautions against sun exposure are advised. Neurological symptoms such as dizziness, headache, and fatigue may manifest. Thromboembolism or musculoskeletal issues such as myalgia and muscle cramps have also been reported. Gastrointestinal disorders or, rarely, pancreatitis, pulmonary abnormalities, hematologic issues, and renal abnormalities may occur. Renal function may deteriorate rapidly, so regular monitoring of renal function is essential. Before administration, ensure a diagnosis of hyperlipidemia is confirmed, and dietary and exercise regimens should be adhered to concurrently. If no therapeutic effect is observed, discontinue drug use. If liver function tests show abnormalities, dosage adjustment or discontinuation may be necessary. If gallstones are detected, discontinue this medication. This medication may interact with other drugs, particularly anticoagulants, statins, and antidiabetic medications, so caution is necessary when co-administered. When used with immunosuppressants, close monitoring of renal function is required. This medication should not be taken during pregnancy as it may harm the fetus, and it is also advisable to avoid it while breastfeeding. Elderly patients may have reduced renal and liver function, so care should be taken in their administration, with a risk of hypoglycemia when combined with antidiabetic medications. In case of overdose, there is no specific antidote, so caution should be exercised, and it should be kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

  • Hypersensitivity reactions: Possible severe allergic reactions such as urticaria, anaphylaxis, angioedema.
  • Severe skin reactions: Severe skin adverse events, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome.
  • Liver abnormalities (jaundice): Reports of jaundice, hepatocellular hepatitis, chronic active hepatitis, cholestatic hepatitis, liver cirrhosis.
  • Respiratory issues: Potential severe respiratory abnormalities.
  • Serious neurological

Mild side effects

  • Hepatobiliary: Increased serum aminotransferase levels, liver enlargement, gallstones, hepatitis, potential cholestatic hepatitis.
  • Skin: Rash, itching, phototoxic reactions, potential hair loss.
  • Nervous system: Fatigue, fever, dizziness, headache, potential peripheral neuropathy.
  • Vascular system: Potential thromboembolic events.
  • Musculoskeletal: Increased creatine kinase, myalgia, muscle cramps, arthralgia, potential myopathy.
  • Gastrointestinal: Abdominal pain, nausea, vomiting,

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air and light, and it is best kept at room temperature between 1 degree and 30 degrees. Storing it this way will help maintain the efficacy of the medication for a longer period.

Appearance and packaging

Appearance

White oblong film-coated tablets

Package unit

100 tablets per box [10 tablets/PTP × 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

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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.