Medication info
Neo Phenol Table 48 mg (Fenofibrate)

Neo Phenol Table 48 mg (Fenofibrate)

Prescription medicationTablet경구
Ingredient · strength
Fenofibrate›48mg / 1 tablet
Manufacturer / importer
(주)녹십자
Appearance
Pink oval film-coated tablet
Packaging
30 tablets/bottle, 90 tablets/bottle
Approval status
Active

MFDS item code 202500240 · Approved 2025.02.06 · Insurance code 643606820

Summary

Main use
Treatment of primary hyperlipidemia (hypercholesterolemia, hypertriglyceridemia)
Who takes it
Adults · Children
Adult dose
As fenofibrate, the usual dose is 145 mg taken orally once daily without regard to meals, but it must be accompanied by a dietary regimen. This medication may be less absorbed when taken on an empty stomach; hence, it is recommended to take it immediately after meals (excluding the 145 mg and 48 mg formulations). In cases of renal impairment, an initial dose of 48 mg is taken orally once daily without regard to meals, followed by evaluations of lipid levels and kidney function before any dosage adjustments are made.
Child dose
There is currently no clinical data regarding the use of this medication in children.

Ingredients

Manufacturer
(주)녹십자

Efficacy & effects

Treatment of primary hyperlipidemia (hypercholesterolemia, hypertriglyceridemia)

  • Primary hyperlipidemia
  • hypercholesterolemia
  • hypertriglyceridemia
View approved original text

This medication is used to treat primary hyperlipidemia, specifically hypercholesterolemia (Type IIa) and mixed hyperlipidemia (Type IIb and Type III), as well as hypertriglyceridemia (Type IV). These conditions are characterized by abnormally high lipid levels in the blood, which can increase the risk of cardiovascular diseases, necessitating effective management. This medication helps improve dyslipidemia by controlling blood cholesterol and triglyceride levels, contributing to the maintenance of cardiovascular health. Therefore, this medication plays an important role in preventing cardiovascular diseases through the improvement of blood lipids.

How to take

Adult dose

As fenofibrate, the usual dose is 145 mg taken orally once daily without regard to meals, but it must be accompanied by a dietary regimen. This medication may be less absorbed when taken on an empty stomach; hence, it is recommended to take it immediately after meals (excluding the 145 mg and 48 mg formulations). In cases of renal impairment, an initial dose of 48 mg is taken orally once daily without regard to meals, followed by evaluations of lipid levels and kidney function before any dosage adjustments are made.

Child dose

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

Precautions

This medication should not be used in patients with impaired liver function. It may be dangerous for patients with severely compromised liver function. In patients with very poor kidney function, this medication may cause muscle damage leading to rhabdomyolysis, thus it should not be administered. Women who are pregnant or may become pregnant, and nursing mothers should not use this medication. Patients with allergies to this medication or any of its components should not take it. Patients with issues with the gallbladder or gallstones should be cautious, as this medication may cause additional gallstone formation. Patients who have previously experienced photosensitivity reactions while taking this medication or similar ones should also avoid using it. This medication is not to be given to children. Patients with bile duct strictures or pancreatitis should also refrain from using this medication. Patients with genetic disorders affecting lactose digestion should not take this medication due to the lactose content. Patients with mildly impaired renal function or past liver issues should use this medication cautiously. Patients taking anticoagulant medications or certain hyperlipidemic agents, and the elderly should be particularly careful. This medication can affect the liver and biliary system, potentially raising liver enzyme levels or leading to gallstone formation. Rashes or itching may occur, and sensitivity to sunlight may develop upon exposure. Neurological symptoms such as dizziness, headache, and lethargy may occur. There is a risk of thrombosis, and myalgia or muscle cramps may develop; patients should consult a physician if symptoms are severe. Gastrointestinal discomfort may occur, and pancreatitis may rarely develop. This medication may also affect the respiratory, blood, and renal systems, so any abnormal symptoms should be reported to medical personnel immediately. Regular liver function tests are required during the course of treatment, and if liver enzyme levels rise significantly, discontinuation of the medication may be necessary. If gallstones are suspected or develop, further testing is needed, and if gallstones are confirmed, the medication should be stopped. This medication may interact with other drugs, so caution is needed when taking it with anticoagulant medications, certain hyperlipidemic agents, or antihyperglycemic drugs. It is safest not to use this medication during pregnancy or breastfeeding. The elderly may have reduced kidney and liver function, so they should be particularly cautious during administration and require regular renal function assessments. There is no specific antidote for overdose, so it is essential to adhere to the prescribed dosage. This medication should be kept out of reach of children, and transferring it to another container may compromise quality.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), severe allergic reactions, severe rash with fever, blisters, skin peeling, pain in oral/conjunctival mucosa, severe dermatologic reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory problems accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, liver dysfunction (jaundice), sudden and severe headaches, thunderclap headaches, seizures, loss of consciousness

Mild side effects

Increased serum aminotransferase levels, hepatic enlargement, rash, itching, photosensitivity reaction, alopecia, weakness, elevated body temperature, dizziness, headache, peripheral neuropathy, thrombosis, increased creatine kinase (CK), myalgia, muscle cramps, arthralgia, gastrointestinal disorders (abdominal pain, nausea, vomiting, diarrhea, bloating), increased serum creatinine and urea, fatigue, sexual dysfunction, weight gain, decreased hemoglobin, leukopenia, eosinophilia

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

Storage

This medication may be sensitive to air and moisture; therefore, it must be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. Storing it this way will help preserve the drug's effectiveness and safety over time.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

30 tablets/bottle, 90 tablets/bottle

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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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.