About this medication
- Fenofibrate helps lower high triglycerides and some other fats in the blood. Keep following the eating and activity plan recommended for you; the tablet is one part of treatment.
- This guide describes LIPIDIL SUPRA 160 mg microcoated tablets. Other fenofibrate products may have different directions.
- Used as an add-on to diet and other lifestyle measures, including in patients with type 2 diabetes, to treat mixed dyslipidemia by lowering triglycerides and LDL cholesterol and raising HDL cholesterol when diet alone has not been enough.
- Used to treat adults with very high triglyceride levels who are at high risk of complications such as pancreatitis from their condition.
- Not indicated for Type I hyperlipoproteinemia, and may not be adequate alone in patients with familial combined hyperlipidemia.
How to use it
How to take or use it
- Take the prescribed LIPIDIL SUPRA 160 mg tablet once a day with your main meal. Swallow it whole with water. Follow the directions on your own prescription if they differ.
- Continue the diet and lifestyle plan recommended for you, even if you feel well.
If you miss a dose
- Take your next dose at the usual time. Do not take two doses together to make up for a missed tablet.
- The usual adult dose is one 160 mg tablet daily, taken with the main meal and swallowed whole with a glass of water.
- The maximum recommended total daily dose is 200 mg.
- In patients with reduced kidney function (creatinine clearance 30 to 60 mL/min), treatment should start at a lower dose and be increased only after assessing tolerance and lipid response; fenofibrate is contraindicated when creatinine clearance is below 30 mL/min.
- If a significant improvement in lipid levels is not seen after three months, the medication should be discontinued.
- If a dose is missed, take the next dose at the usual time; do not double the dose to make up for a missed one.
Pregnancy
- Do not take fenofibrate during pregnancy or while breastfeeding. Speak with your healthcare professional if you are pregnant, planning a pregnancy or breastfeeding.
- Contraindicated during pregnancy, as safety has not been established and the drug has caused embryo loss in animal studies at doses well above the human dose range.
Breastfeeding
- Contraindicated during breastfeeding, since it is not known whether fenofibrate passes into human milk and a risk to the nursing infant cannot be excluded.
Older adults
- Fenofibrate is cleared by the kidney, so older adults, who are more likely to have reduced kidney function, may be at greater risk of adverse effects and should have their dose selected carefully based on renal function.
Children and adolescents
- Not recommended in patients under 18 years of age, as safety and effectiveness have not been established in this age group.
Before you use it
Before you take or use it
- Tell your healthcare professional if you have liver, kidney, gallbladder or pancreas problems, or have had an allergic reaction to fenofibrate.
- This product contains ingredients related to peanut and soya. Check with your healthcare professional before taking it if you have either allergy, or an allergy to any ingredient listed in the monograph.
- Fenofibrate is not recommended for people younger than 18 years of age.
Important warnings
- Keep appointments for blood tests. They help check your blood fats and look for liver, kidney or muscle problems while you take fenofibrate.
- Unexplained muscle pain, tenderness or weakness can signal a serious problem, especially if you also feel unwell or notice dark urine.
- Should not be combined with a statin unless the benefit is judged to clearly outweigh the added risk of muscle toxicity, and never in patients who already have risk factors for muscle problems.
- Use with caution in patients with reduced kidney function, and the dose should be adjusted with regular monitoring of kidney function.
- Use with caution in patients with a history of gallbladder disease.
- Regular liver function testing is recommended, especially during the first year of treatment.
- Periodic blood counts are recommended during the first year of treatment, as mild decreases in hemoglobin, hematocrit, and white cell counts have been observed.
Who should not use it
- Known hypersensitivity to fenofibrate or to any ingredient in the formulation, including patients allergic to peanut, arachis oil, or soya lecithin due to a risk of hypersensitivity reactions.
- Liver impairment, including primary biliary cirrhosis or unexplained persistent abnormal liver function.
- Pre-existing gallbladder disease.
- Severe kidney dysfunction, with creatinine clearance below 30 mL/min.
- Acute or chronic pancreatitis.
- Known photoallergy or phototoxic reaction to fibrates or ketoprofen.
- Should not be co-administered with statins in patients who have predisposing factors for muscle toxicity.
- Pregnancy and breastfeeding.
- Use in patients under 18 years of age.
Possible side effects
- Stomach discomfort, nausea, headache or dizziness can occur. Tell your healthcare professional if an effect is persistent or troublesome.
- Abdominal pain may occur.
- Headache may occur.
- Tiredness (asthenia) may occur.
- Diarrhea may occur.
- Nausea may occur.
- Constipation may occur.
- Indigestion (dyspepsia) may occur.
- Gas (flatulence) may occur.
- Joint pain (arthralgia) may occur.
- Rash or itching may occur.
- Dizziness may occur.
- Decreased sex drive may occur.
When to get help
Get emergency help now
- Get urgent medical help if your face, lips, tongue or throat swell, or you have trouble breathing.
- Seek urgent care for severe unexplained muscle pain or weakness, especially with fever or dark urine, or for sudden severe chest pain or trouble breathing.
Contact your healthcare professional
- Contact your healthcare professional promptly if your skin or eyes turn yellow, you develop severe abdominal pain, or you notice a new rash.
- Fenofibrate may cause muscle inflammation (myositis) or breakdown (rhabdomyolysis), especially when combined with a statin or in patients with kidney problems; report unexplained muscle pain, tenderness, or weakness right away.
- Liver enzyme elevations can occur and should be monitored; rarely, hepatitis with jaundice has been reported.
- Fenofibrate can increase cholesterol excretion into bile and may lead to gallstones and their complications, such as gallbladder inflammation.
- Pancreatitis has been reported, particularly in patients with severe high triglycerides.
- Blood clots, including deep vein thrombosis and pulmonary embolism, have been reported uncommonly.
- Interstitial lung disease has been reported after fenofibrate reached the market.
- Severe skin reactions, including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported rarely.
- Photosensitivity reactions and hair loss have been reported.
- Seek immediate medical attention for muscle pain with weakness or dark urine, yellowing of the skin or eyes, severe abdominal pain, or a spreading skin rash with blistering.
Other medicines and products
- Tell your healthcare professional about all medicines and supplements you use. Statins, blood thinners such as warfarin, cyclosporine and some other cholesterol medicines can change the risks or require closer monitoring.
- Take this specific tablet with food. Ask before changing the way you take it or adding another cholesterol medicine.
- Combining fenofibrate with a statin increases the risk of severe muscle toxicity, including rhabdomyolysis, and should be avoided unless the benefit clearly outweighs the risk.
- Fenofibrate can significantly increase blood levels of pravastatin and its metabolites; combined use should be approached cautiously.
- Bile acid resins such as cholestyramine can reduce fenofibrate absorption, so doses should be spaced at least two hours apart.
- Fenofibrate can enhance the effect of oral anticoagulants, increasing bleeding risk; the anticoagulant dose may need to be reduced and prothrombin time monitored closely.
- Estrogens, including hormonal contraceptives, may raise lipid levels and should be considered individually when prescribing fenofibrate.
- Combining fenofibrate with cyclosporine has been associated with reversible kidney function impairment, requiring close monitoring.
- Combination with ezetimibe is not recommended, as the safety of this combination has not been established.
Food and drinks
- Fenofibrate should be taken with the main meal, as food improves its absorption; taking it on an empty stomach reduces and makes its absorption more variable.
When to use it
- Taken once daily with the main meal.
How to store it
- Store LIPIDIL SUPRA at 15°C to 30°C, away from light and moisture, and out of children's reach.
- Store at 15-30 degrees C and protect from light and moisture.
Key takeaways
- The directions here are for the linked LIPIDIL SUPRA 160 mg monograph. Check the name and strength on your own package, and use your prescription directions for personal decisions.
- Fenofibrate is used to lower triglycerides and LDL cholesterol and raise HDL cholesterol as part of an overall cholesterol-lowering plan that includes diet.
- Take one tablet daily with your main meal, swallowed whole with water.
- Common effects include stomach upset, headache, tiredness, and joint pain.
- Contact your doctor or healthcare professional right away for unexplained muscle pain or weakness, yellowing of the skin or eyes, severe stomach pain, or a new skin rash.
- This medication is not suitable during pregnancy or breastfeeding, and should not be used if you have a peanut allergy given ingredients in the formulation; discuss with your healthcare professional.
- Store at room temperature away from light and moisture, and keep regular appointments for blood tests to monitor liver function and lipid levels.
These practical points are adapted from the linked Health Canada product monograph for this specific formulation.