Lipidil Ez: Uses, Side Effects and Dosage

What LIPIDIL EZ is used for:

LIPIDIL EZ is used in combination with lifestyle changes (low-fat diet, weight loss, and exercise) and other medications to lower the levels of cholesterol and triglycerides (types of fats) in the blood. It is used to treat high blood fat levels in adults:

• with uncontrolled type 2 diabetes.
• who are at high risk of developing other complications due to high fats in the blood.

LIPIDIL EZ can also be used in combination with ezetimibe to lower cholesterol levels in adults with high levels of cholesterol and other fats in the blood.

How LIPIDIL EZ works:

LIPIDIL EZ belongs to a class of medicines known as “lipid metabolism regulators”. It works by speeding the natural processes that remove cholesterol and other fats from the body. Along with changes to your diet and exercise, LIPIDIL EZ can help your body:

• decrease LDL (bad) cholesterol and triglyceride levels.
• increase HDL (good) cholesterol levels.

The ingredients in LIPIDIL EZ are:

Medicinal ingredient: fenofibrate

Non-medicinal ingredients: colloidal silicon dioxide, crospovidone, docusate sodium, D&C Yellow #10 Aluminum Lake (48 mg tablet only), FD&C yellow #6/sunset yellow FCF Aluminum Lake (48 mg tablet only), FD&C Blue #2/Indigo carmine FCF Aluminum Lake (48 mg tablet only), hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, soybean lecithin, sucrose, talc, titanium dioxide, and xanthan gum.

LIPIDIL EZ comes in the following dosage form:

Film-coated tablets: 48 mg and 145 mg of fenofibrate.

Do not use LIPIDIL EZ if:

• you are allergic to:

  • fenofibrate or to any other ingredients in LIPIDIL EZ.
  • peanuts, peanut oil, soya lecithin or related products.
• you have severe liver problems, including cirrhosis of the liver and persistent abnormal liver test results.
• you have gallbladder disease.
• you have severe kidney problems, including if you are undergoing dialysis.
• you have pancreatitis (inflammation of the pancreas).

• you are pregnant, think you might be pregnant or planning to get pregnant. Tell your healthcare professional right away if you discover that you are pregnant.

• you are breast-feeding or planning to breast-feed. It is not known if LIPIDIL EZ can pass into breast milk and harm a breast-fed baby.
• you ever had an allergic reaction to sunlight or UV light while taking fibrate medicines or ketoprofen (used to treat pain and inflammation).
• you are taking statins (another type of medicine used to lower cholesterol) and have muscle problems or are at risk of developing muscle problems.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LIPIDIL EZ. Talk about any health conditions or problems you may have, including if you:

• are taking statins, used to treat high blood cholesterol (e.g., atorvastatin, rosuvastatin, fluvastatin, pravastatin, simvastatin, lovastatin).
• have type 2 diabetes that cannot be controlled by insulin or other medicines.
• have high blood pressure that cannot be controlled by medicine.
• have abnormal levels of proteins in your urine and/or blood. This can be caused by certain conditions (e.g., nephrotic syndrome, kidney failure).
• have gallstones.
• have obstructive liver disease (a condition where the flow of bile from the liver to the gallbladder and small intestine is blocked).
• are a smoker.
• are taking medicines containing estrogen (e.g., birth control pills or hormone replacement therapy).
• are intolerant to lactose or sucrose as LIPIDIL EZ contains both.

• have risk factors for muscle problems. This includes if you:

  • have, have had or have a family history of muscle disorders.
  • had any past problems with muscles (pain, tenderness) after using statins.
  • currently take other fibrates (such as gemfibrozil and bezafibrate), niacin (nicotinic acid) or ezetimibe.
  • have thyroid problems.
  • regularly drink three or more alcoholic drinks daily.
  • do excessive physical exercise.
  • are dehydrated or suffer from excessive vomiting, diarrhea or sweating.
  • are over 70 years of age.
  • have liver or kidney problems.
  • have diabetes accompanied with excess fat build-up in your liver.
  • had surgery or other tissue injury.
  • have a condition that causes weakness or frailty.
  • have a serious infection.
  • have any conditions or take any medicines that may increase the level of LIPIDIL EZ in the blood. Talk to your healthcare professional if you are unsure.

Other warnings you should know about:

Muscle disorders: LIPIDIL EZ may cause serious muscle disorders, especially when taken together with a statin (another medicine used to treat high blood cholesterol). These problems may be accompanied with kidney problems and can lead to death. Tell your healthcare professional right away if you have any severe muscle pain, tenderness, soreness or weakness while taking LIPIDIL EZ.

Gallbladder problems: LIPIDIL EZ may cause gallbladder problems such as gallstones. Tell your healthcare professional right away if you experience:

• sudden and rapid intense pain in the right upper side or center of your abdomen;
• back pain between your shoulder blades or in your right shoulder.

The pain may last a few minutes to several hours and may be accompanied by nausea or vomiting.

Check-ups and testing: Your healthcare professional may do blood tests before you start LIPIDIL EZ and regularly during your treatment. These tests will check:

• the amount of cholesterol and other fats in your blood.
• the health of your liver and kidneys.
• the amount of red blood cells, white blood cells and platelets in your blood.

Depending on your test results, your healthcare professional may adjust your dose, temporarily stop, or discontinue your treatment with LIPIDIL EZ.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with LIPIDIL EZ:

• Medicines used to lower blood cholesterol levels. This includes other fibrates (e.g., gemfibrozil, bezafibrate), statins (e.g., atorvastatin, rosuvastatin, fluvastatin, pravastatin, simvastatin, lovastatin), bile acid sequestrants (e.g., cholestyramine, colestipol, colesevelam) and ezetimibe.
• Medicines containing estrogen (e.g., birth control pills or hormone replacement therapy).
• Medicines used to prevent blood clots (also known as “blood thinners”).
• Rosiglitazone, used to treat type 2 diabetes.
• Cyclosporine, used to suppress the immune system.

How to take LIPIDIL EZ:

• Take LIPIDIL EZ exactly as your healthcare professional has told you.

• LIPIDIL EZ is taken once a day at anytime, with or without food.

• Swallow the tablet whole with a glass of water.
• Do NOT crush or chew the tablet.
• Carefully follow any measures that your healthcare professional has recommended for diet, exercise or weight control.
• Your healthcare professional may also prescribe other medications to be taken in combination with LIPIDIL EZ. Take them exactly as directed by your healthcare professional.

Usual dose:

The usual adult dose is one 145 mg tablet daily. The maximum dose is 145 mg per day.

If you are elderly or have kidney problems the recommended starting dose is 48 mg per day.

Overdose:

If you think you, or a person you are caring for, have taken too much LIPIDIL EZ, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you forget to take a dose, skip the missed dose and take the next dose as scheduled. Do not take a double dose to make up for a missed dose.

Possible side effects from using LIPIDIL EZ:

These are not all the possible side effects you may have when taking LIPIDIL EZ. If you experience any side effects not listed here, tell your healthcare professional.

Side effects with LIPIDIL EZ may include:

• Abdominal pain, upset stomach, constipation, diarrhea, feeling gassy, nausea or vomiting
• Headache
• Dizziness
• Lack of energy
• Stuffy or runny nose
• Trouble sleeping
• Low sex drive
• Skin rashes, redness and itching of the skin, hives, sensitivity of the skin to sunlight or UV light
• Hair loss
• Weight loss
• Joint pain

LIPIDIL EZ can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

• Store at 15°C to 30°C. Protect from light and moisture.
• Keep out of reach and sight of children.

If you want more information about LIPIDIL EZ:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.viatris.ca); or by calling 1-844-596-9526.

Date of Authorization: 2025-12-05

® Lipidil EZ: Registered Trademark BGP Product Operations GmbH; Licenced use by BGP Pharma ULC, a Viatris company.

® NanoCrystal: Registered Trademark Elan Pharma International Limited.; Licensed use by BGP Pharma ULC, Etobicoke, Ontario M8Z 2S6.