Details for: LIPIDIL SUPRA
Company: BGP PHARMA ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02241602 | LIPIDIL SUPRA | FENOFIBRATE | 160 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
LIPIDIL SUPRA® is used in adults, including adults with type 2 diabetes, to lower cholesterol and blood fat levels. LIPIDIL SUPRA® is to be used together with dietary and lifestyle changes.
What it does
LIPIDIL SUPRA® lowers cholesterol by reducing the amount of bad cholesterol (LDL) and fatty substances in the blood (triglycerides). It also increases the amount of good cholesterol (HDL) in the blood.
When it should not be used
- have serious liver or kidney problems;
- have gallbladder problems;
- have pancreatitis (an inflamed pancreas which causes abdominal pain);
- are allergic (hypersensitive) to fenofibrate or similar drugs or if you are allergic to any of the ingredients in LIPIDIL SUPRA®;
- are allergic (hypersensitive) to peanuts, arachis oil, soya lecithin, lactose or related products due to risk of allergic reaction;
- are pregnant, think you may be pregnant or are planning to get pregnant. If you get pregnant while taking LIPIDIL SUPRA®, contact your healthcare professional immediately.
- are breast-feeding or planning to breast-feed;
- have a photoallergy (skin sensitivity to sunlight or UV light) when taking a fibrate (a class of drugs used for lowering cholesterol, which includes LIPIDIL SUPRA® and gemfibrozol) or an anti-inflammatory drug called ketoprofen;
- are taking statins (another type of drug used to lower cholesterol) and have muscle problems or have potential risks of developing muscle problems;
- are under 18 years of age.
What the medicinal ingredient is
fenofibrate
What the non-medicinal ingredients are
colloidal silicon dioxide, crospovidone, lactose monohydrate, microcrystalline cellulose, polyvinyl alcohol, povidone, sodium stearyl fumerate and sodium lauryl sulfate, soybean lecithin, talc, titanium dioxide and xantham gum
What dosage form it comes in
Film-coated tablet: 160 mg
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LIPIDIL SUPRA®. Talk about any health conditions or problems you may have, including if you:
- have liver or kidney problems;
- have pancreas problems;
- have gallstones;
- have thyroid problems;
- LIPIDIL SUPRA® contains lactose. Talk to your healthcare professional before taking LIPIDIL SUPRA® if you have been told that you cannot tolerate or digest lactose.
Other warnings you should know about:
You should have regular check-ups with your healthcare professional while taking LIPIDIL SUPRA®. Your healthcare professional will also do regular blood work to make sure you are responding well to LIPIDIL SUPRA® and that you are not experiencing side effects. These side effects can include serious muscle problems, which can cause kidney damage or even death. The risk of muscle problems is higher in some patients. Tell your healthcare professional if you:
- are over 70 years old;
- have kidney or liver problems;
- have thyroid problems;
- or a close family member has muscle problems which run in the family;
- drink large amounts of alcohol;
- have a serious infection or have recently had surgery or suffered a trauma;
- are dehydrated or suffer from excessive vomiting, diarrhea, or sweating;
- are taking drugs called statins to lower cholesterol such as simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin;
- have ever had muscle problems during treatment with fibrates such as fenofibrate, bezafibrate or gemfibrozil. While taking LIPIDIL SUPRA® if you experience muscle pain, tenderness or weakness, especially with a fever, contact your healthcare professional immediately.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
- Statins (other drugs used to lower cholesterol) such as atorvastatin, pravastatin, simvastatin, etc. Taking a statin at the same time as LIPIDIL SUPRA® may increase the risk of serious muscle problems.
- Ezetimibe (used to lower cholesterol);
- Blood thinners, such as warfarin;
- Cyclosporine (a drug which may be taken following an organ transplant);
- Cholestyramine or similar drugs (used to lower cholesterol);
- Estrogens (hormones which may be found in birth control pills or hormone replacement therapy);
- Some drugs used to treat diabetes, such as rosiglitazone or pioglitazone.
Proper use of this medication
- LIPIDIL SUPRA® should be taken with food.
- Swallow the tablet whole with a glass of water.
- Do not crush or chew the tablet.
Usual adult dose
The recommended dose of LIPIDIL SUPRA® is one 160 mg tablet daily.
Overdose
Missed Dose
If you forget a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking LIPIDIL SUPRA®. If you experience any side effects not listed here, contact your health care professional.
Side effects may include:
- Stomach pain, constipation, diarrhea, gas
- Nausea, vomiting
- Headache
- Dizziness
- Fatigue
- Trouble sleeping
- Low sex drive
- Skin rashes, redness and itching, sensitivity of the skin to light
- Hair loss
- Weight loss
- Joint pain
LIPIDIL SUPRA® can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| UNCOMMON | |||
| Allergic reaction: swelling of the face, lips, tongue or throat, which may cause difficulty in breathing | ✔ | ||
| Blood clot in the lung: sudden chest pain and trouble breathing | ✔ | ||
| Blood clot in the leg: pain, redness or swelling in the legs | ✔ | ||
| Inflammation of the pancreas: stomach pain that lasts and gets worse when you lie down, nausea, vomiting | ✔ | ||
| RARE | |||
| Serious muscle problems: muscle pain or cramps, or muscle weakness, especially together with fever and generally feeling unwell | ✔ | ||
| Liver problems: yellowing of the skin and whites of the eyes, dark urine | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Store at 15 to 30oC. Protect from light and moisture.
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (www.healthcanada.gc.ca); the manufacturer’s website (www.mylan.ca), or by calling 1-844-596-9526
This leaflet was prepared by BGP Pharma ULC
Etobicoke, Ontario M8Z 2S6
® Lipidil Supra: Registered Trademark Fournier Industrie et Santé, Suresnes, France; Licensed use by BGP Pharma ULC, Etobicoke, Ontario, M8Z 2S6
Last revised: January 13, 2017