Sandoz Fenofibrate S: Uses, Side Effects and Dosage

What is Sandoz Fenofibrate S used for?

Sandoz Fenofibrate S is used in adults, including adults with type 2 diabetes, to lower cholesterol and blood fat levels. Sandoz Fenofibrate S is to be used together with dietary and lifestyle changes.

How does Sandoz Fenofibrate S work?

Sandoz Fenofibrate S 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.

What are the ingredients in Sandoz Fenofibrate S?

Medicinal ingredient: fenofibrate

Non-medicinal ingredients: Croscarmellose sodium, hydroxypropylcellulose Type LF, hydroxypropyl methylcellulose 2910 E5, polyethylene glycol 8000, titanium dioxide and purified water.

Sandoz Fenofibrate S comes in the following dosage form:

Film-coated tablet: 100 mg and160 mg

Do not use Sandoz Fenofibrate S if you:

• 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 Sandoz Fenofibrate S;
• 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 Sandoz Fenofibrate S, 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 Sandoz Fenofibrate S 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.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sandoz Fenofibrate S. 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;

Other warnings you should know about:

You should have regular check-ups with your healthcare professional while taking Sandoz Fenofibrate S. Your healthcare professional will also do regular blood work to make sure you are responding well to Sandoz Fenofibrate S 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 Sandoz Fenofibrate S 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.

The following may interact with Sandoz Fenofibrate S:

• Statins (other drugs used to lower cholesterol) such as atorvastatin, pravastatin, simvastatin, etc. Taking a statin at the same time as Sandoz Fenofibrate S 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.

How to take Sandoz Fenofibrate S:

• Sandoz Fenofibrate S 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 Sandoz Fenofibrate S 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.

What are possible side effects from using Sandoz Fenofibrate S

These are not all the possible side effects you may feel when taking Sandoz Fenofibrate S. 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

Sandoz Fenofibrate S 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, talk to your healthcare professional.

Reporting Side Effects

Storage:

Store at 15^oC to 30^oC. Protect from moisture and light.

Keep out of reach and sight of children.

If you want more information about Sandoz Fenofibrate S:

• 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 (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website (www.sandoz.ca), or by calling 1-800-361-3062.

Last Revised: October 31, 2019