Teva-Fenofibrate-S: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

TEVA-FENOFIBRATE-S is used for the treatment of dyslipoproteinemia (abnormal lipoproteins in the blood) in adult patients, including patients with type 2 diabetes.

This medicine should only be used to supplement an appropriate diet recommended and followed up by your doctor for the long-term treatment of raised lipid levels; prescription of this medicine in no way replaces dietary treatment. In addition, depending on the situation, your doctor may recommend further physical exercise, weight loss or other measures. Take exactly as instructed by your doctor. Do not change the dose without your doctor's advice. Consult your doctor before stopping treatment since to do so may result in an increase in your blood lipid levels.

What it does:

TEVA-FENOFIBRATE-S reduces blood cholesterol, in particular cholesterol associated with low and very low density lipoproteins (bad cholesterol). TEVA-FENOFIBRATE-S reduces high triglyceride levels associated with hypercholesterolemia (excess of cholesterol in the blood) and increases the high density lipoprotein (HDL) cholesterol fraction (good cholesterol).

Blood uric acid levels are also reduced by TEVA-FENOFIBRATE-S treatment.

When it should not be used:

• If you have liver or kidney problems;
• If you have a gallbladder problems;

• If you have pancreatitis (an inflamed pancreas which causes abdominal pain);

  • If you are allergic to fenofibrate or similar drug or if you are allergic to any of the ingredients in TEVA-FENOFIBRATE-S tablets (see What the non medicinal ingredient are).
  • If you are allergic (hypersensitive) to peanuts or arachis oil or soya lecithin or related products due to risk of allergic reaction;

  • If you are pregnant, think you may be pregnant or are planning to have a baby; in the event of pregnancy during treatment, your doctor should be informed and TEVA-FENOFIBRATE-S should be discontinued;

  • If you are breast-feeding or planning to breast-feed your baby.
  • If you have a photoallergy (skin sensitivity to sunlight or UV light) when taking a fibrate (a class of drugs used for lowering cholesterol, which includes TEVA-FENOFIBRATE-S and gemfibrozol) or an anti-inflammatory drug called ketoprofen.
  • If you are taking statins and have muscle problems or have potential risks of developing muscle problems.
  • If you are under 18 years of age.

What the medicinal ingredient is:

Fenofibrate, micronized.

What the nonmedicinal ingredients are:

colloidal anhydrous silica, croscarmellose sodium, crospovidone, lactose monohydrate, lecithin (soya), microcrystalline cellulose, polyvinyl alcohol, povidone, sodium lauryl sulphate, sodium starch glycolate, sodium stearyl fumarate, talc, titanium dioxide and xanthum gum.

What dosage forms it comes in:

Film coated tablets, 100 mg and 160 mg

WARNINGS AND PRECAUTIONS

BEFORE you use TEVA-FENOFIBRATE-S talk to your doctor or pharmacist if:

• You have had an allergic reaction to (or poorly tolerated) TEVA-FENOFIBRATE-S any of its ingredients (see What the non medicinal ingredient are) or any other lipid treatment
• You suffer from liver or kidney problems;
• You have an inflamed liver (hepatitis) - signs include yellowing of the skin and the whitesof
• the eyes (jaundice) and an increase in liver enzymes (shown in blood tests);
• You have pancreas problems;
• You have a gall bladder or gallstone problem;
• You have an under-active thyroid gland (hypo-thyroidism);
• You are pregnant, or intend to become pregnant, or are breast-feeding, or intend to breastfeed;
• You are taking other medicines, prescription or non-prescription. Of particular concern are:
• Statins (a class of drugs, which includes atorvastatin, pravastatin, simvastatin, etc., used to lower cholesterol). Taking a statin at the same time as TEVA-FENOFIBRATE-S may increase the risk of muscle problems
• Ezetimibe (another type of cholesterol lowering agent)
• Oral anticoagulants (blood thinning agents, such as warfarin)
• Cyclosporine (a drug which may be taken following an organ transplant)
• Cholestyramine or similar drug (another type of cholesterol lowering agent)
• Estrogens (hormones which may be found in oral contraceptives or hormone replacement therapy)

• a particular class of medicines to treat

  diabetes (such as rosiglitazone or

  pioglitazone)

Your doctor will ask you to have regular medical check-ups and laboratory tests. It is important to respect the dates proposed for these tests: we strongly recommend that you keep these appointments faithfully so that any abnormalities that may occur can be identified promptly. These problems can include muscle inflammation and breakdown, which can cause kidney damage or even death. The risk of muscle breakdown is higher in some patients. Tell your doctor if:

• you are over 70 years old;
• you have kidney problems;
• you have thyroid problems;
• you or a close family member has muscle problem which runs in the family;
• you drink large amounts of alcohol;
• you are taking medicines called statins to lower cholesterol such as simvastatin, atorvastatin,

pravastatin, rosuvastatin or fluvastatin;

• you have ever had muscle problems during treatment with fibrates such as fenofibrate, bezafibrate or gemfibrozil.
• TEVA-FENOFIBRATE-S is not recommended during pregnancy. In the event of pregnancy during treatment, TEVA-FENOFIBRATE-S should be discontinued and your doctor should be informed;
• It is not recommended to take TEVA-FENOFIBRATE-S while breast-feeding;
• Safety of use in children and young adolescents has not been established with TEVA-FENOFIBRATE-S.

INTERACTIONS WITH THIS MEDICATION

BEFORE you use TEVA-FENOFIBRATE-S, talk to your doctor or pharmacist if you are taking other medicines, in particular an oral anticoagulant such as warfarin.

PROPER USE OF THIS MEDICATION

Usual dose:

• TEVA-FENOFIBRATE-S should be taken with meals, as directed by your doctor. Swallow the tablet with a glass of water. Do not crush or chew the tablet.

• It is particularly important to follow this advice because fenofibrate is less well absorbed and hence less effective when not taken with food.
• The recommended dose of TEVA-FENOFIBRATE-S is one 160 mg tablet daily.
• Never change the dose unless directed by your doctor.
• TEVA-FENOFIBRATE-S is not recommended for use in children.

The safety of using TEVA-FENOFIBRATE-S in combination with a statin has not been extensively studied in patients. Therefore, the combined use of fenofibrate with a statin should be avoided unless recommended by your doctor.

Tell your doctor about any health problem that occurs while you are taking TEVA-FENOFIBRATE-S. If you need other medical treatment while taking TEVA-FENOFIBRATE-S, let your doctor know that you are taking TEVA-FENOFIBRATE-S.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

• If you forget a dose of TEVA-FENOFIBRATE-S, 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

In addition to its intended action, any medicine may cause unwanted effects.

Tell your doctor if you feel in any way unwell while taking TEVA-FENOFIBRATE-S.

Some common side effects may include abdominal pain, constipation, diarrhea, flatulence,

nausea, vomiting, headache, dizziness, skin reactions, fatigue and raised levels of liver enzymes

in the blood. This is not a complete list of side effects. If you experience any unexpected symptoms while taking TEVA-FENOFIBRATE-S, contact your doctor or pharmacist.

Stop taking TEVA-FENOFIBRATE-S and see a doctor straight away, if you notice any of the following serious side effects – you may need urgent medical treatment:

• allergic reaction - the signs may include swelling of the face, lips, tongue or throat, which may cause difficulty in breathing
• stomach pain - this may be a sign that your pancreas is inflamed (pancreatitis)
• chest pain and feeling breathless - these may be signs of a blood clot in the lung (pulmonary embolism)
• pain, redness or swelling in the legs - these may be signs of a blood clot in the leg (deep vein thrombosis)

• yellowing of the skin and whites of the eyes (jaundice), or an increase in liver

  • enzymes - these may be signs of an inflamed liver (hepatitis).

Muscle pain or cramps, or muscle weakness, may indicate rare, but more serious, side effects. If you suffer any unexplained muscle pain, stop the drug and contact your doctor immediately.

This is not a complete list of side effects. For any unexpected effects while taking TEVA-FENOFIBRATE-S, contact your doctor or pharmacist.

HOW TO STORE IT

TEVA-FENOFIBRATE-S is only available on prescription.

Store at 15-30°C. Protect from light and moisture.

Keep away from children.

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited,

at: 1-800-268-4127 ext. 1255005 (English)

or 1-877-777-9117 (French)

or druginfo@tevacanada.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: June 13, 2014