Patient Medication Information: uses, side effects, how to take - Fenomax
ABOUT THIS MEDICATION
What the medication is used for:
Fenomax™ reduces blood cholesterol, in particular cholesterol associated with low and very low density lipoproteins (“bad” cholesterol). Fenomax™ also reduces high triglyceride levels associated with hypercholesterolemia (too much cholesterol in the blood) and increases the high density lipoprotein (HDL) cholesterol fraction (“good” cholesterol). Because of its effect on these measures, Fenomax™ is also indicated for the treatment of dyslipoproteinemia (abnormal lipoproteins in the blood) in adult patients with type 2 diabetes. Blood uric acid levels are also reduced by Fenomax™ treatment.
What it does:
See above.
When it should not be used:
Safety of use in children and young adolescents has not been established with Fenomax™.
Fenomax™ is not recommended during pregnancy. In the event of pregnancy during treatment, Fenomax™ should be discontinued and the physician should be informed.
It is not recommended to take Fenomax™ while breast-feeding.
What the medicinal ingredient is:
Fenofibrate
What the important nonmedicinal ingredients are: Hydroxypropylcellulose, lauroyl macrogol glyceride, polyethylene glycol, sodium starch glycolate. The capsule shells contain titanium dioxide and gelatin.
What dosage forms it comes in:
100 mg and 160 mg capsules
WARNINGS AND PRECAUTIONS
BEFORE you use Fenomax™ talk to your doctor or pharmacist if:
you have had an allergic reaction to (or poorly tolerated)
Fenomax™, any of its ingredients, or any other lipid treatment;
- you suffer from liver or kidney problems;
- you have a gall bladder or gallstone problem;
- you are pregnant, or intend to become pregnant, or are breast-feeding, or intend to breast feed;
- you are taking other medicines, in particular an oral anticoagulant such as warfarin.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with Fenomax™ include: oral anticoagulants, statins, cyclosporine, resins and estrogens.
PROPER USE OF THIS MEDICATION
THIS MEDICINE IS PRESCRIBED FOR A PARTICULAR HEALTH PROBLEM AND FOR YOUR PERSONAL USE. DO NOT GIVE IT TO OTHER PERSONS.
KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.
IF YOU WANT FURTHER INFORMATION, ASK YOUR DOCTOR OR PHARMACIST.
This medicine should only be used to supplement an appropriate diet recommended by your doctor 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. Follow the prescription exactly. 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.
- Fenomax™ should be taken with a main meal, as directed by your doctor.
It is particularly important to follow this advice because fenofibrate is less well absorbed and hence less effective when not taken with food.
- Your doctor will ask you to have regular medical check-ups and laboratory tests. We strongly recommend that you keep these appointments.
- Inform your doctor of any health problem that occurs while you are taking Fenomax™ as well as any prescription or non-prescription medicine. If you need other medical treatment let the doctor know that you are taking Fenomax™.
- Tell your doctor if you feel in any way unwell while taking Fenomax™ (see SIDE EFFECTS).
- Contact your doctor promptly if you suffer any unexplained muscle pain, tenderness or weakness.
- The effects of Fenomax™ in preventing heart attacks, atherosclerosis or heart disease are not yet known. IMPORTANT: PLEASE READ
Usual dose:
One capsule per day, taken with your main meal of the day.
Overdose:
If overdose is suspected, contact your local poison control center or emergency room immediately.
Missed Dose:
If you miss a dose of FenomaxTM, take it as soon as you remember. However, if it is almost time for the next dose, you should skip the dose and take only the next regularly scheduled dose. You should not take a double dose of FenomaxTM to catch-up.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
In addition to its intended action, any medicine may cause unwanted effects.
Unwanted effects may occur in certain patients. They may appear and disappear without involving any particular risk but if any unwanted effects persist or become bothersome you must let your doctor know without delay. Such unwanted effects may consist of abdominal pains, constipation, diarrhea, nausea, headache, dizziness, skin reactions, muscular pain or cramps, fatigue.
This is not a complete list of side effects. For any unexpected effects while taking Fenomax™, contact your doctor or pharmacist.
HOW TO STORE IT
Store at 15-30ºC. Protect from light and moisture. Protect from freezing.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax: 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.oryxpharma.com
or by contacting Oryx Pharmaceuticals Inc., at: 1-866-260-6291