Patient Medication Information: uses, side effects, how to take - NTP-Fenofibrate-S
ABOUT THIS MEDICATION
What the medication is used for:
NTP-FENOFIBRATE-S is used 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 NTP-FENOFIBRATE-S treatment.
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. Comply exactly to the terms of the prescription. 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:
NTP-FENOFIBRATE-S reduces blood cholesterol, in particular cholesterol associated with low and very low density lipoproteins (bad cholesterol). NTP-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).
When it should not be used:
You have had an allergic reaction to (or poorly tolerated)
NTP-FENOFIBRATE-S, any of its ingredients, or any other lipid treatment (See What the nonmedicinal ingredients are).
- 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.
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, povidine, sodium lauryl sulphate, sodium starch glycolate, sodium stearyl fumarate, talc, titanium dioxide and xanthum gum.
What dosage forms it comes in:
NTP-FENOFIBRATE-S 100mg: White to off white, oval shaped film coated tablet, debossed with “FM” on one side and “100” on the other.
NTP-FENOFIBRATE-S 160mg: White to off white, oval shaped film coated tablet, debossed with “93” on one side and “7331” on the other.
WARNINGS AND PRECAUTIONS
BEFORE you use NTP-FENOFIBRATE-S talk to your doctor or pharmacist if:
- You suffer from liver or kidney problems;
- You have a gall bladder or gallstone problem;
- NTP-FENOFIBRATE-S is not recommended during pregnancy. In the event of pregnancy during treatment, NTP-FENOFIBRATE-S should be discontinued and your doctor should be informed;
- It is not recommended to take NTP-FENOFIBRATE-S while breast-feeding;
- Safety of use in children and young adolescents has not been established with NTP-FENOFIBRATE-S.
INTERACTIONS WITH THIS MEDICATION
BEFORE you use NTP-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
- Your doctor will ask you to have regular medical check-ups and laboratory tests. It is important to respect the dates proposed: we strongly recommend that you keep faithfully these appointments.
- Inform your doctor of any health problem that occurs while you are taking NTP-FENOFIBRATE-S as well as any prescription or non-prescription medicine. If you need other medical treatment let the doctor know that you are taking NTP-FENOFIBRATE-S.
Tell your doctor if you feel in any way unwell while taking
NTP-FENOFIBRATE-S (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM).
- Contact your doctor promptly if you suffer any unexplained muscle pain, tenderness or weakness.
- The effects of NTP-FENOFIBRATE-S in preventing heart attacks, atherosclerosis or heart disease are not yet known
Usual dose:
NTP-FENOFIBRATE-S should be taken with meals, as directed by your doctor.
IMPORTANT: PLEASE READ
It is particularly important to follow this advice because
fenofibrate is less well absorbed and hence less effective when not taken with food.
Overdose:
If you accidentally take too many NTP-FENOFIBRATE-S tablets, consult your nearest hospital emergency department or doctor immediately.
Missed Dose:
If you miss a dose of NTP-FENOFIBRATE-S, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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 NTP-FENOFIBRATE-S, contact your doctor or pharmacist.
HOW TO STORE IT
NTP-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
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 obtained by contacting the sponsor, Teva Canada Ltd.,
at: 1-800-268-4127 ext. 5005
or druginfo@tevacanada.com
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9