Patient Medication Information: uses, side effects, how to take - Act-Bezafibrate SR
ABOUT THIS MEDICATION
What the medication is used for:
ACT-BEZAFIBRATE SR is used:
- to treat patients with hyperlipidemia (high cholesterol)
to treat patients with high to very high levels of
triglycerides (a type of fat in the body that is an important energy source forming much of the fat stored in the body).
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.
What it does:
ACT-BEZAFIBRATE SR lowers cholesterol and high triglyceride levels in the blood. When taken by patients who previously suffered a heart attack, ACT-BEZAFIBRATE SR has been shown to slow down any hardening of the arteries, and can help prevent a second heart attack. ACT-BEZAFIBRATE SR is only available on prescription.
When it should not be used:
ACT-BEZAFIBRATE SR should not be used:
- if you have severe liver damage
if you have kidney disease, kidney damage, or if you
are on dialysis
- if you have a pre –existing gallbladder disease
if you are allergic to bezafibrate, any component of
ACT-BEZAFIBRATE SR or to other cholesterol lowering medications known as Fibrates. For a complete list of the components of ACT-BEZAFIBRATE SR, please see “What the nonmedicinal ingredients are”.
if you have taken ACT-BEZAFIBRATE SR or any
other drug in the fibrate class before and it has caused a sensitivity reaction, including sensitivity to sun.
if you are pregnant or breast feeding
if you have very high levels of lipids, a condition
known as Type 1 hyperlipoproteinemia
If you are taking other cholesterol lowering medication
known as Statins and are predisposed to develop muscle weakness
What the medicinal ingredient is:
The medicinal ingredient in ACT-BEZAFIBRATE SR is bezafibrate.
What the nonmedicinal ingredients are:
Colloidal silicon dioxide, hydroxypropyl methylcellulose 2208 & 2910, lactose, magnesium stearate, methyl methacrylate, polyethyl acrylate, polyethylene glycol, 10000, polysorbate 80, povidone K25, sodium citrate, sodium lauryl sulphate, talc, and titanium dioxide.
What dosage forms it comes in:
ACT-BEZAFIBRATE SR is a sustained release 400 mg tablet.
WARNINGS AND PRECAUTIONS
BEFORE you use ACT-BEZAFIBRATE SR talk to your doctor or pharmacist if:
- if you have taken ACT-BEZAFIBRATE SR or any other drug in the fibrate class before and if it caused an allergy or was otherwise poorly tolerated.
if you suffer from liver or kidney problems. ACT-
BEZAFIBRATE SR should not be used in elderly patients above the age of 70.
if you are pregnant or intend to become pregnant.
ACT-BEZAFIBRATE SR should not be taken during pregnancy. If you are a woman who could become pregnant, use adequate contraception during treatment. In the event of pregnancy during treatment, ACT-BEZAFIBRATE SR should be discontinued and the physician should be informed.
If you are breast feeding, or intend to breast feed.
ACT-BEZAFIBRATE SR should not be taken while breast-feeding.
- if you are taking other medicines prescribed by your doctor, in particular an oral anticoagulant such as warfarin (WARFILONE) or cyclosporine (SANDIMMUNE, NEORAL).
- If you are taking any over-the-counter medicines or herbal supplements.
Inform your doctor of any health problem that occurs while taking ACT-BEZAFIBRATE SR as well as any prescription or non-prescription medicine. If you need other medical treatment let the doctor know that you are taking ACT-BEZAFIBRATE SR. Safety in children and young adolescents has not been established with ACT-
BEZAFIBRATE SR.
This medicine is prescribed for a particular health problem and for your personal use. Do not give it to other persons.
ACT-BEZAFIBRATE SR tablets should not be used after the expiry on the pack.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with ACT-BEZAFIBRATE SR include:
- Anticoagulants (blood thinners)
Immunosupressants (medication that lowers the body’s
ability to defend itself against foreign substances)
HMG CoA reductase inhibitors or stains (cholesterol
lowering medication)
- Cyclosporine
- MAO-inhibitors (antidepressants)
- Estrogens
- Bile acid resins (cholesterol lowering medications)
If you are taking both ACT-BEZAFIBRATE SR and a bile acid resin concurrently, an interval of 2 hours should be maintained between the two drugs.
PROPER USE OF THIS MEDICATION
Usual dose:
Standard dosage is one 400 mg sustained release tablet once (1) daily, taken in the morning or evening with or after meals. The sustained release tablet should be swallowed whole with sufficient fluid. Do not chew ACT-BEZAFIBRATE SR tablets.
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.
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.
ACT-BEZAFIBRATE SR is only available on prescription. 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.
Overdose:
In cases of overdose or suspected overdose, contact the poison control centre or your physician immediately.
Missed Dose:
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular regular dosing schedule. Do not take 2 doses at the same time.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, ACT-BEZAFIBRATE SR can have side effects. The most common side effects are rash, headache, diarrhoea, nausea and abdominal pain.
Tell your doctor if you are unwell while taking ACT-BEZAFIBRATE SR.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmac ist | ||
| Only if severe | In all cases | |||
More Common | Diarrhoea Constipation Abdominal Pain Skin reactions | √ | ||
Less common | Muscular pain, weakness or cramps Dizziness Fast decrease in kidney function (i.e., decreased amount of urine output to almost none) | √ | ||
This is not a complete list of side effects. For any unexpected effects while taking ACT-BEZAFIBRATE SR, contact your doctor or pharmacist.
HOW TO STORE IT
Store ACT-BEZAFIBRATE SR between 15-30°C. Store in a dry place.
Keep all medicines out of reach of children.
REPORTING SUSPECTED 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 3 ways:
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- 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 0701D
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ 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
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.
or by contacting the sponsor, ACTAVIS Group PTC ehf at, .
Warfilone® is a registered Trade-Mark of Merck Frosst Canada & co
Sandimmune® is a registered Trade-Mark of Novartis AG Neoral® is a registered Trade-Mark of Novartis AG
Imported By: Accuristix, Mississauga, ON, L5R 3Y4