Patient Medication Information: uses, side effects, how to take - Jamp-Bezafibrate SR
ABOUT THIS MEDICATION
What the medication is used for:
JAMP-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:
JAMP-BEZAFIBRATE SR lowers cholesterol and high triglyceride levels in the blood. When taken by patients who previously suffered a heart attack, JAMP-BEZAFIBRATE SR has been shown to slow down any hardening of the arteries, and can help prevent a second heart attack. JAMP-BEZAFIBRATE SR is only available on prescription.
When it should not be used:
JAMP-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 Bezafibrate SR or to other cholesterol lowering medications known as Fibrates. For a complete list of the components of JAMP-BEZAFIBRATE SR, please see “What the nonmedicinal ingredients are”.
- if you have taken JAMP-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 JAMP-BEZAFIBRATE SR is bezafibrate.
What the nonmedicinal ingredients are:
Lactose monohydrate, Sodium lauryl sulphate, Povidone (K-30), Hypromellose (HPMC K100 LV), Silica colloidal anhydrous, Magnesium Stearate, Hypromellose (HPMC E-5), Ethyl acrylate and Methyl methacrylate copolymer, Macrogol (PEG 8000), Purified Talc, Titanium dioxide, Polysorbate 80, Sodium Citrate.
What dosage forms it comes in:
JAMP-BEZAFIBRATE SR is a sustained release 400 mg tablet.
WARNINGS AND PRECAUTIONS
BEFORE you use JAMP-BEZAFIBRATE SR talk to your doctor or pharmacist if:
- if you have taken JAMP-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.
JAMP-BEZAFIBRATE SR should not be used in elderly patients above the age of 70.
- if you are pregnant or intend to become pregnant.
JAMP-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, JAMP-BEZAFIBRATE SR should be discontinued and the physician should be informed.
- If you are breast feeding, or intend to breast feed.
JAMP-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 JAMP-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 JAMP-BEZAFIBRATE SR. Safety in children and young adolescents has not been established with JAMP-BEZAFIBRATE SR.
This medicine is prescribed for a particular health problem and for your personal use. Do not give it to other persons.
JAMP-BEZAFIBRATE SR tablets should not be used after the expiry on the pack.
IMPORTANT: PLEASE READ
| 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 seek immedia te emergen cy medical attention | ||
| 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 (ie decreased amount of urine output to almost none) | √ | ||
INTERACTIONS WITH THIS MEDICATION
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Drugs that may interact with JAMP-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 JAMP-BEZAFIBRATE SR and a bile acid resin concurrently, an interval of 2 hours should be maintained between the two drugs.
Like all medicines, JAMP-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 JAMP-BEZAFIBRATE SR .
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 JAMP-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.
JAMP-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 dosing schedule. Do not take 2 doses at the same time.
This is not a complete list of side effects. For any unexpected effects while taking JAMP-BEZAFIBRATE SR , contact your doctor or pharmacist.
IMPORTANT: PLEASE READ
HOW TO STORE IT
JAMP-BEZAFIBRATE SR (bezafibrate) tablets should be stored at room temperature (15-30ºC). Protect from moisture. Keep all medicines out of reach of children.
REPORTING SUSPECTED SIDE EFFECTS
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
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- Online at MedEffect;
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and
sending it by:
- Fax to 1-866-678-6789 (toll free);
Mail to:
Canada Vigilance Program
Health Canada Postal Locator 0701E Ottawa, Ontario K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.
NOTE: Contact your health professional if you need information about how to manage your side effects. 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 by contacting the sponsor,
JAMP Pharma Corporation, at:1-866-399-9091
Last prepared: March 16, 2016