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Patient Information

This information is Part 3 of a three-part "Product Monograph" published when TIAZAC XC was approved for sale in Canada and is designed specifically for consumers. The following information is a summary and will not tell you everything about TIAZAC XC. Contact your doctor or pharmacist if you have any questions about the drug.

ABOUT THIS MEDICATION: What the medication is used for: TIAZAC XC is used for the treatment of angina (chest pain) and mild to moderate high blood pressure. TIAZAC XC should normally be used in those patients in whom treatment with other blood pressure reduction medications has been ineffective, or have been associated with unacceptable side effects.

What it does: TIAZAC XC relaxes the arteries and slows heart rate, thereby lowering blood pressure. TIAZAC XC increases the supply of oxygen to heart muscle, thereby controlling chest pain.

When it should not be used: See WARNINGS AND PRECAUTIONS: Do not use TIAZAC XC if:

• You are pregnant or plan to become pregnant.
• You have a known allergy to diltiazem.
• You have very low blood pressure (< 90 mmHg systolic).
• You have heart rhythm disorders in the absence of a pacemaker.
• You have severe heart failure with fluid in the lungs.

What the medicinal ingredient is: Diltiazem hydrochloride
What the important non-medicinal ingredients are: microcrystalline cellulose, polyacrylate dispersion, povidone, sucrose stearate, magnesium stearate, talc, titanium dioxide, hydroxypropylmethylcellulose, polysorbate, simethicone, microcrystalline wax, pregelatinized starch, sodium starch glycolate, croscarmellose sodium, colloidal silicone dioxide, hydrogenated vegetable oil, polydextrose, polyethylene glycol, carnauba wax.

What dosage forms it comes in: 120 mg, 180 mg, 240 mg, 300 mg, 360 mg tablets

WARNINGS AND PRECAUTIONS: Inform your doctor or pharmacist if:

• You are pregnant or plan to become pregnant.
• You have a known allergy to diltiazem or any of the non-medicinal ingredients in TIAZAC XC extended-release tablets (see TIAZAC XC Ingredients, above).
• You are breast feeding.
• You have very low blood pressure.
• You have ever had a bad or unusual reaction to any drug containing diltiazem in the past.
• About all health problems you have or have had in the past.
• About all medicines you take including ones you can buy without a prescription.
• You visit more than one doctor; make sure each knows about all the medicines you are taking.
• You have liver or kidney disease.

INTERACTIONS WITH THIS MEDICATION: Inform your doctor of all prescription and over-the-counter medicines that you are taking. Additional monitoring of your dose or condition may be needed if you are taking other drugs for blood pressure or other medical conditions. As with all drugs, care should be taken when using multiple medications. When taken together, TIAZAC XC may increase the effects of some medications including:

• Sleeping pills;
• Other blood pressure medications;
• Medications used to control seizures;
• Medications used to control the immune system, such as cyclosporine;
• Cholesterol lowering medications.

Medications used to control stomach ulcer will increase the effects of TIAZAC XC. Certain antibiotics should not be taken with TIAZAC XC. Check with your pharmacist.

PROPER USE OF THIS MEDICATION: Usual dose: TIAZAC XC is taken once daily at bedtime. TIAZAC XC is taken with or without food, but should be so taken consistently. It is important to take TIAZAC XC at night, at approximately the same time. If you miss a dose, check with your doctor or pharmacist to see what you should do. Tablets are not to be chewed or crushed.

Overdose: If you have taken more medication than your doctor has instructed, contact either your doctor, hospital emergency department, or nearest poison control centre immediately.

Missed Dose: If a dose of this medication has been missed, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule.

Side Effects: TIAZAC XC, like any medication, may have some side effects. It is important that you keep your doctor informed of all side effects especially if you experience one of the following for more than a week. The most common side effects are: headache, dizziness, peripheral edema (swelling of the ankles), nausea (feeling like vomiting), inflammation in the nose and throat, respiratory tract infection, flushing (facial redness) or feeling unusually warm, a racing heartbeat or low heartbeat, unusual tiredness and weakness, rash, upset stomach. In rare instances, laboratory test results consistent with liver injury have been observed with diltiazem and resolved following discontinuation of therapy. Discuss how you feel on TIAZAC XC with your doctor or pharmacist. DO NOT STOP OR RESTART TIAZAC XC ON YOUR OWN.

HOW TO STORE IT: Store tablets at room temperature. Avoid excessive humidity and temperatures above 30ºC.

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.biovail.com or by contacting the sponsor:

Biovail Pharmaceuticals Canada
1-866 825-8120 or
MedInfo@Biovail.com