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IMPORTANT: PLEASE READ
PART III: CONSUMER INFORMATION
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APO-DILTIAZ TZ
Diltiazem Hydrochloride Extended-Release Capsules
This leaflet is part III of a three-part “Product Monograph”
published when APO-DILTIAZ TZ was approved for sale in
Canada and is designed specifically for Consumers. This
leaflet is a summary and will not tell you everything about
APO-DILTIAZ TZ. Contact your doctor or pharmacist if you
have any questions about the drug.
ABOUT THIS MEDICATION
What the medication is used for:
APO-DILTIAZ TZ is used for the treatment of mild to moderate
high blood pressure. It 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.
The empty capsule shells contain the non-medicinal ingredients
gelatin, titanium dioxide and the following colouring agents:
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What it does:
APO-DILTIAZ TZ works by slowing the heart rate, and by
relaxing and widening blood vessels (arteries), which reduces the
blood pressure. Widening of the arteries also increases the amount
of blood reaching the heart, which can reduce the symptoms of
angina.
When it should not be used:
See WARNINGS AND PRECAUTIONS
Do not use APO-DILTIAZ TZ if:
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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.
What the medicinal ingredient is:
Diltiazem Hydrochloride
What the important nonmedicinal ingredients are:
APO-DILTIAZ TZ 120 mg, 180 mg, 240 mg, 300 mg and 360 mg
capsules contain the following nonmedicinal ingredients:
Carboxymethylcellulose Sodium, Eudragit, Methylcellulose,
Microcrystalline Cellulose and Talc.
FD&C blue#1, FD&C red#3
FD&C green#3
FD&C blue#1, FD&C red#3, FD&C green #3
FD&C blue#1, FD&C red#3
FD&C green#3
What dosage forms it comes in:
Capsules -- 120 mg, 180 mg, 240 mg, 300 mg and 360 mg
WARNINGS AND PRECAUTIONS
Before starting APO-DILTIAZ TZ and to get the best possible
treatment, be sure to tell your doctor if you:
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APO-DILTIAZ TZ can also be used for the treatment of chest
pain (angina).
120 mg:
180 mg:
240 mg:
300 mg:
360 mg:
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If you are pregnant or plan to become pregnant.
If you are breast feeding.
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.
If you visit more than one doctor, make sure each
knows about all the medicines you are taking.
If you are allergic to “non-medicinal” substances like
food products, preservatives or dyes, which may be
present in APO-DILTIAZ TZ Capsules (see APODILTIAZ TZ Ingredients).
If you have ever had a bad, unusual or allergic reaction
to any drug containing diltiazem in the past.
INTERACTIONS WITH THIS MEDICATION
Inform your doctor of all prescription and over-the-counter
medicine 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, APO-DILTIAZ TZ may increase the effects of some
medications including:
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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 APO-DILTIAZ TZ. Certain antibiotics should not be
taken with APO-DILTIAZ TZ. Check with your pharmacist.
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PROPER USE OF THIS MEDICATION
Usual dose:
APO-DILTIAZ TZ is taken once daily. It is important to take
APO-DILTIAZ TZ at about the same time every day. Capsules
are not to be chewed or crushed.
Take APO-DILTIAZ TZ exactly as your doctor tells you. Do not
miss doses or take extra doses, unless your doctor tells you. If you
are not clear about the direction, ask your doctor or pharmacist.
Capsules are not to be chewed or crushed.
Overdose:
If you have taken more medication than your doctor has
instructed, contact either you doctor, hospital emergency
department, or nearest poison control centre immediately.
Missed Dose:
If you miss a dose, check with your doctor or pharmacist to see
what you should do.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
APO-DILTIAZ TZ , 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), flushing or feeling unusually warm, a
racing heartbeat and unusual tiredness.
This is not a complete list of side effects. For any unexpected
effects while taking APO-DILTIAZ TZ, contact your doctor or
pharmacist.
HOW TO STORE IT
Store at room temperature (15-30°C). Avoid excessive humidity.
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: [email protected]
By regular mail:
Canadian Adverse Drug Reaction Monitoring
Program
(CADRMP)
Health Canada
Address Locator: 0201C2
Ottawa, ON K1A 1B9
NOTE: Before contacting Health Canada, you should
contact your physician or pharmacist.
MORE INFORMATION
For more information, please contact your doctor, pharmacist or
other healthcare professional.
This leaflet plus the full product monograph, prepared for health
professionals, can be obtained by contacting DISpedia, Apotex's
Drug Information Service at:
1-800-667-4708
This leaflet can also be found at: http://www.apotex.ca/products.
This leaflet was prepared by Apotex Inc., Toronto, Ontario,
M9L 1T9.
Last revised: January 19, 2007
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