[product monograph template - standard]

IMPORTANT: PLEASE READ
PART III: CONSUMER INFORMATION
What the non-medicinal ingredients are:
HYTRIN®
HYTRIN® 1 mg tablets also contain corn starch, lactose terazosin hydrochloride tablets
monohydrate, magnesium stearate, povidone and talc. This leaflet is part III of a three-part "Product Monograph"
HYTRIN® 2 mg tablets also contain corn starch, FD&C yellow published when HYTRIN® was approved for sale in Canada
No. 6, lactose monohydrate, magnesium stearate, povidone and and is designed specifically for consumers. This leaflet is a
summary and will not tell you everything about HYTRIN®.
Contact your doctor or pharmacist if you have any questions
about the drug.
HYTRIN® 5 mg tablets also contain corn starch, iron oxidee, lactose monohydrate, magnesium stearate, povidone and talc. ABOUT THIS MEDICATION
HYTRIN® 10 mg tablets also contain corn starch, FD&C blue No. What the medication is used for:
2, lactose monohydrate, magnesium stearate, pregelatinized starch What dosage forms it comes in:
$ Benign prostatic hyperplasia (enlargement of the prostate HYTRIN® is available as a tablet in the following strengths: HYTRIN® is for symptomatic benign prostatic hyperplasia (BPH) and not for prostate cancer. It is possible for men to have both WARNINGS AND PRECAUTIONS
BPH and prostate cancer at the same time. HYTRIN® is not a treatment for prostate cancer. Serious Warnings and Precautions
Doctors usually recommend that men be checked for prostate cancer once a year when they turn 50 (or 40 if a family member HYTRIN® should not be used if you have been
has had prostate cancer). These checks, including Prostate Specific diagnosed with micturition syncope (fainting shortly
Antigen (PSA), should continue while you are taking HYTRIN®. after or during urination).
What it does:
BEFORE you use HYTRIN® talk to your doctor or
HYTRIN® works by relaxing blood vessels so that blood passes pharmacist if:
through them more easily. This helps to lower blood pressure. HYTRIN® also blocks smooth muscle receptors of the bladder you are using sildenafil (e.g., Viagra®), tardenafil (e.g., neck and the prostate called alpha-1 adrenoceptors. This blockade causes the smooth muscles of the bladder neck and prostate to relax and decreases muscle tone. This can lead to a rapid improvement in urine flow and symptoms within a 2 week period. you have had or will have prostate surgery; When it should not be used:
HYTRIN® should not be used if you are allergic to any component During initiation of HYTRIN® therapy, after your HYTRIN®
of HYTRIN®, including active ingredient and non-active dose has been increased, or after interruption of therapy
when treatment with HYTRIN® is resumed you should not
drive, operate heavy machinery, or do any hazardous task,
What the medicinal ingredient is:
until you are used to the effects of HYTRIN®. In these cases,
for 12 hours after taking HYTRIN®, you should avoid
situations where injury could result should fainting occur. If
you begin to feel dizzy, sit or lie down until you feel better.

HYTRIN® Product Monograph Page 37 of 40 Date of Revision: December 13, 2010 and Control No.138238 INTERACTIONS WITH THIS MEDICATION
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Tell your doctor or pharmacist if you are taking or have recently Along with its needed effects, a medicine may cause some taken any other medicines including natural health products, unwanted effects. These are referred to as “side effects”. prescription and non-prescription medicines. Although not all of these side effects may occur, if they do occur In general, you should avoid the use of phosphodiesterase (PDE5) inhibitors such as sildenafil (e.g., Viagra®), tardenafil (e.g., HYTRIN® can cause a sudden drop in blood pressure after the Cialis®) or vardenafil (Levitra®) when taking HYTRIN® due to the very first dose. You may feel dizzy, faint, or "light-headed", risks of developing serious hypotension (low blood pressure). particularly after you get up from bed or from a chair. This is more likely to occur after you have taken the first dose, but can Administration of HYTRIN® with verapamil (e.g., Isoptin®, occur at any time while you are taking the drug. It can also occur Tarka® or Chronovera®) to hypertensive patients may result in low if you stop taking the drug and then restart treatment. blood pressure and/or a rapid heart beat. Because of this effect, your doctor may have told you to take Do not take these drugs with HYTRIN® without your doctor’s HYTRIN® at bedtime. If you take HYTRIN® at bedtime but need to get up from bed to go to the bathroom, get up slowly and cautiously until you are sure how the medicine affects you. It is also important to get up slowly from a chair or bed at anytime PROPER USE OF THIS MEDICATION
until you learn how you react to HYTRIN®. Usual dose:
Other side effects with HYTRIN® include back pain, constipation, diarrhea, drowsiness or sleepiness, dry mouth, flatulence, Follow your doctor’s instructions very carefully about how to take headache, impotence, indigestion, libido decreased, nasal HYTRIN®. The starting dose is 1 mg at bedtime. The 1 mg dose congestion, nausea, urinary frequency, urinary incontinence should be maintained during the first week of treatment, and primarily reported in postmenopausal women, weakness or should be taken every day as prescribed by your doctor. Your doctor will then gradually increase the strength of your prescription to 2 mg, 5 mg, or 10 mg depending on how well you respond. The maximum recommended daily dose is 20 mg per day. SERIOUS SIDE EFFECTS, HOW OFTEN THEY
HAPPEN AND WHAT TO DO ABOUT THEM
You should see an effect on your symptoms in 2 to 4 weeks. While taking HYTRIN®, you should have regular check-ups to evaluate Symptom / effect
Talk with your
Stop taking
your progress regarding your BPH and to monitor your blood doctor or
drug and seek
pharmacist
immediate
emergency
Overdose:
attention
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
If you or someone you know accidentally takes more than the
stated dose, tell your doctor or hospital how much was taken and
show them the tablets. Treat even small overdoses seriously.
Missed Dose:
If you forget to take a dose, take another as soon as you remember,
unless it is almost time for your next dose. If it is, do not take the
missed dose at all.
Never double-up on a missed dose.
Talk to your doctor if you have not taken HYTRIN® for a few
days. You may have to restart at the 1 mg dose. Be cautious about
possible dizziness.
Date of Revision: December 13, 2010 and Control No.138238. IMPORTANT: PLEASE READ
SERIOUS SIDE EFFECTS, HOW OFTEN THEY
SERIOUS SIDE EFFECTS, HOW OFTEN THEY
HAPPEN AND WHAT TO DO ABOUT THEM
HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect
Talk with your
Stop taking
Symptom / effect
Talk with your
Stop taking
doctor or
drug and seek
doctor or
drug and seek
pharmacist
immediate
pharmacist
immediate
emergency
emergency
attention
attention
This is not a complete list of side effects. For any unexpected
effects while taking HYTRIN®, contact your doctor or
pharmacist.
characterized by abdominal pain (with or HOW TO STORE IT
vomiting). If you notice
Keep HYTRIN® and all other medicines out of reach of children. swelling or feel pain in
these areas, inform your
HYTRIN® tablets should be stored at 15 to 25°C. doctor immediately. You
should also inform your
Do not take your tablets after the expiry date shown on the label. doctor if you have
unexplained fever, rash
It is important to keep the HYTRIN® in the original package. or itching.
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:
Report on line at:
Call toll-free at 1-866-234-2345
 Complete a Canada Vigilance Reporting Form and:
Fax toll-free to 1-866-678-6789
Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701C
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form
and the adverse reaction reporting guidelines are
available on the MedEffect™ Canada Web site at
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.
HYTRIN® Product Monograph Page 39 of 40 Date of Revision: December 13, 2010 and Control No.138238 MORE INFORMATION

This document plus the full product monograph, prepared for
health professionals can be found at:
or by contacting the sponsor, Abbott Laboratories, Limited, Saint-
Laurent, Qc H4S 1Z1 at: 1-800-699-9948
This leaflet was prepared by Abbott Laboratories, Limited.
Last revised: December 2010
Chronovera®, Cialis®, Levitra® and Viagra® are trademarks of their
respective owners and are not trademarks of Abbott Laboratories,
Limited.
Date of Revision: December 13, 2010 and Control No.138238.

Source: http://www.abbott.ca/static/cms_workspace/en_CA/content/document/HytrinPM-13DEC10-PI.pdf