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PRODUCT MONOGRAPH

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HOW TO STORE IT<br />

Keep out of the reach and sight of children.<br />

Store between 15 and 30°C. Protect from light and moisture. Do<br />

not refrigerate. Keep the blister in the outer carton. Do not keep<br />

outdated medicine or medicine no longer needed. Be sure that any<br />

discarded medicine is out of the reach of children.<br />

REPORTING SUSPECTED SIDE EFFECTS<br />

You can report any suspected adverse reactions associated with the<br />

use of health products to the Canada Vigilance Program by one of the<br />

following 3 ways:<br />

Report online at www.healthcanada.gc.ca/medeffect<br />

Call toll-free at 1-866-234-2345<br />

Complete a Canada Vigilance Reporting Form and:<br />

– Fax toll-free to 1-866-678-6789, or<br />

– Mail to: Canada Vigilance Program<br />

Health Canada<br />

Postal Locator 0701E<br />

Ottawa, ON<br />

K1A 0K9<br />

Postage paid labels, Canada Vigilance Reporting Form and the<br />

adverse reaction reporting guidelines are available on the MedEffect <br />

Canada Web site at www.healthcanada.gc.ca/medeffect.<br />

NOTE: Should you require information related to the management of<br />

side effects, contact your health professional. The Canada Vigilance<br />

Program does not provide medical advice.<br />

IMPORTANT: PLEASE READ<br />

MORE INFORMATION<br />

Also, you can report any suspected adverse reactions associated<br />

with the use of health products to Merck Canada Inc. by one of<br />

the following 2 ways:<br />

• Call toll-free at 1-800-567-2594<br />

• Complete a Canada Vigilance Reporting Form and:<br />

– Fax toll-free to 1-800-369-3090, or<br />

– Mail to: Merck Canada Inc.<br />

Pharmacovigilance<br />

P.O. Box 1005<br />

Pointe-Claire−Dorval, QC H9R 4P8<br />

This document plus the full product monograph, prepared for<br />

health professionals can be found at: http://www.merck.ca or by<br />

contacting the sponsor, Merck Canada Inc. at: 1-800-567-2594.<br />

This leaflet was prepared by Merck Canada Inc.<br />

Last revised: November 15, 2011<br />

® Registered trademark of N.V. Organon. Used under license.<br />

© 2011 Merck Canada Inc., a subsidiary of Merck & Co., Inc. All rights<br />

reserved.<br />

ANDRIOL ® (testosterone undecanoate capsules) Page 26 of 26

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