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CHAMPIX (varenicline tartrate) - Changes to the Canadian Product Monograph - For the Public

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Contact: Marketed Health Products Directorate

The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Pfizer Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.

Public Communication
Health Canada Endorsed Important Safety Information on CHAMPIX
(varenicline tartrate)

June 3, 2010

Subject: Important Safety Information regarding CHAMPIX^® (varenicline tartrate)

Pfizer Canada, in collaboration with Health Canada, is advising consumers of important changes to the CHAMPIX^® Product Monograph and Consumer Information section.

CHAMPIX^® (varenicline tartrate) is a prescription medicine that is used in combination with supportive counselling to help motivated adults quit smoking.

Patients using CHAMPIX^® should stop the treatment and contact their healthcare provider immediately if they experience, or if their families or caregivers observe, signs or symptoms including:

• Changes in mood or behaviour (such as depressed mood, agitation, aggression, hostility, thoughts of self-harm or harm towards others);
• Serious allergic reactions (such as swelling of the face, lips, gums, tongue and throat that can cause trouble breathing) and skin reactions (such as rash, swelling, redness, and peeling of the skin).

Patients should also be aware that:

• Neuropsychiatric side-effects have occurred in patients taking CHAMPIX^® with or without a history of psychiatric disorder;
• Quitting smoking can be associated with changes in mood or behaviour, even without taking medication to help quit;
• Drinking alcohol may increase the risk of experiencing neuropsychiatric side effects; and
• Side-effects such as sleepiness, dizziness, loss of consciousness, seizures, or difficulty concentrating may also occur. Patients should not engage in potentially hazardous activities, such as driving a car or operating dangerous machinery until they know how they may be affected by CHAMPIX^®.

A letter has been posted to healthcare professionals on the Health Canada Web site and can be accessed by means of the link below:

http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/index-eng.php

Managing marketed health product-related adverse reactions depends on healthcare professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious or unexpected adverse reactions in patients receiving CHAMPIX^® should be reported to Pfizer Canada or Health Canada at the following addresses:

Sincerely,

original signed by

Bernard Prigent, MD, MBA
Vice-President and Medical Director
Pfizer Canada Inc.

^® C.P. Pharmaceuticals International C.V.
Pfizer Canada Inc., licensee