OTTAWA, Ontario -- July 18, 2008 -- Health Canada is warning patients not to use the prescription drug Sandoz Timolol Ophthalmic Solution in 0.25% and 0.5% strengths because some bottles may contain more of the active ingredient (timolol maleate) than indicated on the label, exposing patients to an increased risk of adverse events.
Sandoz Timolol Ophthalmic Solution 0.25% and 0.5% are eye drops taken for the treatment of increased intraocular pressure and glaucoma.
Potential adverse events may include red eye, eye irritation, inflammation of the eyelids and/or cornea, drooping of the upper eyelid, double vision, dizziness, headache, abnormally slow heartbeat, abnormally low blood pressure, shortness of breath, difficulty breathing, and cardiac failure.
Patients taking either Sandoz Timolol Ophthalmic Solution 0.25% or 0.5% eye drops should discontinue use and consult their healthcare practitioner immediately to ensure that treatment of intraocular pressure is not interrupted. Patients should return the product to their pharmacist for safe disposal.
The manufacturer, Sandoz Canada Inc., is recalling the products, and Health Canada is continuing to monitor the effectiveness of this recall.
Patients requiring more information about this advisory can contact Health Canada's public enquiries line at 613-957-2991 or toll free at 1-866-225-0709.
To date, no cases of adverse reactions linked to the use of this product have been reported in Canada. To report a suspected adverse reaction to this product, please contact the Canada Vigilance Program of Health Canada by one of the following methods:
Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789
Canada Vigilance Program
Mail: Marketed Health Products Directorate
Ottawa, Ontario, AL 0701C
K1A 0K9
E-mail: CanadaVigilance@hc-sc.gc.ca
SOURCE: Health Canada
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