OTTAWA - Health Canada is warning consumers not to use some strengths of the prescription drug Sandoz Timolol Ophthalmic Solution because some bottles may contain more of the active ingredient than indicated on the label, exposing patients to an increased risk of adverse events.
Sandoz Timolol Ophthalmic Solution 0.25 per cent and 0.5 per cent are eye drops taken for treatment of increased intraocular pressure (high fluid pressure inside the eye) and glaucoma. The active ingredient is timolol maleate.
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 Health Canada said in an advisory Friday.
Patients taking either Sandoz Timolol Ophthalmic Solution 0.25 per cent or 0.5 per cent eye drops should discontinue use and consult their health-care practitioner immediately to ensure that treatment of the original condition (intraocular pressure) is not interrupted. Consumers should return the product to their pharmacist for safe disposal.
The manufacturer, Sandoz Canada Inc., is recalling the products. Sandoz will also be notifying doctors and pharmacists of the recall.
Consumers requiring more information about this advisory can contact Health Canada's public inquiries line at (613) 957-2991, or toll-free at 1-866-225-0709.
To date, there have been no cases of adverse reactions linked to the use of this product reported in Canada.
