Health Canada is warning consumers 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 treatment of increased intraocular pressure (high fluid pressure inside the eye) and glaucoma.
Prescription Drugs
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 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, and Health Canada is continuing to monitor the effectiveness of this recall. A separate communication will be sent by Sandoz to doctors and pharmacists notifying them of the recall.