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warnings and cautions
5 WARNINGS AND PRECAUTIONS 5.1 For topical ocular use only. Not for injection or oral use. 5.2 Contamination of Tip and Solution As with any eye drop, to prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use. 5.3 Contact Lens Use Patients should be advised not to wear a contact lens if their eye is red. Olopatadine hydrochloride ophthalmic solution USP, 0.2% should not be used to treat contact lens related irritation. The preservative in Olopatadine hydrochloride ophthalmic solution USP 0.2%, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red, should be instructed to wait at least ten minutes after instilling olopatadine hydrochloride ophthalmic solution USP, 0.2% before they insert their contact lenses. For topical ocular use only. Not for injection or oral use (5.1).
6 ADVERSE REACTIONS Symptoms similar to cold syndrome and pharyngitis were reported at an incidence of approximately 10%. The following adverse experiences have been reported in 5% or less of patients: Ocular: blurred vision, burning or stinging, conjunctivitis, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, pain and ocular pruritus. Non-ocular: asthenia, back pain, flu syndrome, headache, increased cough, infection, nausea, rhinitis, sinusitis and taste perversion. Some of these events were similar to the underlying disease being studied. Symptoms similar to cold syndrome and pharyngitis were reported at an incidence of approximately 10%. (6) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceutical Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch