FDA label 9a253c36-0ce2-4e6b-8683-c17379c85e83

5 WARNINGS AND PRECAUTIONS • Epistaxis, nasal ulceration, and nasal septal perforation. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Discontinue if ulcerations or perforations occur. Avoid use in patients with nasal disease other than allergic rhinitis (5.1) . • Avoid engaging in hazardous occupations requiring complete mental alertness and coordination such as driving or operating machinery when taking Olopatadine Hydrochloride Nasal Spray (5.2) . • Avoid concurrent use of alcohol or other central nervous system depressants with Olopatadine Hydrochloride Nasal Spray (5.2) . 5.1 Local Nasal Effects Epistaxis and Nasal Ulceration : In placebo (vehicle nasal spray)-controlled clinical trials of 2 weeks to 12 months duration, epistaxis and nasal ulcerations were reported [see Adverse Reactions (6) ]. Nasal Septal Perforation : Three placebo (vehicle nasal spray)-controlled long term (12 months) safety trials were conducted. In the first safety trial, patients were treated with an investigational formulation of Olopatadine Hydrochloride Nasal Spray containing povidone (not the commercially marketed formulation) or a vehicle nasal spray containing povidone. Nasal septal perforations were reported in one patient treated with the investigational formulation of Olopatadine Hydrochloride Nasal Spray and 2 patients treated with the vehicle nasal spray. In the second safety trial with Olopatadine Hydrochloride Nasal Spray, which does not contain povidone, there were no reports of nasal septal perforation. In the third safety trial, one patient exposed to the 3.7 pH vehicle nasal spray (containing no povidone) reported a nasal septal perforation [see Adverse Reactions (6)] . Before starting Olopatadine Hydrochloride Nasal Spray, conduct a nasal examination to ensure that patients are free of nasal disease other than allergic rhinitis. Perform nasal examinations periodically for signs of adverse effects on the nasal mucosa and consider stopping Olopatadine Hydrochloride Nasal Spray if patients develop nasal ulcerations. 5.2 Activities Requiring Mental Alertness In clinical trials, the occurrence of somnolence has been reported in some patients taking Olopatadine Hydrochloride Nasal Spray [see Adverse Reactions (6) ]. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery after administration of Olopatadine Hydrochloride Nasal Spray. Concurrent use of Olopatadine Hydrochloride Nasal Spray with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur.

6 ADVERSE REACTIONS The most clinically significant adverse reactions described in other sections of labeling include; Epistaxis, Nasal Ulceration, and Nasal Septal Perforation [ see Warnings and Precautions (5.1) ] Somnolence [ see Warnings and Precautions (5.2) ] The most common (>1%) adverse reactions included bitter taste, headache, epistaxis, pharyngolaryngeal pain, post-nasal drip, cough, and urinary tract infection in patients 12 years of age and older and epistaxis, headache, upper respiratory tract infection, bitter taste, pyrexia, and rash in patients 6 to 11 years of age (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact Sandoz, Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.