Levocetirizine - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Somnolence: Somnolence, fatigue, and asthenia have been reported with use of levocetirizine dihydrochloride tablets in some patients in clinical trials.

Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking levocetirizine dihydrochloride tablets.

Avoid concurrent use of alcohol or other central nervous system depressants with levocetirizine dihydrochloride tablets.

Urinary Retention: Urinary retention has been reported with use of levocetirizine dihydrochloride tablets.

Use with caution in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia).

Discontinue levocetirizine dihydrochloride tablets if urinary retention occurs.

Risk of New Onset Pruritus After Discontinuation of Levocetirizine dihydrochloride tablets: New onset pruritus within a few days after discontinuation of Levocetirizine dihydrochloride tablets has been reported, usually after long-term use (e.g., few months to years) of Levocetirizine dihydrochloride tablets.

Symptoms may improve with restarting or tapering Levocetirizine dihydrochloride tablets .

5.1 Somnolence In clinical trials the occurrence of somnolence, fatigue, and asthenia has been reported in some patients under therapy with levocetirizine dihydrochloride.

Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness, and motor coordination such as operating machinery or driving a motor vehicle after ingestion of levocetirizine dihydrochloride.

Concurrent use of levocetirizine dihydrochloride 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.

5.2 Urinary Retention Urinary retention has been reported post marketing with levocetirizine dihydrochloride.

Levocetirizine dihydrochloride should be used with caution in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as levocetirizine dihydrochloride may increase the risk of urinary retention.

Discontinue levocetirizine dihydrochloride if urinary retention occurs.

5.3 Risk of New Onset Pruritus After Discontinuation of Levocetirizine Dihydrochloride Tablets Cases of pruritus after discontinuation of levocetirizine dihydrochloride tablets have been reported in the postmarketing setting in patients where pruritus was not present before initiation of levocetirizine dihydrochloride tablets.

Pruritus occurred within a few days of discontinuing levocetirizine dihydrochloride tablets among patients who used levocetirizine dihydrochloride tablets long-term (e.g., few months to years).

Reported cases of pruritus were infrequent, but some were serious with patients experiencing widespread severe pruritus [see Adverse Reactions ] .

If pruritus occurs after discontinuation of levocetirizine dihydrochloride tablets, symptoms may improve with restarting or tapering levocetirizine dihydrochloride tablets.