Indications and Important Safety Information

XYZAL is indicated for the relief of symptoms associated with allergic rhinitis (seasonal and perennial) and the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.

The use of XYZAL is contraindicated in: patients with a known hypersensitivity to levocetirizine or any of the ingredients of XYZAL or to cetirizine (observed reactions range from urticaria to anaphylaxis); patients with end-stage renal impairment at less than 10 mL/min creatinine clearance or patients undergoing hemodialysis; and pediatric patients aged 6 to 11 years with impaired renal function.

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 XYZAL. Concurrent use of XYZAL with alcohol or other central nervous system (CNS) depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.

In clinical trials, the most common adverse reactions in ≥2% of adult and adolescent patients (12 years of age and older) taking XYZAL 2.5 mg, XYZAL 5 mg, or placebo were somnolence (5%, 6%, 2%), nasopharyngitis (6%, 4%, 3%), fatigue (1%, 4%, 2%), dry mouth (3%, 2%, 1%), and pharyngitis (2%, 1%, 1%), respectively.

In clinical trials, the most common adverse reactions in ≥2% of pediatric patients (6-12 years of age) taking XYZAL 5 mg included pyrexia (4% vs 2% placebo), cough (3% vs <1% placebo), somnolence (3% vs <1% placebo), and epistaxis (2% vs <1% placebo).

XYZAL^® is a trademark of UCB Group of companies.
© 2008 UCB, Inc. and sanofi-aventis U.S. LLC. All rights reserved. X1104-1008