Xyzal Special Precautions

Alcohol: Precaution is recommended with intake of alcohol (see Interactions).
Risk of Urinary Retention: Caution should be taken in patients with predisposing factors of urinary retention (eg, spinal cord lesion, prostatic hyperplasia) as levocetirizine may increase the risk of urinary retention.
Lactose: Xyzal contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Xyzal film-coated tablet.
Oral Solution/Drops: Methyl and Propyl Parahydroxybenzoate: The presence of methyl and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed) (see Contraindications).
Oral Solution: Maltitol: Xyzal contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take Xyzal oral solution.
Effects on the Ability to Drive or Operate Machinery: Comparative clinical trials have revealed no evidence that levocetirizine at the recommended dose impairs mental alertness, reactivity or the ability to drive.
Nevertheless, some patients could experience somnolence, fatigue and asthenia under therapy with levocetirizine. Therefore, patients intending to drive, engage in potentially hazardous activities or operate machinery should take into account their response to Xyzal.
Impairment of Fertility: There are no relevant data available.
Use in Children: Even if some clinical data are available in children 6 months to 12 years (see Pharmacology: Pharmacodynamics under Actions and Adverse Reactions), these data are not sufficient to support the administration of levocetirizine to infants and toddlers <2 years. Therefore, the administration of levocetirizine to infants and toddlers <2 years is not recommended.
Film-Coated Tablets: The use of the film-coated tablet is not recommended in children <6 years since this formulation does not allow for appropriate dose adaptation. It is recommended to use a pediatric formulation of levocetirizine.
Use in Pregnancy: Caution should be exercised when prescribing to pregnant women.
For levocetirizine, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.
Use in Lactation: Caution should be exercised when prescribing to lactating women. Cetirizine is excreted in human milk.