Xyzal Special Precautions

Alcohol: Precaution is recommended with concurrent intake of alcohol (see Interactions).
Risk of urinary retention: Caution should be taken in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as levocetirizine may increase the risk of urinary retention.
Risk of seizure aggravation: Caution should be taken in patients with epilepsy and patients at risk of convulsion as levocetirizine may cause seizure aggravation.
Allergy skin tests: Response to allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.
Withdrawal syndrome: Pruritus may occur when levocetirizine is stopped even if those symptoms were not present before treatment initiation (see Adverse Reactions). The symptoms may resolve spontaneously. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.
Excipients: Lactose: Levocetirizine dihydrochloride, 5 mg, film-coated tablet: This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Methyl parahydroxybenzoate, propyl parahydroxybenzoate: Levocetirizine dihydrochloride, 5 mg/mL, oral drops, solution; Levocetirizine dihydrochloride, 500 mcg/mL, oral solution: The presence of methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed) (see Contraindications).
Maltitol: Levocetirizine dihydrochloride, 500 mcg/mL, oral solution: This medicinal product contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Ability to perform tasks that require judgement, motor or cognitive skills: Comparative clinical trials have revealed no evidence that levocetirizine at the recommended dose impairs mental alertness, reactivity or the ability to drive and use machines.
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 their response to the medicinal product into account.
Use in children: Infants and children under 2 years: Even if some clinical data are available in children aged 6 months to 12 years (see Adverse Reactions), these data are not sufficient to support the administration of levocetirizine to infants and toddlers aged less than 2 years. Therefore the administration of levocetirizine to infants and toddlers aged less than 2 years is not recommended.
Film-coated tablets: Children aged less than 6 years: The use of the film-coated tablet formulation is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation. It is recommended to use a paediatric formulation of levocetirizine.