Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE
Xyzal 0.5 mg/ml oral solution is indicated for symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and urticaria in adults and children aged 2 years and above.
Adults and adolescents 12 years and above:
The daily recommended dose is 5 mg (10 ml of solution).
Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Renal impairment below).
The dosing intervals must be individualised according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in ml/min is needed. The CLcr (ml/min) may be estimated from serum creatinine (mg/dl) determination using the following formula:
CLcr = [140 – age (years)] x weight (kg) / 72 x serum creatinine (mg/dl) (x 0.85 for women)
Dosing adjustments for patients with impaired renal function:
| Group | Creatinine clearance (ml/min) | Dosage and frequency |
|---|---|---|
| Normal | ≥80 | 5 mg once daily |
| Mild | 50–79 | 5 mg once daily |
| Moderate | 30–49 | 5 mg once every 2 days |
| Severe | <30 | 5 mg once every 3 days |
| End-stage renal disease – Patients undergoing dialysis | <10 | Contra-indicated |
In paediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient and his body weight. There are no specific data for children with renal impairment.
No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment and renal impairment, adjustment of the dose is recommended (see Renal impairment above).
Children aged 6 to 12 years: The daily recommended dose is 5 mg (10 ml of solution).
Children aged 2 to 6 years: The daily recommended dose is 2.5 mg to be administered in 2 intakes of 1.25 mg (2.5 ml of solution twice daily).
Even if some clinical data are available in children aged 6 months to 12 years (see section 4.8, 5.1 and 5.2), these data are not sufficient to support the administration of levocetirizine to infants and toddlers aged less than 2 years (see also section 4.4).
An oral syringe is included in the package. The appropriate volume of oral solution should be measured with the oral syringe, and poured in a spoon or in a glass of water. The oral solution must be taken orally immediately after dilution, and may be taken with or without food.
Intermittent allergic rhinitis (symptoms experienced for less than four days a week or for less than four weeks a year) has to be treated according to the disease and its history; it can be stopped once the symptoms have disappeared and can be restarted again when symptoms reappear. In case of persistent allergic rhinitis (symptoms experienced for more than four days a week or for more than four weeks a year), continuous therapy can be proposed to the patient during the period of exposure to allergens.
There is clinical experience with the use of levocetirizine for treatment periods of at least 6 months. In chronic urticaria and chronic allergic rhinitis, there is clinical experience of use of cetirizine (racemate) for up to one year.
Symptoms of overdose may include drowsiness in adults. In children, agitation and restlessness may initially occur, followed by drowsiness.
There is no known specific antidote to levocetirizine.
Should overdose occur, symptomatic or supportive treatment is recommended. Gastric lavage may be considered shortly after ingestion of the drug. Levocetirizine is not effectively removed by haemodialysis.
Shelf life: 2 years.
After first opening: 3 months.
This medicinal product does not require any special storage conditions.
Type III amber glass bottle closed with a white polypropylene child-resistant closure in a cardboard box also containing a 10 ml oral syringe graduated at 0.25 ml (polyethylene, polystyrene).
Pack sizes: 75 ml, 150 ml and 200 ml.
Not all pack sizes may be marketed.
No special requirements.
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