Indications
The relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis and chronic idiopathic urticaria.
Contraindications
Patients with end-stage renal disease (CLcr < 10 ml/min) and patients undergoing hemodialysis. Pediatric patients 6 to 10 years of age with impaired renal function.
Hypersensitivity to levocetirizine, to any of the excipients, to hydroxyzine or to any piperazine derivatives.
Compositon/Ingredients
Levocetirizine 5mg
Dosage and administration
Adults and children aged 12 years and over: 5 mg once daily.
Children aged 6 to 12 years: 5 mg daily.
Adult patients with renal impairment: CLCr 50 – 79 ml/min: 5 mg once daily;
CLCr 30 – 49 ml/min: 5 mg every 2 days;
CLCr < 30 ml/min: 5 mg every 3 days;
Clcr < 10 ml/min and undergoing dialysis: Not use.
Precaution
The use of Stadeltine not recommended in children aged less than 6 years.
Caution is recommended when use Stadeltine in epileptic patients and patients at risk of convulsions.Concurrent use of with alcohol or other central nervous system depressants levocetirizine should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Stadeltine. Stadeltine should be used during pregnancy only if clearly needed. Use of Stadeltine in nursing mothers is not recommended.
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 Stadeltine.
Patients intending to drive, engage in potentially hazardous activities or operate machinery should take their response to the medicinal product into account.
Storage
Store at temperature below 30°C, protect from light.
