Stadeltine

OTC

Indications

• The relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis and chronic idiopathic urticaria.

Dosage

• 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.

Usage

• Stadeltine is orally administered, taken with or without food.

• 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 ingredients, to hydroxyzine or to any piperazine derivatives.

Common

• Somnolence;
• Dizziness, headache;
• Paryngitis, rhinitis in children;
• Abdominal pain, dry mouth, nausea;
• Fatigue.

Uncommon

• Agitation;
• Paraesthesia;
• Diarrhoea;
• Pruritus, rash;
• Asthenia, malaise.

• 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.