Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Alfasigma S.p.A, Via Ragazzi del '99, n. 5, 40133 Bologna (BO), Italy
Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.
Oral administration.
1 mg twice daily with food. In patients susceptible to sedation, a slow increase in dosage is recommended during the first week of treatment, starting with ½ tablet twice daily, and increasing to the full therapeutic dose. If necessary the dose may be increased to 2 mg twice daily. At the higher dose, an accelerated onset of efficacy may be expected.
Children aged 2 to 3 years: For younger children, who cannot swallow tablets or where the required dose cannot be administered using tablets, Zaditen Oral Solution 1mg/5ml is available.
Dosage: 0.05 mg (=0.25 ml Zaditen Oral solution 1mg/5ml) per kilogram body weight twice daily (morning and evening).
Children over 3 years of age and adolescents: 1mg twice daily with food.
No evidence exists that elderly patients require different dosages or show different side effects from younger patients.
Patients known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days.
No studies have been performed in renally impaired patients and hence no dosing recommendations can be provided for these patients (see section 5.2).
No studies have been performed in hepatically impaired patients and hence no dosing recommendations can be provided for these patients (see section 5.2).
The main symptoms of acute overdose include: drowsiness to severe sedation; dizziness, confusion and disorientation; tachycardia and hypotension; especially in children, hyperexcitability or convulsions; reversible coma. Bradycardia and respiratory depression should be watched for.
Treatment should be symptomatic. If the drug has been taken very recently, emptying of the stomach may be considered. Administration of activated charcoal may be beneficial. If necessary, symptomatic treatment and monitoring of the cardiovascular system are recommended; if excitation or convulsions are present, short-acting barbiturates or benzodiazepines may be given. Zaditen cannot be eliminated by dialysis.
4 years.
Do not store above 25ºC.
PVC/PVDC blister pack, containing 7, 14 or 28 or 60 tablets.
Not all pack sizes may be marketed.
No special requirements.
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