Source: Health Products Regulatory Authority (ZA) Revision Year: 2024 Publisher: Austell Pharmaceuticals (Pty) Ltd, 1 Sherborne Road, Parktown, Johannesburg, 2193, Tel: +27 11 611 1400 or +27 860 287 835
ZELARY 10 is indicated for the symptomatic relief of allergic conditions such as allergic rhinitis, and allergic skin conditions such as urticaria.
One 10 mg tablet daily.
One 10 mg tablet once daily or 5 mg (half a tablet) twice daily.
No dose adjustment is necessary in healthy elderly patients with normal renal function.
In patients with renal impairment, where the creatinine clearance is less than 40 mL/min, the recommended daily dose of cetirizine should be halved.
In moderate to severe hepatic impairment half the recommended daily dose should be used.
ZELARY 10 is contraindicated in children under the age of two years, as safety and efficacy have not been demonstrated (see section 4.3).
ZELARY 10 is for oral administration.
Drowsiness is an expected symptom of overdosage.
Adverse events reported after an intake of at least 5 times the recommended daily dose is: somnolence, confusion, diarrhoea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, rash, restlessness or agitation, sedation, somnolence, stupor, tachycardia, tremor, and urinary retention.
To date there is no specific antidote.
Cetirizine is not effectively removed by dialysis.
Further treatment is symptomatic and supportive.
36 months.
Store at or below 25°C. Protect from light.
Keep blisters in carton until required for use.
ZELARY 10 tablets are packed in PVC/PVDC Aluminium Blister.
The tablets are packed in blisters of 10’s.
The pack sizes are 1 × 10 and 3 × 10’s in a unit carton.
Not all pack sizes may be marketed.
No special requirements.
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