Source: Marketing Authorisation Holder Revision Year: 2022 Publisher: Oethmaan Biosims (Ply) Ltd, 14 Komatie Road, Emmarentia, Johannesburg, 2195
Allergic processes responding to a histamine H1 receptor antagonist.
Adults or children 12 years of age or older: One 10 mg tablet daily.
Children 6 to 12 years old: 10 mg (one tablet) once daily or 5 mg (half a tablet) twice daily.
At present there are no data to suggest that the dose needs to be reduced in elderly patients with normal renal function.
In patients with renal insufficiency (creatinine clearance less than 40 ml/min), the dosage should be reduced to half the recommended dose.
Half the recommended daily dose should be used in patients with moderate to severe hepatic impairment.
Drowsiness can be a symptom of overdosage. Overdosage in children may produce agitation, somnolence, pruritus, rash, urinary retention, fatigue, tremor and tachycardia. In the case of massive overdosage, gastric lavage should be performed together with the usual supportive measures. To date there is no specific antidote. Cetirizine is not effectively removed by dialysis. Further treatment is symptomatic and supportive.
Store at or below 25°C in original package.
Keep tablets in a dry place. Protect from light.
Keep out of reach of children.
Packaged in transparent PVC film and aluminium foil blister strips of 10 tablets. Strips are packed per unit carton to market as 10’s or 30’s.
Not all pack sizes are marketed at any one time.
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