CETIRIZINE AUROBINDO
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
21-03-2023
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Active ingredient:
CETIRIZINE DIHYDROCHLORIDE
Available from:
Aurobindo Pharma (Malta) Limited
Dosage:
10 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2009-07-03
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Cetirizine Aurobindo 10mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg cetirizine dihydrochloride.
Excipient: 155.2 mg lactose monohydrate/ film-coated tablet
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, film-coated, off-rectangular tablets, debossed with ‘X’ on one side with ‘20’ on the other side.
Score line between ‘2’ and ‘0’.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
In adults and paediatric patients 6 years and above:
•
Cetirizine is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
•
Cetirizine is indicated for the relief of symptoms of chronic idiopathic urticaria.
4.2 Posology and method of administration
Oral use.
Children aged from 6 to 12 years: 5mg twice daily (a half tablet twice daily).
Adults and adolescents over 12 years of age: 10mg once daily (1 tablet).
The tablets need to be swallowed with a glass of liquid.
Elderly subjects: data do not suggest that the dose needs to be reduce
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