CLARITYN RAPIDE ALLERGY
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
28-03-2023
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Active ingredient:
LORATADINE
Available from:
Merck Sharp & Dohme Ireland (Human Health) Limited
Dosage:
10 Milligram
Pharmaceutical form:
Oral Lyophilisate
Authorization date:
2010-11-26
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Clarityn Rapide Allergy 10 mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each oral lyophilisate contains 10 mg loratadine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral lyophilisate
White, round, tablet - shaped unit debossed with 'C10'.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Clarityn Rapide Allergy Tablets are indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic
urticaria.
4.2 Posology and method of administration
Adults and children 12 years of age and over:
10mg once daily (one oral lyophilisate once daily).
The oral lyophilisate may be taken without regard to mealtime.
Children 2 to 12 years of age are dosed by weight:
Bodyweight more than 30kg: 10mg once daily (one oral lyophilisate once daily).
The 10mg strength oral lyophilisate is not appropriate for children with a bodyweight less than 30kg.
Efficacy and safety of Clarityn Rapide Allergy Tablets in children under 2 years of age has not been established.
Patients with severe liver impairment should be administered a lower initial dose because they may have reduced
clearance of loratadine. An initia
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