Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
LORATADINE
Merck Sharp & Dohme Ireland (Human Health) Limited
10 Milligram
Oral Lyophilisate
2010-11-26
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 initial dose of 10mg every other day is recommended for adults and children weighing more than 30kg. No dosage adjustments are required in the elderly or in patients with renal insufficiency. 4.3 CONTRAINDICATIONS Clarityn Rapide Allergy Tablets are contraindicated in patients who are hypersensitive to the active substance or to any of the excipients in these formulations. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/04/2011_ _CRN 2080079_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS Прочитать полный документ