Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
LORATADINE
G & A Licensing Limited
10 Milligram
Tablets
2010-12-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clarityn 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg Loratadine Excipient: Contains lactose monohydrate For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet _Product imported from the UK_ White to off-white, oval tablets with Schering trademark (flask and dish logo), score and '10' on one side, plain on the other side. The scoreline of the tablet is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clarityn Tablets are indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children over 12 years of age: 10mg once daily (one tablet once daily). The tablet may be taken without regard to mealtime. Children 2 to 12 years of age are dosed by weight: Body weight more than 30Kg: 10mg once daily (one tablet once daily). The 10mg tablet is not appropriate in children with a bodyweight less than 30kg. Efficacy and safety of Clarityn 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 Tablets are contraindicated in patients who are hypersensitive to the active substance or to any of the excipients in these formulations. IRISH MEDICINES BOARD ________________________________________________________________________ Belgenin tamamını okuyun