Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
CALCIUM CARBONATE COLECALCIFEROL
Shire Pharmaceuticals Limited
500mg/400I %v/v
Tablets Chewable
1996-10-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calcichew-D 3 Forte Chewable Tablets, calcium carbonate/colecalciferol equivalent to 500mg Calcium/400 IU colecalciferol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Chewable tablet. Round, white, uncoated and convex tablet. May have small specks. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Calcichew-D 3 Forte Chewable Tablets should only be used as a therapeutic supplement when the diet is deficient. It should not be used as a food supplement. The prophylaxis and treatment of combined vitamin D and calcium deficiency particularly in housebound and institutionalised elderly subjects. The supplementation of vitamin D and calcium as an adjunct to specific therapy for osteoporosis or as a therapeutic supplement in established osteomalacia, pregnant patients at high risk of deficiency or malnutrition when dietary intake is less than that required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral. _Adults and elderly: _2 chewable tablets per day, preferably one tablet morning and evening. The tablet may be chewed or sucked. _Dosage in hepatic impairment:_ No dose adjustment is required. Per tablet: Calcium carbonate 1250 mg (equivalent to 500 mg of elemental calcium) Colecalciferol 400 IU (equivalent to 10 micrograms vitamin D 3 ) Contains sorbitol 390mg; isomalt, 49.90mg; aspartame 1mg and sucrose 0.77mg. For a full list of excipients, see section 6.1. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/05/2011_ _CRN 2094651_ _page number: 1_ _Dosage in renal impairment:_ Calcichew-D 3 Forte chewable tablets should not be used in patients with severe renal impairment. Calcichew-D 3 Forte chewable tablets are not intended for use Les hele dokumentet