Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CALCIUM CARBONATE COLECALCIFEROL
Shire Pharmaceuticals Limited
500mg/400I %v/v
Tablets Chewable
1996-10-10
License 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) Colecalcife Read the complete document