Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
CALCIUM CARBONATE CHOLECALCIFEROL CONCENTRATE (POWDER FORM)
Shire Pharmaceuticals Limited
1000/20
Tablets Chewable
2009-12-11
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calcichew-D 3 Forte Double Strength 1000 mg / 800 IU Chewable Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains: Calcium carbonate equivalent to 1000 mg calcium. Cholecalciferol concentrate (powder form) equivalent to 800 IU (20 microgram) cholecalciferol (vitamin D 3 ) Excipient(s): Isomalt (E953), 99.9 mg Soya-bean oil, hydrogenated, 0.66 mg Sucrose, 3.3 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet Round, white, uncoated and convex tablets. May have small specks. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention and treatment of vitamin D and calcium deficiency in the elderly. Vitamin D and calcium supplement as an adjunct to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults and elderly_ One chewable tablet once daily. The tablet may be chewed or sucked. _Dosage in hepatic impairment_ No dose adjustment is required _Dosage in renal impairment_ Calcichew-D 3 Forte Double Strength 1000 mg / 800 IU Chewable Tablets should not be used in patients with severe renal impairment. Calcichew-D 3 Forte Double Strength 1000 mg / 800 IU Chewable Tablets are not intended for use in children. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/11/2011_ _CRN 2098233_ _page number: 1_ 4.3 CONTRAINDICATIONS Diseases and/or conditions resulting in hypercalcaemia and/or hypercalcuria Severe renal impairment Nephrolithiasis Hypervitaminosis D Hypersensitivity to soya or peanut Hypersensitivity to the active substances or to any of the excipients 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Dur Прочитајте комплетан документ