Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CALCIUM CARBONATE
Shire Pharmaceuticals Limited
500 Milligram
Tablets Chewable
1993-12-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calcichew 500mg Chewable Tablets calcium carbonate equivalent to 500mg Calcium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Per tablet: Calcium carbonate 1250 mg equivalent to 500 mg of elemental calcium. Also contains 390mg Sorbitol (E420), 62mg Isomalt (E953) and 1mg Aspartame (E951) For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Chewable Tablet. Round, white, uncoated and convex tablet. May have small specks. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS To correct calcium deficiency states and maintain appropriate balance in such disorders as osteoporosis, osteomalacia, rickets, tetany, malabsorption states and in pregnancy and lactation. As a phosphate binding agent in the management of renal failure in patients on renal dialysis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral The tablets should be taken just before, during or just after each meal. The tablets should be chewed or sucked. _Dosage in hepatic impairment:_ No dose adjustment is required. _Dosage in renal impairment:_ In patients with severe renal failure having a creatinine clearance of less than 25 ml/minute, dosage adjustments may be necessary dependent on serum calcium levels. See section 4.4 _Adults and elderly:_ Adjunct to osteoporosis therapy: 2 to 3 tablets daily. Dietary deficiency: 2 to 3 tablets daily. Osteomalacia: 2 to 6 tablets daily. _Children:_ Dietary deficiency: 2 to 3 tablets daily _Phosphate Binder:_ Adults, children and elderly: Dose as required by the individual patient depending on serum phosphate level. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 27/10/2010_ _CRN 2080008_ _page number: 1_ 4.3 CONTRAINDICATIONS Severe hyper Read the complete document