Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
CALCIUM CARBONATE COLECALCIFEROL
BellPharma Limited
1.5g/400 International Unit
Tablets Effervescent
2004-12-22
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bellcalcid Calcium Carbonate 1500 mg and Colecalciferol 400 I.U. Effervescent Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each effervescent tablet contains: 1500 mg of calcium carbonate (equivalent to 600 mg or 15 mmol of calcium) and 400 I.U. (10 micrograms) colecalciferol (vitamin D 3 ) as colecalciferol concentrate (powder form). For excipients, see 6.1. 3 PHARMACEUTICAL FORM Effervescent tablet A white, round effervescent tablet, with the odour and flavour of lemon. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Correction of combined vitamin D 3 and calcium deficiencies. Vitamin D 3 and calcium supplementation as an adjunct to specific treatment for osteoporosis in patients, where combined calcium and vitamin D deficiencies have been diagnosed or at high risk of such deficiencies. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults take 1 - 2 effervescent tablets daily (equivalent to 600-1200 mg of calcium and 400-800 I.U. of vitamin D 3 ). For pregnancy and lactation, see paragraph 4.6 ‘Pregnancy and Lactation’. The effervescent tablets should be dissolved in a glass of water (approx. 200ml) and drunk immediately. Oral use - For adults only. 4.3 CONTRAINDICATIONS Hypersensitivity to one of the constituents of the effervescent tablet Hypercalcaemia. Hypercalciuria. Kidney stones. Nephrocalcinosis. Primary hyperparathyroidism. Vitamin D overdose. Myeloma. Bone metastases. Long term immobilisation in combination with hypercalciuria and/or hypercalcaemia. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 11/09/2006_ _CRN 2027708_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE During long-term use, serum and uri Pročitajte cijeli dokument