Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
CALCIUM CARBONATE, COLECALCIFEROL
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
A12AX
CALCIUM CARBONATE, COLECALCIFEROL
600 mg + 400 IU Base Milligrams
Tablets Effervescent
Product not subject to medical prescription
Calcium, combinations with other drugs
Authorised
2016-07-15
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calcium-D-Sandoz 600 mg + 400 IU, effervescent tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 effervescent tablet contains 1500 mg of calcium carbonate (equivalent to 600 mg or 15 mmol of calcium) 400 I.U. or 10 µg cholecalciferol (vitamin D 3 ) as cholecalciferol concentrate ‘powder form’. Excipient(s): 52 mg of sodium, 1.52 mg of sucrose, 50 mg of lemon flavouring (contains: sorbitol (E 420)), 0.30 mg of partially hydrogenated soybean oil For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Effervescent tablet White-round tablet, smooth and not vaulted. 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 section 4.6 ‘Pregnancy and Lactation’. The effervescent tablets should be dissolved in a glass of water (approx. 200 ml) and drunk immediately. Dosage in hepatic impairment: No dose adjustment is required. Dosage in renal impairment: Calcium-D-Sandoz should not be used in patients with severe renal impairment. Oral use - For adults only. 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substances, soya, peanut or to any of the excipients, • Hypercalcaemia, hypercalciuria, • Nephrocalcinosis, nephrolithiasis • Disease and/or conditions resulting in hypercalcaemia and/or hypercalciuria (e.eg. primary hyperparathyroidis Läs hela dokumentet