Land: Sverige
Språk: svenska
Källa: Läkemedelsverket (Medical Products Agency)
kalciumkarbonat; kolekalciferol
2care4 ApS
A12AX
calcium carbonate; cholecalciferol
500 mg/800 IE
Filmdragerad tablett
kolekalciferol 20 mikrog Aktiv substans; sackaros Hjälpämne; kalciumkarbonat 1261 mg Aktiv substans
Apotek
Receptbelagt
kombinationer med vitamin D och/eller övriga läkemedel
Avregistrerad
2015-02-03
SUMMARY OF THE PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Recikalc-D forte 500 mg/ 800 IU film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains calcium carbonate equivalent to 500 mg calcium, cholecalciferol (Vitamin D 3 ) 800 IU (20 microgram). Excipients with known effect: sucrose 1.8 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, oval, engraved R150, 8.5 x 19 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention and treatment of calcium and vitamin D deficiency in the elderly. Vitamin D and calcium supplement in addition to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency. Recikalc-D forte film-coated tablets is indicated in adults aged 18 years and over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and older people_ One film-coated tablet (500 mg/800 IU) daily. The amount of calcium in Recikalc-D forte is less than the usually recommended daily intake. Recikalc-D forte is therefore primarily to be used by patients with need of D-vitamin substitution but with a dietary intake of calcium of 500 mg-1000 mg per day. The patients dietary intake of calcium should be estimated by the prescriber. _Patients with hepatic impairment_ No dose adjustment is required _Patients with renal impairment_ Recikalc-D forte should not be used in patients with severe renal impairment (see section 4.3). _Paediatric population_ There is no relevant use of Recikalc-D forte film-coated tablets in children or adolescents. Method of administration Tablets shall be swallowed with water, whole, crushed or divided. 4.3 CONTRAINDICATIONS Hypercalciuria and hypercalcaemia and diseases and/or conditions, which lead to hypercalcaemia and/or hypercalciuria (e.g. myeloma, bone metastases, primary hyperparathyroidism). Nephrolithiasis. Nephrocalcinosis Hypervitaminosis D. Severe renal impairment and renal failure. Hypersensitivity to the active Läs hela dokumentet