Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
calcium (calcium carbonate), colecalciferol
Takeda AS
առկա չէ (A12AX)
calcium (calcium carbonate), colecalciferol
500mg+ 5mcg(200IU)
tablets chewable with orange flavour
(20), (50), (100) in plastic container
OTC
Registered
2018-03-12
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Calcium D3 Nycomed 500 mg/200 IU chewable tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains: Calcium carbonate equivalent to 500 mg calcium Cholecalciferol concentrate (powder form) equivalent to 200 IU (5 microgram) cholecalciferol (vitamin D3) Excipients: Isomalt (E953) Sucrose For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Chewable tablets with orange flavour. Round, white and convex tablets. May have small specks. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention and treatment of vitamin D and calcium deficiency. 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 POSOLOGY _ _ _ADULTS AND ELDERLY _ _Adjunctive therapy in osteoporosis _ One tablet 2-3 times per day _Calcium and vitamin D deficiency _ One tablet 1-3 times per day _PAEDIATRIC POPULATION _ _Calcium and vitamin D deficiency (only) _ One tablet 1-2 times per day. _IMPAIRED RENAL FUNCTION _ Calcium D3 Nycomed tablets should not be used in patients with severe renal impairment (see section 4.3). _ _ _IMPAIRED HEPATIC FUNCTION _ No dose adjustment is required. METHOD OF ADMINISTRATION Oral. The tablets should be chewed or sucked. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 Severe renal impairment (glomerular filtration rate < 30 ml/min/1.73m 2 ) Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria Renal calculi (nephrolithiasis) Hypervitaminosis D 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE During long-term treatment, serum calcium levels should be followed and renal function should be monitored through measurement of serum creatinine. Monitoring is especially important in elderly patients on concomitant treatment with cardiac glycosides or diuretics (see section 4.5) and in patie Read the complete document