País: Suècia
Idioma: suec
Font: Läkemedelsverket (Medical Products Agency)
kalciumkarbonat; kolekalciferol
Orifarm AB
A12AX
calcium carbonate; cholecalciferol
500 mg/400 IE
Tuggtablett
aspartam Hjälpämne; sackaros Hjälpämne; kolekalciferol 10 mikrog Aktiv substans; sorbitol Hjälpämne; isomalt Hjälpämne; kalciumkarbonat 1250 mg Aktiv substans
Apotek
Receptbelagt
kombinationer med vitamin D och/eller övriga läkemedel
Avregistrerad
2013-07-02
SUMMARY OF THE PRODUCT CHARACTERISTICS 1. N AME OF THE M EDICINAL P RODUCT Calcichew-D 3 Spearmint 500 mg/400 IU chewable tablets 2. Q UALITATIVE AND Q UANTITATIVE C OMPOSITION One tablet contains: Calcium carbonate equivalent to 500 mg calcium Cholecalciferol concentrate (powder form) equivalent to 400 IU (10 microgram) cholecalciferol (vitamin D 3 ) Excipients with known effect: One tablet contains 20.5 mg isomalt (E953), 0.8 mg sucrose For a full list of excipients, see section 6.1 3. P HARMACEUTICAL F ORM Chewable tablet Round, white, uncoated and convex tablets of 14 mm. May have small specks. 4. C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention and treatment of vitamin D and calcium deficiency in adults with an identified risk. 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, INCLUDING ELDERLY_ One tablet twice daily. SPECIAL PATIENT POPULATIONS _PAEDIATRIC POPULATION:_ Calcichew-D 3 Spearmint is not intended for use in children. _IMPAIRED RENAL FUNCTION:_ Calcichew-D 3 Spearmint 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 other 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 monitored. Renal function should also be monitored, through measurements of serum creatinine. Monitoring is especially important in elderly patients on concomitant treatment with cardiac glycosides or diuretics (see secti Llegiu el document complet