Country: Svíþjóð
Tungumál: sænska
Heimild: Läkemedelsverket (Medical Products Agency)
kalciumkarbonat; kolekalciferol
Orifarm Healthcare A/S
A12AX
calcium carbonate; cholecalciferol
1000 mg/800 IE
Tuggtablett
kalciumkarbonat 2500 mg Aktiv substans; sackaros Hjälpämne; kolekalciferol 20 mikrog Aktiv substans; xylitol Hjälpämne; isomalt Hjälpämne
Apotek
Receptbelagt
kombinationer med vitamin D och/eller övriga läkemedel
Förpacknings: Burk, 15 tabletter; Burk, 30 tabletter; Burk, 40 tabletter; Burk, 60 tabletter; Burk, 90 tabletter; Blister, 7 tabletter; Blister, 14 tabletter; Blister, 28 tabletter; Blister, 56 tabletter; Blister, 84 tabletter; Blister, 112 tabletter; Blister, 140 tabletter; Blister, 168 tabletter; Blister, 50 x 1 tabletter (endos)
Godkänd
2008-10-24
1 PACKAGE LEAFLET: INFORMATION FOR THE USER Calcichew-D 3 Citron 1000 mg/800 IU chewable tablets calcium/cholecalciferol (vitamin D 3 ) For medicinal products available only on prescription: READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. For medicinal products available without prescription: READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. <[To be completed nationally]> WHAT IS IN THIS LEAFLET 1. What Calcichew-D 3 Citron is and what it is used for 2. What you need to know before you take Calcichew-D 3 Citron 3. How to take Calcichew-D 3 Citron 4. Possible side effects 5. How to store Calcichew-D 3 Citron 6. Contents of the pack and other information 1. WHAT CALCICHEW-D 3 CITRON IS AND WHAT IT IS USED FOR Calcichew-D 3 Citron are chewable tablets containing calcium and vitamin D 3 , which both are important substances in bone formation. Calcichew-D 3 Citron is used in the prevention and treatment of calcium and vitamin D deficiency in the elderly, and as a supplement to specific treatment of osteoporosis. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCICHEW-D 3 CITRON DO NOT TAKE CALCICHE Lestu allt skjalið
1 Produktinformationen för Calcichew-D3 Citron, 1000 mg/800 IE tuggtablett, MTnr 26065, gäller vid det tillfälle då läkemedlet godkändes. Informationen kommer inte att uppdateras eftersom läkemedlet inte marknadsförs i Sverige. Av samma anledning finns inte någon svensk produktinformation. Den engelska produktinformationen kommer dock att uppdateras för de produkter där Sverige är referensland. Om läkemedelsnamnet i följande produktinformation inte stämmer med namnet på dokumentet, beror det på att läkemedlet i Sverige är godkänt under ett annat namn. 2 1. NAME OF THE MEDICINAL PRODUCT Calcichew-D 3 Citron 1000 mg/800 IU chewable tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains: Calcium carbonate equivalent to 1000 mg calcium. Cholecalciferol concentrate (powder form) equivalent to 800 IU (20 microgram) cholecalciferol (vitamin D 3 ) Excipient(s): Isomalt (E953), 99.9 mg Soya-bean oil, hydrogenated, 0.66 mg Sucrose, 3.3 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablet Round, white, uncoated and convex tablets. May have small specks. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention and treatment of vitamin D and calcium deficiency in the elderly. 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 _Adults and elderly_ One chewable tablet once daily. The tablet may be chewed or sucked. _Dosage in hepatic impairment_ No dose adjustment is required _Dosage in renal impairment_ Calcichew-D 3 Citron should not be used in patients with severe renal impairment. Calcichew-D 3 Citron tablets are not intended for use in children. 3 4.3 CONTRAINDICATIONS Diseases and/or conditions resulting in hypercalcaemia and/or hypercalcuria Severe renal impairment Nephrolithiasis Hypervitaminosis D Hypersensitivity to soya or peanut Hypersensitivity to the active substances or to any of the excipients 4.4 Lestu allt skjalið