国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
CALCIUM CARBONATE, COLECALCIFEROL
Meda AB
A12AX
CALCIUM CARBONATE, COLECALCIFEROL
500mg/800 International Unit
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Calcium, combinations with other drugs
Authorised
2012-05-11
mock ups (replace 689139) Pia Salonen Bookletetikett Kalcipos-D forte 60 tablets - 44x120 mm 2017-05-16 Pharma code Prepared by Country Ireland Project Number Product Date Size/Template Black EAN code Art Works team Solna, Sweden Braille PMS186 PMS307 60 FILM-COATED TABLETS 60 FILM-COATED TABLETS Norway: Kalcipos-Vitamin D 500 mg/800 IE filmdrasjerte tabletter Portugal: Recifor 500mg/800UI comprimido revestido Slovakia: Kombi-Kalz 500 mg/800 IU filmom obalené tablety Spain: KALCIPOS-D 500 MG/800 IU COMPRIMI- DOS RECUBIERTOS Sweden: Recikalc-D forte, 500 mg/800 IE filmdragerad tablett THIS LEAFLET WAS LAST REVISED IN NOVEMBER 2016 PACKAGE LEAFLET: INFORMATION FOR THE USER KALCIPOS-D FORTE 500 MG/800 IU FILM-COATED TABLETS Calcium/cholecalciferol (Vitamin D 3 ) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. Iceland: Kalcipos-D forte 500 mg/ 800 a.e. filmuhúðuð tafla Ireland, United Kingdom: Kalcipos-D Forte 500mg/800IU film coated tablets Italy: Calciduran 500 mg + 800 UI compresse rivestite con film Latvia: Kalcipos-D forte 500 mg/ 800 SV apvalkotās tabletes Lithuania: Kalcipos-D forte 500 mg/800 TV plėvele dengtos tabletės Netherlands: Kalcipos-D 500 mg/800 IE filmomhulde tablet THIS MEDICINAL PRODUCT IS AUTHORISED IN THE MEMBER STATES OF THE EEA UNDER THE FOLLOWING NAMES: Austria: Calciduran Vit D3 500mg/800IU - Filmtabletten Begium, Luxembourg: Maxical 500 mg/800 IU comprimés pelliculés Denmark, Poland: Kalcipos-D Finland: Kalcipos-D forte 500 mg/800 IU kalvopäällysteinen tabletti Germany: Calcipot, 500 mg/800 I.E., Filmtablette Greece: Kalcipos-D forte - If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Kalcipos-D forte 500mg/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 a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (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. Kalcipos-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 Kalcipos-D forte is less than the usually recommended daily intake. Kalcipos-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_ Kalcipos-D should not be used in patients with severe renal impairment (see section 4.3). _Paediatric population_ There is no relevant use of Kalcipos-D forte film-coated tablets in children or adolescents. Method of administration Tablets shall be swallowed with water, whole, crushed or divided. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ 阅读完整的文件