国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
CALCIUM CARBONATE, COLECALCIFEROL
Takeda UK Limited
A12AX
CALCIUM CARBONATE, COLECALCIFEROL
500mg/400IU mg/IU
Tablets Chewable
Product not subject to medical prescription
Calcium, combinations with other drugs
Transfer Pending
2014-01-06
PATIENT INFORMATION LEAFLET CALCICHEW*-D 3 FORTE 500 MG/400 IU CHEWABLE TABLETS calcium/colecalciferol READ ALL OF THIS LEAFLET CAREFULLY 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. - You must talk to a doctor if you do not feel better or if you feel worse after two weeks. - 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. IN THIS LEAFLET: 1. What Calcichew-D 3 Forte is and what it is used for 2. What you need to know before you take Calcichew-D 3 Forte 3. How to take Calcichew-D 3 Forte 4. Possible side effects 5. How to store Calcichew-D 3 Forte 6. Contents of the pack and other information 1. WHAT CALCICHEW- D 3 FORTE IS AND WHAT IT IS USED FOR Calcichew-D 3 Forte Chewable Tablets are lemon flavoured chewable tablets containing calcium and vitamin D 3 which are both important substances in bone formation. Both are found in the diet and vitamin D is also produced in the skin after exposure to the sun. Calcichew-D 3 Forte is used to treat and prevent vitamin D/calcium deficiency, which may occur when your diet or lifestyle does not provide enough, or when body requirements are increased. This medicine may also be prescribed or recommended for certain bone conditions, for example osteoporosis, or during pregnancy. 2. BEFORE YOU TAKE CALCICHEW- D 3 FORTE DO NOT TAKE CALCICHEW- D 3 FORTE CHEWABLE TABLETS IF YOU: are allergic to calcium, vitamin D, or any of the other ingredients of this medicine (listed in section 6) have severe kidney problems have a condition that causes excessive amounts of calcium in your blood or urine (hypercalcaemia or hypercalciuria) e.g. o renal (kidney failure) o cancer that has affected your bones have excessive amounts of vitamin D in your blood 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calcichew-D 3 Forte 500 mg/400 IU Chewable Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Excipients with known effect: isomalt (E953) 49.90 mg and sucrose 0.77 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet. Round, white, uncoated and convex tablet. May have small specks. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Calcichew-D 3 Forte Chewable Tablets should only be used as a therapeutic supplement when the diet is deficient. It should not be used as a food supplement. The prophylaxis and treatment of combined vitamin D and calcium deficiency particularly in housebound and institutionalised elderly subjects. The supplementation of vitamin D and calcium as an adjunct to specific therapy for osteoporosis or as a therapeutic supplement in established osteomalacia, pregnant patients at high risk of deficiency or malnutrition when dietary intake is less than that required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _ADULTS AND ELDERLY_ One tablet twice daily. SPECIAL PATIENT POPULATIONS _PAEDIATRIC POPULATION:_ Calcichew-D 3 Forte Chewable Tablets are not intended for use in children. Per tablet: Calcium carbonate 1250 mg (equivalent to 500 mg of elemental calcium) Colecalciferol 400 IU (equivalent to 10 micrograms vitamin D 3 ) 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _9_ _/_ _0_ _8_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _9_ _6_ _4_ _4_ _1 阅读完整的文件