Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM)
Takeda UK Limited
A12AX
CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM)
500/10
Film Coated Tablet
Product not subject to medical prescription
Calcium, combinations with other drugs
Authorised
2014-01-06
1 PACKAGE LEAFLET: INFORMATION FOR THE USER Calcichew-D 3 Forte 500 mg/400 IU film-coated tablets calcium / colecalciferol (vitamin D 3 ) 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. WHAT IS IN THIS LEAFLET: 1. What Calcichew-D 3 Forte film-coated tablets are and what they are used for 2. What you need to know before you take Calcichew-D 3 Forte film-coated tablets 3. How to take Calcichew-D 3 Forte film-coated tablets 4. Possible side effects 5. How to store Calcichew-D 3 Forte film-coated tablets 6. Contents of the pack and other information 1. WHAT CALCICHEW-D 3 FORTE FILM-COATED TABLETS IS AND WHAT IT IS USED FOR Calcichew-D 3 Forte film-coated tablets are film-coated tablets containing calcium and vitamin D3, which both are important substances in bone formation. Calcichew-D 3 Forte film-coated tablets are 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 FORTE FILM-COATED TABLETS DO NOT TAKE CALCICHEW-D 3 FORTE FILM-COATED TABLETS: - if you have excessive amounts of calcium in the blood or in the urine. - if you have severe kidney problems - if you have kidney stones. - if you have excessive amounts of vitamin D in the blood. - if you are allergic to calc Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calcichew-D 3 Forte 500 mg / 400 IU Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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: Sorbitol (E420), 154 mg Sucrose, 0.7 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Oval, white/off white, film-coated tablets. May have hardly visible grey spots. 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 POSOLOGY _ADULTS AND ELDERLY_ One tablet twice daily. SPECIAL PATIENT POPULATIONS _PAEDIATRIC POPULATION:_ Calcichew-D3 Forte 500mg/400 IU Film-coated tablets is not intended for use in children. _IMPAIRED RENAL FUNCTION:_ Calcichew-D3 Forte 500mg/400 IU Film-coated 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 tablet should be swallowed or chewed. 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_ _0_ _/_ _0_ _1_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _ Belgenin tamamını okuyun