Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Cholecalciferol; Calcium carbonate
Imbat Limited
A12AX
Cholecalciferol; Calcium carbonate
500mg/400IU mg/IU
Chewable tablet
Product not subject to medical prescription
Calcium, combinations with vitamin D and/or other drugs
Authorised
2012-09-28
Base Label - 175mm Height - 60mm Front Cover - 115mm Page 20 - 95mm Height - 60mm Doncaster Pharmaceuticals 20pp Kleerformat 02/02/2012 60x175mm 60x115mm(folded) RNC Page 17 - 95mm Page 4 - 95mm Height - 60mm Page 19 Page 2 Page 3 Page 18 Page 5 - 95mm Page 16 - 95mm Height - 60mm Page 15 Page 6 Page 13 - 95mm Page 8 - 95mm Height - 60mm Page 7 Page 14 Page 9 - 95mm Page 12 - 95mm Height - 60mm Page 11 Page 10 Each tablet contains 1250mg calcium carbonate (equivalent to 500mg calcium) and 400IU colecalciferol (equivalent to 10 micrograms vitamin D3) Also contains sorbitol (E420), isomalt (E953), sucrose and aspartame (E951) Please read the patient information leaflet for further information For oral administration Adults and the elderly: 2 chewable tablets a day, preferably one tablet morning and evening The tablets should be chewed or sucked Keep out of the sight and reach of children Do not store above 30°C. Store in the original package to protect from moisture Manufactured by Nycomed Pharma AS, Drammensveien 852, N-1385 Asker, Norway Procured from within the EU by the PPA holder: Imbat Ltd, Unit L2, North Ring Business Park, Santry, Dublin 9 Repackaged by: Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, South Yorkshire, DN3 1QR, UK PPA No: 1151/155/1 ECMA No: 08557/0029 * Registered trademark PATIENT INFORMATION LEAFLET CALCICHEW*-D3 FORTE CHEWABLE TABLETS calcium carbonate / colecalciferol equivalent to 500mg calcium / 400IU colecalciferol Your medicine is available using the name Calcichew-D3 Forte Chewable Tablets but will be referred to as Calcichew-D3 Forte throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to take Calcichew-D3 Forte carefully to get the best results from it. People with diets and lifestyles that mean they will obtain less than the recommended intake of calcium and vitamin D are at risk of weakened bones. Prolonged lack of adequate calcium an Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calcichew-D 3 Forte Chewable Tablets, calcium carbonate / colecalciferol equivalent to 500mg Calcium / 400 IU colecalciferol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Per tablet: Calcium carbonate 1250 mg (equivalent to 500 mg of elemental calcium) Colecalciferol 400 IU (equivalent to 10 micrograms vitamin D3) Contains sorbitol 390mg, isomalt 49.90mg, aspartame 1mg and sucrose 0.77mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet. _Product imported from the UK_ 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 Oral. _Adults and elderly:_ 2 chewable tablets per day, preferably one tablet morning and evening. The tablet may be chewed or sucked. _Dosage in hepatic impairment:_ No dose adjustment is required. _Dosage in renal impairment:_ Calcichew-D 3 Forte chewable tablets should not be used in patients with severe renal impairment. Calcichew-D 3 Forte chewable tablets are not intended for use in children. I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Izlasiet visu dokumentu