Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Calcium carbonate; Colecalciferol
PCO Manufacturing Ltd.
A12AX
Calcium carbonate; Colecalciferol
500 mg/400 IU mg/IU
Chewable tablet
Product not subject to medical prescription
Calcium, combinations with vitamin D and/or other drugs
Authorised
2007-09-28
_ _ 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. • renal (kidney failure) • cancer that has affected your bones have excessive amounts of v Perskaitykite visą dokumentą
Health Products Regulatory Authority 11 November 2020 CRN009Y8G Page 1 of 2 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 Per tablet: Calcium carbonate 1250 mg (equivalent to 500 mg of elemental calcium) Colecalciferol 400 IU (equivalent to 10 micrograms vitamin D 3 ) Excipients with known effect: Sucrose, sorbitol (E 420), isomalt (E953), aspartame (E951). For the 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 As per PA2229/005/002 5 PHARMACOLOGICAL PROPERTIES As per PA2229/005/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Sorbitol (E420) Povidone Isomalt (E953) Flavouring (lemon) Fatty acid mono- and di-glycerides Aspartame (E951) Magnesium stearate Sucrose Tocopherol Modified Maize starch Medium chain triglycerides Sodium ascorbate Anhydrous colloidal silica 6.2 INCOMPATIBILITIES Not applicable. Health Products Regulatory Authority 11 November 2020 CRN009Y8G Page 2 of 2 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30 °C. Keep the container tightly closed to protect from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER White, high density polyethylene bottles. Bottles containing 60 or 100 tablets with tamper evident seal. Not all pack sizes may be marketed. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/156/002 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORIS Perskaitykite visą dokumentą