Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Calcium
PCO Manufacturing Ltd.
A12AA; A12AA04
Calcium
500 milligram(s)
Chewable tablet
Product not subject to medical prescription
Calcium; calcium carbonate
Authorised
2005-12-02
_ _ _ _ _ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER CALCICHEW ® 500 MG CHEWABLE TABLETS calcium 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. − 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 500 mg is and what it is used for 2. What you need to know before you take Calcichew 500 mg 3. How to take Calcichew 500 mg 4. Possible side-effects 5. How to store Calcichew 500mg 6. Contents of the pack and other information 1. WHAT CALCICHEW 500 MG IS AND WHAT IT IS USED FOR Calcichew 500 mg Chewable Tablets are orange flavoured chewable tablets containing the active ingredient calcium. Calcium is found in the diet and is an important substance in bone formation. Calcichew 500 mg is used to treat and prevent calcium deficiency which may occur if 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. It may also be given to patients receiving kidney dialysis to remove the phosphate from the blood that cannot be removed by dialysis. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCICHEW 500 MG DO NOT TAKE CALCICHEW 500 MG CHEWABLE TABLETS IF YOU: • are allergic (hypersensitive) to calcium or any of the other ingredients of this medicine (listed in section 6)_ _ • have a condition that causes excessive amounts of calcium in your blood or urine (hypercalcaemia or hypercalciuria) • have kidney stones. WARNINGS AND PRECAUTIONS TALK Lire le document complet
Health Products Regulatory Authority 27 May 2022 CRN00CVR7 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calcichew 500 mg chewable tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1250 mg calcium carbonate, equivalent to 500 mg elemental calcium. Excipient(s) with known effect Isomalt (E953) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable Tablet. _ _ _Product imported from Greece and Spain:_ White, round chewable tablets with orange flavour. 4 CLINICAL PARTICULARS As per PA2239/013/001 5 PHARMACOLOGICAL PROPERTIES As per PA2239/013/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Xylitol (E967) Povidone Flavouring (orange) Magnesium stearate Sucralose (E955) Isomalt (E953) Monoglycerides and diglycerides of fatty acids 6.2 INCOMPATIBILITIES Not applicable. 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 bottle tightly closed in order to protect from moisture. Health Products Regulatory Authority 27 May 2022 CRN00CVR7 Page 2 of 2 6.5 NATURE AND CONTENTS OF CONTAINER Bottles of 60 chewable tablets contained in an outer cardboard carton. 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 PPA0465/156/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02 December 2005 Date of last renewal: 02 December 2010 10 DATE OF REVISION OF THE TEXT May 2022 Lire le document complet