国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Calcium carbonate
Special Order
A12AA04
Calcium carbonate
250mg
Oral tablet
No Controlled Drug Status
Valid as a prescribable product
BNF: 01010201
_S678 LEAFLET Calcichew 20190611 _ PACKAGE LEAFLET: INFORMATION FOR THE USER CALCICHEW ® 500 MG CHEWABLE TABLETS (calcium carbonate) Your medicine is known as Calcichew ® 500mg Chewable Tablets but will be referred to as Calcichew throughout the following leaflet. 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 is and what it is used for 2. What you need to know before you take Calcichew 3. How to take Calcichew 4. Possible side-effects 5. How to store Calcichew 6. Contents of the pack and other information 1. WHAT CALCICHEW IS AND WHAT IT IS USED FOR Calcichew is orange flavoured chewable tablets containing the active ingredient calcium. Calcium is found in the diet and is an important substance in bone formation. Calcichew 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 DO NOT TAKE CALCICHEW 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 hyper 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calcium Carbonate / Colecalciferol 1250mg / 400IU chewable tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains Calcium Carbonate 1250mg (equivalent to Calcium 500mg) Colecalciferol as Colecalciferol Concentrate (Powder Form) 400 IU (equivalent to Vitamin D3 10micrograms). Excipients with known effect: Aspartame (E951), Sorbitol (E420), and Sucrose (part of the Vitamin D3 concentrate: approximately 0.8 milligrams per tablet). For the full list of excipients, see Section 6.1 3 PHARMACEUTICAL FORM Chewable Tablet White to off white coloured, circular biconvex chewable tablet debossed with ‘BP’ on one side and ‘4’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tablets should be used only as a therapeutic and not as a food supplement when the diet is deficient or when normal requirement of both components is increased. Tablets may be used as an adjunct to specific therapy for osteoporosis or as a therapeutic supplement in established osteomalacia, pregnant patients at high risk of needing such a therapeutic supplementation or malnutrition when dietary intake is less than that required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral. Adults and elderly and children over 12 years of age: Two chewable tablets per day, preferably one tablet each morning and evening. Children: Not recommended for children under 12 years. 4.3 CONTRAINDICATIONS Absolute contra-indications are hypercalcaemia resulting for example from myeloma, bone metastases or other malignant bone disease, sarcoidosis; primary hyperparathyroidism and vitamin D overdosage. Severe renal failure. Hypersensitivity to any of the tablet ingredients. Relative contra-indications are osteoporosis due to prolonged immobilisation, renal stones, and severe hypercalciuria. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients with mild to moderate renal failure or mild hypercalciuria should be supervised carefully including periodic checks of pl 阅读完整的文件