البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ergocalciferol; Calcium lactate; Calcium phosphate
Accord-UK Ltd
A12AX
Ergocalciferol; Calcium lactate; Calcium phosphate
10microgram ; 300mg ; 150mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09060400; GTIN: 5012617018687
83.6mm C L 210mm +/- 0.5mm to centre line of next eye mark 65mm 15mm 15mm Pharmacode Position Calcium and Ergocalciferol tablets User Test Pil item no: 50130495 0044 1271 311400 0044 1271 311449 artworkstudio@actavis.co.uk 0044 1271 327411 print proof no: 06 origination date: 23/08/07 originated by: R.Wrey revision date: 19/12/08 revised by: R.Wrey dimensions: 148x210 Reel Fed pharmacode: design repeat (single): web: colours/plates: approved for print/date Non Printing Colours 1. Black 2. 3. 4. 5. 6. 1. 2. 3. Supplier: MYH MOCK UP ONLY 50130495 _Continued over page_ _Continued top of next column_ CALCIUM AND ERGOCALCIFEROL TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. INDEX 1 WHAT CALCIUM AND ERGOCALCIFEROL TABLETS ARE AND WHAT THEY ARE USED FOR 2 BEFORE YOU TAKE 3 HOW TO TAKE 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE 6 FURTHER INFORMATION 1 WHAT CALCIUM AND ERGOCALCIFEROL TABLETS ARE AND WHAT THEY ARE USED FOR Calcium and Ergocalciferol (vitamin D 2 ) tablets may be used to treat vitamin D deficiency including rickets (weak bones and teeth). 2 BEFORE YOU TAKE DO NOT TAKE Calcium and Ergocalciferol tablets and TELL your doctor if you: • are ALLERGIC (hypersensitive) to calcium lactate, calcium phosphate, ergocalciferol (vitamin D) or any of the other ingredients in Calcium and Ergocalciferol tablets (see secion 6) • have HIGH levels of CALCIUM in the blood (hypercalcaemia) or urine (hypercalciuria) • have an OVERACTIVE THYROID GLAND (hyperthyroidism) • have severe KIDNEY FAILURE • have OSTEOPOROSIS (brittle bones) caused by immobility or tumours • have recently had a large intake of VITAMIN D. CHECK WITH YOUR DOCTOR OR PHARMACIST before taking Calcium and Ergocalciferol tablets if you: • have KIDNEY or HEART اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT CALCIUM AND ERGOCALCIFEROL TABLETS 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Calcium Lactate 300mg, Calcium Phosphate 150mg equivalent to 2.415mmol of calcium (Ca 2+ ) and Ergocalciferol (Vitamin D 2 ) 10µg (equivalent to 400iu). 3 PHARMACEUTICAL FORM White uncoated tablets. White circular, biconvex uncoated tablets impressed with the identifying letters “C” and “CV” on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of nutritional deficiency in: 1) Vitamin D deficiency including nutritional rickets. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults _ _and _ _children _ _over _ _6 _ _years:_ One tablet daily, crushed before administration. It is recommended that the tablets are taken after meals. _Children under 6 years:_ Not recommended. _Elderly:_ Continuous regular use in the elderly (more than 1-2 months) is not recommended. For oral administration. 4.3 CONTRAINDICATIONS Patients with known hypersensitivity to calcium or ergocalciferol (vitamin D) or any ingredient in the tablet. Severe hypercalcaemia and hypercalciuria (_eg_ in hypervitaminosis D, hyperthyroidism, severe renal failure, osteoporosis due to immobility and decalcifying tumours such as plasmocytoma and skeletal metastases). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose – galactose malabsorption should not take this medicine. Patients with rare hereditary problems of fructose intolerance, glucose - galactose malabsorption or sucrase - isomaltase insufficiency should not take this medicine. Calcium salts should be given cautiously to patients with impaired renal function or cardiac disease. During long-term treatment, serum calcium levels should be followed and renal function should be monitored through measurements of serum creatinine. Monitoring is especially important in elderly patients on concomitant treatment wi اقرأ الوثيقة كاملة