מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Colecalciferol; Calcium carbonate
Forum Health Products Ltd
A12AX
Colecalciferol; Calcium carbonate
1000unit ; 2.5gram
Chewable tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09060400; GTIN: 5391512453220
WHAT IS IN THIS LEAFLET 1. What CALCI-D is and what it is used for 2. What you need to know before you take CALCI-D 3. How to take CALCI-D 4. Possible side effects 5. How to store CALCI-D 6. Contents of the pack and other information 1. WHAT CALCI-D IS AND WHAT IT IS USED FOR CALCI-D chewable tablets contain two active substances, calcium carbonate and colecalciferol (vitamin D3). Both calcium and vitamin D3 are found in the diet and vitamin D is also produced in the skin after exposure to the sun. CALCI-D chewable tablets may be prescribed by doctors to treat and prevent vitamin D/calcium deficiency. CALCI-D is used: • in the correction of calcium and vitamin D deficiencies in the elderly, • in combination with osteoporosis treatments where calcium and vitamin D levels are too low or where there is a high risk of them being too low. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCI-D DO NOT TAKE CALCI-D: • If you are allergic to calcium carbonate or colecalciferol (vitamin D3) or any of the other ingredients of this medicine (listed in section 6); • if you are inactive and have high levels of calcium in your blood (hypercalcaemia) or urine (hypercalciuria); • if you have calcium deposits in the tissues of your body; • if you have serious kidney problems; • if you have kidney stones or calcium stones in general; • if you have abnormally high levels of vitamin D; • if you are less than 18 year of age. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking CALCI-D. Take special care with CALCI-D if you: • if you have had kidney stones or other kidney problems (your doctor will need to monitor your treatment carefully if your kidneys are not working properly to make sure you do not build up too much calcium in your blood) • if you stay in bed for a long period (months) and if you have osteoporosis (brittle bones) because you may have high levels of calcium in your blood • if you are taking any other medicines containing calcium or vitamin D (your doctor or your pharmacist will קרא את המסמך השלם
OBJECT 1 CALCI-D 1000 MG /1000 IU CHEWABLE TABLETS Summary of Product Characteristics Updated 09-Mar-2016 | Consilient Health Ltd 1. Name of the medicinal product CALCI-D 1000 mg /1000 IU chewable tablets 2. Qualitative and quantitative composition One tablet contains: calcium carbonate colecalciferol (Vitamin D3) 2500 mg (equivalent to 1000 mg calcium) 1000 I.U. (equivalent to 0.025 mg) Excipients with known effect: sucrose, isomaltitol (E953). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Chewable tablet The chewable tablet has a round shape and is white to almost white with a break mark. The tablet can be divided into equal doses. 4. Clinical particulars 4.1 Therapeutic indications Correction of calcium and Vitamin D deficiency in the elderly. CALCI-D may be used as an adjunct to specific therapy for osteoporosis, in patients with either established vitamin D and calcium combined deficiencies or in those patients at high risk of needing such therapeutic supplements. 4.2 Posology and method of administration Posology Adults and elderly: 1 tablet/day for oral use The tablets may be chewed or sucked, they should not be swallowed whole. It is advisable to take the preparation during the evening meal. Paediatric population: There is no relevant use of CALCI-D chewable tablets in the paediatric population. Dosage in pregnant women: One half- tablet a day (see section 4.6). Patients with hepatic dysfunction: No dosage adjustment is required. Patients with renal dysfunction: CALCI-D should not be used in patients with severe renal dysfunction. 4.3 Contraindications - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. - Hypercalcaemia (>10.5 mg/dl), hypercalciuria (300 mg or 7.5 mmol/24 hours), severe renal insufficiency, nephrolithiasis, nephrocalcinosus, calcification of tissues, diseases and/or conditions resulting in hypercalciurea and/or hypercalcaemia. - Hypervitaminosis D. 4.4 Special warnings and precautions for use - During long-term treatmen קרא את המסמך השלם