Prescribing Information

Kalcipos®-D 500 mg/800 IU prescribing information (UK)

Presentation: Kalcipos®-D contains calcium carbonate equivalent to 500 mg calcium, cholecalciferol (vitamin D3) 800 IU (20 microgram). Indications: Prevention and treatment of calcium and vitamin D deficiency in the elderly. Vitamin D and calcium supplement in addition to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency. Dosage and administration: One chewable tablet (500 mg/800 IU) daily. To be chewed or slowly melted in the mouth. Contra-indications: Diseases and/or conditions resulting in hypercalcaemia or hypercalciuria, nephrolithiasis, nephrocalcinosis, hypervitaminosis D, renal failure, hypersensitivity to calcium carbonate or cholecalciferol, hypersensitivity to any of the excipients, Kalcipos®-D contains partially hydrogenated soya-bean oil and must not be used by persons allergic to peanuts or soya. Precautions: Prescribe with caution to patients suffering from sarcoidosis, impairment of renal function, immobilised with osteoporosis due to increased risk of hypercalcaemia, when prescribing other medicinal products containing vitamin D, co-administration with tetracyclines or quinolones. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Interactions: Thiazide diuretics reduce the urinary excretion of calcium, concomitant use of phenytoin or barbiturates may reduce the effect of vitamin D3 and systemic corticosteroids reduce calcium absorption. Hypercalcaemia may increase the toxicity of cardiac glycosides during treatment with calcium and vitamin D. Administration of calcium and levothyroxine should be separated by at least four hours. If a bisphosphonate is used concomitantly, this preparation should be administered at least one hour before the intake of Kalcipos®-D. Calcium may also reduce absorption of sodium fluoride and iron salts, and such preparations should be administered at least three hours before the intake of Kalcipos®-D. Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D. Calcium carbonate may interfere with the absorption of concomitantly administered tetracycline preparations, therefore tetracycline preparations should be administered at least two hours before or four to six hours after oral intake of calcium. The absorption of quinolone antibiotics may be impaired if administered concomitantly with calcium. Quinolone antibiotics should be taken two hours before or six hours after intake of calcium. Oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole cereals) may inhibit calcium absorption through formation of insoluble compounds with calcium ions, therefore do not take calcium products within two hours of eating foods high in oxalic acid and phytic acid. Pregnancy and lactation: Kalcipos®-D is not recommended during pregnancy. Kalcipos®-D can be used during breastfeeding but calcium and vitamin D3 pass into breast milk. Undesirable effects: Hypersensitivity reactions, hypercalcaemia, hypercalciuria, constipation, flatulence, nausea, abdominal pain, diarrhoea, pruritus, rash and urticaria. Prescribers should consult the Summary of Product Characteristics in relation to other side-effects. Special precautions for storage: Store in the original container, in order to protect from light. Keep container tightly closed in order to protect from moisture. Basic price (UK): 30 Tablet bottle £4.21 Product licence number: 15142/0056 Legal category: POM. Marketing Authorisation Holder: Meda Pharmaceuticals Ltd, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU Date of preparation of prescribing information: January 2011 UK/KAL/11/0018

Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to Meda Pharmaceuticals.