Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Calcium carbonate; Colecalciferol
Thornton & Ross Ltd
A12AX
Calcium carbonate; Colecalciferol
1.5gram ; 400unit
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09060400; GTIN: 5060222940053
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Accrete D3 film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg calcium (as calcium carbonate 1500 mg) and 10 micrograms of colecalciferol (equivalent to 400 IU vitamin D 3 ) Excipients with known effect: Each film-coated tablet contains 0.3 mg hydrogenated soya-bean oil and 1.52 mg sucrose. For the full list of excipients, see 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. Ochre oval film-coated tablets, scored on one side. When broken the exposed surface is white. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention and treatment of vitamin D and calcium deficiency in the elderly. Vitamin D and calcium supplement as an adjunct to specific osteoporosis treatments of patients who are at risk of vitamin D and calcium deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and elderly _ One tablet twice a day (e.g. one tablet in the morning and one tablet in the evening). Dose reduction should be considered as necessary following the monitoring of calcium levels as indicated in section 4.4 and 4.5. _Hepatic impairment _ No dose adjustment is required. _Renal impairment _ Accrete D3 film-coated tablets should not be used in patients with severe renal impairment. _Children and adolescents _ Accrete D3 film coated tablets are not intended for use in children and adolescents. Method of administration It is recommended that the film-coated tablet is taken within one and a half hours of a meal with a glass of water or juice, without chewing it. The tablet can be broken in half, if needed. 4.3 CONTRAINDICATIONS • Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria (e.g. myeloma, bone metastases, primary hyperparathyroidism). • Nephrolithiasis / nephrocalcinosis • Severe renal impairment and renal failure • Hypervitaminosis D • Hypersensitivity to Đọc toàn bộ tài liệu