国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
BENDROFLUMETHIAZIDE
Ranbaxy Ireland Limited
BENDROFLUMETHIAZIDE
5 Milligram
Tablets
Withdrawn
2007-02-24
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bendroflumethiazide Tablets BP 5mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bendroflumethiazide 5.0 mg For excipients, see 6.1 3 PHARMACEUTICAL FORM White circular biconvex tablet with a breakline on one side and embossed “RIMA” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a diuretic in the management of oedema such as arise from cardiac, renal or hepatic origin, toxaemia or pregnancy, corticosteroid administration. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION For oral administration only. ADULTS: The usual initial dose is 5-10mg as a single dose, with a maintenance dosage of 2.5-10mg daily, preferably in the morning. 4.3 CONTRAINDICATIONS Use of this product in the presence of hypokalaemia, pre-coma associated with hepatic cirrhosis or Addison’s disease. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Patients who are being treated with this preparation require regular supervision with monitoring of fluid and electrolyte state to avoid inadequate potassium supplementation or excessive loss of fluid. The preparation should only be used with particular caution in elderly patients, or those with potential obstruction of the urinary tract, or with disorders rendering their electrolyte balance precarious. Hyperuricaemia and gout may be induced by this preparation. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION The concomitant administration of this preparation with cardiac glycosides or hypotensive agents may necessitate adjustment of the dosage of these drugs. The preparation may induce hyperglycaemia particularly in patients with latent diabetes, and may necessitate adjustment of control by hypoglycaemic agents in cases of diabetes mellitus. Concurrent use with lithium salts may increase toxicity 阅读完整的文件