Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
TERAZOSIN HYDROCHLORIDE
McDermott Laboratories Ltd t/a Gerard Laboratories
TERAZOSIN HYDROCHLORIDE
5 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
2013-10-03
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Benph 5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5mg of terazosin (in the form of terazosin hydrochloride dihydrate). Excipient(s): 110mg lactose monohydrate 0.01mg sunset yellow (E110) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets Light orange, round, flat, bevel edged, tablet imprinted “E” and “453” on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Benph® tablets are indicated for: - symptomatic treatment of benign prostatic hyperplasia (BPH). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dose of terazosin should be managed according to each patient’s response. An initial dose of 1.0mg daily should be given in the evening. This dose may be increased by approximately doubling the dose at weekly intervals to achieve the desired reduction in symptoms. The maintenance dose is usually 5 to 10mg once daily. At present there are insufficient data to suggest symptomatic relief with doses above 10mg. USE WITH THIAZIDE DIURETICS AND OTHER ANTIHYPERTENSIVE AGENTS The dose of terazosin should be re-titrated if a thiazide diuretic or antihypertensive agent is added to a patients medication. On initiation of the new medication hypotension may be observed. _ELDERLY:_ In the elderly, dosage should be kept as low as possible and increments made under close supervision. _RENAL DYSFUNCTION:_ Pharmacokinetic studies indicate that patients with impaired renal function need no alteration in the recommended dosage. There is no evidence that terazosin aggravates renal dysfunction. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/06/2012_ _CRN 2107135_ _page numb Đọc toàn bộ tài liệu