国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
DOXAZOSIN MESILATE
IPS Healthcare Limited
DOXAZOSIN MESILATE
1 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
2013-03-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cardura 1 mg tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1.213mg doxazosin mesilate equivalent to 1mg doxazosin. Each tablet also contains lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from the UK:_ White round biconvex tablets: marked “CN 1” on one side and marked with the Pfizer logo on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension: Cardura is indicated for the treatment of hypertension and can be used as a sole agent to control blood pressure in hypertensive patients. In patients inadequately controlled on single antihypertensive therapy, Cardura may be used in combination with a thiazide diuretic, beta-adrenoceptor blocking agent, calcium antagonist or an angiotensin-converting enzyme inhibitor. Benign Prostatic Hyperplasia: Cardura is indicated as an adjunct in the treatment of urinary outflow obstruction and symptoms associated with benign prostatic hyperplasia (BPH). It may therefore be of value in patients awaiting prostatic surgery or for whom surgery is not possible. Cardura may be used in BPH patients who are either hypertensive or normotensive. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Cardura is used in a once daily regimen and may be administered in the morning or evening. Hypertension: It is recommended that therapy be initiated at 1 mg given once daily for one or two weeks to minimise the potential for postural hypotension and/or syncope (see section 4.4 Special warnings and special precautions for use). The dosage may then be increased to 2 mg once daily for an additional one or two weeks. If necessary the daily dosage should then be increased grad 阅读完整的文件