Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
DOXAZOSIN
B & S Healthcare
DOXAZOSIN
4 Milligram
Tablet Prolonged Release
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER CARDURA™ XL 4MG PROLONGED-RELEASE TABLETS CARDURA™ XL 8MG PROLONGED-RELEASE TABLETS (doxazosin (as mesilate)) The name of your medicine is CARDURA XL Prolonged- release Tablets but will be referred to as CARDURA XL throughout this leaflet. IN THIS LEAFLET: 1. What CARDURA XL is and what it is used for 2. Before you take CARDURA XL 3. How to take CARDURA XL 4. Possible side effects 5. How to store CARDURA XL 6. Further information 1. WHAT CARDURA XL IS AND WHAT IT IS USED FOR CARDURA XL is one of a group of medicines called alpha- blockers. It is used to treat high blood pressure. CARDURA XL can be used to treat high blood pressure (hypertension), by relaxing blood vessels so that blood passes through them more easily. This helps to lower blood pressure. 2. BEFORE YOU TAKE CARDURA XL DO NOT TAKE CARDURA XL: • If you have had an allergic reaction in the past to CARDURA XL, the active ingredient doxazosin, other types of quinazolines (such as prazosin or terazosin) or any of the other ingredients listed in section 6. This may have been itching, reddening of the skin or difficulty in breathing. • If you are breast-feeding • If you have any form of obstruction of the digestive tract • If you are under 12 years of age • If you have a history of a condition known as ‘orthostatic hypotension’ which is a form of low blood pressure that causes you to feel dizzy or light Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cardura XL 4mg Prolonged-release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4mg doxazosin (as mesilate). For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged-release Tablet. _Product imported from the UK, Poland and Spain:_ White, round, biconvex shaped tablets with an orifice on one side marked ‘CXL4’ and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cardura XL 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 XL may be used in combination with a thiazide diuretic, beta-adrenoceptor blocking agent, calcium antagonist or an angiotensin-converting enzyme inhibitor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The initial dose of Cardura XL is 4mg once daily. A significant number of patients will be controlled on this dose. If necessary, the dosage may be increased to 8mg once daily according to patient response. The maximum recommended dose is 8mg once daily. Cardura XL can be taken with or without food. The tablets should be swallowed whole with a sufficient amount of liquid. They should not be cut or chewed. _ELDERLY: _In common with other drugs of this class, the dosage should be kept as low as possible and increments made under close supervision. _USE IN RENALLY IMPAIRED PATIENTS_: Since the pharmacokinetics of doxazosin are unchanged in patients with renal insufficiency, and there is no evidence that doxazosin aggravates existing renal dysfunction, the usual dosages may be used in these patients. Cardura XL is not dialysable. _USE IN HEPATICALLY IMPAIRED PATIENTS_ Olvassa el a teljes dokumentumot