Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
DOXAZOSIN
IMED Healthcare Ltd.
DOXAZOSIN
4 Milligram
Tablet Prolonged Release
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER CARDURA™ XL 4MG CARDURA™ XL 8MG PROLONGED –RELEASE TABLETS doxazosin (as mesilate) IMPORTANT THINGS THAT YOU SHOULD KNOW ABOUT YOUR MEDICINE: Cardura XL is a treatment for high blood pressure This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. You should take Cardura XL regularly to get the maximum benefit, even if you are feeling well. Most people do not have serious problems when taking Cardura XL but side effects can occur – see Section 4 for details. If you experience swelling of the face, tongue or windpipe, see your doctor immediately. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Taking other medicines may sometimes cause problems. Check with your doctor or pharmacist before taking this or any other medicines. If you are, or are trying to become, pregnant, do not take Cardura XL and tell your doctor. Please read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important to you. If you have any further questions, ask your doctor or pharmacist. 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 us Прочетете целия документ
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:_ White, round, biconvex shaped tablets with an orifice on one side marked ‘CXL4’. 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 inhypertensive patients. In patients inadequately controlled on single antihypertensive therapy, Cardura XL may be used in combination with athiazide 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. Ifnecessary, 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: There are only limited data in patients with l Прочетете целия документ