Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Doxazosin
Pfizer Healthcare Ireland
C02CA; C02CA04
Doxazosin
8 milligram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Alpha-adrenoreceptor antagonists; doxazosin
Marketed
1999-10-29
mock up 8342 Package leaflet: Information for the patient IRELAND CARDURA ® XL 4mg CARDURA ® XL 8mg Prolonged–release Tablets Doxazosin (as mesilate) Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness 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. If you experience swelling of the face, tongue or windpipe, see your doctor immediately. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. • 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 or pharmacist. What is in this leaflet 1. What Cardura XL is and what it is used for 2. What you need to know before you take Cardura XL 3. How to take Cardura XL 4. Possible side effects 5. How to store Cardura XL 6. Contents of the pack and other 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. In patients with an enlarged prostate gland, CARDURA XL is taken to treat poor and/or frequent passing of urine. This is common in patients with an enlarged prostate gland. CARDURA XL works by relaxing muscle around the bladder exit Прочитајте комплетан документ
Health Products Regulatory Authority 07 April 2021 CRN00C2HQ Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cardura XL 8 mg Prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Doxazosin mesilate: 9.70 mg equivalent to 8 mg doxazosin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. White, film coated, round, biconvex shaped tablets with an orifice on one side, marked CXL8. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _HYPERTENSION:_ 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. _ _ _BENIGN PROSTATIC HYPERPLASIA: _ Cardura XL is indicated for the treatment of urinary outflow obstruction and symptoms associated with benign prostatic hyperplasia (BPH). Cardura XL may be used in BPH patients who are either hypertensive or normotensive. While the blood pressure changes in normotensive patients with BPH are not usually clinically significant, patients with hypertension and BPH have had both conditions effectively treated with doxazosin monotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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. _ELDERLY PATIENTS:_ In common with other drugs of this class, the dosage should be kept as low as possible and increments made under close supervision. _PATIENTS WITH RENAL IMPAIRMENT:_ Since the pharmacokinetics of doxazosin are unchanged in patients with renal insufficiency, and there is no evidence that doxazosin aggravates existing renal dysfu Прочитајте комплетан документ