Land: Malta
Taal: Engels
Bron: Medicines Authority
DOXAZOSIN
Pfizer Hellas S.A.
C02CA04
DOXAZOSIN
TABLET
DOXAZOSIN 1 milligram(s)
POM
ANTIHYPERTENSIVES
Authorised
2006-02-06
Page 1 of 6 Pfleet: 2017-0033380 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CARDURA ® 1MG TABLETS CARDURA ® 2MG TABLETS Doxazosin 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. • Cardura is a treatment for high blood pressure, or the symptoms caused by enlargement of the prostate gland in men. • 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 regularly to get the maximum benefit, even if you are feeling well. • Most people do not have serious problems when taking Cardura 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 and tell your doctor or pharmacist. WHAT IS IN THIS LEAFLET 1. What Cardura is and what it is used for 2. What you need to know before you take Cardura 3. How to take Cardura 4. Possible side effects 5. How to store Cardura 6. Contents of the pack and other information 1. WHAT CARDURA IS AND WHAT IT IS USED FOR Cardura is one of a group of medicines called alpha-blockers. It is used to treat high blood pressure, or the symptoms caused by enlargement of the prostate gland in men. Cardura is 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 is taken to treat poor and/or frequent pa Lees het volledige document
Page 1 of 10 Pfleet : 2017-0033380 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT CARDURA 1mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Doxazosin mesilate 1.213mg equivalent to 1mg doxazosin. Excipient with known effect: Each tablet contains 40mg of lactose monohydrate. Each tablet contains 0.06 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. 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 Posology _ _ _ _ _ADULTS:_ Cardura is used in a once daily regimen and may be administered in the morning or evening. _HYPERTENSION:_ Page 2 of 10 Pfleet : 2017-0033380 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). 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 gradually at similar intervals to 4 mg, 8 mg, and l6 mg as determined by patient response to achieve the desired reduction in blood pressure. The usual dose is 2-4 mg once daily. The max Lees het volledige document