Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DOXAZOSIN MESYLATE
PFIZER (MALAYSIA) SDN. BHD.
DOXAZOSIN MESYLATE
100 Tablets
Pfizer Manufacturing Deutschland GmbH.
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ CARDURA ® Doxazosin mesylate (2 mg) 2 WHAT IS IN THIS LEAFLET 1. What CARDURA is used for 2. How CARDURA works 3. Before you use CARDURA 4. How to use CARDURA 5. While you are using it 6. Side effects 7. Storage and Disposal of CARDURA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11 Serial Number WHAT CARDURA IS USED FOR _Hypertension_ Doxazosin is indicated for the treatment of hypertension and can be used as the initial agent to control blood pressure in the majority of patients. In patients not adequately controlled on a single antihypertensive agent, doxazosin may be used in combination with .another agent such as a thiazide diuretic, a beta-blocker, a calcium antagonist or an angiotensin- converting enzyme inhibitor _Benign Prostatic Hyperplasia_ CARDURA is also indicated for the treatment of the blockage in urinary flow and symptoms associated with (enlargement of prostate gland in men) benign prostatic hyperplasia (BPH). CARDURA may be used in BPH patients who are either hypertensive (high blood pressure) or normotensive (normal blood pressure). While the blood pressure changes in normal blood pressure patients with BPH are clinically insignificant, patients with high blood pressure and BPH have had both conditions effectively treated with doxazosin monotherapy. HOW CARDURA WORKS CARDURA is one of a group of medicines called alpha-blockers.. CARDURA 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 works by relaxing muscle around the bladder exit and prostate gland so urine is passed more easily. BEFORE YOU USE CARDURA - _When you must not use it_ Do not take CARDURA: If you have had an allergic reaction in the past to CARDURA, the active ingredient doxazosin, other types of quinazolines or any of the other ingredients l Baca dokumen lengkap
Pfizer confidential LPD Title: Cardura LPD Date: 19 September 2017 Country: Malaysia Reference Document: CDS version 8.0, effective date 06 May 2016 and CDS version 9.0, effective date 14 July 2016 Reason for Change: Site transfer from West Ryde to Freiburg, Germany PFIZER CARDURA ® Doxazosin Mesylate 1. NAME OF THE MEDICINAL PRODUCT CARDURA 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: doxazosin The tablets contain doxazosin mesylate salt equivalent to 1 mg, 2 mg and 4 mg doxazosin. 3. PHARMACEUTICAL FORM Tablets 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Hypertension Doxazosin is indicated for the treatment of hypertension and can be used as the ini tial agent to control blood pressure in the majority of patients. In patients not adequately controlled on a single antihypertensive agent, doxazosin may be used in combination with another agent, such as a thiazide diuretic, a beta -blocker, a calcium anta gonist or an angiotensin -converting enzyme inhibitor. Benign Prostatic Hyperplasia Doxazosin is also indicated for the treatment of the urinary outflow obstruction and symptoms associated with benign prostatic hyperplasia (BPH). Doxazosin may be used in BPH patients who are either hypertensive or normotensive. While the blood pressure changes in normotensive patients with BPH are clinically insignificant, patients with hypertension and BPH have had both conditions effectively treated with doxazosin monoth erapy. Baca dokumen lengkap