Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DOXAZOSIN MESYLATE
VIATRIS SDN. BHD.
DOXAZOSIN MESYLATE
100 Tablets
Pfizer Manufacturing Deutschland GmbH.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ CARDURA ® TABLET 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 listed under Soma hati kamili
2 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 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_ 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 monotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Doxazosin may be administered either in the morning or in the evening. _Hypertension_ 3 The full dosage range of doxazosin is 1 mg to 16 mg daily. It is recommended that therapy be initiated at 1 mg once daily for 1 or 2 weeks to minimize the potential for postural hypotension and/or syncope (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). The dosage may then be increased to 2 mg once daily for an additional 1 or 2 weeks. If necessary, the daily dosage should then be increased gradually at similar intervals to 4 mg, 8 mg, and 16 mg, as determined by patient response, to achieve the desired reduction in blood pressure. The usual dose is 2 mg to 4 mg once daily. _Benign Prostatic Hyperplasia_ The recommended initial dosage of doxazosin is 1 mg once daily to minimize the potential for postural hy Soma hati kamili