Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DOXAZOSIN MESYLATE
VIATRIS SDN. BHD.
DOXAZOSIN MESYLATE
30 Tablet Tablets; 100 Tablet Tablets
PFIZER PHARMACEUTICALS LLC
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ CARDURA ® XL TABLETS Doxazosin mesylate (4 mg) 1 WHAT IS IN THIS LEAFLET 1. What CARDURA XL is used for 2. How CARDURA XL works 3. Before you use CARDURA XL 4. How to use CARDURA XL 5. While you are using it 6. Side Effects 7. Storage and Disposal of CARDURA XL 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11 Serial Number WHAT CARDURA XL IS USED FOR _Hypertension_ CARDURA XL 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 XL is indicated for the treatment of clinical symptoms in (enlargement of prostate gland) benign prostatic hyperplasia (BPH) and for reduced urinary flow associated with BPH. CARDURA XL may be used in BPH patients who are either hypertensive (high blood pressure) or normotensive (normal blood pressure). While the blood pressure changes in normotensive (normal blood pressure) patients with BPH are clinically insignificant, patients with hypertension (high blood pressure) and BPH have had both conditions effectively treated with CARDURA XL monotherapy. HOW CARDURA XL WORKS 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. Poor and/or frequent urination is common in patients with enlarged prostate gland. CARDURA XL works by relaxing muscle around the bladder exit and prostate gland so urine is passed more easily. BEFORE YOU USE CARDURA XL - _When you must not use it_ Do not take CARDURA XL: If you have had an allergic reaction in the past to CARDURA XL, the active ingredient doxazosin, other types of quinazolin Read the complete document
1 CARDURA XL* Doxazosin mesylate GITS 1. NAME OF THE MEDICINAL PRODUCT CARDURA XL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: doxazosin The GITS tablets contain doxazosin mesylate equivalent to 4 mg and 8 mg doxazosin. 3. PHARMACEUTICAL FORM Controlled-release tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Hypertension_ Doxazosin GITS 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 GITS is indicated for the treatment of clinical symptoms in benign prostatic hyperplasia (BPH) and for reduced urinary flow associated with BPH. Doxazosin GITS 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 the conditions effectively treated with doxazosin GITS monotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Hypertension and Benign Prostatic Hyperplasia_ Doxazosin GITS can be taken with or without food. The GITS tablets should be swallowed whole with a sufficient amount of liquid. Patients should not chew, divide or crush the tablets (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE: _Information for Patients_). The initial dose of doxazosin GITS is 4 mg once daily. Over 50% of patients with mild to moderate severity hypertension will be controlled on doxazosin GITS 4 mg once daily_. _The optimal effect of doxazosin may take up to 4 weeks. If necessary, the dosage may be increased following this period to 8 mg once daily according to patient response. The maximum recommended dose is 8 mg once daily. 2 _Use in Elderly_ Normal adult dosage is recommende Read the complete document