Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
tamsulosin hydrochloride, Quantity: 400 microgram
Astellas Pharma Australia Pty Ltd
Tamsulosin hydrochloride
Tablet, modified release
Excipient Ingredients: colloidal anhydrous silica; macrogol 8000; macrogol 7000000; hypromellose; butylated hydroxytoluene; iron oxide yellow; magnesium stearate
Oral
30 Tablets, 10 tablets
(S4) Prescription Only Medicine
For the relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
Visual Identification: 9mm, round, biconvex, yellow, film-coated tablet debossed with '04' on one side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2006-01-18
FLOMAXTRA ® F L O M A X T R A ® Prolonged release tablets CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING FLOMAXTRA®? FLOMAXTRA ® is used in men who have a medical condition called benign prostatic hyperplasia (also known as BPH). In BPH the prostate gland is bigger than normal. BPH is NOT prostate cancer. FLOMAXTRA ® belongs to a group of medicines called alpha-blockers. For more information, see Section 1. Why am I using FLOMAXTRA®? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE FLOMAXTRA ® ? FLOMAXTRA® is for use by MEN only. If you are a woman or a child, do not take FLOMAXTRA®. If you are not sure whether you should start taking FLOMAXTRA® you should contact your doctor. There are a number of circumstances in which a person should not use this medicine or may need to use caution. It is important to understand if these apply to you before taking FLOMAXTRA ® (see Section 2. What should I know before I use FLOMAXTRA®? in the full CMI for more details). 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with FLOMAXTRA ® and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE FLOMAXTRA ® ? The usual dose is one tablet a day. The tablet should be swallowed whole, preferably with a glass of water. Do not crunch, bite or chew the tablet. More instructions can be found in Section 4. How do I use FLOMAXTRA®? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING FLOMAXTRA ® ? THINGS YOU SHOULD DO • If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking FLOMAXTRA ® . • If you are going to have eye surgery for cataracts or glaucoma, please tell your surgeon that you are taking or have taken FLOMAXTRA ® . THINGS YOU SHOULD NOT DO • Do not give FLOMAXTRA ® to anyone else, even if they have the same condition Baca dokumen lengkap
1 AUSTRALIAN PRODUCT INFORMATION FLOMAXTRA ® (TAMSULOSIN HYDROCHLORIDE) PROLONGED RELEASE TABLETS 1 NAME OF THE MEDICINE Tamsulosin hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION FLOMAXTRA® is a film-coated, prolonged release tablet containing 400 µg tamsulosin hydrochloride, an α1-adrenoceptor blocking agent, equivalent to 367 µg of tamsulosin per tablet For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM FLOMAXTRA® is a film-coated, prolonged release tablet. FLOMAXTRA® tablets are yellow, approximately 9 mm, round, bi-convex, film-coated and debossed with the code ‘04’ on one side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS For the relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). 4.2 D OSE AND METHOD OF ADMINISTRATION One tablet daily. The tablet must be swallowed whole and not be broken, crunched or chewed, as this compromises the prolonged release properties of the tablet for the active ingredient. FLOMAXTRA® can be taken on an empty stomach, or before, with or after food. 4.3 CONTRAINDICATIONS • Hypersensitivity, including drug-induced angioedema, to tamsulosin hydrochloride or any other component of the product. • A history of orthostatic hypotension. • SEVERE hepatic impairment (Child-Pugh scores >9). • SEVERE renal impairment with creatinine clearance of less than 10mL/min. • Concurrent use of another 1 -adrenoceptor inhibitor. 2 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE SYNCOPE AND POSTURAL HYPOTENSION Patients beginning treatment with FLOMAXTRA® tablets should be cautioned to avoid situations where injury could result should syncope occur. Postural hypotension can occur during treatment with FLOMAXTRA®, but rarely results in syncope. However, the patient should be warned of this possibility and advised to sit or lie down if symptoms of hypotension should occur. EXCLUSION OF PROSTATIC CARCINOMA AND OTHER UROLOGICAL CONDITIONS Carcinoma of the prostate and other condit Baca dokumen lengkap