国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
tamsulosin hydrochloride, Quantity: 400 microgram
Sandoz Pty Ltd
Tamsulosin hydrochloride
Tablet, modified release
Excipient Ingredients: quinoline yellow; purified talc; polyethylene oxide; cochineal; microcrystalline cellulose; magnesium stearate; hyprolose; butylated hydroxytoluene; macrogol 400; titanium dioxide; iron oxide black; hypromellose; colloidal anhydrous silica
Oral
30, 10
(S4) Prescription Only Medicine
For the relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
Visual Identification: Brown, round, biconvex film-coated tablets with debossing '0.4' on one side and 'SZ' on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2013-03-06
TAMSULOSIN SANDOZ ® SR 1 TAMSULOSIN SANDOZ ® SR _tamsulosin hydrochloride modified release tablet _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Tamsulosin Sandoz SR. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT TAMSULOSIN SANDOZ SR IS USED FOR TAMSULOSIN SANDOZ SR IS FOR USE BY MEN ONLY. This medicine is used for the relief of lower urinary tract symptoms (LUTS) associated with a condition called benign prostatic hyperplasia (BPH). BPH is NOT prostate cancer. BPH is a condition where your prostate gland (which is near your bladder) has become bigger making it more difficult for you to pass urine. This can lead to symptoms such as: • weak or interrupted stream of urine • delay before you start to pass urine, and you have to strain to do so. • feeling that you cannot empty your bladder completely • may dribble at the end of passing urine. • needing to pass urine often, especially at night • feeling that you must pass urine right away. BPH occurs only in men and is common over the age of 50 years. In some men, BPH can lead to serious problems, including urinary tract infections and the sudden inability to pass urine at all. This medicine contains the active ingredient tamsulosin hydrochloride. Tamsulosin hydrochloride belongs to a group of medicines called alpha- blockers. Tamsulosin Sandoz SR works by helping relax the smooth muscles in the prostate, in that way it improves the flow of urine, thus relieving the pain when passing urine. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescri 完全なドキュメントを読む
190815-Tamsulosin Sandoz SR-pi Page 1 of 13 AUSTRALIAN PRODUCT INFORMATION TAMSULOSIN SANDOZ ® SR (TAMSULOSIN HYDROCHLORIDE) MODIFIED RELEASED TABLETS 1 NAME OF THE MEDICINE Tamsulosin hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Tamsulosin Sandoz SR 400 µg modified release tablet contains 400 µg tamsulosin hydrochloride. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Tamsulosin Sandoz SR 400 µg are brown, round, biconvex film-coated tablets with debossing ‘0.4’ on one side and ‘SZ’ on the other 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 DOSAGE One tablet daily. METHOD OF ADMINISTRATION 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. Tamsulosin Sandoz SR can be taken on an empty stomach, or before, with or after food. 4.3 C ONTRAINDICATIONS • 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 10 mL/min. • Concurrent use of another α 1 -adrenoceptor inhibitor. 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE SYNCOPE AND POSTURAL HYPOTENSION Patients beginning treatment with Tamsulosin Sandoz SR tablets should be cautioned to avoid situations where injury could result should syncope occur. Postural hypotension can occur during treatment with Tamsulosin Sandoz SR, but rarely results in syncope. However, the 190815-Tamsulosin Sandoz SR-pi Page 2 of 13 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 o 完全なドキュメントを読む