Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
silodosin, Quantity: 4 mg
Mayne Pharma International Pty Ltd
silodosin
Capsule, hard
Excipient Ingredients: mannitol; sodium lauryl sulfate; magnesium stearate; Gelatin; titanium dioxide; iron oxide yellow; pregelatinised maize starch
Oral
10 (starter pack), 30
(S4) Prescription Only Medicine
Urorec is indicated for the relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia in adult men
Visual Identification: An opaque yellow/opaque yellow size 3 hard gelatine capsule; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2017-05-23
UROREC ® 1 UROREC ® _silodosin _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about UROREC. 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 UROREC against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT UROREC IS USED FOR UROREC IS FOR USE BY MEN ONLY. UROREC is used for the relief of lower urinary tract symptoms associated with a medical condition called benign prostatic hyperplasia or BPH. BPH is a condition where the 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 • feeling that you cannot empty your bladder completely • delay before you start to pass urine • needing to pass urine often, especially at night • feeling that you must pass urine straight 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 silodosin. Silodosin belongs to a group of medicines called alpha-blockers. UROREC works by helping relax the smooth muscles in the prostate, in that way it improves flow of urine. This makes it easier for you to pass water and relieves your symptoms. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. UROREC is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE UROREC _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE UROREC IF YOU HAVE AN ALLERGY TO: • any medicine containing silodosin • a Soma hati kamili
v 4.0 1 AUSTRALIAN PRODUCT INFORMATION UROREC ® (SILODOSIN) CAPSULES 1. NAME OF THE MEDICINE Silodosin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION UROREC hard gelatin capsules contain either 4 mg or 8 mg of silodosin. 3. PHARMACEUTICAL FORM UROREC 4 mg is presented as yellow, opaque, hard gelatin capsules. UROREC 8 mg is presented as white, opaque, hard gelatin capsules. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS UROREC is indicated for the relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in adult men. 4.2. DOSE AND METHOD OF ADMINISTRATION DOSAGE The recommended dose is one capsule of UROREC 8 mg daily. METHOD OF ADMINISTRATION A capsule should be taken with food, preferably at the same time every day. It should not be broken or chewed but swallowed whole, preferably with a glass of water. DOSAGE ADJUSTMENT Use in the Elderly No dose adjustment is required in the elderly. Use in Renal Impairment No dose adjustment is required for patients with mild renal impairment (CL CR ≥ 60 to ≤ 89 ml/min; eGFR ≥ 60 to ≤ 89 ml/min/1.73 m 2 ; CKD stage G2). A starting dose of 4 mg once daily is recommended in patients with moderate renal impairment (CL CR ≥ 30 to ≤ 59 ml/min; eGFR ≥ 30 to ≤ 59 ml/min/1.73 m 2 ; CKD stage G3a and G3b). After a minimum of one week a dose increase may be considered. The dose can be v 4.0 2 carefully increased to 8 mg once daily depending on the individual patient’s response (see _section 4.4 Special Warnings and Precautions for Use_ and _section 5.2. Pharmacokinetic _ _Properties – Use in Renal Impairment_ ). The use in patients with severe renal impairment (CL CR < 30 ml/min; eGFR < 30 ml/min/1.73m 2 ; CKD stage G4 and G5) is not recommended (see _section 4.4. Special _ _Warnings and Precautions for Use_ ). Use in Hepatic Impairment No dose adjustment is required for patients with mild to moderate hepatic impairment. As no data are available, the use in patients with severe hepatic impairment is not recommended (see _ Soma hati kamili