Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Alfuzosin hydrochloride
Sun Pharma UK Ltd
G04CA01
Alfuzosin hydrochloride
10mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040100; GTIN: 5015525222917
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VASRAN XL 10 MG PROLONGED-RELEASE TABLETS Alfuzosin hydrochloride WHAT IS IN THIS LEAFLET : 1. What Vasran XL 10 mg prolonged release tablets are and what they are used for 2. What you need to know before you take Vasran XL 10 mg prolonged release tablets 3. How to take Vasran XL 10 mg prolonged release tablets 4. Possible side effects 5. How to store Vasran XL 10 mg prolonged release tablets 6. Contents of the pack and other information 1. WHAT VASRAN XL 10 MG PROLONGED RELEASE TABLETS ARE AND WHAT THEY ARE USED FOR Alfuzosin belongs to a group of medicines called alpha- blockers. Alfuzosin can be used to treat the symptoms of BENIGN PROSTATE HYPERPLASIA . This is when the prostate gland enlarges (hyperplasia), but the growth is not cancerous (it is benign). It can cause problems in passing water (urine). This happens mainly in older men. - The prostate gland lies underneath the bladder. It surrounds the urethra. This is the tube that takes your water to the outside of the body. - If the prostate gets bigger it presses on the urethra making it smaller. This makes it difficult to pass water. - Your tablets work by relaxing the prostate gland muscle. This allows the urethra to get bigger and so makes it easier to pass water. In a few patients with benign prostatic hyperplasia, the prostate gland gets so big that it stops the flow of urine completely. This is called ACUTE URINARY RETENTION. - This is very painful and you may need a short stay in hospital. - A thin, flexible tube (catheter) is passed into the bladder. This drains the water and relieves the pain. - During this time, alfuzosin may be used to help the water to flow again. This has READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist - This medicine has been prescribed for you only. Do not pass it on to others. It may harm Прочетете целия документ
OBJECT 1 VASRAN XL 10 MG PROLONGED-RELEASE TABLETS Summary of Product Characteristics Updated 21-Oct-2016 | Ranbaxy (UK) Limited a Sun Pharmaceutical Company 1. Name of the medicinal product Vasran XL 10 mg prolonged-release tablets. 2. Qualitative and quantitative composition Each tablet contains 10 mg alfuzosin hydrochloride. Excipients with known effect: lactose For the full list of excipients, see section 6.1. 3. Pharmaceutical form Prolonged-release tablet. White to off-white, round, uncoated, biconvex tablets with flattened edges, debossed with 'RY 10' on one side. 4. Clinical particulars 4.1 Therapeutic indications Treatment of moderate to severe functional symptoms of benign prostate hyperplasia (BPH). As an adjunct therapy in connection with catheterisation in acute urinary retention (AUR) related to BPH. 4.2 Posology and method of administration Posology: _Adults:_ BPH: The recommended dose is one 10 mg prolonged-release tablet daily. AUR: One 10 mg prolonged-release tablet daily after a meal to be taken from the first day of catheterisation. Efficacy in the long-term treatment of AUR has not been established. _Older people (over the age of 65 years)_ The recommended dose is the same as that for adults. Pharmacokinetic and clinical safety studies have shown that dose adjustment is not necessary in the case of elderly patients. _Patients with renal impairment_ Based on pharmacokinetic and clinical safety data, patients with renal insufficiency (creatinine clearance ≥30 ml/min) can be treated with the usual dose. Alfuzosin 10 mg should not be given to patients with severely impaired renal function (creatinine clearance < 30 ml/min) as there are no clinical safety data available for this patient group (see section 4.4). _Hepatic insufficiency:_ Alfuzosin, given as 10 mg prolonged-release tablets are contraindicated in patients with hepatic insufficiency. Preparations containing a low dose of alfuzosin hydrochloride might be used in patients with mild to moderate hepatic insufficiency as instructed in the Прочетете целия документ