Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
ALFUZOSIN HYDROCHLORIDE
Milpharm Limited
G04CA01
ALFUZOSIN HYDROCHLORIDE
10 Milligram
Tablet Prolonged Release
Product subject to prescription which may be renewed (B)
Alpha-adrenoreceptor antagonists
Authorised
2014-08-08
PACKAGE LEAFLET: INFORMATION FOR THE USER ALFU 10 MG PROLONGED-RELEASE TABLETS alfuzosine hydrochloride 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 them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Alfu is and what it is used for 2. What you need to know before you take Alfu 3. How to take Alfu 4. Possible side effects 5. How to store Alfu 6. Contents of the pack and other information 1. WHAT ALFU IS AND WHAT IT IS USED FOR Alfu belongs to a group of medicines called alpha-1-blockers. Alfu is used to treat moderate to severe symptoms of Benign Prostate Hyperplasia. This is a condition where the prostate gland enlarges (hyperplasia), but the growth in itself is not cancerous (benign). It occurs most often in older men. The prostate gland is situated under the bladder surrounding the urethra (the tube that takes your urine to the outside of the body). With age, the prostate gland may grow and press the urethra making it smaller. This may cause problems with urination such as frequent urination and difficulty in passing urine. Alfu works by relaxing the prostate gland muscle. This reduces the narrowing of the urethra and so makes it easier to pass urine. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALFU DO NOT TAKE ALFU - if you are allergic to alfuzosine or the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include: a rash, swelling of your lips, throat, or tongue, difficulty in swallowing or breathing. - If you are allergic (hypersensitive) to alfuzosin-equivalent substances (such as terazosin, doxazos সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alfu 10 mg Prolonged-release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 10 mg alfuzosin hydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. White to off-white round (diameter 8.1 mm), biconvex, film-coated tablets debossed with ‘X’ on one side and ‘47’ on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of moderate to severe functional symptoms of benign prostate hyperplasia (BPH). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral Use The prolonged-release tablet should be taken whole with sufficient amount of fluid (e.g. a glass of water). The prolonged-release tablets must not be crushed, chewed or divided (see section 4.4). The first dose should be taken at bedtime. The prolonged-release tablet 10 mg should be taken immediately after the same meal each day. _Adults:_ The recommended dose is one 10 mg prolonged-release tablet daily. _Elderly patients (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. _Impaired renal function_ Mild to moderate renal insufficiency (creatinine clearance > 30 ml/min): Dose reduction is usually not necessary (see section 5.2). _Severe renal insufficiency_ 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 corresponding product information. H E A L T H P R O D U C T S R E G U L A T O R Y A সম্পূর্ণ নথি পড়ুন