Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
ALFUZOSIN HYDROCHLORIDE
Rowex Ltd
G04CA; G04CA01
ALFUZOSIN HYDROCHLORIDE
10 milligram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Alpha-adrenoreceptor antagonists; alfuzosin
Not marketed
2006-04-28
PACKAGE LEAFLET: INFORMATION FOR THE USER ALFUZOSIN HYDROCHLORIDE ROWEX 10 MG PROLONGED-RELEASE TABLETS Alfuzosin 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. 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 Alfuzosin hydrochloride Rowex is and what it is used for 2. What you need to know before you take Alfuzosin hydrochloride Rowex 3. How to take Alfuzosin hydrochloride Rowex 4. Possible side effects 5. How to store Alfuzosin hydrochloride Rowex 6. Contents of the pack and other information 1. WHAT ALFUZOSIN HYDROCHLORIDE ROWEX IS AND WHAT IT IS USED FOR Alfuzosin hydrochloride Rowex belongs to a group of medicines called alpha-adrenoreceptor antagonists or alpha-blockers. It is used to treat moderate to severe symptoms caused by an enlarged prostate gland, a condition that is also called benign prostatic hyperplasia. Enlarged prostate glands can cause urinary problems such as frequent and difficult urination, especially at night. Alpha-blockers relax the muscles in the prostate and bladder neck. This allows urine to flow out of the bladder more easily. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALFUZOSIN HYDROCHLORIDE ROWEX DO NOT TAKE ALFUZOSIN HYDROCHLORIDE ROWEX if you are allergic to alfuzosin, other quinazolines (e.g. terazosin, doxazosin, prazosin) or any of the other ingredients of this medicine (listed in section 6). if you suffer from conditions that cause a marked drop in blood pressure when standing up. if you have liver problems. if you take other medicines that belong to the group of alpha-blo Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alfuzosin hydrochloride Rowex 10 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg alfuzosin hydrochloride. Excipients with known effect: Each tablet contains 8 mg Lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. White, round, bevelled-edge, uncoated tablets, approximately 10mm in diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of moderate to severe functional symptoms of benign prostatic hyperplasia (BPH). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The prolonged-release tablet should be swallowed whole with a sufficient amount of fluid. _Adults_ 1 prolonged-release tablet 10 mg once daily. The first dose should be taken at bedtime. The tablet should be taken immediately after the same meal each day. _Older people (over 65 years)_ As adults. Pharmacokinetic and clinical safety data demonstrate that dose reduction is usually not necessary to elderly patients. _Reduced renal function_ Mild to moderate renal insufficiency (creatinine clearance 30ml/min): Dose reduction is usually not necessary (see section 5.2). Severe renal insufficiency (creatinine clearance < 30ml/min): Alfuzosin hydrochloride Rowex 10 mg should not be given to patients with severely impaired renal function as there are no clinical safety data available for this patient group (see section 4.4). _Hepatic insufficiency_ Alfuzosin hydrochloride Rowex given as 10 mg prolonged release tablets are contraindicated in patients with hepatic insufficiency. Preparations containing a low dose alfuzosin hydrochloride might be used in patients with mild to moderate hepatic insufficiency as instructed in the corresponding product information. _Paediatric population_ Efficacy of alfuzosin has not been demonstrated in children aged 2 to 16 years (see section 5.1). Therefore, alfuzosin is 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 U T H O R I T Y ___ __ Διαβάστε το πλήρες έγγραφο