Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
ALFUZOSIN HYDROCHLORIDE
Teva Pharma B.V.
G04CA01
ALFUZOSIN HYDROCHLORIDE
10 Milligram
Tablet Prolonged Release
Product subject to prescription which may be renewed (B)
alfuzosin
Not marketed
2007-08-10
common-pl-10 mg / CCSI und QRD – September 2014 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TEVAX 10 mg, prolonged release tablets Alfuzosin hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - 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 TEVAX 10 mg is and what it is used for 2. What you need to know before you take TEVAX 10 mg 3. How to take TEVAX 10 mg 4. Possible side effects 5. How to store TEVAX 10 mg 6. Contents of pack and other information 1. WHAT TEVAX 10 MG IS AND WHAT IT IS USED FOR This drug belongs to the group of medicines called 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEVAX 10 MG DO NOT TAKE TEVAX 10 MG, PROLONGED RELEASE TABLETS: - if you are allergic to alfuzosin, other quinazoline (e.g. terazosin, doxazosin) 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 hepatic impairment (liver function disorder); - if you are taking other medicines belonging to the group called alpha1-blockers (e.g. tamsulosin). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking TEVAX 10 mg, - if you have severe kidney problems. - if you take other medicines to treat high blood pressure. In this case your doctor will check your blood pressure regularly, especially at the beginning o Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT TEVAX 10 mg, prolonged release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One prolonged release tablet contains 10 mg of alfuzosin hydrochloride. Excipient with known effect : each tablet contains 8 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release tablet. White, round, bevelled-edges tablets. 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 _Adults:_ The recommended dose is one 10 mg tablet daily _Elderly (over 65 years)_ As adults. Pharmacokinetic and clinical safety data demonstrate that dose reduction is usually not necessary to elderly patients. _Renal impairment_ Mild to moderate renal insufficiency (creatinine clearance > 30 ml/min) Dose reduction is usually not necessary (see section 5.2). Severe renal insufficiency (creatinine clearance < 30 ml/min) Tevax 10 mg prolonged-release tablets 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_ Tevax given as 10 mg prolonged release tablets are contraindicated in patients with hepatic insufficiency. After careful medical consideration, a preparation containing a lower dose of alfuzosin hydrochloride might be considered appropriate. Refer to the corresponding product information for dosing instructions. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Lestu allt skjalið