Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
ALFUZOSIN HYDROCHLORIDE
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
G04CA01
ALFUZOSIN HYDROCHLORIDE 10 mg
PROLONGED-RELEASE TABLET
ALFUZOSIN HYDROCHLORIDE 10 mg
POM
UROLOGICALS
Authorised
2014-04-11
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER ZOCHEK 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 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 Zochek is and what it is used for 2. What you need to know before you take Zochek 3. How to take Zochek 4. Possible side effects 5. How to store Zochek 6. Contents of the pack and other information 1. WHAT ZOCHEK IS AND WHAT IT IS USED FOR Zochek belongs to a group of medicines called alpha-1-blockers. Zochek 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. Zochek works by relaxing the prostate gland muscle. This reduces the narrowing of the urethra and so makes it easier to pass urine. In a few patients with benign prostatic hypertrophy, 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, Citiți documentul complet
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Zochek 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). Adjunctive therapy with urethral catheterisation for Acute Urinary Retention related to BPH. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults: _ BPH: The recommended dose is one 10 mg prolonged-release tablet once daily to be taken after a meal. Acute urinary retention: One 10mg tablet daily after a meal to be taken from the first day of catheterisation. The treatment should be administered for 3-4 days, 2-3 days during catheterisation and 1 day after catheter removal. In this indication, No benefit on progression of acute urinary retention has been established in patients under 65 years of age or if treatment is extended beyond 4 days. _Elderly (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). Page 2 of 9 _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. _ _ _Hepatic insufficiency: _ Alfuzosin, given as 10 mg prolonged-release tablets are contraindicated in patients with hepatic insufficiency (see section 4.3). Preparations Citiți documentul complet