Nazione: Regno Unito
Lingua: inglese
Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)
Alfuzosin hydrochloride
Waymade Healthcare Plc
G04CA01
Alfuzosin hydrochloride
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040100
PATIENT INFORMATION LEAFLET ALFUZOSIN HYDROCHLORIDE 2.5MG TABLETS 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 symptoms 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). IN THIS LEAFLET: 1. What alfuzosin is and what it is used for 2. What you need to know befor e you take alfuzosin 3. How to take alfuzosin 4. Possible side effects 5. How to store alfuzosin 6. Contents of the pack and other information 1. WHAT ALFUZOSIN IS AND WHAT IT IS USED FOR WHAT ALFUZOSIN IS The name of your medicine is Alfuzosin Hydrochloride 2.5mg Tablets (called alfuzosin throughout this leaflet). This belongs to a group of medicines alpha-blockers. HOW ALFUZOSIN WORKS Alfuzosin can be used to treat the symptoms of BENIGN PROSTATIC HYPERTROPHY. 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 blad Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alfuzosin Hydrochloride 2.5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5mg alfuzosin hydrochloride. Excipients: Each tablet contains 61 mg lactose anhydrous. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. White round, film coated tablet for oral administration marked Xatral 2.5 on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of the functional symptoms of benign prostatic hypertrophy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Alfuzosin Hydrochloride 2.5mg Tablets should be swallowed whole. The first dose should be given just before bedtime. Adults The usual dose is one tablet three times daily. The dose may be increased to a maximum of 4 tablets (10mg) per day depending on the clinical response. Elderly and treated hypertensive patients As a routine precaution when prescribing alfuzosin to elderly patients (aged over 65 years) and the treated hypertensive patient, the initial dose should be 1 tablet in the morning and 1 tablet in the evening. Renal insufficiency In patients with renal insufficiency, as a precaution, it is recommended that the dosing be started at Alfuzosin Hydrochloride 2.5mg Tablets twice daily adjusted according to clinical response. Hepatic insufficiency In patients with mild to moderate hepatic insufficiency, it is recommended that therapy should commence with a single dose of Alfuzosin Hydrochloride 2.5mg Tablets/day to be increased to Alfuzosin Hydrochloride 2.5mg Tablets twice daily according to clinical response. Paediatric population Efficacy of alfuzosin has not been demonstrated in children aged 2 to 16 years (see section 5.1). Therefore, alfuzosin is not indicated for use in the paediatric population. Lactose Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 4.3 CONTRAINDICATIONS • Hypersensitivity to the acti Leggi il documento completo