País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Alfuzosin hydrochloride
DE Pharmaceuticals
G04CA01
Alfuzosin hydrochloride
10mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040100
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER XATRAL ® XL 10MG TABLETS (alfuzosin hydrochloride) Your medicine is available using the name Xatral XL 10mg Tablets but will be referred to as Xatral XL throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Xatral XL is and what it is used for 2. Before you take Xatral XL 3. How to take Xatral XL 4. Possible side effects 5. How to store Xatral XL 6. Further information 1. WHAT XATRAL XL IS AND WHAT IT IS USED FOR The name of your tablets is Xatral XL. This belongs to a group of medicines called alpha-blockers. Xatral XL can be used to treat the symptoms of BENIGN PROSTATIC HYPERPLASIA. 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 bladder. This drains the water and relieves Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xatral XL 10 mg prolonged release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg alfuzosin hydrochloride. Excipient: Hydrogenated castor oil For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged release tablet. Round biconvex, three layer tablet: one white layer between two yellow layers. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of the functional symptoms of benign prostatic hypertrophy (BPH). For information on use in acute urinary retention (AUR) related to BPH see sections 4.2 and 5.1. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Xatral XL should be swallowed whole (see section 4.4). BPH: The recommended dose is one 10mg tablet to be taken once daily after a meal. AUR: In patients 65 years and older, one 10 mg 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 its removal. In this indication no benefit has been established in patients under 65 years of age or if treatment is extended beyond 4 days. Paediatric Population Efficacy of Xatral XL has not been demonstrated in children aged 2 to 16 years (see section 5.1). Therefore Xatral XL is not indicated for use in the paediatric population. 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substance or to any of the excipients (see Section 6.1 List of excipients); • history of orthostatic hypotension; • combination with other alpha-1 receptor blockers; • hepatic insufficiency. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As with all alpha-1-blockers in some subjects, in particular patients receiving antihypertensive medications or nitrates, postural hypotension with or without symptoms (dizziness, fatigue, sweating) may develop within a few hours following administration. In such cases, the patient should lie down until the symptoms have completely disappeared. These effects are transient Leia o documento completo