Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Alfuzosin hydrochloride
Necessity Supplies Ltd
G04CA01
Alfuzosin hydrochloride
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040100
PATIENT INFORMATION LEAFLET XATRAL ® 2.5MG FILM-COATED TABLETS (alfuzosin hydrochloride) _ _ 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. The name of your medicine is Xatral 2.5mg Film-coated Tablets, but will be referred to as Xatral throughout the remainder of the leaflet. IN THIS LEAFLET: 1. What Xatral is and what it is used for 2. Before you take Xatral 3. How to take Xatral 4. Possible side effects 5. How to store Xatral 6. Further information 1. WHAT XATRAL XL IS AND WHAT IT IS USED FOR The name of your tablets is Xatral. This belongs to a group of medicines called alpha-blockers. Xatral 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. 2. BEFORE YOU TAKE XATRAL DO NOT TAKE XATRAL IF: • You are allergic (hypersensitive) to alfuzosin or any of the other ingredients of Xatral (see Section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, throat, or tongue. • You are taking another alpha-blocker. See section below on ‘Taking Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xatral 2.5 mg film coated tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5mg alfuzosin hydrochloride. Excipient: Lactose For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film coated tablet White round tablet 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 Xatral 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 Xatral 2.5mg 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 Xatral 2.5mg/day to be increased to Xatral 2.5mg 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. 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substance or any of the excipients (see Section 6.1 List of excipients); • history of orthostatic hypotension; • combination with other alpha-1 receptor blockers; • severe hepatic insufficiency. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As with all alpha-1-blockers, in some subjects, in particular patients receiving antihypertensive med Lugege kogu dokumenti