Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Alfuzosin hydrochloride
Teva UK Ltd
G04CA01
Alfuzosin hydrochloride
10mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040100; GTIN: 5017007314158
Top of page cut-off to middle of registration mark: 44 mm. PAGE 1: FRONT FACE (INSIDE OF REEL) Pharma code 891 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT pressure. You should discuss with your doctor whether to continue or stop your treatment with Fuzatal ® XL, especially when the chest pain recurs or worsens - if you have an abnormal heart rhythm called QTc prolongation (long QT) or you are taking medicines likely to increase the risk of QTc prolongation. Tell your doctor if you suffer from this condition or are taking any other medicines. - if you are over 65. This is due to the increased risk of developing low blood pressure (hypotension) and related side effects in elderly patients. - if you are undergoing eye surgery because of cataract (cloudiness of the lens) please inform your eye specialist before the operation that you are using or have previously used Fuzatal ® XL. This is because Fuzatal ® XL may cause complications during the surgery which can be managed if your specialist is prepared in advance. OTHER MEDICINES AND FUZATAL ® XL Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine, including medicines obtained without a prescription. Fuzatal ® XL and some medicines may interfere with each other. These include: - other medicines that belong to the group of alpha-blockers: you must not take such medicines at the same time as Fuzatal ® XL (see “Do not take Fuzatal ® XL” above) - ketoconazole and itraconazole (medicines used to treat fungal infections) and ritonavir (medicine used to treat HIV - certain antibiotic drugs (clarithromycin, erythromycin) - medicines you receive before an operation (general anaesthetics). Your blood pressure can drop markedly. If you have to undergo an operation, please tell the doctor that you are taking Fuzatal ® XL. FUZATAL ® XL WITH FOOD AND DRINK The tablet should be taken immediately after the same meal each day. PREGNANCY AND BREAST-FEEDING Fuzatal ® XL is only intended for men. DRIVING AND USING MACHINE Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fuzatal ® XL 10mg 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 Posology 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) Alfuzosin 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 Alfuzosin 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. _Paediatric population _ Efficacy of alfuzosin has not been demonstrated in children aged 2 to 16 years (see section 5.1).Therefore, alfuzosin 10 mg prolonged release tablets is not indicated for use in paediatric population.There is no relevant indication for use of Alfuzosine 10 mg prolonged release tablets in children. Method of administration Oral use. The prolonged-release tablet should be swallowed whole with a sufficient amount of fluid (e.g. Läs hela dokumentet