国家: 以色列
语言: 英文
来源: Ministry of Health
ALFUZOSIN HYDROCHLORIDE
SANOFI ISRAEL LTD
G04CA01
TABLETS PROLONGED RELEASE
ALFUZOSIN HYDROCHLORIDE 10 MG
PER OS
Required
SANOFI WINTHROP INDUSTRIE, FRANCE
ALFUZOSIN
ALFUZOSIN
Treatment of certain functional symptoms of benign prostatic hypertrophy particularly if surgery has to be delayed for some reason. Adjuvant treatment to a catheter in acute urinary retention related to benign prostatic hypertrophy.
2021-07-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed by doctor’s prescription only XATRAL XL 10 MG PROLONGED-RELEASE TABLETS Each prolonged release tablet contains: alfuzosin HCl 10 mg. Inactive ingredients and allergens: see Section 6 ‘Additional information’. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine was prescribed for you. Do not pass it on to others. It can harm them even if it seems to you that their medical condition is similar to yours. The medicine is intended for men. This medicine is not intended for treating children and adolescents under 16 years of age. 1. WHAT IS THE MEDICINE INTENDED FOR? Xatral is used to treat symptoms of benign growth of the prostate, particularly if surgery is delayed, and as adjuvant treatment to a catheter in acute urinary retention related to benign prostatic hypertrophy. THERAPEUTIC GROUP: Xatral XL belongs to a group of medicines called alpha blockers, and it is a selective blocker of the α1 (alpha one) receptor. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE: • if you are sensitive (allergic) to alfuzosin or to any of the ingredients of the medicine (see Section 6) • if you have or have had orthostatic hypotension (sudden drop in blood pressure that occurs when suddenly getting up from a sitting or lying position) • in combination with other α1-blockers • if you have an impaired liver function SPECIAL WARNINGS RELATING TO USE OF THE MEDICINE TALK TO YOUR DOCTOR BEFORE TAKING THIS MEDICINE: • If you show symptoms of orthostatic hypotension (sudden drop in blood pressure when changing position). Orthostatic hypotension may occur in the first few hours after taking this medicine. This is especially common at the beginning of treatment and when you are also being treated for increased blood pressure or have a cardiac 阅读完整的文件
1/8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Xatral XL 10 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active substance is alfuzosin. Each tablet contains 10 mg alfuzosin hydrochloride. Excipient with known effect: each tablet contains 41.4 mg hydrogenated castor oil. For the 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 certain functional symptoms of benign prostatic hypertrophy (BPH), particularly if surgery has to be delayed for some reason. Adjuvant treatment to a catheter in acute urinary retention (AUR) related to benign prostatic hypertrophy. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Oral use. The tablet must be swallowed whole with a glass of water (see section 4.4 Special warnings and special precautions for use). BPH: The recommended dosage is one 10-mg tablet per day, to be taken immediately after the evening meal. AUR: The recommended dosage is one 10-mg tablet per day, to be taken after the evening meal, starting on the day of insertion of the urethral catheter. The treatment is administered for 3 to 4 days, with 2 to 3 days during catheterisation and 1 day following its removal. Paediatric patients 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 paediatric population. 4.3. CONTRAINDICATIONS - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 2/8 - Antecedents of orthostatic hypotension. - Combination with other alpha-1 blockers. - Hepatic insufficiency. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Warnings As with all 1 -blockers, orthostatic hypotension may occur during the first few hours after intake of the medicinal product, especially at the beginning of the treatment, especially in individuals treated wit 阅读完整的文件