Страна: Израел
Език: английски
Източник: Ministry of Health
ALFUZOSIN HYDROCHLORIDE
SANOFI ISRAEL LTD
G04CA01
TABLETS SUSTAINED RELEASE
ALFUZOSIN HYDROCHLORIDE 5 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
2023-03-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) -1986 The medicine is dispensed by doctor’s prescription only XATRAL SR 5 MG SUSTAINED-RELEASE TABLETS Each Xatral SR 5 mg tablet contains: alfuzosin HCl 5 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 SR is used to treat symptoms of benign growth of the prostate, particularly if surgery is delayed. THERAPEUTIC GROUP: Xatral 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 reduced 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 disorder. It may be associated with the following symptoms: dizziness, fatigue, and sweating. In this case, you should Прочетете целия документ
1/8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Xatral SR 5 mg sustained-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active substance is alfuzosin. Each tablet contains 5 mg alfuzosin hydrochloride. Excipient with known effect: each tablet contains 19.6 mg hydrogenated castor oil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pale yellow biconvex film coated sustained release tablet for oral administration. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Treatment of certain functional symptoms of benign prostatic hypertrophy, particularly if surgery has to be delayed for some reason 4.2. POSOLOGY AND METHOD OF ADMINISTRATION _ORAL USE _ _ _Xatral SR 5mg tablet must be swallowed whole with a glass of water. The first dose of Xatral SR 5mg tablet should be given just before bedtime. _Adults: _ The usual dose is one Xatral SR 5 mg tablet morning and evening _Elderly patients (over 65 years) or patients treated for hypertension:_ As a systematic precaution, it is recommended that treatment be started with one Xatral SR 5 mg tablet in the evening and that the dosage then be increased on the basis of the patient individual response, without exceeding the maximum dosage of one Xatral SR 5mg tablet morning and evening. Some patients should receive a lower dose of XATRAL, in particular the following patient groups: - Renal insufficiency - Hepatic insufficiency If lower dose is not optional, the physician should consider alternative therapies for these patients. 2/8 _Paediatric population _ The efficacy of Xatral in children aged 2 to 16 years has not been established (see section 5.1). Therefore Xatral is not indicated for use in paediatric patients. 4.3. CONTRAINDICATIONS - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Antecedents of orthostatic hypotension. - Combination with other alpha-blockers. - Hepatic insufficiency. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Warnings As with all 1 -bl Прочетете целия документ