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- XATRAL SR TABLET 5 MG [SIN09546P]
XATRAL SR TABLET 5 MG [SIN09546P]
Active ingredients: XATRAL SR TABLET 5 MG
Product Info
XATRAL SR TABLET 5 MG
[SIN09546P]
Product information
Active Ingredient and Strength | ALFUZOSIN HCL - 5 MG |
Dosage Form | TABLET, EXTENDED RELEASE |
Manufacturer and Country | SANOFI WINTHROP INDUSTRIE - FRANCE |
Registration Number | SIN09546P |
Licence Holder | SANOFI-AVENTIS SINGAPORE PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | G04CA01 |
Therapeutic indications
Treatment of functional symptoms of benign prostatic hyperplasia.
Dosage and method of administration
Oral use.
The tablet must be swallowed whole with a glass of water
(see Special warnings and special precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Adults
One XATRAL SR 5 mg tablet morning and evening.
In elderly patients 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’s individual response, without exceeding the maximum dosage of one XATRAL SR 5 mg tablet morning and evening.
Patients with impaired liver function: it is recommended that treatment be started with one XATRAL 2.5 mg tablet per day and that the dosage then be increased on the basis of the patient’s individual response, without exceeding one XATRAL 2.5 mg tablet twice daily.
Contraindications
This medicinal product must not be administered in the following situations:
hypersensitivity to alfuzosin and/or any of the other ingredients;
postural hypotension;
severe liver failure (class C in the Child-Pugh classification);
severe kidney failure (creatinine clearance <30 ml/min),
in combination with ritonavir
concomitant administration with potent CYP3A4 inhibitors
