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XATRAL SR TABLET 5 mg

Prescription Only
Drug type: Therapeutic
ATC code: G04CA01
Dosage form: TABLET, EXTENDED RELEASE
Route of administration: ORAL
Active ingredient: ALFUZOSIN HCl; ALFUZOSIN HCL

Therapeutic indications

Treatment of functional symptoms of benign prostatic hyperplasia.

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

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 useplease 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.

Registrant
SANOFI-AVENTIS SINGAPORE PTE. LTD.
Approval Date
1997-11-21
Approval Number
SIN09546P
Manufacturer
SANOFI WINTHROP INDUSTRIE
Licence Holder
SANOFI-AVENTIS SINGAPORE PTE. LTD.