Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET
**Posology and method of administration** Benign Prostatic Hypertrophy (BPH): The recommended dosage is one 10-mg tablet per day, to be taken immediately after the evening meal. Adjuvant treatment to a catheter in the first episode of acute urinary retention related to benign prostatic hypertrophy: The recommended dosage is one 10-mg tablet per day, to be taken after a meal, from the first day of catheterization onwards. The treatment is administered for 3 to 4 days, i.e. 2 to 3 days while the catheter is in place and 1 day after it is removed. 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_).
ORAL
Medical Information
**Therapeutic indications** Treatment of the functional symptoms of benign prostatic hypertrophy (BPH). Adjuvant treatment to a catheter in first episode of acute urinary retention (AUR) related to benign prostatic hypertrophy (BPH).
**Contraindications** This medicine must not be administered in the following situations: - hypersensitivity to alfuzosin and/or any of the other ingredients; - postural hypotension, - liver failure; - severe kidney failure (creatinine clearance <30 ml/min), - in combination with ritonavir - Concomitant administration with potent CYP3A4 inhibitors
G04CA01
alfuzosin
Manufacturer Information
SANOFI-AVENTIS SINGAPORE PTE. LTD.
SANOFI WINTHROP INDUSTRIE
Active Ingredients
Documents
Package Inserts
Xatral XL tablet 10mg PI.pdf
Approved: November 5, 2018