Regulatory Information
ASTELLAS PHARMA SINGAPORE PTE. LTD.
ASTELLAS PHARMA SINGAPORE PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
TABLET, FILM COATED, EXTENDED RELEASE
**DOSAGE AND ADMINISTRATION** One tablet daily. The tablet must be swallowed whole and not be broken, crunched or chewed, as this compromises the prolonged release properties of the tablet for the active ingredient. Harnal® OCAS can be taken on an empty stomach, or before, with or after food.
ORAL
Medical Information
**INDICATIONS** For the relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
**CONTRAINDICATIONS** - Hypersensitivity to tamsulosin hydrochloride, including drug-induced angioedema or any other component of the product. - A history of orthostatic hypotension. - Severe hepatic impairment (Child-Pugh scores >9). - Severe renal impairment with creatinine clearance of less than 10 mL/min. - Concurrent use of another α1-adrenoceptor inhibitor.
G04CA02
tamsulosin
Manufacturer Information
ASTELLAS PHARMA SINGAPORE PTE. LTD.
Astellas Pharma Europe B.V.
Active Ingredients
Documents
Package Inserts
Harnal OCAS PI.pdf
Approved: February 14, 2020