Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
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. Tamsulosin hydrochloride tablet 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 10mL/min. - Concurrent use of another α1-adrenoceptor inhibitor.
G04CA02
tamsulosin
Manufacturer Information
TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
Teva Pharmaceutical Works Private Limited Company
Active Ingredients
Documents
Package Inserts
Tamsulosin-Teva Prolonged Release tablet 400mcg PI.pdf
Approved: May 11, 2021