- Approval Id
- df33b05a1a80f94d
- Drug Name
- HARNAL OCAS PROLONGED RELEASE FILM-COATED TABLET 400MCG
- Product Name
- HARNAL OCAS PROLONGED RELEASE FILM-COATED TABLET 400MCG
- Approval Number
- SIN13696P
- Approval Date
- 2009-08-21
- Registrant
- ASTELLAS PHARMA SINGAPORE PTE. LTD.
- Licence Holder
- ASTELLAS PHARMA SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong><br>
One tablet daily.</p>
<p>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.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS</strong><br>
For the relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong></p>
<ul>
<li>Hypersensitivity to tamsulosin hydrochloride, including drug-induced angioedema or any other component of the product.</li>
<li>A history of orthostatic hypotension.</li>
<li>Severe hepatic impairment (Child-Pugh scores >9).</li>
<li>Severe renal impairment with creatinine clearance of less than 10 mL/min.</li>
<li>Concurrent use of another α1-adrenoceptor inhibitor.</li>
</ul>
- Atc Code
- G04CA02
- Atc Item Name
- tamsulosin
- Pharma Manufacturer Name
- ASTELLAS PHARMA SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/astellas-pharma-singapore-pte-ltd
