RENATA PLC (BANGLADESH)🇸🇬 Health Sciences Authority
Approval Date
Jul 3, 2025
Approval ID
12dbc1e738006b01
Company
RENATA PLC (BANGLADESH)
Type
Therapeutic
Approval Details
Approval Id
12dbc1e738006b01
Drug Name
XOLINE TABLET 500MCG
Product Name
XOLINE TABLET 500MCG
Approval Number
SIN17275P
Approval Date
2025-07-03
Registrant
SEA PHARMA CONSULTANCY PTE LTD
Licence Holder
SEA PHARMA CONSULTANCY PTE LTD
Drug Type
Therapeutic
Forensic Classification
Prescription Only
Dosage Form
TABLET
Dosage
<p><strong>4.2 Posology and method of administration</strong><br>
<strong><u>Posology</u></strong><br>
<u>Adults</u><br>
Treatment of acute gout attack:<br>
1 mg (2 tablets of 500 micrograms) to be taken initially followed by 500 micrograms every two to three hours until pain subsides. A total dose of 6 mg should not be exceeded. After completion of a course, another course should not be started for at least three days.</p>
<p><u>Patients with renal impairment</u><br>
Use with caution in patients with mild renal impairment. For patients with moderate renal impairment, reduce dose or increase interval between doses. Such patients should be carefully monitored for adverse effects of colchicine (see also section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).<br>
For patients with severe renal impairment, see section 4.3.</p>
<p><u>Patients with hepatic impairment</u><br>
Use with caution in patients with mild/moderate hepatic impairment. Such patients should be carefully monitored for adverse effects of colchicine.<br>
For patients with severe hepatic impairment, see section 4.3.</p>
<p><u>Elderly</u><br>
Use with caution.</p>
<p><u>Method of administration</u><br>
For oral administration<br>
Tablets should be swallowed whole with a glass of water.</p>
Route Of Administration
ORAL
Indication Info
<p><strong>4.1 Therapeutic indications</strong><br>
Adults<br>
Treatment of acute gout.</p>
Contraindications
<p><strong>4.3 Contraindications</strong></p>
<ul>
<li>Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</li>
<li>Patients with blood dyscrasias</li>
<li>Pregnancy</li>
<li>Breastfeeding</li>
<li>Women of childbearing potential unless using effective contraceptive measures</li>
<li>Patients with severe renal impairment</li>
<li>Patients with severe hepatic impairment</li>
<li>Colchicine should not be used in patients undergoing haemodialysis since it cannot be removed by dialysis or exchange transfusion.</li>
<li>Colchicine is contraindicated in patients with renal or hepatic impairment who are taking a P-glycoprotein (P-gp) inhibitor or a strong CYP3A4 inhibitor (see section 4.5 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
</ul>
