- Approval Id
- e492b343aa2f4859
- Drug Name
- SALOFALK 500 TABLET 500 MG
- Product Name
- SALOFALK 500 TABLET 500 MG
- Approval Number
- SIN09340P
- Approval Date
- 1997-05-20
- Registrant
- DCH AURIGA SINGAPORE
- Licence Holder
- DCH AURIGA SINGAPORE
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- ENTERIC COATED TABLET
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p><em>Adults</em><br>
Depending upon the clinical requirements in individual cases, the following daily doses are recommended:</p>
<img src="/TGIF/Salofalk-Table1_290825.png" alt="Salofalk Dosage Table 1" /><br><br>
<p><u>Method of administration</u><br>
Salofalk 500mg should be taken in the morning, at midday and in the evening, 1 hour before meals. They should be swallowed whole, not chewed, and taken with plenty of fluid.</p>
<p>Treatment with Salofalk 500mg should be administered regularly and consistently, both during the acute inflammatory stage and during maintenance therapy in order to achieve the desired therapeutic effect.</p>
<p>The duration of use is determined by the physician.<br>
An acute exacerbation of ulcerative colitis or Crohn’s disease generally subsides after 8–12 weeks.</p>
<p>For relapse prophylaxis of ulcerative colitis the dose can usually be reduced to 1.5 g mesalazine/day.</p>
<p><u>Note</u><br>
In rare cases, in patients who have undergone bowel resection/ bowel surgery in the ileocoecal region with removal of the ileocoecal valve, it has been observed that Salofalk 500mg, gastro-resistant tablets, were excreted undissolved in the stool, due to an excessively rapid intestinal passage.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<ul class="dash">
<li>Ulcerative colitis: treatment of acute exacerbations and relapse prophylaxis</li>
<li>Crohn’s disease: treatment of acute exacerbations</li>
</ul>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Salofalk 500mg must not be administered to patients with</p>
<ul class="dash">
<li>known hypersensitivity to the active substance, salicylates or 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>severe impairment of hepatic or renal function.</li>
</ul>
- Atc Code
- A07EC02
- Atc Item Name
- mesalazine
- Pharma Manufacturer Name
- DCH AURIGA SINGAPORE
