- Approval Id
- 9ccbb97e48ebcd03
- Drug Name
- SALOFALK GASTRO-RESISTANT PROLONGED-RELEASE GRANULES 500MG/ SACHET
- Product Name
- SALOFALK GASTRO-RESISTANT PROLONGED-RELEASE GRANULES 500MG/ SACHET
- Approval Number
- SIN14426P
- Approval Date
- 2013-11-08
- Registrant
- DCH AURIGA SINGAPORE
- Licence Holder
- DCH AURIGA SINGAPORE
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- GRANULE, DELAYED RELEASE
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p><em>Adults and the elderly</em><br>
<u>For the treatment of acute episodes of ulcerative colitis</u><br>
Once daily, 1 sachet of Salofalk granules 3g, 1–2 sachets of Salofalk granules 1.5g, 3 sachets of Salofalk granules 1g or 3 sachets of Salofalk granules 500mg (equivalent to 1.5–3.0 g mesalazine daily) preferably to be taken in the morning according to the individual clinical requirement.<br>
It is also possible to take the prescribed daily dose in three divided doses (1 sachet of Salofalk granules 500mg 3 times daily or 1 sachet of Salofalk granules 1g 3 times daily) if this is more convenient to the patient.</p>
<p><u>For the maintenance of remission of ulcerative colitis</u><br>
The standard treatment is 0.5 g mesalazine 3 times daily (in the morning, at midday and in the evening) corresponding to a total dose of 1.5 g mesalazine per day.</p>
<p><em>Paediatric population</em><br>
There is only limited documentation for an effect in children (age 6–18 years).</p>
<p><u>Children 6 years of age and older</u><br>
<strong>Active disease:</strong> To be determined individually, starting with 30–50 mg/kg bw/day once daily preferably in the morning or in divided doses. Maximum dose: 75 mg/kg bw/day. The total dose should not exceed the maximum adult dose.</p>
<p><strong>Maintenance treatment:</strong> To be determined individually, starting with 15–30 mg/kg bw/day in divided doses. The total dose should not exceed the recommended adult dose.</p>
<p>It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg and the normal adult dose to those above 40 kg.</p>
<p><u>Method of administration</u><br>
The contents of the sachets of Salofalk granules should not be chewed. The granules should be taken on the tongue and swallowed, without chewing, with plenty of liquid.</p>
<p>Both in the treatment of acute inflammatory episodes and during long term treatment, Salofalk granules should be used on a regular basis and consistently in order to achieve the desired therapeutic effects.</p>
<p>The duration of use is determined by the physician.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>For the treatment of acute episodes and the maintenance of remission of ulcerative colitis.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Salofalk granules are contra-indicated in patients with</p>
<ul class="dash">
<li>hypersensitivity to the active substance, to salicylates 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>severe impairment of hepatic or renal function.</li>
</ul>
- Atc Code
- A07EC02
- Atc Item Name
- mesalazine
- Pharma Manufacturer Name
- DCH AURIGA SINGAPORE
