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SALOFALK 500 TABLET 500 MG [SIN09340P]
Active ingredients: SALOFALK 500 TABLET 500 MG
Last updated 26 October 2025
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Product Info
SALOFALK 500 TABLET 500 MG
[SIN09340P]
Product information
Active Ingredient and Strength | MESALAZINE - 500 MG |
Dosage Form | ENTERIC COATED TABLET |
Manufacturer and Country | LOSAN PHARMA GMBH - GERMANY |
Registration Number | SIN09340P |
Licence Holder | DCH AURIGA SINGAPORE |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | A07EC02 |
4.1 Therapeutic indications
Ulcerative colitis: treatment of acute exacerbations and relapse prophylaxis
Crohn’s disease: treatment of acute exacerbations
4.2 Posology and method of administration
Posology
Adults
Depending upon the clinical requirements in individual cases, the following daily doses are recommended:
Method of administration
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.
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.
The duration of use is determined by the physician.
An acute exacerbation of ulcerative colitis or Crohn’s disease generally subsides after 8–12 weeks.
For relapse prophylaxis of ulcerative colitis the dose can usually be reduced to 1.5 g mesalazine/day.
Note
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.
4.3 Contraindications
Salofalk 500mg must not be administered to patients with
known hypersensitivity to the active substance, salicylates or any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
severe impairment of hepatic or renal function.