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SALOFALK 500 SUPPOSITORIES 500 MG [SIN09296P]
Active ingredients: SALOFALK 500 SUPPOSITORIES 500 MG
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Product Info
SALOFALK 500 SUPPOSITORIES 500 MG
[SIN09296P]
Product information
Active Ingredient and Strength | MESALAZINE - 500 MG |
Dosage Form | SUPPOSITORY |
Manufacturer and Country | CORDEN PHARMA FRIBOURG AG, ZWEIGNIEDERLASSUNG ETTINGEN - SWITZERLAND |
Registration Number | SIN09296P |
Licence Holder | DCH AURIGA SINGAPORE |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | A07EC02 |
4.1 Therapeutic indications
Treatment of acute episodes of ulcerative colitis that is limited to the rectum.
4.2 Posology and method of administration
Posology
Adults and elderly
For the treatment of acute episodes of ulcerative colitis
One Salofalk 500 mg suppository is inserted into the rectum three times daily (equivalent to 1500 mg mesalazine daily), according to the individual clinical requirement.
Children and adolescents
There is little experience and only limited documentation for an effect in children.
Method of administration
When used three times daily, Salofalk 500 mg suppositories should be inserted into the rectum in the morning, at midday and at bedtime.
Treatment with Salofalk suppositories must be administered regularly and consistently, because only in this way can healing be successfully achieved.
An acute episode of ulcerative colitis generally subsides within 8 – 12 weeks. The duration of use is determined by the physician.
4.3 Contraindications
Salofalk suppositories are contraindicated in patients with
known hypersensitivity to the active substance, salicylates or to 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
