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Suppository: Gastrointestinal side effects: Abdominal discomfort, diarrhoea, flatulence, nausea and vomiting have been reported rarely.
Central nervous system side effects: In isolated cases under treatment with mesalazine central nervous phenomena such as headache and dizziness have been observed.
Hypersensitivity reactions: Hypersensitivity reactions that are not dose-dependent and are common to salicylic acid and its derivatives such as allergic rush, drug fever, bronchospasm, peri- and myocarditis, acute pancreatitis and interstitial nephritis are possible in rare cases.
Sporadic cases of allergic alveolitis have been observed during treatment with mesalazine. In isolated cases pancolitis may occur.
Under certain conditions, some drugs with a similar chemical structure to mesalazine may cause a lupus erythematosus-like syndrome. Thus, the onset of this syndrome cannot be ruled out under treatment with Salofalk 500 mg suppositories.
Other side effects: Myalgia and arthralgia have been observed rarely.
Elevated methaemoglobin levels cannot be excluded on account of the chemical structure of the active constituent.
In isolated cases changes in the blood count (aplastic anemia, agranulocytosis, pancytopenia, neutropenia, leucopenia, thrombocytopenia) have been reported after the use of drugs containing mesalazine.
There have been occasional reports of inflammation of the liver (hepatitis), in rare cases changes in liver function parameters (elevated transaminase levels) occur.
Note: Salofalk 500 mg suppositories should be taken under medical supervision. A blood count and urine status should be performed at the attending physician's discretion during treatment. As a general guideline we recommend tests 14 days after beginning treatment, and then another 2 to 3 times at 4-weekly intervals.
If the findings are normal, follow-up tests are required every three months or if additional signs of illness occur. The recommended kidney function tests are serum urea (BUN) and creatinine assays as well as urine sediment tests.
Patients should be monitored for elevated methaemoglobin values.
In patients with pulmonary function disturbances, in particular asthma, close medical supervision is necessary during treatment with drugs containing mesalazine.
Treatment with Salofalk 500 mg suppositories should only be started under medical supervision in patients with known hypersensitivity to preparations containing sulphasalazine. If acute signs of intolerability, e.g. cramps, acute abdominal pain, fever, severe headache and skin rash occur, treatment must be withdrawn immediately.
Enema: The following undesirable effects have been observed ater administration of mesalazine: (See Table 3.)
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