Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
Reports of renal impairment, including minimal change nephropathy, acute / chronic interstitial nephritis and renal failure have been associated with preparations containing mesalazine and pro-drugs of mesalazine. Mezavant should be used with caution in patients with confirmed mild to moderate renal impairment. It is recommended that all patients have an evaluation of renal function prior to initiation of therapy and at least twice a year, while on treatment.

Patients with chronic lung function impairment, especially asthma, are at risk of hypersensitivity reactions and should be closely monitored.

Following mesalazine treatment, serious blood dyscrasias have been reported rarely.
If the patient develops unexplained bleeding, bruising, purpura, anaemia, fever or sore throat, haematological investigations should be performed. If there is suspicion of blood dyscrasia, treatment should be terminated. (See sections 4.5 and 4.8).

Mesalazine induced cardiac hypersensitivity reactions (myo- and pericarditis) have been reported rarely with Mezavant and with other mesalazine containing preparations. Caution should be used in prescribing this medication to patients with conditions predisposing to the development of myo- or pericarditis. If such hypersensitivity reaction is suspected, products containing mesalazine must not be reintroduced.

Mesalazine has been associated with an acute intolerance syndrome that may be difficult to distinguish from a flare of inflammatory bowel disease. Although the exact frequency of occurrence has not been determined, it has occurred in 3% of patients in controlled clinical trials of mesalazine or sulphasalazine. Symptoms include cramping, acute abdominal pain and bloody diarrhoea, sometimes fever, headache and rash. If acute intolerance syndrome is suspected, prompt withdrawal is required and products containing mesalazine must not be reintroduced.

There have been reports of increased liver enzyme levels in patients taking preparations containing mesalazine. Caution is recommended if Mezavant is administered to patients with hepatic impairment.

Caution should be exercised when treating patients allergic to sulphasalazine due to the potential risk of cross sensitivity reactions between sulphasalazine and mesalazine.
Organic or functional obstruction in the upper gastrointestinal tract may delay onset of action of the product.

Interference with Laboratory Tests
Use of mesalazine may lead to falsely elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection, because of the similarity in the chromatograms of normetanephrine and mesalazine’s main metabolite, N-acetylaminosalicylic acid (N-Ac-5-ASA). An alternative, selective assay for normetanephrine should be considered.

Effects on Driving

4.7     Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Mezavant is considered to have negligible influence on these abilities.