Special Warning : אזהרת שימוש

4.4     Special warnings and precautions for use
Caution is recommended when treating patients allergic to sulphasalazine (risk of allergy to salicylates). Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment. In case of acute symptoms of intolerance, i.e. abdominal cramps, abdominal pain, fever and severe headache, and/or the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other signs of hypersensitivity, the treatment should be discontinued immediately.

Caution is recommended in patients with impaired liver function. Liver function parameters like ALT or AST should be assessed prior to and during treatment, at the discretion of the treating physician.

The drug is not recommended for use in patients with impaired renal function and in patients with haemorrhagic diathesis. Baseline renal function measurement is required in all patients initiating treatment with mesalazine. Urinary status (dip sticks) should be determined prior to and during treatment at the discretion of the treating physician. The renal function should be regularly monitored (e.g. serum creatinine), especially during the initial phase of treatment based on clinical judgment taking baseline renal function into account. Mesalazine-induced renal toxicity should be suspected in patients developing renal dysfunction during treatment.
The concurrent use of other known nephrotoxic agents, such as NSAIDs and azathioprine, may increase the risk of renal reactions. Treatment should be discontinued if renal function deteriorates.
Caution is recommended in patients with active peptic ulcer.
Patients with pulmonary disease, in particular asthma, should be very carefully monitored during a course of treatment please refer to section 4.8..

Mesalazine induced cardiac hypersensitivity reactions (myo- and pericarditis) have been reported rarely. Serious blood dyscrasias have been reported very rarely with mesalazine (see section 4.5). Blood tests for differential blood counts is recommended prior to and during treatment, at the discretion of the treating physician. Treatment should be discontinued on suspicion or evidence of these adverse reactions.
Cases of nephrolithiasis have been reported with the use of mesalazine including stones with a 100% mesalazine content. It is recommended to ensure adequate fluid intake during treatment.

As a guideline, follow-up tests are recommended 14 days after commencement of treatment, then a further two to three tests at intervals of 4 weeks. If the findings are normal, follow-up tests should be carried out every three months. If additional symptoms occur, these tests should be performed immediately.

Effects on Driving

4.7     Effects on ability to drive and use machines
PENTASA has no or negligible influence on the ability to drive and use machines.