Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
Blood tests (differential blood count; liver function parameters such as ALT or AST; serum creatinine) and urinary status (dip-sticks) should be determined prior to and during treatment, at the discretion of the treating physician. 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 3 months. If additional symptoms occur, these tests should be performed immediately.
Renal impairment
Asacol should not be used in patients with renal impairment. Asacol-induced renal toxicity shall be suspected if the renal function is impaired during the treatment and the treatment should be stopped immediately.
It is recommended that the renal function is monitored prior to and repeatedly whilst on Asacol therapy.
Nephrolithiasis
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.
Urine Discoloration
Mesalazine may produce red-brown urine discoloration after contact with sodium hypochlorite bleach (e.g., in toilets cleaned with sodium hypochlorite contained in certain bleaches).


Severe cutaneous adverse reactions
Severe cutaneous adverse reactions (SCARs), including Drug reaction with eosinophilia and systemic symptoms (DRESS) Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment. Mesalazine should be discontinued, at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity.
Blood dyscrasia
Very rarely have serious blood dyscrasia been reported. Asacol therapy should be stopped immediately if there is a suspicion or evidence of blood dyscrasia (signs of unexplained bleeding, bruising, purpura, anaemia, persistent fever or sore throat), and the patient should seek immediate medical advice.
Liver impairment
There have been reports of increased liver enzyme levels in patients taking preparations containing Asacol. Caution is recommended if Asacol is administered to patients with liver impairment.
Cardiac hypersensitivity reactions
Asacol-induced hypersensitivity reactions (myo- and pericarditis) have been reported rarely with Asacol. In case of a suspected cardiac hypersensitivity, Asacol must not be reintroduced. Caution should be taken in patients with previous myo- or pericarditis of allergic background regardless of its origin.
Pulmonary disease
Patients with pulmonary disease, in particular asthma, should be very carefully monitored during treatment with Asacol.
Hypersensitivity to sulphasalazine
Patients with a history of adverse drug reactions to sulphasalazine, therapy should be kept under close medical supervision. Treatment must be stopped immediately if acute symptoms of intolerance occur such as abdominal cramps, acute abdominal pain, fever, severe headache and rash.
Gastric and duodenal ulcers
Caution is recommended when treating patients with active gastric or duodenal ulcer.
Asacol contains sodium
Each tablet contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.
Elderly patients
Asacol should be administered with caution in elderly patients, it should only be given to patients with normal renal or hepatic function or mild to moderate renal or hepatic impairment (see section 4.3).
Paediatric population
There is only limited documentation for an effect in children, see section 4.2.


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