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.

Caution is recommended in patients with impaired hepatic function.

Mesalazine should not be used in patients with impaired renal function.
Mesalazine-induced renal toxicity should be considered if renal function deteriorates during treatment. If this is the case, Rafassal granules should be discontinued immediately.

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.

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).

Serious blood dyscrasias have been reported very rarely with mesalazine.
Hematological investigations should be performed if patients suffer from unexplained haemorrhages, bruises, purpura, anaemia, fever or pharyngolaryngeal pain. Rafassal granules should be discontinued in case of suspected or confirmed blood dyscrasia.

Cardiac hypersensitivity reactions (myocarditis, and pericarditis) induced by mesalazine have been rarely reported. Rafassal granules should then be discontinued immediately.

Patients with pulmonary disease, in particular asthma, should be very carefully monitored during a course of treatment with mesalazine.

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.

Patients with a history of adverse drug reactions to preparations containing sulphasalazine should be kept under close medical surveillance on commencement of a course of treatment with mesalazine. Should Rafassal Granules cause acute intolerance reactions, such as abdominal cramps, acute abdominal pain, fever, severe headache and rash, therapy should be discontinued immediately.

Rafassal Granules contain aspartame. Rafassal 1 gram Granules contains 2mg aspartame in each sachet, Rafassal 1.5 gram Granules contains 3mg aspartame in each sachet and Rafassal 3 gram Granules contains 6mg aspartame in each sachet. Aspartame is a source of phenylalanine. It may be harmful in patients with phenylketonuria (PKU).


Rafassal Granules contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase-isomaltase insufficiency should not take these medicines.

This medicine contains less than 1 mmol sodium (23mg) per sachet, that is to say essentially 'sodium-free'.

Effects on Driving

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