Salofalk Special Precautions

Tablet: Blood tests (differential blood count; liver function parameters such as transaminases; serum creatinine) and urine status (dip sticks/sediments) should be checked before and during treatment, at the discretion of the doctor. As a guideline, controls are recommended 14 days after starting treatment, then a further two to three times at intervals of 4 weeks.
If the findings are normal, follow-up tests are required every three months. If additional symptoms develop, tests must be performed immediately. The recommended kidney function tests are serum urea (BUN) and creatinine assay as well as urine sediment test.
Caution is recommended in patients with impaired hepatic function.
Salofalk 500 mg enteric coated tablets should not be used in patients with impaired renal function. Mesalazine-induced renal toxicity should be considered, if renal function deteriorates during treatment.
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 Enteric-coated tablet 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of intolerability e.g. cramps, acute abdominal pain, fever, severe headache and skin rash occur, treatment must be withdrawn immediately.
Granules: 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 three 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, Salofalk 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. Salofalk 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. Salofalk granules must 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 sulfasalazine should be kept under close medical surveillance on commencement of a course of treatment with mesalazine. Should Salofalk granules cause acute intolerance reactions, such as abdominal cramps, acute abdominal pain, fever, severe headache and rash, therapy should be discontinued immediately.
This medicine contains 3 mg aspartame in each sachet of Salofalk 1.5 g granules. Aspartame is a source of phenylalanine. It may be harmful in patients with phenylketonuria (PKU).
Salofalk 1.5 g granules contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially 'sodium-free'.
Effects on ability to drive and use machines: Mesalazine has no influence or negligible influence on the ability to drive and use machines.