Salofalk Special Precautions

Tablet/Enema: 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.
Salofalk 500mg tablets/enemas should not be used in patients with impaired renal function. Mesalazine-induced renal toxicity should be considered, if renal function deteriorates during treatment.
Patients with pulmonary disease, in particular asthma, should be very carefully monitored during a course of treatment with Salofalk 500mg tablets/enemas.
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 Salofalk 500mg tablets/enemas. Should Salofalk 500mg tablets/enemas cause acute intolerance reactions such as abdominal cramps, acute abdominal pain, fever, severe headache and rash, therapy should be discontinued immediately.
Tablet/Granules: Photosensitivity: More severe reactions are reported in patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema.
Tablet: 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.
Note: In rare cases, in patients who have undergone bowel resection/bowel surgery in the ileocoecal region with removal of the ileocoecal valve, it has been observed that Salofalk 500 mg tablets were excreted undissolved in the stool, due to an excessively rapid intestinal passage.
This medicinal product contains 49 mg sodium per tablet, equivalent to 2.5% of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 22% of the WHO recommended maximum daily intake for sodium. Salofalk 500 mg tablets are considered high in sodium. This should be particularly taken into account for those on a low salt diet.
Granules: In patients with phenylketonuria, it should be kept in mind that Salofalk granules contain aspartame as a sweetening agent, equivalent to 0.56 mg (Salofalk 500mg granules), 1.12 mg (Salofalk 1000mg granules), 1.68 mg (Salofalk 1.5g granules) and 3.36 mg (Salofalk 3g granules) phenylalanine.
Enema: Due to their potassium metabisulphite content, Salofalk enemas can provoke allergic reactions with anaphylactic symptoms and bronchial constriction (bronchospasm) in sensitive patients, particularly in those with asthma or a history of allergies.
Because the product contains sodium benzoate, it may provoke hypersensitivity reactions in suitably predisposed patients in the form of irritation of the skin, eyes and mucous membranes.
Effects on ability to drive and use machines: No effects on the ability to drive and use machines have been observed.