Salofalk Special Precautions

Blood tests (differential blood count; liver function parameters such as ALT or AST; serum creatinine) and urinary status (test strips/sediment for gastro-resistant tablet; dip sticks for suppository/enema/gastro-resistant prolonged-release granules) 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 hepatic dysfunction.
Salofalk should not be used in patients with impaired renal function. Mesalazine-induced renal toxicity should be considered, if renal function deteriorates during treatment.
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.
Patients with pulmonary disease, in particular asthma, should be very carefully monitored during a course of treatment with Salofalk.
Severe cutaneous adverse reactions: Severe cutaneous adverse reactions (SCARs), including 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 Salofalk. Should Salofalk cause acute intolerance reactions such as abdominal cramps, acute abdominal pain, fever, severe headache and rash, therapy should be discontinued immediately.
Gastro-resistant tablet: This medicinal product contains 49 mg sodium per tablet, equivalent to 2.5% of the WHO recommended maximum daily intake of sodium. The maximum daily dose of this product is equivalent to 22% of the WHO recommended maximum daily intake of sodium. Salofalk 500 mg tablets are considered high in sodium. This should be particularly taken into account for those on a low salt diet.
Suppository: Cetyl alcohol, an excipient of Salofalk 500 mg suppositories can cause local skin irritation (e.g. contact dermatitis).
Enema: Salofalk 2 g/30 ml enemas contain potassium metabisulphite which may rarely cause severe hypersensitivity reactions and bronchospasm.
Each Salofalk 2 g/30 ml enema contains 30 mg sodium benzoate. Sodium benzoate may cause local irritation.
Gastro-resistant prolonged-release granules: This medicine contains 3 mg/6 mg aspartame in each sachet of Salofalk granules 1.5 g/3 g. Aspartame is a source of phenylalanine. It may be harmful in patients with phenylketonuria (PKU).
Salofalk granules contain sucrose. Patient with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take medicines.
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: No effects on the ability to drive and use machines have been observed.
Use in Children: Gastro-resistant tablet: Salofalk 500 mg should not be used in children under 6 years of age.