Blood tests (differential blood count; liver function parameters such as ALT or AST; serum creatinine) and urine status (test strips/sediment) 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.
Effects on ability to drive and use machines: No effects on the ability to drive and use machines have been observed.
Patients with pulmonary disease, in particular asthma, should be very carefully monitored during a course of treatment with Salofalk.
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: Salofalk 250mg/500mg should not be used in patients with impaired renal function. Mesalazine-induced renal toxicity should be considered, if renal function deteriorates during treatment.
Salofalk 250 mg/500 mg should not be used in children under 6 years of age.
1 Salofalk 250 mg tablet contains 2.1 mmol (48 mg) sodium. This must be taken into consideration in patients on a sodium-controlled (low-sodium/low-salt) diet.
Suppository: Salofalk suppositories should not be used in patients with impaired renal function. Mesalazine induced renal toxicity should be considered, if renal function deteriorates during treatment.
Cetyl alcohol, an excipient of Salofalk 500 mg suppositories can cause local skin irritation (e.g. contact dermatitis).
Enema: Salofalk enemas should not be used in patients with renal function. Mesalazine-induced renal toxicity should be considered, if renal function deteriorates during treatment.
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.
Gastro-resistant prolonged release granules: Salofalk granules 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 phenylketonuria, it should be kept in mind that Salofalk Granules contain aspartame as a sweetening agent, equivalent to 0.56 mg (Salofalk granules 500 mg), 1.12 mg (Salofalk granules 1 g), 1.68 mg (Salofalk granules 1.5g) and 3.36 mg (Salofalk granules 3g) phenylalanine.