Salofalk Special Precautions





DCH Auriga
Full Prescribing Info
Special Precautions
Blood tests (differential blood count; liver function tests such as ALT or AST; serum creatinine) and dip stick urinalysis should be determined prior to and during treatment, at the discretion of the treating physician. As a guideline, further testing is recommended 14 days after commencement of treatment, then a further two to three times at intervals of 4 weeks.
If the findings are normal, control examinations should be carried out every three months. If additional symptoms occur, control examinations should be performed immediately.
Caution is recommended in patients with impaired hepatic function.
Salofalk are not recommended in patients with impaired renal function. Mesalazine-induced renal toxicity should be considered if renal function deteriorates during treatment.
Patients should be monitored for elevated methaemoglobin values.
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 sulfasalazine should be kept under close medical surveillance on commencement of a course of treatment with Salofalk. Should Salofalk cause acute intolerability reactions, such as abdominal cramps, acute abdominal pain, fever, severe headache and rash, therapy should be discontinued immediately. In isolated cases, hypersensitivity reactions principally in the form of respiratory problems may also be experienced by non-asthmatics due to potassium sulphite content of the enema.
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.
Photosensitivity: More severe reactions are reported in patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema.
Effects on ability to drive and use machines: Granules: No effects on the ability to drive and use machines have been observed.
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