Salofalk Special Precautions

Before using Salofalk: Caution should be exercised in patients who have a history of lung problems, particularly those suffering from bronchial asthma; who have a history of allergy to sulphasalazine; who suffer with liver problems; who suffer with kidney problems; who have ever developed a severe skin rash or skin peeling, blistering &/or mouth sores after using mesalazine.
Mesalazine may produce red-brown urine discoloration after contact with sodium hypochlorite bleach in the toilet water. It concerns a chemical reaction between mesalazine and bleach and is harmless.
Further precautions: During treatment, patients may be kept under close medical supervision, and regular blood and urine tests may need to be performed.
Kidney stones may develop with use of mesalazine. Symptoms may include pain in sides of abdomen and blood in urine. Patients should take care to drink sufficient amounts of liquid during treatment with mesalazine.
Serious skin reactions 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. Patients should stop using mesalazine and seek medical attention immediately if they notice any of the symptoms related to these serious skin reactions described in Side Effects.
Driving and using machines: Salofalk has no or negligible influence on the ability to drive and use machines.
Gastro-resistant prolonged-release granules: Aspartame, sucrose and sodium: This medicine contains 2 mg aspartame in each sachet of Salofalk 1000mg granules. Aspartame is a source of phenylalanine. It may be harmful in patients who have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Salofalk 1000mg granules contain sucrose. Patients who have been told by their doctor that they have an intolerance to some sugars should contact their doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially 'sodium-free'.
Enema: Potassium metabisulphite and sodium benzoate: Salofalk 4g/60ml enemas contain potassium metabisulphite. Potassium metabisulphite may rarely cause severe hypersensitivity reactions and bronchospasm.
This medicinal product contains 60 mg sodium benzoate in each enema. Sodium benzoate may cause local irritation.