Salofalk Special Precautions

Take special care with Salofalk.
Before taking Salofalk, caution should be exercised in case of: History of problems with the lungs, particularly if suffering from bronchial asthma; History of allergy to sulphasalazine, a substance related to mesalazine; Any liver problems; Any kidney problems.
Gastro-resistant tab 500 mg/PR granules/Supp: Severe skin rash or skin peeling, blistering and/or mouth sores after using mesalazine.
Gastro-resistant tab 500 mg/PR granules: 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, the patient may be kept under close medical supervision, and may need to have regular blood and urine tests.
Gastro-resistant tab: In rare cases, in patients who have undergone bowel resection/bowel surgery in the ileocoecal area with removal of the ileocoecal valve, it has been observed that Salofalk tablets are excreted undissolved in the stool, due to an excessively rapid passage through the bowel. Patients should seek medical attention if one notice this occurrence.
Gastro-resistant tab 500 mg/PR granules/Supp: Kidney stones may develop with use of mesalazine. Symptoms may include pain in sides of abdomen and blood in urine. It is advised to drink sufficient amount of liquid during treatment with mesalazine.
Serious skin reactions including Drug reaction with eosinophilia and systemic symptoms (DRESS) (Gastro-resistant tab 500 mg), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported in association with mesalazine treatment. Mesalazine should be stopped, and patients should seek medical attention if one notice any of the symptoms related to these serious skin reactions described in Side Effects.
Driving and using machines: There are no effects or negligible influence on the ability to drive and use machines.
Gastro-resistant tab: Salofalk tablets contain sodium: 250 mg: One Salofalk 250 mg tablet contains 2.1 mmol (48 mg) sodium. Take this into consideration if patient needs to be on a controlled sodium salt diet.
500 mg: The maximum recommended daily dose of this medicinal product contains 441 mg sodium (found in table salt). This is equivalent to 22% of the adult recommended maximum daily dietary intake for sodium. Caution should be exercised if there is a need for 7 or more Salofalk 500mg tablets daily for a prolonged period, especially if it is advised to follow a low salt (sodium) diet.
Gastro-resistant PR granules: Salofalk 1000 mg granules contain aspartame, sucrose and sodium.
This medicine contains 2 mg aspartame in each sachet of Salofalk 1000 mg granules. Aspartame is a source of phenylalanine. It may be harmful if patient has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
If the patient has an intolerance to some sugars, contact a 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: Salofalk 4g/60ml enemas contain potassium metabisulphite and sodium benzoate: This medicine contains potassium metabisulphite. It may therefore cause allergic reactions like allergic shock and bronchial constriction (bronchospasm) particularly if the patient suffers from asthma or have a history of allergies.
Salofalk 4g/60ml enemas also contain sodium benzoate which may provoke hypersensitivity reactions like irritation of the skin, eyes and mucous membranes.
Supp: 500 mg: Salofalk 500mg Suppositories contain cetyl alcohol: Cetyl alcohol can cause local skin irritation (e.g. contact dermatitis).