| In section 4.2 (Posology and method of administration) ulcerative colitis and Crohn's disease have been added.
In section 4.3 (Contraindications) Text updated to read 'sulfasalazine is contraindicated in' Infants under the age of two years. Patients with a known hypersensitivity to sulfasalazine, its metabolites or any of the excipients as well as sulfonamides, salicylates or the sodium benzoate preservative. Patients with porphyria.
In section 4.4 (Special warnings and precautions for use): Added text includes a precaution that complete blood counts, liver function tests and assessment of renal function be performed in all patients before starting therapy and during first 3 months of therapy and thereafter as clinically needed. Pallor, purpura and jaundice have been added to the list for immediate reporting as the may indicate myelosupression, haemolysis or hepatoxicity. Deleted text: haematological and hepatic side effects may occur. Differential white cell, red cell and platelet cell should be performed initially and at least monthly for a minimum of the first three months of treatment. The sentence regarding stopping of treatment has been shortened to remove ‘if there is a suspicion or laboratory evidence of a potentially serious blood dyscrasia’ and now includes ‘whilst awaiting blood test results’. Further reference to ‘liver function tests being carried out at monthly intervals, caution in liver disease and checking of kidney function at regular intervals’ has been removed. The reference to oligospermia and infertility no longer includes 'changes in blood picture can be normalised by the administration of folic acid or folinic acid. The occurrence in men has been noted. A precaution for use in impaired hepatic, renal function and blood dyscrasias has been added. A caution with use in severe allergy and bronchial asthma has been included. A precaution regarding the inhibition of absorption and metabolism of folic acid has been added. Risks for crystalluria and kidney stone formation have also been added.
In section 4.5 (Interaction with other medicinal products and other forms of interaction). The text regarding the absorption of digoxin has been reworded. Deleted text: Uptake of digoxin and folate may be reduced. Adequate fluid intake and avoidance of acidification of the urine may minimise crystalluria and stone formation.
In section 4.6 (Pregnancy and lactation): The sub-heading 'pregnancy' has been removed. Information regarding use in pregnancy and lack of evidence of harm to the foetus has been included A reference to the risk of folic acid deficiency has been added. A section on lactation has been added.
In section 4.8 (Undesirable Effects) the text has been arranged by class and frequency.
In section 10 (Date of Revision of the Text) the date has been updated to 11 March 2010
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