4.3 Contraindications
The word 'necrotising' has been deleted.
4.4 Special Warnings and Special Precautions for Use
The following paragraphs have been added -
Patients should be cautioned to minimise exposure to ultraviolet light.
Auranofin has not been co-administered with other disease modifying agents such as penicillamine, levamisole and chloroquine/hydrochloroquine and, therefore, concomitant use cannot be recommended.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Enterocolitis is a rare but potentially serious side effect, the development of diarrhoea with rectal bleeding or rectal bleeding alone unless rapidly explained otherwise mandates the immediate cessation of therapy. Patients should be warned to seek medical advice as soon as possible if they develop these symptoms.
4.5 Interaction with other Medicinal products and other forms of Interaction
'None stated' has been deleted and the following paragraphs added -
Specific experience of interactions with auranofin is lacking. However, the theoretical potential for interaction with gold therapy, both oral and parenteral, should be considered.
Concomitant therapy with metal antagonists and potentially nephrotoxic or haemotoxic drugs should be administered with caution. Such drugs include penicillamine, aminoglycosides, amphotericin B, penicillins, phenylbutazone, phenytoin, sulfonamides, NSAIDs, acyclovir and alcohol.
Drugs affecting GI motility and those which are highly protein-bound may alter the absorption and binding, respectively, of auranofin.
4.8 Undesirable Effects
The following paragraph has been deleted -
Ulcerative enterocolitis has been very rarely reported (<0.01%), as with all gold containing drugs. Therefore patients with gastrointestinal symptoms should be carefully monitored for the appearance of gastrointestinal bleeding and treatment stopped if this occurs. See table.
In the table, the name Ulcerative enterocolitis has been changed to Enterocolitis. Also Dizziness and Colitis have been added.
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