Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

Mild to moderate renal impairment
Given that the metabolites of para-aminosalicylic acid are largely excreted via glomerular filtration, caution is warranted in patients with mild to moderate renal impairment (see also section 4.3).

Gastric ulcer
Para-aminosalicylic acid should be used with caution in patients with peptic ulcer.

Hepatic impairment
Para-aminosalicylic acid should be used with caution in patients with hepatic impairment.
Hepatic toxicity
Para-aminosalicylic acid may cause hepatitis. The first symptoms usually appear within three months of the start of therapy with a rash as the most common adverse reaction followed by fever and much less frequently by gastrointestinal disturbances of anorexia, nausea or diarrhoea. Treatment should be stopped immediately in this case.

Hypersensitivity
The patient must be monitored carefully during the first three months of therapy and treatment must be discontinued immediately at the first sign of a rash, fever or other premonitory signs of intolerance.
See section 4.2 for posology adjustments for desensitization.

Hypothyroidism in HIV co-infected patients
Para-aminosalicylic acid may be associated with an increased risk of hypothyroidism in HIV co-infected patients. Thyroid function should be monitored in HIV co-infected patients before commencing treatment and regularly during treatment, in particular when para-aminosalicylic acid is co-administered with ethionamide/prothionamide.

Patients should be advised that the skeletons of the granules may be seen in the stools.

Effects on Driving

4.7   Effects on ability to drive and use machines
Para-aminosalicylic acid must be used with caution. Para-aminosalicylic acid may affect the ability to drive and use machines.