AIRCORT Nasal spray, suspension Ref.[50135] Active ingredients: Budesonide

Special care is needed in patients with fungal and viral nasal infections. The use of corticosteroids in patients affected by tuberculosis must follow a careful evaluation of therapeutical advantages against potential adverse reactions. Because of the inhibitory effect of corticosteroids on the healing processes of skin lesions, patients with nasal ulcerations, recent nasal operations or nasal trauma, should be treated with topical nasal corticosteroids only after being completely cured.

Patients currently treated with oral steroids should be switched to nasal treatment with Aircort only under medical control in order to avoid pituitary-adrenal unbalance. Aircort must be added to the treatment and then gradually reduce the oral dose of steroids. Long term treatments in children should be avoided.

Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary for individual patients and between different corticosteroid preparations. Potential systemic effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

For those who practice sport activity: the use of the product without therapeutic need is classed under doping and may determine positive results to doping tests.

The influence of cimetidine on the kinetics and dynamics of budesonide after concomitant oral and intravenous administration is of minor clinical importance.

Administration during pregnancy should be avoided unless there are compelling reasons. In pregnant animals, administration of budesonide causes abnormalities of fetal development. As the relevance of this to man has not been established, the use of Aircort in pregnant women must be avoided, especially during the first three months of pregnancy.

There is no information available regarding the passage of budesonide into breast milk. As advised with all corticosteroids, the use of Aircort during breast-feeding should be avoided.

Aircort does not affect the ability to drive or use machines.

Clinical studies, scientific publications and post marketing experience indicate that the following undesirable effects may occur especially if administered at high dosage and for prolonged time:

None.