1. NAME OF THE MEDICINAL PRODUCTBudenisone Budesonide-R Aerosol

2. QUALITATIVE AND QUANTITATIVE COMPOSITIONEach metered dose (ex-valve)/actuation contains Budesonide-R 100 micrograms.

3. ContraindicationsHistory of hypersensitivity to budesonide R or any of the excipients. Active pulmonary tuberculosis. Special care is needed in patients with quiescent pulmonary tuberculosis and with fungal and viral infections in the airways.Budesonide R has also been shown to decrease airway reactivity to histamine and methacholine in hyperreactive patients.

4.HPA axis function Studies in healthy volunteers with inhaled budesonide R (administered as a dry powder via Turbohaler) have shown dose-related effects on plasma and urinary cortisol. At recommended doses Pulmicort Turbohaler causes less effect on adrenal function than prednisolone 10 mg, as shown by ACTH tests.