The Italian Medicines Agency (AIFA) wishes to draw attention on important changes in the product information of medicinal products containing salbutamol and ipratropium bromide in fixed-dose combination (0.375% + 0.075%).

Following a review of the efficacy and safety data of these medicinal products, the indications have been limited to the treatment of bronchospasm in adult patients with chronic obstructive pulmonary disease (COPD) who require regular treatment with both ipratropium bromide and salbutamol. Therefore, the use of medicines based on this combination has been restricted to the adult population (>18 years of age). Use in children and adolescents is no longer indicated.

The restriction was necessary because of an increase in adverse events, often serious, due to medication errors in the use of the medicine, particularly in paediatric patients. Current clinical practice guidelines 1 do not recommend the use of the fixed combination of salbutamol/ipratropium in children with asthma. Salbutamol is one of the agents used for rapid relief of asthma symptoms (phase 1), while ipratropium bromide may be considered for the treatment of severe exacerbations (phase 2) in combination with ß2 agonists at a dose to be determined according to the child's age. If necessary, paediatric patients can be treated with the two available monotherapy products containing the two separate active ingredients to allow for dose adjustment according to the patient's needs.
The Summary of Product Characteristics and Package Leaflet of all medicinal products based on salbutamol and ipratropium bromide in fixed combination (0.375% + 0.075%) have been updated to reflect changes to the therapeutic indications and the safety information have been updated to currently available evidence.