Information Letter on Spiolto Respimat: Possibly defective dose indicator
2024.03.01
Active substance: tiotropium bromide/olodaterol hydrochloride
The company Boehringer Ingelheim Pharma GmbH & Co. KG informs about possibly defective dose indicators in the batches E44551A and E56624 of the medicinal product Spiolto Respimat 2.5 micrograms/2.5 micrograms. After the delivery of approximately 10 doses, the dose indicator may stop counting at a remaining display of about 50 doses. In addition, the Respimat is not automatically locked after the delivery of 60 doses. Despite the error, a correct amount of medication is delivered by the inhaler. According to the root cause analysis, only a limited number of packages of the concerned batches are potentially affected by the defect.
The Respimat (spray nebulizer) used for inhalation with the possible defect was also used for batches of the medicinal product Spiriva Respimat (active substance: tiotropium bromide). BfArM informs that batches of the parallel imported medicinal products Spiolto Respimat and Spiriva Respimat may therefore also be affected by this defect.