Product Defect Correction

Boehringer Ingelheim is advising customers for the potential for the dose counter to stop counting after the 10^th dose and not lock after the 60^th dose. The batches affected are:

The potentially affected batches have been distributed in Australia from September 2023 onwards.

This issue does not affect any other batches of SPIRIVA RESPIMAT^® or SPIOLTO RESPIMAT^®.

What’s the problem?

There have been a small number of technical product complaints (five) in overseas markets related to the product above. In each of the cases the dose indicator of Spiriva Respimat stopped counting after the delivery of approximately 10 doses. While the device continued to deliver the appropriate dose to patients beyond the 10th dose, the dose counter did not reflect these additional doses, and the device did not automatically lock after the delivery of 60 doses.

There have been no reports of this defect to date in Australia.

What are the risks?

The potential medical risks include repeated actuations and inhalations if a patient gets confused by the non-moving dose counter. This could lead to overdose of the medication. There is also a risk of underdosing if lower doses are delivered after the cartridge should have locked and required replacement.

What should patients do?

If you do experience this issue DO NOT stop using your medicine, you should return the product to your place of purchase or contact Boehringer Ingelheim Medical Information on 1800 226 315 or medinfo.syd@boehringer-ingelheim.com. Please continue to use the device to administer the medication as directed (without any additional doses) until you receive a replacement so that your medication remains uninterrupted.

Further Information

For pharmaceutical technical product complaints please contact the Boehringer Ingelheim Medical Information on 1800 226 315 or medinfo.syd@boehringer-ingelheim.com