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Spiriva Respimat is used for the maintenance treatment of chronic obstructive pulmonary disease (COPD) (including chronic bronchitis and emphysema) and asthma. It is sold as an inhalation solution in an inhaler device that counts the doses provided, up to a maximum of sixty doses.
Boehringer Ingelheim Pty Ltd is advising customers of a problem with some batches of this medicine. There have been reports of the dose counter stopping after the 10th dose and not locking after the 60th dose.
The dose counter is still functional, and the device will continue delivering doses after the 10th dose, but the counter does not move any further. It remains as showing only 10 doses delivered.
If you experience this problem, do not stop using your medicine. The Respimat device will continue to deliver the approved dose of your medication. The product is not being recalled, as this would lead to a shortage in the market. However, health professionals and patients need to be aware of this problem to ensure safe use and avoid harms.
Batches affected are:
| Batch no. | Manufacturing date | Expiry date |
|---|---|---|
| E96634 | Oct 2022 | Oct 2025 |
| E63130 | Dec 2022 | Dec 2025 |
| E61076 (samples) | Nov 2022 | Nov 2025 |
What do I need to do?
If your Spiriva Respimat is from any of the above batches, you can continue to use it. However, should the dose counter stop after the 10th dose, you should return the product to your place of purchase or contact Boehringer Ingelheim’s Medical Information line on 1800 226 315 to arrange a replacement.
Please continue to use your medicine as directed until you receive a replacement. Do not take additional doses if you become confused as to the number provided.
What are the risks?
Confusion caused by the dose counter not working correctly could lead to either an overdose (due to the dose counter not changing), or inadequate / underdosing (due to the ‘lock out’ function not working).
If you have any concerns about this problem, please talk to your pharmacist or doctor.
Further information
For further information please contact Boehringer Ingelheim’s Medical Information line on 1800 226 315 # or visit the Boehringer Ingelheim website - external site.
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to our monitoring of these products.
We cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.