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a alert imageMay 30 2018

Health professionals are being asked to ensure patients using Braltus (tiotropium) know how to put the capsule in a Zonda inhaler.

An MHRA alert says there is a risk of the capsule being inhaled if it is placed in the incorrect chamber. This follows two reports of patients having inhaled a Braltus capsule from the mouthpiece into the back of the throat, “resulting in coughing and risking aspiration or airway obstruction.”

The MHRA is advising health professionals should: 

  • train patients in the correct use of their inhaler – a placebo device is available for training purposes from Teva Medical Information (on This email address is being protected from spambots. You need JavaScript enabled to view it. or 0207 540 7117), and instructions for patients are provided in the patient information leaflet and on the carton;
  • tell patients to store capsules in the screw-cap bottle provided (never in the inhaler) and to always check the mouthpiece is clear before inhaling;
  • pharmacists dispensing Braltus capsules should remind patients to always read the instructions for use in the package leaflet and that they must never place a capsule directly into the mouthpiece;
  • continue to report adverse incidents during use of the inhaler as well as suspected adverse reactions to the medicine on a Yellow Card.

“It is essential that patients know never to place a capsule directly into the mouthpiece (see diagram in package leaflet),” said the MHRA.

Link:
MHRA alert       

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