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Label Changes for:

Spiriva HandiHaler (tiotropium bromide inhalation powder)

June 2008

Changes have been made to the ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

Sections Modified

ADVERSE REACTIONS

  • ...The following adverse reactions have been identified during worldwide post-approval use of Spiriva HandiHaler:
    • application site irritation (glossitis, mouth ulceration, and pharyngolarygeal pain)

PATIENT PACKAGE INSERT

  • The following statement was added on page 1, under drug name:
    • Do Not Swallow Capsules.
      For Use With HandiHaler Only.
  • Removing a Spiriva Capsule (Figure 4):
    • Do not swallow Spiriva Capsules.

Label approved 06/20/2008 is not available on Drugs@FDA 

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