Label Changes for:

Lamisil (terbinafine hydrochloride) Tablets and Oral Granules

November 2011

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2011

 

ADVERSE REACTIONS

Postmarketing Experience
  • photosensitivity reactions
Drug-Drug Interactions
  • ...terbinafine may convert extensive CYP2D6 metabolizers to poor metabolizer status.

PATIENT COUNSELING INFORMATION

  • Photosensitivity reactions have been reported with the use of Lamisil. Patients should be advised to minimize exposure to natural and artificial sunlight (tanning beds or UVA/B treatment) while using Lamisil
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