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
