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Label Changes for:

Jalyn (Dutasteride and Tamsulosin Hydrochloride) Capsules

April 2013

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2013

 

CONTRAINDICATIONS

  • Patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema, urticaria, pruritus, respiratory symptoms) to Dutasteride, other 5 alpha-reductase inhibitors, tamsulosin, or any other component of JALYN.
 
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