ol [see Warnings and Precautions (5.1)].
Fever and/or Bloody Stool
Inform the patient that AEMCOLO is not recommended for use if they have fever and/or bloody stool[see Warnings and Precautions (5.1)].
Clostridium difficile-Associated DiarrheaAdvise patients that diarrhea is a common problem caused by antibacterial drugs, which usually endswhen the antibacterial drugs is discontinued. Sometimes after starting treatment with antibacterialdrugs, patients can develop watery or bloody stools (with or without stomach cramps and fever) evenas late as two or more months after having taken the last dose of AEMCOLO. Inform the patient thatif diarrhea occurs after therapy or does not improve or worsens during therapy, patients shouldcontact their physician as soon as possible [see Warnings and Precautions (5.2)].
Important Administration Instructions
Instruct the patients that:
• AEMCOLO tablets should be swallowed whole with a full glass of liquid (6-8 ounces).
• AEMCOLO must not be taken concomitantly with alcohol.
• AEMCOLO tablets must not be chewed, crushed or broken.
• AEMCOLO may be taken with or without food.
Antibacterial Resistance
Patients should be counseled that antibacterial drugs including AEMCOLO should only be used totreat bacterial infections. They do not treat viral infections (e.g., the common cold). When AEMCOLOis prescribed to treat a bacterial infection, patients should be told that although it is common to feelbetter early in the course of therapy, the medication should be taken exactly as directed. Skippingdoses or not completing the full course of therapy may (1) decrease the effectiveness of the
immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will notbe treatable by AEMCOLO or other antibacterial drugs in the future.
Manufactured for:
Cosmo Technologies, Ltd.
Dublin, Ireland
Manufactured by:
Cosmo S.p.A.
Lainate, Milan, Italy
Made in Italy
Distributed by:
Aries Pharmaceuticals, Inc.
9276 Scranton Rd. Suite 600
San Diego, CA 92121 (USA)
888-ARIES-08 (888-274-3708)
U.S. Patents:
http://www.cosmopharma.com/activities/patents
https://www.ariespharma.com/wp-content/uploads/2018/11/1-AEM18176-NDA-210910-Approved-PI-11-16-18.pdf |
