Information for Patients: A patient instruction sheet is included in
the package of fentanyl transdermal systems dispensed to the patient.
Patients receiving fentanyl transdermal system should be given the following
instructions by the physician:

4. Patients should be advised that fentanyl transdermal system should be applied
immediately upon removal from the sealed package and after removal of the
protective liner. Additionally the patient should be advised of the following :
" The fentanyl transdermal system should not be used if the seal is broken,
or if it is altered, cut, or damaged in any way prior to application. The
transdermal patch should be pressed firmly in place with the palm of the
hand for 30 seconds, making sure the contact is complete, especially
around the edges"  The patch should not be folded so that only part of the patch is exposed.

PROPOSED PRECAUTIONS:

Information for Patients : A patient instruction sheet is included in
the package of fentanyl transdermal systems dispensed to the patient.
Patients receiving fentanyl transdermal system should be given the following
instructions by the physician: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4 . Patients should be advised that fentanyl transdermal system should be applied
immediately upon removal from the sealed package and after removal of the
protective liner. Additionally the patient should be advised of the following :
" The fentanyl transdermal system should not be used if the seal is broken,
or if it is altered, cut, or damaged in any way prior to application. The
transdermal patch should be pressed firmly in place with the palm of the
hand for 30 seconds, making sure the contact is complete, especially
around the edges.
" The patch should not be folded so that only part of the patch is exposed.

" Fentanyl transdermal system may not stick to all patients. Ifthe patch does
not stick well or comes loose after applying, Mti-lan's fen.tanyl tran5dermal
system may be secured with a Bioclusive"'~ dressing to help maintain
adhesion. If the patch falls off, throw it away and put a new one on at a
different skin site.

Source: May 25, 2006 Mylan Letter to FDA regarding Mylan Fentanyl Transdermal System 

Mylan Fentanyl Patch - Attachment B to FDA and Part 1 

Mylan Fentanyl Patch - Letter to FDA - Attachment B Part 2