Drug Information for Vagifem (estradiol vaginal tablets) Initial U.S. Approval: 1999 (Novo Nordisk): 17 PATIENT COUNSELING INFORMATION

[See Section 17.5 FDA-APPROVED PATIENT LABELING]

Inform postmenopausal women of the importance of reporting vaginal bleeding to their healthcare provider as soon as possible [see Warnings and Precautions (5.3)].

Inform postmenopausal women of possible serious adverse reactions of estrogen therapy including Cardiovascular Disorders, Malignant Neoplasms, and Probable Dementia [see Warnings and Precautions (5.2, 5.3, 5.4)].

Inform postmenopausal women of possible less serious but common adverse reactions of estrogen therapy such as headache, breast pain and tenderness, nausea and vomiting.

Step 1: Tear off a single applicator.

Step 2: Separate the plastic wrap and remove the applicator from the plastic wrap as shown in Figure A.

Step 3: Hold the applicator so that the finger of one hand can press the applicator plunger as shown in Figure B.

Step 4: Next select the best position for vaginal insertion of Vagifem (estradiol vaginal tablets) that is most comfortable for you. See suggested reclining Figure C or standing Figure D position illustrated below:

Step 5: Using the other hand, guide the applicator gently and comfortably through the vaginal opening (see Figures C and D above). If the tablet has come out of the applicator prior to insertion, do not attempt to replace it. Use a fresh tablet-filled applicator.

Step 6: The applicator should be inserted (without forcing) as far as comfortably possible, or until half of the applicator is inside your vagina, whichever is less.

Step 7: Once the tablet-filled applicator has been inserted, gently press the plunger until the plunger is fully depressed. This will eject the tablet inside your vagina where it will dissolve slowly over several hours.

Step 8: After depressing the plunger, gently remove the applicator and dispose of it the same way you would a plastic tampon applicator. The applicator is of no further use and should be discarded properly. Insertion may be done at any time of the day. It is advisable to use the same time daily for all applications of Vagifem (estradiol vaginal tablets). If you have any questions, please consult your healthcare provider or pharmacist.