Products - CombiPatch™

CombiPatch^® (estradiol/norethindrone acetate)

First U.S. Combination Patch

Another of Noven’s advanced menopausal hormone therapies is a combination patch containing estradiol and a progestogen, norethindrone acetate (NETA). It was the first combination transdermal therapy system approved for marketing by the FDA. It has also been approved for the same indication by regulatory authorities in over a dozen foreign countries. Novogyne Pharmaceuticals presently markets the product under the brand name CombiPatch^® in the United States. Novartis markets the product under the name Estalis^® internationally.

INDICATION
CombiPatch is used after menopause to: reduce moderate to severe hot flashes; treat moderate to severe dryness, itching and burning in or around the vagina; and treat certain conditions in which a young woman’s ovaries do not produce enough estrogens naturally. If you use CombiPatch only to treat your dryness, itching and burning in or around the vagina, talk with your healthcare professional about whether a topical vaginal product would be better for you.

IMPORTANT SAFETY INFORMATION

Do not use estrogens and progestins to prevent heart disease, heart attacks, strokes or dementia (decline in memory and thinking skills). Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots, and may increase your risk of dementia.

Do not use CombiPatch if you have had your uterus removed (hysterectomy). CombiPatch should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the breast or uterus; had a stroke or heart attack in the recent past (for example, in the past year); currently have or have had blood clots; currently have or have had liver problems; or think you may be, or know that you are, pregnant.

The most common side effects that may occur with CombiPatch are breast pain, vaginal bleeding, and headache.

You and your healthcare professional should talk regularly about whether you still need treatment with CombiPatch and whether you are taking the lowest dose that works for you.

Click here for the Full Prescribing Information, including Boxed WARNINGS, for CombiPatch.

Available by prescription only.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information on CombiPatch^®, please visit www.combipatch.com

For patient and physician inquiries
regarding CombiPatch^®, please contact:

Customer Interaction Center
Novartis Pharmaceuticals Corporation
One Health Plaza
Building 122
East Hanover, New Jersey 07936
Ph: 888-669-6682
Fax: 973-781-3115
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