COMBIPATCH® IMPORTANT SAFETY INFORMATION
INDICATION
COMBIPATCH® (estradiol/norethindrone acetate) transdermal system is a prescription medicine used to treat moderate to severe hot flashes associated with menopause; treat moderate to severe dryness, itching and burning in or around the vagina associated with menopause; 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 estrogen alone or estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function)
- Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
- Using estrogen alone or estrogens with progestins may increase your chance of getting dementia, based on a study of
women 65 years of age or older.
- Using estrogen-alone may increase your chances of getting cancer of the uterus (womb)
- Using estrogen-alone may increase your chance of getting stroke or blood clots
- You and your healthcare provider should talk regularly about whether you still need treatment with COMBIPATCH.
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, blood clots, or liver problems; had a stroke or heart attack; have been diagnosed with a bleeding disorder; are allergic to COMBIPATCH or any of its ingredients; or think you may be, or know that you are, pregnant.
Before you take COMBIPATCH, tell your healthcare provider if you have unusual vaginal bleeding, have any other medical conditions, are going to have surgery or will be on bed rest, are breast feeding, and about all of the medicines you take.
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.
The most common side effects that may occur with COMBIPATCH are breast pain, vaginal bleeding, and headache. These are not all the possible side effects of COMBIPATCH.
Click here for the Full Prescribing Information, including Boxed WARNING for CombiPatch.
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.
CombiPatch® is a registered trademark of Noven Pharmaceuticals, Inc.
MINIVELLE® (estradiol) transdermal system
INDICATION
MINIVELLE® (estradiol) transdermal system is a prescription medicine patch that contains estradiol (an estrogen hormone). MINIVELLE is used to reduce moderate to severe hot flashes due to menopause and to help prevent postmenopausal osteoporosis (thin weak bones). The 0.025 mg/day dose is only approved for the prevention of postmenopausal osteoporosis.
If you use MINIVELLE only to prevent osteoporosis from menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you.
IMPORTANT SAFETY INFORMATION
- Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using MINIVELLE. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
- Do not use estrogen-alone or estrogen with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function).
- Using estrogen-alone may increase your chances of getting strokes or blood clots, while using estrogens with progestins may increase your changes of getting heart attacks, strokes, breast cancer, or blood clots.
- Using estrogen-alone or estrogen with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older.
- You and your healthcare provider should talk regularly about whether you still need treatment with MINIVELLE
MINIVELLE should not be used if you have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack, currently have or have had blood clots, currently have or have had liver problems, have been diagnosed with a bleeding disorder, are allergic to MINIVELLE or any of its ingredients, or think you may be pregnant.
Before you take MINIVELLE, tell your healthcare provider if you have unusual vaginal bleeding, have any other medical conditions, are going to have surgery or will be on bed rest, are breast feeding, and about all of the medicines you take.
MINIVELLE should be used at the lowest effective dose and for the shortest duration consistent with your treatment goals and risks. You and your healthcare professional should talk regularly about whether you still need treatment with MINIVELLE.
The most common side effects that may occur with MINIVELLE are headache, breast tenderness, back and limb pain, common cold, upset stomach,
nausea, inflammation of the sinuses and irregular vaginal bleeding or spotting.
These are not all the possible effects of MINIVELLE. Please read the Patient Information section within the full Prescribing Information before taking MINIVELLE. For more information ask your healthcare provider or pharmacist for advice about side effects.
Click here for the full Prescribing Information, including Boxed WARNING.
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.