Vivelle (Estradiol) – 8 0.1mg/24hr Patches Box
Actual product appearance may differ slightly.
Chemical Name: ESTRADIOL (es-tra-DYE-ol)
This medicine is a female hormone usually given to women who no longer produce
the proper amount. It is used to reduce menopause symptoms such as hot flashes
or vaginal dryness/discomfort or to prevent bone loss (osteoporosis) in those at
high risk. This medicine may be use to treat other conditions as determined by
WARNING: Estrogens have been reported to increase the chance of womb
(endometrial) cancer, especially in women who receive estrogen-only hormone
therapy. Estrogens may also increase the risk of cancer of the ovary.
Estrogen-containing products should not be used to prevent heart disease or
dementia. Estrogen used alone or in combination with another hormone (progestin)
can increase the risk for heart disease (including heart attacks), stroke,
serious blood clots in the lung (pulmonary embolism) or leg (deep venous
thrombosis), cancer of the breast, or dementia. These risks appear to depend on
the length of time this medicine is used and the amount of estrogen per dose.
Therefore, this medicine should be used for the shortest possible length of time
at the lowest effective dose, so you obtain the benefits and minimize the chance
of serious side effects from long-term treatment. Consult your doctor or
pharmacist for details. Some medicines or medical conditions may interact with
this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and
over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR
DOSE OR CONDITION may be needed if you are taking corticosteroids (such as
prednisone), seizure medicines (such as phenytoin, carbamazepine, or
phenobarbital), “blood thinners” (such as warfarin), certain antifungal
medicines (such as ketoconazole or itraconazole), macrolide antibiotics (such as
clarithromycin or erythromycin), cimetidine, rifampin, ritonavir, tacrine, or
St. John’s wort. DO NOT START OR STOP ANY MEDICINE without doctor or pharmacist
approval. Inform your doctor of any other medical conditions including any
personal or family history of cancer, breast lumps, clotting problems, womb
problems (such as uterine fibroids or endometriosis), heart disease (such as
high blood pressure, heart attacks, or congestive heart failure), stroke,
diabetes, cholesterol/lipid problems, gallbladder problems, low thyroid hormone
(hypothyroidism), high blood pressure during pregnancy (toxemia), yellowing of
the eyes/skin (cholestatic jaundice) during pregnancy or with past estrogen use,
depression, asthma, seizures, migraine headaches, kidney problems, abnormal
calcium level in the blood, lupus, growths on the liver, history of tobacco use,
excessive weight gain, allergies, pregnancy, or breast-feeding. USE OF THIS
MEDICINE IS NOT RECOMMENDED if you have a history of undiagnosed or abnormal
vaginal bleeding, certain types of cancers (such as breast cancer),
estrogen-dependent growths, history of blood clots or clotting problems, liver
problems, certain blood disorders (porphyria), active/recent (within the past
year) stroke or heart attack. Contact your doctor or pharmacist if you have any
questions or concerns about taking this medicine.
Follow the directions for using this medicine provided by your doctor. This
medicine comes with a patient information leaflet. Read it carefully. Ask your
doctor, nurse, or pharmacist any questions you may have about this medicine. The
patch is usually replaced twice a week (about every 3 to 4 days), or as directed
by your doctor. Follow the dosing schedule carefully. Do not open the sealed
pouch containing the patch until ready to use. Tear open the pouch (do not use
scissors) and remove the patch from the protective liner. Apply the patch to a
clean, dry, hairless area of the body as described in the patient information
leaflet or on the package. Avoid applying to an area that is oily, irritated, or
injured. Do not place the patch on the breast. Avoid applying to the waistline
since tight clothing may rub the patch off. Do not put the patch on areas where
sitting may loosen it. Do not apply to a site that is exposed to sunlight. If
you have any questions about where to apply the patch, contact your doctor,
nurse, or pharmacist for instructions. Press the patch firmly against the skin
for about 10 seconds to be sure the patch stays on. When it is time to change
the patch, remove it slowly, fold in half (sticky sides together), and dispose
of it properly. Apply a new patch to a different area to prevent skin
irritation. It is best to rotate the areas where the patch is applied, allowing
at least 1 week in between applications to the same site. If the area around the
patch becomes red, itchy, or irritated, try a new site. If the irritation
continues or becomes worse, notify your doctor promptly. Contact with water
while bathing, showering, or swimming will not affect the patch. STORE THIS
MEDICINE at room temperature below 86 degrees F (30 degrees C), in the original
sealed pouch, away from heat, moisture, and light. Use this medicine regularly
to receive the most benefit from it. Using this medicine at the same times each
week will help you to remember. IF YOU MISS A DOSE OF THIS MEDICINE, use it as
soon as possible. If a patch falls off, reapply it or apply a new patch and wear
it for the rest of the scheduled period, then resume your usual dosing schedule.
Do NOT use 2 doses at once.
DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or are
allergic to any ingredient in this product. DO NOT EXCEED THE RECOMMENDED DOSE
or take this medicine for longer than prescribed without checking with your
doctor. Laboratory and/or medical tests, including blood pressure measurements,
triglyceride blood levels, breast and pelvic examinations, PAP tests (for
cervical cancer), or mammogram may be performed to monitor your progress or to
check for side effects. Follow your doctor’s instructions for performing monthly
breast self-examinations and report any lumps immediately. KEEP ALL DOCTOR AND
LABORATORY APPOINTMENTS while you are taking this medicine. If you take this
medicine for an extended period of time, you should be evaluated regularly by
your doctor to determine if you need to continue taking this medicine. This
medicine may affect certain lab test results. Make sure laboratory personnel and
your doctors know you take this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL
TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are
taking this medicine. If you will be having surgery or will be confined to a
chair (such as a long plane flight) or bed for a long period of time, notify
your doctor beforehand. THIS MEDICINE MAY CAUSE DIZZINESS. DO NOT DRIVE, OPERATE
MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you
react to this medicine. Using this medicine alone, with other medicines, or with
alcohol may lessen your ability to drive, or to perform other potentially
dangerous tasks. THIS MEDICINE MAY CAUSE dark skin patches on your face (melasma).
Exposure to the sun, sunlamps, or tanning booths may make these patches darker.
Use a sunscreen or protective clothing if you must be outside for a prolonged
period. THIS MEDICINE MAY CAUSE HYPERGLYCEMIA (high blood sugar). Symptoms of
hyperglycemia include thirst, increased urination, confusion, drowsiness,
flushing, rapid breathing, or fruity breath odor. If these symptoms occur, TELL
YOUR DOCTOR IMMEDIATELY. SMOKING WHILE USING THIS MEDICINE may increase your
risk of stroke, heart attack, blood clots, high blood pressure, or other
diseases of the heart and blood vessels. BEFORE YOU BEGIN TAKING ANY NEW
MEDICINE, either prescription or over-the-counter, check with your doctor or
pharmacist. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY OR IN
CHILDREN because they may be more sensitive to the effects of this medicine.
Growth patterns in children should be monitored as this medicine may affect
their growth. FOR WOMEN: DO NOT USE THIS MEDICINE if you are pregnant. IF YOU
SUSPECT THAT YOU COULD BE PREGNANT, contact your doctor immediately. THIS
MEDICINE IS EXCRETED IN BREAST MILK. IF YOU WILL BE BREAST-FEEDING while you are
taking this medicine, check with your doctor or pharmacist to discuss the risks
to your baby. IF YOU HAVE DIABETES, this medicine may affect your blood sugar.
Check blood sugar levels closely and ask your doctor before adjusting the dose
of your diabetes medicine.
SIDE EFFECTS, that may go away during treatment, include dizziness, headache,
breast pain or tenderness, or skin redness/irritation at the application site.
If they continue or are bothersome, check with your doctor. CHECK WITH YOUR
DOCTOR AS SOON AS POSSIBLE if you experience stomach upset, pain, or bloating;
persistent nausea; vomiting; unexplained weight changes; unusual vaginal
discharge/itching/odor; increased/decreased interest in sex; or hair loss.
CONTACT YOUR DOCTOR IMMEDIATELY if you experience mental/mood changes (such as
severe depression, memory loss, or confusion); severe dizziness or fainting;
sudden severe headache; one-sided weakness; slurred speech; vision changes (such
as a change in contact lens fit, loss of vision, or double vision); chest pain;
shortness of breath; pain or swelling of the hands, legs, or feet; calf pain,
swelling, or tenderness; breast lumps; nipple discharge; changes in vaginal
bleeding (such as spotting, breakthrough bleeding, or prolonged bleeding);
seizures; yellowing of eyes or skin; irregular heartbeat; or muscle cramps. AN
ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical
attention if it occurs. Symptoms of an allergic reaction include rash, itching,
swelling, severe dizziness, or trouble breathing. If you notice other effects
not listed above, contact your doctor, nurse, or pharmacist.
Drug interactions can result in unwanted side effects or prevent a medicine from
doing its job. Use our drug interaction checker to find out if your medicines
interact with each other.
If you take too
If overdose is suspected, contact your local poison control center or emergency
room immediately. Symptoms of overdose may include severe nausea and vomiting
and excessive vaginal bleeding.
It is important that you and your physician regularly re-evaluate your need for
this medicine. Non-drug therapy to help prevent bone loss includes a
weight-bearing exercise plan, as well as adequate daily calcium and vitamin D
intake. Consult your doctor or pharmacist for more details. DO NOT SHARE THIS
MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE
for other health conditions. KEEP THIS MEDICINE out of the reach of children and
pets. AFTER REMOVING THE USED PATCH, fold over with the sticky side together.
Discard the patch out of reach of children and pets. IF USING THIS MEDICINE FOR
AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.