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Chemical Name: NORETHINDRONE (nor-eth-IN-drone) ACETATE and ETHINYL ESTRADIOL
(ETH-in-il es-tra-DYE-ole)
This medicine is a combination of hormones (estrogen and progestin) used to
treat menopausal symptoms (e.g., hot flashes, vaginal dryness). It is also used
to prevent bone loss (osteoporosis) in people at high risk. If you are only
being treated for vaginal menopause symptoms, products applied locally such as
vaginal creams, tablets, or rings should be considered before products taken by
mouth or absorbed through the skin. There are several medicines (e.g. raloxifene
or bisphosphonates) that are safe and effective to prevent or treat bone loss.
These medicines should be considered for use before estrogen/progestin HRT for
osteoporosis. If you have other medical conditions as well and are prescribed
estrogen/progestin HRT for more than one condition, consult your doctor about
your treatment plan and its options.
WARNING: Combination hormone replacement therapy (estrogen and progestin HRT)
should not be used to treat heart disease. Two-drug combination hormone
replacement therapy can infrequently cause cancer of the breast, heart disease
(e.g., heart attack), stroke, dementia, or blood clots in the lung (pulmonary
embolism) or leg. Estrogens may also increase the risk of cancer of the ovary.
These risks appear to depend on the length of time this combination is used and
the amount of estrogen per dose. Therefore, two-drug HRT 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. Discuss the risks and benefits with your doctor. If you use this
medicine for an extended period, you should be evaluated at least once a year.
See Cautions section. 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 also taking corticosteroids (e.g.,
prednisone), hydantoins (e.g., phenytoin), warfarin, drugs which affect certain
liver enzymes (CYP450-3A4 enzymes) such as azole antifungals (e.g., ketoconazole,
itraconazole), carbamazepine, macrolide antibiotics (e.g., clarithromycin,
erythromycin), phenobarbital, rifamycins, (e.g., rifampin), ritonavir,
cimetidine, 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 a family medical history (especially for breast lumps or cancer),
asthma, diabetes, seizures, migraine headaches, heart disease (e.g., high blood
pressure, heart attacks, congestive heart failure), kidney disease, low thyroid
hormone (hypothyroidism), abnormal calcium level in the blood, depression, high
blood pressure during pregnancy (toxemia), yellowing of the eyes and skin (cholestatic
jaundice) during pregnancy or with past estrogen use, womb problems (e.g.,
uterine fibroids, endometriosis), cholesterol or lipid problems, gallbladder
disease, excessive weight gain, certain blood disorders (porphyria), allergies,
pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you
have undiagnosed abnormal vaginal bleeding, cancer (e.g., of the breast or
ovary), blood clots, liver disease, or active/recent 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 that you may have before using this
medicine. This medicine is usually taken once daily. This medicine may be taken
with food or immediately after a meal to prevent stomach upset. TRY TO TAKE THIS
MEDICINE at the same time every day. STORE THIS MEDICINE at room temperature at
77 degrees F (25 degrees C), away from heat, moisture, and light. Brief storage
between 59 and 86 degrees F (15 and 30 degrees C) is permitted. IF YOU MISS A
DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for
your next dose, skip the missed dose and go back to your regular dosing
schedule. DO NOT take 2 doses at once.
KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine.
You should have a complete physical examination, including blood pressure
measurements, breast and pelvic examinations, and a PAP test (for vaginal
cancer), at least once a year. You should also have periodic mammograms as
determined by your doctor. Follow your doctor's instructions for examining your
own breasts, and report any lumps immediately. DO NOT INCREASE YOUR DOSE, take
this medicine more often than prescribed, or stop taking this medicine without
checking with your doctor. BEFORE YOU HAVE SURGERY, or will be confined to a
chair or bed for a long period of time (e.g., a long plane flight), tell the
doctor that you are using this medicine. Special precautions may need to be
taken in these circumstances while you are taking this medicine. THIS MEDICINE
MAY AFFECT CERTAIN LAB TEST RESULTS. Make sure your doctors and laboratory
personnel know you are using this medicine. 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. Limit alcoholic beverages. THIS
MEDICINE MAY CAUSE dark skin patches on your face (melasma). Exposure to the sun
may make these patches darker. If patches develop, consult your doctor about the
use of sunscreen or protective clothing when exposed to the sun, sunlamps, or
tanning booths. SMOKING WHILE USING THIS MEDICINE may increase your risk of
blood clots (especially in women over the age of 35). DO NOT USE THIS MEDICINE
if you are pregnant. IF YOU SUSPECT THAT YOU COULD BE PREGNANT, contact your
doctor immediately. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED IN BREAST MILK.
DO NOT BREAST-FEED while using this medicine.
SIDE EFFECTS that may go away during treatment, include dizziness,
lightheadedness, headache, stomach upset, bloating, irritability, changes in
sleep patterns, fatigue, nausea, weight changes, increased or decreased interest
in sex, or breast tenderness. If they continue or are bothersome, check with
your doctor. CHECK WITH YOUR DOCTOR IMMEDIATELY if you experience mental or mood
changes (e.g., severe depression, memory loss); calf pain or swelling; sudden
severe headache; chest pain; trouble breathing; one-sided weakness; slurred
speech; vision changes (e.g., change in contact lens fit, loss of vision);
breast lumps; swelling of hands and feet; changes in vaginal bleeding (e.g.,
spotting, breakthrough bleeding, or prolonged bleeding); unusual vaginal
discharge, itching, or odor; or yellowing of eyes or skin. 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 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.
Non-drug therapy to help prevent bone loss includes a weight-bearing exercise
plan and adequate daily calcium and vitamin D. 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. IF USING THIS MEDICINE FOR AN
EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.
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